Assay Guidance Workshop —
November 18-19, 2020
This two-day virtual workshop hosted by NCATS Assay Guidance Manual (AGM) covered a broad range of critical concepts underlying assay development and implementation for high-throughput screening and lead discovery projects. This workshop was designed to disseminate best practices for the development and implementation of robust assay methods. It is particularly relevant for researchers developing molecular probes or clinical candidates. Many of the workshop instructors have 20 to 30 years of experience in the field of drug discovery and share information not readily found in a classroom or published material outside of the AGM. This workshop also covered emerging technologies and modalities in drug discovery, including the use of stem cells, antibody therapeutics, DNA-encoded libraries, and advances in COVID-19 therapeutics.
Goals and Objectives
The goal of the AGM workshop series is to help participants design and implement robust assays in early translation research by providing them a broad, practical perspective on assay development and data analysis. Our aim is to help participants improve their research projects involving drug discovery and know where to find further information; identify reagents, methods and instrumentation that are well suited to robust assays; and develop robust assays and the required counter and secondary assays for targets of interest. The workshops also provide participants with broad overviews and practical perspectives on new and emerging modalities in drug discovery.
View the agenda (PDF - 267KB)
Spotlight Video
Welcome to the AGM Workshop
Christopher P. Austin, M.D.
Director
National Center for Advancing Translational Sciences (NCATS)
In his welcome address, Dr. Austin introduces the audience to NCATS, its mission to conduct and disseminate translational science, and to the Assay Guidance Manual (AGM). Dr. Austin also highlights the upcoming events on the AGM calendar.
Day 1
Watch all of the workshop videos from Day 1.
Robust or Go Bust: An Introduction to the Assay Guidance Manual
Sarine Markossian, Ph.D.
Editor-in-Chief, Assay Guidance Manual (AGM); Lead, AGM Translational Science Resources Program
National Center for Advancing Translational Sciences (NCATS)
Dr. Markossian introduces the audience to assays and their importance in the drug discovery pipeline, and to the Assay Guidance Manual (AGM) program including the e-book and the workshops. Dr. Markossian also highlights the objectives and goals of the workshop.
Target Qualification Strategies: Functional Genomics for Target ID and Validation
Yueming Wang Ph.D.
Principal Scientist, Primary Pharmacology Group, Medicine Design
Pfizer Inc.
Dr. Wang discusses the importance of improving the quality of target selection and details strategies to achieve that goal. He also takes a deep dive into the importance of functional genomics for target ID and validation.
Strategies for Assay Selection and for the Development of Robust Biochemical Assays
Nathan P. Coussens, Ph.D.
Director, Molecular Pharmacology Laboratories
Frederick National Laboratory for Cancer Research
Dr. Coussens discusses strategies for choosing the right assay for HTS. Dr. Coussens also expands on biochemical assays for enzymes and for molecular interactions.
Treating Cells as Reagents to Design Reproducible Assays
Terry Riss, Ph.D.
Senior Product Manager, Cell Health
Promega Corporation
Dr. Riss provides strategies to help design reproducible cell-based assays. He also addresses the major causes of variability in cell-based assays and provides avenues for establishing SOPs for consistent handling of cells.
Day 2
Watch all of the workshop videos from Day 2.
Basic Assay Statistics, Data Analysis & Rules of Thumb (ROT)
Thomas “TC” D.Y. Chung, Ph.D.
Director, Translational Outreach Programs
Sanford Burnham Prebys Medical Discovery Institute
Dr. Chung introduces basic statistical concepts for proper HTS data analysis and validation. Dr. Chung then describes the Z-factor (Z’) as a simple parameter that summarizes an assay’s robustness.
Reproducibility Assessment of In Vitro Screening Results
Viswanath Devanarayan, Ph.D., FAAPS
Senior Statistics Director
GlaxoSmithKline
Dr. Devanarayan introduces minimum significant ratio (MSR) as a metric for evaluating the reproducibility of potency results from dose-response screening assays. He then discusses how MSR is calculated and describes different ways of estimating MSR.
Assay Operations: Keeping your Assays Robust and Reproducible
Jeffrey R. Weidner, Ph.D.
Founder
QualSci Consulting, LLC
Dr. Weidner introduces and defines key statistical concepts for assay robustness and reproducibility. He then introduces the audience to Statistical Process Control (SPC) which applies statistical methods to optimize reproducibility, reliability, and quality.
Kinetics of Target Binding: Impact on Drug Activity from Bench to Bedside
Sam Hoare, Ph.D.
Founder
Pharmechanics, LLC
Dr. Hoare introduces basic concepts and principles in binding kinetics and its impact on drug measurements. Dr. Hoare then describes methodologies for measuring binding kinetics and highlights when to apply kinetics in drug discovery.