Assay Guidance Workshop Agenda — September 10-11, 2018

September 10, 2018 — 7:30 a.m. - 5:00 p.m. ET

William F. Bolger Center, 9600 Newbridge Drive, Potomac, Maryland 20854

7:30 a.m.: Registration

8:00 a.m.: Robust Assays Define Success in Preclinical Research
Nathan P. Coussens, Ph.D., NCATS, NIH

8:15 a.m.: Target Validation in Physiologically Relevant Drug Discovery Models
Madhu Lal-Nag, Ph.D., NCATS, NIH

9:00 a.m.: Treating Cells as Reagents to Design Reproducible Screening Assays
Terry Riss, Ph.D., Promega Corporation

9:45 a.m.: Beverage Break

10:00 a.m.: Concepts in the Development and Validation of Robust Cell-Based and Biochemical Assays
Timothy L. Foley, Ph.D., Pfizer Inc.

10:45 a.m.: Statistical Design of Experiments for Assay Development
Steven D. Kahl, Eli Lilly and Company

11:30 a.m.: Lunch

1:00 p.m.: Introduction to Mass Spectrometry for Drug Screening and Lead Optimization
Kenneth D. Roth, Ph.D., Eli Lilly and Company

1:45 p.m.: Integration of Biophysical Techniques for the Screening of Fragment Libraries and Lead Optimization
Jose M. M. Caaveiro, Ph.D., Graduate School of Pharmaceutical Sciences, Kyushu University

2:30 p.m.: Basic Assay Statistics, Data Analysis and Rules of Thumb
Thomas D. Y. Chung, Ph.D., Sanford Burnham Prebys Medical Discovery Institute

3:15 p.m.: Beverage Break

3:30 p.m.: Reproducibility and Differentiability of Compound Potency Results from Screening Assays in Drug Discovery
Viswanath Devanarayan, Ph.D., Charles River Laboratories

4:15 p.m.: Assay Operations: Keeping Your Assays Robust and Reproducible
Jeffrey R. Weidner, Ph.D., QualSci Consulting, LLC

5:00 p.m.: Adjourn

September 11, 2018 — 7:30 a.m. - 5:30 p.m. ET

NCATS, 9800 Medical Center Drive, Rockville, Maryland 20850

7:30 a.m.: Registration

8:00 a.m.: Bioassay Interference by Aggregation and Chemical Reactivity
Jayme L. Dahlin, M.D., Ph.D., Brigham and Women’s Hospital

8:45 a.m.: In Vitro Toxicological Testing Using a qHTS Platform
Menghang Xia, Ph.D., NCATS, NIH

9:30 a.m.: In Vitro Assessments of ADME Properties of Lead Compounds
Xin Xu, Ph.D., NCATS, NIH

10:15 a.m.: Beverage Break

10:30 a.m.: Lead Selection and Optimization by Medicinal Chemistry
Samarjit Patnaik, Ph.D., NCATS, NIH

11:15 a.m.: Assay Development for High-Content Screening
O. Joseph Trask, Jr., PerkinElmer, Inc.

12:00 p.m.: Lunch

1:15 p.m.: Machine Learning in Cellular Assays: Getting Simple Answers from Complex Data
Steve Haney, Ph.D.

2:00 p.m.: Hands-On Data Analysis Sessions (Participants will need to bring Laptop Computers)

Data Analysis for High-Content Screening
Jonny Sexton, Ph.D., Michigan Institute for Clinical and Health Research
David A. Egan, Ph.D., Core Life Analytics

Tools for Assay Operations and Validation
Jeffrey R. Weidner, Ph.D., QualSci Consulting, LLC

5:30 p.m.: Depart