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Breakthrough Business Models Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (2009) / Chapter Skim
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2 Current Model for Financing Drug Development: From Concept Through Approval
Pages 7-11

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From page 7...
... Thomas Caskey, M.D., Director and Chief Executive Officer and Chief Operating Officer of the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases at the University of Texas Health Science Center.
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From page 8...
... One such example is the California Institute for Regenerative Medicine, a state agency established in 2005 by the California Stem Cell Research and Cures Initiative, which provides grants and loans for stem cell research and facilities at California's research institutions and universities. Another example is the Texas Cancer Initiative, under which state funds are dedicated to cancer research conducted in Texas.
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From page 9...
... In addition to government programs and philanthropy- and state-funded initiatives, many start-up companies, launched to develop discoveries emerging from academic laboratories, are being supported initially by venture capitalists and "angel investors." Current Status of Investments Inhibitors of Development Caskey argued that, despite the desire for development of new therapies, several environmental factors negatively affect new investments in drug development. Examples include decreased funding for basic research, regulatory barriers, and problems with drug safety that lead to product withdrawals.
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From page 10...
... Another platform example is bio­ chemical pathway analysis using mass spectrometry to measure analytes, rather than nucleic acid methods or proteomics. Such a high-throughput method for assessing numerous markers and pathways associated with a disease or drug action can contribute to efficacy and safety analysis prior to clinical use of a drug.
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From page 11...
... – FDA needs to be adequately funded so it can partner with drug developers and direct the research being performed toward answering important regulatory questions. • Private initiatives – Small Business Innovation Research and Small Business Tech nology Transfer regulations need to be revisited and revised to allow for greater investment.
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Key Terms

  • drug discovery
  • discovery research
  • cell research
  • venture capitalists
  • stem cell

  • facilitate drug
  • drug safety
  • basic discovery
  • texas cancer
  • innovation research

  • discovery process
  • cancer initiative
  • mrna expression
  • cures initiative
  • critical step

  • business innovation
  • product withdrawals
  • caskey argued
  • fewer investments
  • funded primarily

  • california stem
  • drug action
  • enhancing drug
  • drug therapy
  • proposed drug

  • drug failures
  • facilitating drug
  • drug targets
  • cancer research
  • funding research


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