Event Highlights
FDA Speakers You Can Meet by Attending
October 25 - 27, 2017
Top 10 Analytical Inadequacies in IND or BLA Submissions
Alfred Del Grosso, Ph.D., Team Leader, Analytical Chemistry, FDA/CBER/OCBQ/DBSQC, U.S. FDA
Regulatory Considerations on the Expedited Review Programs
Cara R. Fiore, Ph.D., Microbiologist, Master Reviewer, Division of Vaccines and Related Products Application, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. FDA
Characterization of Fc-Fusion Protein Interactions with the Repertoire of Human Fc Receptors
Daniel Lagasse, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
Pre-Conference Workshops
Wednesday, October 25, 2017, 9:00am-5:00pm
Workshop 1
An Introduction to Bioassay Development
Workshop 2
Mass Spectrometry and Other Analytical Technologies to Enable Protein Characterization
Well-Characterized Biologics
Thursday-Friday, October 26-27, 2017
Top 10 Analytical Inadequacies in IND or BLA Submissions
Alfred Del Grosso, Ph.D., Team Leader, Analytical Chemistry, FDA/CBER/OCBQ/DBSQC, U.S. FDA
Regulatory Considerations on the Expedited Review Programs
Cara R. Fiore, Ph.D., Microbiologist, Master Reviewer, Division of Vaccines and Related Products Application, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. FDA
Characterization of Fc-Fusion Protein Interactions with the Repertoire of Human Fc Receptors
Daniel Lagasse, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
Physical or Functional? Which is the Most Important Analytical Characteristic of a Biotech or Biosimilar Product?
Nadine M. Ritter, Ph.D., Global Biotech Experts, LLC
New Techniques for Characterization of Glycoprotein (Antibody) Drug Products
Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia
Considerations for In-Use Stability Studies for Monoclonal Antibody Therapeutics
Suzanne Hudak, M.S., Scientist, Formulation Sciences, Medimmune
Strategies to Evaluate the Structure of Vaccines Absorbed to Adjuvants
Carol Shultz, Ph.D., Associate Director, Analytical Standard Harmonization Team Lead, Merck & Co., Inc.
Host Residual DNA Testing: New Paradigms and New Techniques
Musaddeq Hussain, Ph.D., Principal Scientist, Merck & Co., Inc.
Biosimilars: Update on FDA Scientific and Regulatory Expectations for Characterization and Approval
Emily Shacter, Ph.D., Independent Consultant, ThinkFDA, LLC
A Novel System for Improved Quantification of the ADCC Activity of Biosimilars and Innovator Products
Dr. Michael Tovey, Ph.D., INSERM Director of Research, Ecole Normale Superieure de Cachan
Analytical Methods in Development: Robust Strategies for Charge Variants, Size-Exclusion Methods and other Methods
Dr. Elisabeth Krug, Principal Research Scientist, Eli Lilly and Company
Biological Assays
Thursday-Friday, October 26-27, 2017
Change or Replace? Lifecycle Management of Bioassays for Commercial Products
Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen
Quality by Design in the Bioassay Development Lab
Kenneth R. Miller, Ph.D., Senior Scientist, Bioassay Development, Department of Analytical Sciences, Medimmune
Lifecycle Management for Bioassay Development and Validation
Steven Walfish, Principal Science & Standards Liaison, United States Pharmacopeia (USP)
Accelerating Potency Bioassay Delivery by Leveraging Automation and Cellular Assay Platforms
John Lehrach, Research Scientist, Bristol-Myers Squibb
Physical or Functional? Which is the Most Important Analytical Characteristic of a Biotech or Biosimilar Product?
Nadine M. Ritter, Ph.D., Global Biotech Experts, LLC
A Road Map for Addressing Changes on a Validated Reporter Gene Bioassay
Xin Li, Scientist II, Global Technical Operations, AstraZeneca
Use of DoE Approaches for Potency Assay Development
Xuan Gao, Ph.D., Scientist, Analytical Development and Quality Control– Biological Technologies, Genentech
Development of a Murine Reporter Cell Line System to Support Potency Assays Targeting Immuno-Modulatory Receptors
Ray Zhang, Ph.D., Associate Principle Scientist, Merck
Strategies for Bridging Late Phase Cell-Based Potency Assays
Amy Teale, Ph.D., Senior Analytical Scientist, Regeneron Pharmaceuticals
MoA-reflective Bioassays for a Monoclonal Antibody Targeting a T Cell Co-Stimulatory Receptor
Ganesh Shankarling, Ph.D., Scientist, Molecular and Analytical Development, Bioassay Center of Excellence, Bristol-Myers Squibb
Functional Assays for Similarity Assessment of Biosimilars
Rajani Srikakulam, Ph.D., Principal Scientist, Bioassay Development, Oncobiologics
September 23-26, 2024,
Hynes Convention Center in Boston, USA