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Dr. Bhasker V. Shetty

Vice

President,

Pharmacokinetics,

Dynamics and Metabolism group, Pfizer Worldwide Research and

Development, La Jolla Laboratories, California, USA

Bhasker V. Shetty, Ph.D., is Vice President, Pharmacokinetics, Dynamics & Metabolism, Pfizer Research & Development, La Jolla Labs. Dr. Shetty has more than 20 years of experience in the field of pharmaceutical research and development. He began his career in pharmacology and drug metabolism with Agouron Pharmaceuticals, Inc. in 1990. Over the last 20 years Dr. Shetty has been involved in the discovery and development of treatments for cancer, HIV, hepatitis C, diabetes and eye diseases. In 2001 Dr. Shetty was appointed Head of Pharmacokinetic, Dynamics and Metabolism group in Pfizer's La Jolla Laboratories, California. Dr. Bhasker is member of the Pfizer La Jolla Leadership team and serves on a number of leadership and governance committees in Pfizer. He is active in the San Diego Science community. He was the founding member and President of the Southern California Pharmaceutical Discussion Group. He actively collaborates with local universities like UCSD School of Pharmacy and Cal State San Marcos in developing scientific forums and curriculum support. Dr. Shetty received his Bachelor of Pharmacy degree from the College of Pharmaceutical Sciences, Manipal, India and his Ph.D. in pharmaceutical sciences from the University of Missouri, Kansas City. After graduation, he completed a post-doctoral fellowship in the pharmaceutical chemistry department at the University of Kansas. Application of Pharmacokinetics, Pharmacodynamics and Drug Metabolism

Knowledge during Drug Discovery and Development The objective of this presentation is to provide examples of how pharmacokinetic, pharmacodynamic and drug metabolism knowledge derived in discovery and development phases of R&D can impact overall productivity of the pharmaceutical industry.

62nd Indian Pharmaceutical Congress 2010 | Manipal 17-19 December 2010 | Speaker Profile

One of the major challenges facing the pharmaceutical industry is the high attrition rates of NCEs (New Chemical Entity) in clinical development. A drug can fail for a number of reasons, such as poor pharmacokinetics (example: short half-life, poor absorption), safety, lack of efficacy or other commercial reasons. In the early 1990's many pharmaceutical companies invested in building pharmacokinetic/drug metabolism groups to provide information early in the discovery phase to help reduce the attrition of NCEs due to poor pharmacokinetics. In parallel the discipline of pharmacokinetics and drug metabolism

evolved to produce better in-vitro, in-silico and preclinical tools tailored for different stages of R&D. The availability of appropriate resources and the right science at the right time has translated to better prediction of pharmacokinetics in humans and significant decrease in attrition rate due to poor pharmacokinetics in clinical development. While there has been a significant improvement in the rate of attrition due to pharmacokinetic reasons the attrition rate due to safety and lack of efficacy still continue to challenge the industry. To address these challenges many companies are starting to develop systems biology level modeling that integrate pharmacokinetic and pharmacodynamics knowledge in early discovery phase to help with selecting the right compound for clinical development. All these approaches could eventually help reduce the high attrition rates of NCEs in late stage development.

62nd Indian Pharmaceutical Congress 2010

|

Manipal 17-19 December 2010

|

Speaker Profile

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