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  5. FDA Grand Rounds – CURE ID and FDA’s Drug Repurposing Efforts - 09/24/2026
  1. FDA Grand Rounds

Webcast | Virtual

Event Title
FDA Grand Rounds – CURE ID and FDA’s Drug Repurposing Efforts
September 24, 2026

Date:
September 24, 2026
Time:
12:00 p.m. - 1:00 p.m. ET

Speakers

Heather Stone, M.P.H.


Heather Stone, M.P.H.
FDA CURE ID Team Lead,
Health Science Policy Analyst,
Office of Medical Policy, 
Center for Drug Evaluation and Research, 
U.S. Food & Drug Administration 

Amy Scott Rick, J.D.


Amy Comstock Rick, J.D.
Director of Strategic Coalitions, Rare Disease Innovation Hub,
Associate Director for Rare Disease Strategy, 
Office of the Center Director,
Center for Drug Evaluation and Research
U.S. Food & Drug Administration 

About the Speakers

Heather Stone, M.P.H., is a Health Science Policy Analyst at the U.S. Food and Drug Administration, in the Clinical Methodologies Group of the Office of Medical Policy, Center for Drug Evaluation and Research. She received her bachelor’s degree in Anthropology from Smith College in Massachusetts in 2010. She then completed her master’s in public health in  epidemiology from the University of Maryland School of Public Health in 2012, before joining the FDA.

She has led the CURE ID program since 2013, which is a joint FDA and NCATS/NIH drug repurposing initiative to gather real-world data through reports of off-label treatment experiences shared by patients, caregivers, and clinicians. The goal is to use this data to encourage robust trials to test the initial signals identified.

Ms. Stone’s research focus at the FDA is on the creation of policies that will encourage drug development for infectious diseases and other diseases with high unmet medical need. She is globally recognized for her leadership in the drug repurposing space and for her efforts to encourage access to effective treatments for the patients most in need. She also applies her policy expertise to issues related to innovation in clinical trial design and has helped to lead the agency’s efforts to develop guidance on integrating randomized trials into routine clinical practice.

Amy Comstock Rick, J.D., is Associate Director for Rare Disease Strategy at the Center for Drug Evaluations and Research (CDER) and Director of Strategic Coalitions for the FDA’s Rare Disease Innovation Hub (the Hub). She serves in a crosscutting role across  both CDER and  the FDA’s Center for Biologics Evaluation and Research (CBER) to facilitate implementation of the Hub. She also works closely with both centers to develop and carry out a rare disease strategic agenda. Ms. Rick, with support from staff in CBER’s and CDER’s rare disease programs, is the Hub’s primary point of engagement for parties external to the FDA.

Most recently, Ms. Rick served as Principal Consultant at Leavitt Partners, focusing on health policy matters, with a primary focus on rare disease and medical product development. Before Leavitt Partners, she served as President and Chief Executive Officer of the Food and Drug Law Institute (FDLI), a nonprofit organization dedicated to providing an innovative, open, balanced exchange of ideas and viewpoints across the field of food and drug law.

Before joining FDLI, Ms. Rick was Chief Executive Officer of the Parkinson’s Action Network. Ms. Rick also served as President of the Coalition for the Advancement of Medical Research and on the Boards of Directors for Research America, the National Health Council, and the American Brain Coalition.

Ms. Rick had previous federal service as a career attorney at the U.S. Department of Education in 1988, focusing primarily on the field of government ethics. She was the Senate-confirmed Director of the U.S. Office of Government Ethics from 2000 to 2003 and Associate Counsel to the President in the White House Counsel’s Office from 1998 to 2000. She received a Bachelor of Arts degree from Bard College and a Juris Doctor degree from the University of Michigan.

About the Presentation

This lecture will discuss the CURE ID website and mobile app, and how it can serve as an important real-world data tool to help identify treatments for diseases that don’t have good, approved treatment options. The speakers will situate CURE ID in the context of the broader FDA repurposing initiatives that are ongoing.

Learning Objectives

  1. Describe the challenges of repurposing of off-patent drugs
  2. Describe CURE ID’s objectives as a real-world data tool for drug repurposing
  3. Discuss how the FDA is trying to tackle the challenges of repurposing drugs and its new repurposing initiatives in 2026

To Attend

For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov; Ayan.Ibrahim@fda.hhs.gov

Continuing Medical Education (CME) Credit

As CME credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CME credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CME credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation. 

Accreditation Statement

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Johns Hopkins University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This regularly scheduled series has been approved for a 52-week cycle beginning October 23, 2025.

Other Credits

Reciprocity exists with the following boards that accept AMA PRA Category 1 Credits™ from organizations accredited by the ACCME:

  • American Nurses Credentialing Center 
  • American Academy of Nurse Practitioners National Certification Program 
  • National Commission on Certification of Physicians Assistants 
  • Psychologists: JHUSOM is authorized by the Maryland State Board of Examiners of Psychologists as a provider of continuing education. The JHUSOM maintains responsibility for this program.
  • Social Workers: The Maryland Board of Social Work Examiners certifies that this program meets the criteria for 1 credit hour of Category 1 of continuing education for social workers licensed in Maryland. The JHUSOM is an approved sponsor of the Maryland Board of Social Work Examiners for continuing education credits for licensed social workers in Maryland.

These professionals should submit their transcript to their respective boards to convert their credits to CEUs.

Policy on Presenter and Provider Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the presenter globally disclose conflicts of interest and any discussion of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place to identify and mitigate relevant conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education. 

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