Division of Translational and Precision Medicine (DTPM)
Overview
The Division of Translational and Precision Medicine (DTPM) is part of the Office of Clinical Pharmacology (OCP) in the Office of Translational Sciences (OTS).
DTPM is a multidisciplinary team of translational scientists with expertise in clinical pharmacology, human genomics, epidemiology, and molecular biology. Through regulatory review, research, policy development, and outreach activities we promote the appropriate application of clinical pharmacology and precision medicine principles throughout all phases of drug development.
Across therapeutic areas, DTPM focuses on pharmacogenomics, genetically targeted therapies, rare diseases, biomarkers, and novel technologies.
What We Do
- Evaluate the clinical pharmacology of new drugs for rare diseases to inform dosing and support determinations of effectiveness and safety.
- Assess pharmacogenomic interactions and biomarker-guided drug development programs to translate molecular studies to patient care.
- Contribute to the development, evaluation, and qualification of biomarkers to inform regulatory decision-making.
- Provide scientific expertise in the evaluation of genetically-targeted therapies such as RNA-directed oligonucleotides.
- Collaborate with government, academic, and industry partners to conduct research that addresses knowledge gaps and improves drug development and use.
Contact Information
Michael Pacanowski, Pharm.D., M.P.H.
Director, Division of Translational and Precision Medicine
OTS/OCP/DTPM
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
E-mail: Michael.Pacanowski@fda.hhs.gov
Telephone: (301) 796-3919