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The Use of Animal Models in Pre-Clinical Drug Development
November 16, 2016
The Use of Animal Models in Pre-Clinical Drug Development

The workshop will provide an overview of the use of animal models in preclinical drug development. We will focus on the transition from in vitro activity to in vivo efficacy, the choice of the right animal model for proof of concept studies, provide examples of relevant animal models with supportive data and interpretation of results as it relates to the clinical condition.

Workshop LEADER

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Mark Pulse

Assistant Director , University of North Texas Health Science Center

Mark holds a Masters of Science degree in molecular microbiology and immunology, and his research at the University of North Texas Health Science Center has primarily been focused on bacterial pathogenesis and pre-clinical drug evaluation within in vivo models. For the last 10years he has been directly involved in the development of several in vivo models that have included GI- and respiratory-associated infectious diseases, device-associated (biofilm) infections, and pharmacokinetic studies within multiple animal species. He also has experience with survival surgery in multiple animal species, including USDA species. In addition to in vivoresearch, his in vitro work has involved the use of multiple molecular techniques to determine important virulence pathways associated with Staphylococcus aureus infections.

University of North Texas Health Science Center

The Pre-Clinical Services group at the University of North Texas Health Science Center conducts studies utilizing established models of both acute and chronic bacterial infections in several different animal species. In addition, pharmacokinetic studies with accompanied bioanalytical LCMS / HPLC analysis can be performed in-house for submitted compounds.
Infection models or protocols other than those described herein can also be established or adapted as required to meet the more specific needs of interested Sponsors.
UNTHSC Pre-clinical Services together has over 33 years of pharmaceutical and specialized biotech experience in the performance of therapeutic efficacy models and drug discovery / development. The group uses this experience to guide the drug discovery process, through protocol design, implementation and analysis for compound lead selection. Studies are conducted in state-of-the-art facilities with excellent support staff and services.

 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Opening remarks and introductions

William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

Mark Pulse, Assistant Director , University of North Texas Health Science Center

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9:10

Preclinical Drug Development

  • Overview of preclinical testing
  • Discovery to lead selection
  • The development model: then and now
  • Antibacterial research efforts
  • William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

    Mark Pulse, Assistant Director , University of North Texas Health Science Center

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    9:50

    Experimental Design and Methodology

  • Experimental design profoundly influences the outcome of a research study
  • Clearly define the question or problem being studied
  • Realistic objectives (achievable)
  • Choose the best research model
  • William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

    Mark Pulse, Assistant Director , University of North Texas Health Science Center

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    10:30

    Morning Coffee

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    11:00

    Animal Models – Examples

  • Acute infection models – Bacteremia, Sepsis
  • Chronic infection models – Pneumonia, skin, abscesses
  • GI related – C. difficile, H. pylori
  • Device related – Biofilm, endocarditis, prosthetic joint
  • William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

    Mark Pulse, Assistant Director , University of North Texas Health Science Center

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    11:40

    Animals in Research

  • Institutional Animal Care and Use Committee (IACUC)
  • Justify why animals are necessary, minimize pain and distress, husbandry and care
  • Use of appropriate euthanasia methods
  • The 3 R’s
  • William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

    Mark Pulse, Assistant Director , University of North Texas Health Science Center

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    12:20

    Closing Remarks

    William Weiss, Director of Pre-Clinical Services, University of North Texas Health Science Center

    Mark Pulse, Assistant Director , University of North Texas Health Science Center

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    12:30

    End of Workshop

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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