Assay Guidance Workshop Agenda - April 2016

Tuesday, April 5, 2016 – 8:30 a.m. – 5:30 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

8:30 – 8:50 a.m.: Robust or Go Bust: An Introduction to the Assay Guidance Manual
Nathan P. Coussens, Ph.D., NCATS, NIH

9:00 – 9:50 a.m.: Treating Cells as Reagents to Design Reproducible Screening Assays
Terry Riss, Ph.D., Promega Corporation

10:00 – 10:50 a.m.: Use of 3D InSight™ Human Liver Microtissues as a Tool for Prediction of Drug-induced Liver Injury
Ivy Mead, MSc., InSphero Inc.

11:00 – 11:50 a.m.: Identifying and Mitigating Assay Artifacts Arising from Chemical Library Screening
James Inglese, Ph.D., NCATS, NIH

12:00 – 1:00 p.m.: Lunch

1:00 – 1:50 p.m.: Basic Assay Statistics, Data Analysis and Rules of Thumb
Thomas D.Y. Chung, Ph.D., Mayo Clinic

2:00 – 2:50 p.m.: Reproducibility and Differentiability of Compound Potency Results from Screening Assays in Drug Discovery
V. Devanarayan, Ph.D., AbbVie Inc.

3:00 – 3:50 p.m.: Assay Operations: Keeping your Assays Robust and Reproducible
Jeffrey R. Weidner, Ph.D., AbbVie Inc.

4:00 – 5:30 p.m.: Special Topics Sessions

  1. Cell Based Assays
  2. Assay Artifacts and Statistics

Wednesday, April 6, 2016 – 9:00 a.m. – 4:00 p.m. EST

9:00 – 9:50 a.m.: Application of Quantitative High Throughput Screening for In Vitro Toxicological Testing
Menghang Xia, Ph.D., NCATS, NIH

10:00 – 10:50 a.m.: In Vitro Assessment of ADME Properties of Lead Compounds
Xin Xu, Ph.D., NCATS, NIH

11:00 – 12:30 p.m.: Establishing Robust Biochemical and Cellular Assays
Lisa Minor, Ph.D., In Vitro Strategies, LLC

12:30 – 1:30 p.m.: Lunch

1:30 – 2:30 p.m.: Special Topics Sessions

  1. Biochemical Assays
  2. Absorption, distribution, metabolism, and excretion (ADME) Assessment and Toxicity Assays

2:45 – 4:00 p.m.: Special Topics Sessions

  1. Special topics on data evaluations (DoE for assay development, multivariate assay correlations, etc.)
  2. Assay Operations and Automation

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