Process Scale-Up for Pharmaceutical and Biologics Development January 30, 2007

Process Scale-Up for Pharmaceutical and Biologics Development January 30, 2007
Philadelphia, PA
Benefits of Attending
Why should I attend?
Process Scale-up for Pharmaceutical and Biologics Development will focus on the challenges treading the interface between development and market. The program will present a diversity of perspectives and lessons learned from companies? experiences bringing new treatments from clinical R&D to commercialization, emphasizing the developmental, technical and regulatory challenges in the scale-up process. Attendees will gain an invaluable wealth of comparative insight on bridging R&D with full compliance in a manufacturing environment.
Who will I meet and who is speaking?
Dr. William J. Kelly, Department of Chemical Engineering, Villanova University
Bikash Chatterjee, President, Pharmatech Associates, Inc.
Maureen A. Costello, Ph.D., Principal and Founder, Seraphim Life Sciences, LLC
Melanie Miller, Ph.D., Executive Director, Process R&D, Bristol-Myers Squibb Co.
Nita U. Patel, Ph.D., Vice President of Regulatory Affairs, GenVac, Inc.
Euqene B. Johnston, Ph.D., VP of Quality Assurance and Regulatory Affairs, Biolex, Inc.
Ruhi Ahmed, Ph.D., Senior Manager, Regulatory Affairs, BioMarin Pharmaceuticals
Kevin Koski, Senior Process Development Engineer, Talecris Biotherapeutics
Charlie Sodano, Ph.D., Manager, Information Services, Berlex Biosciences/Schering AG
Jill Mastromonica, Manager, QC Laboratory Systems, ImClone Systems Inc.
Suketu Desai, Ph.D., Principal Scientist, Worldwide Technical Operations, Johnson & Johnson, Global Biologics Supply Chain LLC
Top Five Reasons to Attend this Dynamic Event...
Implement fast, efficient and cost effective technology transfer from bench scale to commercial scale
Negotiate FDA requirements for clinical testing and GMP compliance
Improve data generation and transfer throughout development to demonstrate comparability in scale-up and keep a well documented development history
Apply risk based quality systems in scale up to maintain process flexibility in GLP development
Develop a wealth of comparative insight for seamless transition from development to commercialization

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