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Review

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

Jeffrey Strovel  1 , Sitta Sittampalam  2 , Nathan P. Coussens  2 , Michael Hughes  3 , James Inglese  2 , Andrew Kurtz  4 , Ali Andalibi  4 , Lavonne Patton  5 , Chris Austin  6 , Michael Baltezor  3 , Michael Beckloff  5 , Michael Weingarten  4 , Scott Weir  3
Sarine Markossian  1 , Abigail Grossman  1 , Hannah Baskir  1 , Michelle Arkin  2 , Douglas Auld  3 , Christopher Austin  4 , Jonathan Baell  5 , Kyle Brimacombe  1 , Thomas D.Y. Chung  6 , Nathan P. Coussens  7 , Jayme L. Dahlin  8 , Viswanath Devanarayan  9 , Timothy L. Foley  10 , Marcie Glicksman  11 , Kirill Gorshkov  12 , Stefan Grotegut  13 , Matthew D. Hall  1 , Samuel Hoare  14 , James Inglese  1 , Philip W. Iversen  15 , Madhu Lal-Nag  16 , Zhuyin Li  12 , Jason R. Manro  13 , James McGee  17 , Allison Norvil  13 , Mackenzie Pearson  13 , Terry Riss  18 , Peter Saradjian  19 , G. Sitta Sittampalam  20 , Michael A. Tarselli  21 , O. Joseph Trask Jr.  22 , Jeffrey R. Weidner  23 , Mary Jo Wildey  24 , Kelli Wilson  1 , Menghang Xia  1 , Xin Xu  1
, editors.
In: Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004.
[updated ].
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Review

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

Jeffrey Strovel et al.
Free Books & Documents

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.

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References

Literature Cited

    1. Pre-IND Consultation Program. US Food and Drug Administration. [Online] [Cited: August 17, 2010.] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped....
    1. Apparent activity in high-throughput screening: origins of compound-depedent assay interference. Thorne N, et al. 2010, Curr Opin Chem Biol, p. doi: 10.1016/j.cbpa.2010.03.020. - DOI - PMC - PubMed
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    1. The price of innovation: new estimates of drug development costs. DiMasi, J.A., Hansen, R.W., and Grabowski, H.G. 2003, Journal of Health Economics, pp. 151-185. - PubMed
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Additional References

    1. Eckstein, Jens. ISOA/ARF Drug Development Tutorial.

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