Format

Send to

Choose Destination

Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies.

Source

Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
2012 May 1 [updated 2016 Jul 1].

Author information

1
National Center for Advancing Translational Sciences, National Institutes of Health
2
University of California, San Francisco
3
Novartis Institutes for Biomedical Research
4
Monash Institute of Pharmaceutical Sciences
5
Western Michigan University
6
Laboratory of Global Healthcare Graduate School of Pharmaceutical Sciences, Kyushu University
7
Conrad Prebys Center for Chemical Genomics, Sanford Burnham Prebys Medical Discovery Institute
8
Molecular Pharmacology Branch, Frederick National Laboratory for Cancer Research
9
Brigham and Women's Hospital
10
GlaxoSmithKline
11
Pfizer
12
Orig3n
13
Eli Lilly & Company
14
Pharmechanics, LLC
15
U.S. Food and Drug Administration
16
Bristol-Myers Squibb
17
Q-State Biosciences
18
Promega Corporation
19
Merck & Co., Inc.
20
PerkinElmer, Inc.
21
QualSci Consulting, LLC
22
ConverGene, LLC, Gaithersburg, MD
23
National Center for Advancing Translational Sciences (NCATS), National Institutes for Health (NIH), Bethesda, MD
24
Institute for Advancing Medical Innovation, University of Kansas, Lawrence, KS
25
Small Business Innovation Research, National Cancer Institute, Washington, DC
26
Beckloff Associates, Inc. Overland Park, KS
27
NIH Chemical Genomics Center, Bethesda, MD

Excerpt

Setting up drug discovery and development programs in academic, non-profit and other life science research companies requires careful planning. This chapter contains guidelines to develop therapeutic hypotheses, target and pathway validation, proof of concept criteria and generalized cost analyses at various stages of early drug discovery. Various decision points in developing a New Chemical Entity (NCE), description of the exploratory Investigational New Drug (IND) and orphan drug designation, drug repurposing and drug delivery technologies are also described and geared toward those who intend to develop new drug discovery and development programs. Note: The estimates and discussions below are modeled for an oncology drug New Molecular Entity (NME) and repurposed drugs. For other disease indications these estimates might be significantly higher or lower.

Supplemental Content

Support Center