Investigator-Initiated Research (IIR) Program
Kedrion Biopharma welcomes unsolicited research proposals from qualified 3rd party investigators as part of our commitment to bring innovative plasma therapies to patients in need. Kedrion Biopharma recognizes the importance of supporting investigators in order to broaden understanding of Kedrion Biopharma’s products and generate ideas for further clinical research. The IIR Program is designed to help us achieve our overarching goal: to improve patient care.
Types of Funding Available
IIR funding is available to provide product and/or financial support for Phase 4 studies involving Kedrion’s products approved for use in the US. Kedrion will evaluate funding requests based on scientific merit and alignment with our strategic interests:
- Other Bleeding Disorders
- Hyperimmune Globulin Therapy
- Critical Care
To request product and/or funding for in vitro or in vivo animal studies, please contact Kedrion Biopharma Medical Affairs.
The Review Process
- Investigators will first submit a brief Concept Proposal, which is designed to provide Kedrion Biopharma with enough information about a proposed study to determine whether a request for a Full Research Proposal is warranted. Submitted Concept Proposals will be reviewed and an answer provided to the investigator within 14 days.
- Sponsors of approved Concept Proposals will be invited to submit a Full Research Proposal. Formal notification of award of funding for a Full Research Proposal will be made when a decision is reached.
- Kedrion Biopharma will acknowledge receipt of all completed submissions. Proposals will be reviewed by the Kedrion Biopharma IIR Review Committee and decisions will be made based upon scientific merit, quality of study design, alignment with Kedrion Biopharma’s strategic interests and the amount of funding requested. Sponsors will be notified of the outcomes of all proposal reviews.
Investigators must be medical professionals with the demonstrated ability to initiate, design, and carry out scientific research. All study personnel must attest that they have not been subject to disqualification action by the FDA or excluded from US Federal Healthcare programs.
To learn more: The Kedrion Biopharma Medical Affairs Team is available to guide you through the IIR application process.
The Kedrion Biopharma IIR Program is intended only for unsolicited funding requests for research by Healthcare and Research Professionals in the US.