SHORT COURSES*

Tuesday, October 15
morning 10:00 am – 1:00 pm

SC1: Mechanism of Action and Risk Based Approach for Developing Neutralizing Antibody Assays - Detailed Agenda

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Shan Chung, PhD, Associate Director and Principal Scientist, Genentech, Inc.

Tuesday, October 15
Afternoon 2:30 – 5:30 pm

SC2: Overcoming Drug and Target Interference in ADA Assays - Detailed Agenda

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Lilia Macovei, PhD, Bioanalytical Principal Investigator, Senior Scientist, Pfizer Inc.

Tuesday, October 15
Dinner 6:30 – 9:30 pm

SC3: Validation of ADA Assays and Cut Point Calculations - Detailed Agenda

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Angela Yang, PhD, Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.

Thursday, October 17
dinner 6:15 – 9:15 pm

SC4: Advice on Putting Together an Integrated Summary of Immunogenicity - Detailed Agenda

Instructors: Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA

Bonita (Bonnie) Rup, PhD, Biopharmaceutical Consultant, Bonnie Rup Consulting, LLC

SC5: Bioassay Quality by Design - Detailed Agenda

NEW: Instructor: Daniel Harding, Principal Consultant, Bioassay Sciences

*Separate registration is required to attend short courses.