Certificate Program in Regulatory, Translational, or Entrepreneurial Science

Program Overview

The Certificate Program provides training in translational science through the completion of four course units of coursework and a research project. The certificate is designed for:

  • PhD-level pre- or post-docs who want to extend their research into a clinical setting 
  • Pre- and post-graduate clinical trainees (MD, VMD, DMD, MSN) who want to enhance their expertise in clinical research to inform research at the bench

The program is built on three pillars: (1) a curriculum that focuses on regulatory science, clinical and translational science, or entrepreneurial science, (2) engagement in a one-year translational research project, and (3) active mentorship.

There are three certificates from which to choose:


Alumni Spotlight

Dr. Jesse Carlin, a predoctoral CTSA TL1/T32 trainee, graduated in 2014 with her PhD in Pharmacology and a Certificate in Translational Science. After her postdoctoral fellowship at the NIDDK, Dr. Carlin joined a pharmaceutical company where she continues to bridge fundamental scientific discoveries with clinical applications. Dr. Carlin deploys her clinical and translational science skills as she led a Phase III clinical trial that identified the potential therapeutic benefits of tradipitant for gastroparesis and critical methodological insights for future clinical trials. Although tradipitant did not meet the primary endpoint, Dr. Carlin's sophisticated post-hoc analyses revealed significant efficacy in specific patient populations and demonstrated an exposure-response relationship that provided a pathway forward. Her work creates real-world impact by addressing an unmet medical need in gastroparesis treatment and advancing the scientific understanding of how to effectively evaluate therapies for conditions with high placebo response.

Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clinical Gastroenterology and Hepatology. 22,2506-2516 (2024).