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Challenges in Developing Biologics: Industry and Regulatory Expectations
Sunday, November 11
8:30 am – 4:00 pm
Short Course
ACPE #073-999-07-504-L04
The application of biotechnology to produce humanized proteins has resulted in increased interest in development of protein-based drugs in the last two decades. The products based on biotechnology including proteins and monoclonal antibodies are increasingly becoming an important part of the pharma industry portfolio. Successful commercialization of biologics present a unique set of challenges mainly due to molecular complexity, analytical difficulties, instability and regulatory expectations. The objective of this short course is to provide a comprehensive overview of the challenges encountered during development of biologics. Both industry and regulatory perspectives will be addressed. This highly interactive short course is designed to serve as a good one-stop learning tool for entry-level as well as experienced scientists. This short course is designed to meet that critical need. This meeting will be useful for industrial scientists involved in developing biologics. Both experienced as well as entry level scientists will benefit from this short course. Graduate students looking to pursue a career in biologics development will find this short course extremely useful as well.
Moderators
Manisha Dali, Ph.D.
Bristol-Myers Squibb Company
Pankaj Paranjpe, Ph.D.
Bristol-Myers Squibb Company
Sailesh A. Varia, Ph.D.
Bristol-Myers Squibb Company
Drug Substance Stability: Implications on Formulation Development
Siddharth Advant, Ph.D.
Diosynth Biotechnology
Degradation Pathways of Therapeutic Biologics
Satish Singh, Ph.D.
Pfizer, Inc.
Analytical Tools for Characterization of Macromolecules
Robert Dodge, Ph.D.
Princeton Bioanalytical Laboratory
Formulation for Protein Stabilization
Steven Shire, Ph.D.
Genentech, Inc.
Rational Specification Setting During Development of Biologics
Kirk Leister, Ph.D.
Bristol-Myers Squibb Company
Developing Specifications for Biotechnology Products: Regulatory Perspective
William Egan, Ph.D.
PharmaNet Consulting