Navigating the Biotech Network in India and China
9:45am – 11:00am

The panel will discuss the economic, political, and business barriers and opportunities in India and China for Bay Area life science companies to expand business operations from developing market opportunities to identifying active agents from traditional medicine to outsourcing trends in R&D, pre-clinical research in including animal testing, clinical research & manufacturing. The panel will include a discussion on the opportunities for India and China to commercialize their science and technology with Bay Area companies. With emerging development of promising technologies and quality products in India and China, they are looking for a conduit to commercialization in the US and the rest of developed world. They are also seeking to form alliances with US firms to commercialize their science (from patents to sales). This session will explore the following questions: How do we make business easier to conduct on both sides of the conduit? What actions does the Bay Area need to take to make doing business here easier? What is the market reality in India and China? How do multinational and domestic companies compete in India and China? What are the labor issues US companies will face in India and China? How do multinational companies overcome the operational hurdle? What are the lessons learned from other industries?

Panel Moderator:

Glenn Snyder
Principal, Deloitte Consulting LLP

Panel Speakers:

Ken Fong
Chairman, Kenson Ventures, LLC

Sri Mosur
Chief Executive Officer, Jubilant Discovery Services

Nandini Tandon
Venture Partner, MDS Capital

Jonathan Wang, Ph.D., MBA
General Manager, Greater China, Burrill & Co.

Dong Wei, Ph.D., MBA
Senior Manager, Program Management, BioMarin Pharmaceutical, Inc.

Market Access: a Practical Approach Conducting Clinical Research Abroad
11:15am – 12:30pm

This session will provide practical guidance on conducting and managing multi-site clinical trials abroad, including navigating national regulations. Panelists will discuss major issues and opportunities. Executives from several local companies will share their experiences of conducting clinical trials abroad, including initial approach to market. The moderator will touch upon resources available to aid companies in assessing the foreign markets.

Panel Moderator:

Michael R. Schuppenhauer
Senior Vice President, CoActive PR

Panel Speakers:

Graeme Currie, Ph.D.
Senior Director, Clinical Operations, PDL BioPharma

Jan Murray, Esq.
Partner, Squire, Sanders & Dempsey, L.L.P.

Maggie Neptune
Senior Director, Clinical Operations, ARYx Therapeutics

Jhansi Reddy
Chief Executive Officer, Maya Clinicals

Japan/East Asia: Partners & Partnering Isn't What it Used to Be
2:00pm – 3:15pm

Japan continues to be the 2nd largest healthcare and pharmaceuticals country market in the world. Those over 65 are climbing to nearly 20% and soon projected to be 30% of Japan’s 127 million population. Japan’s top 10 largest domestic drug manufacturers went through several major mergers in just the past year. Sankyo and Daiichi have merged; Yamanouchi and Fujisawa are now Astellas; Sumitomo and Dainippon have become one. A panel of experts will explore partnering paradigms of the 1990s and present a comprehensive picture of the current trends: what are the most common but incorrect strategic alliance planning assumptions by US biotech companies; strategic options for partnering in Japan; how to get Japanese NDA if your drug is now in the US Preclinical or Clinical stage; what are the options for Bridging Studies in Japan; what alliances and equity investments are Japanese Rx companies seeking; what are the reasons for the Japanese NCEs to seek a USA licensee; and more.

Panel Moderator:

Ted Tetsudo Tanaka
Japan Partnering Consultant, Tanaka International

Panel Speakers:

William Hodder
Vice President, Business Development, FibroGen, Inc.

Keiko Oishi
Senior Managing Director, International Business Development, CMIC Co., Ltd. (Japan's #1 CRO)

Dr. Fumio Suzuki
President, Kyowa America Inc., New York, subsidiary of Kyowa Hakko Kogyo Co., Ltd., Tokyo, Japan

Global Pandemic Threats: Balancing Risks and Rewards Among Vaccine Manufacturers, Governments and the General Public
3:30pm – 4:45pm

The number of manufacturers producing vaccines for the US market is waning. In 1967 there were 26 companies producing vaccines. Today only five companies remain in this market and of those, only three produce flu vaccines. As the number of vaccine manufacturers dwindles and the global health risks from avian flu increase, it becomes critical for all sectors to collaborate on solutions--short term and long term. While the US Government has appropriated $7 billion to address the threat of an avian flu pandemic, government efforts alone will not address this potential threat. In light of the limited private sector activity in this area, a delicate risk/reward balance must be achieved to bring preventive vaccines to market. What are the factors affecting the creation of new avian flu vaccines, and how can they be optimized to promote public health? An effective program to combat this threat includes three components: treatment of infected populations, containment of outbreaks, and most importantly, prevention. This presentation addresses these issues and provides recommendations as to how vaccine manufacturers, governments, and other public and private sector entities can work together to minimize the risk posed by avian flu and other infectious agents.

Panel Moderator:

Michael Shuster
Partner, Fenwick & West LLP

Panel Speakers:

John Donnelley
Senior Director Vaccine Research, Novartis Vaccines

Susan Fernyak, MD
Community Health Epidemiology and Disease Control
City of San Francisco, Department of Public Health

Lance Gordon
Chief Executive Officer, VaxGen

George Kemble
Vice President, R & D, Vaccines, MedImmune

J. Leighton Read, MD
General Partner, Alloy Ventures