Tuesday, December 7, 2010

Executive Spotlight: Dr. Ed Holmes, President and CEO of the Sanford Consortium for Regenerative Medicine

Dr. Ed Holmes
The Sanford Consortium for Regenerative Medicine combines the intellectual resources of four of the world's leading biomedical research institutions (UC San Diego, the Salk Institute for Biological Studies, the Sanford-Burnham Institute for Medical Research and The Scripps Research Institute) to pursue collaborative research projects that advance the search for breakthrough cures. The Sanford Consortium unites San Diego's brightest researchers to work side by side to harness the regenerative power of stem cells to diagnose, treat and cure degenerative diseases and injuries. The Sanford Consortium integrates the collective knowledge of these foremost biomedical research institutions, with the support of surrounding industry and local community, to create a global resource for stem cell research.

Dr. Holmes is a distinguished professor of the University of California and vice chancellor/dean emeritus of Health Sciences at UC San Diego. He is also executive deputy chairman of the Biomedical Research Council and chairman of the National Medical Research Council, Singapore. Holmes has served on numerous advisory boards including the National Diabetes and Digestive and Kidney Diseases Advisory Council of the National Institutes of Health, the board of directors of Tularik and the scientific advisory board of GlaxoSmithKline, which he chairs. He is a member of the American Society for Clinical Investigation and the Association of American Physicians. He is also a fellow of the American Association for the Advancement of Science and a member of the Institute of Medicine of the National Academy of Sciences. He holds a medical degree from the University of Pennsylvania.

Q: Tell me about the origins of the Sanford Consortium.

A: We came into being after the bond issue (Prop. 71) was passed and the California Institute for Regenerative Medicine (CIRM) was formed. The San Diego community, including UCSD, Scripps, Salk and Burnham, decided to approach this by working together.

Q: The Sanford Consortium seems unique in that way. How did scientists in San Diego overcome the boundaries that can typically block them from coming together?

A: I think what’s interesting about this is it is really something that sort of happened on three levels. One, that the scientists actually wanted to work together. Also, the four institutional leaders (UCSD, Salk, Scripps and Burnham) saw an advantage to working together. And, then, we had community leaders in the form of Malin Burnham and John Moores and Irwin Jacobs in the beginning. And, now, Denny Sanford.

I think the four institutions and the scientists within them all working together is really what got us started. And that’s continued to be the foundation of what we do.

Q: Tell me about the building itself. What kind of progress has been made to date?

A: To get started, we need a place to house our folks. But it is important to recognize that, certainly, CIRM providing a $43 million major facilities grant was essential in this, but we would not have gotten there without the $30 million gift from Denny Sanford.

This is a beautiful location in every sense of the word—both views and the prime space. Chancellor Marye Anne Fox and UCSD helped us in that regard. This is one example of her vision—without her support we wouldn’t have gotten the loan we needed (public debt guaranteed by the UC Regents).

Denny gave us the $30 million and we’ll be using less than $20 million of that for construction of the building; the rest will be used to fund research. As for the rest, $43 million came from the CIRM grant and we sold $62 million worth of bonds, but it yielded $65 million worth of proceeds.

We are now on track for Sept. 22, 2011. We will be able to get in there July 1 and start installing equipment so that, by and large, we have a certificate of occupancy and, by the end of September, we’re ready to go.

Q: We’re at a dynamic time for stem cell research—especially with the first human trial on spinal cord injury. What excites you most about the research about to happen here?

A: We’ve begun to engage a wide group of scientists from all four institutions and you can see the genuine excitement. We’ve also begun to identify three theme areas to work in. Neurosciences, because that’s an important area for stem cell research. Also, in the area of cancer biology we’ve got a tremendous amount of strength, and in cardiovascular disease.

But what we’ve discovered is there’s so much more and we don’t want to exclude people, so we’ll probably concentrate on these three areas but embrace, though special projects, other things that would be important to bring into this.

We’re in the position to choose among the very best people, but, at the same time, we envision the consortium to be more than this building. It’s the science but it’s also all four institutions. Just because you’re not located in the building does not mean that you’re not a part of the Sanford Consortium. So, they’ve come up with some clever ways to engage people who might not be in the building long-term with special projects.

Q: Are there plans for engaging the local business community?

A: What we see as a tremendous opportunity as we build this out is, “How can we leverage what we have with partnerships in the private sector?”

One example is the basement in this building has a phenomenal capability for doing preclinical imaging studies that we think would be valuable to our investigators, but might also represent an opportunity to partner with the private sector. Some biotechs, particularly small biotechs, who cannot afford to buy some of the equipment that we will have.
We would like to leverage both our science and our resources to work with this private sector and we’re just beginning our conversations.

We eventually want to do something with people. And it’s very hard to come up with things you do for people that don’t involve collaborations with the private sector. So, we have begun some very preliminary conversations right now with some of the biotech people in town. We’re also interested in talking to pharmaceutical and medical device leaders.

Q: A lot of this depends on the leveraging of federal funds and right now this is still up in the air, with stem cell research held up in the courts. What concerns do you have there?

A: Nobody can predict what’s going to happen in Washington and obviously it’s an up and down situation. But I would say the disquiet in Washington has been a boon for California. You find people who want to come anyway, but they want to come even more now. It’d be really nice if the federal government gets it sorted out—and I, personally, think they will. I’m optimistic the federal government will straighten itself out and begin to make investments.

Q: What kind of design plans does the building call for to get scientists working collaboratively?

A: For collaboration to work, first you need opportunity. And you need to run into people at the water cooler. We have rooms intended to reduce certain types of behavior and encourage collaboration. We have team rooms so six people can hook up computers at a time. It’s a smartboard, so they can write on the screen so it captures the image plus what they annotate on their screen.

We also learned that scientists go 10x horizontal before they go 1x vertical. Or, as we say, “The ability to collaborate is inversely proportional to the square of the distances.”

The building calls for wide open staircases and large open spaces that connect. It should allow people to more vertically circulate.

Q: Did you model this building after any other facilities in the country?

A: The exterior was designed to acknowledge that it has to fit contextually with the iconic structure that is the Salk. It started with the scientists back in 2007. They said, “This is what we think we need.” We had a lab planner work with them and come up with a program. And the architects then worked with the program to develop it.

This is a LEED gold building. We’re using chilled beams throughout.

We’re also taking advantage of the fact that we live in a great part of the world. We face the ocean here on top of the Torrey Pines Mesa, which allows for some fantastic views. We plan to build an open-air reception space and fully take advantage of the Southern California climate.

CHI-Advancing California biomedical research and innovation

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Monday, November 22, 2010

Executive Spotlight: Cheryl Hankin, Founder and CSO of BioMedEcon

Cheryl Hankin
Cheryl Hankin, Ph.D., is the founder of BioMedEcon and serves as the company's president and chief scientific officer.

Hankin’s experience in health economics and outcomes research includes roles as director of outcomes research Johnson & Johnson companies, assistant professor at Boston University School of Public Health and research health scientist at the Department of Veterans Affairs, Health Services Research and Development Center of Excellence.

BioMedEcon provides health economics and outcomes research for pharmaceutical, biotechnology, drug delivery and medical device companies. Hankin offers extensive experience in comparative effectiveness research, competitive product analysis, and pricing, coverage and reimbursement.

Q: It looks like your career has spanned the industry, academia and the public sector. What led you to start BioMedEcon?

A: Several years ago, I was in the public sector working with post-traumatic stress disordered veterans in the VA system and noticed that they weren’t getting better. It occurred to me that we had large scale claims databases that provided all sorts of information about the types of care, medications, surgeries, procedures these patients received. This was maybe 15 or 20 years ago and I said, “Why not mine this information to find out what works best for these patients?”

Q: At the time were you involved in patient care?

A: Yes, I was a clinical psychologist working primarily with extremely traumatized patients. I was so interested in identifying best practices for these patients that I applied for and received grant funding from the VA to complete dual post-doctoral fellowships in health services research and mental health. I became a research scientist at the VA Health Services Research and Development Centers of Excellence, where my interests broadened to include other illnesses such as cardiovascular disease, diabetes, cancer, etc. I had very early and excellent training in this field before it was in vogue.

Q: How did your career progress from there?

A: ALZA Corp., a drug delivery technology company, had a need for a health economics and outcomes researcher. This was my first foray into private industry. ALZA was acquired by J&J and I joined J&J to head up outcomes research for one of their companies on the East Coast.

Prior to receiving my doctorate, I was a corporate accountant working with Silicon Valley hi-tech start-ups. I really enjoy that entrepreneurial energy and longed to return to it. So, in 2004, I started my own company and I have never looked back. Health economics and outcomes research is the perfect combination of my skills and interests in patient care, research, corporate finance and marketing.

Q: What is the primary focus at BioMedEcon today?

A: We work with new and emerging companies as well as well-established pharmaceutical manufacturers to identify and demonstrate the value of their products. The therapeutic “space” we work within includes respiratory disease, acute and chronic pain, dermatology, diabetes, obesity, endocrinology and psychiatry. Our clients find us solely by word-of-mouth referrals based on the recommendations of those who know our work, and our client relationships are long-standing.

Q: What kinds of questions are you answering?

A: In this highly competitive and cost-conscious environment, we serve as the bridge between clinical research and commercialization with answers to questions such as: What is the unique value proposition of our client’s product and what is the most meaningful manner in which to demonstrate this value to health plans, providers and patients? Our mission is to optimize product access, coverage, pricing and reimbursement. We collaborate closely with public and private payers, clinical opinion leaders, high prescribers and patient advocacy groups to ensure that these value propositions are meaningful and compelling.

Q: How, then, do you go about demonstrating that value?

A: We use a variety of techniques to demonstrate value. We may re-examine clinical trial data, create study protocols, identify additional endpoints for inclusion in pivotal trials, conduct market research with payers and providers, prepare systematic literature reviews and meta-analyses, develop pharmacoeconomic models, convene expert panels and advisory boards, examine large-scale retrospective databases, develop and validate measures, conduct chart reviews—the possibilities for creative approaches are endless. We also develop and implement publication and presentation plans to ensure that these compelling and meaningful results are appropriately disseminated.

Q: With comparative effectiveness an important piece of the health reform legislation, what’s happening in this area for BioMedEcon?

A: It’s certainly a burgeoning field, and we are seeing a growing interest in our capabilities from new types of  "consumers." For example, physician groups and professional associations have asked us to help them demonstrate their ability to provide "accountable care." In another case, a professional medical society has asked us to identify patient and provider characteristics associated with variation in patient adherence to treatment. In yet another example, a healthcare institution has just asked us to examine risk factors associated with the occurrence of specific “never events” (adverse events that should never happen and that are not reimbursed by CMS, such as hospital-acquired infections). So, our client-base now extends beyond the traditional pharmaceutical industry. I believe this is due to both the potentially broad impact of health reform legislation on all sectors of healthcare delivery and to our proven track record in demonstrating value.

Q: What keeps you awake at night?

A: I love the work that we do. I stay awake at night not because I’m worried or unhappy, but because I get carried away with the intricate and delightful puzzles we are presented with. I may be thinking about an economic or financial forecasting model, or a presentation we’re preparing, and before I know it, the hours have slipped away. I’m very lucky. I can’t think of a more enjoyable occupation.

CHI-Advancing California biomedical research and innovation

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Monday, October 18, 2010

Legislator Spotlight: Assemblyman Jerry Hill (D-San Mateo)

Assemblyman Jerry Hill
Jerry Hill was elected to the California State Assembly in November 2008. In Sacramento, Assemblyman Hill has demonstrated an ability to reach across party lines. This year, 19 out of his 20 bills approved by the Legislature and sent to the governor received bi-partisan support. Hill chairs the Majority Caucus in the Assembly and is a member of Speaker Perez' leadership team, where he is responsible for negotiating key issues and guiding legislative priorities. As chair of the Select Committee on Biotechnology and as a member of the Committee on Improving State Government, Hill has tirelessly tackled some of the most pressing issues facing San Mateo County and California, including government efficiency and economic development. He is working closely with transportation officials and residents on issues related to the construction of a high-speed rail through San Mateo County. He has also assumed a leadership role in the investigation of the San Bruno natural gas pipeline explosion and in the shaping of a legislative response.

Hill’s district includes the cities of Belmont, Brisbane, Burlingame, Daly City, Foster City, Half Moon Bay, Hillsborough, Millbrae, Pacifica, San Bruno, San Mateo, South San Francisco and parts of unincorporated San Mateo County.

Q: As a legislator from San Mateo County, your interest in the biomedical industry seems quite natural. How do you promote the value of the industry to your colleagues in other parts of the state that may not have as strong a biomedical presence?

A: It’s important to start, initially, with the tremendous benefit that’s derived from the industry. I’ve been to BioMarin Pharmaceutical in Marin County, Exelixis in South San Francisco, UCSF, Edwards Lifesciences in Irvine, Life Technologies in San Diego, etc. With each one comes the realization of the life-saving products, devices and therapies, that are being developed through this industry.

The first part is making sure my colleagues and members of the Legislature are aware of what is actually happening in California. It’s important that they know these companies exist and how crucial the therapies and devices that they manufacture are to modern medicine. Each one of them should be able to identify someone in their family who has benefitted from this, whether it’s a cancer therapy from Genentech or a heart valve from Edwards Lifesciences.

Q: Do you see the potential for ramping up California's biomedical manufacturing capacity in communities hard hit by the recession in the interior parts of the state?

A: I see that as a real potential, however, I also see our tax structure as a deterrent to that. One of the stories that I tell repeatedly is the fact that Genentech, obviously a homegrown San Mateo County company, built a facility in the last year in Hillsboro, Oregon. What we’ve lost is the benefit, to some extent. When these companies begin they are local. They have local roots, they generally have families in the Bay Area and people don’t want to leave.

In this economic downturn, the biomedical sector is one of the only areas that actually increased in employment. Once legislators see the lifesaving benefit, then they can also see the economic benefit in terms of good, high paying jobs.

Q: Let's discuss Prop. 24. As you know, California has had difficulties in attracting and retaining existing companies, let alone developing missed opportunities such as biomedical manufacturing. How do you think Prop. 24 plays into that conversation?

A: I certainly don’t support it. I think its bad public policy. When I explain to anyone how the current tax structure works, in practicality, people say, “You’re kidding.” They ask, “Build a bigger plant, hire more employees, pay more money and I’m going to pay more income tax?” And, I say, “Yes, that’s true.” They don’t believe it; they think it’s crazy. But, sadly, that’s not how it’s playing out in the press or in the campaign. The biomedical business is unique. And, that’s the other part we have to convince my colleagues about, the uniqueness of biomedical industry. That it takes 10 to 15 years for a therapeutic to be developed, a billion and a half dollars and, at the end of the day, the odds of producing a successful therapy are slim.

Q: What can the biomedical industry do to better educate legislators and others about the value of our work?

A: To me, it’s a matter of communication, and I think the industry has done a good job of being there and involving legislators on issues that are important to them.

I was in Sacramento the other day and Johnson & Johnson had an exhibit at the California Museum on their biomedical devices. It was open to staff members and I went because of my involvement and interest. That’s what’s important and what I hope to work with the industry on early next session, to bring the industries either here or to organize road trips to their locations.

To sit at Edwards and watch 400 employees making heart valves, that take eight hours to make, is phenomenal. I think you have to see that and really understand the magnitude of the industry and the benefit that it brings to this state.

We have to do this early, instead of six months or a year later when this legislation affects them. By then, it’s too late.

Q: Talk a little about the importance of STEM education. I know you pushed to restore cuts to UC and CSU as part of the budget negotiations. How well are we funding science education?

A: We have done a poor job, lately, in supporting and funding science education in California, especially at the K-12 level. We don’t compensate teachers enough to bring highly trained people into the field to teach science at a level we need to develop an educated workforce. Fortunately, we have a higher education system that has been able to attract from all over the world. That is truly our lifeblood for sustaining our leadership in the sciences. We want it to be homegrown, though, and we have to put the resources to develop better science education in our K-12 and sustain it at the college level.

Q: What do you consider some of your biggest accomplishments as the Chair of the Select Committee on Biotechnology?

A: I think the biggest accomplishments have been that we have really done what we have set out to do, which is highlight the industry, to really look at it from a number of areas.

We were able to educate, inform and enlighten colleagues on the value of the industry, which is, I think the most important part. Because of term limits and how fast time flies, people don’t realize that every two years a third of that Legislature changes.

CHI-Advancing California biomedical research and innovation

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Thursday, October 7, 2010

Event Spotlight: Larry Bock, Executive Director, USA Science & Engineering Festival

Larry Bock
Each year, the San Diego Science Festival plays host to hundreds of thousands of people who participate in engaging, hands-on science activities across town, concluding with a free, two-day Expo held downtown.
Planned as the West Coast’s largest science event, the festival has attracted corporate and individual donors dedicated to encouraging the nation’s youth to pursue careers focused in science, research and mathematics.
This year, following a successful San Diego event in the spring, USA Science & Engineering Festival Executive Director Larry Bock was inspired to bring the fun to our nation’s capital during October. Bock, who was the inspiration behind the popular San Diego festival, is a successful serial entrepreneur who has founded, co-founded or financed the early stage growth of 40 companies in the life and physical sciences from inception to achieving an aggregate market capitalization in excess of $30 billion.

Q: I understand this event is geared toward reinvigorating the interest of Americans in the sciences. Explain the root of the issue and how it might be reversed?

A: There is a perfect storm of events going on. Americans are not pursuing advanced science positions, and, because of H1B visa issues, we are not retaining foreigners who are trained in the area. Right now, something like 80 percent of people being trained with advanced degrees in the sciences in the United States are from abroad.
Also, the opportunities are now greater abroad. So, even if we did try to retain them, they are more motivated to go back. We have to reinvigorate the interest of Americans in science and math. And why aren’t Americans interested in it? Our premise is our society gets what it celebrates. We celebrate Lindsay Lohan and Britney Spears and we generate a lot of them. But we don’t celebrate science and engineering. We need to celebrate the rock stars of science, such as computer scientists Larry Page and Sergey Brin who founded Google.

Q: Do you envision a day where we’re celebrating scientists as celebrities?

A: That’s our goal. We try to do that by having a festival where it’s a pinnacle moment for society to come together to celebrate science and engineering, art, music, film and comedy. What the festival’s organizers are trying to do is bring scientists into schools to show them that scientists really are rock stars.
This year, we’ll bring 25 Nobel Laureates into schools to have brown bag lunches with students. We also have 100 scientists to go in and really get kids excited about what scientists do.

Q: How does this event tie into classroom-based teaching?

A: Basically, we try to get these scientists to come into the schools for a presentation but then form a long-term relationship with the schools. We’re bringing in scientists like National Institutes of Health Director Francis Collins, AIDS researcher Tony Fauci and Paul Anastas, the “father of green chemistry” at the Environmental Protection Agency.
Science and engineering professionals will fan out across the D.C. area in October to speak about their careers at various middle and high schools.

Q: How did the San Diego Science Festival help you prepare for this year’s event in D.C.?

A: I wasn’t planning on doing it in D.C., but one of my sponsors in San Diego, Lockheed Martin, encouraged me to do it on a national scale and they gave us a huge sponsorship to do that. They said, “What would it take to make it a national event?” With the generous help of our corporate sponsors, we have raised over $2 million, along with $2.5 million in media partnerships in under a year.
In Washington, we have organizations from all over participating. We have probably over 750 organizations participating. We have approximately 150 universities. We have well over 100 professional science and engineering societies. We have about 100 government agencies and federal labs, all of which are based in Washington.

Other community-based organizations, such as Girl Scouts and Boy Scouts and Project Lead the Way, are also participating on the premise of giving back to the community with the added bonus of learning something about science.

Q: Give me a few of the event’s highlights.

A: We have exciting guests like the MythBusters (Discovery Channel), Bill Nye the Science Guy, Storm Chasers (Discovery Channel), the inventor of the Rubik’s Cube. Then, we have the sciences of pretty much anything you can imagine, including the physics of NASCAR, the chemistry of Thanksgiving dinner, the science of Harry Potter. Through the generous contribution of time, energy and resources of our participating organizations, we are also able to offer sophisticated exhibits like virtual reality environments, surgical robots and fighter jet simulators.

Q: Give me an idea of what’s involved in the science of Harry Potter.

A: It’s actually looking at the real science behind the magic of Harry Potter. There is real science now to do cloaking, which is what Harry does when he puts on the invisible cape.

Q: How did you first get involved in this event?

A: I was taking a year abroad in Europe for fun when I saw the science festivals there. In Europe they’ve been going on for years, taking place all over England, the United Kingdom, Italy, Germany. The one in India draws 1 million people to it. That was my impetus to do the inaugural San Diego Science Festival. I loved the month of activity, but, for me, the really “aha” moment was when Balboa Park was completely filled. In the Spring of 2009, the inaugural San Diego Science Festival drew 200,000 people to participate in more than 500 free activities.

Q: What will be unique about this year’s event?

A: We’re on the National Mall, from the U.S. Capitol Building to 7th street. And then we’ve closed down Pennsylvania Avenue between 12th and 14th Streets. I think we have one of the largest footprints of any expo in Washington separate from the inauguration.

Q: How many people do you anticipate will attend the event?

A: Well, of course it’s weather dependent. My goal would be for a quarter of a million people each day during the Expo Days, held Oct. 23 and 24. Our goal is also to have a million people nationwide involved in this celebration, between what we’re doing and all the satellite events going on nationwide.

Q: At the end of the day, what do you hope to achieve?

A: My dream for this event is that it will have been considered the “Woodstock of science.” Hopefully, with less rain.

Click here to find out all the details of this year’s event already underway in Washington, D.C.

CHI-Advancing California biomedical research and innovation

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Friday, October 1, 2010

Executive Spotlight: Terry Gregg, President and CEO DexCom

Terry Gregg, DexCom President & CEO
Terrance H. Gregg is president and chief executive officer of DexCom Inc. He is also a special venture partner with Galen Partners, a private equity firm specializing in the healthcare industry. In 2002, he retired as president of Medtronic MiniMed, a world leader in diabetes management systems. He became president and chief operating officer of MiniMed Inc. in 1996 and was instrumental in Medtronic's $3.4 billion acquisition of MiniMed in 2001. He also served in executive positions with Smith and Nephew and Allergan Inc. Gregg served as the 2003-2004 Chair of the Research Foundation Board of the American Diabetes Association. He received his bachelor’s of science from Colorado State University in 1971. In 2003, Gregg and his wife were recognized by the American Diabetes Association with an award for Outstanding Service in Diabetes Research Funding.

Q: Share with me a brief history of DexCom and some of the important milestones of the company.

A: Dexcom designs, develops, and commercializes continuous glucose monitoring systems for managing diabetes. The company was really founded in 1999. The premise of that original founding was to develop a fully implanted subcutaneous sensor that would reside in place, in the abdomen, for upwards of a year, maybe 18 months. At the time, reliable, home-based continuous glucose monitors had yet to hit the market.

But by the mid 2000s, it was clear that the opportunity for a home based continuous glucose monitor that provided real-time values to the patient was going to be big.

Around 2003, it became apparent to the company that the amount of resources, capital, etc., in order to commercialize that product, would be more than the company could raise. But they took the lessons learned and the knowledge and then converted the product into an ambulatory one, for use at home.

A three-day sensor was approved by the FDA in March 2006.
About a year later, June in 2007, the product was then extended to seven days. That became what we call the Seven System. In March 2009, the next generation, the Seven Plus System was approved by the FDA. That’s a product we have on the market today. The fourth generation sensor is currently pending PMA review by the FDA.

Q: You spent most of your career with Medtronic before retiring. What brought you out of retirement to join DexCom?

I have, personally, been pursuing a hospital glucose sensor since around 1997. One of the reasons I came out of retirement to join DexCom was that I believed that they had a sensor that would be adequate for that intensive care environment. Studies show that when a patient's blood glucose level is high for prolonged periods, recovery from surgery takes longer and the risk of infection increases. Currently, tight glycemic control is achieved by obtaining samples every 30 to 60 minutes, however this testing practice may be too intermittent and cumbersome.
So, we developed a blood-dwelling sensor that goes into a peripheral vein for continuous glucose monitoring and we licensed that technology in co-development to Edwards Lifesciences for the ICU. It is pending before the FDA although it has received CE marks in Europe.

Q: What other work has been going on at DexCom?

A: We’ve engaged in two relationships with pump companies, one being J&J Animus (that product will go into the FDA at the end of this year) and the second relationship is with Insulet Corp., which has a disposable insulin infusion system called the Omnipod. That product is actually pending review before the FDA now.

Q: What would you like to call attention to when it comes to diabetes?

A: I think that the most compelling thing that one can do now is to encourage patients to take on their own responsibility for the treatment of their disease. If you look at what the future holds, we’re not going to be able to adequately afford the care that patients will need. Unfortunately, diabetes is growing at a rate that we can’t stop it. We have to educate patients and patients have to be more demanding.

Q: Given what we know and how much work has left to be done, how far are we from an artificial pancreas? One that can monitor blood glucose levels in real-time and respond to them by releasing insulin just as a normal pancreas would?

A: I would say we’re in the five- to 10-year horizon to get to a semi-closed loop system. We’re also unfortunately dealing with a regulatory arena that is more restricted than we’ve seen in a long time. I think two things are going to happen. There will be delays in development in the U.S. And, at the same time, we’re all looking outside the U.S. as fertile ground to move our newer technology. But reimbursement is a concern. It’s an interesting dynamic that we are going to struggle with at least for the next four years, in my opinion.

Q: DexCom recently worked with the FDA on changes sought by the agency in the way DexCom labels certain glucose monitoring devices. Any advice for companies going through similar issues?

A: Read all the guidance documents you can and interpret them in the most conservative way you can. I think the second thing is be very proactive but cooperative with the agency. Working to a joint conclusion that is in the best interest of the patient is really what the FDA wants. I think companies want that as well. Certainly we continue to have what I consider to be a fabulous relationship with the agency. Even in spite of the warning letter, there was no interruption of the review of our files.

Q: What are you doing when you’re not in the office?

A: This isn’t a job; this is a passion. I get to do this. Certainly, I have fun. We have adult children and two grandkids that live in San Diego County. We have a beautiful sailboat that I get down to once in awhile. Certainly, I am blessed in that I have been remunerated more than I ever should be. My wife and I are strong philanthropists. To date, I think we’ve given over $2 million to diabetes research and we will continue to do things of that nature. It’s something we believe very strongly in. When you are blessed like that you should give back.

CHI-Advancing California biomedical research and innovation

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Wednesday, September 22, 2010

Executive Spotlight: Stanley Crooke, Founder, Chairman & CEO, Isis Pharmaceuticals

Stanley Crooke, CEO of Isis Pharmaceuticals

Dr. Stan Crooke is founder, chairman and chief executive officer of Carlsbad, Calif.-based Isis Pharmaceuticals. In 2006, he was named in Nature Biotechnology as one of biotechnology’s influential individuals. Crooke is currently on the board of Regulus Therapeutics Inc., a company jointly owned by Isis. Prior to founding Isis, Crooke was president of research and development for SmithKline Beckman Corp. (SKB). He also coordinated the research and development activities of SKB including its instruments, diagnostics, animal health and clinical laboratory businesses. Prior to joining SKB, Crooke helped establish the anticancer drug discovery and development program at Bristol-Myers, which succeeded in bringing to market a significant number of drugs. During his career, Crooke has supervised the development of 19 drugs on the market and others in development. He received his master's and doctorate degrees from Baylor College of Medicine and his bachelor's in pharmacy from Butler University.

Q: Share with me a brief history of Isis. How did the company first get started?

A: I founded it 21 years ago to pursue what was a novel idea at the time that had no data, which was the notion of antisense technology. We’ve persevered in that process in what I think has proven to be an important enterprise.
When I started the company I said the probability of our success was near zero and that it would be 20 years and at least $2 billion before we really knew, and I think that’s been proven the case.

Q: Tell me what antisense technology means.

A: It’s the only direct route from genomics to drugs that I know of. It’s the use of chemically modified oglionucleotides (short chains of nucleotides made synthetically to replicate the human DNA sequence) to interact with specific messenger or other RNAs to cause their function to be disrupted.

Think of it as the third platform for drug discovery. Small molecules are 120 years old now. Protein therapeutics are really quite old, but monoclonal antibodies are about 35 or 40 years old. We think antisense will take place alongside those as a third platform.

Q: How did you get to the point to where you were discovering and developing drugs that bind to RNA instead of proteins?

A: I’ve always been interested in RNA as a place in drug action. I feel the proposition is simpler. It seemed to me that it was time to evaluate whether one could create oglionucelotides that had good drug properties. And, if we could, then the hope was antisense drugs would be more specific because you can build them to be gene-specific. And the technology would be much more efficient than small molecule or protein-based drug discovery because the basic rules of how the oglionucleotide interacts with the target RNA are understood.

Armed with that information, then it becomes a much more rational process for drug discovery. All of those things, I think, have been borne out as we’ve made progress over the last 20 years.

Q: Talk a little about Isis’ strategy to license drugs in the earlier stages of development. I hear you’ve generated more than $1.6 billion from the successful execution of this partnership strategy?

A: It’s really quite simple. With small molecule and protein therapeutics you never know when you’re going to get another drug.

So, the idea was to invest in innovation tied to a technology that was sufficient enough that we could generate large numbers of drug opportunities per unit of time with a small group of people. And not to build an infrastructure that gets in the way of innovation.
Our goal has been to keep the company small. It’s a mantra here at Isis that we intend to stay small, around 300 to 400 people, which is where we are now. And, armed with that technology, we can create five new drugs a year. Today, we have 23 drugs in development. Next year, we’ll have 28. And we will do the discovery, the early development to proof of concept and then let organizations that are geared to the brute force of Phase 3 and marketing and sales do that.

Q: What’s on the immediate horizon for Isis?

A: Mipomersen, our Phase 3 cholesterol-lowering drug being developed with Genzyme, gets filed in the first half of next year, in the U.S. and Europe, for the first group of patients. These are patients who have severe high cholesterol and extreme cardiovascular risk. Then, there will be subsequent filings for an ever-growing volume of patients and long-term safety.
It’s going to treat people who have high cholesterol, who can’t get their cholesterol down with existing drugs and who can’t take statins. It’s an exciting drug that’s going to make a big difference in patients’ lives.

Q: When you’re not at work, where else do you spend your time?

A: My wife and I have a home in Sedona, Ariz. so we like hiking in the red rocks. Other than that, I like to read, play chess and generally goof around.

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Wednesday, September 15, 2010

Childhood Obesity Summit Calls Attention to Public Policy

Michael Goran, founding director of USC's Childhood Obesity Research Center (left), and Dr. Kenneth Moritsugu of the Johnson & Johnson Diabetes Institute tackle the topic of childhood obesity. Photo courtesy USC.

Given the knowledge that childhood obesity rates have more than tripled in the past 30 years, lawmakers and healthcare leaders convened Sept. 10 on the campus of the University of Southern California to discuss ways of tackling the problem at home, in the schools and through public policy decisions made at the local and national levels.

To find out more about this issue and its related healthcare disparities among racial and ethnic groups, I traveled to Los Angeles to attend
Childhood Obesity: A Call to Action.

The event, organized by CHI-member USC in cooperation with members of the Congressional Hispanic Caucus, Congressional Black Caucus and Congressional Asian Pacific American Caucus, was designed to help lay the groundwork for federal policy as Congress considers legislation regarding elementary and secondary education, child nutrition and transportation programs.

Rep. Lucille Roybal-Allard (D-East Los Angeles), who represents USC's Health Sciences Campus, led the congressional delegation attending the event, which included Reps. Michael Honda (D-Silicon Valley/San Jose), Judy Chu (D-East Los Angeles/El Monte), Grace Napolitano (D-Suburban Los Angeles), Diane Watson (D-Central Los Angeles) and Donna Christensen (D-Virgin Islands).

Roybal-Allard called childhood obesity a “national crisis” and noted how research demonstrated that obese youth were more likely to become obese adults. The summit highlighted some of USC’s own research and policy expertise in childhood obesity, particularly among racial and ethnic minorities. One program, initiated by USC Pharmacy School Dean Dr. Mel Baron, used
comic book-like “fotonovelas” to increase awareness of diabetes and related health issues among Latino communities.

Los Angeles City Councilwoman Jan Perry spoke of the efforts to eliminate so-called “food deserts,” or regions where fast-food restaurants dominate but access to grocery stores selling fresh fruits and vegetables is limited to none.

And an effort to improve the accuracy of health messages on television and in movies is gaining traction, according to Sandra de Castro Buffington, who serves as director of USC’s Hollywood, Health & Society program.

Corporations, too, are doing their part, as exemplified by Dr. Kenneth Moritsugu of the Johnson & Johnson Diabetes Institute.

He mentions, though, that we have a complicated route ahead. “Twenty-six percent of Americans are obese and we have no good data on type 2 diabetes,” he said.

Overall, the program served as an excellent example of how such a large problem has many solutions, and good public policy decisions and corporate leadership can lead the way.

For more information on the Childhood Obesity: A Call to Action event held at USC, click here.

For more information about childhood obesity, visit the website for the
Centers for Disease Control and Prevention.

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Tuesday, August 17, 2010

Executive Spotlight: Michael Narachi, President and CEO Orexigen

Michael Narachi joined the Orexigen Therapeutics Inc. management team as president and chief executive officer in March 2009. He has more than 24 years of biotechnology and pharmaceutical experience across a broad range of functions including clinical development, commercialization, strategic business development and planning. Prior to joining Orexigen, Narachi served as chairman, chief executive officer and president of Ren Pharmaceuticals Inc., a private biotechnology company based in South San Francisco, and executive chairman of the board of Naryx Pharma Inc., a private pharmaceutical company located outside of Santa Barbara.
Before that, Narachi spent 20 years at Amgen, most recently as an officer and vice president and general manager of the company’s anemia business. He retired in 2004.
Narachi received his bachelors’ degree in biology and a master’s in biology and genetics from the University of California at Davis. He also received a master’s in business administration from the Anderson Graduate School of Management at University of California, Los Angeles. He is also chairman of AMAG Pharmaceuticals Inc.

Q: It seems like a dynamic time for the obesity space, in particular for companies like yours working to develop new treatments. We recently heard the Centers for Disease Control and Prevention (CDC) numbers regarding obesity rates among the states, and it’s not looking good. Not a single state met its target for reducing obesity rates, and the number of states reporting rates of 30 percent or more tripled since 2007 to nine states. Where does the problem lie and where does Orexigen fit in?

A: I think that the CDC numbers and the growth of the rates of obesity just point out what people have been reporting on quite a bit in the last year, and that is that we’ve got a big problem here and I think its around both behavior and biology. The way the mechanism of action is designed in Contrave, Orexigen’s obesity drug, is that it tries to impact both behavioral and biological drivers of obesity.

What happens in nature is people are designed to be food seekers and to be rewarded when you find it. For the majority of the evolutionary period here, food has been scarce, and if you didn’t find it, the consequences were severe. So, there are so many mechanisms driving us to find food and then be rewarded when we eat it. People don’t eat just because they’re hungry. We’ve all experienced those meals where you’re full, you’ve got plenty of energy, you’ve got excess storage of energy, and somebody puts something interesting in front of you and you still eat it.

Q: Some people would argue that losing weight is simply a matter of diet and exercise. What do you tell them?

A: We know people are educated and they’re intelligent and they know that having excess body weight in terms of fat is a risk. But diet and exercise alone are not working. It is a cornerstone of what we need to do to be more healthy, but it is not working and there’s this big gap between continually telling people to diet and exercise or, maybe on the other end of the spectrum, people are going and having bariatric surgery. I think what the world is trying to do, or at least pharmacotherapy development companies are trying to do, is develop something in the middle that becomes an enabler to do that diet and exercise cornerstone.

Q: Given what’s already happened in the marketplace with previous failures like Fen-phen (an anti-obesity medication which consisted of two drugs: fenfluramine and phentermine), describe the atmosphere for introducing one of the first prescription products in a decade that could potentially help people safely and effectively lose weight?

A: We look at what happened in the marketplace in the past, particularly when fenfluramine and dexfenfluramine (Redux) were pulled from the market. Once that cardiovascular signal showed up, the FDA does what it normally does, which, if there’s a drug-related signal, takes the drug off the market. That happens in many categories. That happened in Vioxx and Celebrex, too. But that doesn’t mean people stopped working on an anti-inflammatory. And, here, it doesn’t mean people stopped working on treatments for obesity.

The background is that there is a huge unmet need. Obesity is driving all kinds of morbidities and co-morbidities that are costing healthcare systems enormous amounts of money. Diabetes and heart disease alone are huge and there are plenty of drugs that are safe and effective to treat those conditions. We’ve got $30 or $40 billion each for anti-hypertensive meds and Lipitor, for example, and we’ve got the diabetes drugs on top of that. So we’re over $100 billion of useful drugs to treat the conditions that are, in a large part, being driven from obesity. Where we are aiming our therapy is let’s help people lose weight so that we can decrease or even prevent some of those downstream conditions from occurring.

Q: What are your expectations regarding timelines for approval and introduction to the marketplace?

A: Our PDUFA date for the regulatory review for the FDA is January 2011. So the big things on our plate right now are partnership and approval. The partnership and approval is focused on the U.S. Immediately after that we have ex-U.S. partnership. We have our launch and we have our second product, Empatic. Those are the five big things. All of those have enormous implications for the company.

Q: What have you learned about Orexigen since you joined the company early last year?

A: The main thing I’ve learned from joining is just how dedicated the team is here. We’ve really built an excellent team here and people are doing a terrific job. We get questions from the FDA and our turnaround time is fast. We’ve got people at both the leadership and the team level that are very, very skilled and experienced, who have done this before for other companies.

Q: Besides work, where else do you like to spend your time?

A: Well, I’m a surfer, and my family likes to spend time near the ocean. The Channel Islands are a favorite family spot. I also like to spend family time in the mountains. We like to go to really wild backcountry places on my mule and packhorses. We ride mostly in the mountains in the San Rafael wilderness area, up in the Santa Barbara area where we still have a ranch and keep the horses and mules.

Q: If you could meet anyone in the world, who would it be? What would you ask them?

A: Right now, as I’m focused on obesity and healthcare, I’d like to meet the head of Health and Human Services, Kathleen Sebelius. Or, I’d be interested in meeting someone a short time in the future who heads the HHS after we introduce Contrave. Our hope would be that I would ask the question: “Would you ever imagine that we could have this much of a positive impact on healthcare in the United States with obesity therapeutics?” By that time, maybe some of those states would have met their obesity goals.

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Tuesday, July 27, 2010

Executive Spotlight: Robert "Chip" Hance, President of Abbott Vascular

Robert “Chip” Hance is president of Abbott Vascular, a division of Abbott based in Santa Clara, Calif., and one of the world’s leading vascular care businesses. Previously, Hance served as president of Abbott’s diabetes care business from 2007 to 2008. He began in the interventional cardiology field in 2002 as head of Perclose and led Abbott’s Vascular Devices division until 2006, where he oversaw the development and launch of several key new cardiovascular technologies.

Hance joined Abbott in 1989 in sales for Abbott
's diagnostics division, and held a number of marketing and commercial management positions, including vice president for the Europe, Africa and the Middle East regions. Prior to joining Abbott, Hance was an associate fellow at Harvard Business School and a product development engineer at Proctor and Gamble. He earned a bachelor's degree in chemical engineering from the Massachusetts Institute of Technology and a master's degree in business administration from Harvard Business School.

He will be part of CHI's upcoming FDA 510(k) Process Under the Microscope: How Will Changes Impact You?, to be held July 29, in Newport Beach at the Balboa Bay Club & Resort.

Q: Many of us know the name Abbott, but tell me a little about Abbott Vascular.

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. The division offers a comprehensive device portfolio, including products for carotid artery disease, coronary artery disease, peripheral vascular disease, structural heart disease and vessel closure.

Q: How has the company grown in recent times?

A: Abbott spends significant capital in R&D effort with total spending at $2.7 billion last year across research pipeline programs. Our vascular business has the most robust pipeline in the industry, and we have said we expect to bring more than 10 coronary technologies to market over the next five years.

The corporation continues to generate growth both organically and from targeted acquisitions. In Abbott's pharma business, the company completed its acquisition of Solvay Pharmaceuticals earlier this year, marking an important step for the company in expanding its presence in key emerging markets.

In addition, Abbott announced earlier this year the acquisition of Indian pharmaceutical company Piramal, which will make Abbott the No. 1 pharmaceutical company in India.

In its vascular business, in 2006, Abbott purchased the vascular device division of Guidant Corporation, which at the time was developing the Xience drug eluting stent, which has since become the market leading stent worldwide. Last year, we acquired Evalve Inc. of Menlo Park, which provided Abbott a presence in the growing area of non-surgical treatment for structural heart disease.

Q: What do you consider most important about your work?

A: Put simply, it is about helping patients get the best care. At Abbott Vascular, we are dedicated to transforming the treatment of vascular disease through better medical device innovations.

Q: What do you consider the most at risk in the current regulatory environment?

A: I’m most concerned that patient access to new, innovative devices will be challenged by the complexity of a changing regulatory environment. It is important that we continue to innovative, and continue to balance patient needs and access to new medical technologies with regulatory requirements. We do not want to lose sight of the patient.

We also want to ensure access to new medical technologies does not diminish in the
United States. Many of the products still considered “investigational” in the United States are receiving approvals in Europe and other countries.

Q: What are you hoping to take from the CHI event FDA 510(k) Process Under the Microscope: How Will Changes Impact You?

A: I hope to engage in robust discussions about the biomedical industry and its future. Through these discussions, I hope to come away with better ways of communicating the importance of medical technology for patients and the world they live in. It is only through innovation that we continue to thrive and improve on what we already know.

Hance will be speaking at CHI’s FDA 510(k) Process Under the Microscope: How Will Changes Impact You? on Thursday, July 29, in Newport Beach. To find out more, click here.

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Monday, July 12, 2010

Executive Spotlight: Joshua Makower, Founder and CEO of ExploraMed

Joshua Makower, M.D. has dedicated his life to the creation of medical technologies that improve the quality of life for patients. He is chief executive officer and founder of ExploraMed Development LLC, a venture-backed medical technology incubator based in Mountain View, Calif., and is also a venture partner with New Enterprise Associates.

Josh also serves as a consulting associate professor of medicine at Stanford University Medical School and is co-founder of Stanford’s Biodesign Innovation Program. He has founded several companies through the ExploraMed incubator that have achieved successful mergers and acquisitions, including Acclarent Inc. (sold to Johnson & Johnson this year); TransVascular Inc. (sold to Medtronic in 2003); and EndoMatrix (sold to C.R. Bard in 1997). Up until 1995, Josh was founder and manager of Pfizer’s Strategic Innovation Group, a group chartered to create new medical device technologies and businesses for Pfizer’s medical device divisions. Josh also serves on the board of directors for NeoTract Inc., Moximed Inc., Intrinsic Therapeutics Inc., ExploraMed III Inc. and Vibrynt Inc.

He will be a part of CHI’s upcoming FDA 510(k) Process Under the Microscope, to be held July 29, in Newport Beach at the Balboa Bay Club & Resort.

Where do most of our ideas for new medical technologies come from today?
Medtech innovations come mostly from physicians and those who see patients’ needs firsthand. As these caregivers treat patients everyday, they can see for themselves which technologies and procedures are working, and which need improvement. It is the inspirations from these experiences which allow them to bring new ideas forward as products.

It’s difficult to imagine a world without some of the innovations that have been developed through this process, such as joint replacements and cardiac stents. Many of these innovations have increased the duration and quality of our lives. Life expectancy is up 4 percent from 1980 to 2000.

How has medical device development changed in recent times?
In 1988, the Institute of Medicine was commissioned to report on how new medical devices were created and developed. Even in those days, new medical technologies came from individual practitioners, entrepreneurs and small firms. It is amazing how much that process has remained the same over the last 20 years!

Even though many of the first insights into these new technologies came from physicians outside the
U.S., it was the American economy and the way that we inspire and create business opportunities for entrepreneurs that really drove the development and adoption of these innovations, providing for access to these new technologies for patients.

You talk about a medical technology ecosystem, which starts with those you call “fuelers.” Can you tell me what you mean by this?
Every new technology, every new idea that touches a patient’s life and improves it started with an investor writing a check. The American dream and small businesses are at the heart of what continues to drive the system today. The U.S. has provided incentives for innovators to succeed, and when they develop technologies that improve patients’ lives, both investors and patients are rewarded.

Unfortunately, much of this system is now at risk with the decline of venture capital dollars flowing into the industry. From 2008 to 2009, venture investment in firms pursuing medtech dropped more than $1 billion. I don’t think we realize the full impact that this drop will have on the flow of technologies to improve human health, but it definitely is not going to be good.

What are some of the challenges to that system today?
The survival of small companies is critical for delivering innovation to patients. Innovation depends on the willingness of VCs to continue fueling small companies.

It’s important to recognize that very little money actually flows into medtech innovation out of the total amount of venture capital. Less than 5 percent (of institutional investments) actually goes to VC. Of that, less than 15 percent goes to medtech.

As I mentioned, institutional investments have shrunk, putting venture funds in a difficult place. Overall, this kind of environment threatens to hamper what’s needed to support small startups with innovative ideas.

What’s the biggest take-home message when it comes to the 510(k) process?
The 510(k) process is a fundamentally important pathway for small medtech firms. Many valuable, safe and effective technologies have passed through this process and patients have benefitted greatly. Eliminating 510(k) would be a terrible tragedy for patients and their access to new technologies. To force all new medtech products to pass through a pre-market approval process (PMA) is not practical and would result in halting innovation, delaying or extinguishing important innovations that patients need. We cannot make the process too costly or challenging to navigate for small firms. These processes, if too difficult, will deter even the most talented and creative innovators to even enter in the system. We want to make sure that doesn’t happen. If we want to ensure that we’re going to have safe and effective innovations to sustain and improve human health we need to have systems that are predictable and reasonable to navigate.

Makower will be speaking at CHI’s FDA 510(k) Process Under the Microscope: How Will Changes Impact You? on Thursday, July 29, in Newport Beach. To register, click here.

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