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

Matthew Margolis:    Greetings from OneMedRadio. I’m Matt Margolis. Today, we’re speaking with Neil Warma, president and CEO of Opexa Therapeutics, a biotechnology company developing patient-specific cellular therapies for the treatment of autoimmune diseases. Opexa’s lead candidate, Tcelna, is a personalized T-cell immunotherapy treatment of multiple sclerosis. Opexa trades on the NASDAQ under the symbol OPXA. Thank you for joining us, Neil.

Neil Warma:  Well thanks very much, Matt, for the opportunity.

MM:     So let’s start with an overview of the company, and secondary progressive multiple sclerosis. What is this condition, what are some global trends?

NW:   Sure, Matt. Well as you mentioned at the outset, Opexa is developing a novel personalized therapy that really has the potential in numerous autoimmune diseases. We are currently preparing to conduct a phase II clinical trial in secondary progressive multiple sclerosis and if we’re successful, this could be the first safe and effective treatment for these patients who currently have limited treatment options.

You specifically were asking about secondary progressive and we’ve taken the choice over the past six months to focus on this specific indication of MS. Secondary progressive MS is the more advanced form of multiple sclerosis. Most patients are initially diagnosed with the relapsing/remitting form of multiple sclerosis. This is a chronic neurological disease so over the course of several years, almost all of these relapsing/remitting patients do evolve or do progress to the more advanced form known as secondary progressive MS. SPMS or secondary progressive MS is characterized really by a steady progression of clinical neurological damage, which may be accompanied by relapses but doesn’t have to be and really at any one time approximately half of all MS patients will meet the diagnosis criteria of secondary progressive.

Looking at treatment options for these patients, currently there’s only a single product with the distinct labeling to treat the large subgroup of MS subjects who have progressed to secondary progressive. The drug that is indicated for secondary progressive is rarely utilized in the population because of the side effects. They are significant and this puts an extra burden of responsibility on to the prescribing physician as well. So really treatment options for patients with secondary progressive MS are very limited. So therefore treatment alternative for SPMS subjects has great potential, which is why we have high hopes for Tcelna as that could be the treatment of choice for patients with secondary progressive MS.

MM:    So what is T cell based therapy and why is this particular strategy opportunistic to target MS and other autoimmune diseases?

NW:    Well T cells are the main cells that compromise our immune system and they play obviously a central role in cell-mediated immunity. So a T cell therapy, T cell based therapy therefore is one that will impact the immune system or immune cells and autoimmune diseases are those disease in which an individual’s immune system is faulty or dysfunctional.

So a T cell therapy such as the one that we’re working on here at Opexa, Tcelna, it’s a therapy that can be used to treat a multitude of autoimmune diseases. So a T cell platform if you will could theoretically be applied to a number of autoimmune diseases. Our first focus here at Opexa as we’ve mentioned is multiple sclerosis and this specific disease is well suited to our antigen specific disease approach.

Multiple sclerosis is caused by a subpopulation of immune cells that become activated and begin to attack nerve fibers in the brain. For MS patients, their immune system is unable to control these destructive cells. They have an autoimmune disease, therefore, their dysfunctional immune system doesn’t allow them to protect themselves against these individual T cells. So Tcelna, Opexa’s therapy, will selectively target only these pathogenic or destructive T cells and Tcelna does not impact the entire T cell population like other MS drugs. Because we’re selective in only targeting these pathogenic T cells, we believe our side effects are that much less than other drugs.

To look at it from a higher level, Tcelna or T cell therapy aims to restore the function of the body’s immune system and because of this impact on the overall immune system, we do believe it has applications in several other autoimmune diseases.

MM:      Can you discuss some intriguing data surrounding the anticipated phase IIb trial?

NW:  Well it’s interesting. I mean we’re planning to conduct a IIb study in secondary progressive patients. So looking at the data that we’ve generated in secondary progressive and we’ve treated really a range of patients from relapsing/remitting to secondary progressive and we’ve seen benefits kind of across the range of MS patients. So in theory, we think it could be really a therapy of choice for all MS patients. The side effect profile for Tcelna seems to be really superior we believe to all other products and the efficacy seems to be at least as good as the best. I think our mechanism of action for Tcelna does set us apart from other drugs.

When we look at the data that we’ve generated from secondary progressive patients, it is quite encouraging. We treated a number of patients. There were a number of clinical studies done by us and also by Baylor College of Medicine and when we look at the patients across the board. 80% of all the patients treated with Tcelna showed no disease progression after two years, which is highly encouraging. Also, in these secondary progressive patients, the majority of them were having relapses at study entry and what we saw following Tcelna treatment was that the relapse rate for these patients dropped almost to zero. So in 21 years of cumulative patient follow-up on this group of patients we were investigating in our earlier studies, only one patient had one relapse. Additionally in the two years following treatment, the secondary progressive patients showed no worsening of physical or psychological conditions and these are two quality of life indicators.

So really across those three endpoints if you will, we’re very encouraged by the data that we’ve generated in secondary progressive. If we can continue to develop Tcelna and see data such as this developing both a safe and effective therapy, again it could be one of the dominant therapies in this indication. Currently, the MS market generates approximately $11B of annual revenue so again we’re strongly believing in the potential for Tcelna.

MM:     Now in November, the FDA granted fast track designation to Tcelna, can you discuss receiving this FDA fast track approval?

NW:   Certainly. It was a significant milestone for the company. We have developed kind of very strong relationships with the FDA here in the US and also with Health Canada, the regulatory authority in Canada and we submitted our dossier to the FDA a number of months ago requesting fast track. FDA grants fast track only in diseases of significant unmet need and to therapies that demonstrate the potential to have a significant benefit in these diseases. So by granting us fast track, the FDA recognizes that certainly the secondary progressive is a disease of high unmet medical need and that Tcelna has the potential to benefit these patients. So again, we were very pleased to get this endorsement from the FDA really as it recognizes the potential of the therapy and it should also speed our time to commercialization we hope.

MM:       So in that light, maybe you can talk a little bit about a development and commercialization timeline. Your most recent preliminary meeting with prospective clinical trial investors is particularly interesting.

NW:     Certainly. As we’ve stated, we are planning to initiate a phase IIb clinical trial in secondary progressive patients and then if this is successful, we would envision in moving immediately in a phase III pivotal trial and this would be subject to FDA approval. Each of these trials will likely be a two-year trial and if the data from both of these trials are encouraging, we would then look to seek approval by FDA following such a clinical program.

The recent meeting you referred to at the annual neurology conference, the AAN was very successful. We had some of the biggest names in MS, some of the key opinion leaders in MS in attendance. Really, we spent a fair amount of time to speak about the specific trial design, the phase II trial design. Also issues around patient enrolment, side questions, and answers so it was a very motivating discussion for us and again many of the MS leaders reflected on the potential of Tcelna in secondary progressive MS so again highly encouraging.

Operationally, we believe we remain on track to initiate the trial in the coming months. We’re all working diligently here to finalize preparations and as we’ve also stated in order to initiate the trial, we need to secure additional financing either through a potential partnership or additional capital raise. This continues to be an important focus for us as well.

MM:       Now your proprietary T-cell technology platform is said to generate multiple drug opportunities. So where else are you focusing? What is your progress with those candidates?

NW:     Very good question. We’ve had a lot of internal discussion about the potential of the platform kind of across numerous autoimmune diseases and we believe as we’ve stated earlier in this interview that there is potential in many other autoimmune diseases and we’ve discussed such relevant diseases, such as type 1 diabetes, rheumatoid arthritis, all of these are antigen driven diseases. There’s also some orphan and niche indications that could be very attractive to us as well. We have a strong patent position that should allow us to expand nicely into other disease areas as well. So we’ve had a lot of internal discussion. We’re certainly, you know, focused on the MS trial and getting that up and moving forward, but again just to reiterate, the potential to expand the pipeline beyond multiple sclerosis we believe is quite high.

MM:  And what challenges and opportunities do you see going forward?

NW:  Well, there’s always challenges and opportunities for any company, certainly in the biotech industry as well. I think challenges for us, you know, certainly being a public company, we are influenced by kind of the capital markets both positively and negatively, the volatile capital markets. I think for us as well building and maintaining evaluation for Opexa that is more reflective of our true potential is also a challenge. We do believe given the state of development and the novelty of the platform, we are undervalued so working to build value in the company is very important.

As far as opportunities, I think there are several key ones. I think firstly, you know, we are pleased. We do have a novel therapy that has demonstrated promising clinical efficacy and a superb safety profile really in an area of significant medical need and with substantial market opportunity as well. So we are really in the position of advancing one of the more promising therapies for MS through clinical development towards commercialization so a huge opportunity for us. I think if we’re successful, the return on investment for our shareholders will be significant as well.

We also have the opportunity coming at it very motivated by our discussions and interactions with patients and we really have the opportunity to bring to market really for the first time a safe and effective treatment for secondary progressive MS patients. Again, our interactions from the patient community make this a highly motivating element and opportunity for us tremendously.

MM:     What are your key strategies for building shareholder value?

NW:    Neil Warma:   I believe key to building shareholder value is executing on the upcoming MS clinical trial first and foremost. We will certainly continue the evaluation of additional autoimmune diseases that we can potentially treat with our T cell platform, but really the focus is on the upcoming MS trial. Should this trial be successful as we believe it will be, the value generation for Opexa would be significant and we will have delivered a substantial return on investment for our shareholders.

MM:    That was a company snapshot of Opexa Therapeutics with Neil Warma, president and CEO. Opexa trades on the NASDAQ under the symbol O-P-X-A. This is Matt Margolis with OneMedRadio signing off.

Just as smartphones are replacing books within the personal realm, electronic tablets are quickly taking the place of paper in doctors’ offices, and are doing so on a global scale. Part I of this report discussed how we got here, and took a look  at how the consumer-grade tablet market has entered the space.

Part II discusses The Waiting Room and the introduction of health tablets as a replacement to magazines making a patient visit more informative and efficient.

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As part I of this report noted, there seems to be some issue with consumer-grade tablets entering healthcare. As such, several smaller companies are gaining notoriety by producing tablets specifically for clinical settings, and even in waiting rooms. At February’s Startupalooza in Newark, New Jersey, 43 digital and eHealth startups pitched their businesses directly to six investors. Investor judges selected six companies to present their pitches to the audience, and two winners were chosen – with Epion Health taking the eHealthcare category.

Epion is a private company launching a mobile tablet geared toward enabling the patient visit to the doctor’s office to begin the moment they check in with the receptionist. Epion reports that the average wait time is 34 minutes – more than a half hour that can and should be spent making the visit more informative and efficient. Epion’s Smart Screen® lets patients view information about their condition while they wait, with peer-reviewed educational material from sources such as the Mayo Clinic. Patients can also download the material to their mobile device

The company also provides its preloaded tablets to doctors at no charge. Physicians can also use the Smart Screen® to access digital medical tools, utilize pre-loaded medical apps, and view results of health assessments. Epion has completed several successful trials funded by a major pharmaceutical company and is seeking $1 million to complete its pilot program.

The value of a patient reading targeted healthcare information instead of old golf magazines is obvious to most. According to experts, however this is a paradigm shift that may lead to new parameters of the healthcare complex-patient relationship. Healthcare ad spending is on the rise, and The New York Times attaches some interesting figures to the issue. In the first six months of 2011, funds spent on advertising by American hospitals, clinics, and medical centers reached $717.2 million, a rise of 20.4% from $595.5 million in the same period of 2010, according to the Times.

Like hospitals, pharmaceutical companies are able to take advantage of tablets as a way to direct information at patients as well. The pharmaceutical industry spends upwards of $57.5 billion a year on promotion in the US, according to an NYU study, with 12.5 percent allotted to direct-to-consumer advertising, according to McGill University. And, according to an eMarketer report, US healthcare and pharmaceutical online advertising spending reached $1 billion in 2012.

Drug companies and healthcare providers thus spend billions of dollars targeting a general population, many of whom will never use their products. The tablet, however, presents the opportunity for a highly targeted ad campaign.

Considering that the proportion of adults who are online and have ever used the Internet to look for health information has increased to 88% in 2012, there is little doubt that information made available through these tablets will be valued by the patient. Patients can walk into appointments not only having been freshly educated about the health science regarding their particular conditions, but will have just been informed about drugs on the market to treat those conditions. Dr. Cindy Haines, health information guru and author of The New Prescription, believes tools that empower the patient this way will have a profound effect on righting the healthcare system.

The true value of these tablets will be measured by consumer reception. Thus for every statistic quoted, for every dollar saved, enterprises must also stay in touch with patient preference – sometimes as simple as a game or a piece of entertainment.

As such, some tablet companies have set out to present said content to patients through games that can be played during waiting room time, which “reward” patients for correct moves with factoids about specific diseases. What better way to become more health savvy than through tic-tac-toe?

Blood test for bowel cancer

A team of Australian scientists report that they identified new genes that show identifiable changes in the blood of people with bowel cancer. The discovery, they say, could have the potential to underpin a new blood test that would signal the early stages of bowel cancer.

The research, which was presented at Digestive Diseases Week held in San Diego last week, is the result of over five years of scientific collaboration between the Australian biotechnology company Clinical Genomics, the Commonwealth Scientific and Industrial Research Organization (CSIRO) and the Flinders Centre for Innovation in Cancer at Flinders University in Adelaide,

A bowel cancer blood test based on these discoveries is now under development and is currently being tested with patients from Australia, the United States and Europe. The Australian research team is hoping to attract interest from other clinicians and scientists around the world to help them further validate the test.

Affymetrix and ScreenCell collaborate on circulating tumor cell technology

Affymetrix (NASDAQ: AFFX) and ScreenCell report that they have signed a worldwide distribution agreement covering ScreenCell’s isolation devices and dilution buffers, designed for the collection of circulating tumor cells (CTCs) in peripheral blood. Affymetrix becomes the exclusive distributor of ScreenCell®products used in combination with in situ hybridization (ISH) assays, microarray assays, and other non-PCR based nucleic acid assays.

Quest extends endocrine diagnostic test menu

Quest Diagnostics says that it has extended its endocrine diagnostics menu with the introduction of four new tests panels for congenital adrenal hyperplasia (CAH), an endocrine disorder found in newborns, children and women. The new offerings feature a comprehensive panel for newborn screening for CAH. The panel enables analysis of all 13 steroids associated with CAH using the highly sensitive and specific liquid-chromatography tandem mass spectrometry (LC/MS/MS) measurement technique. The test can be performed on a sample volume of 0.1 milliliter, making it suitable for newborn heel-prick sample collection.

Van Andel Research Institute and Dako to work on MET4 MAb

The inappropriate expression of the c-MET cell surface receptor in human solid tumors has directed research towards the development of companion diagnostics to identify those patients who could benefit from c-MET targeted therapies.

It has been found that the MET4 monoclonal antibody, developed by George F. Vande Woude, Ph.D. and Brian Cao, M.D. of the Van Andel Research Institute (VARI) and Beatrice Knudsen, M.D., Ph.D., formerly of the Fred Hutchinson Cancer Research Center, detects the MET cancer-causing gene in human tumors and works well in classical diagnostic procedures.

Now VARI and Dako have announced an agreement to license, manufacture and distribute cancer diagnostics utilizing the MET4 antibody. Diagnostic tools with the MET4 antibody will be developed and manufactured by Dako for clinically relevant diagnostic indications and commercialized worldwide. Dako also holds the right to develop MET4 companion diagnostic assays (pharmDx™ assays) in collaboration with pharmaceutical companies to identify cancer patients who may benefit from MET-targeted therapies.

-Peter Winter

Recent front page articles in popular magazine such as Barron’s and American Profile highlight the importance of work on Alzheimer’s Disease by dedicated firms that range in size from Anavex Life Sciences (OTC: AVXL) to major pharmaceutical giants such as Pfizer (NYSE: PFE) and Eli Lilly (NYSE: LLY)

The articles below present interesting news and developments in the field.

USA Today “Alzhemier’s Mistaken Diagnosis” 

Time “New Drug Trial Aims To Prevent Alzheimer’s Before It Starts” 

MPR  “Researcher gets govt. investment for Alzheimer’s treatment technique”  http://minnesota.publicradio.org/display/web/2012/05/16/alzheimers-treatment-technique/

Click below to hear full audio interview.

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.

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.

Just as smartphones are replacing books within the personal realm, electronic tablets are quickly taking the place of paper in doctors’ offices, and are doing so on a global scale.

Healthcare is steadily moving in the direction of digitization, and electronic health records (EHRs) and tablets have already become an integral part of how doctors and nurses do business in the backend of the healthcare system. Now, digitization is steadily revolutionizing the waiting room, a paradigm shift which many experts view as the simplest way to fix the flawed healthcare complex.

In light of some recent news by Epion Health, an private, emerging company in the consumer health information space, we are embarking on a special report analyzing the importance of digitizing clinician administration, and the patient-physician communication. Part I of this report asks how we got here, and looks at how the consumer-grade tablet market has entered the space. The results may surprise, and in turn open the door for smaller, more focused companies.

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EHRs are considered to be an avenue through which healthcare costs can be lowered, supported by doctors and Congress, as evidenced by the American Recovery and Reinvestment Act of 2009 to funding for EHR incentives. Doctors are embracing the power of digital communication, too, as a means of making healthcare more efficient. It is reported that 94 percent of physicians are using smartphones to communicate, manage personal and business workflows, and access medical information.

Needless to say, companies are embracing the opportunity to expand healthcare’s move toward the digital beyond just the smartphone. DrChrono is a start-up in Silicon Valley offering an application for electronic devices that helps both doctors and patients track electronic documents. Since it was founded in April 2010, the company has reportedly had more than 50,000 doctors and 400,000 patients register with the service. Apple says that more than 80 percent of the ‘top hospitals’ in the United States are using iPads, according to MedScape Today.

In the backend of healthcare establishments, tablets have already improved practitioners’ ability to fulfill the most important aspect of their job: tending to patients. Nottingham University Hospital, the fourth-largest hospital in the UK, recently invested in tablets and a mobile app in order to improve communication among staff. Before, the hospital had been relying on PCs, Excel spreadsheets, pagers, and phone calls to arrange staff assignments. Assignments were sometimes missed due to sloppy record-keeping, and junior doctors already tending to an issue were interrupted by pages.

Nottingham’s IT group implemented Cisco’s end-to-end network, purchased Cisco tablets for nurses and doctors, and worked with third-party app developer NerveCenter to build an Android app to serve as a task-assignment workflow tool . Doctors can now receive assignments on their mobile devices, and the entire staff can use their devices to see whether or not an issue is being addressed. Moreover, the system can communicate tasks to specialists with more efficiency, and in turn leave non-specialized jobs to junior-level doctors.

Reportedly, coordinators and nurses previously spent 97 percent of their time in ward offices using the phones and computers, and now spend just 40 percent of their time in offices – instead, they are moving around the hospital with tablets or smartphones, checking on patients.

In Ontario, Canada, Ottawa Hospital CIO Dale Potter purchased 3,000 iPads  in response to the scrutiny of Canadian healthcare system spending, noting the inefficiencies of the paper model. Physicians were printing stacks of patient charts, he said, and making their daily rounds with their clipboards, or they would leave patients’ bedsides to gather or enter data and then return. Potter reported that efficiency has improved greatly, stating, “I have attending physicians who say they feel more engaged than they have in the 25 years they have been practicing.”

Still, Potter reports that Ottawa Hospital grapples with the iPad’s limitations. The iPad was originally a consumer device, and Apple did not envision uptake by healthcare, mobile sales, and other business users. Limitations include weak administrative features, he told TabTimes, which hinder the remote control of images.

Industry insiders also question if tablets not specifically geared for healthcare can – or should – dominate the market. In January, Independent research group BizTechReports published a survey concluding that healthcare IT executives have concerns regarding the usage of iPads in their establishments. Namely, 66 percent of respondents believe consumer tablets create governance challenges for their organizations. Further, 74 percent said consumer-grade tablets present challenges for entering data into enterprise-grade healthcare applications. Another 66 percent have issue with the technical support costs of consumer-grade tablets. Durability is also reported as being less than optimal. Interestingly, the study was sponsored by Panasonic.

Likewise, in 2011, the Seattle Children’s Hospital reported a failed experiment with iPads in clinical settings. A group of five physicians and two nurses could not access EHRs through the tablet web-browsers, among other hindrances.

Apple and Samsung have little published on their future efforts in healthcare, their silence perhaps a consequence of their upcoming tablet patent infringement lawsuit.

Stay tuned for Part II: Tablets in the Waiting Room

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

Brett Johnson:       Welcome, Brett Johnson, New York City, OneMedRadio. Today, I am with Dr. Eric Topol. He is the author of The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare. Dr. Topol is a director of the Scripps Translational Science Institute and the co-founder and the vice-chairman of the Western Wireless Health Institute. He’s regarded as one of the country’s leaders and has been one of the most cited clinical research in the area of Cardiology. He’s a member of the National Academy of Sciences. He’s been named one of the 12 rock stars of science in GQ. Thanks for joining us today, Eric.

Dr. Eric Topol:    Oh, great to be with you Brett.

BJ:    So Eric, can you quickly tell us why did you write this book?

ET: That’s an easy one. For me, it was that I’ve never done a book for the public, but I saw the changes that were occurring, what can occur in medicine are profound, and they only would occur in a reasonable timeframe if I could get consumers educated and activated, and that was all about getting a book out that hopefully would be having the right information, be readable, and help stimulate a conversation.

BJ:  What do you think are the things that are the most important for people to know?

ET:     Well, I mean there’s a couple things that probably are major themes that are not generally appreciated, but the first might be the fact that we had this remarkable asymmetry of information, with the medical community and doctors being the ones that held all the data and information, and now, that’s,  rapidly moved to the patient and consumer level, and that will be held on smartphone, or from a genome sequencer, all sorts of ways that that shift is very rapidly going to occur, and that I think is something that represents the biggest shift in history of medicine alone because that’s like back to the printing press days and the whole Gutenberg transformation.

So that changed a lot of what tradition to do. Instead of being the holders of the day, they’re helping to interpret and partner with patients, and that’s a really big shift at how obviously a lot of physicians are not ready to make nor the American Medical Association, and many other parts of the medical community.

So that’s  one big thing that this book is emphasizing, and I don’t think a lot of people realize that this has already started, and there was a false sense that that was going to happen in the ‘90s with the internet and access to medical information, but that turned out to be completely wrong because while you can get information through the internet, it’s not your information and this is a whole different look when it’s actually your data whether it’s your blood pressure or you name it to your data, and now it’s processed, through all sorts of algorithms and geographically displayed, and all of a sudden now, you’ve got insights you’ve never had before, and I include none of us had before because we didn’t have a way to get a blood pressure reading every minute, not even,  during sleep or to do one’s own sleep studies at home, and all sorts of things like that.

The other big one though is more in the future like where is this take us to, and that’s where that shifted people have talked about for years. It needs to occur from sickness to wellness or what I should say chronic disease to prevention of disease, and I think we have the tools and the power to now make that shift. And I say that because, the science is advancing so quickly, and we can bring together disciplines in biomedical research that never occurred before.

I’m particularly referring to as one example of embedded nanosensors.

You probably saw in the book about where this can go, but when you take a sensor that’s the size smaller than a grain of sand and put it in the bloodstream, and now, you have personally no added power requirement because just the blood moving itself is enough to power a nano chip for years. So now you have a sensor that can see something  that’s circulating in the blood on a moment-to-moment basis, which whether that’s a cancer cell, the first cancer cell, or whether that’s a cell sloughing off from an artery that’s ultimately going to lead to a heart attack, or whether that’s an antibody that’s directed against one own tissue like the pancreas islet itself or diabetes or any other immune disease like, for example, a multiple sclerosis attack before it ever happens or asthma, you name it. You’ve got embedded now sensors and signals that we never would conceive as possible.

A lot of people think, oh genomics. Genomics is just a sequence and how you’re going to have susceptibility to diseases defined, but no, I look at it as genomics is having your body under constant surveillance because genomics gives us new markers of that afford prevention, true prevention for the first time. So you not only know who by genomics might need the sensor, the nanosensor embedded, but you’re also using genomic signatures to direct the signal from the nanosensor to the cell phone. It’s basically turning a body, digitizing you and being like a car where it says lights up, you know, your doors open or your transmission is shot, and here, you’ve got the same warning lights on your phone about your body.

BJ:   Now, is that going to be economically possible?

ET:                        Oh, it’s going to be economically not possible to use it because pervading diseases, of course, isn’t worth all that

BJ:                               Right.

ET:      So once you have a stroke, or once you’ve got a significant heart attack, or once you developed a metastatic cancer, the cost of those things are profound. So if you can prevent any of them, any of these chronic diseases,  that is going to be like the greatest return on our investment we could imagine.

BJ:      Right. So you see hope that the dilemma of unsustainable healthcare cost could be a sense reversed or certainly diminished by the development of this new technologies.

ET:      Yes. I mean I think the ones that we’re discussing, of course, are little ways off, but even today, you could remotely monitor people to keep them out of the hospital. That’s going to become really big in the next year or two. You can prevent the need for sleep study in the hospital which cost $3,000 just by doing it in one’s own home, the comfort of your home bed, for instead of $3,000, you can do it for $100.

And then you can use that same equipment for everybody in the neighborhood like in a family.

So the whole idea is that this is innovating out of the mess that we’re in in healthcare crisis, and one of the frequent questions is well, you’ve got this great technology. It’s very hyper innovative, whatever, but in the past, new technology in the biomedical spaces lead to increased cost, which is kind of what you were getting at, and the difference here is that that could not even be conceived, and new technology now at increased cost is dead in the water.

ET:      If it doesn’t have a marked-savings-pay-for-itself-type look it’s not going to go anywhere.

BJ:    Right. So the kinds of things you’re describing are really changing the way the healthcare system works, in any case, you talked about in your book, it’s ossified, it’s rigid, it’s the least flexible, and it has made little or no change. Can these new ideas overcome the status quo of people not wanting to change because it changes the economics of our entire existence?

ET:       Yes.  I really think that’s the case. We’re about to witness, especially if we take a blurred temporal window of some X number of years now,  this enormous shakeup like that which we’ve never seen. And in this,  new tools, just as we saw how mobile device has changed our daily lives in the last decade, this is the next phase. This is the most precious for our health. So I don’t have any question of the power of the tools that we have at our disposal and how they’re going to continue to really zoom ahead, but this is much more transformative than most people would even imagine.

BJ:    Is there going to be pushback from the status quo?

ET:   Oh, there always is, especially in the medical community. And the problem partly there is there’s so many threats to reimbursement. When you don’t have to go to an optometrist, but you can just get a $2 add-on to your phone and look in it and get refraction of your eyes, and text to get your eyeglasses made, or you can just take a picture of a skin lesion and don’t have to go to the dermatologist and on and on and on, there’s a lot of pushback, a lot of threat of the traditional reimbursement channels which doesn’t go over too well.

BJ:    No, but which means the whole idea of consumers in health is necessary for this to work.

ET:   That’s actually the big old reason why I did the book is I felt like we need to fire up the consumerism and the activism. I mean this is what it’s all about. It won’t happen soon enough without that force. And that force is a multiplier now from the social network standpoint, and the power of people is so augmented today relatively to  just a few years ago. So that’s why I really believe we have, to some person, an ability to catalyze this.

BJ:      So has anyone done a book or who else has been in the space of trying to talk about the issues that you’ve been raising?

ET:   I haven’t seen anything yet. I think the digital world is turning everything else upside down, but I haven’t seen yet a dedicated thing on this – I think the idea of their disruptive innovation of Clayton was as close as it was to get to it, but it wasn’t specifically all the digital tools that are going to achieve this, including on the consumer side, the social networking, which is a critical part of all this. But that book of his was, I think, published 4 years ago, and I think things have changed a lot since then.

And so I don’t know of anything else yet that’s been dedicated to have a digital revolution will feel this. And it ain’t just feeling the tool, but also the potential of this consumer-driven revolution. I mean there’s kind of this other level of it. It is oh yeah, they got this the ways to capture data that we didn’t have before, but it’s also getting that to be the mainstay of care prevention, you know, daily routine practice of medicine, and that normally takes 17 years, and that we can’t wait for, and hopefully, we won’t.

BJ:  What can we do? What advice do you give to citizens today and how they can help make this new reality happen?

ET: I think that’s the key. What I try to do is say, first of all, you need to seize control of your data because it’s going to be a lot – there’s going to be a flood of it coming and you will be directing it. So for example now, there are recent things like a JAMA paper. Should patient have access to the laboratory data? And I’m saying, “Wait a minute now. How can you publish an article with that question in 2012?”

So the idea that each citizen owns their data and so, that’s like step number one. That includes genomic data, laboratory data, scan data. Of course the office notes across the board. Now, built on that framework and that tenet is the idea that there are new data to be had, and so if you have high blood pressure, you may want to get an app for your phone like the High Health to get a lot more readings that, of course, will be graphically displayed on your phone, and then of course, you can share that with your physician, but also, you know, let’s apply that across the board to other things whether it’s glucose or brain waves for sleep, or you know, and on and on and on.

That data you can get now. And so do you know that? Do you want to get this? Are you ready for this? Are you ready to go beyond e-mail and surfing the web on your phone?

BJ:     Interesting. So what’s the next step? Now you’ve done this book. Do you plan a follow up or is there any ongoing work to get this message out?

ET:     That’s a great question. I mean I need a recovery period since the book took more out of me than I ever imagined, and it was the hardest I’ve ever worked on anything in my whole career so I got to take a break from that, but I – To me, right now, the whole idea is to try to get as many interested parties like yourself to help prod and get the conversation into higher gear. And so whether it’s people like Reed Tuckson at United Health is a big advocate now. They represent the healthcare industry. Or the informatics, the HIMMS Organization, or mHealth, and the CTA wireless organizations, companies that you might not have ever thought of that would be engaged, but maybe,  companies like Qualcomm or Apple, or, GE.

So if we start getting this from multiple fronts, and I’m just kind of a cheerleader here, but if we get key leadership across large segments of the healthcare industry, and in particular, more than anything, consumers, then we can start to,  get this actualized.

BJ:   Well, thanks for joining us today.

ET:    Yeah, I really enjoyed the discussion with you.

BJ:    Okay, so that is Eric Topol, M.D., who has written the book The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare. It’s recently out now, and is, I think, one of the best books that’s been written on understanding the rapidly changing healthcare world. This is Brett Johnson in New York City with OneMedRadio. Good day.

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 help with administrative processes, and at the same time educate readers on their 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.

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 choose 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, prefer buy an iPad, download a few health information apps (everything from iTriage to HealthDay, e.g.), and put on some games? Epion offers their Smart Screen health tablet to physicians at no cost.

CH: The obvious response from Epion is they make your (physician’s) life easier: if you [opt for] 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.

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.

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

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.

In addition, editor Lara Morrow brings us Part I of a two part series on healthcare’s digital revolution.

OneMedForum NY 2012 Sponsor,  Aptiv Solutions Educates the Market on Adaptive Clinical Trials in their first OneMedRadio interview. And “Rockstar of Science” and influential doctor, Eric Topol,  talks about his book ” The Creative Destruction of Medicine.”

Sincerely,

Brett Johnson

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

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, we’re joined by Dr. James Tong, director and CFO of Tianyin Pharmaceutical Company, a leading pharmaceutical manufacturer and supplier developing modernized traditional Chinese medicines and branded generics. Tianyin is based in the Sichuan Province in China and trades on the AMEX under the symbol TPI. Dr. Tong, thank you for joining us.

Dr. James Tong:          Thank you, Matt, for the opportunity of a radio interview.

MM:    Of course. So maybe we can start with the biggest news in your company lately, the construction of a new manufacturing facility in Qionglai.

JT:    We have started the construction of the new facility at Qionglai County of Chengdu pretty much the beginning of this year. We have communicated with our investors that the reason for the construction is, one, that reassignment of different regions to be different industrial zone and our previous facility is located in Longchang County and then that was designated to the automotive center. One of the reasons for relocation is that Qionglai County is going to be designated as a biological, biotechnology center and we are moving there. Second of all is that we are combining our pre-extraction plant with our current formulation plant all together into one bigger facility at Qionglai County and it will be certified for a new GMP standard. So there are multiple purposes for this construction and we look forward to the final completion of phase 1, which is estimated to be at the end of 2012.

MM:    And when do you believe it will be fully operational?

JT:      We believe the pre-extraction plant should be fully operational by the end of this year 2012, it depends on the scale of expansion. Our formulation plant, we expect that the formulation plant will be fully operational in 2013. Expectedly, there will be no interruption of the production because we are working with the government which gave us the time to finish the new plant and at the same time keep the original formulation plant operational until the whole relocation is completed.

MM:    How have investors responded to this announcement

JT:   I think the investors originally had expressed concern regarding the relocation because it will cost some of the capital expenditure, which we estimated to be $20M. There is some concern about interruption of the production, but as I have mentioned, before that these are under control. The $20M will be spent from our working capital and cash reserve, which is currently around $35M. There will be no interruption of the production. So when we have communicated with the investors since last year and early this year and then during our annual meeting, we found that investors understand and certainly support this relocation project.

MM:  So maybe you can talk a little bit about TPI’s product portfolio and the related pipeline?

JT:   We currently have 58 products, which includes Gingko Mihuan, which the short form is GMOL, which is Gingko Mihuan Oral Liquid, our lead product. We actually have some news out  actually a few hours ago that Gingko Mihuan has been listed as provincial essential drug. Essential drug list includes about 300 products, which are fully reimbursed by the national insurance program by China. And listed in the essential drugs in two provinces in Henan province as well as Shandong province, is likely to support the sales expansion in these provinces. We are really excited about this progress and we’re certainly making our effort to further expand the sales should there be more provinces list Gingko Mihuan or GMOL as their essential drugs. Again, these provincial supplementary lists are in addition to the national EDL list.

We have other products, I’ll mention a few. We have Xuelian Chongcao (XLCC), which is you can say a nutraceutical-pharmaceutical, which is very special for China. That it’s listed as a drug, approved as a pharmaceutical license, but it’s actually a nutraceutical when it was first formulated and it’s for immunity enhancement. Also, we have another product is western generic, it’s Benorylate Granules. In Chinese it’s called Apu Shuangxin and the sales has been increasing. We have another product that’s called azithromycin tablet, which in China, its generic antibiotics and we have a raw material plant support the raw material supply for this azithromycin tablet. The last product I would like to mention is Qingre Jiedu, which is an antiviral cold medicine formulated with herbal extracts, which is one of our legacy product, that is selling fairly well especially during the winter. In addition to these five products portfolio, we have over 50 products, which is our generics, modernized Chinese medicine. We also distribute some other pharmaceutical’s products, which will bring the whole portfolio over 70 products.

MM:  It’s very impressive. And in light of this GMOL news, I think I’d like to talk about the current Chinese healthcare reform. You know, it created some price restrictions. So under this dynamic competitive environment, what type of company do you think will be favored?

JT: We think that if we look at before this reform, the companies making generics or copycats are competing with any other companies in the market that make the same products. With the pricing restriction and at the same time with the increased, more stringent GMP certification, we see lesser companies. “Lesser” means that they’re less capitalized and their products are not standing out, also these companies are small and less capitalized, various reasons cause these companies are on their way out.

Currently, China has about over 3,000 pharmaceuticals and we believe in five years, we might see a third of them are gone. “Gone” means that they could be absorbed into bigger pharmaceuticals or through various market mechanism or M&A mechanism that we will end up with bigger companies with better products, larger product portfolios. Another group of companies that are favored are those with certain product portfolios that are not duplicates of others. Our GMOL product, which is a proprietary prescription medicine and has a patent protection. We’re looking into building more products, the type of proprietary portfolio, that certainly will cause time and effort and especially capital. But I think that in five years or even a decade, we see the companies are bigger with all around portfolio will favor and also the company with unique products, good margin and also innovative medicine or in combination will be favored after this round of reform.

MM:     So let’s shift gears to the capital market. Now you’re a case study sorts on how a Chinese company can build a presence in the West. So how has TPI separated itself as an ideal supplier and developer in China of international pharmaceuticals?

JT:      We think that most people look at China stocks or US listed Chinese stocks as one way that US investor or international investors participate in the growth of China. We see this as the opportunity for international investors, but at the same time, we see that the listing in the US market will likely provide a great platform for a Chinese company to go to the world.

Currently, we do not have any international sale, but we are looking forward to and we are actually developing some of the raw materials sale in Bangladesh with our Azithromycin raw material plant. In addition , we are also looking for distributors to develop sales in the US because we sellthe modernized tradition Chinese medicine. You know, some of the products may not be approved as a pharmaceutical in the US, but very likely can be sold as a nutraceuticals or dietary supplements. These are all various ways that with listing in the US that we open the doors both ways.

MM:  Now some talking heads maintain that the disclosure and balance fraud in China is increasing to a point that is difficult to manage. You’ve previously discussed the current transitional period of weeding out that fraud. Can you go into some detail about that?

JT:    For the past two years that we have seen the decrease or shrinkage of China US-listed companies market cap. Some of the companies have lost their market cap by 50% to 80% and some of the companies due to various reasons there was litigations, there were the trading halt and delisting and you also see some of the companies went private. I think that we are certainly in a trial of confidence that this is what we hear from various investors who have lost money, have indeed experienced the risks of investing in foreign issues, which has always been the case, but the past two years have been a fairly dramatic experience for them.

I think that for us and particularly companies and certainly to other Chinese companies who are listed in the US, that we are making the best effort to bridge the communication with our investors and also working with various professionals, our legal counsel, auditors, IR and great public relations company like [OneMedPlace] to reach out to our investors and tell our stories and just you mentioned before the developing substantial business presence in the US through various export and import. I think that by doing this, we’ve not only really grown the company and we’re growing the company visibly. We attend lots of the investor’s conference meetings. We hope that we can, you know, attend more meetings in addition to investor conference that was more like pharmaceutical companies, collaboration, or various ways we can develop our business in the US or internationally.

I think that this period will pass. You know, we do not have an estimate how long will it last, but we believe that by working day by day and communicating with our investors that we will sooner or later really see the light at the end of the tunnel.

MM:  In that light, what is the short-term future and long-term future of TPI?

JT:  For the short term, we are still looking into various ways to develop a growth strategy under the current healthcare reform. Let me have a quick summary of the healthcare reform policy here. If you look at across the board of the China healthcare companies that they have more or less experienced the price reduction and various stringency tests of their product under this healthcare reform. And the government believe that by limiting the tender prices that they could weed out a lot of siphoned profit which were collected by various distributors. But at the same time, we might have quality issues if you really push the margin to be very low. Because some of the companies are not compliant to certain GMP standard and that’s how they can offer a very low tender price or bidding price. So at the same time, we’ll keep our quality standards and also cope with this as a dynamic market/competitive environment.

I think the short term, we are going for several quarters of, one, developing the sales, maintaining the sales, and developing our core product portfolio like GMOL and the drugs that I have mentioned above. And also developing proprietary products like innovative medicine, which if there is any substantial progress will be communicated with our investors readily. Third of all is the relocation project, which we will do our best to finish on time or earlier and remove any uncertainties during these capital expenditure projects.

For the long term, we see hope and promise that various growth strategies might take certain incubation times to take effect. But we have grown from 1994, a very small company to the current size under  the big picture of the growth of China. We think that our current trends of healthcare reform or the pricing was periodic. We look forward to a greater and brighter future for TPI in the several decades down the line.

MM:  That was a company snapshot with Dr. James Tong of Tianyin Pharmaceuticals trading on the AMEX under the symbol TPI.

OneMedForum New York 2012

OneMedPlace is a virtual community that connects emerging companies seeking capital, distribution, and visibility with investors and strategic partners looking for health and medical innovations to invest in, acquire, license, distribute, purchase or utilize.

Founded in 2008, OneMedForum events are held biannually in San Francisco in January and in New York in June/July.  They are designed to create a communications platform for emerging companies to connect with strategic partners and investors.

“OneMedForum New York, now in its third year, has become the premier venue for companies with a global outlook, focusing on trans-Atlantic opportunities,” said Brett Johnson, OneMedPlace Founder and CEO. “European and American investors join key thought leaders to meet companies developing revolutionary disruptive technology on the cusp of major success.”

OneMedForum has helped build relationships between companies, strategic partners, and institutional investors. The expected audience will include a diverse group of high-net worth family, venture, private equity, angel and corporate investors, as well as presenting CEOs, company executives, academic experts and industry experts.

“This year, OneMedForum invites experts to lead panel sessions on six volatile life sciences areas: Diagnostics, Regenerative Medicine, Oncology, Biotechnology, Medical Devices, and Health Information,” said Johnson. “We will open our panels with a brief overview about the sector, in the form of encompassing investor guides featuring expert interviews, market analysis, and a company directory.”

The conference will also feature special panels on investment opportunities and creative financing strategies, including entering China and crowdfunding. Attendees also will benefit from focused workshops providing strategic insights on specific financial and operational issues.

“The traditional financing landscape is experiencing a massive paradigm shift, and there remain significant challenges, as well as promising opportunities,” added Johnson. “The new successful investor must be educated in these new conventions, and aware of cutting-edge technology that will soon drive market growth.”

Companies will present in a unique multi-media format, which will include live streaming provided by OneMedTV. In addition, several companies will be showcased via technology snapshots after and before presentations. The unique 1×1 meeting system allows attendees to locate and reserve private discussions with interested parties.

For more about OneMedForum NY2012 visit  http://www.onemedplace.com/forum/

For information about presenting or sponsorship opportunities, please contact forum@onemedplace.com