Opportunities in De-risking and Advancing Biologic Development—Integrating Characterization, CMC and Clinical Program Data and Analysis

October 9, 2018  |  Boston, MA

Overview

Northeastern University, the Barnett Institute, and Cambridge-based BioAnalytix have partnered to develop an annual summit focused on key areas in the advanced development of biologic therapeutics.

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.

DATE
October 9, 2018

TIME
2:00pm-6:30pm

LOCATION
Northeastern University
Interdisciplinary Science
and Engineering Complex (ISEC)
805 Columbus Ave.
Boston, MA 02118

RSVP DEADLINE
September 21, 2018

Meet our Speakers and Panelists

Steve Kozlowski

Steve Kozlowski, MD

Keynote Speaker

Director, Office of Biotechnology Products, US Food and Drug Administration

Wassim Nashabeh

Wassim Nashabeh, PhD

Keynote Speaker

Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group

Patrick Swann

Patrick Swann, PhD

Panelist

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

Katy Stein

Katy Stein, PhD

Panelist

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

Patrick Swann

Pamela M. Klein, MD

Panelist

Principal, PMK BioResearch
Former Chief Medical Officer, Intellikine (acquired by Millennium/Takeda) and Vice President, Development, Genentech