NCATS and FDA Host Assay Guidance Workshop

Assay Guidance Manual cover

More than 100 participants attended the “Assay Guidance Workshop for High-Throughput Screening and Lead Discovery” on April 5–6, 2016, in College Park, Maryland. Hosted by NCATS and the Food and Drug Administration (FDA), the workshop was designed to provide participants with a broad and practical perspective on how to develop and implement robust assays for early-stage drug discovery projects.

Participants included researchers from NIH, FDA, National Institute of Standards and Technology, industry and academia. Workshop leaders with more than 20 years of drug discovery experience covered a broad range of critical concepts underlying robust assay development and screening strategies, including the following:

  • Practical approaches for developing robust biochemical and cell-based assays
  • in vitro assays for testing compound toxicity
  • Strategies to identify and mitigate common assay artifacts
  • The use of important statistical and data analysis concepts for improved data collection and go/no-go decision points
  • Assessment of absorption, distribution, metabolism and excretion (ADME) properties of lead molecules

There was also open discussion for participants to share experiences and seek practical advice about individual research interests.

The workshop was initiated as an extension of NCATS’ Assay Guidance Manual (AGM). Originally developed by Eli Lilly and Company, the AGM is a freely available best practices resource that provides step-by-step guidance on planning and developing projects from high-throughput screening to lead optimization and early phases of regulated drug development. With contributions from more than 100 scientists worldwide, the AGM is managed by an editorial staff of 26 experts from industry, academia, and government who update the manual on a quarterly basis.

The next workshop is scheduled for October 2016. Contact Nathan Coussens for details.