Back to: FDA ADEPT 10: Addressing Challenges in Neonatal Product Development
Panel Discussion: Regulatory Perspective: How can Expedited Programs, Incentive Pathways, and other Regulatory Initiatives be Leveraged for Neonatal and Rare Disease Drug Development?
Moderator:
Cynthia Rothblum-Oviatt, PhD
Rare Diseases Team (RDT), Division of Rare Diseases and Medical Genetics (DRDMG), CDER, FDA
Panelists:
Amy C. Rick, JD
Rare Disease Innovation Hub, FDA
Erika N. Torjusen, MD, MHS
Office of Orphan Products Development (OOPD), OCMO/OC/FDA
Janet Maynard, MD, MHS
Office of Rare Diseases, Pediatrics, Urology and Reproductive Medicine (ORPURM), CDER, FDA
Najat Bouchkouj, MD
Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), FDA
Ralph Bax, MD, MA
Paediatric Medicines Office, Scientific Evidence Generation Department, Human Division, EMA
Panel Discussion: Stakeholder perspective: Lessons Learned, Gaps and Future Directions
Moderator:
Gerri Baer, MD
Division of Hepatology and Nutrition (DHN), CDER, FDA
Panelists:
Yuliya Yasinskaya, MD
DRDMG, CDER, FDA
Annapurna Poduri, MD, MPH
Harvard Medical School
Susan McCune, MD
Scendea
Antonello Pileggi, MD, PhD, MSCTI
NICHD, NIH
Ronald J. Bartek
Friedreich’s Ataxia Research Alliance (FARA)
Betsy Pilon
Hope for HIE