On Wednesday, November 9, 2022, the U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) hosted a one-day, virtual workshop entitled "Bridging Drug Efficacy and Safety to the Obese: Considerations and Scientific Approaches." 

The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition.

This workshop was open to the public with no cost to attend. 

Besides the major health and socioeconomic implications of obesity, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug PK in obese pediatric patients, the relationship between pediatric obesity and drug response, including efficacy and safety, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to conduct of such studies and potential innovative solutions to improve data generation and analysis.  

Meeting Objectives:

1. Review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition

2. Discuss:

(a) if adult and pediatric patients should be identified and studied as a special population in new drug development programs.

(b) when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients.

The event agenda is available online.

This workshop was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.


Wednesday, November 9
8:15 a.m. – 4:15 p.m.


Welcome & Introduction   
VideoPresentation (PDF)                                                                           

Welcome & Introductory Remarks

Varsha Mehta, Pharm.D., M.S.
Senior Staff Fellow for Pediatrics
Office of Clinical Pharmacology, CDER, FDA
U.S. Food and Drug Administration

Presentation (PDF)

Opening Remarks

Robert M. Califf, M.D.
Commissioner of Food and Drugs
Office of the Commissioner, FDA


Epidemiology of Adult & Pediatric Obesity

Frank B. Hu, M.D., M.P.H., Ph.D.
Professor and Chair
Department of Nutrition
Harvard T.H. Chan School of Public Health

Video | Presentation (PDF)

Special Populations and Regulatory Considerations in Drug DevelopmentObese Patients Rajanikanth Madabushi, Ph.D.
Associate Director for Guidance and Scientific Policy
Office of Clinical Pharmacology, CDER, FDA

Video | Presentation (PDF)

Impact of Obesity on Drug Disposition and Response David J. Greenblatt, M.D.
Louis Lasagna Endowed Professor
Tufts University School of Medicine

Video  | Presentation (PDF)  

Role of Modeling and Simulation in Obesity - Evaluating the Effects on Drug
Disposition and Efficacy in Adult Patients
Hao Zhu, Ph.D., Mstat
Division Director, Pharmacometrics
Office of Clinical Pharmacology, CDER, FDA

Video  | Presentation (PDF)  

How a systems approach may help drug development cater for better dose
adjustment in obese patients
Amin Rostami-Hodjegan, Ph.D., FCP, FAAPS, FJSSX, FBPS
Commissioner of Food and Drugs
Office of the Commissioner, FDA

Video  | Presentation (PDF)

Case Examples in Obesity and Drug Use in Adult Patients

Dosing contraceptives in Obese patients Alison Edelman, M.D., M.P.H.
Professor, Obstetrics and Gynecology
Department of Obstetrics & Gynecology
Complex Family Planning Fellowship Director at Oregon Health & Science University

Presentation (PDF)

Dosing Anesthetics and analgesics in the Obese patient Michel M.R.F. Struys, M.D., Ph.D., FRCA
Professor and Chair, Department of Anesthesiology
University of Groningen-University Medical Center Groningen, The Netherlands
 Professor, Department of Basic and Applied Medical Sciences
Ghent University, Gent, Belgium

Presentation (PDF)

Session 2: Obesity and Drug Development in Pediatric Patients 

Review Session Objectives Varsha Mehta, Pharm.D., M.S.
Senior Staff Fellow - Pediatrics
Office of Clinical Pharmacology, CDER, FDA


Obesity Considerations in Pediatric Drug Development Program
Applications submitted to the FDA
Varsha Mehta, Pharm.D., M.S.
Senior Staff Fellow for Pediatrics
Office of Clinical Pharmacology, CDER, FDA

Presentation (PDF)

Current Methods to Characterize Drug Disposition and Optimize Dosing in
Children with Obesity
Daniel Gonzalez, Pharm.D., Ph.D.
Associate Professor
Division of Pharmacotherapy and Experimental Therapeutics
UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill

Presentation (PDF)       

Dosing Anti-infectives in the Obese Pediatric Patient

Michael Neely, M.D., MSc, FCP
Chief, Division of Infectious Diseases
Director, Laboratory of Applied Pharmacokinetics and Bioinformatics,
The Saban Research Institute,
Children's Hospital Los Angeles
Professor and Clinical Scholar, Department of Pediatrics,
Keck School of Medicine, University of Southern California

Presentation (PDF)    

Pharmacokinetics and Dose Optimization of Anticoagulants in Children with
Jackie Gerhart, Ph.D., M.B.A., M.S.
Associate Director
Clinical Pharmacology Lead
GPD Pfizer
Collegeville, PA

Presentation (PDF)

Panel Discussion     
Moderator: Varsha Mehta, Pharm.D., M.S., Senior Staff Fellow – Pediatrics
Office of Clinical Pharmacology, CDER, FDA   
Video   | Questions              


Alexander (Sander) Vinks Ph.D., Pharm.D., FCP
Professor of Pediatrics & Pharmacology
University of Cincinnati, College of Medicine
Cincinnati Children’s Research Foundation Endowed Chair
Director, Division of Clinical Pharmacology
Cincinnati Children's Hospital



Joga Gobburu, Ph.D.
Professor of Pharmacy Practice and Science and School of Medicine
 Director, Center for Translational Medicine
University of Maryland



Gilbert Burckart, Pharm.D.
Associate Director-Pediatrics
Office of Clinical Pharmacology, CDER, FDA



Jaya Vaidyanathan, Ph.D.
Associate Director-Therapeutic Review
Division of Cardiometabolic and Endocrine Pharmacology
Office of Clinical Pharmacology, OTS, CDER, FDA



Laura Higginbotham, M.D., M.P.H.
Lead Physician, Division of Diabetes, Lipid Disorders, and Obesity



Kenneth T. Moore, MA, MS, FAHA
Scientific Director, Cardiovascular and Metabolism Medical Affairs
Janssen Pharmaceuticals Inc.
Titusville, USA


Closing Remarks

Issam Zineh, Pharm.D., MPH, FCP, FCCP
Director, Office of Clinical Pharmacology, CDER, FDA