Selecting and Managing a CRO
Date: December 6th, 2007
Time: 8:00 a.m. - 9:00 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Robert Ternansky, Ph.D., former Senior VP of Chemistry at Attenuon, LLC
Presentation Summary
Outsourcing is increasingly becoming a key business strategy for the biotech and pharmaceutical industry. A recent survey by Frost and Frost and Sullivan found that 85% of companies will outsource at least 20% of their operations by 2008. The decision to outsource drug development activities is an important decision that requires intense planning and scrutiny of potential outsourcing partners. Dr. Ternansky will provide insight into the process of outsourcing drug development work to a CRO. He will discuss why and when a company should outsource, criteria for selecting a CRO, and aspects of managing the relationship and science once a project is outsourced. Dr. Ternansky will share his seven plus years of experience managing drug development outsourcing relationships through real world examples and case studies.
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About the Speaker
Robert Ternansky, Ph.D. was most recently Senior Vice President of Chemistry at Attenuon, LLC, where he was responsible for drug product development, outsourcing, manufacturing, and all related CMC regulatory activities. He was previously the Director of Medicinal Chemistry at IDUN Pharmaceuticals, Inc. (acquired by Pfizer in 2005), where he co-invented a series of caspase inhibitors for the prevention of apoptotic cell death. Prior to his work at IDUN, Dr. Ternansky held the position of Associate Director of Inflammation at La Jolla Pharmaceuticals, Inc., where he led the analytical team on the pre-clinical development of LJP-394, which is currently in Phase III trials. Prior to joining La Jolla Pharmaceuticals, Dr. Ternansky was a Research Scientist and Team Leader at Eli Lilly and Co., where he invented LY193239, the first pyrazolidinone antibacterial agent to be developed for clinical investigation. He was also a member of the pre-clinical discovery/development team for loracarbef (Lorabid), the first marketed 1-carbacephalosporin antibacterial agent. Dr. Ternansky also invented trovirdine, a NNRT inhibitor of HIV-1 RT, which is currently in Phase II trials for the treatment of HIV infection. He is currently a lecturer in the Chemistry and Biochemistry Department at the University of California, San Diego, and has recently been named Adjunct Professor at the Center for Combinatorial Chemistry, Jilin University in Changchun, China. He also serves on the Scientific Advisory Board of American Life Science Pharmaceuticals, Inc.
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