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Assay Guidance Manual eBook

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 eBook Editorial Board

AGM Program Leadership

Sarine Markossian, Editor-in-Chief and Lead

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, 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.

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Hannah Baskir, Associate Editor

Hannah Baskir is a Scientific Program Manager for the AGM Program. She serves as an Associate Editor of the AGM eBook, assisting with the editorial process, and provides support for workshops, webinars, collaborative research, and other AGM projects.

Kyle Brimacombe, Project Manager, ETB

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, 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

PHOTONAMEAFFILIATIONLOCATIONAREAS OF EXPERTISE
Michelle Arkin, Ph.D.Michelle Arkin, Ph.D.University of California, San FranciscoSan Francisco, CAprotein-protein interactions; molecular glues; high-throughput screening; fragment-based drug discovery
Douglas Auld, Ph.D.Douglas Auld, Ph.D.Novartis Institutes for Biomedical ResearchCambridge, MAhigh-throughput screening; assay development; open science
Christopher Austin, Ph.D.Christopher Austin, M.D.Vesalius Therapeutics and Flagship PioneeringCambridge, MAdrug development and commercialization; human genetics as applied to target identification; translational science
 Jonathan Baell, Ph.D.Lyterian TherapeuticsSan Francisco, CA 
Thomas D.Y. ChungThomas D.Y. Chung, Ph.D.Sanford Burnham Prebys Medical Discovery InstituteLa Jolla, CAlab automation; assay development; development & positioning of drug discovery technologies; strategic alliance management; lead discovery operations
Nathan P. Coussens, Ph.D.Nathan P. Coussens, Ph.D.Frederick National Laboratory for Cancer Research Frederick, MDassay development; high-throughput screening; molecular pharmacology; enzymology; cell-based assays; 3D cell culture models
Jayme L. DahlinJayme L. Dahlin, M.D., Ph.D.Agios PharmaceuticalsWashington, DCchemical biology; assay interferences; clinical pathology; high-throughput screening; assay development and validation
Viswanath Devanarayan, Ph.D.Viswanath Devanarayan, Ph.D.Eisai Inc., and University of Illinois ChicagoSouderton, PAmachine learning; statistics; biomarkers
Timothy L. FoleyTimothy L. Foley, Ph.D.Pfizer Inc.Groton, CTmechanistic pharmacology; enzymology; chemical biology DNA-encoded libraries; high-throughput screening
Marcie Glicksman, Ph.D.Marcie Glicksman, Ph.D.EnClear TherapiesSalem, MAcell biology; assay development; high-throughput screening; preclinical animal models; iPSC differentiation and cell therapy; devices
Kirill Gorshkov, Ph.D.Kirill Gorshkov, Ph.D.Bristol Myers SquibbLawrenceville, NJcell-based assays; high-content screening; high-throughput screening; pharmacology; assay development
Samuel Hoare, Ph.D.Samuel Hoare, Ph.D.Pharmechanics, LLCOwego, NYpharmacology; kinetics; data analysis; development & positioning of drug discovery technologies; cell-based assays
James Inglese, Ph.D.James Inglese, Ph.D.NCATS and National Human Genome Research Institute, National Institutes of Health (NIH)Rockville, MDchemical biology; molecular pharmacology; assay development; high- throughput screening
Philip W. Iversen, Ph.D.Philip W. Iversen, Ph.D.Luther CollegeDecorah, IAstatistics; assay validation; preclinical drug combination studies
 Madhu Lal‑Nag InSphero AG 
Zhuyin Li, Ph.D.Zhuyin Li, Ph.D.Bristol Myers SquibbPrinceton, NJhigh-throughput screening; phenotypic screening; high content screening; preclinical biomarker identification
Jason R. Manro, M.S.Jason R. Manro, M.S.Eli Lilly and CompanyIndianapolis, INPreclinical Statistics; In Vitro and In Vivo Assay Design, Optimization, Validation, and Analysis; Reproducibility and Quality Control; 3Rs.
James McGee, Ph.D.James McGee, Ph.D.Eli Lilly and CompanyIndianapolis, INhigh throughput mass spec
Owen McManusOwen McManus, Ph.D.Quiver BioscienceCambridge, MAion channels; drug discovery; electrophysiology; phenotypic screening
Mackenzie Pearson, Ph.D.Mackenzie Pearson, Ph.D.Eli Lilly and CompanyIndianapolis, INmass 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.Terry Riss, Ph.D.Promega CorporationFitchburg, WIcell biology; cell-based assay development; 3D culture models; high-throughput screening
Peter Saradjian, Ph.D.Peter Saradjian, J.D.Beth Israel Deaconess Medical CenterBoston, MAantibody therapeutics; small molecule high-throughput screening; robotic automation
Michael A. Tarselli, Ph.D.Michael A. Tarselli, Ph.D. M.B.A.TetraScienceBoston, MAcloud data management; external collaboration; high-throughput screening; scientific informatics; machine learning
O. Joseph Trask, Jr., B.S.O. Joseph Trask, Jr., B.S.Revvity, IncResearch Triangle Park, NCcellular assay development; basic and complex cell models (2D, 3D, 4D); high content screening; microscopy; flow cytometry; high-throughput screening
Jeffrey R. Weidner, Ph.D.Jeffrey R. Weidner, Ph.D.QualSci Consulting, LLCCarmel, INdrug 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.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.Kelli Wilson, Ph.D.NCATS, NIHRockville, MDTI/TV; advanced assay technologies; assay development and validation; reproducibility and replication concepts; drug repurposing
Menghang Xia, Ph.D.Menghang Xia, Ph.D.NCATS, NIHRockville, MDin vitro toxicology; pharmacology; assay development; high-throughput screening; high-content screening
Xin Xu, Ph.D.Xin Xu, Ph.D.NCATS, NIHRockville, MDpharmacokinetics; absorption, distribution, metabolism and excretion studies; drug discovery and development

Last updated on August 14, 2024