Thursday, February 25, 2010

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

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Thursday, February 18, 2010

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

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Tuesday, February 9, 2010

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