The Division of Translational and Precision Medicine (DTPM) is located within FDA’s Office of Clinical Pharmacology. The DTPM staff is a multidisciplinary team consisting of translational scientists with clinical pharmacology, human genomics, epidemiology, and molecular biology expertise. Our division works to ensure that clinical pharmacology principles and precision medicine strategies are applied appropriately in all phases of drug development to maximize benefit and reduce risk to patients.
Precision medicine, also referred to as personalized medicine, tailors disease treatment and prevention by taking into account individual variability in genes, environment, and lifestyle. The goals of precision medicine include advancing the development and availability of safe and effective targeted treatments and promoting efforts to incorporate omics-based tools, technologies, and biomarkers in drug development.
Clinical pharmacology plays a central role in precision medicine and drug development through therapeutic optimization and individualization based on various intrinsic (e.g., organ impairment, genotype) and extrinsic factors (e.g., food, drug interactions). DTPM focuses on the integration of genomics, advancement of targeted therapies, and support of biomarker qualification across therapeutic areas. DTPM also leverages clinical pharmacology data to maximize development of therapeutics for the treatment of rare diseases and inborn errors of metabolism. Core functions include regulatory review, regulatory science, guidance and policy development, and education and outreach (Figure below).
To facilitate and accelerate the development of drugs and biological products, DTPM reviewers apply pharmacogenomic, pharmacokinetic, and pharmacodynamic principles in the evaluation of intrinsic and extrinsic factors on drug exposure, safety, and efficacy.
DTPM conducts research projects and works with scientists throughout government, academia, and industry to address knowledge gaps. Research projects focus on ways to increase efficiency in drug development by utilizing biomarkers, genomics, and pharmacokinetic/pharmacodynamic data to improve patient care.
Guidance and Policy Development
DTPM works to identify emerging issues in drug development to inform stakeholders on FDA’s current thinking through guidance and policy development.
Education and Outreach
DTPM engages and educates the community via public workshops, conferences, and other partnerships on ways to improve drug discovery and development.
Michael Pacanowski, Pharm.D., MPH
Director, Division of Translational and Precision Medicine
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Telephone: (301) 796-3919