In addition offering free consultations and fee-for-service laboratory services, the Center has developed a Partnership Program to facilitate the development of new therapies at the University.
This program utilizes funds that the Academic Health Center has allocated exclusively for the purpose of translating discoveries by University of Minnesota investigators into the clinic. The Center for Translational Medicine (CTM) works with inventor(s) to create a development plan and utilizes these funds to conduct the preclinical testing and manufacturing necessary to translate the discovery into the clinic. The Center also supports IND/IDE development, preparation of clinical supplies, and Phase I clinical trial design and implementation.
Partnership deliverables include:
- Product-specific pharmacology, safety and toxicology testing plan consistent with FDA requirements, including GLPs as appropriate;
- Studies executed according to the development plan and in compliance with SOPs, IACUC and regulatory requirements (including GLP as necessary);
- Comprehensive and concise study reports prepared in accordance with FDA guidances;
- Project management and coordination of program activities; oversight for program quality, timelines, budget;
- Therapeutic index model based on safety, efficacy and PK data;
- First-in-human (FIH) clinical dose and dose escalation scheme based on preclinical data.
- Clinical protocol supporting FIH clinical trial.
Eligibility and preliminary review
UMN investigator-initiated drug, biologic and device therapeutics and diagnostics and are eligible. Prior to the submission of an application the scientific director will meet with the inventor/investigator to review available data, potential clinical applications, development options, and resource requirements. The CTM will then work with the investigator to ensure that all of the information necessary for a thorough evaluation of the project is available. This includes a summary of key data, a preclinical development plan, a preliminary program budget and timeline, a development team, a synopsis of the first-in-human clinical trial, commercialization potential, and a resource- and revenue- sharing plan.
Approval process and selection criteria
Applications are accepted on a rolling basis. The completed application will be submitted to the Scientific Advisory Board for review and approval. Selection criteria include: scientific merit, developmental feasibility, clinical impact, resource and expertise requirements, regulatory pathway and current or potential funding sources.
The Center for Translational Medicine has partnered with inventors from across the University to develop drugs, biologics, devices and combination therapies. Current Partnership Programs include potential therapies for diabetes, cancer and pain (see graphic).
Contact the scientific director, Robert J. Schumacher, PhD, for more details about the Partnership Program or for more information about how the CTM supports translational development.