Regeneron is committed to supporting third-party research that promote the advancement of medical and scientific knowledge regarding Regeneron’s products and therapeutic areas of interest. Such research may expand Regeneron’s understanding of our products and their potential applications, improve patient care, provide answers to important scientific / clinical questions, and spark new ideas for further disease-related research.
There are two types of research proposals covered by this homepage:
1) Investigator Initiated Studies (IIS) are designed and operationalized by an external third-party, not Regeneron. Support in the form of funding and/or product may be provided by Regeneron. The third-party serves as the sponsor and accountable party for all regulatory and legal requirements.
2) Research Collaborations are operationalized by an external third-party, who serves as the sponsor and accountable party for all regulatory and legal requirements. Regeneron contributes to designing the study and approves the study endpoints. Regeneron may provide funding and/or products.
|Data Sharing Requests: Qualified third-party researchers seeking access to individual patient or aggregate level data from a Regeneron sponsored clinical study can submit a research proposal at https://vivli.org/.
Please note drug candidates include compounds developed by Regeneron in collaboration with other partners and may require redirection to the partner’s portal. For a list of compounds with partners, please see the table below:
Support in the form of funding and/or drug, if any, will be granted based on scientific merit. If funding is being sought, the proposed budget must be reasonable and appropriate for the study. Scientific expertise will also be considered.
Key Areas of Interest
Submitting a Proposal
When submitting a proposal, you will be guided through the electronic submission process by instructions and help options. All proposals submitted will be reviewed by the respective Therapeutic Area (TA) cross functional team.
1) Concept Review
Submitted proposals go through a two-stage process.
A Concept is a brief summary of your proposal. It must contain an adequate level of information for Regeneron to determine whether it will be of interest to the program. If the Concept is found to be of interest, Regeneron will request a Full Protocol for further review.
2) Protocol Review
A Protocol submission must contain full details of the proposed research study, preferably as a MS Word Document, to make a final determination for support. The Protocol must include Background & Rationale, Study Design, Study Objectives/Endpoints, Treatment Plan, Study Duration, Study Procedures, Safety Reporting including SAEs, AESI and Pregnancy and Statistical Considerations including the sample size justification. The Protocol submission entry must also include planned study timelines as well as a publication plan.
With the submission, please include the requested support (drug, funding or both), budget (including Direct, Indirect, per Patient Costs, and Fees), Organizations W-9 and Investigators (CV).Click here for the Regeneron Privacy Notice
If you are using this request submission system for the first time, please click on "Create new account" above. If you have already registered, enter your username and password and click "Log in."
Regeneron is committed to conducting business in compliance with all Regeneron policies, American Medical Association (“AMA”) Guidelines on Gifts to Physicians, the AMA Ethical Opinion on Continuing Medical Education, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) code on Interactions with Healthcare Professionals, the Accreditation Council for Continuing Medical Education (“ACCME”) Standards for Commercial Support, the U.S. Food and Drug Administration (“FDA”) regulations and guidance, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) guidance and all applicable federal and state laws and regulations.