Assay Guidance Workshop Agenda — February 2, 2019

February 2, 2019 — 8:00 a.m.-5:00 p.m. ET

Walter E. Washington Convention Center, 801 Mount Vernon Place, NW, Washington, DC 20001

8:00 a.m.-8:20 a.m.: Robust or Go Bust: An Introduction to the Assay Guidance Manual
G. Sitta Sittampalam, Ph.D., NCATS, NIH

8:20 a.m.-9:05 a.m.: Key Concepts for Robust Biochemical & Cell-Based Assays
Timothy L. Foley, Ph.D., Pfizer Inc.

9:10 a.m.-9:55 a.m.: Treating Cells as Reagents to Design Reproducible Screening Assays
Terry Riss, Ph.D., Promega Corporation

10:00 a.m.-10:30 a.m.: Beverage Break

10:30 a.m.-11:15 a.m.: Assay Interpretation: Studies in Mechanisms and Methods in Assay Interferences
Douglas Auld, Ph.D., Novartis Institutes for BioMedical Research

11:15 a.m.-12:00 p.m.: Biophysical Approaches to Small Molecule Discovery and Validation
Michelle Arkin, Ph.D., University of California, San Francisco

12:00 p.m.-1:00 p.m.: Lunch

1:00 p.m.-1:45 p.m.: In Vitro Toxicological Testing Using a qHTS Platform
Menghang Xia, Ph.D., NCATS, NIH

1:45 p.m.-2:30 p.m.: In Vitro Assessments of ADME Properties of Lead Compounds
Xin Xu, Ph.D., NCATS, NIH

2:30 p.m.-3:00 p.m.: Beverage Break

3:00 p.m.-3:45 p.m.: Basic Assay Statistics, Data Analysis and Rules of Thumb
Thomas D.Y. Chung, Ph.D., Mayo Clinic

3:50 p.m.-4:35 p.m.: System Suitability of In Vitro Screening Assays in Drug Discovery
V. Devanarayan, Ph.D., Charles River Laboratories

4:40 p.m.-5:00 p.m.: Open Discussion