John J. Alexander, MD, MPH

Deputy Director, Division of Pediatrics and Maternal Health
Center for Drug Evaluation and Research
Office of New Drugs
FDA

Dr. John Alexander is Deputy Director of the Division of Pediatrics and Maternal Health in the Center for Drug Evaluation and Research at FDA. Dr. Alexander is a pediatrician who joined the US Food and Drug Administration in 1995 as part of a joint fellowship in pediatric infectious diseases with FDA and Children’s National Medical Center. After completion of his fellowship, he became a full-time medical officer, and subsequently a team leader, in the Division of Anti-Infective Products. Dr. Alexander also obtained a Masters in Public Health degree from the George Washington University School of Public Health in 2001. He has been involved in drug regulation and pediatric drug development for more than 25 years.

Samina Ali, MD

Professor of Pediatrics and Emergency Medicine, University of Alberta

Shila Azodi, MD

Senior Physician
DNPD1, ONPD, OND, CDER, FDA

Russell D. Bradford, MD, MSPH

Senior Vice President, Medical Affairs
PEGUS Research, Inc.

Dorothy Chang, MD

Deputy Director for Safety, Division of Nonprescription Drugs I, Office of Nonprescription Drugs, FDA

Corrie Chumpitazi, MD

Chief, Division of Emergency Medicine, Duke University Health System

M. Petrea Cober, PharmD, BCNSP, BCPPS, FASPEN

Professor of Pharmacy Practice, Director of Professional and Workforce Development, Northeast Ohio Medical University

Wade Delk

‍Board Member and Treasurer, Protecting Access to Pain Relief Coalition
Director, Governmental Affairs, American Society for Pain Management Nursing

Aklil Getachew, MD

Medical Officer, DNPD 1 ꟾONPD ꟾ OND ꟾ CDER ꟾ FDA

Sally Greenberg

Executive Director, National Consumers League

Diane E. Hindman, MD, PharmD, BScPhm, FAAP, FACMT

Attending Physician, Emergency Department, Phoenix Children’s Medical
Toxicologist, University of Arizona Poison and Drug Information Center

Mona Khurana, MD

Pediatric Team Leader, CDER, Office of New Drugs, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, DPMH

Jennifer N. Lind, PharmD, MPH, MBA

CAPT, United States Public Health Service
Partnerships & Prevention Lead, Medication Safety Program
Division of Healthcare Quality Promotion, CDC

Theresa Michele, MD

Director, Office of Nonprescription Drugs (ONPD), Office of New Drugs, CDER, FDA

Ndidi Nwokorie, M.B.B.S.

Senior Scientist. Division of Pediatrics and Maternal Health, OND, CDER, FDA

Ian M. Paul, M.D., M.Sc.

University Professor of Pediatrics and Public Health Sciences, Pennsylvania State University College of Medicine

Dr. Ian M. Paul is the University Professor of Pediatrics and Public Health Sciences at the Pennsylvania State University College of Medicine. He is also Chief of the Division of Academic General Pediatrics and Vice Chair of Faculty Affairs in the Department of Pediatrics at Penn State Children’s Hospital in Hershey, PA, USA.

Dr. Paul is a general pediatrician and clinical and health services researcher with principal interests in a) primary preventive interventions for newborns, infants, and families and b) clinical therapeutics for children. His research focuses on these two areas with grants from the National Institutes of Health for obesity prevention and the improvement of maternal-child cardiovascular health. His work in this field includes the first ever study to demonstrate that behavioral interventions delivered in the months after birth can lead to slower infant weight gain and lower body mass index through age 3 years.

He has also studied newborn weight loss and breastfeeding with research that generated the first ever nomograms depicting newborn weight loss for exclusively breastfed and exclusively formula fed term neonates during the birth hospitalization (www.newbornweight.org) and through the first month after birth. In total, Dr. Paul has ~200 peer-reviewed scholarly contributions including those published in the New England Journal of Medicine, JAMA, Proceedings of the National Academy of Sciences, JAMA Pediatrics, Pediatrics, Obesity, Annals of Emergency Medicine, and Journal of Allergy and Clinical Immunology.

Dr. Paul is also an internationally recognized expert on the pediatric treatment of the common cold and its symptoms having led numerous investigations related to cough/cold medications and antipyretics. Dr. Paul has served the American Academy of Pediatrics in leadership positions including the Section of Clinical Pharmacology and Therapeutics Executive Committee as well as the Committee on Drugs. Dr. Paul has served as a Steering Committee member for the NIH-funded Pediatric Trials Network since its inception.

In recognition of his contributions to the health of infants, mothers, and children in the United States, in 2019 he received the Director’s Award from the U.S. Health Resources & Services Administration’s Maternal and Child Health Bureau. In 2022 he received the prestigious Research Award from the Academic Pediatric Association. Locally at Penn State, he received the Excellence in Career Mentoring Award in 2020.

A clinician as well, Dr. Paul has a thriving general pediatric practice where he provides medical care for children from birth through age 21 years. He has been recognized several times for superior patient satisfaction.

‍Dr. Paul received his B.A. from Franklin and Marshall College (cum laude) with a major in Chemistry (with honors), received both graduate degrees (M.D. and M.Sc.) from The Penn State College of Medicine, and completed his pediatric residency at Duke University.

John Routt Reigart, MD, FAAP

Professor Emeritus of Pediatrics, Medical University of South Carolina
Chair, Committee on Drugs, American Academy of Pediatrics

Kate M. Reynolds, MPH

Director of Research, Rocky Mountain Poison & Drug Safety (RMPDS), Denver Health & Hospital Authority

Maribeth L. Sivilus, MPH

Epidemiologist, Medication Safety Program, Division of Healthcare Quality Promotion, CDC

Susan Sirota, MD

CEO, PediaTrust

Jody Thomas, Ph.D.

Chief Executive Officer, Meg Foundation
Licensed Clinical Psychologist
Adjunct Lecturer, Stanford University School of Medicine

Leanne West

Chief Engineer of Pediatric Technologies, Georgia Institute of Technology

Lynne Yao, MD

Director, Division of Pediatric and Maternal Health (DPMH), Office of New Drugs, Center forDrug Evaluation and Research, FDA

H. Shonna Yin, MD, MSc

Associate Professor of Pediatrics and Population Health, NYU School of Medicine

Jonathan Zipursky, MD, Ph.D., FRCPC

Staff Physician, Divisions of General Internal Medicine and Clinical Pharmacology & Toxicology, Sunnybrook Health Sciences Centre
Assistant Professor, Temerty Faculty of Medicine, University of Toronto
Adjunct Scientist, ICES and Sunnybrook Research Institute

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Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age

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