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Tuesday, June 18 • 1:15pm - 2:15pm
#254: FDA Rare Disease Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-593-L04-P; CME 1.00; RN 1.00

Hear from senior FDA leadership about challenges and opportunities in reviewing drugs for rare diseases. Representatives from key Agency Offices/Centers will provide updates on key trends and initiatives, then will discuss hot topic questions.

Learning Objectives

Discuss recent trends in the development and FDA review of orphan drugs; Explain new and ongoing FDA policies and initiatives to facilitate the development of drugs for rare diseases; Identify opportunities to further address the challenges associated with rare disease medical product development.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Peter W. Marks, MD, PhD


Speakers
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States
Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum