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Translational Research Resource Links

Sample Preclinical Development Plan:

  • Preclinical development plans provide a guide to the strategies and steps required for a drug candidate to advance to an Investigational New Drug (IND) application to the FDA.  Typically, PDPs include an analysis of market opportunity, assessment of status, Gantt chart of steps and timelines, and cost estimates.  These assessments are useful for academics seeking grant opportunities, tech transfer officers seeking licensing partners, and start-up companies seeking a detailed component of their overall business plan.  SRI preclinical experts can contract to draft a PDP, and SRI’s full service preclinical contract research organization (CRO) is available to complete the specified tasks.
Example Preclinical Development Plan   PDF

Related Articles:

  • Weisbach, J.A., and W.H. Moos.  Diagnosing the decline of major pharmaceutical research laboratories: A prescription for drug companies.  Drug Development Research  34:243-259, 1995.
  • Kenyon, G.L., D.M. DeMarini, E. Fuchs, D.J. Galas, J.F. Kirsch, T.S. Leyh, W.H. Moos, G.A. Petsko, D. Ringe, G.M. Rubin, and L.C. Sheahan.  Defining the mandate of proteomics in the post-genomics era: Workshop report.  Mol. Cell. Proteomics  1:763-780, 2002.
  • Spack, E.G.   Minding the drug development gap.  The Scientist  19 (21):36-37, 2005.
  • Frank, G.D, L. Jong, N. Collins, and E.G. Spack.  Nonprofit model for drug discovery and development.  Drug Development Research 68: 186-196, 2007.
  • Moos, W.H. The intersection of trategy and drug research (Chapters 2.01–2.27). In Comprehensive Medicinal Chemistry II (2nd Edition), Vol II: Strategy and Drug Research. J.B. Taylor and D.J. Triggle, Eds. W.H. Moos, Vol. 2 Ed., 1–1087. Elsevier, Oxford, UK, 2007.
  • Collins, N.  Helping out: Hiring a contract research organization can expedite the drug development process.  Dru Discovery & Development  10 (11):42-46, 2007
  • Mirsalis, J.C. Editorial: The new R&D landscape of orphan and neglected infectious diseases. Drug Disc News. p. 13, September 2007.
  • Spack, E.G.  Hybrids help out.  Drug Discovery and Development 11 (10):38-40, 2008.

NIH Translational Development Programs:

Foundation Programs:

A growing number of disease-focused foundations have established programs to fund translational development beyond basic research and drug discovery.  Some examples: