human

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plant

animal

human
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Improving Animal and Human Health by Accelerating
Drug and Device Development
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History behind TIPS

• DeBakey VAD - Micromed
• Federal Initiatives (2 M)
• GLP inspection
• Outcome (needs)
• Administrative buy-in
• Establishment of Quality System
• Independent Quality Assurance
• Within VPR Office
• Reports to Research Compliance

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TIPS Vision
to become the leading facility to conduct
comprehensive preclinical/GLP large animal
studies that will improve the efficacy and
efficiency of drug and device development by
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Three Main Objectives

• GLP/pre-clinical studies

• Molecular and Translational Imaging

• Spontaneous animal disease

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Educational Impact of TIPS

• Only 17 universities in the US currently offer
  programs for regulatory affairs degrees or
  certificates
• Northeast, west coast, and one in Georgia.
• GLP training and study
• director training limited
• to in-house customized
• programs, contract training,
• or CE at trade conferences.

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Research Endeavors

• Cardiovascular devices
• Emergency medicine
• Orthopedics
• Oncology
• Stem cell research regenerative medicine
• Imaging
• Nanotechnology/therapeutics/drug delivery
• Spontaneous Animal Models

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Collaborations

• Federal government
• DoD, NIH, USDA
• State government
• ETF
• University (inter/intra)
• Private industry
• Large commercial
• Start up

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Product Type
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TAMU GMP Facility

• Expand TAMU GMP capabilities and competencies
• Tie together key drug development components to
  create a one-stop shop
• Genomic research (TIGM)
• Pre-clinical (animal) studies (TIPS)
• GMP manufacturing, process development,
  regulatory competencies
• Apply for grant-funded GMP, process development
  opportunities

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Site Plan
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TIPS Facility

• 112,000 sq feet
• -state-of-the art large animal hospital
• -acute housing for 240 large animals
  pasture/barn for long term holding
• -advanced imaging center
• -incubator space for start-up companies
• -office of technology commercialization

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Construction Photos
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Interior Photos
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Floor Plan First floor
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Floor Plan Second floor
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64 slice PET/CT
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Fixed Cardiac Catheterization Lab
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3-T MRI with XMR
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7-T MRI
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TIPS Clinical Pathology Laboratory
Olympus AU400 Bio Plex 200 System
Cell Dyn 3700 Benchmark Plus
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TIPS Clinical Pathology Laboratory

• Current Capabilities
• CBCs on 5 different species
• Routine serum chemistry screening
• ELISA testing
• GLP quality
• Future Capabilities
• Addition of study-specific species for CBCs
• Add-on study-specific chemistry assays
  (serum/urine)
• Multiplex bead array assays

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Current Status Timeline

• New building
• April 10th, 2009 substantial completion, Animal
  housing
• June 28th, 2009 substantial completion, offices
  and core facility

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Many Thanks!
Texas AM Institute for Preclinical Studies Dr.
Theresa (Terry) W. Fossum 4474 TAMUCollege
Station, TX 77843-4474phone [phone]  
Fax  [phone] http//tips.tamu.edu