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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  4. Center for Drug Evaluation and Research (CDER)
  5. CDER Offices and Divisions
  6. Office of Clinical Pharmacology
  1. CDER Offices and Divisions

Office of Clinical Pharmacology

The mission of the Office of Clinical Pharmacology is two-fold: 1) play a pivotal role in advancing development of innovative new medicines by applying state-of-the-art scientific principles; and 2) promote therapeutic optimization and individualization through best practices in research, policy development, and drug evaluation throughout the product lifecycle.

What We Do

  • Generate, evaluate, and use knowledge of drug disposition, pharmacology, and disease biology to progressively reduce regulatory uncertainty and inform public health decision-making;
  • Employ mechanistic and model-informed drug development (MIDD) strategies to maximize the value of early and late phase clinical drug development;
  • Use experimental and analytical approaches to identify, account for, and ultimately predict patient variability in drug responses;
  • Promote therapeutic individualization and personalized medicine by translating knowledge of patient diversity into clinical recommendations for safe and effective drug use; and
  • Conduct research to address immediate and emerging regulatory science issues that impact the development, evaluation, and utilization of new therapeutic products.

Office Organization

Immediate Office (OCP-IO)

Office Director: Issam Zineh, Pharm.D., M.P.H.

Deputy Director: Shiew-Mei Huang, Ph.D.

Associate Director for Biosimilars and Therapeutic Biologics: Yow-Ming Wang, Ph.D.

Associate Director for Guidance and Scientific Policy: Rajanikanth Madabushi, Ph.D.

Associate Director for Innovation and Partnership: Qi Liu, Ph.D., M.Stat

Associate Director for Knowledge Management: Peter Lee, Ph.D.

Associate Director for Labeling and Health Communication: Joseph Grillo, Pharm.D.

Associate Director for Lifecycle Management: Ethan Stier, Ph.D., R.Ph.

Associate Director for Pediatrics: Gilbert Burckart, Pharm.D.

Associate Director for Regulatory Affairs: Jessica M. Benjamin, MPH

Associate Director for Strategic Communications: Kimberly Bergman, Pharm.D.

Division of Infectious Disease Pharmacology (DIDP)

Director: Kellie Reynolds, Pharm.D.
Deputy Director: Zhixia (Grace) Yan Danielsen, Ph.D.
Associate Director for Therapeutic Review: Vikram Arya, Ph.D., FCP

Focuses on the development and regulatory evaluation of:

  • Anti-infective Products
  • Antiviral Products

Division of Cancer Pharmacology I (DCP I)

Director: Brian Booth, Ph.D.
Deputy Director: Olanrewaju (Lanre) Okusanya, Pharm.D.

Focuses on the development and regulatory evaluation of:

  • Oncology Products
  • Hematology Products
  • Medical Imaging Products

Division of Cancer Pharmacology II (DCP II)

Director: Nam Atiqur (Atik) Rahman, Ph.D.
Deputy Director: Stacy Shord, Pharm.D.

Focuses on the development and regulatory evaluation of oncology products for solid tumors

Division of Neuropsychiatric Pharmacology (DNP)

Director: Mehul Mehta, Ph.D.
Deputy Director: Ramana Uppoor, Ph.D.
Associate Director for Therapeutic Review, Sabarinath (Sab) Sreedharan, Ph.D.

Focuses on the development and regulatory evaluation of:

  • Neurology Products
  • Psychiatric Products
  • Anesthesia, Analgesia and Addiction Products

Division of Cardiometabolic and Endocrine Pharmacology (DCEP)

Director: Shirley Seo, Ph.D.
Deputy Director: Doanh (Donny) Tran, Ph.D.
Associate Director for Therapeutic Review: Jayabharathi Vaidyanathan, Ph.D.

Focuses on the development and regulatory evaluation of:

  • Reproductive and Urologic Products
  • General Endocrinology Products
  • Cardiovascular and Nephrology Products
  • Non-Malignant Hematology Products
  • Diabetes, Lipid Disorder, and Obesity Products

Division of Inflammation and Immune Pharmacology (DIIP)

Director: Chandrahas Sahajwalla, Ph.D.
Deputy Director: Suresh Doddapaneni, Ph.D.

Focuses on the development and regulatory evaluation of:

  • Pulmonary, Allergy, and Rheumatology Products
  • Gastroenterology Products
  • Transplant Products
  • Ophthalmology Products
  • Dermatology and Dental Products
  • Critical Care Products
  • Liver Products

Division of Pharmacometrics (DPM)

Director: Hao Zhu, Ph.D.
Deputy Director: Vacant
Associate Director for Therapeutic Review: Jiang Liu, Ph.D.

Focuses on the application of quantitative approaches that integrate drug pharmacology, disease pathophysiology, and clinical trial characteristics

Division of Applied Regulatory Science (DARS)

Acting Director: Rodney Rouse, DVM, MBA, Ph.D.
Associate Director: Ksenia Blinova, Ph.D.
Associate Director: Jeffry Florian, Ph.D.

Focuses on applied research to develop novel standards, tools, and approaches

Division of Translational and Precision Medicine (DTPM)

Director: Michael Pacanowski, Pharm.D., MPH

Deputy Director: Robert Schuck, Pharm.D., Ph.D.

Focuses on the development and regulatory evaluation of:

  • Rare Disease Products
  • Genomic Tools and Technologies
  • Targeted Therapies
  • Biomarkers

OCP Reports

OCP Presentations



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