Office of Clinical Pharmacology (OCP)

The mission of the Office of Clinical Pharmacology (OCP) is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of the Center for Drug Evaluation and Research's Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs. Through research, we assure that regulatory policy and decision making are based on the best available science.

 

What We Do

• Evaluate what the body does to the drug and what the drug does to the body
• Understand inter-patient variabilities that relate to benefit and risk
• Optimize dose and dose regimen to balance benefit and risk
• Translate knowledge from NDA/BLA reviews into labeling language that is understandable and actionable
• Conduct research to expand our knowledge of clinical pharmacology to better evaluate benefit and risk

 

Office Organization

Immediate Office (OCP-IO)

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

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

Genomics Group Team Leader: Michael Pacanowski, Pharm.D., M.P.H.

Associate Director for Drug Safety: Darrell Abernethy, M.D., Ph.D.

Associate Director for Regulatory Policy: Gilbert Burckart, Pharm.D.

Special Assistant to Office Director: Lei Zhang, Ph.D.

Division of Clinical Pharmacology I (DCP I)

Director: Mehul Mehta, Ph.D.
Deputy Director: Ramana Uppoor, Ph.D.

Focuses on the development and regulatory evaluation of:

• Cardiovascular and Renal Products
• Neurology Products
• Psychiatric Products

Division of Clinical Pharmacology II (DCP II)

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

Focuses on the development and regulatory evaluation of:

• Anesthesia, Analgesia and Addiction Products
• Metabolism and Endocrinology Products
• Pulmonary, Allergy, and Rheumatology Products

Division of Clinical Pharmacology III (DCP III)

Director: Dennis Bashaw, Pharm.D.
Deputy Director: Hae-Young Ahn, Ph.D.

Focuses on the development and regulatory evaluation of:

• Dermatology and Dental Products
• Gastroenterology and Inborn Errors Products
• Reproductive and Urologic Products

Division of Clinical Pharmacology IV (DCP IV)

Director: John Lazor, Pharm.D.
Deputy Director: Kellie Reynolds, Pharm.D.

Focuses on the development and regulatory evaluation of:

• Anti-infective Products
• Antiviral Products
• Transplant Products
• Ophthalmology Products

Division of Clinical Pharmacology V (DCP V)

Director: Atiqur Rahman, Ph.D.
Deputy Director: Brian Booth, Ph.D.

Focuses on the development and regulatory evaluation of:

• Oncology Products
• Hematology Products
• Medical Imaging Products

Division of Pharmacometrics (DPM)

Focuses on the application of Pharmacometrics in the development and regulatory evaluation of drug products in all therapeutic areas

• Acting Director: Shiew-Mei Huang, Ph.D.

Genomics Group (GG)

• Genomics Group Team Leader: Michael Pacanowski, Pharm.D., M.P.H.

Drug Safety Group

• Associate Director for Drug Safety: Darrell Abernethy, M.D., Ph.D.

Pediatric Clinical Pharmacology Group

• Associate Director for Regulatory Policy: Gilbert Burckart, Pharm.D.