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Regeneron is committed to supporting externally sponsored research that promotes 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.
Types of Eligible Research:
-
Investigator-Initiated Studies (IIS):
Independent, unsolicited research where the external researcher conceives the research,
develops the protocol, and serves as the Sponsor-Investigator.
-
Research Collaboration:
Jointly defined research conducted in collaboration with an external researcher. Each
collaboration may differ based on the type of collaboration, i.e., protocol development, publication,
and sample analysis. Despite involvement from Regeneron, the researcher still serves as the
Sponsor-Investigator.
This doesn't include pre-clinical studies for proprietary animal models, cell lines, and/or other
technologies, etc. Please refer to the Regeneron
Preclinical Research Collaborations portal for pre-clinical studies for proprietary animal models, cell
lines, and/or other technologies, etc., submissions.
All submissions are non-confidential. If you have any program-related questions, please send an email
to ExternalResearchRequests@regeneron.com.
For proposals for IIS/RC to be conducted outside the US for the investigational agents aflibercept, dupilumab and
evinacumab, requests should be submitted to the partner company. For a list of compounds with partners, please see
the table below:
FAQs
How do I create an account?
Click on CREATE ACCOUNT in the top menu.
How do I submit a request?
Refer to the instructions in the submission process guide above.
How do I reset my password?
Use the "Forgot Password?" link to reset your password. Please enter the email address
you are registered with,
the code shown, and check for the password reset email. Please check your email for
further instructions. Copy
and paste the validation code from your email, click the “Validate” button, enter a new
password, and complete
the password reset.
If you do not receive the message, please check your spam folder. Otherwise, please
start this process again.
How do I track the status of my request?
You may view the status of your submission via the MY REQUESTS tab
after you've logged into your account.
Proposal Submission Overview
When submitting a proposal, follow the guided electronic submission process and review the acknowledgment to move
forward.
All submitted proposals will be reviewed by the respective Therapeutic Area (TA) cross-functional team.
Submitted proposals go through a two-stage process.
-
Concept Review
A Concept is a 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 of interest, Regeneron will
request a Full Protocol for further review.
-
Protocol Review
Protocol Clinical Interventional and Clinical Non-Interventional
Full protocol submission must be uploaded as a MS Document and contain full details of the proposed
research study to make a final determination for support. The Protocol must include Background & Rationale,
Study Design, Study Objectives/Endpoints, Eligibility, Treatment Plan, Study Duration, Study Procedures, Safety
Reporting including SAEs, AESI, Pregnancy, and Statistical Considerations, including the sample size
justification. The Protocol submission entry must also include the planned study's timelines and a publication
plan.
Protocol Non-Clinical
Full protocol submission must be uploaded as a MS Document and contain full details of the proposed
research study to make a final determination for support. The Protocol must expand on the sections outlined in
the concept, including the Study Aim, Outcome Measures, Background & Rationale, Experimental Design,
Methodology, Study Duration, and Statistical Considerations, including the sample size justification. The
Protocol submission entry must also include planned study timelines and a publication plan.
Proposal Submission Process
To begin the proposal submission process, the submitter must create an account or access the existing Regeneron portal account, select the “ESR” button, confirm acknowledgment, complete a submission form, and attach the required documents. A complete and detailed submission will facilitate the management and evaluation of your proposal.
A completed submission request online must include the following:
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Confirm Acknowledgment
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Complete the submission form, including the requested support (drug, funding, or both).
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Attach the required documents:
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Principal Sponsor-Investigator's Curriculum Vitae
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Organization's W-9/W-8, where applicable.
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Estimated budget (where applicable), including direct, indirect, per-patient costs, and fees.
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Submit a proposal request.
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Regeneron will send an email notification acknowledging receipt of submission.
-
Incomplete submissions that do not include required documents will not be processed and returned to the
submitter until all requested information is received.
-
Upon receipt of a complete application and review by the committee, Regeneron will notify the submitter of the
proposal review decision.
Protocol Submission
If approved, the full protocol must be submitted within 60 to 90 days of the study proposal approval notification, depending on the product, including the detailed budget.
Support
Support in the form of funding and/or a 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.
Support
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Drug
-
Funding
-
Concept Submission: An Estimated Budget.
-
Protocol Submission: A Detailed Budget.
Protocol - Clinical Interventional and Clinical Non-Interventional
Clinical Protocol: A detailed budget must be uploaded preferably as a MS Excel Document containing reasonable protocol-related costs, which may include fees related to cost per patient (CPP), institution, i.e., study start-up, IRB fees, pharmacy fees, overhead, etc., and/or correlative/exploratory analysis. Final budgets will be subject to review and assessment of fair market value (FMV). The committee will consider the budget as part of the protocol submission. Any changes to the submitted budget following the protocol review will be subject to re-evaluation.
Non-Clinical Protocol – A detailed budget must be uploaded, preferably as a MS Excel Document containing reasonable protocol-related costs to conduct the research, i.e., study start-up, maintenance, closeout, overhead, etc. Final budgets will be subject to review and assessment of fair market value (FMV). The committee will consider the budget as part of the protocol submission. Any changes to the submitted budget following the protocol review will be subject to re-evaluation.
Funding and other support will be provided for approved protocols upon contract execution, where applicable, depending on the product and receipt of all study start-up documents.
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