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  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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