Short Courses*

Monday, October 22

MORNING | 10:00 AM - 1:00 PM

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

Instructors:
Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire

Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb

AFTERNOON | 2:30 - 5:30 PM

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

Instructors: Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire

Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.

DINNER SHORT COURSES | 6:15 - 9:15 PM

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

Instructors: Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire

Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.

Wednesday, October 24

DINNER SHORT COURSES | 6:15 - 9:15 PM

SC5: Back to Basics: Optimizing Bioassay Design and Analysis - Detailed Agenda

Instructors: Sofie Pattijn, CTO, ImmunXperts

Annemie Wielant, Senior Scientist, Bioassay Development, UCB

Sylvia Janetzki, MD, President, ZellNet Consulting

SC6: Advice on Putting Together an Integrated Summary of Immunogenicity - Detailed Agenda

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

Bonnie Rup, PhD, Bonnie Rup Consulting LLC

*Separate registration is required to attend short courses.