Assay Guidance Workshop Agenda - July 2015

July 17, 2015 – 9:00 a.m. – 3:30 p.m. EST

Harvey W. Wiley Federal Building, FDA, Center for Food Safety and Applied Nutrition, Wiley Auditorium, Room 1A-003, 5100 Paint Branch Parkway, College Park, MD 20740

9:00 – 9:30 a.m.: Robust or Go Bust: An Introduction to the Assay Guidance Manual
Nathan P. Coussens, Ph.D., NCATS, NIH

9:30 – 10:10 a.m.: The Basics of High Throughput Screening in Toxicity Testing
Menghang Xia, Ph.D., NCATS, NIH

10:10 – 11:30 p.m.: Establishing Robust Biochemical and Cellular Assays
Lisa Minor, Ph.D., In Vitro Strategies, LLC

11:30 – 12:30 p.m.: Lunch on Own

12:30 – 1:10 p.m.: Designing Cell-Based Assays for Screening
Terry Riss, Ph.D., Promega Corporation

1:10 – 1:50 p.m.: Assay Interpretation: Studies in Mechanisms and Methods in Assay Interferences
Douglas Auld, Ph.D., Novartis Institutes for BioMedical Research

1:50 – 2:30 p.m.: In Vitro Assessment of ADME and PK Properties of Lead Compounds
Xin Xu, Ph.D., NCATS, NIH

2:30 – 3:10 p.m.: Assay Statistics and Data Analysis
Thomas D.Y. Chung, Ph.D., Sanford-Burnham Medical Research Institute

3:10 – 3:30 p.m.: Final Remarks and Questions

Acknowledgements: Chris Austin, Laura Carter, Nolan Chase, Adrian Choice, Janice Crum, Suzanne C. Fitzpatrick, Nicholas Gelardi, David Hanley, Sandy Ismail, Emet LaBoone, A. Renee Madden, Cindy McConnell, Anton Simeonov, Geoff Spencer, and Ashley Stewart