Rosemary M. Addy is a Supervisory Consumer Safety Officer for the Division of Pediatric and Maternal Health in CDER. She joined the FDA in 2002 as a Regulatory Health Project Manager, and has worked throughout that time to implement the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Rosemary earned her Masters in Health Science from Johns Hopkins University and her Bachelor of Science in Political Science from Oklahoma State University.

Dr. Freda Cooner is currently a Senior Director in Eli Lilly and Company. Prior to that, she is a Statistics Director in Amgen, leading the prostate cancer statistics program and exploration of innovative designs for several oncology and non-oncology products, including master protocols and seamless trials. Before joining Amgen late 2018, she was an associate director in Sanofi leading several diabetes products and studies. Prior to Sanofi, Dr. Cooner worked in FDA for over 10 years, where she reviewed hundreds of products in multiple therapeutic areas and led several working groups. She obtained her Ph.D. in Biostatistics from School of Public Health, University of Minnesota.

Andrew is currently Senior Vice President, Regulatory Affairs at Neurogene Inc, a company devoted to gene therapy approaches to management of neurodegenerative disorders in children and adults. Formerly, he served Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics from 2016-2020. He served as Division Deputy Director of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) since 2010-2016. From 2000-2010 Andrew was Portfolio Leader in Established Products responsible for worldwide leadership of Internal Medicine products in Johnson and Johnson.Andrew is a graduate of Columbia College of Columbia University and Mt. Sinai School of Medicine.

Lily Mulugeta is th Associate Director for Policy and Research in the Division of Pediatrics and Maternal Health at the FDA. She engages in scientific and regulatory review and research related to pediatric drug development. Dr. Mulugeta serves as a representative for the Division on the FDA Pediatric Review Committee (PeRC). Prior to joining the Division in 2017, Lily was the Scientific Lead for Pediatrics in the Division of Pharmacometrics at the FDA. Prior to joining the FDA, Dr. Mulugeta practiced as a Critical Care Specialist at Children’s National Medical Center (CNMC) in Washington D.C. She also served as a faculty member in the Department of Pediatrics at the George Washington School of Medicine and in the Department of Pharma

Dianne Murphy, MD, FAAP, is Director of the Office of Pediatric Therapeutics (OPT) Office of the Commissioner at FDA. Dr. Murphy was a medical officer at Bethesda Naval; Dir. of the virology laboratory at the U. of Tenn., Knoxville & tenured Professor at the U. of Florida, Jacksonville. She has authored numerous articles. May 2013. she received the AAP’s Excellence in Public Service Award & in 2014 FDA's Dr. Francis Kelsey Award.

Robert “Skip” Nelson, MD, MDiv, PhD. is currently Executive Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine.

Melissa Tassinari is a Senior Clinical Advisor with the Division of Pediatric and Maternal Health (DPMH), in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population; and improve collection of data to support the safe use of drugs and biological products in pregnant and lactating individuals. She collaborates with numerous stakeholders both inside and outside of FDA to advance development of safe and effective therapies for children, and pregnant and lactating women.