Investigator Sponsored Studies (ISSs) and Externally Sponsored Collaboration (ESC) Portal
Ipsen considers unsolicited proposals from healthcare professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for research support based on scientific merit and strategic fit with Ipsen’s areas of research interest.
Requests for support will be assessed for scientific merit as well as safety, legal, ethical and budgetary considerations. Support for endorsed proposals may be provided in the form of financial support and/or study drug supply pursuant to a written agreement which requires that you – as sponsor – comply with applicable local laws, rules, guidelines and regulations.
There are two types of unsolicited proposals: Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC):
- Investigator Sponsored Studies (ISS) are defined as independent unsolicited research, designed and sponsored by an external sponsor entity, institution or organization.
- Externally Sponsored Collaborations (ESC) are conducted in collaboration with an institution or organization based on a jointly defined research where primary regulatory sponsorship is held externally to Ipsen.
To be noted:
- An Investigator Sponsored Study (ISS) may become a study under a collaborative model (ESC) during the discussion/evaluation of the ISS proposal from the external sponsor.
- The funding of your research does not impose an obligation, expressed or implied, on the recipient to purchase, prescribe, provide favorable formulary status for, or otherwise support Ipsen products
You are invited to submit your research proposal (concept) via VisionTracker platform, an interactive system supporting the end-to-end workflow from concept submission up to project closure.
You will be invited to provide all relevant information directly online during the entire research lifecycle.
- Concept: Short description of the research/study. If in scope, the concept will move to synopsis requested stage.
- Synopsis: More detailed description of the proposed research/study.
- Protocol: Provide all study details.
- Project Set-up: Contracting, ethics review/regulatory approvals, budgeting, product shipment.
- Active Project: Research/study executed as per protocol and contract.
- Project closure: Final study report and publications, final reconciliations
- Click here to access Ipsen’s ISS and ESC portal
- If you have difficulty with portal access, please email InvestigatorSponsoredStudies@ipsen.com for additional assistance.
For any questions related to the process and/or submissions, contact us via InvestigatorSponsoredStudies@ipsen.com.
- Concept: study title, hypothesis, objectives, endpoints, sample size, support requested.
- You shall have the appropriate scientific and operational capabilities and resources to conduct the study on agreed timelines.
- You shall conduct the study in compliance with laws, rules, regulations and ethical standards (e.g. Declaration of Helsinki, Good Pharmacovigilance Practices, ICH-Good Clinical Practices, Good-Pharmaco-Epidemiology Practices, Good Laboratory Practices).
- A mutually agreeable contract must be executed prior to study initiation.
- You shall provide contractual agreed-upon study status updates.
- You shall monitor and report safety data to the appropriate authorities, in a timely and accurate manner.
- In addition to reporting safety data to all relevant authorities, you have the responsibility to report the safety information to Ipsen as per contract.
- You shall complete a final study report and/or manuscript in all cases (study completed as per plan or study prematurely terminated).
- Researchers have an ethical duty to publish the clinical research they do.
- Publishing your scientific research can benefit patients and society as a whole – as well as the wider research community.
Request for Proposal (RFP)
Adult PFIC Case Studies
Request for Proposals (RFP) for Progressive Familial Intrahepatic Cholestasis (PFIC)
Odevixibat was FDA-approved for pruritic of Progressive Familial Intrahepatic Cholestasis (PFIC) in the United States in 2021 and cholestatic pruritus of Alagille syndrome in 2023. There is a clinical and scientific need to better understand the real-world clinical experience with odevixibat in these two rare diseases. Given the dearth of real-world evidence, Ipsen recognizes the additional context that case series and case reports may be able to provide to clinical practice and the medical community. As such, Ipsen is issuing a request for proposals (RFP) for case reports and/or case series on the real-world use of odevixibat.
Ipsen will evaluate proposals for case series or case reports on the use of odevixibat for pruritus of PFIC or cholestatic pruritus of Alagille syndrome in routine clinical practice. Proposals must contribute to medical knowledge and have clear educational value.
Each proposal must include the following three elements:
- Scientific Rationale: The underlying hypothesis or reasoning for the case.
- Clinical Context: Relevant patient background and disease characteristics.
- Intervention or Treatment: Description of the use of odevixibat in the case.
Areas of interest include:
- Long term effectiveness and tolerability of odevixibat
- Use of odevixibat following previous treatments for pruritus
- Use of odevixibat across disease severity and/or extrahepatic manifestations
- Impact of odevixibat on biochemical markers of cholestasis and/or liver injury
Instructions:
Email a 1 page proposal and budget to InvestigatorSponsoredStudies@ipsen.com. Proposals should include a publication plan to present findings at scientific/medical congresses and/or publish results in a peer-reviewed journal.
All proposals are due by February 28, 2026. Proposals will then be evaluated by an Ipsen review committee for alignment with areas of interest as noted above. Accepted proposals will be given reimbursement for the use of a third-party medical writing agency.
Additional Requirements:
- All patient data must be de-identified in accordance with applicable data privacy regulations.
- Any adverse events (AEs) described must be reported through appropriate pharmacovigilance channels.
- The HCP must obtain written patient consent for publication of the case report; confirmation must be submitted with the proposal.
- The HCP must provide a financial disclosure statement.
Please reach out to your local Ipsen MSL (Medical Science Liaison) for any questions about the RFP or application process.
References:
Disclaimer
The above information is in line with all appropriate Ipsen Standard Operating Procedures (SOPs) and international best practice guidelines, and this information is provided freely to assist anyone considering submitting an application to Ipsen for support.
ISS only: The decision of when, how, and where to publish the results of an ISS is left completely to the discretion of the investigators.