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-6:00pm

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

RSVP DEADLINE
September 7, 2018

 

Meet our Speakers and Panelists

Steve Kozlowski

Steve Kozlowski

Keynote Speaker

Director, Office of Biotechnology Products, FDA

Wassim Nashabeh

Wassim Nashabeh

Keynote Speaker

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

Katy Stein

Katy Stein

Panelist

Principal, Kathryn Stein Consulting; formerly Director of the Division of Monocolonal Antibodies FDA and SVP Product Development and Regulatory Affairs, Macrogenics

Patrick Swann

Pamela M. Klein, M.D.

Panelist

Principal of PMK BioResearch; former CMO of Intellikine (acquired by Millennium/Takeda) and Vice President of Development at Genentech

Patrick Swann

Patrick Swann

Panelist

Vice President, Quality Science and Technology, Amgen