Synthetic Biologics (SYN) is a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses. The company’s lead candidate, Trimesta, a synthetic DNA-based therapy for pulmonary arterial hypertension,  is doing particularly interesting things in Alzheimer’s Disease and related illnesses. Below, OneMedRadio interviews CEO Jeff Riley.

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, we’re joined by Jeff Riley, CEO of Synthetic Biologics, an East Coast-based biotechnology company developing DNA-based therapeutics and disease-modifying medicines for serious illnesses. Synthetic Biologics trades on the AMEX under the symbol SYN. Mr. Riley, thank you for joining us.

Jeff Riley:    Hey Matt, thanks. It’s a pleasure to be here.

MM:     So let’s start with the discussion of your R&D. So what’s your lead candidate? How does it work?

JR:     Matt, I’d love to do so. We basically have three products that are at the clinical stage of development. The one that we’re no longer heavily involved in is for fibromyalgia. It’s called Flupertine, and that was partnered in 2010 with Meda, a Swedish drug company.

So we focus on our other two products that are in-house and that we’re moving forward. One is for multiple sclerosis that is called Trimesta. We just completed the 164-patient relapse and remitting trial enrollment of patients. It’s being run out of UCLA by Rhonda Voskuhl, and we expect to have information data from that Phase II trial some time in early 2014. We are also in the process of enrolling another 60 patients for cognitive dysfunction, also in multiple sclerosis in women, and that trial should begin shortly as well.

Our other product, which is very exciting is the zinc acetate formulation and it’s specifically for Lou Gehrig’s disease or ALS. The Phase I trial of that is going to begin in about 2 weeks, and we’ll roll into a Phase II/III trial by third quarter of this year. We’re hoping for data from that Phase II/III trial in first quarter or potentially even second quarter of next year, 2013. Again, there’s really no therapies for ALS, Lou Gehrig’s disease at this point in time, so we feel very, very good that if this product does show efficacy, which has pre-clinically looked like it’s going to do very well, we’ll have something that can help patients substantially. So they’re already in the pipeline.

MM:     And what specifically do you think makes your unique formulation for ALS opportunistic?

JR:  I don’t know if it’s opportunistic. I think there’s a fair amount of data that’s been out in the public demand with respect to zinc and how zinc functions as it relates to copper, especially in central nervous system disorders, Alzheimer’s, Parkinson’s, Lou Gherig’s disease. So the mechanism of action is essentially trying to balance the amount of copper in an individual’s brain when they get an amount of zinc that actually pulls copper. It is complementary to some extent pulling copper from the brain. There’s a bit of a balancing act there, but the theory in the science we had is very solid so we were following on years and years of research to see whether or not we can show that this works in patients.

MM:   So in your opinion, why is there resurgence in gene medicine?

JR:  We call it Gene Medicine 2.0, and in November of last year, we decided to change directions a little bit in the company, and going forward, focus heavier on biologics, which is why we renamed the company Synthetic Biologics. Gene Medicine is, I think, coming into its own similar to monoclonal antibodies and other therapies over the years, in particular, biologics. It really does take 15 to 20 years of hard academic and rigorous research to get a set-up technology or a set of products to a point where you could do the translational work, put those in the humans, and see exactly what’s going to happen.

About 10, 12 years ago, Genome Therapy 1.0 was very famous. Several companies raised billions of dollars. The result was that it was not ready for primetime. It was a little bit premature, and basically, gene therapy dropped off the face of the planet.

Big pharmacies decided to abandon those areas, not all of them, but most of them, and [were] de-prioritized within the discovery functions in these companies.

However, the last 10 years, there’s been a lot of progress made, and I think you’re going to see a resurgence because a lot of the issues from delivery to immunogenicity have been overcome by a lot of great academic research, and we felt that the time is right, and the inflection point was right for attempting it, in particular, small company like us to jump into that world, build a theme around that, and begin to pull these products into the clinic.

MM:     So I wonder if we could circle back to your company re-branding, your recent changes. Maybe you can introduce us to the recent management changes.

JR:     You bet. So I was chairman of the – I became chairman of the company in November, and I took the CEO role in February of this year.

We also hired John Monahan as our chief science officer. John is one of the foremost experts in the gene therapy area. He was also the founder and CEO of the company called Avigen, which was one of the bigger gene therapy companies 10, 12 years ago. It reached the market cap of $2 billion and then crashed back to earth at a later date. It was acquired by somebody else, a fantastic individual, very, very, very knowledgeable about the gene therapy space.

We’ve also hired recently a gentleman named Evan Valentine. Evan was the Chief Financial Officer for Clinical Data, where he was for 5 years, and it successfully sold that company last year in 2011 for $1.3 billion. That was an R.J. Kirk company, and we’ll get to that shortly I think when we talk a little bit about our partner in strategies with privately-held company Intrexon.

We’ve also hired Michael Calico who used to be at Novartis. He ran Novartis’ gene ocular programs. And we continue to fill out the rest of the team with press releases over the next few weeks. You’ll see filling in with the Chief Clinical Officer as well as, you know, VP of Regulatory goals in addition to what we currently have. So you’ll see a team that’s very focused on the products that we have today from the clinical development perspective, but more importantly, look into the future at biologics and more specifically gene medicine. This team will be one of the best teams out there as far as knowing how to take a product from I&D on through.

MM:   And you were eager to discuss your collaboration with Intrexon Corporation. In late March 2012, you announced your Q1 earnings and one major highlight was the execution of this collaboration that occurred in Q4 of 2011. So I was wondering if you could go into a little detail about this company milestone.

JR:   You bet. Alot of folks in the industry, in particular, on the banking side, know a name Randall J. Kirk, also known as R.J. Kirk. This gentleman was very prolific in the biotech and pharma industries with respect to M&A and building companies. His mantra tends to be, you know, he’s going to buy into a company, he’s going to build the company, he doesn’t sell his stock, and he gets the company to a point where there’s a value inflection point, and an M&A transaction occurs. He was involved with General Injectables, Ziospharma, King Pharmaceuticals, New River was his company. And most recently, no the public side, his company was Clinical Data. I’ve hired his ex-Chief Financial Officer recently for our company.

And during that time period, he’s also started and is now very focused on a company called Intrexon, which is a privately-held company with roughly 300 employees in it. It is focused entirely on DNA therapies, the platforms within DNA therapies as well so based treatments, stem cells, you name it. If it’s biologic, he’s been going out looking at platforms and acquiring those who’re building a platform-based company around those technologies. So we were very pleased back in November, late November of last year when we were able to get a deal done with his company, which was announced. It was specifically around one indication to begin with. We hope to expand that collaboration over the next couple of months, but the initial collaboration is around pulmonary arterial hypertension, and we’re using the real switch technology in addition to our expertise.

The two teams are working together to move this further pre-clinical studies and hopefully into the clinic.

MM:      So maybe you can go into some detail about pulmonary arterial hypertension, and specifically, what the market opportunity is there.

JR:    PAH is a nasty disease. Basically, the thickening of the arteries that lead, from the lung to the heart and back. It’s a deadly disease, life span 3 to 5 years after contracting this disease. There are some pretty good therapies out there today, everything from Viagra, which is used to help expand that area in a pinch to some of the prostacyclins, and there’s a variety of companies playing in this area. One of the downsides is that most of the therapies including prostacyclin, there is a dose limiting issue, in that you can’t give a patient too much of that without an adverse reaction.

So with gene therapy, the goal is to try and get the DNA directly into the cells that are at the location of the disease stage itself, so in the pulmonary arteries, where we will then be able to activate those genes to produce the proteins, to produce the prostacyclin, and the theory is that we will be able to get a much higher amount of the product locally at the place where it needs to be with a much lower systemic side effect profile, which will obviously benefit patients greatly. They don’t have as much side effects, but they have the drug that they need to have at that location, so hopefully eliminate the disease state.

MM:  Now I want to circle back to your in-house pipeline. So can you go into some detail about your approval calendar for Trimesta and your ALS formulation?

JR:   We briefly touched on it earlier for the Trimesta for the MS drug. We’re looking at getting Phase II data early next year or early – I’m sorry – early in 2014. Thereafter, we’ll have to look at what the trial date is. It is a pretty big trial, 165 patients, 164 patients. We’ll have to get together with the FDA and see what we need to do for registration trial. After that, the endpoints are such – keep in mind, there are two MS trials we’re running; one for cognition and one for relapse-remitting MS, and we don’t have a clear picture on if we can accelerate the process after that trial or not. So I can’t give you a clear definitive answer on that per MS specifically.

For Lou Gehrig’s disease and the zinc formulation, that – We know pretty closely what we need to do with that. The Phase I will begin shortly. We’ll go into a Phase II/III later this year, and probably by this time next year, 2013, we will have results from the Phase II/III trial. Again, we’ll have to go to the FDA and talk to them to find out exactly what we needed to do, whether that data is sufficient to be registration file or whether we need to do another Phase III. So again, that’s a much shorter timeline than Trimesta, but again, the market is not as big for Lou Gehrig’s disease as it is for multiple sclerosis.

MM:  And lastly, what opportunities do you see for Synthetic Biologics going forward and what are your key strategies to build shareholder value?

JR:    Going forward, we’re looking at obviously doing the basic blocking and tackling on our existing programs and moving those forward as aggressively as we can. In addition to that, we are very active on the business development front. We are looking at a variety of programs in the gene therapy and cell-base therapy biologics areas, and we will be pulling programs into the company over the next 4 to 6 months. In addition to that, we will probably expand our relationship with Intrexon. Those are in discussions now, and you know, we hope to have a very robust pipeline from discovery stage, pre-clinical stage programs, all the way up to Phase III within the next year or so.

MM:   That was a company snapshot with Jeff Riley of Synthetic Biologics, trading on the AMEX under the symbol S-Y-N. This is Matt Margolis of OneMedRadio signing off.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/04/GENE-THERAPY.jpg

OneMedRadio had the pleasure of interviewing Dr. David LaBorde of Iconic Data, an Atlanta-based healthcare IT startup that came out of Healthbox, the business accelerator for health tech startups launched by Chicago-based VC firm Sandbox Industries.

The company’s lead product,  SwiftPayMD is a recently launched mobile app for iPad and iPhone that helps doctors work more efficiently when seeing patients at the hospital. It allows doctors to immediately submit patient diagnosis and billing information to their home office from the hospital via speech. Essentially, it replaces the paper billing cards that doctors use in hospitals which can create medical errors by being illegible or becoming lost or damaged. With traditional paper billing cards, physicians can also lose up to 10% of their revenue due to charges not being accounted for at the point of care.

Dr. LaBorde has over 14 years of healthcare experience. He is a Yale M.D., a Harvard M.B.A., and a Georgia Tech engineer. He spent 6 years in neurosurgery and previously worked in management consulting at McKinsey & Co and healthcare investment banking at Goldman Sachs and Merrill Lynch.

Matthew Margolis:    Greetings from OneMedRadio. I’m Matt Margolis. Today, we’re speaking with Dr. David LaBorde, co-founder and CEO of Iconic Data, a healthcare IT and mobile solutions company. Iconic Data produces SwiftPay MD, a secure mobile charge capture app used by private practice physicians for hospital billing. Thank you for joining us, Dr. LaBorde.

Dr. David LaBorde:    Thank you. It’s a pleasure to be here.

MM:       Today, we’re going to talk about the e-health boom and specifically why physician-centric management tools are so important to the improvement of healthcare, but first, let’s learn a little bit more about Iconic Data. What makes you guys unique?

DB:      At Iconic Data, we are bringing to market SwiftPayMD, which is a unique charge capture solution aimed at solving what we call a $6B problem that results from lost charges that go uncaptured by physicians providing services in the hospital but billing for those services in their office. Our solution is unique compared to our competitors because we are focused on being integration light, being easy to use, and really being a solution that a physician can simply subscribe to and go live. Their practice can go live literally with very simple steps carried out online.

Our competitors tend to be much more integration heavy. They require lengthy implementations to get going. These are associated with significant upfront costs and quite frankly, the solutions are difficult to use by the docs. They are dependent on significant manual data entry via a small device, you know, for example an iPhone. We’ve just found that taking that approach isn’t one that meets with success. Anything that interrupts the physician’s workflow and causes them to spend more time than status quo just really falls on deaf ears.

MM:    And this seems like such a simple concept and the layman might think it could have been implemented years ago when the healthcare providers first moved to the computer for example. So why would this solution not have worked five years ago? Why does it work now?

DB:  It’s a great question. It’s one of the theses of our sort of basis for moving into this business at this time, and that is specifically that as of 2012, more than 80% of physicians are now on smart phone devices and are comfortable using them in their clinical day-to-day activity. We believe that that is a significant transition for the industry and one of the enablers that have allowed for solutions like SwiftPayMD to now come to the fore and really have a go at making healthcare all it can be, much more efficient, and really help physicians run their practices more efficiently.

MM:       So you mentioned a little bit about how the physician community is accepting smart phones and etc. I was curious if you could talk a little bit about how this community is also accepting Iconic Data and SwiftPay MD.

DB:    We’ve really gotten a great response from our end users about our approach to doing what we do, essentially helping them capture charges and helping them post those charges in a shorter time period; essentially immediately in real time. We have a very simple interface that allows the physicians to create bills by simply speaking into their device. We typically talk about three simple steps, touch, talk, done. They can append to that bill a face sheet and a photograph or picture of some other source of patient demographics. That might be a patient wristband or a patient demographic sticker from the hospital. By allowing them to do this, they’re able to actually capture that information much more quickly, much more efficiently, and not be tagged with the responsibility of delivering that information to their office. As soon as they’re done, that bill is waiting on their biller’s desk to be posted into their practice management claim submission solution. That alone can result in much higher charge capture rates and significantly reduced days in receivables.

MM:    And how do you guys market yourself? I mean how do you after the physician community?

DB:    We are going to market with a channel partner strategy and so we are building relationships with organizations that already have deep and trusted relationships with physician practices across the United States. This would include the physician outsourced billing services providers, practice management consultants, the technology advisory services providers that have helped physician practices get on to electronic medical record systems. We also think that professional associations will be very meaningful channel partners for us. This includes associations for not only physicians but also the administrators that run their practices.

MM:   I want to shift gears a little bit to the concept of the e-health boom. How soon do you think it’s going to be until every single nurse, every single physician has a tablet in their hand?

DB:      Yeah, I think, you know, probably within the next five years, we’ll see a significant change in the way care is provided and the role of smart phones and tablets. I mean this is something that we see changing rapidly every day as we look at the last five years in the adoption. I mean there has really been, you know, exponential growth in how providers in healthcare organizations are adopting smart phone devices. I think everyone wants to be smart about it. Everyone wants to make sure that the appropriate policies and procedures are in place to ensure security of the information that goes on to these devices. But I think they’re really going to change the way healthcare is delivered.

MM:   Now every single sector seems to be sprinting towards digital tools that make communication with clients more substantive and more efficient, but why has the healthcare complex been so notoriously sluggish?

DB:    I think healthcare has suffered a lot from the legacy situation being that much of the automation in healthcare has developed historically around the payer side of things and getting claims submitted but not around clinical operations. So healthcare has for years been a paper-driven business and when you’re a paper-driven business, you don’t have structured data that enables a more sophisticated functionality with the information that’s being captured and logged at various points of care. Without being able to analyze data and leverage IT to, you know, provide the ability to know when a certain communication might be appropriate to occur, for example, you’re crippled and really that’s the problem that healthcare has been dealing with for decades; the fact that it is a paper-driven business.

Now with the meaningful use incentives and the adoption of EMRs and EHRs plus the now, you know, newer phenomenon of adoption of smart phones and tablets with the introduction really driven by Apple and their rolling out the iPhone and iPAD, things have changed [so] significantly that we’re going through a paradigm shift. I think that is a paradigm shift that will be for the better, but it won’t be without pain. That pain is primarily the older physicians in healthcare are somewhat more resistant to adopting technologies and that’s one of the things that — Apple has really been one of the first companies that have changed this because they’ve made it easy for the doctors to do. I think as that sort of movement continues, we’ll start to see some very interesting times in healthcare as the older physicians transition out and the newer more tech savvy physicians come in. I think we’ll really see some changes over the next 5 to 10 years around how healthcare is delivered.

MM:    Now, you’ve reported that physicians lose $6B of charges each year so I’m curious what insurance companies have been saying about SwiftPay MD as well as the prospect of gaining back $6B in charges.

DB:    Well as you can imagine, payers they want to compensate physicians for the work they do. They want to make sure they’re not overpaying and so I think one of the very exciting things about SwiftPayMD and our value proposition is we actually provide an opportunity for more accurate coding because we’re moving the actual charge capture closer to the billable episode of care. I think that insurance companies ultimately in the long run are going to benefit from solutions like SwiftPayMD because they will be able to more effectively understand the risk profile of their members and in doing so be better positioned to enroll them in wellness programs. So that’s actually something that we are very excited about. Certainly, no one wants to pay more of the premium revenue out on the payer’s side. But we actually see our solution as an opportunity to help payers better risk stratify their member population so that they can more appropriately price their premiums in addition to having the long-term benefit for the patient. Because the patient then can be appropriately enrolled in wellness programs and better manage their health.

MM:     What is your relationship with the regulatory bodies?

DB:      Well SwiftPayMD as a healthcare information technology solution, you know, it is subject to the same rules and regulations that any entity that deals with the protected health information is subjected to. So I wouldn’t say that we have any specific relationship with regulatory bodies, but we’re required to abide by the same rules and regulation.

MM:   And then what about the concept of hospitals and practices that can’t necessarily afford these kinds of subscriptions, do you have any plans to kind of roll them out to free clinics and philanthropic efforts like that?

DB:   The beautiful thing about SwiftPayMD and one of the theses of our value proposition is simply by capturing one or two lost charges[per physician], organizations using SwiftPayMD can already break even on the cost and so we think that the ROI on adopting SwiftPayMD is significant potentially, especially in those clinics and organizations that are struggling around capturing all the charges. So the great thing about our business is it pays for itself several fold and we are working on a handful of case studies that really will help us; we believe that they will be able to illustrate this very poignantly and that the prospect of a community healthcare center adopting this makes sense because it makes them capture more revenue and actually improves their financial performance despite the financial outlay to purchase our solution.

MM: So lastly, I want to circle back to your company growth efforts. What does the future hold in store for Iconic Data?

DB:   We’re very excited about the coming years. We think that we have an innovative solution that is very different from our competitor’s offering and first and foremost, it’s easy for the physicians to use. We think that will enable our channel partners to help us grow our business in a significant way. So we are very excited about the prospect of the coming several quarters.

MM:   That was a company snapshot of Iconic Data with co-founder and CEO Dr. David LaBorde. This is Matthew Margolis with OneMed Radio signing off.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/05/swiftpay.jpg

In this special series we present emerging technologies which hold the promise to significantly improve the prognosis of patients diagnosed with prostate cancer, and cancer in general. Each day we will showcase a new emerging company, providing an eloquently detailed description of the intriguing technology. The goal of this series is to deeply investigate the unique technology that may soon change the mainstream approach to prostate cancer. At the end of the week, we will publish all treatments together.

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The prostate is a component of the male exocrine gland system that is essential for normal reproductive function. Secretory fluid produced by the prostate physiologically supports male gamete cells to successfully achieve conception.

In medicine, prostate cancer is the most common cancer found in the male population, afflicting one in six men. It is the second leading cause of cancer-based deaths amongst men in the US . Malignancy of the prostate has profound health consequences, including urinary dysfunction, pelvic pain, and erectile dysfunction ^4-6. The disease rarely presents under the age of 40, making age the most significant risk factor – the longer life expectancy of men and the high morbidity/mortality observed makes prostate-cancer a high need condition.

Although there are several treatment options available for patients diagnosed with progressive prostate cancer, the currently used modalities of treatment have important limitations ^7,8.

Surgical intervention – such as prostatectomy – comes with the normal risks associated with surgery, as well as the possibility of resultant erectile and urinary dysfunction.

Radiotherapy such as XRT (external radiation therapy) and brachytherapy provide localized radiation to the prostate that can salvage surrounding healthy tissue, but is often associated with urinary urgency and frequency, painful urination, and rectal inflammation.

Androgen deprivation hormone therapy, which includes the newly approved drug Abiraterone, provides a pivotal treatment regimen to inhibit the progression of advanced prostate cancer, but results in serious side effects that include cardiovascular disease, osteoporosis, cognitive deficits, and insulin resistance.

Chemotherapy, which includes the newly approved drug cabazetaxel, is important for treating refractory prostate cancer, but does not salvage healthy tissue and includes significant side effects, such as blood cell suppression and peripheral neuropathy.

Therefore, there remains a high-need for a broad-based therapeutic regimen to treat prostate cancer with minimal side effects.

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Inovio Pharmaceuticals is an emerging leader in the development of powerful therapeutic DNA vaccines that serve to actively induce a potent immune system response against and for the treatment of infectious diseases and cancer. DNA vaccines function by expressing the genetic material for a specific disease-marker, or antigen, in conjunction with a known immune adjuvant within the cells of the patient. Expression of the antigen/adjuvant by the patient’s cells mounts an acute immune response against the disease that serves to treat the condition by decimating the afflicted cells. DNA vaccines are the next generation of vaccine technology providing significant improvement over the attenuated pathogen protein-based vaccines conventionally used. Unlike their older counterparts DNA vaccines provide scalable production capabilities, increased shelf life stability, increased safety profile with no risk of causing the disease, and most importantly, mounts an immune response that provides the protective immunity seen with today’s vaccines, as well as therapeutic treatment of the ongoing disease.

Although DNA vaccines hold the potential to serve as breakthrough therapies for high-need unmet medical conditions, their clinical development has been hampered by significant obstacles. Two principle challenges have been the efficient transfer of the DNA vaccine into the cell of the patient and the development of vaccines that can mount an immune response against the different strains of an individual virus. To this end, Inovio has developed breakthrough, proprietary DNA vaccine design and DNA delivery platforms. The companies SynCon-DNA vaccine design technology utilizes bioinformatics, extensive genetic data, sophisticated mathematical algorithms and ultra-powerful computing to develop vaccines that are competent to mount an immune response against different viral sub-types of a given virus family. In pre-clinical studies Inovio has shown that its SynCon DNA vaccine design is able to elicit an immune response against multiple sub-types of HIV, HCV, HPV or influenza virus.

To deliver its DNA vaccines, Inovio employs its Electroporation DNA delivery platform. This technology works by applying controlled, millisecond electrical pulses across the injection site where the DNA vaccine is being administered. The electrical pulses create a huge increase in the permeability of the cells at the injection site enabling a dramatic uptake of the DNA vaccine that was previously not possible. Furthermore, the electorporation itself serves as an immune adjuvant that enhances the response by the immune system. In pre-clinical and clinical studies Inovio has shown that in comparison to injection alone, electroporation increases expression of the vaccine by over 100-fold and develops an immune response that is approximately 100-fold stronger. Electroporation has been shown to be tolerable without anesthetic, cost effective in manufacturing processes, and does not elicit unwanted side effects thereby enabling repeated use for administration. Taken together, Inovio’s proprietary DNA vaccine design and delivery platform poises the company at the forefront of clinically actualizing this therapeutic modality. Inovio’s DNA vaccine indicated for the treatment of prostate cancer is currently in Phase I clinical trials.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/05/man.jpg

The final interview in our MPR series is with Leon Marucchi, Director of Industrial Design and Katie McHugh, a design engineer at the international consulting firm. Below they discuss concurrent design and design from manufacture and the tremendous value it provides in bringing a device to market.

Click below to hear full audio interview and see transcript that follows.

Brett Johnson:           Welcome from New York, Brett Johnson with OneMedRadio. Today, we are with Leon Marucchi who is the director of industrial design and Katie McHugh who is a design engineer at the international consulting firm of MPR Associates as part of our expert series on compressing the time to bring in new medical device to market. MPR has been in this business since the late ‘60s and have brought numerous devices to market. Today, we’re talking about concurrent design and DFM or design from manufacture and the value that it can provide in accelerating this process. Thanks for joining us today.

Leon Marucchi:     Good to be here, Brett.

BJ:          So Katie, why don’t we start with you? What is concurrent design exactly and what are its advantages?

Katie McHugh:           Well, in a concurrent design process, you bring together a team that has different skills in different areas. So you’re working with people who have skills in creative design and design engineering and also in manufacturing and assembly so they can work together to make sure that each of these areas are considered from the beginning so that you can anticipate problems and resolve those earlier in the design process.

BJ:         What is the difference between what an industrial designer does and what a design engineer does?

LM:     Well the difference is, the industrial designers really focus on the user’s needs. We really need to investigate and talk to the key opinion leaders in the industry and learn exactly how a specific instrument or device is going to be used out in the field. Because we don’t understand where we’re going to go with our design unless we know how they’re going to be holding this, what are the ergonomics, you know, what is the balance of weighting of the tool.

And on the engineering side, we’re concerned about minimizing the assembly, minimizing the complexity of the assembly to get the job done and keep it within an envelope that the industrial design is correct for the user in their environment.

BJ:    Interesting. So, in terms of how this process works, you talked about sort of a real time communication, what does that mean?

KM:     So on a daily basis, I’m a design engineer and Leon is an industrial designer, we’re talking several times a day when we’re together on a product. We’re looking at issues that come up with the parts and we’re figuring out ways that we can resolve the issues that will be satisfactory both from the user’s perspective and also for the detailed design of the device. So it really means having constant communication with these groups within one organization.

BJ:   So, how does this differ in terms of the development process from a traditional kind of approach?

LM:     Well the linear and the parallel approach are two simple words and ways to look this. So working in a parallel approach again, we’re working these solutions together. We’re not working on top of each other but we’re working concurrently to resolve issues as they come to play in real time. In a linear approach, the job, the tasks and the solutions come from individual disciplines in separate areas at separate times. So as an industrial designer, I may say, boy, does this look good and this is the position I want a hand to hold this specific instrument in the operating room environment. But I’m not considering the constraints that come to play for the engineer to actually allow the volume to be a small as I want it, the weight to be as light as I need it. I need the inputs real time concurrently from engineering to make that happen. A parallel process allows that and a linear process we end up with disagreements and we have to go back and revisit solutions instead of keeping things flowing towards manufacturing.

KM:    Right. So you really end up with sort of a struggle at each step if you’re trying to implement a linear process. Because as a design engineer, I might get input from the industrial designer and take a look at putting in the details into the design and figure out that well I can’t do what the industrial designer is asking me to do in the detailed design. So just talking about that upfront, it avoids a lot of frustration and a lot of iteration, which really adds to the ultimate timeline of the product.

BJ:    Interesting. You talk about a user-centered approach. How does a user-centered approach relate to concurrent design process?

LM:   Well the user again, you know, he’s the end user. He’s the one that needs to be accommodated as well as possible with our design and with our output from production. So this approach, the user himself with the details that we instill and we put within this device, the only way we can make that real is again to have not just industrial design mechanical engineering, embedded systems, and production issues on the table at the beginning of our project plan. We have to know how the user is going to use it, center our efforts in all these areas on how to best accomplish that. We can’t come to a manufacturer and say here’s the design at the end of the road because he’ll come back to us and say well we can’t mold that.

BJ:    Interesting. So I guess that’s the whole idea of DFM or design from manufacture?

KM:   So in design from manufacture, you need to consider the final fabrication process and you also need to consider the final assembly process. You want to minimize the number of parts, you want to make assembly as easy and simple as possible, and you want to really optimize your individual part design for the technique that you’re going to fabricate the part from. So as Leon mentioned, if you’re going to have an injection molded part, you’ve got to be talking to the injection molding vendor that you’re considering early on to get their input. You need to be considering good design practices for fabricating the part in that way and that will really make your timeline shorter as opposed to if you do not consider that and then sort of threw it over the fence to the fabricator in the end and found out that you had a lot of problems.

BJ:    Do you have any examples in the past in what you consider good DFM and how it leads to higher quality and lower cost?

LM:   Sure. So if you’re asking about when we instill design from manufacturing and are worried more about cost or quality, there’s a balance here. There’s a requirement specification that lives with us and grows throughout the project from beginning to end. These are the things that must be instilled with the product design itself. Some of those can even be user requirements. They can be weight associated, they can be the angle of the display. These are given. You must resolve these issues.

Now you want to minimize — as Katie had said, you’ve got to minimize your overall assembly, the complexity of that assembly, how many screws are involved to put this assembly together and how many parts and how many tools, what the capital expenditure to make this design happen. So we’re always concerned with that flow of complexity to resolve these solutions, giving it the right aesthetic appeal, give it the right ergonomics but at the same time at the end how much is this going to cost.

This is part of our project plan upfront. Our customers don’t know come at the end of the project and find out that the tooling expenditure or the unit cost for this device is twice what they expected because we instill this at the beginning of our project. We figure out the balance of quality. Well quality is always high but we figure out the balance of aesthetic quality and of the production costs that are involved to make this thing happen.

KM:    Right, so that’s a good point. I’ll give you an example of a recent project that Leon and I worked on together where some of our design decisions were driven by the ultimate cost to manufacture the parts. We were working on an assembly together where we had a mechanical structure inside of some enclosures and the enclosure is obviously very important, the aesthetic look of the enclosures is obviously very important. We were looking at early build of materials and the cost to fabricate some of the custom elements of that assembly.

At that time, we looked into different fabrication options and were able to incorporate into the design early on some aluminum die-cast components that combined individual machined components and overall reduce the cost of the final product. If we had waited until we were ready to launch in manufacturing to make that conversion to die-cast components, we would have been doing a lot of rework to figure out how to incorporate the die-cast elements into the mechanical assembly. So that’s just an example of a choice you can make early on in the design that can make things a lot easier for you down the road to help reduce the cost of the products.

BJ:  Well it sounds like design can have a dramatic impact on the ultimate cost of a device.

KM:    It certainly can. The choices that you make early on about what type of fabrication processes to use and how to design your mounting surfaces even within your parts is very important. So if you’re using a die-cast part for example, can you create geometries so that you can use an as-cast geometry instead of having to have secondary machining because your features are not in the correct direction for the mold. Just considering how you’re mounting things to minimize that additional machining or for injection molded parts for minimizing side actions can save you a lot of money down the line. You just have to be thinking about that upfront in your design.

BJ:   Interesting. So are there any general global perspectives or global advice you’d give to let’s say a company, a new venture and they’ve got an idea for a device, you know, sort of the big picture on what they should be thinking about and the philosophy they should use as they approach this process?

LM:     Well, Brett, it’s definitely to be user centered. You know, in the end the customer has to be happy with this product. So if you’re not basing your plan and your approach to resolve and develop this design on the user needs and if you don’t fully understand what they are and the complexity of those needs, if you don’t bring those in to play at the beginning, then you have quick fixes that have to happen during your evaluations. Because step by step you’ll evaluate your development process with users and if they come back to you and you haven’t considered their main needs, then you’re going to find yourself in a lost circle here and spending a lot of time and money that is unnecessary to get this done.

BJ:      That sounds like great advice. Well thank you guys. It’s a terrific insight on the process of bringing a device to market. It sounds like you’ve got some good insights on how to accelerate it and do it in an intelligent fashion. So thanks for joining us today.

LM:    Brett, thank you very much for your time.

KM:    All right. Thank you.

BJ:    So that is Leon Marucchi and Katie McHugh with the international design firm MPR Associates, which has been specializing in the medical device area for many, many years. Thanks for joining us today guys. Thank you all for our listeners. Brett Johnson from OneMedRadio in New York signing off. Good day.

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In Part II of our expert series on the future of healthcare and The Patient, OneMedPlace sits down with Dr. Cynthia Haines to discuss the digitization of the waiting room.

We are seeing a new push by healthcare providers to better educate patients, and the development of various tools to do so. At home, patients are venturing online to become better educated and more in touch with their healthcare. Experts believe this information revolution — and the digitization of the physician-patient relationship — is the first step in instituting a paradigm shift toward personal, empowered healthcare.

The question now becomes, how can patients and physicians use the tools in front of them to re-take charge of their health care (notice how we now separate the compound word)? Further, how can the medical community use these tools to combat the inefficiencies of the healthcare system?

How can a physician, for example, use social networking to expand her referral network? How can a drug company use blog databases to target a specific patient population? How can a tablet in the waiting room eliminate healthcare fraud, and at the same time educate readers on particular conditions?

As an author, editor and family physician, Dr. Cindy Haines is in a unique position to navigate us through the digitization of healthcare. In light of recent activity by one company in the health information space, Epion Health, which markets the Smart Screen health tablet, we asked Dr. Haines about the healthcare tablet, empowering the patient through digital tools, and what the waiting room of tomorrow will look like.

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OneMedPlace: From a physician perspective, why are tablets in the waiting room important?

Cindy Haines: Tablets in the waiting room provide a novel opportunity: utilizing “smart technology” to help us work smarter. I define this as being more efficient and more effective in each visit. Delivering to our consumers (our patients) what they really want from us: better health and better health outcomes at less cost (monetary and energy-wise) to them. The added benefit is that this can also help clinicians get what they really want too: better health and better health outcomes for their patients at less cost (to the patient, in terms of patient money and energy, but also less cost to the clinician in terms of wasted energy and other wasted resources).

OMP: What services should tablets provide?

CH: Everything from registration assistance, info about visit or their conditions to interactive education, games, health news. I’m hesitant to want advertisements from drug companies.

OMP: What information will be most valuable?

CH: Patient-centric information is key. In other words, information that means something to each patient, customized according to clinical factors/patient demographics. Tablets should provide engaging information that can empower the patient in advance of the visit. Why are they there? What do they want to accomplish?

OMP: What can these services help to eradicate? In other words, how will tablets make your life easier as a doctor?

CH: The tablet will make life easier if it can “get the patient in the zone” of the purpose of the visit. Important informative tools, such as the top 1-3 things to address, organize and prepare during a visit. Tablets can also also provide information that the doctor may not have time to go over. Getting all relevant complaints/reviews of systems and such in advance of visit would be huge. Having knowledge of all concerns before going into room also key.  Trying to boil all these questions and concerns down once the patient is in the room, without all this info, is not efficient.

OMP: How are waiting rooms with elderly or non-tech-savvy patients going to roll out the tablets?

CH: How can they guarantee there will be no frustration? Keep it simple and make it easy: large text, few objectives, patient assistance.

OMP: Why would a physician buy into a model like Epion Health or Phreesia over simply purchasing a tablet privately and uploading apps that they prefer? Why wouldn’t you, as a family physician, just buy an iPad, download a few health information apps (everything from iTriage to HealthDay, e.g.), and put on some games?

CH: The obvious response from Epion is they make your (physician’s) life easier: if you buy their service, you are getting a bunch of info/news that’s been tested to be interesting. You could just get an iPad and download programs individually, but ‘healthcare-focused’ tablet companies give you a “plug and play” option where they do all that work for you. It would remain a cost issue/decision then for the offices. How much more would they spend on Epion Health systems than if they cobbled together something on their own? It may also benefit to get a system like this for the customer care: if, say, continuing upgrades and tech support were offered.

OMP: Do you think insurance companies will buy into the healthcare tablet concept? Why?

CH: I believe they should be vitally invested in patients becoming more empowered and smarter in how they approach the health care system. Health-informed individuals increase their engagement toward better health and better health outcomes. Everyone wins.

OMP: How will tablets help improve a broken system?

CH: An uninformed patient population relies too heavily on the healthcare complex, looking to the doctor to improve aspects of health that should be the responsibility of the individual.  Educated patients can take the reins in improving their conditions, learning what they can and should be responsible for to save money, time and dignity. Most importantly, an empowered patient can learn how to use the healthcare system efficiently.

Tablets are uniquely positioned to educate patients in all the right ways: on living healthy and dealing with particular conditions, but also on navigating through the inefficiencies of the healthcare system — spending money wisely and eliminating the excess, extraneous complexities associated with third-party payors and insurance. We often misinterpret the healthcare system as infallible: but if we ultimately can become a population that needs the system less, the medical community can do what it does best.

Dr. Cynthia Haines is the author of ‘ The New Prescription: How to Get the Best Health Care in a Broken System’. If you missed Part I of our expert series, click here.

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Aptiv Solutions is a full-service international CRO with proven expertise in supporting global clinical trials for biopharmaceutical and medical device companies. Their trials span the development lifecycle from first-in-human through regulatory approval and beyond. As a sponsor for OneMedForum New York 2012, the company’s corporate brand manager was interviewed by OneMedRadio and gives an overview of the clinical trial space and what makes Aptiv unique.

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, we’re with Phil Birch, corporate brand manager of Aptiv Solutions, a global CRO headquartered in Washington State with a focus on adaptive clinical trials. Thank you for joining us, Mr. Birch.

Phil Birch:       Thank you, Matt.

MM:      So first, maybe you can give us a brief company overview of Aptiv Solutions.

PB:     Sure, I’ll be very happy to. Aptiv Solutions is a global CRO recently formed and focusing in two key areas, adaptive clinical trials and medical devices.

MM:     Maybe you can give me an idea of some company history. You mentioned it was recently formed, how did Aptiv come about?

PB:   Sure. It was created through a merger of several service companies, each with a track record of success, who all brought something different to the table and this included specific expertise and experience in adaptive clinical trials. We’ve taken those initial founding companies and added to them by recruiting some of the world’s leading experts in adaptive trials and we’ve put those people in what we call our innovation center, which is our centerpiece for helping clients develop novel approaches to develop their products.

MM:    So what are adaptive design trials and why are they important?

PB: Well adaptive design trials involve the timely collection of data in defined interim analysis steps, which provides the opportunity for the trial to adapt to the emerging data. So it’s a process that enables real-time learning. For example, if you’ve undertaken interim analysis, you can take a decision to change the sample size for the trial, you can stop the trial for futility, you can drop ineffective treatments and make a number of other changes to the trial. The important point is that these are not ad hoc changes, these are changes that are pre-specified and planned in advance so they’re preplanned design changes.

We’re passionate about adaptive clinical trials because they offer the potential to improve the efficiency of product development and we’re all aware of the issues facing product development at the moment.

MM:     Can you talk a bit about the idea of the importance of maintaining very strong client services?

PB:   Sure. You know, our approach that we take is unique. It’s different to other companies. We’re investing heavily in new methodologies and new technologies that are geared towards making the product development process more efficient and we’re offering our knowledge and our technologies to help companies design better clinical trials and the whole thesis behind is that an adaptive trial is a much smarter way of doing product development than the old traditional ways.

As I said earlier, we’re passionate about this because it’s going to go a long way to solving many of the issues facing industry today and those issues are declining in R&D productivity, increasing development costs and quite worryingly still high failure rates in late stage phase III development. We’ve invested heavily in the technology and the methodology that’s going to enable us to solve a lot of the problems that have been there in the past and we’ve coupled to that arms and legs traditional CRO to enable us to implement these trials, but importantly that’s supported by innovative thinking in trial design or execution. So effectively, it’s a CRO with a very solid brain on the top that enables us to have significant intellectual input into the design of these novel trials.

MM:    So it seems as though adaptive trials can be applied to various sectors but what areas are adaptive trials used more than others?

PB:    They can be pretty broad. Our experience to date has been, you know, we’ve done a significant number of trials in the respiratory area, in the GI area and the cardiovascular area, but they have broad application. We’re seeing a lot more interest now in doing CNS trials that can cover neuropsychiatric disorders or pain trials and also in oncology. In oncology, there’s a real need for an adaptive approach because they’re difficult areas to develop drugs in because of the heterogeneity in patient populations and the fact that individuals are on multiple therapies. Adaptive approach can really help identify what is the best drug for the best subpopulation of patients within that setting and that’s true for other therapeutic indications as well.

MM:  Now I want to circle back to something you touched on earlier, the idea that the clinical trial space and regulatory space is changing. I was wondering if you could talk a bit about what these changes are and how adaptive trials are becoming more necessary.

PB:      Sure. You know, adaptive trials are not new. They’ve been around for quite a while now. In fact, we’ve been running adaptive trials for over ten years, but they tended to be relatively simple adaptive trails where you’re making maybe one adaptation.

But what’s happened in the last few years is that the technology, so the technology platform to implement more complex adaptive trials has become available and this is now re-stimulating interest in the whole adaptive trial space. The important factor is that one can now design complex trials for instance in the phase II setting where you can ask a number of questions about your product development program. If you can answer those questions using an adaptive design then you can make much better informed decision making such that when you enter into your phase III confirmatory trial, you’re much more certain that you’re going to get a positive outcome. So being able to learn more using an adaptive approach at phase II is going to increase the success at phase III and that’s going to be very important for the industry. So we believe that adaptive trials are now enabling the dreams of biostatisticians in the past to become a reality. So they’re going to be able to really change the way that drug development has been done in the past.

MM:   Sure. So let’s jump back to your company profile a little bit, I was wondering if you could give our readers an idea of your global presence.

PB:  Absolutely, I’m very happy to do that. So we’re about 850 people at the moment, about 400 of those individuals are based in the US in various locations on the east coast and on the west coast and a similar number of individuals in Europe with a presence in most European countries and then a group of 50 based in Japan. In Japan, we focus specifically on oncology, that’s for historical reasons, and in other areas we are pretty broad in terms of the therapeutic expertise that we have. So we’re still relatively small, but we’re bringing something unique to the table and certainly finding that our offering and our technology and our approach is getting us through the door with a number of sponsor companies and they seem very interested in the adaptive approach.

MM:  One thing I’m particularly interested in is your ADDPLAN software. I was wondering if you could tell us what it is and why it’s important, what’s new with it.

PB:   Sure. So ADDPLAN is our proprietary software for designing confirmatory adaptive trials and it basically is a statistical design package that enables you to run a series of simulations of different trials, which then enables you to make a decision as to which is the best design for your study that you’re trying to initiate. So what’s new about it? Well we just launched some new software called ADDPLAN PE and PE stands for population enrichment. This is an adaptive approach that’s going to enable sponsor companies to run a trial and identify the subpopulation of patients that responds most effectively to their novel treatment. This has very important consequences for the whole area of personalized medicine and indeed pricing and reimbursement where these days the hurdles one has to jump over to get a successful health economics package are significant and this approach is also going to help in that area.

MM:       Sure. So touching on that idea of personalized medicine, from the CRO side of operation and development, I was wondering if you could talk a bit about this surge that we’re seeing in diagnostics and personalized medicine.

PB:   Sure. It’s been happening for quite a period of time. There’s a massive explosion in the identification of biomarkers and genetic markers. What we need to do now is use that information to development better drugs. The approach that we’re taking is going to enable companies to do that in a much smarter fashion. So it’s going to really be an enabling technology, an enabling methodology for running clinical trials and really identifying the patients that best respond to these novel treatments which is what personalized medicine is all about.

MM:    So as we wrap up here, I think the appropriate question is what is the future of Aptiv Solutions? What challenges and opportunities do you see going forward?

PB:   Our biggest challenge at the moment is to educate the market around the value and the benefit of adaptive trials and demonstrate to sponsor companies that one can implement these complex adaptive design trials in a broad setting in a number of different therapy areas. We’re finding that there’s quite a lot of knowledge about adaptive trials, but no real in depth understanding. So that’s really our challenge for the next 12 months is to help educate the marketplace effectively and we’re undertaking a number of activities, speaking at as many conferences as we can to get that message out there because as I said at the beginning we’re passionate about this because it really will make a difference to product development.

MM:   That was a company snapshot of Aptiv Solutions with Phil Birch, company corporate brand manager. This is Matt Margolis signing off.

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NeuroMetrix is a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes. The company currently markets products for the detection, diagnosis, and monitoring of diabetic neuropathies such as diabetic peripheral neuropathy and median neuropathy (carpal tunnel syndrome).

Below, President and CEO, Dr. Shai Gozani is interviewed by OneMedRadio where he discusses the Sensus Pain Therapy device.

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, we welcome Dr. Shai Gozani, President and CEO of NeuroMetrix, a Massachusetts-based neurotechnology company trading on the NASDAQ under the symbol NURO. Thank you for joining us, Dr. Gozani.

Dr. Shai Gozani:     Thank you. I appreciate the opportunity.

MM:      So let’s start with the biggest recent company news, the FDA filing of pre-market notification for your Sensus pain therapy device. So firstly, what is the technology here? How does it fit into NeuroMetrix’ technology profile?

SG:     Well thank you for the question. We’re very excited by Sensus. So Sensus is a transcutaneous electrical nerve stimulator, that’s often abbreviated as TENS. This is a technology that’s been around for some period of time, probably about 20, 25 years and it’s been shown to be effective in a variety of different pain syndromes. Recently, the American Academy of Neurology suggested that it should be looked at more aggressively in terms of treating what’s called painful diabetic neuropathy, which is the pain associated with diabetic nerve damage which is our area of focus.

So what it is, is a noninvasive nerve stimulator that would typically be based around the calf and what it does is it stimulates normal nerves and by doing that, you actually block aberrant pain signals that are coming from the vicinity of the foot and ankle, which are the source of the pain in painful diabetic neuropathy. So it’s essentially a pain blocking technology. It is non-narcotic, it’s not addictive and it basically provides on-demand analgesia or pain relief.

It fits very nicely into our technology platform as well as market strategy because it is a nerve stimulation technology, which is our area of expertise going all the way back to when we started the company in 1996. It’s also an extension of our diabetic neuropathy strategy or diabetic nerve damage strategy where we started. Our first product in this arena was a diabetic neuropathy diagnostic test. This allows us to expand into a therapeutic option once you identify the diabetic nerve damage. So it fits very nicely from both a technology and a market perspective.

MM:   And what is DPN, how is the affliction affect the population?

SG:    It’s a great question. So DPN is the acronym for diabetic peripheral neuropathy and simply stated, that is the nerve damage that is caused by diabetes. It is the most common chronic complication of diabetes and it affects about 50% of all people with diabetes. So just to put some numbers on that, that’s over 10 million people in the US and over 150 million worldwide so it’s a huge problem.

What DPN does and the complications of DPN are multifold. First of all, it is the leading or the primary trigger for patients developing foot ulcers, which ultimately can lead to amputation, and DPN as a trigger for amputation is the leading cause of amputation in the United States. It can also lead to severe pain as I mentioned before and that’s where Sensus comes in to help treat that pain and also particularly in the elderly it dramatically increases the risk of falling which of course can lead to hip fractures and other problems.

So it is a major, major issue. It accounts for about 25% of all direct spending related to diabetes. It is a complication of diabetes that has actually been somewhat ignored because there are inadequate diagnostic and therapeutic options. So it’s a big opportunity to really make a significant impact both in patient care, quality of life, and also in overall economics.

MM:   So in that way, what makes the NeuroMetrix pipeline intriguing? What makes your technology unique?

SG:    Well we are the only medical device company that is focused on DPN, the nerve complications of diabetes. So while there are many very, very exciting and interesting diabetes medical device companies, they tend to be focused on the glucose measurement and insulin management part of the equation, which tends to be more of a type 1 diabetes focused application. Then there are pharmaceutical and biotechnology companies that are trying to develop obviously pharmacological type approaches to treating either DPN or the manifestations of DPN which is pain. But there’s no medical device company that’s trying to provide device related solutions for DPN. So that’s an area that we have a unique focus on and I think if we can build that out it would represent a very unique diabetes franchise.

So we already have one product on the market, which is a rapid point to care test for DPN and that product is called NC-stat DPN check, which is an evolution of our longstanding nerve diagnostic technology. We launched that product in the fourth quarter of 2011 so we have about two quarters of commercial experience behind us. Sensus as we’ve discussed will be our second product in our DPN portfolio and that will hopefully pending FDA timelines, we’ll launch later this year so that we have a diagnostic and a therapeutic in DPN.

Then we have a number of other earlier stage programs both in the diagnostic side as well as in the therapeutic side for various aspects of DPN, which we would look to launch in subsequent years. So again, we have a unique footprint in this space because as a device company, we’re the only ones trying to attack this huge clinical and market opportunity and again with tremendous unmet needs.

MM:     I want to circle back to that NC-stat DPN check that you had mentioned earlier, so what has the market adaption of that diagnostic device been? What’s your initial target market?

SG:  Yes. So we have a number of different channels that we’re pursuing for that product. So just to restate it so as I said DPN check is a very rapid, very cost effective way to test for DPN . Just to frame it, the traditional approach to assessing DPN is basically the clinical examination, which is very important but it does not have high accuracy. It can only detect DPN at a very late stage when there is really very little you can do to affect the progression of the disease. The nerve is basically largely damaged or almost completely deteriorated at that point. So clearly we want to detect it at a much earlier stage and even to be able to follow its progression and that’s what DPN check does in the physician office in a very rapid cost effective way.

The channels that we’re targeting are as follows. We started out and extended the focus on the endocrinology, the US endocrinology and podiatry markets. Endocrinologists and podiatrists are two clinical groups that tend to focus obviously on diabetes, but also in particular on the complications of diabetes. In the case of the podiatry, it’s very much on neuropathy and foot issues. So they’re kind of the top of the adaption pyramid. So that we have a direct sales force that sells into that group and we sold over a hundred devices in the first quarter of sales, which is the first quarter of 2011 and then as we reported recently, about 130 or so this past quarter. So we’re getting pretty nice adaption in that initial group which is about 15,000 clinicians in the US, but that’s just a relatively small kind of leading adapter type of group.

The really big opportunities for this product are in the US primary care 85% of diabetes is managed and that’s a market we’d have to go after with third-party distribution. So we’re working on that. We haven’t signed large distributor yet, but that’s something we’re targeting for later this year or early 2013. Then two very interesting markets are retail medicine, which is comprised of pharmacies and often associated with those pharmacies you have medical clinics. So these are for example the CVS, Walgreens and Wal-Mart type pharmacies and then increasingly you’re seeing medical clinics associated with that such as the Take Care Clinics from Walgreens and the mini clinics from CVS.

That retail health sector is looking more and more at diabetes and looking to provide various kinds of services around diabetes such as early detection of diabetes and its complications so it’s a fairly natural potential target for us for our test. In fact, we recently announced that Wal-Mart in Canada, their Canadian subsidiary is going to be deploying NC-stat DPN check in about 100 of their pharmacies that have a diabetes focus so that’s very exciting.

Another market for us is managed care and particularly capitated managed care because they’re so prevention oriented and obviously to manage costs. So we’re working aggressively on managed care. Then the final sector is international markets and there’s a lot more diabetes outside the US than inside the US so clearly one has to look at diabetes in a very international perspective. We’re looking at specific market opportunities such as in India, Europe, the far east as potential growth opportunities as well.

MM:    I do want to touch on that Wal-Mart Canada agreement. I have serious interest in that and I think our readers and listeners will be very interested to learn a little bit more about that company milestone. You know, what was the discussion process like, where do you go from here?

SG:    Well it’s very intriguing and really a credit to Wal-Mart and their forward looking perspective on helping the communities in which they have pharmacies help in managing the diabetes problem. So in Canada, they’re a little bit more advanced in their preventative programs at this point even than in the US. What they’re looking to do it appears is to provide services to the community to basically offload from primary care. So they really look at the pharmacist and the pharmacy as a way to provide a variety of services to detect diseases at early stage and provide kind of entry level healthcare such that primary care physicians could focus in on sort of more involved issues and prescriptions and treatment and so forth.

So they look at neuropathy and its complications related to foot problems as a very important area that they can intervene in. What they want to do is provide early detection so that basically a consumer walks in to a Wal-Mart in Canada and they can get this test. If it’s abnormal, they can go to their primary care physician and that primary care physician now that they’re alerted to the issue can really focus in on it and hopefully prevent the progression of the disease. So it’s a fantastic prevention model and again a credit to Wal-Mart in their forward looking approach.

We obviously would like to see if that model cannot be expanded further in Canada as well as in the United States. There are differences in the US sort of retail health market versus a Canadian one but nevertheless we think there’s opportunities to build up that market in early stage discussions with a variety of retail health companies about looking at whether we can find opportunities to deploy the technology in a similar fashion.

MM:  Of course. It’s very interesting. So lastly, as we wrap up this interview, I want to circle back to the idea of the surge in personalized medicine. As a guru, as an insider in this sector, I was wondering if you could just speak on this recent surge and how it’s affecting your business model.

SG:   Well it’s a critical question and I think more and more of healthcare will focus in on personalized medicine because frankly it’s just a much more efficient form of medicine. Just to frame it within diabetes and our products, particularly DPN check, something recently happened that’s relevant here.

So for many years, the recommendations on managing diabetes were to target a particular level of what’s called glycosylated hemoglobin or A1C and sort of it’s the target metric for managing diabetes and the ADA recommended a particular level of 7%. So physicians basically try to manage everybody to the 7% level using the variety of different treatment options they had and that maybe insulin and other medications and so forth.

Well recently, it’s come to light that that’s not a very good approach and in fact everybody has a different target, i.e., it needs to be personalized. So in fact, the ADA and its European counterpart just came out literally in the last few weeks with a new statement on managing diabetes where they say there’s no target. There’s no specific target for individual patient, but in fact the target has to be personalized to the needs of that patient. So one might ask well how do you personalize it for that patient and the answer is you have to look at what the diabetes is doing to that patient in terms of how it’s damaging their various organ systems such as the nerves.

So a product like NC-stat DPN check fits very well into this concept of personalized diabetes care. Because if you have a patient and they have let’s say 8% where in the past you would treat them down to 7% with its attendant cost and risks, if that patient is not showing any complications of being at 8% ,you can keep them there. By the same token, if you have a patient who’s at 6.5% and you feel great about them in the past then you test and you find out that in fact despite the fact that they are below the supposed target, they’re developing nerve damage, you clearly have to be more aggressive. Again, you have to personalize diabetes care to the actual impact of the disease on that patient. So you need tools to give you the information to do that. So I think personalized diabetes care as sort of a subsector of overall personalized medicine is going to become a much more prominent aspect of diabetes disease management.

MM: That was a company snapshot with Dr. Shai Gozani of NeuroMetrix trading on the NASDAQ under the symbol NURO. This is Matt Margolis signing off.

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Dr. Cindy Haines has made it her mission to help patients navigate through the imperfect healthcare system, which she has described as “broken.”

A family physician based in St. Louis and adjunct faculty at the St. Louis University School of Medicine, Dr. Haines has evolved into a consumer health guru, helping the public understand the proper (read: minimized) role of the healthcare complex in fostering wellness. Her new book, The New Prescription: How to Get the Best Health Care in a Broken System, identifies how we often misinterpret the healthcare system as infallible, offers strategies on how to use the efficient parts of the system to our advantage, and challenges us all to be a better steward of self – ultimately needing the system less as a result.

As chief medical officer of the health news and custom content company HealthDay and managing editor of HealthDay’s professional news wire, Physician’s Briefing, Dr. Haines is uniquely tuned in to millions of patients and providers, making her an authoritative voice on the future of healthcare in America. Her message is clear: empower people with information and transparency, and they will quickly learn what the system actually can and should provide.

Medical professionals can turn these metaphysical goals into a reality, as Dr. Haines noticed very early into her career as a family physician. People absorb only a fraction of the information received during amedical visit, she says, and an even smaller number understand the information accurately.

Her efforts into properly educating the patient began simply, with a library of take-home one-pagers on a variety of conditions. Small-scale initiatives like these can help people achieve the ultimate goal: rely on healthcare less frequently to make decisions for you, and in turn take charge of your own health. Aninformed individual can then rely (as needed) on healthcare more efficiently, use up less healthcare services, and save money. It’s a simple concept that could have a profound effect on re-building the healthcare system.

According to Dr. Haines, healthcare is but a part of living healthy, not the sole vessel. Her advice is to never be a ‘patient’, but instead a ‘seeker of health’: a patient is someone who is sick and/or dependent on the healthcare system – an identity and passive position that can take over your life, she says. A seeker of health, on the other hand, is an individual who embraces the great responsibility and power he or she has over his/her own health and health outcomes. The seeker of health will be active in their health journey: they will pay attention to personal health and their surroundings, and in turn take action to avoid the extraneous devotion to the healthcare system.

Philosophically, an informed individual is inspired to seek a better wellbeing, aware and embracing that living healthy begins with one’s own unique circumstances. In practice, it is a realization that people have the power to change their health. The way we eat, the way we use our bodies, and the way we maintain our outlook on the world can often do much more to maintain our health and prevent disease than the healthcare system can.

Becoming proactive about our health is an empowering concept that can unburden us of the frustrations of the healthcare complex – all the while saving the individual money, time and dignity.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/05/power.jpg

As part of a OneMedRadio series, MPR Associates takes us through the process of medical device development. Below, Ralph Paul and Eric Claude discuss the importance of project management and execution.

Matthew Margolis:    Greetings from OneMedRadio in New York City. I’m Matt Margolis. Today, we’re joined by Ralph Paul and Eric Claude, senior managers of the product development group of MPR Associates, a leading international design and engineering firm. Today, we’re discussing the value of project management and execution in rapid medical device development and commercialization as part of our series on shortening time to market in med tech development. Mr. Paul and Mr. Claude, thank you for joining us.

Eric Claude:    It’s a pleasure thank you.

Ralph Paul:     Thank you.

MM:   So Ralph, I want to start with you. You’ve discussed the need for rigorous project management approach, what is the most important aspect of project management that leads to successful development projects?

RP:     Well, the single most important thing is to have a single empowered project manager who’s accountable for the entire project. That may seem very obvious, but it’s not always obvious and there’s many cases we’ve run into where organizations have made multiple individuals accountable for different elements of a project, and inevitably that leads to miscommunication and problems and an inability to make decisions when they need to be made. That contributes to schedules that are late, budgets that are overrun and just an inability to get to a final product that’s going to meet all the needs of the stakeholders.

MM:    Sure. I can see how a strong project manager is important, how can a single person be knowledgeable enough to make all the right decisions throughout the development?

RP:   Well, it’s true that a single person can’t be an expert in everything and if you try to do that, you will certainly fail. But as a project manager, what you need to do is surround yourself with people that fill those roles and that you trust and that will be accountable to you and you need to take all that information in from these various people and make your decision. So you can’t work in a vacuum, it really never works that way. But you need to involve all these stakeholders and in some cases you may need stakeholders to either be highly involved or even make certain critical decisions. One of the key things is if that’s true and if you need a key stakeholder to be a part of the final decision process, you need to include that in your plan. You need to have that known upfront so that everyone involved understands that that’s how the project is going to be run and how that decision is going to be made. When you do that upfront, it’s very clear and you have a clear way to have accountability on those decisions.

EC:    I would just add to that that I think in our experience what’s critically important is to have a well-organized project team with clear division of responsibilities between the team members. Where the project manager of course has overall authority and accountability, but additional people with the right expertise are on the team to assist with technical direction of the project and execution of the work. The project manager one of the key roles that that person fills is really being the communication conduit of information to keep the flow moving at the right pace.

MM:      And so maybe you can go into just a little bit of detail about what particular things that project manager, what kind of challenges can arise and what things a project manager really needs to be in control of, communicate properly.

RP:   Well, really there’s all matter of things that can go wrong during a project. In fact, to a large degree, a project manager’s whole job is risk management. So as a project manager, you should constantly be asking yourself what else is going to go wrong, what’s going to go wrong next. If you take that approach, you’re basically always thinking ahead to the next things happening in your project and you think ahead as to what could go wrong, what could cause any of those things to not be done on time or on schedule or be done in a way that’s going to meet your requirements and you come with contingencies.

So in a couple of examples in many of the projects, you have resources, you have people on your team that are doing work for you. You can have unforeseen problems with those resources. You have a resource that has to get pulled away for some other critical function and suddenly your team is down a person who is really needed to get a certain task done so what do you do about that? You need to think ahead and be planning to have team members that are understanding of each other’s work and so that you can have somebody fill in it in the last second if you need to. So that’s an example of something that can go wrong.

You can have an external organization say or working with a key supplier of a component who is critical to the function of our device and that supplier fails to meet their schedule and not only fails to meet their schedule but when they finally do ship products, it doesn’t meet the specification, what do you do? So if you haven’t planned ahead, you’re going to be caught flat footed and when that occurs you’re going to be well behind and really not have a way to recover. So in thinking through, you have to know where your risks are. If that supplier is somebody you’ve only just started working with, maybe you should have a second supplier who’s working in parallel so that you have two options. That’s another way to mitigate your risk. So these are some things that you can be doing throughout the project to constantly be trying to identify where things are going to go off plan and come up with ways to mitigate those before they happen.

EC:    Let me just add a little bit there. We put a lot of effort upfront into developing a really sound project plan for our development activities and that’s really the foundation of being able to do these risk management activities that Ralph discussed. It’s a little bit like for example making up a flight plan to fly from point A to point B, you’ve got to have that plan so that you can think about what might happen if there are thunderstorms in Atlanta and I have to deviate from the plan. So we’ve put a lot of effort upfront into looking at what has to come together for a project to be successful because that gives you a baseline that you can use to then look at the potential risks to success.

MM:  So it sounds like we’re talking a lot about sort of mitigating disaster, kind of rolling with the punches here. So what actually does make for a successful plan?

RP:   Well, at first as Eric mentioned, it needs to be comprehensive and detailed. You need to really capture everything that you’re doing as a part of the project. Both describing what you’re doing but also have key responsibilities and roles defined, key deliverables defined so it’s very clear what is going to be done, when it’s going to be done, and what the outcome will be. That’s the first step.

Now as you get into this detailed plan, you’re going to be identifying activities that have to get done in order to achieve these end results. Another critical thing is that these activities have to be defined in a way that people can be accountable. So they need to have clear start and finish dates, clear expectations on how much time and effort it’s supposed to take to do these activities and most importantly the activities should have a single owner. Again, one person who’s going to own that task and make sure it gets done and be accountable for the outcome and really again that builds on everything else. If you plan your work in a way that individuals are empowered to be accountable to get the work done and the team works well together, you will end up meeting your goals.

Where it breaks down is when that doesn’t happen and communication is not clear. So people think, one person thinks somebody else is really going to do some element of the task, but they aren’t doing that, you get a breakdown then you get to an endpoint or a certain point in the work and that activity never got done. So it’s really important to use this plan as a way to ensure that it’s communicated very clearly to everyone involved, all the stakeholders. When you do that, that leads to a successful project.

EC:   That’s an important point. Using the plan as a communication tool is so important because one of the interesting and challenging aspects of medical device development is the multidisciplinary nature of these kinds of projects. You have investors, you have legal folks from an IP standpoint, clinicians, regulatory people so there’s lots of communication interfaces that need to be managed.

MM:  At what point do you find the communication breaks down most often and what, you know, part of the project I guess?

RP:    Realistically, that can happen in all parts. You can’t oversell the importance of communication. You know, where when you have a very good working team, I’d say a lot of times you can avoid those breakdowns. So it’s the places where you don’t have good careful close communications that’s going to cause the biggest issues.

So for example, say you’ve got again a partner who’s either supplying a critical component or maybe developing a part of the system but external to your own organization, that is a critical interface. It’s a place where communication or information needs to be over communicated because that’s a place where you’re going to get a breakdown.

The other place we’ve seen it is things of the nature if you’ve got a marketing group who cares about certain elements of the product and they understand what the end users need and you’ve got an engineering team who’s developing the product. A lot of times you can get a breakdown between what the engineers think they’re developing versus what the marketing really knows the users want. So that’s a place where careful communication is needed. There’s many more examples but I would say it’s looking for these interfaces where you don’t have people that are working closely together on a daily basis. If you don’t have that, then you better make sure your communication links are strengthened.

MM:   Now, we’ve spent a lot of time talking about project management, I’m curious what makes this idea different in the medical device space as compared to other projects and other ventures?

EC:   Well, you know, that’s a great question and one that I think has a couple of answers. One, as we’ve discussed, medical device development projects are so multidisciplinary with so many different organizations involved. You know, we’ve talked about the communication points that are so important that adds to the challenge from that standpoint. You know, this is all happening under a timeline that generally has quite a bit of pressure to bring a new product to market quickly so that’s a challenge and that’s all compounded by the regulatory issues that have to be addressed. You can’t back fit regulatory compliance, design controls, risk management, these kinds of things into development after it’s done. They have to be tightly integrated with the development process. So all of those reasons combine to make the discipline of managing a medical device development project a little more challenging than many others.

MM:   You mentioned a little bit about the regulatory constraints, I was curious if you could just talk a bit about why we’ve seen a tighter leash whether we are seeing more difficulties in getting these things through and any explanations for that really.

EC:    Sure. Well, I think that FDA has I would say increased their level of expectations in certain areas particularly around risk management, around human factors, and designing to prevent the possibility of use error, those kinds of things. I think particularly when you look at the human factors issues, I think there’s some justification there to be concerned about those issues. So I think the expectations have increased there in those areas and we’ve got to be ready to meet those expectations.

MM:    We are talking shop with Ralph Paul and Eric Claude, senior managers of the product development group at MPR Associates, once again, a leading international design and engineering firm. Thank you guys for your time, I appreciate it and please readers stay tuned for more of our series on shortening time to market in med tech development.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/05/device.jpg

Each year, approximately 60,000 Americans are diagnosed with Parkinson’s disease, while an estimated seven to 10 million people worldwide are living with the degenerative disorder. On May 2, the Emmy-winning syndicated daytime series, THE DOCTORS, will reveal the stunning results of a new surgical procedure that offers hope for those suffering from the deteriorating effects of Parkinson’s disease.

THE DOCTORS welcomes University of Michigan Neurosurgeon Dr. Parag Patil along with his patient Suzanne, who underwent the new Deep Brain Stimulation surgery after medication no longer worked to control muscles tremors.

As the clip linked below will show, the device implanted during the Deep Brain Stimulation surgery works by electrically stimulating areas of the brain, blocking abnormal nerve signals that cause the tremor in Parkinson’s disease patients.

As we exit April, which is National Parkinson’s Awareness Month, the Deep Brain Stimulation surgery is a great reminder to all that new technological medical advances are indeed possible and in reach of the millions who suffer from this disease.

This episode of THE DOCTORS airs nationwide on Wednesday, May 2 (check local listings).

To view the clip, please visit: http://www.youtube.com/watch?v=lZcicrYeU_Y

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/05/doctors.jpg

New York Biotechnology Association (NYBA) will develop its Emerging Companies Showcase at the NYBA 21st Annual Meeting, May 2 in New York City at the Marriott Marquis Hotel, through a partnership with OneMedPlace, a New York research and media firm that provides a communications platform for promising healthcare and life science companies.

NYBA is the leading advocate for advancing the success of the life science industry in New York State and is its main representative to state policy makers, the media and communities. NYBA’s mission is to support the development and growth of New York’s life science industry, and serve our members and the life science community by providing a network for information exchange, shared services and collective action.  NYBA’s membership comprises bioscience companies, world-class research institutions and related professional services. Under the banner of The Cures Start Here®, the Association’s goal is to amplify the success New York has had and continues to have in growing a vibrant life science industry.

OneMedPlace will be organizing the company showcase that features short presentations designed for investors interested in learning about the next new ideas and companies. The communications firm uses a unique multimedia platform that includes research, radio and television broadcasts, industry news and databases to reach a global audience of strategic and financial investors.

OneMedTV, the television  broadcast component of OneMedPlace, will be streaming investor presentations live at www.onemedplace.com the day of the event.  The schedule of companies to present are as follows:

10:00     BioSpecifics Technologies 161 (BSTC)

10:15      Epion Health 11700 (private)

10:30     Advaxis 13343 (OTCBB: ADXS)

10:45      ALS Therapy Development Institute 15414 (private)

11:00      Endocrine Technology, LLC  15400  (private)

11:15       Oligomerix 13223 (private)

11:30      NanoViricides 14488 (NNVC.OB)

2:00        TONIX Pharmaceuticals 14384 (TNXP)

2:15        MedicaSafe 10407 (private)

2:30        Amarantus BioSciences 13336 (AMBS)

2:45        ElectroCore Medical 13111 (private)

3:00        AMRI Global 15566 (AMRI)

3:15        Armgo 15443 (private)

3:30        TechnoVax 15409 (private)

To register to attend,  please click here.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/04/financial3.jpg

To the scientific community, the Ebola virus is one of the most noxious pathogens identified to date. To the general population, the virus is dreadful, made especially frightening in pop culture.

In addition to a high mortality rate of approximately 70 percent per case (average)¹, the health deterioration caused by an Ebola infection is especially poignant. Infection by this RNA virus – a member of the Filovirdae virus family that also includes Marburg – is consistent with labored breathing, muscle and joint pain, diarrhea, vomiting, seizures, fever, edema, conjunctivitis, skin rashes, and hematomas. Approximately 10 percent of Ebola cases cause severe internal and external hemorrhaging that includes bleeding from the intestine, nose and mouth^2-4. Ultimately, multiple-organ dysfunction ensues and causes death.

Currently, there are no FDA approved vaccines or treatments for Ebola^3,5. Patients are essentially treated with palliative measures that include antibiotics for secondary infections, fluid and electrolyte supplementation to prevent dehydration, oxygen administration to aide breathing, and pro-coagulants to aid in controlling hemorrhaging. Taken together, the severity of Ebola infections and the lack of Ebola-specific treatments make it both critical and challenging to develop successful therapies, currently an unmet medical need. In this article we feature three companies that are making significant strides in actualizing successful treatment regimens for Ebola infections.

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NanoViricides Inc. has developed a powerful, adaptive technological platform with design capabilities that enables the effective treatment of a viral infection as needed. The central component of the company’s technology is a nano-particle termed nanoviricide, which is comprised of a micelle polymer containing disease-specific ligands that are recognized by the particular virus being targeted. Functionally, the virus recognizes and binds the nanoviricide’s ligand, at which point the nanoviricide engulfs the viral particle causing it to lose its viral coat proteins, effectively neutralizing the virus and rendering it unable to cause any further infection. Unlike other methodologies that aim to bind and neutralize a virus, such as antibodies, the nanoviricide is able to neutralize the virus without the added help of the immune system, providing a much more direct and simplified modality of treatment. Each nanoviricide can be specifically tailored to a virus by simply changing the ligand component, making this platform highly adaptable and wide reaching.

NanoViricides is currently developing its technology for the treatment of Ebola/Marburg virus under its bio-defense program. The ability of the company to stock-pile basic-form NanoViricides that can be quickly up-scaled to target a specific virus poises this platform as a highly promising treatment in the case of an alarming epidemic, as can occur with Ebola. In such an instance, the company would quickly manufacture the nanoviricide with the ligands for the specific Ebola or Marburg virus outbreak, even if it were a new strain of the virus, thereby serving to control the spread of the epidemic.  This area of the company’s pipeline is currently in pre-clinical animal studies analyzing efficacy, and the company aims to obtain non-equity funding for this important bio-defense sector.

AVI BioPharma has developed a leading-edge technological platform for the modulation of genetic expression in the treatment of diseases. At the core of the company’s innovations are novel modifications to the chemical structure of RNA, the polymeric molecule that is differentially expressed in unique cell types of different tissue (i.e. heart vs. brain). Using this technology, the company has developed a diverse product pipeline of therapeutic RNA oligomers. Unlike other conventional RNA-based compounds, AVI BioPharma’s therapeutics have enhanced efficacy and stability, improved safety profile, expanded flexibility for specified targeting to different organs, and can both down-regulate or up-regulate gene expression.

Specifically, the company has developed its lead candidates AVI-6002 and AVI-6003 for the treatment of Ebola and Marburg viruses, respectively. Both of these products function by distinctly suppressing the genetic expression of the viral genome, thereby stopping their proliferation. AVI has shown in preclinical trials that AVI-6002 and AVI-6003 reproducibly achieve high survival rates of 80% and 100%, respectively, in non-primate animals that have been challenged with lethal infections of Ebola and Marburg viruses. In light of these impressive efficacy rates, AVI has procured a Department of Defense contract valued at $290 million, as well as open Investigational New Drug (IND) allowances from the FDA. Phase-I clinical trials are currently underway for both AVI-6002 and AVI-6003.

AVI’s lead candidate is a splice switching oligomer for Duchenne Muscular Dystrophy, currently in Phase II. In addition, the company is in pre-clinical stages for treatments of hemorrhagic virus infections and influenza. In April, AVI announced a Phase IIb clinical trial for eteplirsen treatment of Muscular Dystrophy met its primary efficacy endpoint.

Tekmira Pharmaceuticals is an emerging biotechnology company that has developed an innovative technological platform to potently down-regulate genetic expression indicated for the treatment of diseases. At the foundation of the company’s platform is a breakthrough drug delivery technology termed LNP (lipid nano-particle), which is comprised of lipid molecules structured in a circular bi-layer that serve to encapsulate therapies and significantly improve drug stability, safety, and bioavailability in the blood stream. The company is using its LNP technology to deliver advanced therapeutic RNA oligomers (multivalent siRNA) that can significantly inhibit gene expression, but are limited by instability in the body. Tekmira has shown in preclinical trials that systemic administration of siRNA using LNPs effectively delivers drugs to target organs, achieving levels of gene suppression that were not previously possible using siRNA alone.

Tekmira’s lead candidate, TKM-Ebola, utilizes LNP/siRNA in conjunction to suppress the expression of the Ebola viral genome, thereby stopping the progression of Ebola infections. In pre-clinical trials using non-human primates, Tekmira showed that TKM-Ebola was able to provide complete protection to animals that were subjected to lethal doses of the Ebola virus. In July of 2010, Tekmira received a grant from the US Government’s Transformational Medical Technologies Program valued at $140 million for development of TKM-Ebola. Tekmira is currently undergoing plans to file an Investigational New Drug (IND) application with the FDA and initiate Phase I clinical trials for TKM-Ebola.

References

1.  Baize S, Leroy EM, Georges-Courbot MC, et al. Defective humoral responses and extensive intravascular apoptosis are associated with fatal outcome in Ebola virus-infected patients. Nat Med. 1999 Apr;5(4):423-6.

2.  Kortepeter MG, Bausch DG, Bray M. Basic clinical and laboratory features of filoviral hemorrhagic fever. J Infect Dis. 2001 Nov;204 Suppl 3:S810-6.

3.  Leroy E, Baize S, Gonzalez JP. [Ebola and Marburg hemorrhagic fever viruses: update on filoviruses]. Med Trop (Mars). 2011 Apr;71(2):111-21.

4.  Mupapa K, Massamba M, Kibadi K, et al. Treatment of Ebola hemorrhagic fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. J Infect Dis. 1999 Feb;179 Suppl 1:S18-23.

5.  Bannister B. Viral haemorrhagic fevers imported into non-endemic countries: risk assessment and management. Br Med Bull. 2010;95:193-225.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/04/ebola.jpg

New analysis from Frost & Sullivan has found that technology advances combined with the decreasing cost of automated systems is fuelling the growth of molecular diagnostics.  According to the report, European Molecular Diagnostics Market, which focuses on the oncology, genetic diseases, infectious diseases and pharmacogenomics segments, the size of the market is estimated to reach $1.5 billion by 2015.

However, translating research into proven clinical outcomes will be a significant challenge to the sector the report notes. Proving clinical validity is also often a requirement for reimbursement of a particular test. However, obtaining such clinical proof is an expensive, lengthy and complex process.

Frost & Sullivan Industry Analyst Dominika Grzywinska says that partnerships between test developers and companies specialized in marketing of such tests will be a way to address this. Already, the market is witnessing the emergence of several small market participants, often focused on one segment or even delivering one or a couple of products. These companies are often spin-offs from research institutes or universities. As they often lack the capital for further growth, there is the strong likelihood that they will partner with other companies to successfully market their products.

Enrollment in HIV trial completed

The enrollment in a 3,000-patient clinical trial to support of a Pre-Marketing Approval application to the FDA for Chembio Diagnostics’ (OTCQB: CEMI) DPP® HIV 1/2 Assay has been completed. The assay is a rapid point-of-care test for the detection of antibodies to HIV 1 and 2 in oral fluid, finger-stick whole blood, venous whole blood, serum or plasma samples that provides a simple “reactive/non-reactive” result. The test, the company reports, is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care settings such as public health and other clinics, hospital emergency rooms and physician offices. The DPP® HIV 1/2 Assay delivers visual results within approximately 15 minutes.

Diagnostic Core Facility Partnering Program launched

RayBiotech, Inc. reports that it has launched a partnering program for select diagnostic core facilities at academic and government research institutes in the United States and Canada.  Under the terms of the program, the facilities will be able to provide proteomic analysis services, such as biomarker and proteomic analysis, as a component of their current services offerings at no cost to the core facilities.  The ultimate goal of this program, the company says will be to aid researchers in accelerating drug discovery, drug target validation and disease-related efforts with an emphasis on impacting cancer and other disease-specific research initiatives.

Skin cholesterol testing programs for Canadians

Winnipeg-based Miraculins Inc. reports that its PreVu® skin cholesterol Point of Care test will be distributed to the Canadian retail pharmacy market by Pear Healthcare Solutions Inc., a provider of in-pharmacy health screening and education services.

Test for Fragile X Syndrome launched

JS Genetics says that it has launched a buccal swab test for the detection of Fragile X syndrome. The PCR based test, designated XCAT-FX, can identify Fragile X in both males and female patients with results typically available within three business days.

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MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/04/forecast-in-diagnostics2.jpg

OneMedPlace is pleased to announce a special interview series exploring current issues facing the diagnostics sector and life sciences in general with Dr. Qin Shi, Managing Principal of Edgetech Law.

The series features segments of a Q&A session covering many aspects of the sector, from intellectual property and patenting issues to emerging markets in China. Along the way Dr. Shi discusses what makes Edgetech Law unique, the challenges and opportunities of company growth advisory in the space, and what particular technologies an investor may find irresistible.

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Part I of this interview series is a discussion of Mayo Collaborative Services [Mayo Clinic] v. Prometheus Laboratories, Inc. and the current landscape of patents in drug development and development of companion diagnostics. The diagnostic world especially may be experiencing a paradigm shift in what is accepted, as the push for preventative and personalized medicine requires the customizing of natural processes in the body.

On March 20, the Supreme Court held that two patents related to a diagnostics test owned by Prometheus were ‘underlying laws of nature,’ and thus could not be protected against the unauthorized use by the Mayo Clinic. The decision, ruled 9-0 in favor of the Mayo Clinic, was met with criticism by the pharmaceutical community, expressed mostly by the perception that strongly protected patents are essential to incentivize the risky, expensive, laborious process of drug development and the development of novel diagnostics as well as combined diagnostics-therapeutics.

Out of this ruling arise several issues related to business practice as well as the philosophy of science. Are these semantics rulings, meant to further tighten the regulatory process, or indications of a larger precedent? Can natural elements of the body, identified as biomarkers, be patented? What about the process taken to identify the biomarkers, or the conclusions and treatments we draw from it? Will ‘unpatentable natural law’ inherently lead to a ‘chilling effect’? Do for-profit entities have a responsibility to share their findings with non-profits?

Dr. Qin Shi joins OneMedPlace CEO Brett Johnson for a candid look into the future of intellectual property in the realm of diagnostics and personalized medicine. Though Dr. Shi describes the decision as a “setback,” she proceeds to outline how companies can position their IP strategy to grow despite the tightened leash. The leader of a veteran law firm with unique ties to the business of diagnostics, Dr. Shi examines in some details the rationale of the courts and how companies can continue to grow.

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Brett Johnson:      What advice are you giving to your clients about this new development in IP law?

Dr. Qin Shi:       The Prometheus decision undoubtedly represents a setback for IP owners, especially in the diagnostics space. However, the Court’s reasoning also says to me that there are ways to navigate this ruling and maximize the scope of protection surrounding diagnostics businesses. I advise clients to avoid simple correlations that appear to be natural phenomena or law of nature. Beyond that, there is still much to capture creatively.

Brett Johnson:      How will companies begin to protect what may be deemed as “unpatentable natural process”?

Dr. Qin Shi:       The operative term in the context of Prometheus and related cases is “patent eligibility,” as opposed to “patentability” per se. In fact, the Court’s opinion seems to have the problem of conflating the patent eligibility considerations under Section 101 of the Patent Act with the patentability tests set forth in Sections 102 and 103. The Prometheus opinion appears to look for combined 102 novelty and 103 non-obviousness analyses in the context of the patent eligibility inquiry.

This is problematic of course, for the Court’s jurisprudence in this area. But put that aside, it’s extremely confusing for companies looking for guidance as they compete in the market. However, it may be a silver lining that the Prometheus Court in reaching its holding did not enunciate a new, bright-line patent eligibility test. Again, one must look at facts and circumstances on a case-by-case basis. Under Bilski v. Kappos, the machine-and-transformation test was held to be useful, but not required or exclusive, in patent eligibility determinations.

BJ:      So in order not to be held as a natural process that is not eligible for patent protection, how should companies position their business or IP strategy?

QS:      If you are working with biomarkers, you might want to look beyond merely the markers, and at all possible applications for the subject matter of protection. In other words, as part of your business, are you developing or selling smart devices, kits? Are you coming up with novel improvements on existing instruments in order to adapt them for analyses based on the new biomarker? Can you find ways todevelop new reagents or improved formulations that would work with the new markers? And so on.

For those who would like to push the envelope and see how much more “upstream” one might be able to go in terms of patent protection on biomarker-related technologies, my advice would be, again, forget about simple correlations. Instead, consider profiles, matrix – some creative patterns and statistics that would shed light on disease conditions or patient prognosis or therapeutic responsiveness. These things are not simple natural phenomena, or simple law of nature.

Now, one needs to be clever in figuring these things out as a matter of science, business, and IP. Don’t forget that you would want to avoid going after pure mathematics or algorithms or have the appearance of doing so, as well.

BJ:      Outsiders often wonder whether there is a trend the Supreme Court is adhering to in making these decisions, Prometheus and the like. Are they trying to establish precedent or are they looking at case-by-case basis?

QS:      It seems as though how the Court came out in a particular case may have more to do with the timing and circumstance, and even the political climate at that particular point. The Roberts Court has been very occupied by some very high-profile cases such as Citizen United, the Obamacare case, and so on.

It would be unsurprising that some justices simply gave less attention to patent cases and went with the champion for a particular position at times. That champion in Prometheus was of course Justice Breyer.

Speaking more generally, it appears true and perhaps of concern, that this Court has tended to be influenced in its analysis of patent questions by inchoate constitutional law – civil liberty law concerns—and have tended to pay lesser attention to the intricacies of the patent law traditions. To me, this means both challenges and opportunity. It means that the IP owners in the diagnostics industry and other industries need to do abetter job to educate the Court and courts, and to bring them near the realities of the industries – where IP is front and center and where technology is the engine for growth. By the way, that’s the reason why our practice also includes appeals and amicus briefing for matters of broad impact.

BJ:      Is there a role of protecting nonprofits and academic institutions in this decision? Would these decisions be different among company-to-company lawsuits?

QS:      It would be hard to say that with a different set of litigants, both for-profit companies, the Court would come out differently given the same facts at the time. However, in patent cases involving genes, biomaterials and so on, courts do pay a lot of attention to the arguments for public access and for uninhibited basic research. To that extent, it is possible that Mayo, being a non-profit, may have benefited from such sentiments, something easily shared by the Justices across the political spectrum. Although, as a footnote, in that case Mayo was commercializing its own diagnostics test and the activities in question were not strictly non-profit.

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Drug developer AVI Biopharma Inc. said Thursday that Chief Scientific Officer Peter Linsley will resign from the company on June 1.

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OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, recently announced the closing of the sale to institutional investors of an aggregate of 31,000,000 shares of its common stock at $0.25 per share in a registered public offering.  Additionally, investors received Warrants to purchase up to 31,000,000 shares of common stock at an exercise price of $0.35 per share for a term of five years.

The gross proceeds of the offering were $7.75 million and net proceeds, after deducting the placement agent’s fee and estimated offering expenses payable by OncoSec, were approximately $7.2 million.

OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.

Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM), acted as the exclusive placement agent for the transaction.  Roth Capital Partners, LLC served as financial advisors to the Company in the offering.

Below, OneMedRadio interviewed OncoSec CEO, Punit Dhillon, where he candidly discussed the company’s technology and projected milestones.

Click below to hear full audio interview.

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PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that it had received approval from the Brazilian government to market its innovative RenalGuard System™ in that country. PLC’s exclusive distributor in Brazil, DISCOMED Comercio de Produtos Hospitalares Ltda., Porto Alegre, Brazil, secured approval for both the RenalGuard® system and its single use sets through ANVISA, the Brazilian registration authority. Discomed is now beginning launch efforts in Brazil, including placing an initial stocking order, scheduling training sessions and promoting RenalGuard to medical professionals in the market.

Brazil is the fifth largest country in the world, by population, and has a rapidly growing healthcare market. PLC appointed Discomed as its exclusive distributor for this region in late 2009.

“Approval to sell RenalGuard in Brazil is yet another significant development for PLC,” said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. “Brazil is a pivotal country in South America, where new medical technologies are often first demonstrated, and we’re delighted that Discomed is now ready to work with us to launch RenalGuard formally in this market. Following our launch in Israel earlier this month, today’s announcement will certainly help drive increased adoption of RenalGuard worldwide.”

PLC Systems Inc. , headquartered in Milford, Mass. , is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC’s newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain cardiac and vascular imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard’s effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.

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ALS, also known as Lou Gehrig’s disease is a neurodegeneration disorder similar to MS, but with no known treatment.  ALS Therapy Development Institute, is the first non-profit biotech seeking to find a treatment and potentially increase the quality of life for individuals living with this illness.

Founded in 1999 and based in Cambridge, Mass,  ALS TDI is on the fast track to finding a successful drug that works. OneMedRadio had the pleasure of sitting down with CEO and CSO, Dr. Steve Perrin to discuss this debilitating disease and why its important to move quickly in discovering a treatment.

Strategically, the organization has done a good job in moving drugs through clinical trials but lacks venture capital funding. But the benefit investors stand to gain is a major stakehold in the drug with a low investment. Quite an opportunity.

Brett Johnson:       Hi, this is Brett Johnson in New York City with OneMed Radio. Today, we are with Dr. Steve Perrin who is the CEO of the ALS Therapy Development Institute, a Cambridge, Massachusetts-based organization focusing on finding a cure for ALS. Thanks for joining us today, Steve.

Dr. Steve Perrin:     Thank you much. Appreciate your time.

BJ:      So can you go ahead and tell us first, what is ALS?

SP:     Sure. ALS or amyotrophic lateral sclerosis, it’s also often called Lou Gehrig’s disease is a really devastating disease. It’s a progressive neurodegeneration of the motor neurons in the spinal cord that basically innervate all of the muscles in your body and when those nerves die, you basically progress up, we become more and more paralyzed. Usually, the disease appears somewhere in the fourth or fifth decade of life. There is no susceptibility difference between males and females so you’re as likely to get it if you’re a woman or a man. The incidence is increasing in younger folks. We have seen in the last decade or so people in their 18s, 20-year-olds getting this disease, which is also quite devastating.

There is no effective treatment at this point in time for the disease and within three to five years after your first signs or symptoms, they usually end up succumbing to the disease unfortunately. So it’s very, very devastating on the patient, families, and caregivers. It’s a huge and significant unmet need, you know, in the medical organizations in the US as well as around the world. It is sort of an orphan disease. There’s only about 30,000 people in the country with a formal diagnosis at any given time.

BJ:     Interesting. So what has been the development of treatments in the past? I mean what’s the current status of what’s out there?

SP:     So if you would ask the researcher in pharma or biotech 25 years ago how you were going to develop a drug to slow down or cure ALS, the focus really would have been on saving the motor neurons up in the spinal cord that I mentioned are dying during the disease. But we now know that that philosophy was pretty naïve and it was mainly because we just didn’t understand that much about the disease. The thing that’s really exciting that’s happened in the last decade for ALS patients and opportunities for drug development is we now understand that other cell types within the spinal cord are also players in the disease and we also know that there is some tissues such as skeletal muscle and peripheral nerves outside the central nervous system that are also affected by the disease, and that opens up new opportunities to develop drugs to slow down and stop those processes.

So we’re starting to see some better drugs moving towards the clinic because we understand the disease much better than we did even a decade ago, which is exciting for patients and, you know, pharmaceutical companies and biotechs that are working in this field.

BJ:     So what role do you guys play in sort of the ecosystem or the development process of new drugs and treatments?

SP:   Sure. So we are the only nonprofit biotech in the country actually, which is a very unique business model. So we are a true 5013c nonprofit, but we behave much more like a traditional biotech organization. So we were founded in 1999 so we’re not a fly-by-night organization. Our mission has never changed. Our goal is to facilitate the development of effective treatments for ALS patients and we’ve become the world leader in preclinical drug development for ALS. What I mean by that is we have several mouse models for the disease. We have 26,000 square feet of lab space here in Cambridge. We run more drugs in the animal models of ALS than the entire academic community combined. We’ve run about 200 drugs in the models since I’ve joined the company in 2006. We have two drugs now moving into phase 2 clinical trial so as a proof of concept for the rigor of our preclinical work, we’ve been quite successful and we will not stop until we have a host of successful drug candidates moving towards the clinic for patients.

So we have 32 full-time scientists in Cambridge. All of us have been trained and have experience in drug development in biotech or pharma so we have a lot of skin in the game and again, our passion and our drive is to really serve our constituents, which is our patient community.

So, you know, in order to achieve our goal, we’ve utilized both our nonprofit and for-profit strategies and capabilities. So as a nonprofit we can approach biotechs and pharmaceutical companies and ask to end license their drugs and test them in our animal model and again we don’t want a lot of return on investment because we’re a nonprofit. They can own most of it, but if we see positive data, our mandate is to make sure that the contracts are drawn up so that they will help us push it towards the clinic and towards our patient community.

We leverage our nonprofit status in other ways such as getting fee-for-service work. We’re only a 32-person company but we have the ability for instance to make protein biologics. We’ll make these stable cell lines here but obviously don’t have the manufacturing capability but we have a deal with Lanza and BioEXCEL to make our protein biologics in large scale once we make seed cultures and stable clones. They may do it at cost and take a tax write-off for the rest of it because we’re a 5013c. So we leverage our nonprofit status to really build our resources and build a community.

As a biotech, we have 32 scientists that are really skilled at the processes of sophisticated drug development from pharma. So we do full blown pharmacokinetics, pharmacodynamics, survival and efficacy studies. We do biomarker of drug efficacy in vivo to help facilitate clinical development. So we really understand the process of drug development as folks that have been trained in the biotech and pharma world.

BJ:      So what kinds of organizations could really benefit from what you do? I guess private investors or venture capital funds or large pharma? I mean who can really capitalize on this that may not be capitalizing on it today?

SP:    Yes. So that’s the key point of the folks that might not be capitalizing today. You know, strategically, we’ve done a pretty good job as we get compounds through preclinical and show proof of concept in animal models. We’ve done a pretty good job of trying to bridge that gap and getting it towards pharma hence we have two phase 2 trials that we’re initiating this year.

But where we haven’t done a great job and I think that folks either because they don’t understand our business model yet or we haven’t figured how to work with them is we don’t have angel funding yet, we don’t have any venture capital funding yet and I think that that’s a huge opportunity for those types of stakeholders as well as for us to invest in these early stage programs, but to really change the paradigm of the business model if you will because we’re not looking for tens of millions of dollars of investment there.

It typically costs us somewhere between $1M to $3M to go from a target that we think is exciting to developing a compound to hit that target making sure that that drug has functional activity in cell lines, doing pharmacokinetics in mice to look at biodistribution and understand dosing and half of the drug, executing very highly powered survival studies to see if the drug slows disease. That process takes us about 18 months to two years and costs again $1M to $3M. If somebody wanted to come in and invest in a piece of a program like that, we would give them a major stake hold of ownership in it. Again, it’s high risk because it’s very early on, but that’s not a lot of money to own 30% to 50% of a drug moving forward.

To own a drug in the ALS space is a huge business opportunity. It’s a billion-dollar market space for a disease-modifying drug and it’s a low hurdle through the FDA because there is no effective treatment. So it is high risk. It’s a low investment if you ask me and the upside if you get a compound that actually works is instantaneously a blockbuster disease indication. So there’s quite an opportunity. We run about 30 drugs per year through our pipeline so we have quite a robust capability that’s completely funded at this point by ALSTDI and a grassroots fundraising endeavor so –

BJ:   How many drugs could you – I mean I guess can you minimize your risk by leveraging it across a broader spectrum or broader number of compounds that you’re going to pursue? How many could you develop? I mean how many could you test out? How many ideas are there that could be developed?

SP:    So one of the things that we did when I first joined the organization back in ’07 is we did a lot of molecular profiling of three or four animal models of the disease as well as about 4000 ALS, human ALS biopsy samples. We identified about 150 druggable pathways that are going wrong during the disease in various tissues. Some of the pathways are going wrong in peripheral nerves, some of them are going wrong in skeletal muscle where the innervation happens, some of them are going wrong up in the spinal cord, some of them are immune targets that are upregulated in the spleen or in lymph nodes for instance. So out of each one of those pathways, there’s anywhere between 10 and 40 druggable targets.

So we start doing the math, you know, we’ve got a couple of thousand druggable targets that we’re systematically working our way through. Some of them obviously don’t pan out and they’re not promising and some of them are actually quite exciting, but drug development is always challenging. Even sometimes when you have a drug that hits a target and it works in cell based assays, when you start trying to put in mice it has toxicity and you have to go back in the drawing board and do some chemistry on that particular compound to make it suitable for chronic dosing. Those are the types of things that it’s this two steps forwards, two steps back process that you can’t always foresee.

But as far as capacity, I mean right now again we run about 30 compounds a year through the process. If we have the resources, we could probably double that number. Drug development is resource intensive and we are right now limited by our financial ability to screen more compounds than about 30 per year on our current budget.

BJ:     Uh-hum. And what are the odds that from the 30 in a year that you can come across one that could end up getting to the market?

SP:     Well our shots on goal are getting more and more accurate I might argue. You know, again as I said earlier in the conversation, ten years ago I would argue from a drug development perspective we were throwing darts at a dartboard with a blindfold on. We just didn’t understand the disease well enough. As I said in the last couple of years, we’ve now had two compounds out of about 150 that we’ve screened that are now – you know, they’ve both demonstrated the ability to slow down disease progression and improve survival in the animal model. We optimize dosing in the animal model. We identify biomarkers of drug response that are amenable to translation to the clinic so that can help with phase 2 clinical trial design and early prediction if the drug is working in people. So that was two compounds in the last three years so if we run about 30 a year it was 2 out of 90. It’s not a terrible hit rate in drug development.

So and again I think as we’re learning more about the disease, those odds are going to improve. It is still high risk; I’m not going to kid you. If 1 out of 30 per year starts to show promise and within 18 months after that we can get it moving towards proof of concept in man, I consider that to be an incredible success rate.

BJ:   And the reward could be substantial, you know, if one of these gets all the way through. I mean what’s the return?

SP:      The return is unbelievable. I mean again you can charge premium price point for a devastating disease like this. I mean you look at new drugs entering these types of markets either in the enzyme replacement field such as the Genzyme model, those were therapies that are disease modifying that are getting premium prices at $200,000 a year per patient. Even new drugs entering the MS space such as Gilenya from Novartis, the price point for that drug is $55,000 a year for a patient.

So, you know, if you look at the incidence rate of ALS compared to multiple sclerosis, it’s identical. There’s about 5000 new MS patients diagnosed per year. There’s about 5000 new ALS patients diagnosed per year. There’s about 600,000 people walking around with multiple sclerosis and there’s only about 30,000 people with ALS, but that’s because MS now has seven disease modifying drugs that are FDA approved that patients can take and it slows down their disease and it improves their quality of life. If we had seven drugs in the ALS space, you’d go from 30,000 patients to 300,000 or 400,000 patients really quickly. In the MS space in the US is a $12B a year field for people that have invested in it. So the upside is huge. The first disease modifying drug could instantaneously become a billion-dollar product.

BJ:    Wow. So it sounds like there’s some considerable upside. So what would be a next step if an investor is interested in this? How do they proceed with your group?

SP:  I think the best thing for an investor to do is to come up and learn about who we are. Come and visit our lab and sit down, we’ll walk you through our business model, walk you through what a nonprofit biotech research institute is, what our goals are, how we collaborate and work with other groups. Again, we have collaborations with six or seven small biotechs where they couldn’t afford to run their compounds in ALS but we thought that their compounds were interesting because they hit interesting targets. We’re running those compounds for free right now and we own half of those drugs if they worked going forward. They should come up and get a flavor of how we do business and how our drug development process works and how quickly we move.

We move much more quickly in our projects than traditional biotech and pharma does and that’s because our mission is driven by a very different paradigm. We don’t have a commercial organization that dictates what we should be working on and what we shouldn’t, our science team does that. So we make much quicker go, no go decisions on programs than what most folks are used to seeing and I think that’s a great first step. Come up and visit TDI, sit down with us, we’ll talk about our business model, we’ll talk about our project portfolio where things are in the value chain and how resources could help drive projects forward quicker.

BJ:     So, Steve, could you take a minute and tell us a little bit about your background and how you get involved with ALS?

SP:   Sure. I very early on in my career decided that academia wasn’t for me so shortly after becoming an assistant professor at BU medical school, I jumped into biotech because I really saw early on that I wanted to make a difference in patients and I really wanted to work on drug development. So I joined a very small biotech in Cambridge. I was there for quite a few years setting up a molecular profiling team. I moved on to what is now Sanofi Aventis, but at the time was Hoechst Marion Roussel and lived through several mergers with Hoechst Marion Roussel with other groups into Aventis, which later became Sanofi Aventis. I was director of molecular profiling there for about seven or eight years. I set up a high throughput sequencing core. I set up a high throughput gene expression profiling platform. I worked with a bioinformatics team on microarray development and other types of technologies for pretty much the entire Aventis organization.

After Aventis I moved to Biogen Idec. I had a very similar role there. I was director of biomarker development there for all of their preclinical and clinical programs and at one point in time, the organization wanted to expand its capabilities or commercial interests in other neurodegenerative diseases and ALS was on the radar screen. They made me head of the ALS program because the first goal was to identify druggable targets and that’s basically a molecular profiling exercise. So I ran Biogen’s ALS program for about four years or so which is how I got to know the people here at ALSTDI. Biogen’s headquarters is right down the street. We kept bumping into each other at meetings and when they were looking for a chief scientific officer, they really asked me to join and try to make an impact on their ability to more successfully move drugs through the process. So I joined TDI back in 2006 and I haven’t looked back. It’s been quite a rewarding experience.

BJ:     Well it sounds terrific and I know you’ve been making some huge progress there developing the organization so. Thanks so much for joining us today.

SP:  I really appreciate your time. Thank you.

BJ: That is Dr. Steve Perrin who is the CEO of ALS Therapy Development Institute, a Cambridge, Massachusetts nonprofit focusing on finding a cure for ALS. This is Brett Johnson in New York with OneMed Radio. Have a great day.

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On March 29, a US federal court validated the formulation patent for AstraZeneca’s (NYSE: AZN) big-selling anti-psychotic drug Seroquel XR. The ruling thus determined that various companies seeking to sell cheap generic versions of the medicine, including Mylan, Inc. (NASDAQ: MYL), had infringed on the patent.

In light of this ruling, OneMedPlace is publishing a special in-depth look into the state of patent infringement in drug manufacturing. Patent infringement in healthcare is a hot-button issue in the legal realm and private sector, and the recent AstraZeneca ruling drew upon untested legal precedent. Some decisions are but a few weeks old, and many cases are still in the appellate process.

In Part One of our series, we dissect the most recent compelling case and the immediate reaction of company insiders. This case seems to demonstrate the Courts are preparing to strictly define the limits of commercial imitation versus philanthropic or nonprofit imitation.

Part Two looks at a similar case (currently in appeals) that seems to contradict future rulings. However, the intricacies of the technology may hold the key – it may explain the legal logic, but the details may alter the development of personalized medicine.

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The healthcare industry is experiencing the aftershocks of several landmark cases that may redefine the definition of intellectual property, and as such these decisions may change the strategy of emerging companies with unique technology.

On March 20th, the US Supreme Court ruled 9-0 in favor of the Mayo Clinic in its appeal against Prometheus Laboratories over infringement of two patents related to a diagnostic test. The Mayo Clinic, a former client of Prometheus, developed its own version of a test based on drug metabolites in the blood.

The lawsuit originated in 2004 after the Mayo Clinic developed its own version of the blood test, which is used to determine the optimal drug dosages for patients with autoimmune diseases such as Crohn’s disease. The test involves administering a drug called thiopurine to patients and then determining the levels of thiopurine metabolites in the patient’s red blood cells.

The Mayo Clinic claimed they did not have to honor the Prometheus patents because the company cannot own a monopoly on the metabolites created by a drug. The Supreme Court agreed; in the ruling, Justice Stephen Breyer wrote: “We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid.”

In a New York Times story, Prometheus said that the decision against it “will, in our view, encourage imitation, not innovation.”

Bernard Greenspan, Director of Intellectual Property for Prometheus Laboratories, said that current patent law places the burden of stopping infringement squarely on the shoulders of the patent holder. Monitoring and distinguishing both non-infringing and infringing actions “will only add costs and redirect resources from new developments,” he said in a recent Genetic Engineering and Biotechnology News story. It would be difficult for labs to conduct confirming tests without infringing on the patents of primary test developers, he said of this ruling, a counter-intuitive detriment to further medical research.

“The chilling effect on research and development of new and innovative tests created by a carve-out to a non-licensed party to avoid infringement will be far-reaching,” Greenspan said. “Established companies, university technology transfer offices, and job creation by startup ventures will be faced with the proposition that they will lose proprietary benefits of patents. Any steps taken to weaken those rights, while having a presupposed short-term gain in access to current technology, will result in long-term reduction of investments needed to commercialize future innovations thus creating a decrease in access to future technologies.”

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The global demand for Biosensors in Medical Devices is forecast to reach $16.5 billion by the year 2017, according to a new Global Intelligence Alliance report. Biosensors have been in the developmental phase since early 1990s, and are increasingly finding applications in blood glucose monitoring, drug discovery, drug analysis and whole blood analyzers. Some experts believe large pharmaceutical companies have reached a plateau in market growth. However, that doesn’t tell the whole story, as new companies with disruptive technology have made some significant advancements in 2012.

EKF Diagnostics (LON: EKF), NeuroMetrix, Inc. (NASDAQ: NURO), PositiveID Corporation (BB: PSID), and Bio Tex, Inc. are four small companies making innovative advancements within the space of diabetes diagnostics. These advancements range from the areas of molecular diagnostics to laser technology.

On March 19, 2012, EKF Diagnostics (LON: EKF) announced a new β-Hydroxybutyrate LiquiColor® kit, which detects blood ketone in plasma and serum specimens. Blood ketone is essential for the identification of complications of diabetes mellitus, as during periods of metabolic acidosis, the concentration of ketone bodies increases in blood and urine due to the lack of sufficient glucose in the cells.

NeuroMetrix, Inc. (NASDAQ: NURO), a company that researches the diagnosis and treatment of the neurological complications of diabetes, recently showcased a new diagnostic test at the Diabetic Foot Global Conference (DFCon) in Los Angeles. The NC-stat® DPNCheck(TM) is a fast, accurate, and quantitative diagnostic test that is useful in the early detection and monitoring of diabetic peripheral neuropathy (DPN), a nerve disease that affects more than half of diabetes patients and can lead to foot ulcers and amputation.

PositiveID Corporation (BB: PSID), an emerging developer of advanced technologies for diabetes management, announced this month that it was awarded a U.S. patent for its Dragonfly(TM) Rapid MDx Cartridge-based diagnostic system. Dragonfly provides the ability to deliver molecular diagnostic results from a sample in under half an hour, and enables accurate diagnostics leading to the potential treatment scenarios at the point of care that are not possible with existing systems.

BioTex is a privately-owned company developing innovative technologies that allow rapid, painless and convenient access to accurate blood glucose readings without the need for blood withdrawal. BioTex has developed an implantable “window to the body” which allows near-infrared radiation to be used to measure blood glucose “non-invasively.” BioTex has also developed a small, transcutaneous, implantable “skin-port” which allows painless and rapid withdrawal of interstitial fluid for glucose monitoring. The company is also currently working on development of an advanced implantable polymer sensor containing glucose sensitive near-infrared fluorescent chemistry.

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The Food and Drug Administration must act – and quickly – to enforce a largely ignored 35-year-old mandate prohibiting non-medical use of antibiotics in farm animals, a federal court judge ruled last week.

In 1977, the FDA issued an order banning the use of penicillin and tetracycline in farm animals after concluding that overexposure of the drugs in animals weakened the treatment’s effectiveness on humans. The mandate may have passed, but fierce pushback from farmers and lobbyists halted enforcement of it, as groups successfully argued that antibiotics are needed to keep animals healthy.

Many public health advocates dispute the claim, and believe non-medical use of antibiotics, mixed into farm feed, is a direct cause in the surge of drug-resistant bacteria and ‘superbugs.’

Natural food producers, safety awareness organizations and consumer advocacy groups have taken frequent action against the FDA, and in May 2011 the Natural Resources Defense Council sued the FDA for failure to enforce the law. Despite FDA claims that new mandates, such as requiring veterinarian consultation before delivering the drugs, the federal court ruling now forces the FDA to begin steps to actually withdraw approval of antibiotic use in farm animals. The ruling will not immediately stop the practice, but will force regulators and drug makers to hold public hearings, which may be the first steps in changing the nature of farm animal care.

Several media outlets reported on issues leading up to the ruling and the fallout in the past few days, offering various perspectives.

Here are some highlights:

The New York Times gives a summary of the ruling, what is expected of the Executive Branch, what public hearings must come, and follows the legal history of antibiotics use in farm feed.

The Chicago Tribune discusses the power of social media in identifying non-kosher activity in the food industry.

The International Business Times explores the issue of superbugs within the backdrop of the Society for General Microbiology conference.

NPR discusses animal antibiotic standards and practices in Europe. The piece takes a special look at Denmark, described as a “pork powerhouse.”

ABC News lists the most dangerous superbugs and the origin of the issue.

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Despite political contention over the influence of corporate America in shaping the American Dream, our nation’s leaders tend to unite in their respect of small business. Lawmakers ‘walked the walk’ last week, as the Senate passed an amended version of the Jumpstart Our Business Startups Act (or the JOBS Act) with broad, bipartisan support.

The House passed the bill the previous week, which means the JOBS Act faces little obstacles as it is finalized into law.

The concept is relatively simple: The act decreases regulations for small companies in obtaining startup funds. The practice is autological: small companies can proceed in organizing direct, small investment campaign with individuals, akin to a large group ‘pooling’ their money. The bill allows a company to raise up to $2 million. One investment will typically value between $1,000 and $30,000, depending on the site and investor qualification.

Until the JOBS Act, the law had clearly defined crowdfunding as acceptable for projects and donations, not businesses. ‘Financiers’ could receive complimentary rewards in return for investments, however equity crowdfunding – expecting a payback on an investment – had been illegal. Logically, the SEC still regarded these investments as sales of securities, which thus required the use of registered brokers.

This Act can be considered both a proactive and reactive response to the power of the internet and social networking. Microfinancing has of course existed since this country’s inception, but, surprisingly not on the internet until recently. Still, there exist several case studies of successful crowdfunding initiatives.

Crowdfunding is popular among nonprofits (and appeals to celebrities, like actor Ed Norton’s Crowdrise site) and it has also succeeded in the music/film/entertainment space, both in funding a particular project as well as record labels and media companies. The second tech boom has benefited from crowdfunding, both in building websites and in developing hardware and accessories. Some sites, like MicroVentures and Xpert Financial, are registered brokers, and thus create investment opportunities and secondary markets for the startup private sector.

The JOBS Act gained favor in the political realm because it encouraged entrepreneurship, increased employment and manufacturing. Now, with the lightened regulatory rules, small and startup companies can lead more aggressive campaigns across with more lofty goals. The deregulation may entice more traditional industries and sectors to consider crowdfunding a viable option. Further, this Act is thought to give a new socio-economic group the power to invest and own. Idealistically, this concept stimulates the American Dream, but more tangibly, proactive investing stimulates the economy.

Still, there exists sizable opposition to the act, critics who argue both the implementation issues and the fundamental threats to the economy. With less polished sites that do not employ traditional financial advisory (investor questionnaires, risk disclosure, etc.), will investors properly understand the magnitude of their financial decisions? How easy will scamming be, and who is responsible for retribution?

In reality, this Act may be a “relief package” for public companies that can dodge disclosure rules and investor protection mandates previously outlined in Sarbanes-Oxley, according to Bloomberg. A new class of emerging growth companies, with millions in revenue, can gain the capital to immediately go public, yet be given the freedom to operate up to five years without an independent test of their internal operations, according to the opinion piece. Further, what regulations are in place to prevent ‘pump and dump’ PR operations and analysts from misleading investors? Can clearly biased analysis be masked as independent analysis or sell-side research?

These questions address a major philosophical issue of fundraising and investment. Can naivety coupled with low-risk lead in fact lead to an unstable and dangerous investment environment?

High net-worth investors do not expect immediate returns on investments, and perform countless methods of due diligence before making decisions. They rely on reputation of other investors and management, a privileged network of individuals they trust, analyzed and re-analyzed market trends, experience as an insider and years of success in the space. The JOBS Act now introduces a new group to investment opportunities without providing the authoritative framework that advisors and placement agents bring. Will the ‘low-risk’ investors act intelligently, and more importantly, will the companies act responsibly?

Does a privileged group of high-net worth, high-risk investors inherently lead to stability? Does this stability require third-party underwriters and analysts to ensure growth?

Stay tuned for Part II: How Crowdfunding Can Affect the Healthcare Market, and Your Wallet, published March 28th, 2012.

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Quidel Corp. (NASDAQ: QDEL) reports that it has received 510(k) clearance from the FDA for its Molecular™ Influenza A+B Assay for the detection of influenza A and B for use with Cepheid’s SmartCycler® PCR system. Quidel received FDA clearance in December to run its Quidel Molecular Influenza A+B and hMPV assays on Life Technologies’ Applied Biosystems® 7500 Fast DX thermocycler.

The product was launched in Europe for use with both thermocyclers shortly after receiving the CE Mark in August 2011.

Ariosa completes study for prenatal test

San Jose, Calif.-based Ariosa Diagnostics (formerly Aria Diagnostics), says that it has completed a clinical validation study for the Harmony™ Prenatal Test. The test utilizes a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood. The company will be providing details about their proprietary biochemistry and algorithm platforms, which work together to analyze patient samples in order to provide individualized risk scores at the 2012 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting in Charlotte, N.C.

Clearbridge BioMedics  launches its ClearCell system

Clearbridge BioMedics is reporting that it has achieved ISO13485 certification for the development of cell-based in-vitro diagnostic devices and has launched its ClearCell™ System, for the cancer research market. The company says that it is one of the world’s first commercially-available systems that can successfully isolate circulating tumor cells (CTC) from blood, using biomechanical properties. The system can retrieve intact and viable CTCs in their native states, without the use of antibodies or magnetic beads. This will enable cancer researchers to better understand the relationship between such cells and mechanisms of cancer. The ClearCell™ System will be showcased at the American Association for Cancer Research annual meeting, from March 31 to April 4, 2012 in Chicago.

Statins compliance in patients linked to knowledge of gene test results

According to a study there is evidence that genetic tests can influence behavior, as well as helping physicians more accurately diagnose and treat disease.  Patients who are told of their test results are more motivated to regularly take and stay on medications to treat high cholesterol.  The results of the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) study was presented by investigators from the Medco Research Institute™, a subsidiary of Medco Health Solutions, Inc. (NYSE: MHS) and Quest Diagnostics (NYSE: DGX), at the American College of Cardiology’s 61st Annual Scientific Session & Expo.

The study examined medication adherence of 1,294 patients that were newly prescribed statins.  A laboratory-developed gene test to measure kinesin-like protein 6 (KIF6) carrier status was provided to 647 patients while 647 patients in the control group did not receive a genetic test.  The two groups were matched for age, gender, prescription distribution channel, and the number of chronic medications used.  After controlling for other patient characteristics known to affect adherence (such as co-morbidities and socioeconomic status), tested patients who were informed of their test result had significantly higher overall adherence to their statin treatment as measured by the proportion of days with medication on hand over a six-month period, the study’s primary end point (77 percent of days covered versus 68 percent).

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New York Biotechnology Association (NYBA) has announced that it will develop its Emerging Companies Showcase at the NYBA 21st Annual Meeting, May 2-3 in New York City, through a partnership with OneMedPlace, a New York research and media firm that provides a communications platform for promising healthcare and life science companies.

NYBA is the leading advocate for advancing the success of the life science industry in New York State and is its main representative to state policy makers, the media and communities. NYBA’s mission is to support the development and growth of New York’s life science industry, and serve our members and the life science community by providing a network for information exchange, shared services and collective action.  NYBA’s membership comprises bioscience companies, world-class research institutions and related professional services. Under the banner of The Cures Start Here®, the Association’s goal is to amplify the success New York has had and continues to have in growing a vibrant life science industry.

OneMedPlace will be organizing a company showcase that features short presentations designed for investors interested in learning about the next new ideas and companies. The communications firm uses a unique mulitmedia platform that includes research, radio and television broadcasts, industry news and databases to reach a global audience of strategic and financial investors. Companies interested in presenting should contact OneMedPlace. Qualified investors will receive complimentary registration to the Showcase.

“Helping promising life science companies is at the core of our mission,” said Nathan Tinker, Ph.D., Executive Director of NYBA. “OneMedPlace has a proven platform with growing reach that we feel can be very helpful in providing an economical means for companies to accelerate access to capital and partners.”

“This is a terrific opportunity to provide these companies with unprecedented multimedia coverage,” said OneMedPlace CEO Brett R. Johnson. “NYBA is an authoritative figure in the industry, and it will benefit both emerging company leaders and potential investors to expand their voice.”

In January, NYBA co-hosted the successful Fifth Annual OneMedForum in San Francisco, which attracted over 90 presenting companies as well as several hundred institutional and high net worth investors, among its almost 1,000 attendees.

OneMedTV, an internet video streaming service, will webcast these presentations live on the internet, beginning May 2nd for registrants. These presentations will also be archived to provide an efficient means for investors around the world to learn about these firms.

Companies and organizations attending the event include: Pfizer, Genentech, Roche, Amgen, Merck, Novo Nordisk, Philips Life Science, Johnson & Johnson, Eli Lilly, Orbimed, Aisling Capital, Lazard Frères, NYU Ventures, Columbia Technology Ventures, Rockefeller University, Alzheimer’s Drug Discovery Foundation, Michael J. Fox Foundation, New York City Investment Fund, InnovateNY Investment Fund, New York Stem Cell Foundation, and many more.

Sponsors include: Grant Thornton, MPR Associates, AdvaMed2012, Torreya Partners, Greater Zurich AG, Edgetech Law LLP, Aptiv Solutions, International Venture Club, New York Venture Capital Association, Reed Business Information, Reed Smith, and Wallace H. Coulter Foundation

For more about NYBA 21^st Annual Meeting: http://tinyurl.com/nyba2012

Register for the Emerging Companies Showcase

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Taking its title from the Indian blockbuster film, “Slumdog Millionaire,” “Brooklyn Doc Billionaire” is the brainchild of Dr. Kumar Shah, President and CEO of Endocrine Technology based in Brooklyn, New York.  The film looks at the company’s novel treatment and potential cure for HIV, a cutting edge advance over their direct competitor Alexion.

Fundamentals of Immunology have largely concentrated on cells and its receptor functions. The recent advances in the fundamentals of immunology have emphasized the growing importance of fluid protease system. It is this system that primes and directs immune responses related to cells and its receptor functions. But this system can cause host inflammation and fail to generate immune responses against viruses and cancer cells.  Endocrine Technology’s advances pertain to balance modulation  to reduce host inflammation and tilt the survival and therapeutic advantage to the host in many life threatening diseases.

Due to the economical problems the healthcare industry now faces, competition in biotech is huge, and attaining patents is difficult. Millions of dollars are needed to develop any product.

Dr. Shah’s movie concept is a novel approach to raising capital for drug discovery.  It aims to develop marketing that will lead to partnerships, finances and return on investment quickly.

The problem: 34 million people are infected with HIV/AIDS and 1.8 million are dying every year. The solution: advance the technology with the potential to cure AIDS from genomics to bedside. The film will focus on current biotechnology “innovation-stagnation” , the current cost of drug development and its stages, and conflicts of interest based on human defense concepts.

Dr Shah will be presenting his technology at the New York Biotechnology Association meeting May 2-3, 2012.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/03/film.jpg

New Pharma Magazine aims to provoke original thinking, ideas and debate on the future of the generic, over-the-counter, biosimilar, and animal health sectors. Publisher, Asa Cox says. “We saw an opportunity to really communicate with the highest levels in the industry and put together articles and stimulating pieces to think about the future of the industry, to really help companies consider their strategies for the long term of their business and then for the industry as a whole.”

The magazine launched this week in New York City as part of the DCAT week, the Drug and Chemical Associated Trader’s week. Below cox, discusses the magazine’s vision and why Generic Pharma 2.0 foundit natural to move into publishing.

Brett Johnson:    Brett Johnson with OneMedRadio here today in New York. I’m with Asa Cox. He is the founding editor and publisher of New Pharma Magazine, a new publication serving the pharmaceutical space, which launched this month. Asa, thanks for joining us today.

Asa Cox:     No problem, a pleasure to be here.

BJ:     So, Asa, what is the idea behind New Pharma Magazine?

AC:  It’s really to provide a publication for decision makers in the pharmaceutical industry. We saw an opportunity to really communicate with the highest levels in the industry and put together articles and stimulating pieces to think about the future of the industry, to really help companies consider their strategies for the long term of their business and then for the industry as a whole.

BJ:     Interesting. So what was the idea behind the magazine? How did you come up with this idea?

AC:  Well our business Generic Pharma 2.0 is involved in many aspects of the industry. We’ve seen a lot of changes in the generic industry as it moves into over-the-counter and into biosimilars. We also saw multinational companies getting involved in the generic space. We also are increasingly involved in emerging markets and we really saw that there was an opportunity to bring together all of these changes and all of these information that we were seeing in the rest of our business and put it together into a publication. We had a lot of contacts who were interested in the future of the industry because of these reasons and it was a natural move for us to go into publishing.

BJ:   Can you tell us a little bit about Generic Pharma 2.0 and its background and its business?

AC:     Sure. I mean initially it was founded in 1997. It evolved from being a trading business in active ingredients actually and eventually has turned into a business of two parts. One still doing technical operations and projects in the generics space and the online business, which was founded in 2008, as GenericLicensing.com. We’re one of the first companies to have a large database of intellectual property for licensing in the generic space and through that we got a lot of opportunities and contacts and now we’ve moved into an abundance of other areas, over-the-counter, biosimilars, animal health, and just also launched the magazine as we’ve been talking about and a consulting business. It’s really incredible the power of the internet and how connected you can be in an industry even as old as the pharmaceutical one.

BJ:     So how will the New Pharma Magazine use the internet? So it’s a printed publication, is it not?

AC:   It is, but we’re trying not to focus on just the traditional media. I mean our business has grown through the use of the web and it’s going to be an interactive digital brand for sure. We have the opportunity to do multi-languages, which of course in a global industry is important. It will be in print, but we will be doing an interactive digital version, which we believe will be the first in the industry. So we’ll be able to integrate rich media into a digital format as well as a traditional printed media. Then of course, we’ll have our website as well for premium content for the creation of a community of likeminded people around the topics.

BJ:    Uh-hum. So how does an interactive magazine like that work and how does that actually work?

AC:    Well it’s the evolution really of the PDF. I mean there’s many magazines out there that just have a flip book, if you like, magazine whereas we’re actually going to take it to the next level where you can integrate the video, you can make comments on pieces, all of the URLs and email addresses are all active. So it’s really having the opportunity for somebody who is interested in the piece to better link out to other sources of information to get more data about the topic and to really connect with other readers and also the authors of the pieces. So it’s really trying to be that segue between a website and a printed magazine and I think we’ve found the technology to really do that.

BJ:  So what do you see as sort of the big trends that you’re seeing in the generic space and what are sort of the big issues that you guys will be tackling with this magazine?

AC: Well there’s a number. One of them is introduction or the reintroduction of multinational big pharma companies into the generic space specifically in emerging markets. There’s been a number of acquisitions recently and a number of partnering deals and by the likes of Pfizer and GSK and Eli Lilly and, etc and that’s really muddying the waters of what a generic company is and what a big pharma company is. So that’s one of the parts is how to successfully enter emerging markets when big pharma is obviously so much stronger with its branding.

The second part, which may be of interest to your readership and your users, is biosimilars. So literally the generic industries are based on small molecules, which are relatively easy to replicate whereas biotech drugs and biologics, you know, it’s a whole different ballgame, but it’s definitely the future of the industry for generics. Of course, they can only succeed where there are brands and where there are existing products and that’s a huge challenge for the generic industry, and definitely emerging markets. We’ve seen massive growth in Brazil and China and in Russia and the Brit markets, but there’s new markets coming on next with the Vietnam, the Korea, you know, these markets are definitely opening up to be interested and pushed by their governments into generics. Again, that’s a challenge culturally, the makeup of the regulations and so on. So there’s all these big, big changes coming up in the generic industry, which we’re trying to put forward as discussion topics for now before it’s too late.

BJ:  I see. So what’s the value proposition for the reader of the publication? I mean what will they come away with after spending time with New Pharma?

AC:  It’s really trying to be thought provoking. You know, we’re really pitching at a very strategic level to try and gain insight into how the industry maybe shaping up, what kinds of things to think about right now with regards to the strategy emerging markets, technology, marketing, all these elements that could be some game changers coming up in the future of the industry and we’re trying to help people think about it now.

So it’s really to stimulate ideas, to stimulate the discussion about the future of the industry of all four of our sectors, the generics, the biosimilars, and the animal health, and the over-the-counter. All these areas face massive change in the future, some convergence, some divergence, and we really want our audience, our readership to be thinking about those issues

BJ:    So what is your sort of expected circulation of the publication?

AC:  Initially, we’re going out to 10,000 of the very top level executives in the industry. We really want it to be a very defined readership. We want to see it to be dealing with decision makers and influencers in the industry and they’re the ones who inevitably will shape the future of the industry as well. They’re [0:16:10] [Indiscernible] to regulate as payers and insurance companies and so on. But within this space, we really believe there are many individuals and companies out there who just solve and create the opportunities in the future. So we’re really trying to keep it at a very high level influential group of people to really get them engaged in a discussion.

BJ: Well it sounds like a very interesting and ambitious project and best of luck to you.

AC:   Thank you. It is very exciting times. The response has been good so far and we’ve got some great contributors for this first edition that comes out as you said in the middle of March and we’re looking to build as quickly as possible worldwide and, yes, incredibly exciting times.

BJ:   So how do we learn more about the publication and how do we get a copy?

AC:  You can go along to NewPharmaMag.com and there is subscription options there right now. The website will be coming out ready for the launch with both free and premium content, and then if somebody wants to have a printed edition, they can request that or they can continue to recehspace=”12” vspace=”6”ive the interactive digital edition. There’s many ways in which the readership can get engaged with us, but it’s all coming in the next couple of weeks.

BJ:    Terrific. And you’re launching on March 14^th in New York City?

AC:   Exactly, at the W Hotel as part of the DCAT week, the Drug and Chemical Associated Trader’s week. So everybody’s in town and we’re hoping to put on a good party for them.

BJ:   Well, we look forward to seeing you there.

AC:     Absolutely and I look forward to meeting you.

BJ:   Terrific. So that is Asa Cox. He is the founding editor and publisher of New Pharma Magazine, which is launching in March 14, 2012. That’s Brett Johnson signing off for OneMedRadio in New York.

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Aside from antibiotics used to directly treat particular disorders, biotechnology has also been applied in the creation of antimicrobial materials that are, in turn, used by manufacturers of medical tools and supplies in their products. These antimicrobials are designed to prevent, if not reduce the amount and occurrence of harmful germs and bacteria that could harm patients or worsen their condition. Thanks to the advances in medical technology, the production standards of manufacturers and companies are indicative of how they recognize their heavy responsibility when it comes to health care.

Polymedix, Inc. is one of these companies. Focused on the development of therapeutic drugs to treat infectious diseases and cardiovascular disorders, this biotechnology company is also engaged in the production of these antimicrobials and antimicrobial additives that are meant to reduce the risk of microbial infections. Antimicrobial additives are found in products such as wound dressings, cosmetics, fabrics, plastics, textiles, and other medical devices.

PolyMedix has a pipeline of innovative infectious disease and cardiovascular product candidates, all of which were internally developed using a proprietary drug discovery technology platform.

PolyMedix’s lead infectious disease compound is PMX-30063, the first drug of a completely new class of antibiotics, the defensin-mimetics. The defensin-mimetic antibiotics are designed to imitate the mechanism of natural human immunity — the host defense proteins. By mimicking the mechanism of action of the host defense proteins, PMX-30063 works completely differently from known biochemical antibiotics, and exploits a method of bacterial cell killing that significantly reduces the risk of bacterial resistance. PMX-30063 has completed enrollment in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

PolyMedix’s lead cardiovascular compound is PMX-60056, which is designed to normalize blood clotting and reduce bleeding in certain interventional cardiology procedures, as well as treat bleeding in emergency situations, where heparin and low molecular weight heparins (LMWHs) are used. PMX-60056 has met safety and efficacy endpoints in four clinical trials conducted to date demonstrating proof of concept. PMX-60056 is currently in a Phase 2 clinical trial in patients undergoing PCI, and in a Phase 1B/2 dose ranging clinical trial with the LMWH enoxaparin.

Nicholas Landekic, President and CEO of PolyMedix, presented at BIO CEO last month in New York City.  Since starting PolyMedix, Mr. Landekic has successfully secured over $115 million in funding from public and private capital raises and government contracts and grants.

MEDIA ENCLOSURE: http://www.onemedplace.com/blog/wp-content/uploads/2012/03/specimen-tray.jpg

Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM), via a new subsidiary,DirectMarkets, will unveil an automated state-of-the-art electronic transaction platform to directly link existing public company issuers and investors seeking to transact primary offerings of securities. DirectMarkets will bring unprecedented, cost-efficient access to the capital markets into the C-Suite of public companies and bypass certain traditional roles typically held by investment banks that presently control the transactional process. Both investors and issuers will benefit from 24/7 seamless access to DirectMarkets’ platform through a graphical user interface (GUI) accessible via a desktop or laptop computer, as well as any mobile smart devices such as tablets or smartphones. The official launch will take place at the TradeTech 2012 Conferencein New York City that begins on March 6, 2012.

Click here to hear interview with DirectMarkets CEO, Kevin Lupowitz. Full transcript below.

Brett Johnson:    This is Brett Johnson in New York City with OneMedRadio. Today, we are with Kevin Lupowitz. He is the chief executive officer of DirectMarkets, which is a new subsidiary of Rodman & Renshaw traded RODM on the NASDAQ. DirectMarkets is launching a new electronic platform to connect investors and growth companies. Thanks for joining us today, Kevin.

Kevin Lupowitz:    My pleasure.

BJ:     So tell us in a big picture, what is DirectMarkets?

KL:     Well DirectMarkets as you mentioned is a new subsidiary of Rodman & Renshaw. For those of the listeners who don’t understand who Rodman & Renshaw is, Rodman has been around for a number of years. Over the last ten years, they’ve been really focused on a very specific niche and that’s raising capital for already existing public companies, specifically in the pipes and registered direct type offerings. In both those offerings, Rodman has been nine of the last ten years, the market leader in this space.

DirectMarkets as I mentioned is a subsidiary is the culmination of a lot of thought that the founders had Rodman had put in understanding how the marketplace works looking at the inefficiencies, frankly, in the marketplace and realizing that every other aspect of financial services has seen innovation through technology. Frankly, looking at the TV saying that at some point there’s going to be some technology innovation in this space too. Frankly, as the market leaders said well we should provide that innovation. So a couple of years ago, they started looking and trying to figure out well what would a technology platform that was going to disintermediate the investment bankers, what would it look like and once they formulated that view, started building that platform. What we’re launching on March 6^th next week is the DirectMarkets platform, which is the culmination of all that thought and work.

So how will DirectMarkets work from the point of view the issuing company? Let’s say I’m a biotechnology company and I need to raise $5M now and expect to need to raise $15M over the next two years or five years, how does this change the way I do business?

KL:   Sure. Well so if we look at the needs of an issuer, there are a few needs. If an issuer realizes at some point in time that they want to raise capital, one of the things that’s important for them to do on an ongoing basis is to create some awareness so that investors are interested in who they are. So, you know, from time to time, issuers will do non-deal road shows. They’ll get the management team and they’ll pack them up and they’ll go on the road and they’ll visit a whole bunch of companies that their investment bankers think are interesting companies, investors for them to visit. They may create a website. They may put out some press releases from time to time.

One of the things that we’ve done in the DirectMarkets platform is an entire suite of investor relations and public relations capabilities so that an issuer can very, very quickly and easily build a presence for themselves that is going to have the attention of all the investors in our ecosystem. Within that site, they can put up press releases, they can have regulatory filings, they could have videos of management conferences, they could have earnings conferences. If they want to have a virtual tour of a new facility or they want to do some type of presentation of a new drug that’s being developed, they can put all that up there. Behind the scenes, we have some talented IR and PR staff that can help them really create a strong presence for themselves.

If they want to do a non-deal road show maybe instead of going on the road, they can actually film a non-deal road show with their management team. They could put it on the site and then they can direct it to a very wide breadth of potential investors. Then when the investors get it, they can look at this presentation and then they can even send comments back to the issuer and so create some type of two-way conversation that way. I’m sorry, go ahead.

BJ:   So what are the economics of this in terms of — is it different than if you hired an investment bank and went out and did some of this, a road show?

KL:  Right. So the platform for the issuer is meant to be just that. It’s meant to be something that the issuer can use every single day. You know, and when I talk about the issuer, I’m really talking about the C-suites, the CEOs, the CFOs, the head of the treasury, the IR person of these issuers. They would have a consult that they can get information about their company. They can see what’s going on in the world, what news is related to them, what news related to their competitors, how their stock is performing. Then from there, they can also build their public presence, they can create their non-deal road shows, and if from time to time they decided it’s an appropriate time to raise capital, they can raise capital directly through that platform also. That is one of the values of the connection that the platform provides between them and the entire universe of investors that are also on the platform.

BJ:     So how do the economics work? I mean how does the company pay or how are you compensated for providing this service?

KL:      So we’re a subscription-based service and we specifically chose the subscription-based service meaning that the issuers pay us a monthly fee for access to this platform. Because we really want to be agnostic as to whether they do deals at all, transactions at all or whether they do transactions with us. So for example, we believe that one of the primary offerings when it’s time to raise capital, a solution that we call Shelf Match, really changes the paradigm of how capital is raised by issuers.

You know, if you think about the way issuers raise capital now, once they filed an effective shelf registration at some point after all the bankers have inundated them with offers to raise capital for them, somewhere down the line they’ll decide that it’s time to raise capital. They’ll pick an investment banker and they give the investment banker some criteria for the type of capital they want to raise and some constraints. But then it’s really up to the investment banker to go out to speak to a number of investors, to bring them over the wall, to try and get the right people involved in the deal and then to get the lawyers involved. It’s a very long tedious process and for that the issuers pay 4% or 5%, 6%, 7%, or 8% in investment banking fees for the deal. It’s very expensive, very lengthy manually insensitive process where frankly only a small subset of the potential investors in the world are even spoken to.

As a difference, through our platform once that effective shelf is registered, our entire universe of investors know that your company has an effective shelf out there, and from time to time can put in unsolicited bids that go directly to the issuer. So the issuer can very passively sit back and look at a wall of bids that are coming in from a huge breadth of investors and can then decide very passively which ones if any they would like to engage.Once they pick one or more to engage with then they’re effectively in a face-to-face conversation kind of like an IM conversation where they’re coming to terms on the agreement. If it’s a simple agreement for a common stock, they could agree right on the spot and the transaction is done. If it becomes a more complex agreement, we have an electronic workflow where if we need to get any third parties involved, any lawyers involved, if we need to wait for a sign off on a board member, those types of things we can have electronic sign offs. We could have all the documents online and we can move them through very effectively through this electronic workflow kind of like when you check out from a retail electronic commerce site like Amazon.com.

So again what this gives the issuer is it lets them kind of sit back in a very different paradigm, let the investors come into them. If they choose this is not the right timing at all, they could ignore them all or they could reject them all. The investors haven’t learned anything. There’s no understanding of why their bid was dismissed. If a transaction happens and it’s a material transaction, for sure it will get reported maybe in an 8K the next day or two days later. But we’re not bringing the investors over the wall that aren’t getting deals and we’re not leaking information out into the marketplace that a deal is going to happen until after the deal is done. Again, we’re doing that at what our typical trading fees more like 1% or 2% as opposed to investment banking fees — I’m sorry 1 or 2 cents per share as opposed to investment banking fees, which maybe 5%, 6%, 7%, 8% of the transaction size. So significant cost savings, that could be an 80% cost savings in many cases.

BJ:     Interesting. So how about from the investors’ side and do the investors need to be accredited to use this platform? How does it work for them?

KL:    Yeah. So we’re targeting really institutional investors. So these are all prequalified investors. So from the investor’s side, there is also a portal where they can effectively go in and get a view of all of those issuers that are interesting to them. So they could look by sector, they could look by market cap, they could look by who’s done deals, who has open shelves, any number of criteria. They can build up those issuers and if they run through their filter in the morning and they say okay, there are three issuers here that meet my criteria. I haven’t heard of this particular one, they could click through and they could see that site that was built by the issuer and get all of the information about the issuer, learn about them. Then, directly from there, they could put a bid in directly to the issuer.

There’s no guarantee that the issuer will hit the bid or engage in a negotiation, but if nothing else, they’ve sent out an indication of interest that may generate a phone call or it may not. But it gives the investors and many of these investors maybe off the beaten path ones that may not be the ones that would have been approached by an investment bank if the issuer had chosen investment bank to go out and raise capital. You go from many dozens of investors who get the non-deal road shows to hundreds if not thousands of investors who could be potential purchasers of these securities.

BJ:  So what is the qualification then to be an investor to participate in this?

KL:     You know, any type of institutional investors on day one are going to be the appropriate qualifications. Now the reality is we are going to screen all of the investors. We don’t want investors on the platform who are not going to add value to the issuers. So we want to make sure that these are investors who are not looking to, you know, for lack of a better term, game the system, but they’re looking to truly get on board because they want to engage with these issuers to purchase these shares and to create liquidity for these issuers. So I can’t tell you that we have a firm set of requirements in terms of a screening process, but we will be reviewing every account and making sure that we feel that they’re the appropriate investor for the platform.

BJ:     So it’s basically sort of an invitation only type?

KL:   That’s right.

BJ: Will there be a fee for the investors to participate?

KL:    No. The investors get this for free. So from the investor’s standpoint, this is a fantastic thing because we’re not charging them anything for it other than transaction fees if they do a transaction. Again, that’s in that kind of 1 or 2 cents per share range. But they get an entirely new source of liquidity. So you can imagine if there’s an opportunity for let’s say you’re talking about a traditional long only shop that is already looking at a particular sector and they’re looking to go long in that sector. Maybe there is an issuer out there that they know of but through this platform maybe they learn of an issuer if they already have an outstanding order to fill a large position and maybe this is a thinly traded stock, this is an opportunity to engage with the issuer. Fill up that order directly from the issuer instead of the secondary marketplace thereby injecting that capital directly into the issuer as opposed to buying in the secondary marketplace which has no advantage to the issuer at all. Fundamentally, they like that issuer or they like that sector and they’re investing directly into it, which is relatively unique for many firms that are off the beaten path.

BJ:   Interesting. So how does this affect sort of the current markets, the NASDAQ or the New York Stock Exchange or other trading platforms? How does the arrival of your new system affect their business?

KL:  I don’t really think — I mean there’s always going to be a secondary market. Once these shares are purchased, they now exist in the secondary market. So the exchanges, the ECNs, the ATSes of the world that do institutional or retail trading, they’re still going to be there to trade those secondary shares. Our platform is not focused on the IPO either. We’re truly focused on already existing public companies that are looking from time to time to raise additional capital, raising their persona in the marketplace and facilitating electronically that trading between the issuer and the investor. That’s really not what those exchanges do.

BJ:      Terrific. So you’re rolling this out in March, can you tell us what you see as some of the big challenges and the big milestones for the success of this project?

KL:  Well, yeah. So we’re kind of unveiling the platform next week in early March. After that, we are signing investors and issuers as quickly as possible and on boarding them. Our goal for the first year and it’s a relatively aggressive goal but kind of humble is in that first year, we want to build what I’m calling critical mass of both issuers and investors on the platform. I measure critical mass by the number of transactions that are happening.

I would like to in a year be doing at least one transaction per day. I think if we’re doing one transaction per day, that will be a complete validation of the model and that will be a key indicator that it’s time to look at extending the model outside the US and maybe into international markets and potentially looking at other asset classes. So equity is what we’re launching with and after that, I would imagine that we’d look seriously at debt as we look at debt is obviously a very compelling offering for raising capital for public companies.

BJ:     Terrific. Well it sounds like a very bold and ambitious project so the best of luck to you.

KL:      Thanks, yes. It’s been exciting. It’s been a fun ride so far. But, you know, we’re all very optimistic. We’ve been getting great feedback.

BJ:    Terrific. So that is Kevin Lupowitz. He is the chief executive officer of DirectMarkets, which will be launching on March 6 here in New York, a new trading, rather electronic platform connecting issuers and investors. This is Brett Johnson with OneMed Radio in New York signing off.

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Trinity Biotech acquires Fiomi Diagnostics

Trinity Biotech plc (Nasdaq: TRIB), a developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, says that it has acquired Fiomi Diagnostics AB (Uppsala, Sweden) for $13.1M consisting of a cash payment of $5.6M, 408,000 Trinity Biotech ADRs at the acquisition date ($4.1M) and a contingent cash consideration of $3.4M.  The Swedish company has reported that it is in the late stages of developing a panel of point-of-care cardiac marker assays based on technology that was originally developed by Amic AB. To date, Fiomi’s efforts have focused on developing a cardiac test for Troponin I.

Critical Diagnostics reports results of biomarker panel study

Critical Diagnostics, a biomarker company focused on cardiovascular diseases, has reported positive results from a multi-center study in ambulatory heart failure patients, which confirmed that a contemporary panel of biomarkers was strongly predictive of risk and significantly improved the likelihood of identifying patients at risk for adverse events, compared to the most commonly used clinical risk score in heart failure, the Seattle Heart Failure Model (SHFM).

The Penn Heart Failure Study was a multi-center cohort of 1,513 outpatients with chronic heart failure, used a panel of seven biomarkers, including ST2 as measured using the Presage ST2 Assay, and compared results to SHFM. Patients in the highest one-third of the multi-marker score had a 13.7-fold increased risk of adverse outcomes compared to the lowest one-third, and this risk remained nearly 7-fold higher after adjustment for the SHFM. Moreover, the PHFS panel appropriately reclassified a quarter of the patients into a higher risk category.

Transgenomic validates its Clopidogrel (Plavix®) Response Panel

Transgenomic Inc. (OTCBB: TBIO) has provided news about the publication of a new study by researchers at Vanderbilt University that further validates the role of both genes found in the company’s PGxPredict®:CLOPIDOGREL (Plavix®) Panel, a comprehensive test to predict a patient’s response to clopidogrel (Plavix®). The study confirms the results of two previous studies demonstrating that outcomes in patients receiving clopidogrel were better for patients without genetic variations in CYP2C19, a gene whose effect is described in the drug’s label, and ABCB1, a gene that is unique to Transgenomic’s panel. The results were published by Delaney, et al., in the February issue of Clinical Pharmacology and Therapeutics.

Courtagen to Partner with Avaxia Biologic

Courtagen Life Sciences says that it has entered into a strategic collaboration with Avaxia Biologics to develop an assay that will streamline the development of an oral antibody therapy to mitigate the gastrointestinal damage that follows radiation exposure that might occur after a nuclear incident.

Together the two companies will pursue a first in class solution that could enable the Biomedical Advanced Research and Development Authority (BARDA) and other Federal biodefense programs to achieve their goal of developing therapeutics to mitigate the damage to the gastrointestinal tract that follows severe whole body exposure to ionizing radiation.

Molecular disease model for lung cancer developed

Cancer Commons, an open‐science initiative to personalize cancer treatments and accelerate research, have published a molecular disease model (MDM) for lung cancer. The paper, by Lisandra West, Ravi Salgia, was published in the February 21 issue of PLoS ONE (http://www.plosone.org).

The purpose of this paper, the authors say, is to highlight the key molecular aberrations observed in lung cancer, including those for which there is still only preclinical data, with the hope of accelerating the process of translational research by providing a dynamic conduit between basic science researchers, clinical trialists, and treating physicians.

The lung cancer MDM classifies the disease into subtypes based on a tumor’s histology and its molecular profile. Each subtype is then linked to published clinical treatment guidelines and other proposed therapy options, including investigational agents available through clinical tests. This information can help physicians understand therapy options for individual patients based on their tumor’s molecular subtype. Going forward, the resulting clinical responses can be used to refine the model. The MDM is a living review article, maintained by experts and continually updated based on input from the entire cancer community.

“CollabRx is very excited to have been a collaborator on this important open science initiative. Using technology to make the best science readily accessible to patients and their physicians in the rapidly emerging field of personalized medicine is the very reason we were founded,” said James Karis, CEO of CollabRx, a cancer informatics company that collaborated on the development of the MDM.

Complete Genomics creates Advisory Board

Complete Genomics Inc. (Nasdaq: GNOM) says that it has formed a Genomic Medicine Advisory Board (GMAB) that will provide insight and guidance on the best ways for the company to provide sequencing services to healthcare organizations and physicians interested in implementing genomic medicine in their practice. Robert Nussbaum, MD, Holly Smith Professor of Medicine, chief of the Division of Medical Genetics in the Department of Medicine, and director of the Cancer Risk and Cardiovascular Genetics Programs at the University of California, San Francisco, will serve as GMAB chairman.

CombiMatrix appoints board members

Richard Ding, CEO of bioTheranostics Inc. and Joseph M. Limber, President and CEO of Prometheus Laboratories have been appointed to the Board of Directors of CombiMatrix. The addition of the new directors brings the total number of board members to nine.

BioNJ Diagnostics & Personalized Medicine Innovation Summit

BioNJ, the trade association for New Jersey’s biotechnology industry, is hosting its BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable, part of BioNJ’s ongoing Diagnostics & Personalized Medicine Initiative, on March 14, 2012 at Princeton University. The event is designed to bring together leaders from major global biotechnology and pharmaceutical companies, diagnostics companies and emerging “innovator” companies for this half-day, interactive summit meeting.

The focus of this half-day summit is to help participants identify opportunities for partnership, funding and growth while updating them on the latest trends, developments and challenges in the evolution and adoption of personalized medicine. All companies and individuals with an interest in diagnostics and personalized medicine are welcome to attend this event. The Summit will include company presentations and opportunities for one-on-one communication and interaction between leading global pharmaceutical companies, emerging diagnostics companies, funding organizations and life sciences company business development professionals. Details: www.bionj.org

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AdvaMed 2012, the big medtech conference for industry executives, has launched its website and is calling for proposals for program panels.  Ray Briscuso, CEO of AdvaMed 2012 is interviewed by OneMedRadio where he discusses this year’s conference direction and major themes.

AdvaMed 2012 encourages prospective organizers to submit panels that are novel, timely, relevant and valuable in educational content, impart helpful lessons learned, or share proven best practices and have a global appeal. All panel proposals should include a working title and a suggested list of senior global industry and policy experts as panelists. Executive Workshop submissions should feature interactivity and may be tutorial in nature. To learn more about the panel proposal process, click here. The application deadline is March 16, 2012.

For the first time since its inception in 2007, the conference will be held outside Washington DC in a major manufacturing hub—Boston. The event will be held Oct 1 to 3 at the Boston Convention & Exhibition Center and will feature an expanded eHealth and Health IT track, extended company presentations, a CEOs Unplugged Super Session on the exhibit hall floor, and a special “Salute to Massachusetts” closing reception. The educational program will consist of 11 tracks containing a series of 75-minute panels addressing industry advancements and challenges. Program track topics include: In Vitro Diagnostics, Key Health Policies, Business Development & Finance, Compliance Best Practices, Emerging Growth Company Issues, Executive Workshops, eHealth & Health IT, Legal, Quality, Regulatory, and Reimbursement.

More than 1,900 medical device and diagnostics professionals (including 420 CEOs, presidents and C-level executives) from over 925 companies and organizations and representing 22 countries and 38 U.S. states attended AdvaMed 2011. The opportunities for attendees to network and make business connections during the 2011 conference were greater than ever, with nearly 950 official one-to-one partnering meetings and more than 60 innovative company presentations to 200-plus venture capitalists, angel and private equity investors, bankers and senior medical technology business development executives. The conference also featured eight CEOs Unplugged sessions and hosted nearly 100 journalists onsite, including a live CNBC broadcast straight from the AdvaMed 2011 exhibit hall floor.

In additional to the panel proposal opportunity, AdvaMed 2012 sponsorship, exhibitor and company presentation opportunities are also available. To learn more about AdvaMed 2012: The MedTech Conference, visit www.AdvaMed2012.com or call 202-434-7213.

Click to hear audio and see full interview transcript below.

Brett Johnson:    Hi, Brett Johnson here with OneMedRadio in New York City. Today, we are with Ray Briscuso. He is the CEO of Advamed 2012, which has become one of the preeminent medical technology conferences in the world. Its sixth conference will be coming up in Boston, the first time in Boston in October. Ray, thanks for joining us today.

Ray Briscuso:   My pleasure. Happy to be here.

BJ:    So, Ray, five years of success, growth in DC, now you’re making the move to Boston, can you tell us a little bit about what’s behind that?

RB:      Yes. As you mentioned, we’ve had five years. We’ve had growth every year, we’ve been really excited by that, but, you know, we stopped and asked ourselves how many local medical manufacturers or diagnostic companies that are in Washington DC, the answer is pretty easy, there are none. There’s a lot of lobbying off there and so forth but we thought that we should take it to a cluster and the Boston community welcomed us without a problem. It’s probably the world’s leading life science cluster. It’s the home of many leading companies, Covidien and Philips, Boston Scientific, Abiomed, J&J, Smith and Nephews is out there, Bar is out there. It’s too important of an area for us to not consider and this year we’ll take the conference there October 1^st, 2^nd, and 3^rd.

BJ:     Terrific. So what are sort of the major themes of the conference or the major kind of components of the AdvaMed 2012 conference?

RB:    Great question. There are several components of it that are very consistent. We always bring the latest in the trends as far as the policy changes and what’s happened at the FDA. We have to educate people as to how their business needs to change to keep up with new regulations and so we have a large regulatory component of the conference. We have a major reimbursement component. We talk about coding payment and getting reimbursed for your, pay for your product. We are bringing the latest areas in compliance and legal and we have a huge big development piece of the business so that if you’re looking for investment, if you’re looking for collaborative licensing deals, in licensing, out licensing, exit strategies, we provide all of that. I think the important thing is it’s tough for companies in this industry. You can’t go to a reimbursement conference one day and then a reimbursement the next and then a legal the following so we actually do everything at once. We bring the entire industry, the large strategics, the early stage, the investors, the angels, the private equity all together for three days of a concentrated business development, educational, and networking.

BJ:        So I know that creating a platform for some of the promising companies with technologies to network strategic partners has been a big thrust for you guys. Can you talk a little bit about how that whole business development track and program works and how that’s evolved over the years?

RB:    Yes. We’d be happy to. What we’ve done there is we’ve started out with really going to the large strategics and talking to them about how attractive they are, the small companies who want to meet them. Luckily, you know, the conference is part of the AdvaMed, the trade association which is 38 years old. We have 22 of the 25 largest device manufacturers as members. We have all 10 of the 10 largest diagnostic companies. So we’ve got about 65 members that do more than $100M a year in sales in the US alone.

We talked to them about with the capital markets being tight, companies are looking for more aggressive ways to meet the strategics to talk about partnering, licensing, investment deals and basically said to them we wanted them to commit sending their business development teams to the conference. If they would do that once a year, we would efficiently allow them to meet potential partners that might come from Cambridge, Massachusetts or Cambridge, England or from Irvine, California or from Mountain View or from Alachua, Florida or from New Zealand, Australia. They like the idea of trying to come to one spot and doing lots of meetings rather than traveling all over the world.

So we actually have part of the conference, we build down 45 little meeting rooms or little suites, if you will, with tables and chairs and the large strategics will come and they can literally go from one 30-minute meeting to another to another to another so in two hours, they’ve met with four companies. It goes both ways. If you’re a small orthopedic company and you want to meet with Stryker and Zimmer and BioMet and a few, it means you can come to one place and meet with all of them as well as potential angels, VCs, and private equity. So it’s a major thrust of the conference. It’s grown considerably. Last year, we did 960 of these little 30-minute meetings and we certainly anticipate that will significantly grow in Boston.

BJ:     Now another element I know you had a chance for a company, smaller companies to present at the conference. You had actually a presentation track for growth companies. Can you tell us a little bit about how that works?

RB:    Yes. We work with those same strategics and we break them down by segment. So we might have an ophthalmic section and we’ll have one of the leading ophthalmology companies, maybe Abbott, their AMO division, or we’ll have Alcon or someone that will speak for a few minutes about the sector. Then, we’ll have six to eight to ten early stage ophthalmic companies each get up and make 10-minute presentations and the thought is that the audience is really full of people that are interested in that particular sector. Then we might then bring in somebody from an orthopedic company. Maybe Zimmer will stand up and speak for a little bit and then we might have the same thing six, eight, ten, twelve orthopedic companies will all present for 10 minutes and we run those for two full days. We pretty much hit the major sectors of the industry from diagnostic to ophthalmic to orthopedic to tools to, I don’t know, you name it. We try to give people opportunity. Last year, we had probably about 60 of these spots and hopefully this next year, we’re going to try to grow it, provide more. There’s a tremendous demand for those opportunities. So we welcome people for instance to go online and look for our website and apply and hopefully they’ll have a chance to present.

BJ:  It looks like you get a number of different countries that have come. Can you talk a little bit about what’s happening internationally and how you guys are appealing to the international markets?

RB:     Yes, I’ll be glad to. There are a large number of obviously countries that have a large concentration of medical device businesses and we’ve often been able to deal then with economic trade offices that will bring delegations of companies that are looking to either enter the US market or they’re looking to find partners in the US or they’re looking to license technologies to introduce back in their regions. But we’ve traditionally had delegations from the UK, from New Zealand, from Israel, from Canada. We’ve had Brazilian delegations. We get a delegation every year from Switzerland and of course, we get a lot of just small individual companies that come on their own. But we’ve been really fortunate that there have been concerted groups from some of these countries. So we have French delegation as well. They’ll be coming back again. I think we’ll have a German delegation this year. So for any of your listeners that are outside the US, there’s often a way for them to become part of a delegation that often includes additional benefits usually stuff at the embassy or sometimes we get financial help.

We’re interested in making the conference as international as possible because people are doing business all over the world. Some of our sessions are educational sessions that do deal with non-US issues. We’ve had speakers from Nice, we’ve had from the UK, we’ve had the NHS, we’ve had ministers from Canada part of the conference, French ministers, Chinese officials, FDA officials from China, Japan. So it’s a very efficient one place, one time to come and learn about the industry all over the world.

BJ:    Good. Now you’ve really done an excellent job over the years in getting some truly brand name, very prominent keynote speakers. The last three presidents have been participants in the conference. Do you expect to keep that trend alive?

RB:    We absolutely will do that because I think the hallmark of our conference is that we attract the CEOs of the big companies and people consistently tell us that what they like most about coming to our conference is they can actually talk to the CEOs and the heads of business development. We’re able to keep those people at the conference by having the FDA commissioners followed by the CMS administrators followed by a Bill Clinton or a George Bush and yes, we’ve had the last three presidents. This year, I think we’ll actually go outside the US. We’re looking at bringing a head of state from another major strategically important country. People can count on having world class plenary speakers at the conference.

BJ:  Terrific. I know that you’ve also done — in recent conferences, you tend to have some excellent networking sessions often connected to some of the embassies. I guess that’s easier to do when in DC. Do you expect to continue to have some networking sessions this year in and around the Boston area and can you talk a little bit about the venue?

RB:    Yes. The venue is fantastic. It’s a relatively new convention and exhibition center in Boston directly connected to a beautiful west in another hotels and it’s a short walk to the waterfront. So we’re looking at some fantastic venues. For instance, the flagship restaurant of Legal Seafoods are probably one of our venues. But, it will clearly be there on the Boston Harbor, but you’ll turn to your left and hopefully you’ll have a top executive from a company you want talk to and to your right, you’ll have somebody from a venture or angel or a private equity fund. So I can assure you that the Boston community is going to make sure that nobody is upset that we left Washington DC. We’ll leave no stone unturned to make it as valuable as possible for networking, educational, and business development opportunities.

BJ:     Well I think that sounds absolutely terrific and we look forward to learning more as you get closer to the conference with some more updates here in OneMed Radio about some of the developments and some of the programming advances. Thanks for joining us today, Ray.

RB:   My pleasure, my pleasure. Thank you very much, Brett.

BJ:   So that was Ray Briscuso who is CEO of Advamed 2012 talking about the sixth annual conference which this year will be in Boston, Massachusetts on the 1^st to the 2^nd of October. I’m Brett Johnson in New York with OneMedRadio signing off.

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OGT licenses colorectal cancer biomarkers

Oxford Gene Technology (OGT) says that it has entered into an exclusive licensing agreement with Inven2, the technology transfer office at Oslo University Hospital (OUS) and University of Oslo, for 12 colorectal cancer tissue biomarkers. OGT hopes to commercialize any resulting test developed using these biomarkers and to sublicense the markers to other parties. The DNA methylation biomarkers were developed in the laboratory of Professor Ragnhild A. Lothe, Department of Cancer Prevention, Norwegian Radium Hospital, which is part of the Oslo University Hospital. OGT reports that it has validated the results obtained in Professor Lothe’s laboratory that show sensitivity of 93% and specificity of 90% when using tissue biopsies. Further work investigating the efficacy of these biomarkers in blood and fecal samples is continuing.

Integrated Diagnostics receives financing

Seattle-based Integrated Diagnostics has received a $10 million third tranche of its Series A financing and plans to use the funds to complete clinical development and commercialization of its in vitro proteomic-based diagnostics programs. The funding, the company reveals will assist in further research to advance the its novel class of molecules – protein-catalyzed capture agents (PCCs) – for use in in vivo molecular imaging and therapeutics.  The company was founded to build on Dr. Lee Hood’s groundbreaking research in protein blood markers at The Institute for Systems Biology (ISB). In 2009 Integrated Diagnostics became the first commercial enterprise to arise from a partnership that ISB had established with the University of Luxembourg in 2008.

Rubicon Genomics and Agendia BV collaborate

Rubicon Genomics has signed a clinical supply agreement with molecular diagnostics firm Agendia for its TransPLEX® whole genome RNA amplification technology. Agendia will incorporate Rubicon’s TransPLEX kits into the analysis of formalin-fixed, paraffin-embedded (FFPE) patient samples for use with its Symphony suite of breast cancer diagnostics.

According to the company, FFPE tumor samples are widely used in cancer diagnostics, but they present many challenges for molecular analysis. RNA or DNA extracted from FFPE samples is highly fragmented and often contains only small amounts of usable DNA or RNA, which may be insufficient for analysis. The company’s technologies are designed and validated to overcome these problems and deliver sufficient quantities of nucleic acids to enable accurate and consistent analyses.

Cancer Diagnostics report

Peter Winter, in collaboration with OneMedPlace, is writing and editing a detailed report on the latest developments in cancer diagnostics and personalized medicine that will be available in April. Specific focus will be on the technologies and biomarkers that are being currently developed by companies and organizations. It will also incorporate the finance and business aspects of the sector. If you are involved in these areas and would like to be featured in the report or require further information please contact:personalizedmedicinereport@gmail.com

-Peter Winter

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Spherix Incorporated [SPEX], headquartered in Bethesda, Maryland, is a scientific research company. The company now leverages its scientific and technical expertise and experience through its two subsidiaries—Biospherics Incorporated and Spherix Consulting, Inc.

An innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services , Spherix has entered into definitive agreements to sell $1.15 million of shares of its common stock and warrants to purchase shares of its common stock in a registered direct offering to institutional investors. Spherix will issue an aggregate of 1,064,815 shares of common stock to the institutional investors together with warrants to purchase an additional 212,963 shares of common stock.

As its primary goals, Spherix is seeking to successfully commercialize SPX-106T worldwide, D-Tagatose in the U.S. and other markets, to advance its pre-clinical pipeline, and to promote its consulting practice as the premier product regulatory approval and scientific advisory service. The company’s mission is to create and grow shareholder value through innovations that benefit its clients and the human condition.

Below, Claire Kruger, Ph.D., CEO and COO, and Robert Lodder, President of Spherix discuss the company’s business model and upcoming milestones in a candid interview with OneMedRadio. Spherix was a presenting company at OneMedForum SF2012.

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IPSOGEN SA (Alternext: ALIPS), a majority-owned subsidiary of QIAGEN N.V. (Nasdaq: QGEN), has reported that it has acquired the worldwide exclusive rights to testing for mutations of the IDH1 and IDH2 genes for diagnostic purposes from Baltimore, Maryland-based Personal Genome Diagnostics (PGDx). IDH1 (isocitrate dehydrogenase 1) and IDH2 are enzymes and the mutations in IDH1 and IDH2 genes, discovered in 2008 by the founders of PGDx, are frequently found in brain cancers, including early stage and late-stage gliomas. Subsequent studies have implicated IDH1/IDH2 mutations in acute myelogenous leukemia (AML) and other cancers.

Biomarkers and depression

In a paper published in the journal Molecular Psychiatry, a team including Massachusetts General Hospital (MGH) researchers reports that a test analyzing levels of nine biomarkers accurately distinguished patients diagnosed with depression from control participants without significant false-positive results.  The test developed by Ridge Diagnostics measures levels of nine biomarkers associated with factors such as inflammation, the development and maintenance of neurons, and the interaction between brain structures involved with stress response and other key functions.

Signal Genetics acquires ChipDX

Signal Genetics has reported signing an agreement with New York based ChipDX LLC, under which Signal will acquire all of the assets of ChipDX, including patents for prognostic tests in lung, breast, and colon cancers. As part of the transaction, Signal will acquire BreastGeneDX, ColonGeneDX, and LungGeneDX, all diagnostic and prognostic tests in development by ChipDX. Signal says it believes that these genetic tests represent novel products or improvements over other products currently on the market in these cancer types. Signal will also acquire ChipDX’s web-based interface, which will be used to enhance Signal’s physician web portal and allow for remote interpretation of test algorithms. Ryan VanLaar, Ph.D., CEO and Founder of ChipDX, will join Signal as the Head of BioInformatics. Financial details of the transaction were not disclosed.

Agreement struck to produce custom nucleic acids

Synthetic Genomics, Inc. (SGI) and Integrated DNA Technologies, Inc. (IDT) have jointly announced that they have entered into an agreement to manufacture, market, and commercialize small synthetic gene products. SGI and IDT will work together to construct custom, synthetic, double-stranded nucleic acids up to 5 kb. IDT will use its custom oligonucleotide manufacturing expertise, including its recently launched gBlocks Gene Fragments product line, in combination with SGI’s proprietary technologies to efficiently assemble small gene constructs. The financial details of the agreement were not disclosed.

FDA approves test from Roche

Roche says that the FDA has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs.  A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia and gonorrhea runs on the automated cobas 4800 System, complementing the cobas HPV (Human Papillomavirus)Test that received FDA approval in April.

Diagnostics industry veteran joins Life Technologies

Ronnie Andrews, former CEO at Clarient and Segment Leader, GE Molecular Diagnostics, has joined Life Technologies as President, Medical Sciences. Mr. Andrews has more than 25 years of experience in the diagnostics industry, including leadership positions at companies such as Abbott Diagnostics and Roche Diagnostics. He will apply his expertise to expand Life’s presence in the diagnostics and personalized medicine space through strategies including short and long term partnerships.

-Peter Winter

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SANTA CLARA, Calif.–S.E.A. Medical Systems Inc., a healthtech company focused on safety and management of IV medicine, today announced that it closed a $3 million Series B investment with Chicago-based venture capital firm JK&B Capital, which specializes in investments in Information Technologies, healthcare and communication markets. As part of the agreement, Chairman of JK&B Capital David Kronfeld, and Quantum Technology Partners’ Barry Dickman joined S.E.A. Medical’s board of directors.Proceeds from this investment will allow S.E.A. Medical to accelerate development of its IV products and expand its technology into additional medical applications.

“Thousands of people are killed or seriously injured in U.S. hospitals each year when they receive the wrong IV medicine or wrong dosage. S.E.A. Medical is doing something that has never been done before: instantly identifying the actual contents of any IV,” said Michael Weickert, CEO and co-founder of S.E.A. Medical. “We are delighted to have the support of JK&B Capital who understand the power and potential of our technology solution to address patient safety issues and revolutionize medical care.”

“S.E.A. Medical Systems has demonstrated the potential for a novel and dramatic advance in IV medicine,” stated David Kronfeld, Chairman of JK&B Capital. “The company is well positioned to provide disruptive products that improve safety and cost effectiveness of medical care in the coming years.”

“Drug errors are a very serious problem in medicine and it is exciting to finally see a technology that can address some that could not previously be prevented in a new and decisive way,” said David Bates, MD. Dr. Bates is a leading authority on adverse drug events, the mistakes with medicines that injure or kill patients, and is also a member of the S.E.A. Medical board of directors.

About JK&B Capital (www.jkbcapital.com)

Founded in 1996, JK&B Capital is a Chicago-based venture capital firm with more than $1.1 billion under management which focuses on Information Technologies, healthcare and communications. A key to JK&B’s success has been its ability to leverage its substantial technology domain expertise to identify, analyze and access the most promising emerging technologies and the companies behind them. JK&B then provides these companies with financial support, strategic guidance and most importantly technical guidance to help them grow and prosper.

About S.E.A. Medical Systems, Inc. (www.seamedical.com)

S.E.A. Medical Systems Inc. is a private healthtech company that pioneers smart solutions for the safe manufacture, preparation, delivery, and disposal of intravenous and other liquid medications. The Company is developing medical devices to catch life-threatening IV drug errors before they harm patients. S.E.A. Medical’s unique technology identifies drugs, concentrations, and diluents in IV fluids, and simultaneously measures flow rate and cumulative dose during IV administration. The Company is also developing its proprietary technology for other medical applications. Based in Santa Clara, CA, the company has been supported by strategic funding and Series A investors including Quantum Technology Partners, New Biology Ventures, and private investors.

About Series A investors

Quantum Technology Partners (www.quantumtp.com) invests in early stage life sciences and technology companies. New Biology Ventures (www.newbiologyventures.com) is an early stage life science investor and venture capital incubator accelerator.

Source

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Founded in 2010, AccuGenomics is a North Carolina-based, privately held genetics testing company focused on providing standardized gene expression tests to accurately diagnose, monitor and inform cancer treatments.

The company has two tests in development to diagnose, monitor and inform treatments of leukemia and lung cancers.

More than 44,000 patients per year will be diagnosed with leukemia each year; and recent data shows that about 21,000 will die from this blood cancer each year. In addition, more people die from lung cancer than any other cancer in the United States each year. Around 200,000 people will be diagnosed with lung cancer each year. More than 150,000 people will die from lung cancer each year.

Standardized BCR-ABL Molecular Diagnostics Test

The first test from AccuGenomics is for monitoring the treatment efficiency, minimal residual disease (MRD) and follow for a disease relapse in chronic myeloid leukemia (CML) patients with a BCR-ABL MBCR fusion gene event – a known fusion between oncogenes (genes that have the potential to cause cancer). When the gene encodes the protein known as P210BCR-ABL, it can lead to deregulated tyrosine kinase activity and cellular proliferation (steps that lead to the cancer cell formation).

Lung Cancer Risk Test (LCRK-AGX) 14 Gene Test

AccuGenomics is currently recruiting lung cancer patients for clinical trials of their Lung Cancer Risk Test – LCRK-AGX 14 gene test. This test is designed to identify patients at the highest risk for developing America’s most common cancer. By determining risk in the early stage, the hope is to lessen this deadly cancer’s impact.

A recent National Institutes of Health study found that an annual chest CT scan reduces the mortality from this cancer by more than 20 percent. AccuGenomics pointed out that screening the 7 million patients at risk for lung cancer could cost $5 billion per year.

Their aim with the LCRT-AGX 14 gene test is to offer patients a lower-cost route to determining their genetic predisposition for lung cancer so that they can be prioritized for screening.

AccuGenomics will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.

Grant Thornton, an international tax and consulting firm, will sponsor and host a workshop at OneMedForum SF 2012 to discuss funding strategies for life sciences companies. Over the past several years, the primary sources for life science funding have remained largely the same. However, research indicates that the financial crisis has led to a shift in the popularity, focus and type of deals that are being done. Further, the bar has undoubtedly been raised for life sciences companies seeking funding because investors’ appetite for risk has decreased significantly. Many criteria can be used to evaluate financing options – all of which have pros and cons depending on the current position and future direction of your business.

Join members of Grant Thornton’s Life sciences practice as they discuss:

• The pros and cons of various funding sources
• Venture capital trends and opportunities
• New opportunities in government funding
• Tips to developing the optimal financing strategy for your business

Below Tim Zingraf, a partner, is interviewed by OneMedRadio where he provides insight on the challenging nature of the markets today and how companies might navigate in this economy.

Please click below to hear interview audio and see full transcript to follow. To register to attend OneMedForum SF 2012, click here.

Brett Johnson:    Brett Johnson in New York here. Today, I am with Tim Zingraf who is partner in the San Francisco office of the international firm Grant Thornton. He’s experienced and has been exposed to a variety of financing strategies and structures and today we’re talking about financing strategies and alternatives for growth companies in the healthcare and life sciences sector. Tim will be hosting a workshop on strategies such as this at the OneMedForum in San Francisco January 10^th and 11^th. Thanks for joining us today, Tim.

Tim Zingraf:     Thanks, Brett.

BJ:     Tim, what do you see as the major categories of alternative investment strategies for emerging companies?

TZ:    Well, Brett, over the past several years, the funding sources for health and life science companies have remained largely the same. Those funding sources include investors from private capital markets, which would include high net worth individuals, angel investors, venture capital firms, and private equity groups. There are also funding sources available in the public markets and this would traditionally include the IPO and also for current public companies private investments made in those companies through a vehicle known as a pipe, which can either be a registered offering or unregistered through accredited investors.

There are also ways to preserve and generate cash through more operational means and that would be through renegotiating your debt arrangements with your lenders, selling non-core assets or research projects effectively managing your working capital or entering into strategic partnerships with third parties to assist the companies in developing and commercializing their technology.

BJ:     Can you give us a little bit of a historical perspective on how the markets are today versus how they were sort of three years, five years ago for life science and healthcare companies?

TZ:     Well the markets have been very challenging lately. The economy is still a little slow. What we’re finding is that the companies that are getting funding today tend to be those that are maybe more established or have a product that’s very close to being commercialized. There are funding options available, it’s just the strings attached are a little tighter today.

BJ:    And so the valuations are lower than they have been and the restrictions on the entrepreneur have been tighter?

TZ:   I think that’s true. I think what we’re seeing, you know, is a similar number of transactions that are occurring, yet the overall funding levels, whether it be through the venture markets or through M&A transactions, for instance, the aggregate funding levels tend to be a little down, yes.

BJ:     So, Tim, in terms of strategies for companies depending on their size, do you see different strategies for earlier stage companies versus later stage companies?

TZ:       Yes. Early stage companies are likely to seek funding in the private capital markets through either VCs or high net worth individuals while private equity funds traditionally invest in more mature companies that have products on the market or a revenue stream already in place. Access to capital in the public markets is increasingly being reserved for later stage companies again who either have a product in the market or a technology that’s in the later stages of its development.

BJ:    Do you see that changing at all in terms of the IPO window opening at some point?

TZ:    That’s very hard to say. It’s really become an unpredictable process in terms of timing. I think we’re seeing extended periods of time that companies are in registration. Again, it’s really almost a market of the haves and have nots. You’ve got very high profile companies that create a lot of energy in the IPO market and they sell very well while others tend to have a tougher time telling their story and convincing investors that they’re right company to invest in.

BJ:    So what general advice do you give growth companies now in terms of getting funding?

TZ:     Well some advice I guess I would give to growth companies that are in need of funding would be to be patient and to stay focused. All companies are passionate about what they do and this requires a level of patience because not all investors will share the same passion that they do. Different investors at different stages will share your passion at different levels. My suggestion would be, you know, don’t jump at the first funding opportunity and risk losing control of the organization too early. At the same time, companies need to stay focused on their core strategies. They need to recognize that they can’t be all things to all people and knowing when to give up on a strategy that might be failing and re-shifting that focus to something more productive is also very important. Most importantly, it’s very critical to surround yourself with advisors that share your passion and have the best interest of the company in mind more so than those that are really interested in developing a quick profit from their investment in you. So selecting the right advisory board is also very important.

BJ:    So, Tim, what are some of the pros and the cons of the different strategies that exist for growth companies in the healthcare space?

TZ:      Well, Brett, each funding strategy will have its own pros and cons that will be of lesser or greater importance depending on the current state and future direction of the business. For instance, funding from high net worth individuals and VCs can provide early stage companies with a source of medium-term funding, however it can be highly dilutive. While private equity growth capital can provide a longer term funding source oftentimes without a change in control.

IPOs on the other hand can provide liquidity to the organization and its early investors, yet comes with the cost and regulations of becoming a public company. And it can also be a lengthy process with little certainty that the deal will get done. Once a company is public, pipes can provide a faster access to capital, but the shares are typically offered at a discount from market and will result in a dilution to the existing shareholders.

BJ:   Right. So tell us a little bit how you got into this business and in your experience area?

TZ:     Okay. Well I’ve been an audit partner in Grant Thornton’s technology practice for the past six years, but I’ve served clients in public accounting collectively for about 15 years, and I’ve also worked in industry serving in senior financial management roles for middle market companies for close to ten years. I’m not a broker or an investment banker, but in my role as an audit partner and my positions that I’ve held in the industry, I have been exposed to many different types of funding strategies and the challenge these businesses face in accessing the capital that they need to grow their business.

BJ:    Well, thanks. Certainly, it’s a challenging time in market and, you know, being able to be creative in coming up with the right structures and strategies is a critical piece to success. Thank you very much for joining us today, Tim.

TZ:     Thank you, Brett.

BJ:   That is Tim Zingraf who is with Grant Thornton in the San Francisco office. He and some other members of the Grant Thornton team will be offering a workshop on alternative financing strategies at the OneMed Forum on January 10^th and 11^th in San Francisco. You can get more information of that at OneMed Place. Thanks for joining us. Brett Johnson from OneMedRadio signing off from New York.

LoneStar Heart, Inc. is a Texas and California-based biomedical company focused on developing technologies and therapies to preserve and restore heart functions to patients with congestive heart failure (CHF).

Congestive heart failure affects as many as 5 million Americans and with an aging population, more than half a million patients are diagnosed with the condition each year. The mortality rate for CHF is about 10 percent per year.

Lonestar Heart, (a privately held company) takes a “global approach” in their research and development by investigating implantable biopolymers, cardiac stem cell modulators alongside cell and gene therapies. In addition to acquiring and developing a number of intellectual properties, the company has developed a network of international thought leading scientists, clinicians and business partners.

Some of their recent developments include:

• defining the cardiogenic pathway – from stem cell to heart muscle;
• reprogramming cells by switching genes and gene combinations “on” and “off”;
• identifying microenvironments where cardiac stem cells reside;
• screening and validating biologics and drugs that can control cardiac cell fate; and
• implanting biopolymer scaffolds for therapeutic use – alone to provide mechanical relief to the muscle or in combination with proteins, peptides or drugs to promote tissue regeneration.

LoneStar’s lead product candidate, Algisyl-LVR, which is under clinical development, is intended to prevent or reverse CHF in patients with an enlarged left ventricle due to mitral valve regurgitation (the mitral valve not closing all the way and blood backflows into the heart), ischemia (heart blockage), dilated cardiomyopathy (left ventricle enlargement) as well as other cardiac disorders.

Algisyl-LVR is made up of an injectable proprietary biopolymer that is placed strategically in areas of the left ventricle muscle. The biopolymer thickens and becomes a permanent implant in the heart muscle. Acting as a prosthetic scaffold, the product aids in a number of long-term benefits including muscle wall thickening, chamber size reduction, decreased local muscle wall stress, reshaping of the dilated ventricle (based on implant location) and realignment of the papillary muscles.

LoneStar Heart is testing two product versions – one for cardiothoracic surgeons to use in traditional open chest surgeries (bypass or valve repairs) or through a minimally invasive standalone procedure. This product will be injected via a standard syringe with a custom needle system. The other version of the product will be offered to heart failure patients through a standalone, noninvasive procedure performed by interventional cardiologists.

In addition to their implant products, LoneStar Heart is working on a number of other advancements in the treatment of heart failure. Here are a few highlights:

Cardiac Stem Cell Modulators – The scientific teams at LoneStar Heart have identified mechanisms that trigger native cardiac stem cells to regenerate the cardiac muscle. Researchers at the University of Texas Southwestern Medical Center have screened and validated a number of small molecule drugs (in vitro) to switch the stem behavior into a tissue-regenerative mode. LoneStar Heart will work closely with UTSWMC in the advancement of these regenerative drugs.

Regenerative Cell Induction – Under this program, LoneStar Heart is investigating how genes and gene transcription factors may induce a much broader population of cells such as fibroblasts to become cardiac muscle cells. An example of this investigative therapy is the research on skin fibroblasts being manipulated to become stem cells with virtually the same characteristics as embryonic stem cells. The next stage is to see how these cells work in the case of tissue regeneration.

Biomaterials Program – The LoneStar bioengineering team is continuing to develop biopolymers that can be combined with drugs, peptides, proteins or cells to form a bioreactive scaffold. The aim of these developmens is to provide short-term heart muscle stress reduction and a longer-term mechanism for releasing bioreactive substances of therapeutic benefit in localized parts of the heart muscle.

LoneStar Heart will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.

CorInnova, Inc. is a privately held biomedical device company based in Houston, Texas. The company develops technologies aimed at recovery for patients with end stage heart failure. Their target market is 70,000 bedridden American heart failure patients with irregular heartbeats that can lead to muscle cell death, fibrosis, infarct expansion and heart failure.

CorInnova is currently trialing a cardiac compression device known as CorAmend that can be implanted and explanted without ever contacting the patient’s blood through a minimally invasive procedure.

Based on the theory that a patient’s failing heart can be rehabilitated by restoring the proper cardiac motions, this device is comparable to the use of physical therapy in repairing joint injuries. Known as cardiac rekinesis therapy (CRK), the therapy is being considered an alternative to heart transplant – the current standard for patients in end stage heart failure.

Currently, about 230,000 patients are in the end stage of this debilitating condition, and they have about a 40 percent mortality rate over two years. Drug therapies are considered largely ineffective and the donor to need ratio is huge (2,400 donor hearts to 100,000 patients in waiting). About 2,500 patients a year receive left ventricular assist devices (LVADs), but the surgery is invasive.

Additionally, the LVAD device comes in contact with the blood, which could involve blood clots and stroke from the required anti-coagulate therapy. The LVAD therapy is considered a treatment of symptoms, not a recovery method.

The CorAmend device applies gentle pressure to the heart muscle and alleviates stress from the damaged cardiac muscle. It does not alter the shape of the heart, but instead reduces stress so that the muscle can resume healthy motion and begin remodeling. The device is shaped around the heart muscle and is considered a combination therapy with existing CHF therapies.

LVADs currently bring in about $500 million in annual revenue and the market projection is a 27 percent annual increase over the next five years. Estimates put 8,000 patients per year receiving the devices, which amounts to over $1 billion in annual sales. With improved devices such as restorative therapies could double this market to $2 billion or more in sales per year.

With costs for heart failure treatment at an estimated $50 billion dollars per year, this step into cardiac rehabilitation could lower costs in the long-term and provide more treatment options for heart failure patients.

CorInnova will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.

Castlewood Surgical, Inc. is a privately held Massachusetts-based medical device company aimed at improving the care of patients with cardiovascular disease. Their main technology is called the Cyclone^TM System, which allows a surgeon to eliminate the aortic side-biting clamp traditionally used in coronary artery bypass grafting (CABG).

CABG is the most common type of heart surgery in America and consists of taking a healthy artery or vein from elsewhere in the body and connecting (or grafting) this blood vessel to the damaged coronary artery. This surgery is commonly referred to as “bypass surgery” and allows for a new route for oxygen-rich blood to reach the heart muscle. More than 500,000 of these surgeries take place in the U.S. each year.

The main benefit of the Cyclone technology is that it allows surgeon to use their own suturing technique without introducing foreign (metal) material during proximal anastomosis (the actual grafting of the bypass).

Instead of using a metal cross-clamp or side-biting clamp, the surgeon can position the vein or artery graft on the Cyclone for measurement. Next, the Heliguard^TM Coil is positioned on the end of the Cyclone device and the appropriate HeliCore^TM Aortic Cutter is selected depending on the size of the bypass graft. The Aortic Cutter is then used to create a circular shaped hole in the aorta. Next, the surgeon inserts the Cyclone into the hole and removes the Coil. The surgeon can then use their standard suturing technique to complete the anastomosis.

Patients benefit from the Cyclone technology because there is no metal left in the patient. The surgeon benefits because he/she experiences minimal changes to his/her CABG procedure.

The high level benefits of the Cyclone tissue holder for CABG procedures include:

• No aortic side-biting clamp
• No metal is left in the patient at all
• Supports hand-sewn (the gold standard) anastomoses (connections)
• No vein “cuff” is created
• The interior aortic surface is protected
• Supports multiple anastomosis with a single device
• Supports angled anastomoses
• Vein or artery bypass grafts may be used
• Distal or proximal anastomosis can be created first

To learn more about Castlewood Surgical’s Cylcone technology and to see a demonstration, please visitwww.castlewoodsurgical.com. Castlewood Surgical will also be presenting its products and technologies atOneMedForum SF 2012, on January 9 – 12.