As part of our commitment to delivering innovative therapies to patients and advancing the scientific understanding of immuno-oncology, Istari believes in supporting ethical, independent, unsolicited research conducted by qualified third-party investigators.
The value of the scientific research produced by these investigators is key to complementing Istari-sponsored research by helping to ensure we better understand the benefit/risk profile of our therapies, as well as enabling us to explore new opportunities addressing unmet medical needs.
We welcome unsolicited proposals from qualified sponsors with promising ideas in our areas of strategic interest (see “General areas of strategic interest” below). Well-written, scientifically sound studies that enhance the understanding of our investigational products, improve patient care, and spark new ideas for disease-related research will be considered. Our medical science personnel are available to guide you through the process, from concept preapproval to submitting the final budget and protocol.
If you have questions or would like to discuss your concept, please contact us or reach out to your known Istari clinical or scientific representative.
Investigator-initiated studies (IIS) are studies initiated, developed, designed, and managed by a qualified sponsor who assumes sole responsibility for conduct and management of the study (including regulatory obligations, etc). Istari will consider working with a broad range of sponsors including but not limited to the following:
Support for an approved IIS may come in various forms including supplying drug products, funding, materials, and/or information as allowed under local laws and regulations. Projects proposing provision of external support will also be considered (eg, grant or institutional funding, materials, use of core services, and support provided by other collaborators/organizations).
The following are not considered investigator-initiated studies: access to investigational medicines through compassionate use or expanded access. Details on these programs can be found here.
All investigator-proposed research must offer meaningful scientific and/or clinical objectives supported by clear and valid study designs in which the privacy rights, safety, and welfare of participants is of paramount importance, as applicable.
Requirements of a sponsor/investigator for Istari to consider supporting an IIS proposal include but are not limited to the following:
Istari’s general areas of strategic interest include but are not limited to IIS in the following areas:
There are 3 main steps in our IIS approval process, and our medical science personnel are available to guide you.
Contact us to request a consult or discuss with your existing clinical or scientific affairs contact. Your representative will discuss your concept with the core IIS review team and provide you with feedback. If there is interest, a concept form (see example) and instructions on how to submit your initial concept proposal in the IIS portal will be provided.
Submit the details of your proposed concept in the IIS portal for consideration by the study review team.
If your proposed concept is approved, you will be provided with the application and link to submit the full proposal with additional details, including final protocol and other pertinent information as applicable (eg, informed consent) and an itemized budget via the IIS portal.
Proposals will be reviewed and approved based on scientific merit and alignment with Istari’s areas of strategic interest. We evaluate all funding requests against local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.
Accepted projects will then move through the following stages:
Please contact us or your known Istari clinical or scientific representative with any questions.