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.

CHI-Advancing California biomedical research and innovation

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.

A: 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.

CHI-Advancing California biomedical research and innovation

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.

CHI-Advancing California biomedical research and innovation

CHI Supports Industry Effort to Curb Illicit Methamphetamine Production
Illicit crystal methamphetamine (crystal meth) production has become a huge problem across the United States, particularly in California. While many other states outrank California for the overall number of meth labs, California has more super laboratories (labs which are capable of producing 10 lbs. of meth or more per cook) were than any other state in the country. In 2008, 13 of the 14 superlabs were in California. Sacramento was one of the top five cited destinations when law enforcement seized meth from smugglers. It was the only city in California to make the top five list.

Meth is cooked using ingredients commonly found around the home, including cough and cold medication, household batteries, rubbing alcohol, paint thinner, table salt, ammonia, nail polish remover, lye, just to name a few. Certain cough and cold medications contain pseudoephedrine and ephedrine (PSE), which when reduced down to its base chemical components is a key ingredient in crystal meth production.

Last year, the California Legislature considered a bill, SB 484 by Sen. Rod Wright (D-Inglewood) that would have required a prescription for PSE. CHI opposed this proposal, as PSE is a safe and effective remedy for cold and allergy sufferers, when used as directed. If a prescription were required for PSE, uninsured Californians would have no access to the products, the state’s Medi-Cal program would have to assume the costs for PSE prescriptions for enrollees, and insured Californians would have to go to the doctor for a consultation to receive a prescription. Additionally, the state, already facing a dire budget shortfall, would lose sales tax dollars as prescription drugs cannot be taxed in California, while over-the-counter remedies can.

While we strongly stand by our conviction that requiring prescriptions for PSE is bad health policy, we also recognize the scourge that crystal meth brings to communities across the state. Crystal meth is a highly addictive drug that activates the brain’s reward pathways, releasing massive quantities of dopamine, serotonin, and norepinephrine, creating a sense of euphoria while heightening physical sensation. At the same time, the drug blocks chemicals in the bloodstream that would otherwise break down crystal meth. As a result, it can stay in a user’s system for more than 12 hours. Prolonged meth use can result in decomposition of the teeth, severe cardiovascular damage, stroke, heart attack, and even death. Aside from the physical toll, a 2009 study by the RAND Corporation showed that in 2005, crystal meth use cost society $23 billion in costs from increased healthcare costs to lost productivity.

In order to address this vexing problem, CHI and our member companies that produce PSE agreed to an alternative to the Wright bill. Our solution, AB 1455 by Asm. Jerry Hill (D-San Mateo) would require that PSE sales be tracked in a real-time database to ensure that current restrictions on the amount an individual can purchase are enforced. Under federal law, individuals can purchase a maximum of 3.6 grams of PSE a single day, or 9 grams total per month. The real-time database will be paid for by a fee on products that contain PSE.

The National Precursor Log Exchange, or NPLEx, is a system that works seamlessly across all participating states to ensure that meth cooks cannot just cross state lines to evade the law. Currently, 10 states use NPLEx, with a handful more slated to come online in the next few years. Opponents, who favored the prescription approach, have pointed out privacy concerns with a database like NPLEx, and our industry took amendments to address these concerns. The amendments require that data be purged after two months (the required time to maintain logs under federal law), require security standards be in place for the database, limit use of the data to open criminal investigations by law enforcement, and inform consumers at the time of sale that the information being collected will be on record and available to law enforcement for up to two months.

E-tracking for PSE sales is an innovative solution that ensures patient access to safe and effective remedies for cold and allergy symptoms remain readily available, while preventing the sale of PSE products in large quantities to those who would use it for illicit purposes. NPLEx has been used to identify and shut down more than 70 percent of the meth labs that are raided in that state, and a Florida pilot project with NPLEx reduced illegal sales by more than 90 percent.

If you would like more information on e-tracking for PSE, please visit http://www.stopmethnotmeds.com. If you live in California, take the time to post your support of AB 1455 (Hill) on your legislator’s Facebook Fan Page, or submit a letter to their office in the state capitol. More information on how to do that can also be found at http://www.stopmethnotmeds.com.

Venture Capital is the Lifeblood of Biotech

Since the inception of the biotechnology industry in 1980, startup companies have looked to venture capitalists to help them move innovations through human trials and into medical practice. This endeavor requires a lot of assistance: the drug development process can take more than 12 years and $1.2 billion. This is the cost for the approximately 10 percent of drug candidates that are successfully commercialized. Nearly 90 percent will fail in development.

Working with emerging companies, venture capitalists often provide five to eight years of equity to startups whose stock is essentially valueless. The goal for both the investor and the company is to advance the potential product through Phase I and Phase II clinical trials and use positive results to complete an initial public offering (IPO) or to engage in a merger and acquisition transaction to regain their investment and advance therapies to the patients who need them.

Figure 1

The firms that have successfully negotiated this pathway have been well rewarded for their work. However, they are a part of a very select group (see Figure 1). According to the graph, of the more than 1,800 U.S. biotechnology companies founded since 1980, fewer than 200 are generating revenues on the product sales today. Of those, only six companies have earned more than they spent in development. Those companies are CHI members Amgen, Biogen Idec, Genentech, Genzyme, Gilead Sciences and MedImmune.

With the stock market crash of 2008, institutional investors rebalanced their risk in part by reducing their venture capital investments. Even venture capital firms specializing in biotechnology are using their reserves to fund their prior investments rather than seeking out new startups. The current economic climate is threatening the formation, funding and forward progress of small biomedical companies—and the therapies, cures and technologies of the future.

As the economy recovers, venture capitalists and other investors will return to biotechnology in proportion to their assessment of the overall lifecycle risks and the lifecycle duration of potential products. They also will calculate the potential value of their investment at their exit. That means that California’s biomedical industry entrepreneurs need to use this time to verify the validity of their ideas, shore up their business plans and lay the groundwork for bringing their dreams to fruition—and trust that investors continue to see the value of biomedical breakthroughs.

Click here to read more in the 2010 California Biomedical Industry Report.

Legislator Spotlight: Rep. Michael Honda a Strong Advocate for the Biomedical Industry in California
Since 2001, Mike Honda has represented the 15th Congressional District of California in the U.S. House of Representatives. He is in his sixth year as chair of the Congressional Asian Pacific American Caucus and also serves on the Appropriations Committee, with postings on several subcommittees. Although born in California, Honda spent his early childhood with his family in an internment camp for Japanese Americans in Colorado during World War II. In addition to serving in the Peace Corps for two years in El Salvador, Honda earned bachelor's degrees in biological sciences and Spanish, and a master's degree in education from San Jose State University. Honda has been a science teacher, has served as a principal at two public schools, and conducted educational research at Stanford University. His political career has included stints on San Jose's Planning Commission, the San Jose Unified School Board, and the Santa Clara County Board of Supervisors. Honda also served in the California State Assembly from 1996 to 2000 before being elected to Congress. He is widowed with two grown children and three grandsons.

Honda has sleep apnea, a condition in which people stop breathing during sleep—sometimes hundreds of times during the night, and often for a minute or longer. With each episode, the brain rouses the person from sleep to resume breathing. The condition is quite common and affects more than 12 million Americans. Sleep apnea is linked to high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency and headaches—as well as diminished motor skills caused by sleep deprivation. Left untreated, the disorder can be life-threatening.

Honda became aware of his condition when he participated in a sleep apnea study at Stanford University. The study was part of a physical exam, which was required for his job on the Santa Clara County Board of Supervisors. The sleep apnea exam was supposed to last two nights, with Honda attached to electrodes to determine the quality and depth of his sleep state.

“My case was so pronounced,” Honda said, “that the technician barged in after four hours.” For the remainder of the evaluation, Honda slept with a continuous positive airway pressure (CPAP) machine, developed by CHI member company ResMed. The San Diego-based company develops, manufactures and markets products for a range of sleep-disordered breathing and other respiratory conditions. “After just four hours [on the CPAP], I woke up so rested and my mind was so clear,” he said; “the difference was profound.” For the first three days, he felt like a completely different person.

Honda’s experience with sleep apnea has changed his perspective on healthcare and the biomedical industry providing treatments to patients. Honda sits on the congressional committee funding the National Institutes of Health (NIH) and National Science Foundation (NSF) and serves as Chairman of the Congressional Asian Pacific American Caucus (CAPAC). In both roles, he has been a strong advocate of healthcare equity. On the appropriations committee he has consistently advocated for increased funding for Title VII diversity training programs and written report language aimed at increasing awareness about health equity issues. As Chairman of CAPAC, he has focused on health equity issues that particularly affect the AAPI community.

Click here to read the full profile on Congressman Mike Honda in the 2010 California Biomedical Industry Report.

CHI's Inaugural Environmental Summit Brings Robust Debate and Dialogue

Photo on left: Asm. Jerry Hill (D-San Mateo) delivers opening remarks. Photo on right: Maziar Movassaghi, Department of Toxic Substances Control.

Pictured from left to right: Panelists from "Setting the Environmental Regulatory Stage in California and Lessons Learned from Europe" Curtis Stephan, Edwards Lifesciences; Michael Whaley, Allergan; Ashley Taylor, Amgen Fremont; Sheri Prosch, Medtronic; Jeffrey Sickenger, KP Public Affairs; and Sandra Pizarro, CHI.

Click here to view more picture from CHI's Environmental Summit.

CHI held its first-ever Environmental Summit this last week at The Citizen Hotel in Sacramento, where Assembly Member Jerry Hill kicked off the day with welcome remarks stressing the importance of California’s biomedical industry and preserving the state’s natural beauty. Recognizing that in recent years, numerous legislative attempts to enact restrictive environmental requirements in California have threatened life sciences research and manufacturing jobs, CHI sought to convene experts from throughout the biomedical industry and public officials to discuss the measures and their potential implications.

More than 80 people attended the inaugural event held on the Metropolitan Terrace, which had beautiful views of the state capitol, and heard from speakers from Allergan, Edwards Lifesciences, Amgen, Pfizer, Amylin, Johnson & Johnson, Genentech and Stanford University, as well as public officials including Maziar Movassaghi, acting director of the Department of Toxic Substance Control (DTSC); Margo Reid Brown, acting director of the California Department of Resources Recycling and Recovery; and Assembly Member Wesley Chesbro (D-Arcata), gave participants a broad overview of what is new, what is changing and what to expect from major state environmental regulatory programs in California. Panel discussion topics focused on the state’s complex environmental regulatory structure, green chemistry, product stewardship, including medical sharps waste and pharmaceuticals in the environment, as well as nanotechnology. Maureen Gorsen, former director of the DTSC and currently with the law firm of Alston + Bird, delivered keynote comments at lunch.

The day wrapped up with a closing reception where attendees were able to discuss environmental issues with all panelists from the program.

CHI gratefully acknowledges its Gold Sponsors: Abbott, Amgen, Edwards Lifesciences, Genentech; Silver Sponsors: BioMarin, and Sanofi Aventis; and Reception Sponsor: Alston + Bird, LLP. CHI welcomes your participation in future discussions on the implications for environmental regulations and California’s ability to maintain its leadership in innovation. Contact Ritchard Engelhardt, associate director of government affairs (916-233-3490 or engelhardt@chi.org) for more information on how to get involved.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Jeffrey Janus, director and SVP of operations, International Stem Cell Corp., and president and CEO, Lifeline Cell Technology

Jeffrey Janus serves as director and senior vice president of operations of new CHI member International Stem Cell Corp. and president and chief executive officer of Lifeline Cell Technology, one of the company’s subsidiaries. International Stem Cell Corp. (ISCO.OB) is a publicly traded stem cell therapy company with research and manufacturing facilities in Oceanside, Calif., and Walkersville, Md. The company’s technology revolves around its discovery of a proprietary and unique class of stem cells called human parthenogenetic stem cells (hpSC). These cells have distinct medical, practical and ethical advantages over embryonic and adult stem cells. They allow immune-matched stem cells and therapeutic cells to be “banked” and available immediately for millions of patients who are in critical need and cannot wait to derive cells from their own bodies. In addition to Lifeline Cell Technology, the company has another subsidiary called Lifeline Skin Care.

Janus is trained in biochemistry and business management and has more than 20 years experience focused on cell-based businesses. He is a member of the team that discovered parthenogenesis and is published in the stem cell field. After joining International Stem Cell Corp., (ISCO) Janus subsequently founded Lifeline Cell Technology to meet a growing need for media and human cells in pharmaceutical drug screening, consumer product testing and basic research at universities and government laboratories and to provide revenue and operational infrastructure for ISCO. The CHI Blog recently caught up with Janus to find out the latest on the company.

Q: How did your company get started?
A: We started this company based on the work of Elena Revazova, M.D., Ph.D., a scientist well known in Russia who had a dream of curing diabetes using embryonic stem cells. She came to the United States to work and her talent and expertise in growing human cells was discovered by ISCO’s founders, who decided to form a company around her knowledge and skill. At the time, U.S. President [George W.] Bush was restricting the use of embryonic stem cells on ethical grounds, and there were also patent issues around embryonic stem cells, as there still are. We recognized that the ethical issue was important, but medially the most important problem with stem cell therapy was likely to be immune rejection. We realized we could address these issues by developing the technology called parthenogenesis and mitigate delays from funding and restrictions by working in Russia. So Dr. Revazova went back to Russia, and we set up a collaboration in Moscow to begin her work with parthenogenesis. Today our company has all of the intellectual property rights to parthenogenesis, a very powerful technology. We have also recently brought in Andrey Semechkin, Ph.D. as our CEO. Dr. Semechkin is a well-known scientist in the field of systems analysis and an accomplished businessman.

Q: How does parthenogenesis work?
A: It’s the derivation of stem cells from an unfertilized human egg. The ethical issue surrounding work with embryonic stem cells is caused by the fact that embryonic stem cells are derived from a fertilized embryo, which has the potential to be a human being. However, if you do not fertilize the egg and yet you can derive stem cells from it that are functional, you’re not destroying a viable human embryo—and that’s exactly what Dr. Revazova did. We perfected parthenogenesis and brought it back to the United States. As a result, we have been able to overcome the ethical issue surrounding using embryonic stem cells with parthenogenesis.

Q: What are your technology’s other advantages?
A: Parthenogenesis makes embryonic stem cells (or what we call parthenogenetic stem cells) that can be immune matched to millions of people. Using embryonic stem cells, the way they are currently made, is sort of like trying to do a bone marrow transplant between one person and another picked at random without making sure you have a match. If someone needs to have a bone marrow transplant, they usually go to brothers or sisters first and try to do an immune match. For a different set of reasons a similar situation exists with blood transfusions, although type O blood can be given to almost everyone. Our cells are similar in that the parthenogenic stem cells can be immune matched to many people, and that’s the unique quality of our cells.

Q: What are the biggest opportunities for your business going forward?
A: We are creating a bank of hpSC that are “pluripotent” and carry common immune types that will match a large percent of the U.S. population, and this is a huge opportunity. These will be clinical grade and will be made in our new manufacturing facility located in Oceanside, Calif. Our biggest opportunity is the potential ability of our stem cells to be universally utilized for therapy. Scientists across the world are working on embryonic stem cells and figuring out ways to make therapeutic cells such as liver cells or nerve cells for a whole host of diseases. Eventually these therapies will need a cell or process that will minimize immune rejection. Our cells can be immune matched to millions of persons and are thus a solution for this need. So in a way, much of the work that’s going on right now across the world with embryonic stem cells accrues to our benefit. In addition, we are focused in four distinct areas—diabetes, liver disease, retinal and corneal disease, and nerve disease. We are currently growing cells to cure corneal blindness and have actually grown cornea tissue. We’re working with the University of California, Irvine to grow cells with a retina for macular degeneration. We have grown cells that are very similar to liver cells that are also related to a cell type called beta cells, which may be useful for diabetes. Collaborations with companies and universities present strong opportunities, and we’ve collaborated with Novocell in San Diego to further our work with diabetes, and we’re collaborating with UC San Francisco to test our liver cells derived from our parthenogenic stem cells and with researchers in Germany to study nerve cells generated from our stem cells.

Q: Tell us a little bit about your subsidiaries.
A: One unique thing about our company is that we are a research-oriented biotech company that actually has income. One of our subsidiaries, Lifeline Cell Technology, is growing very nicely (with a 150 percent increase in sales over the last year) by selling research products to grow human cells and study human disease. Lifeline has more than 70 products and will be releasing more than a dozen more in 2010. Lifeline Skin Care was created in 2009 based on our discovery that derivatives from our parthenogenetic stem cell technology have proven to be beneficial to human skin. Lifeline Skin Care is developing several products and is beginning early-stage clinical trials with these skin products. We anticipate that these skin care products will help to generate income and fund our continuing stem cell therapeutic research.

Q: What are your company’s greatest accomplishments so far?
A. We have successfully created 10 human parthenogenetic stem cell lines, one which carries the most common immune type in the United States and matches over a hundred million persons across the world. We are a fast-growing company with more than 12 scientists working in various areas of therapy and product development. Our stem cells have proven to be able to create cells that may be useful in therapy, including liver-like cells, corneal cells, retinal cells, nerve cells and cell types that may ultimately be useful in the treatment of diabetes. We have set up collaborations with major universities and researchers across the world. The amazing thing about our company is that we have developed into a company that has manufacturing, products, sales, quality control, therapeutic research, and an accounting department in such a short time. We have all the workings of a fully functional product manufacturing and therapeutic research company. It amazes me that we are making sales, whereas most companies our size are basic research and development companies. We know how to make human cells and freeze, store and manipulate them so that they are clinical grade. I think our technology, our knowledge of cell culture and our ability to manufacture are three very strong reasons that we have been successful.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Paul Hastings, president and CEO of OncoMed Pharmaceuticals, Inc.

Paul Hastings is president and chief executive officer of new CHI member OncoMed Pharmaceuticals, Inc., a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. Since joining OncoMed in December 2005, he has been responsible for the forward integration of the company to the development stage, significant private financings, and the closing of a $1.4 billion preclinical, cancer stem cell collaboration with GlaxoSmithKline. Hastings was recently chairman of the board of Proteolix (sold to Onyx Pharmaceuticals in 2009), and served on the boards of ViaCell (sold to Perkin-Elmer in 2008), and Cerimon Pharmaceuticals. He is currently chairman of the board of the Bay Area Biosciences Association (BayBio) and serves on the executive committee of the board of directors of the Biotechnology Industry Association. The CHI Blog recently spoke with Hastings about where he sees OncoMed and the biomedical industry going.

“We’re going to have a great year,” Hastings said. A leader in cancer stem cell research, OncoMed has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such as pancreatic, breast, colorectal and lung cancers. Its lead candidate, OMP-21M18, is currently in Phase I clinical trials. In addition to OMP-21M18, OncoMed’s pipeline includes several novel preclinical product candidates targeting multiple validated cancer stem cell pathways. Based in Redwood City, Calif., OncoMed marked its five-year anniversary in September 2009, and in its five-year history has managed to raise more than $220 million in capital to fund the company.

In addition to its lead candidate, OncoMed has another antibody that’s going to be filed for IND-track development this year and expects to file a third most likely in 2011. Hastings is especially excited about a potential new collaboration in a new pathway that OncoMed has in the works. “We’re looking forward to forging another major partnership in this new exciting cancer stem cell pathway,” he said. “We believe that these kinds of partnerships are what will fuel the growth of our industry, since capital access is so difficult in these days.”

Even before entering into another partnership, OncoMed has cash on hand that takes the company through 2013. Hastings credits the company’s strong capital position to the science at OncoMed, which is generating development candidates, creating value through clinical milestones and leading to future collaborations that will continue funding the company.

With a core team of 75 people, Hastings is focused not on hiring but on achieving results. “We’re all about delivering on milestones that we’ve set with a rather stealth, nimble and focused group of people,” Hastings said.

Another key priority for Hastings is the California biomedical industry. He became chairman of BayBio in January 2010, and looks forward to close collaboration between BayBio, BIO and the California Healthcare Institute, which OncoMed recently joined. He is also focused on improving education to develop the biomedical workforce of tomorrow. One example is BayBio’s support of Biotech Partners through several programs, including a fundraising drive during its 2009 Pantheon Awards. Biotech Partners, a nonprofit organization whose mission is to connect youth to the world of biotechnology, provides an entry-level biotechnology education and training program dedicated to supporting the San Francisco Bay Area’s robust bioscience industry while providing valuable working skills for local young people. Other supporters include CHI member companies Amgen, Bayer and Tethys Bioscience. Beyond K-12 education, he said the biomedical community needs to lobby gubernatorial candidates about the importance of maintaining California’s higher education system. “We need to keep the University of California alive and well, because that’s where the biotech industry came from and where our employee base comes from,” Hastings said. And on the national front, he wants to make sure healthcare reform does not inhibit the industry’s ability to innovate.

From now on, successful biomedical start-ups are going to have to think creatively – and know where their financing will come from early on, Hastings said. Gone, at least for now, are the days when new companies needed just a small amount of capital and then were able to create value through an initial public offering or an acquisition.

Looking ahead, he expects to see fewer but higher-quality companies – and increasing consolidation. “I think the companies that are going to survive in the future, particularly early-stage companies that just get started this year or next, are really going have to have exciting enough science and exciting enough discovery to be able to attract the kinds of dollars that people are getting for later-stage deals, but earlier on,” Hastings said.

When he is not working at OncoMed or on behalf of the biomedical industry, you might find Hastings snowboarding in Whistler in the wintertime or enjoying his Sonoma County house in the summertime. “I’m kind of a busy guy, and that’s what I like to do – stay busy,” he said.

CHI-Advancing California biomedical research and innovation

HUYA Bioscience International

CHI Blog interviews Mireille Gingras, Ph.D., president and chief executive officer of HUYA Bioscience International, about the explosive growth of China’s biopharmaceutical industry and opportunities for Western pharmaceutical companies.

HUYA Bioscience International is the leader in accelerating the global co-development of novel biopharmaceutical product opportunities originating in China. Jointly headquartered in San Diego and Shanghai, the company has established extensive collaborations with Chinese universities, institutes, and bioparks to speed the development and value creation in worldwide markets for China-sourced product candidates. HUYA is the first U.S. biotechnology company to license clinical-stage compounds from China for worldwide commercialization, and among the first to predict the explosive growth of its biopharmaceutical industry. With the largest compound portfolio covering a wide range of therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the worldwide value of biopharmaceutical innovation in China.

Gingras founded the privately held company in 2005. She has 18 years of experience in the biotechnology industry that includes drug development, pre-clinical research design, and experience in establishing academic partnering programs. She has made significant contributions to the study of complex addictive diseases as well as in the research and development of neuroactive steroids and neurological and neurodegenerative diseases.

Gingras was the first to establish extensive collaborations with Chinese academic and commercial biopharmaceutical organizations to speed the development and value creation in worldwide markets for China-sourced novel biopharmaceutical compounds. The company’s co-development model allows HUYA to reduce the risk, time, and cost of drug development by identifying novel compounds in clinical, pre-clinical, and discovery stages that have worldwide marketing potential. HUYA is able to accomplish this through partnerships it establishes with Chinese researchers to co-develop drug candidates to Western standards, and by accelerating global development of novel, validated product opportunities sourced from China. Gingras completed post-doctoral fellowships at Bordeaux University in France and The Scripps Research Institute in La Jolla and holds a Ph.D. from Radboud University Nijmegen in the Netherlands.

Q: What makes HUYA’s business model unique?
A: We have a real first-mover advantage. I founded HUYA five years ago, and since then we have opened six offices in Hangzhou, Beijing, Shanghai, Chengdu, Shenzhen, and Guangzhou. We are the first U.S. company to in-license pre-clinical and clinical compounds from China, and we have the largest portfolio of product opportunities sourced from Chinese researchers. With our unique business model, we work with the Chinese institutes, universities and biotech parks, including collaborations with “sea turtles.” These are Chinese nationals who got their degrees at leading Western universities, then worked at global pharmaceutical companies doing research and development, and now have returned to China to do their own research and development.

Q: How do you help advance novel Chinese compounds to the clinic?
A: We work with Chinese scientists, and once we have identified a good opportunity, we in-license the compound for the rest of the world (ex-China). In the United States, we replicate the data generated in China, expand the studies, and invest in development through to Phase I clinical trials. We then partner with global pharma to take the development programs further through Phase II. Along the way, we work closely with our Chinese partners, using their data as our roadmap, to reduce the cost, risk and time associated with drug development.

Q: What are your most advanced candidates at this point?
A: We have an oncology candidate in Phase II development in China, and we are going to start Phase I studies in the United States at the beginning of this year. We also have a cardiovascular compound about to start Phase II in China.

Q: What value do you offer to your U.S. partners?
A: We work with several global pharma companies, including Abbott and Schering-Plough. When these companies partner with us, they get access to the network that we have developed over the past five years. We have established ourselves as the go-to company for understanding the landscape of biotech and pharma in China.

Q: How does being a woman in science play in China?
A: It is very well received. There are a lot of biotech CEOs who are women in China. If you have substance and you know your science, it doesn’t matter whether you are a man or a woman.

Q: Do you speak Chinese? And how often do you go to China?
A: I am learning, and I go to China every four to six weeks. We have an exceptional team in China, and we are continually expanding. Our scouts in China have established great relationships with PIs [principal investigators]; the international language is science.

CHI-Advancing California biomedical research and innovation