Wednesday, July 27, 2011

Speaker Spotlight: Naser Partovi, Founder and CEO, Sanitas Inc.

Naser Partovi
Partovi has over 25 years of management, corporate development and operating experience. Last year, he established Sanitas Inc., a mobile health technology company that helps patients with chronic conditions manage their treatment. This year, Sanitas is testing its Wellaho product in heart failure patients.

Prior to starting Sanitas, Partovi was president and CEO of SKY MobileMedia, a leading provider of multimedia applications framework for cellular handsets and new generation of connected multi-media devices. Before that, Partovi was a managing director at Enterprise Partners Venture Capital based in San Diego, where he managed a portfolio of companies in the communications industry, including Ascendant Systems, DragonWave, Inc., Quorum Systems and ReliOn, Inc. Before joining Enterprise, Naser served as vice president of strategy and business development for Nortel's optical networks business.
Partovi graduated from Canada’s McGill University with a master’s degree in electrical engineering.

Q: Tell me a little about your background.
A: I am an engineer by training. I graduated from McGill University. Then, I was working at a company called Nortel, a telecommunication company. I was the vice president of business development and strategy at Nortel when I left in 2000. I was recruited from there and joined Enterprise Partners, which was the largest venture capital firm in Southern California. I was a general partner there until 2006, when I left to run one of the companies I had invested in based in San Diego, SKY MobileMedia. We sold SKY in 2008, and, then last year, I started this new company, Sanitas.

Q: Describe, simply, the product that Sanitas is offering.
A: Wellaho is a product to help patients with chronic conditions to manage their treatment. The way we differentiate ourselves from what is out there on the market is what we call the three pillars of our treatment plan. One is education. One is monitoring of progress. And one is getting support from your friends and family and your doctors. There are other companies who are providing bits and pieces of these services. To the best of our knowledge, Wellaho is the only one that’s providing all the three services combined as a continuity of care system.

Q: Monitoring of progress … is that where mobile health technology comes in?
A: Yes. When you or your loved one is diagnosed with a chronic condition, you can do a Google search and you will hit 1 million sites and you need to figure out what is reliable information and what is not. We look up the patients’ own health record. We find out exactly what their diagnosis is, and what their treatment plan is, and we dynamically build a tailored education plan for the patient. Either your primary care doctor, or, in the case of heart failure, your cardiologist, will decide the signs and symptoms they want you to monitor. They set up the parameters.

For example, if I have heart failure and I’m pretty healthy otherwise, they might say, “Okay, your resting shortness of breath should be at this level, and, if you have walked a mile, it should be at this level.” Patients fill in information about themselves using a cell phone or they can do it on their iPad or iPhone or Android application. We bring up the information and say, “Okay, what is your level of shortness of breath?” or “How far did you walk?” “These are your medications. Which one did you take today?”

We tailor monitoring to each patient’s needs based on what their cardiologist wants to know. And the cardiologist can see this information immediately or they can see it the next time they log in, which could be a week. We’re not a real-time monitoring system.

Q: Besides heart health, does this application apply to other conditions, such as cancer?
A: The first module we introduced and the one that we are conducting the field trials on is heart failure. We will announce other modules as they become available. The reason we are introducing different condition modules in a sequence is because we go very deep inside each condition. For example, in heart failure we have over 350 modules. A lot of other applications targeting the conditions go an inch deep, miles wide. We are at the other end of the spectrum. We are going an inch wide and miles deep because we believe that for each condition you need very detailed information on how to treat, what diagnostics options are available and so on and so forth. We have modules scheduled for the next three years to come.

Q: You have a unique perspective as a mobile tech investor. What can you tell me is most influencing investments in the mobile healthcare space?
A: In mobile health, there are a lot of really good companies coming up with a lot of products. My biggest worry about this is who is going to pay for it. The reimbursement mechanism is not out there and insurance companies are not paying and the government is not paying for it. There are a lot of issues around liabilities because, if this is real-time monitoring and the doctor misses that information, what happens? So, I think there are a lot of elements of this mobile health area that need to be figured out.

These things take a lot of time in the healthcare. You need to have a lot of clinical trials, prove the efficacy of the system, go back to the insurance companies, and go back to CMS to convince them that this is improving outcomes. We have tried to take the low-tech route to helping patients because, for example, with heart failure, if we can even improve 1 percent of readmissions to the hospitals by a combination of education, monitoring and support, then that is lots of money saved by hospitals and insurance companies.

Q: What are you looking forward to hearing about at the CHI mobile health event “Take this Pill and Tweet Me in the Morning?”
A: What I would like to learn from other speakers as well as the audience is their experience in dealing with patients, patient adaption, how often patients actually stick with it. How do we convince the insurance companies and the government that this is as important as medication and surgery? So, this is a big cultural change that needs to happen.

CHI-Advancing California biomedical research and innovation

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Monday, July 25, 2011

Guest Column: Patenting Genes and the Future of Personalized Medicine

By Ashwin Mudaliar, Stanford University

Patents pertaining to the use and appropriation of biological information have been in the news prominently over the last year. The majority of attention has been paid to the case of Association for Molecular Pathology v. U.S. Patent and Trademark Office, which challenges the legality of Myriad Genetics' patent of the breast cancer genes BRCA1 and BRCA2, and more broadly, the patentability of human genes in the United States. However, Prometheus Laboratories Inc. v. Mayo Collaborative Services, which considers the patentability of medical methods, may have just as broad an impact over the greater landscape of biotechnology intellectual property.

The Patent Act of 1952 specifies four categories upon which an invention can be judged patentable: proper subject matter, novelty, non-obviousness and utility. It further specifies that a patentable invention be any “process, machine, manufacture, composition of matter, or improvement thereof.” If a prospective invention does not meet all four of these categories, it is not considered germane in view of the law and is thus not eligible for patent protections, as determined by the United States Patent and Trademark Office (USPTO). Laws of nature, physical phenomena, and abstract ideas are explicitly barred from patentability on the basis of not being proper subject matter.

Method patents, which are patents on processes of performing a set of steps (methods) to obtain certain results, have traditionally been awarded as long as a substantive transformation through the method was demonstrated and if the method in question was tied to a specific apparatus. However, the scope of method patents was brought into question in the case of Bilski v. Kappos (In re Bilski), which stems directly from USPTO’s rejection of Bernard Bilski and Rand Warsaw's patent application for a method of hedging commodities risk, whose claims fell under the unofficial category of business method claims. The examiner at the USPTO rejected the claims of the application because the method was not tied to a specific apparatus and that it "merely manipulate[d]" abstract concepts to solve a mathematic question without a substantive transformation. In further appeals through the legal system, the United States Court of Appeals for the Federal Circuit, which is tasked with handling all patent related matters, affirmed the initial rejections of the Bilski patent and went further by significantly modifying the standards for resolving whether any invention is statutory subject matter under the Patent Act through its promulgation of a new test, termed the machine-or-transformation test, to determine patent eligibility for any process claim. This test aims to determine if a claimed process or method is tied to a specific apparatus and/or if the same claim transforms a specific article into a different state. If either stipulation is met, then the claim is deemed statutory assuming it meets the other categories of patentability (novelty, usefulness, etc.). The plaintiffs appealed to the Supreme Court to reconsider this decision, which obliged by granting certiorari to hear the case.

In Prometheus v. Mayo, Prometheus Laboratories, a diagnostics and therapeutics company from San Diego, Calif., sued Mayo Medical Laboratories for patent infringement on two methods for determining the optimal drug therapy for a gastrointestinal autoimmune disease when Mayo Medical announced that it would sell its own diagnostic test based on similar methods. The original patent specified a method for measuring the metabolites 6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG) following the administration of a thiopurine drug for autoimmune diseases. Based on the level of both, drug dosage would be altered for maximal efficacy and minimal toxicity. In March of 2008, a district court in California invalidated two patents held by Prometheus on the grounds that the methods were not patentable subject matter. However, in September of 2009, the United States Court of Appeals for the Federal Circuit overturned this ruling and claimed that the methods described in the patents satisfied the machine-or-transformation test, and more specifically that the administration and determination steps in the original claim brought about sufficient transformation. The lawyers for Mayo Medical argue that observed correlations between blood test results and health are simply “basic, natural biological relationships,” and thus non-patentable, but the Federal Court ruled that any kind of treatment that alters the body in a therapeutic manner could be patentable.

The court argued that the claims in the plaintiff’s patent did not simply cover natural correlations (metabolite levels) or data-gathering (measurement) because the, “asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition (emphasis added).” The court also ruled that measurement that goes beyond “mere inspection” is transformative. Mayo Medical Laboratories quickly filed an appeal to the Supreme Court.

On June 28, 2010, the Supreme Court issued its ruling on the In re Bilski appeal, which affirmed the Federal Circuit’s ruling that Bilski process was not patentable subject matter. However, the Court also ruled that the machine-or-transformation test was not the exclusive test to evaluate method patents but rather just a “useful and important tool” amongst others. It did not offer further or more specific guidance. The Supreme Court then vacated the initial federal circuit court decision in Prometheus and ordered that this court reconsider its decision in light of the new ruling on Bilski. In its reconsideration of Prometheus on Dec. 17, 2010, the federal circuit court reconfirmed that method claimed by Prometheus constituted patentable subject matter and stated that the Bilski decision “did not undermine [its] preemption analysis of Prometheus’s claims.” As such, its ruling was substantively unchanged. Mayo Medical appealed again to the Supreme Court on May 17, and was granted a writ of certiorari on June 20 for consideration. A definitive ruling is expected next summer.

The issues at stake in Prometheus case are very important to the future of commercial diagnostic tests and, more broadly, the commercialization of personalized medicine. Very often, diagnostic methods similar to those described in the Prometheus patents are used to deliver safer and more effective treatments to patients who might otherwise react adversely to a therapeutic intervention. If the Supreme Court were to side with the defendants and invalidate the Prometheus patents in a broad decision, it could potentially call into the question the validity of a number of previously issued diagnostic patents that companies rely on to protect their investments. Considering that many of these sorts of diagnostic tests are created by smaller biotech companies, invalidation of the “method of medical treatment” system could hinder innovation and prevent early-stage biotechs from attracting investments. This is especially critical as we enter an age of increasingly personalized medicine, where therapeutic regimes will be closely tailored to the specific physiological states of individual patients. Without adequate protection for the research and development of such diagnostic methods, we could see a marked reduction in the number of private companies and research institutions that engage in the type of research that leads to these interventions as well as the quality of that research. Given these considerations, the Supreme Court’s ruling next year will have an enormous impact on the future of life sciences and medical technology.

CHI-Advancing California biomedical research and innovation

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Thursday, July 21, 2011

Event Spotlight: CHI Co-Hosts Congressional Briefing on Alzheimer’s Disease

On July 14, CHI and the Healthcare Institute of New Jersey (HINJ) co-hosted a congressional briefing in Washington, D.C. focused on Alzheimer’s disease. Congresswoman Linda Sanchez of California delivered particularly poignant remarks. Sanchez’s father suffers from Alzheimer’s disease, giving her and her siblings, including fellow Congresswoman Loretta Sanchez, personal experience in caring for a parent suffering from this mind-robbing disease. Despite this challenge, Linda Sanchez considers herself fortunate to have the support of her six siblings, asking, “I wonder what it would have been like to be an only child?”

CHI President and CEO David L. Gollaher, Ph.D., and Dean Paranicas, who serves as president and CEO of HINJ, delivered opening remarks, followed by presentations on cutting-edge research and scientific advances achieved by CHI and HINJ members. The event wrapped up with closing remarks from Reps. Chris Smith (R-NJ) and Linda Sanchez (D-CA). The program, held in the Capitol Visitor Center, attracted more than 60 congressional staffers, patient advocates and industry representatives.

The speakers on this day made clear that the experience of the Sanchez family is sadly common, and growing at a rate that will be both emotionally and economically devastating. As Gollaher noted, “The Alzheimer’s crisis is of great import because of its personal and economic effects” which will have “great implications for this country and the rest of the world as populations get older.” To illustrate the scope of the crisis, he noted that 5.4 million people are living with Alzheimer’s disease, and someone develops the disease every 69 seconds. Further, in 2010, family members and friends provided 17 billion hours of unpaid care to those with Alzheimer’s and other dementias — care valued at approximately $202 billion. The effect of the disease in California alone is particularly acute with more than 500,000 Californians suffering from the disease today and estimates that the number will double to 1 million by 2040.

Yet, participants and presenters also made clear that there is hope. California leads the nation in National Institutes of Health funding, making Alzheimer’s disease one of the largest concentrations in the California R&D pipeline, Gollaher noted. A panel of top researchers then offered their unique approaches to treating and potentially curing Alzheimer’s disease. Dr. Stuart Lipton, director of the Del E. Webb Neuroscience, Aging and Stem Cell Research Center at Sanford-Burnham Medical Research Institute, described his ongoing work with NitroMemantine– a combination of an existing Alzheimer’s therapy called memantine and nitroglycerin. As both drugs are already approved for other indications, the compound’s potential speed to market is dramatically shorter than that of a new drug.

Joseph Hammang, Ph.D., the senior director of worldwide science policy for Pfizer, noted that improved diagnostic tools and personalized approaches to treating the disease that rely on a person’s unique genetic make-up are potentially critical advances in treating Alzheimer’s, which actually includes a number of distinct diseases. He said Pfizer has committed $100 million over five years on collaborations with public institutions, demonstrating its continued commitment to work with academic partners in the U.S. and around the world.

Kimberly Scearce-Levie, Ph.D., head of in vivo neurobiology for Genentech, detailed her team’s recent advances in methods to block a protein that composes the plaque thought to be responsible for cognitive impairment in AD sufferers. The Genentech team has developed a way to hijack the body’s own mechanism for passing iron from blood into the brain, essentially tricking the body into transporting a critical blocking agent through its own defenses..

Bob Nelson, Ph.D., research fellow at Lundbeck Research USA, continued the conversation by saying he believes that the story is likely to be more complicated. Lundbeck Research has begun to challenge conventional wisdom about the disease by asking slightly different questions. Are the identified plaque compounds associated with AD strictly bad substances? Might blocking them also have harmful effects? Might the abundance of plaque-causing proteins be caused by victim’s inability to remove or reabsorb the protein rather than due to a problem of overproduction?

Lastly, Wayne Poon, Ph.D., director of the UCI MIND Brain Bank and Tissue Repository, described his approach to solving a basic problem in Alzheimer’s disease diagnosis. The disease, he said, is only diagnosable when a patient has died and his or her brain can be examined. Because of this, up to 15 percent to 20 percent of patients thought to have AD are later found to have been misdiagnosed.

In closing, Rep. Smith of New Jersey, chairman of the Alzheimer’s Disease Caucus for 11 years, thanked the panel for its efforts. The U.S. and the world are facing a figurative pandemic, he said, which is on the verge of a breakout with the arrival of a “demographic winter.”

“We have a crisis and funding is flat-lined,” he said. “We simply aren’t going to have the people to take care of these [AD sufferers].”

Rep. Sanchez concluded, “I wish I was here to celebrate a cure…Yet, with the talent and work of many, we will be able to celebrate that day in the future.”

CHI-Advancing California biomedical research and innovation

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Friday, July 15, 2011

Speaker Spotlight: Anthony Costello, COO Mytrus

Anthony Costello
Mytrus is testing the boundaries of traditional clinical trial research, with the first all-electronic, home-based clinical trial to gain U.S. Food and Drug Administration approval. As co-founder and chief operating officer of San Francisco-based Mytrus, Costello is leading the charge. Costello is a leader in the areas of technology innovation and clinical operations. After beginning his research career at Genentech, Costello went on to co-found several technology start-up companies including Nextrials, a clinical research firm where he worked for 10 years as the vice president of product development. He is a frequent presenter on topics related to the efficient use of technology and clinical research.

Q: What brought you into the clinical research industry?

A: I got into the clinical research industry in the ’90s when I started working at Genentech. At the time, I was in data management and spent pretty much my whole career at Genentech in data management. I ended up overseeing the data management group for their oncology center and working mostly on the Herceptin trials and the early trials for what is now Avastin.

Back in those days, everybody was doing clinical research on paper. We did all of the international Phase 3 trials for Herceptin on three-part no-carbon-required paper, mailing it around the world and then data entering everything. Although I loved Genentech and it has certainly launched my career, I wanted to develop a technology that was faster and more effective. I left Genentech in 1999 to co-found a company that makes electronic data capture systems for clinical trials, called Nextrials.

Q: What happened next?

A: I left Nextrials in 2008, after almost 10 years there, and I met Dr. Steve Cummings (Mytrus CEO and chairman) and got excited by his idea of building more of a consumer-focused clinical trial that would allow patients to participate from home. I joined an advisory board that Steve was putting together to sort of vet out this idea, and we ended up deciding to form Mytrus around that. I joined as a co-founder and as the vice president of product development and commercialization and I now serve as chief operating officer.

Q: Mytrus is hoping to validate a new kind of study model. If this kind of remote results monitoring works, what might the future look like for pharmaceutical companies and their trials?

A: We hope that it’s going to make a big difference. Our hypothesis that is staring to play out is that there are some kinds of trials – we estimate about 15 percent to 20 percent – conducted in the United States annually that can be done using this method. They do not require specialized equipment at a site. They do not require specialized training, and, if a patient is willing and able to correspond via the web and provide their own updates about what is happening to them during the study, then those trials are suitable to use this method. It really changes once you free your mind, as Steve likes to say, from the idea that you have to have a bricks-and-mortar site for trials.

You do not have to have as much monitoring because the patients are the direct source for data and you do not have data being transcribed from the patient to a chart and then from a chart to an electronic data capture system and then from an EDC system to an alpha system. All those data transcription events are the reason monitoring was effective — to make sure nothing got missed or skipped or inadvertently entered. So, you could get rid of a lot of that. You don’t have to go through the contracting and start-up and hierarchy approval with hundreds of clinics around the country.

Q: What are the technology requirements for participation?

A: If you do not have an Internet connection, you cannot do it. In fact, depending on the trial, there are some studies where it is really going to be critical to have an Internet connection in the home. There are other studies where it would be perfectly suitable to have a smart phone or an iPad or even a shared Internet connection in some sort of public place if the patient is comfortable using that and it is private enough that someone can enter their own data. Patients are much more apt these days to use the Internet for their own medical research and they are much more comfortable communicating with doctors over email or over the Internet.

Q: What are you looking forward to hearing about at the CHI mobile health event “Take this Pill and Tweet Me in the Morning?”

A: There is just a lot more focus on health 2.0 technologies these days and so we’re excited about being involved. It seems like the lineup of speakers are people on that leading edge of moving trials or studies or health in a new direction so it is a perfect kind of conference for us.

Hear more from Anthony Costello at “Take This Pill and Tweet Me in the Morning,” happening Aug. 4 at the Salk Institute in San Diego.

CHI-Advancing California biomedical research and innovation

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Tuesday, July 5, 2011

Executive Spotlight: David Shuey, The Willis Group

David Shuey
David Shuey, executive vice president and North America practice leader for The Willis Group’s life sciences practice, thinks “startups now realize they can’t be one-trick ponies – they have to have multiple product candidates in the pipeline.” With 19 years of hands-on experience serving the life sciences industry, he should know. His clients range from early-stage R&D companies to large pharmaceutical firms. Shuey has expertise in therapeutics, medical device, generics, nutraceuticals, consumer products, contract research organizations, laboratories and contract manufacturing. His focus is on casualty lines, particularly product liability and international human clinical trials. Read below to find out how Willis Group’s unique technology platform has helped companies of all sizes remain competitive in the global economy.

Q: Within Willis, how big is the life sciences practice?
A: We are a $3.5 billion revenue public company. Within Willis, life sciences is a large practice and a focus. I think management sees it is a growing area. We’re going to need new medical devices and therapeutics no matter what happens.

Q: Tell me a little about your focus at The Willis Group.
A: I have been with Willis for 22 years with 19 of those focused in life sciences. I started off in medical practice liability for doctor groups and integrated health systems. At the time, I was working in the Baltimore area, around D.C. and the northern Virginia area, and a lot of VC money was coming into the area. They were hiring scientists out of the NIH with a molecule and an idea for a company. So, I started working with a lot of those nascent companies as they were getting started and developed the expertise in life sciences and spent the rest of my career with life sciences companies.

Q: What do you notice are the major differences between biomedical startups today and back then?

A: From a risk perspective, things have definitely changed. I think it was easier to raise money back then. The concept of failing early with molecules and accelerating the discovery process using rational drug design techniques wasn’t available back then and is now – so that would be a change. Back then, the focus was on gene therapy, and, while still popular, I think regenerative medicine has taken over. A lot of med device companies that were developing things for labs are now moving into the clinical setting with personalized medicine a purpose.

Q: Can you give me an example of how The Willis Group came to the aid of a biomedical company or academic research institution in recent times?
A: One of my favorite stories involves a large client that was making an acquisition and it was an orthopedic implant, a Class 3 medical device. During due diligence, our client learned that the company they were acquiring had received an FDA non-approvable letter because their sales and medical reps were recommending an alteration to the implantable orthopedic device during surgery. Our client thought that might be a problem, so asked for a large contingency hold-back in the buy-and-sell agreement. So, we stepped in and wrote a three-year risk or loss mitigation program with a per person coverage limit and a three-year policy aggregate for them. The program had a provision that, if no claims came after three years, our client could commute the policy and get their money back. The insurance company would keep the risk charge and the unused premium at the end of the policy would be returned to the client. The fact that we could transfer that risk from the balance sheet to a risk policy allowed the deal to go through.

Q: With clinical trials management moving overseas for many in the industry, what implications does this have for business moving forward?
A: Even the smallest R&D therapeutics company will take their trials oversees, so small companies become international companies very quickly. That’s a change we’ve identified. We are particularly adept at managing global foreign trials clinical programs. We have something called CTTrack which is a dashboard that allows clients to see where they are in relation to a deadline to meet with insurance and certificate requirements around the world. We maintain a matrix of all the requirements around the world. It is kept real-time on our clients’ desktop so that when they conduct a trial in Israel they can flip on the matrix and go to Israel and find out what the requirements are and what kind of lead time they need to conduct the clinical trials.

Q: What other new offerings does Willis Group provide its clients?
A: We’ve put together a unique program called Diagnostics 2.0. We come in and conduct a mini enterprise risk-management analysis. We conduct an in-depth interview that is designed to uncover the organizational risk. At the end of the process, we’ve done a diagnostic of the risk, so now we can deliver a customized risk/review report. Then, we can go in and look at the insurance programs structure, the pricing, the coverage and match it up with the risk diagnostic. It really peals the onion on risk exposure and it is unique to Willis.

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Friday, July 1, 2011

The Evolving Business Model for Biomarkers

Biomarkers will be one of the major drivers of biotech research, drug and diagnostics development in 21st century medicine. Dr. Jogarao Gobburu (Division of Pharmacometrics, FDA), Stephen Little (Qiagen), Mark Erwin (Prometheus Laboratories), Dr. Bryan Dechairo, (Medco Research Institute) and Dr. Christoph Huls (Merck Serono), explored the evolving business model for biomarkers and personalized medicine during a panel discussion at the 2011 BIO International Convention in Washington D.C. Mark Erwin summarized the common theme throughout the discussion: “Personalized medicine holds the promise for not only greatly improving healthcare for patients all over the world, but to generate cost savings and increase efficiencies in the healthcare system. All of us as healthcare stakeholders need to do what we can to incentivize this innovation.” Watch the video.

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