Drug Development at the University of Minnesota

Therapeutics Development, Preclinical Testing and Clinical Trials Services

The University of Minnesota has an unparalleled ability to support all stages of preclinical and clinical development. From discovery to development, concept to clinical trial, the U of M has the expertise, experience and infrastructure necessary to effectively translate discoveries into new therapies. New projects can enter our development pipeline at any stage. In addition to supporting projects that originated at the U of M, successful development partnerships include those that originated at other academic institutions, private foundations, local biotechs and global pharmaceutical companies.

Target Validation/Therapeutics Development

  • Pharmacogenomics
  • Biological and high throughput screening services
  • Medicinal chemistry and lead and probe development
  • Analytical and purification chemistry

Preclinical Development

  • Drug synthesis, optimization, scale-up, and manufacture
  • Drug formulation services
  • Cell and tissue-based product manufacturing
  • In vitro and in vivo toxicity, safety, ADME and efficacy testing
  • Pharmacokinetic/pharmaco- dynamic (PK/PD) studies
    • Center for Translational Medicine
    • College of Pharmacy
  • Bioanalytical and analytical method development, validation and testing
    • College of Pharmacy
    • Institute for Therapeutics Discovery & Development
  • API and drug product stability
    • College of Pharmacy
    • Institute for Therapeutics Discovery & Development
  • Preclinical regulatory support
    • Clinical and Translational Science Institute
    • Center for Translational Medicine
    • Institute for Therapeutics Discovery & Development

Clinical Studies

  • Phase I clinical studies
    • Clinical and Translational Science Institute
    • Center for Translational Medicine
  • Clinical regulatory support
  • Clinical operations support
  • Biostatistics support
  • Pharmacogenomics
  • Clinical and cognitive pharmacology
  • Clinical pharmacology analytical services
  • Pharmacokinetics and pharmacometrics
  • Cell- and tissue-based product manufacturing (GMP)
  • Drug manufacturing (GMP)
  • Manufacturing regulatory support
    • Molecular and Cellular Therapeutics
    • Institute for Therapeutics Discovery & Development
  • GMP quality assurance