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Tuesday, June 18 • 4:30pm - 5:30pm
#286: Recent Evolution of Accelerated Approval Pathways: Impacts on the Pathways Use and Implementation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-618-L04-P; CME 1.00; RN 1.00

Thought leaders will be brought together in a fireside chat to discuss impacts observed due to recent changes to Accelerated Approval as well as current trends in how the pathway is being used and implemented.

Learning Objectives

Identify the changes to Accelerated Approval resulting from the passage of FDORA; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of Accelerated Approval; Discuss the impacts of the changes to the Accelerated Approval pathway and how it is currently being implemented.

Chair

Danielle Friend Economo, PhD

Speaker

Industry Update
Alexis Miller, JD

FDA Update
Peter W. Marks, MD, PhD

Academic Update
Edward Neilan, MD, PhD


Speakers
avatar for Danielle Friend Economo

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... 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 →
avatar for Alexis Miller

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
avatar for Edward Neilan

Edward Neilan

Chief Medical and Scientific Officer, National Organization for Rare Disorders (NORD), United States
Dr. Ed Neilan is the Chief Medical and Scientific Officer at the National Organization for Rare Diseases (NORD). He is a medical geneticist with experience in both academic medicine and the pharmaceutical industry. His expertise spans laboratory research and medical practice, as well... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum