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Astellas is committed to providing benefit to patients, healthcare professionals, and the community through quality research.
Supporting external medical and scientific organizations in their independent research activities is an important way for Astellas to deepen understanding of patient needs, advance scientific knowledge, and improve health outcomes.
The purpose of this policy is to define the standards that govern the relationship between Astellas and the external third-party (Sponsor‑Investigator or Institution) who engage in ISR.
Astellas principles for support of ISRs include transparent and documented procedures that support compliance with applicable laws, regulations and industry codes.
In alignment with this policy, all ISR concepts and proposals must be unsolicited, and all study ideas, concepts and proposals must originate from an external third-party which is unrelated to Astellas.
The policy applies to ISRs for both clinical and non-clinical research on products for which Astellas is the marketing authorization holder as well as in associated disease areas.
ISRs may be initiated by a single investigator/physician, a medical network, a not‑for‑profit or academic organization or institution, a consortium, or a cooperative group. These parties act as the Sponsor of the research.
Sponsors may request drug supply, financial support, or both to conduct their research.
The Sponsor retains full sponsor responsibilities for the study—regardless of the level of support provided by Astellas—and is accountable for all aspects of the proposal, including study design, implementation, conduct, data analysis, and dissemination.
Sponsors must also ensure compliance with all applicable laws and regulations and hold the Investigational New Drug (IND) application or equivalent, if required.
To guarantee ISR independence, ISR must be submitted via the Astellas ISR Portal. The ISR Portal is a secure, web-based system managed by Astellas.
Only a proposed ISR submitted via the ISR Portal will be considered for potential support.
Astellas Medical Affairs is responsible for supporting ISRs and overseeing the internal processes that govern their submission, review, approval and monitoring of progress.
All ISR submissions undergo review by a cross‑functional scientific review committee.
If an ISR proposal is approved, a fully executed written agreement—detailing the responsibilities of the Sponsor —must be in place before the study can begin.
Once an agreement is executed, Astellas will maintain periodic communication with the Sponsor to monitor study progress.
Astellas Commercial personnel are not permitted to participate in any ISR activities, including initiation, submission, review, approval, or ongoing management.
Astellas will review any publications submitted by the Sponsor. This review is limited to factual verification related to Astellas products, intellectual property considerations, safety/pharmacovigilance requirements, and appropriate disclosure of Astellas support.