Learn more about the new FDA Biosimilar Guidances
at the PDA Annual Meeting!

At PDA's 2012 PDA Annual Meeting we will bring you a unique opportunity to participate in presentations, case studies and exciting discussions on manufacturing innovation, productivity in large scale sterile manufacturing, contract manufacturing, automation, and new technologies such as personalized medicine and cellular therapeutics.

Unmatched presentations:

• Three plenary sessions are scheduled for this meeting. Presentations include:

• Future Benefits for Patients: From Discovery to Commercial Products, Cellular and Gene Therapies
• The Future of Personalized Medicine – Challenges Ahead
• The Future of the Biopharmaceutical Industry
• Manufacturing Polyclonal Antibody Therapies: Process Alternatives, Costs, and Regulatory Considerations
• How FDA will apply a Risk Based Approach to Science and Quality Systems
• Emerging Regulatory Expectations
• Regulatory Approaches to Inspecting New Technologies
  

• Three concurrent tracks have been developed for this year’s conference: Innovation and Productivity in Large Scale Manufacturing, Personalized Medicine/Cellular Therapeutics and Control Strategies for Biopharmaceuticals.
• NEW: Breakfast Sessions on: Career Development Strategies and the Quality and Regulatory Job Market Outlook 2012

Unmatched Presenters:

• Steven Lynn, Office Director (acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER, FDA
• Anders Vinther, PhD, Vice President, Quality Biologics, Genentech
• David Shanahan, President, Mary Crowley Research Center and President, CEO and Founder, Gradalis
• Ted Love, MD, Executive Vice President, R&D and Technical Operations, Onyx Pharmaceuticals
• John E. Butler, PhD, Global Project Leader,
  Bayer Innovation GmbH
• Stephen Brown, PhD, Chief Technology Officer, Vivalis
• Tom Finn, CMC Reviewer, CBER, FDA
• Barbara Potts, PhD, Principal, Potts and Nelson Consulting, LLC
• Michael Wiebe, PhD, President, Quantum Consulting, LLC
• David Urdal, Chief Scientific Officer, Dendreon Corporation
• Stephan Krause, PhD, Principal Scientist/Associate Director, Medimmune
• Matt Croughan, PhD, Professor, Keck Graduate Institute of Applied Life Sciences
• Emily Shacter, PhD, Chief, Laboratory of Biochemistry, CDER, FDA

Immediately following the 2012 PDA Annual Meeting, PDA’s Training and Research Institute (PDA TRI) will be offering eight courses focusing on Biotechnology and Bioprocessing, Sterile Dosage Forms, Manual Aseptic Processes, Process Validation and Verification, and more.

Learn more about the 2012 PDA Annual Meeting
Register by March 6, 2012 and save up to $200!

Exhibition: April 16-17 | Career Fair: April 16-17
Post Conference Workshop: April 18-19 | Courses: April 19-20