Examining Manufacturing Readiness for Breakthrough Drug Development

Affiliations

• ¹ Technical Regulatory Policy, Genentech, a Member of the Roche Group, 1399 New York Ave, NW, Suite 450, Washington, DC, Washington, 20005, USA. [email protected].
• ² Regulatory-CMC, Bristol-Myers Squibb Company, New York, New York, USA.
• ³ Biologics Process Development & Commercialization, Merck & Co., Inc., Kenilworth, New Jersey, USA.
• ⁴ Biologics CMC Regulatory Affairs, Merck & Co., Inc., Kenilworth, New Jersey, USA.
• ⁵ Technical Research and Development, Novartis Pharmaceuticals Corporation, Hannover, New Jersey, USA.
• ⁶ Regulatory Affairs, CMC, Pharmacyclics Inc., Sunnyvale, California, USA.
• ⁷ Quality and Technical Operations, Pharmacyclics Inc., Sunnyvale, California, USA.
• ⁸ Regulatory Affairs, Amgen, Thousand Oaks, California, USA.
• ⁹ Global Chemistry Manufacturing & Controls, Pfizer Inc., New York, New York, USA.
• ¹⁰ Biosimilars and Biologics Policy, Office of Biotechnology Products, CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.
• ¹¹ Office of Pharmaceutical Quality, CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.
• ¹² CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.