Who We Are
The Office of Pediatric Therapeutics (OPT) is mandated by Congress. Its primary mission is to assure access for children to innovative, safe and effective medical products. Historically, many medical products have not been tested for use in children. Pediatric product development studies require additional protection for children. Given its legislative mandate, OPT has developed five distinct yet interrelated programs to support FDA efforts to improve pediatric access.
What We Do
The OPT Scientific Activities Program works with FDA scientists and reviewers to assure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of such issues as exposure-response and extrapolation. OPT specifically reviews submitted pediatric data to develop “lessons learned” and to promote advancement of pediatric regulatory issues and science.
The OPT Ethics Program supports FDA efforts to assure that children are only enrolled in clinical studies which are both scientifically necessary and ethically appropriate. Children should not become a mere commodity in the world market in response to FDA efforts to foster pediatric drug and biologic labeling.
The OPT Safety Program coordinates the mandated pediatric focused safety review by the Pediatric Advisory Committee for drug and biologic products 18 months after labeling changes in response to voluntary and required pediatric studies.
The OPT International Program facilitates communication and collaboration between FDA and partner regulatory agencies around the world. Pediatric clinical trials are necessarily global, given the incidence and distribution of diseases in the pediatric population, and thus FDA has a moral obligation to assure that children are not exposed to unnecessary, duplicative or poorly designed clinical trials world-wide.
The OPT Neonatology Program supports FDA's efforts to promote effective and safe product development for neonates and infants, by consulting with the Centers and encouraging internal and external dialogue about the unique opportunities and challenges involved in evaluating products in neonates.
Through these five distinct yet related programs, OPT works to assure timely access to medical products proven to be safe and effective for children. OPT performs this core mission in a spirit of transparency, working closely with FDA partners to optimize the use of FDA advisory committees, communicate clearly the risks and benefits of FDA-regulated products marketed for children, and assess and publish FDA experience on which our regulatory decisions are based.
|Office Pediatric Therapeutics|
|Director, Office of Pediatric Therapeutics||Susan McCune, MD|
|Deputy Director||Robert "Skip" Nelson, MD, PhD, M.Div|
|Senior Policy Analyst||Terrie Crescenzi, RPh|
|Management Analyst||Brenda Harmon|
|Program Support Specialist||Elizabeth Sanford|
|Pediatric Advisory Committee|
|Associate Director of Regulatory Affairs/Designated Official for Pediatric Advisory Committee||Marieann Brill, MBA, RAC(US), MT(ASCP)|
|Nurse Consultant Pediatric Advisory Committee COI||Sheila Reese, BS, RN|
|Nurse Consultant Pediatric Advisory Committee COI||Shivana Srivastava, MS, RN|
|Program Support Specialist Pediatric Adivsory Committee Logistics||Euneka Joseph, MBA|
|Director of Ethics/Supervisory Medical Officer||Robert "Skip" Nelson, MD, PhD, M.Div|
|Pediatric Ethicist & Health Analyst||Vacant|
|Data Analyst||Catherine Lee, DrPH|
|Program Manager||Carrie Bryant|
|Scientific Activities, Databases and Communications|
|Director of Science/Supervisory Medical Officer||Vacant|
|Deputy Director of Science and Director of KidNet||Ann McMahon, MD, MS|
|Associate Director of Research / Medical Officer||Haihao Sun, MD, PhD|
|Economist/ Program Analyst||Gerold Wharton, MS|
|Director of Pediatric Safety/ Supervisory Medical Officer||Judith Cope, MD, MPH|
|Regulatory Health Project Manager||Pam Weinel MS, MBA, RN|
|Regulatory Health Project Manager||Amy Odegaard, MPH|
|Medical Officer/Epidemiologist||Ken Quinto, MD|
|Health Scientist||Vacant (Backfill)|
|Director of International Programs/Supervisory Medical Officer||Jean Temeck, MD|
|Health Science Administrator||Suzanne Malli, BA, BSN|
|Medical Officer||Vacant (Backfill)|
|Neonatology Director/Supervisory Medical Officer||Gerri Baer, MD|
|Communications/Data Specialist||Deborah Avant, RPh|
|Health Science Administrator||Renan Bonnel, PharmD, MS, MPH|
|Intergovernmental Personnel Act: Stanford University||Ronald Ariagno, MD|
|Intergovernmental Personnel Act: Duke University||Kanecia Zimmerman, MD, MPH|
|University of Maryland Nursing Fellow||3 Month Assignment|
FDA/Office of the Commissioner
Office of Pediatric Therapeutics
White Oak Bldg.32
10903 New Hampshire Ave
Silver Spring, MD 20993-0002