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Wednesday, June 22 • 11:00am - 12:00pm
#318: Rare Disease Data Sharing: A Value Proposition

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-608-L04-P ; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss various experiences with data sharing, and how data sharing can inform disease characterization and trial designs.

Learning Objectives

Describe FDA’s efforts to encourage data sharing; Discuss the benefits of data sharing in the pre-competitive space; Discuss how data sharing can inform disease characterization and trial designs.

Chair

Michelle Campbell, PhD

Speaker

Academic Update
Klaus Romero, MD, MS

FDA Update
Robyn Bent, MS, RN

Industry Update
Jane Larkindale, PhD



Speakers
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Jane Larkindale

Jane Larkindale

Vice President, Clinical Science, PepGen Inc., United States
Jane Larkindale is Vice President of Clinical Science at PepGen, a company developing enhanced delivery oligonucleotide therapeutics for Duchenne muscular dystrophy and myotonic dystrophy. She has dedicated the past 15 years to accelerating therapy development for rare diseases, with... Read More →
KR

Klaus Romero

Chief Scientific Officer, Critical Path Institute (C-Path), United States
Klaus Romero MD, MS, FCP is a clinical pharmacologist and epidemiologist by training, with 15 years combined experience in academic clinical research. Dr. Romero has been with C-Path since December of 2007, and during his tenure, he has helped lead clinical pharmacology, pharmacoepidemiology... Read More →


Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session