Takeda and its alliance partners are committed to improving patient care by supporting scientific advances in medicine and increasing our understanding of important diseases. As part of this commitment, the IISR program supports innovative clinical and basic science studies that address important medical and scientific questions related to our compounds and therapeutic areas of interest.
An IISR is defined as an unsolicited, independent, pre/non-clinical, clinical, outcomes, or disease state research study where the Investigator, organization or institution (academic, private, or governmental) serves as the Sponsor, and Takeda provides support in the form of funding,study drug, and/or authorization to reference Takeda's NDA or other regulatory submissions (e.g., IND).
- Requests for compounds, cell lines and animal models*Clinical
- Clinical trials, observational studies, and patient-reported outcomes research
*Animal models are available for oncology requests only
Please have the following information available at the time of your submission (additional documentation may be requested as applicable):
Study hypothesis (medical/scientific question to be addressed)
Background & rationale
Study design/schedule (including treatments/procedures)
Safety reporting plan (for clinical studies)
Statistical analysis plan
Data management plan
For studies including product, provide:
Updated study documents reflecting amendment requests (e.g. protocol, budget, product request)
Updated ethics approval (after Takeda review and approval of amendment request)