Assay Guidance Manual Program

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Sarine Markossian, Ph.D.

Rapid advances in basic research have led to innovative therapeutic approaches to address unmet medical needs. Yet, a large gap exists between basic research and the translation of those fundamental insights into therapeutics. Our AGM program is a translational science initiative that aims to help bridge this gap.

The AGM program is a world-class source of guidelines and best practices for advancing translational science and research in the preclinical development of novel therapeutics and offers training and insight for those desiring to become translational scientists. This program provides scientists with community-developed best laboratory practices in early translational research, including robust assay development, analytical technologies, data analysis tools and preclinical drug discovery standards. The program also aims to help the preclinical drug discovery workforce understand the value of robust, reproducible and replicable results.

The AGM program provides multiple resources, including the AGM eBook. This manual contains best practices in preclinical drug discovery and is free and publicly available from the National Library of Medicine; its editorial board has members from both the private and public sectors.

The program offers in-person and virtual multiday training workshops and conferences. It also hosts an AGM Preclinical Translational Science Webinar Series. This series highlights distinguished translational scientists who share case studies and information about preclinical translational science.

In addition, the AGM program participates in collaborative research initiatives focused on bottlenecks in translational sciences, such as reproducibility, assay artifacts and interferences, and establishing best practices for preclinical translation.

Learn more about this program in these publications:

1. Assay Guidance Manual: Quantitative Biology and Pharmacology in Preclinical Drug Discovery
2. The NCATS Assay Guidance Manual programme: advancing the practice and rigour of preclinical translation

• Read our updated chapter published in the Assay Guidance Manual: Phenotypic Screening with Primary and Human iPSC-derived Neurons
• Read our editorial in Drug Discovery Today In silico Drug Discovery: Bridging the Gaps in Preclinical Translation
• Watch the AGM In silico Drug Discovery Workshop in a new playlist on YouTube.
• Watch our recent webinar August 27, 2025 How Proximity-Based Drugs Are Redefining Pharmacotherapy, Raymond Deshaies Ph.D.
  View the webinar on YouTube

Browse a listing of AGM-related, peer-reviewed scientific publications that feature research supported by NCATS programs and initiatives.