Turning research discoveries into new therapeutics

The Center for Translational Medicine provides the infrastructure, expertise and resources necessary to translate innovative drugs and biological reagents into Phase 1 clinical trials and facilitate the development of new therapies for patient treatment.

Services:

Consultation regarding regulatory requirements, study designs and preclinical development plans.
Design and conduct preclinical studies for:
In vitro and in vivo safety and efficacy
- Dose, schedule, route of administration and formulation optimization
- Single-dose, repeat-dose and GLP toxicology
- General and safety pharmacology
- Pharmacokinetics and toxicokinetics
Support for FDA meetings and filings; IND and IDE development and submission.
Coordinate development activities such as bioanalytical method development; stability testing; and pilot, scale-up, and GMP manufacturing of clinical product.
Support for Phase I clinical trial design and implementation.

Goals

Our fundamental goal is to function as a service entity for the University by providing the infrastructure, expertise and resources necessary to translate innovative drugs and biological reagents into Phase 1 clinical trials and facilitate the development of new therapies for patient treatment.

We solicit and evaluate promising research leads, identify necessary resources, provide expertise for the preclinical evaluation and testing of novel reagents, GMP manufacture of clinical products, and IND/IDE development and submission, and support Phase I clinical trial design and implementation.

Services: