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October 25-28, 2021
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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