Opportunities in De-risking and Advancing Biologic Development—Integrating Characterization, CMC and Clinical Program Data and Analysis
The Advanced Biologic Development Summit at Northeastern University aims to define, catalyze, and advance translational research and industry-leading standards at the intersection of analytic technologies, data analysis, and biopharmaceutical development.
The topic of the summit, scheduled for October 9, will be opportunities in de-risking and advancing biologic development—Integrating Characterization, CMC, and Clinical Program Data and Analysis.
Hear from industry leaders from organizations such as the Food and Drug Administration, Amgen, and Roche-Genentech.
October 9, 2018
and Engineering Complex (ISEC)
805 Columbus Ave.
Boston, MA 02118
September 21, 2018
Meet our Speakers and Panelists
Director, Office of Biotechnology Products, US Food and Drug Administration
Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group
Vice President, Quality Science and Technology, Amgen
Former Vice President, CMC Regulatory Affairs, Biogen and Deputy Director, Division of Monoclonal Antibodies, US Food and Drug Administration
Principal, Kathryn Stein Consulting
Former Director, Division of Monocolonal Antibodies, US Food and Drug Administration and Senior Vice President, Product Development and Regulatory Affairs, Macrogenics