In many cases today drug components are manufactured
overseas, and increasingly critical elements of basic
research and development are also moving offshore.
This BioE2E panel will explore what it takes to
successfully run operations in other countries.
Thought will be given during the discussion to related
challenges and opportunities for the early stage
entrepreneur. Specifics will include: What can be sent
overseas? How should projects be organized for
success?. What areas of the world offer value and what
are the real costs? Each of the panelists has
real-world experience securing partners and
implementing successful projects overseas.
Networking session will follow.
Presenters:
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Kent Iverson,
Independent Consultant,
Biopharmaceutical Manufacturing and Development
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Kent Iverson has over 19 years experience in the manufacturing and
development of biopharmaceutical products. After completing a
Bachelor's degree in Fermentation Science at UC Davis, Kent began
his career in biotechnology with Genentech. Kent worked within the
manufacturing function and participated in Genentech's first 2
product approvals (Protropin and Activase) and was involved with
the commissioning of Genentech's first large scale mammalian cell
culture facility. Kent then worked with Immunex for 9 years;
during his tenure, Immunex brought 3 biopharmaceutical facilities
into operation and had its first drug approval (Leukine). While
at Immunex, Kent was responsible for the management of a successful
contract management program, and led the team responsible for
production and supply of Enbrel.
Kent led the manufacturing and process development function at
Coulter Pharmaceutical, and after its merger with Corixa, served as
the Vice President of Process Development. Kent was a key
contributor in the development and commercialization of Bexxar,
the first and only centrally manufactured radioimmunotherapy
product. Since October of 2001, Kent has been an independent
biopharmaceutical manufacturing and development consultant serving
clients based in North America, the Asia/Pacific region and Europe.
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Dinesh V. Patel,
Founder, President and Chief Operating Officer,
Miikana Therapeutics
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Dinesh V. Patel has 18 years of experience in the pharmaceutical, biotech and biopharmaceutical industry. Dr. Patel was most recently Senior VP of drug discovery and licensing at Versicor (re-named Vicuron). He was part of the senior management team that incubated Versicor on the US West Coast in 1996 as a spin-off from Sepracor. At Versicor, he led their internal and collaborative research programs (Pharmacia, Novartis) and actively participated in various financing activities of the Company including its IPO, raising over $125 million. Over the years, he assumed increasing responsibility for in- and out-licensing of technologies, research programs and clinical development candidates for the Company. Prior to joining Versicor, Dr. Patel was Director of Drug Discovery at Affymax and led the combinatorial chemistry application efforts aimed at changing the drug discovery paradigm. He also worked at Bristol-Myers Squibb for eight years in various positions including group leader.
Dr. Patel has a proven track record of incubating and leading projects from Targets to INDs. He has successfully managed internal and collaborative research that has led to INDs entering clinical development. Dr. Patel has more than 75 patents and publications to his credit. He received his Ph.D. in organic chemistry from Rutgers, The State University of New Jersey and conducted post-doctoral research at the University of Wisconsin, Madison.
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Victor Shi, Ph.D.,
Founder and Managing Director
Discovery Resources Group
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Dr. Victor Shi is Managing Director of Discovery Resources Group, a
strategic consulting firm he founded to provide services to life science
companies leveraging R&D infrastructure and skill base in Asia. Most
recently he helped SRI International to spin off Bridge Pharmaceuticals to
conduct drug development services in Asia. He was formerly Vice President
of Corporate Development at GenoSpectra, a biochip company in Fremont. He
is also an associate to A. M. Pappas & Associates, a life science venture
capital fund where he previously directed the firm's Asia investment and
consulting business. During his tenure as a management consultant, he
worked on behalf of Quintiles Transnational, Johnson & Johnson, Pharmacia &
Upjohn, Keravision, BioChem Pharma, Genetronics, Chiroscience, among
others, in Asia development and market entry. He was previously a cancer
research scientist at Merck Research Labs and was a faculty member at the
National University of Singapore School of Medicine.
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