WESTBOROUGH, Mass., March 30 /PRNewswire/ -- IBC's Inaugural Early Development of Biotherapeutics event to be held April 26-28, 2004 at the Sheraton San Diego Hotel & Marina in San Diego, CA will feature Chris Joneckis, Ph.D., Senior Advisor for Chemistry Manufacturing and Control Issues, Office of the Director, CBER, FDA presenting on the FDA's Perspective for Comparability. This event, having an unrivaled list of featured presenters, focuses on successful approaches for managing immunogenicity and comparability, interpreting regulations and guidances, and implementing process changes.
Anthony R. Mire-Sluis, Ph.D., Principal Advisor for Regulatory Science and Review, CDER, US FDA will give an Update on Regulatory and Industry Perspectives on the Design and Optimization of Immunogenicity Assays. This will be part of a day of programming on Biological Assays & Development. Early Development of Biotherapeutics attendees and Biological Assay Development & Validation attendees will share a day of sessions which will feature 5 case studies, a luncheon, and a cocktail reception, creating a rare opportunity to share perspectives and strategies with hundreds of leaders in the industry.
Other highlights will include; Case studies on Recombinant Factor VIII, ENBREL(R) and Avastin; ICH guidelines for product quality, stability, methods validation, and cell line characterization; Novel approaches to cell line development; Impact of reversible protein self association on manufacturing, formulation and delivery of protein pharmaceuticals; and Strategies and opportunities for fast tracking and accelerated approval.
Attendees will walk away with the ability to accelerate the development of their recombinant therapeutic protein program by understanding the current industry and regulatory approaches to preclinical, clinical and product development of biotherapeutics.
Scientific Advisory Committee:
-- Jeanne M. Novak, Ph.D., Principal Consultant, CBR International Corp.
-- Fred G. Bader, Ph.D., Vice President, Process Sciences, Centocor
-- John F. Carpenter, Ph.D., Co-Director, Center for Pharmaceutical
Biotechnology, University of Colorado Health Sciences Center
-- Eric Wakshull, Ph.D., Principal Scientist, Biogen Idec Inc.
ATTENTION CALENDAR EDITORS! For more information on attending Early Development of Biotherapeutics at the Sheraton San Diego Hotel & Marina - West Tower, in San Diego, CA visit http://www.lifesciencesinfo.com/3071
CONTACT: Kerry Patterson