The AGM eBook is available on the NCBI Bookshelf.

The Assay Guidance Manual (AGM) eBook is a free, best-practices online resource devoted to the successful development of robust, early-stage drug discovery assays.

The manual was adapted from documents developed by the drug discovery industry (Eli Lilly and Company and Sphinx Pharmaceuticals, Inc.) that were designed to collect institutional knowledge and provide step-by-step guidance on planning and creating projects for high-throughput screening, lead optimization, and early phases of regulated drug development. The AGM has now been expanded into a unique, user-friendly collection of over 50 chapters of well-tested knowledge, much of which is being documented for the first time. Methods outlined in the manual address appropriate statistical ways to analyze assay results and accommodate minor changes to assay protocols to ensure robustness.

Investigators worldwide can use the manual to design biologically and pharmacologically relevant assays for high-throughput screening and lead optimization to evaluate collections of molecules that modulate the activity of biological targets, pathways and cellular phenotypes.

Our staff manage the content of the manual with input from industry, academic, and government experts. The editorial board consists of members from across the preclinical translational science spectrum. More than 100 authors from around the world have contributed content to this free resource, which is updated regularly and housed by the National Library of Medicine. The AGM has proven to be a widely used resource for those working in drug discovery. Since 2017, it has received more than 30,000 monthly views by scientists from both public and private sectors from over 130 countries.

AGM Program Leadership

Sarine Markossian, Editor-in-Chief and Lead

Sarine Markossian is the lead of the Assay Guidance Manual (AGM) Translational Science Resources Program at NCATS. In this role, she serves as the editor-in-chief of the eBook, and manages the program’s training workshops. Markossian also leads and collaborates on research projects focused on eliminating bottlenecks in preclinical translational science and establishing best practices for preclinical research.

Abigail Grossman, Managing Editor

Abigail Grossman is the managing editor of the AGM and manages the logistics for AGM events. She has a dual role as a project lead in NCATS’ Information Technology Resources Branch.

Kyle Brimacombe, Project Manager, ETB

Kyle Brimacombe is a scientific program manager in the Early Translation Branch (ETB) at NCATS. He serves as an associate editor for the AGM eBook, providing graphic design support, editorial assistance and administrative guidance.

Matthew D. Hall, Scientific Director, NCATS

 

Matthew D. Hall, Ph.D., is the scientific director of NCATS and a senior scientist in the Early Translation Branch (ETB) within the center’s Division of Preclinical Innovation. In his role as the scientific director, he leads the center’s intramural research and related initiatives.

Associate Editors

PHOTO	NAME	AFFILIATION	LOCATION	AREAS OF EXPERTISE
	Michelle Arkin, Ph.D.	University of California, San Francisco	San Francisco, CA	protein-protein interactions; molecular glues; high-throughput screening; fragment-based drug discovery
	Douglas Auld, Ph.D.	Novartis Institutes for Biomedical Research	Cambridge, MA	high-throughput screening; assay development; open science
	Christopher Austin, M.D.	Vesalius Therapeutics and Flagship Pioneering	Cambridge, MA	drug development and commercialization; human genetics as applied to target identification; translational science
	Jonathan Baell, Ph.D.	Lyterian Therapeutics	San Francisco, CA
	Thomas D.Y. Chung, Ph.D.	Sanford Burnham Prebys Medical Discovery Institute	La Jolla, CA	lab automation; assay development; development & positioning of drug discovery technologies; strategic alliance management; lead discovery operations
	Nathan P. Coussens, Ph.D.	Frederick National Laboratory for Cancer Research	Frederick, MD	assay development; high-throughput screening; molecular pharmacology; enzymology; cell-based assays; 3D cell culture models
	Jayme L. Dahlin, M.D., Ph.D.	Agios Pharmaceuticals	Washington, DC	chemical biology; assay interferences; clinical pathology; high-throughput screening; assay development and validation
	Viswanath Devanarayan, Ph.D.	Eisai Inc., and University of Illinois Chicago	Souderton, PA	machine learning; statistics; biomarkers
	Timothy L. Foley, Ph.D.	Pfizer Inc.	Groton, CT	mechanistic pharmacology; enzymology; chemical biology DNA-encoded libraries; high-throughput screening
	Marcie Glicksman, Ph.D.	EnClear Therapies	Salem, MA	cell biology; assay development; high-throughput screening; preclinical animal models; iPSC differentiation and cell therapy; devices
	Kirill Gorshkov, Ph.D.	Bristol Myers Squibb	Lawrenceville, NJ	cell-based assays; high-content screening; high-throughput screening; pharmacology; assay development
	Samuel Hoare, Ph.D.	Pharmechanics, LLC	Owego, NY	pharmacology; kinetics; data analysis; development & positioning of drug discovery technologies; cell-based assays
	James Inglese, Ph.D.	NCATS and National Human Genome Research Institute, National Institutes of Health (NIH)	Rockville, MD	chemical biology; molecular pharmacology; assay development; high- throughput screening
	Philip W. Iversen, Ph.D.	Luther College	Decorah, IA	statistics; assay validation; preclinical drug combination studies
	Madhu Lal‑Nag		InSphero AG
	Zhuyin Li, Ph.D.	Bristol Myers Squibb	Princeton, NJ	high-throughput screening; phenotypic screening; high content screening; preclinical biomarker identification
	Jason R. Manro, M.S.	Eli Lilly and Company	Indianapolis, IN	Preclinical Statistics; In Vitro and In Vivo Assay Design, Optimization, Validation, and Analysis; Reproducibility and Quality Control; 3Rs.
	James McGee, Ph.D.	Eli Lilly and Company	Indianapolis, IN	high throughput mass spec
	Owen McManus, Ph.D.	Quiver Bioscience	Cambridge, MA	ion channels; drug discovery; electrophysiology; phenotypic screening
	Mackenzie Pearson, Ph.D.	Eli Lilly and Company	Indianapolis, IN	mass spectrometry based high-throughput screening techniques; lipidomic analysis via LC-MS/MS; small molecule and metabolite LC-MS/MS and GC-TOF analysis
	Terry Riss, Ph.D.	Promega Corporation	Fitchburg, WI	cell biology; cell-based assay development; 3D culture models; high-throughput screening
	Peter Saradjian, J.D.	Beth Israel Deaconess Medical Center	Boston, MA	antibody therapeutics; small molecule high-throughput screening; robotic automation
	G. Sitta Sittampalam, Ph.D.	NCATS, NIH	Rockville, MD	drug target identification/validation (TI/TV); advanced assay technologies; assay development and validation; reproducibility and replication concepts; drug repurposing
	Michael A. Tarselli, Ph.D. M.B.A.	TetraScience	Boston, MA	cloud data management; external collaboration; high-throughput screening; scientific informatics; machine learning
	O. Joseph Trask, Jr., B.S.	Revvity, Inc	Research Triangle Park, NC	cellular assay development; basic and complex cell models (2D, 3D, 4D); high content screening; microscopy; flow cytometry; high-throughput screening
	Jeffrey R. Weidner, Ph.D.	QualSci Consulting, LLC	Carmel, IN	drug discovery; SAR; high throughput screening; bench and integrated in vitro assay automation; in vitro informatics; assay development; ezzymology; assay validation and quality control; process improvement; data science; Six Sigma Blackbelt
	Mary Jo Wildey, Ph.D.	Merck & Co., Inc.	Kenilworth, NJ,	high-throughput screening; bench and integrated in vitro assay automation; in vitro informatics
	Kelli Wilson, Ph.D.	NCATS, NIH	Rockville, MD	TI/TV; advanced assay technologies; assay development and validation; reproducibility and replication concepts; drug repurposing
	Menghang Xia, Ph.D.	NCATS, NIH	Rockville, MD	in vitro toxicology; pharmacology; assay development; high-throughput screening; high-content screening
	Xin Xu, Ph.D.	NCATS, NIH	Rockville, MD	pharmacokinetics; absorption, distribution, metabolism and excretion studies; drug discovery and development