Eisai’s IIS program is focused on the following areas of therapeutic interest for which grant applications are currently being evaluated:
- Epilepsy (Regions/Countries Outside the U.S.)
- Insomnia (Drug Only)
- Breast Cancer
- Endometrial Cancer
- Hepatocellular Carcinoma
- Renal Cell Carcinoma
- Soft Tissue Sarcoma
- Thyroid Cancer
Investigator Initiated Study (IIS) research types that may be considered for funding include, but are not limited to:
- Pre-Clinical Studies
- Prospective Clinical Studies
- Retrospective Studies
Eligible Grant Recipients
Applications are evaluated based upon therapeutic area relevance and applicability, support of product or compound goals, scientifically compelling and innovative research that is congruent with the strategic focus for the product or compound in question, sound science, cost effectiveness and feasibility of proposal.
The following factors are considered by the IIS Committee when determining whether a grant applicant is qualified to receive an IIS research grant:
- Appropriate credentials, education and reputation (including valid medical license for Clinical IIS, lack of FDA debarment/disqualification and disciplinary action by a professional licensing body)
- Demonstrated relevant experience, including publications in peer-reviewed journals and prior research
- Clinical or research background, training and knowledge of disease or therapeutic area in which the research will be conducted
- Ability and potential to successfully conduct the research for which the funds are requested (including staffing and site resources)
- Ability to provide scientifically compelling and/or novel research to Eisai
Ineligible Grant Recipients include, but are not limited to:
- FDA debarred /disqualified or federally excluded individuals and organizations or individuals or organizations with disciplinary action by any professional licensing body
- Institutions who have been previously awarded IIS grants but who have not fulfilled their contractual obligations to Eisai
- Eisai will not provide funding and/or drug supply, or be responsible for providing funding and/or drug supply for any grant applications until
- a complete grant application has been properly submitted;
- the grant application has been approved by the Eisai IIS Committee;
- an agreement between Eisai and the grant applicant, in a form acceptable to Eisai, has been executed
- Grant applicants must complete the Eisai budget template included with the application
- Grant recipients are required to provide a final study report upon completion of the grant study
- Eisai’s support of the study must be clearly acknowledged and disclosed in all publications and presentations of the study data and results
- THE IIS APPLICANT IS SOLELY RESPONSIBLE AND HAS FULL CONTROL OVER THE PLANNING AND EXECUTION OF THE STUDY
- Applicant must complete the following and submit all documents to the IIS email: email@example.com
- Download and Fill-out the IIS Application. If funding is requested, download and Fill-out the IIS Budget Detail
- Create and sign an IIS Cover Letter including the following information:
- A statement requesting the funds and a short description of the IIS application
- A statement declaring to whom the funds should be paid to (provide contact and address details).
- Signed by the appropriate representative
- The subject line of the letter should read as follows: “Subject: IIS Application; <Product Name>; <study title>"
- Include full contact information
- E-mail the IIS Application, IIS Budget Detail, Cover Letter, CV’s and Medical Licenses for any Investigators participating in the study to the following email address firstname.lastname@example.org
- Once your application has been submitted, the Eisai IIS Administrator ensures the documents have been correctly completed and forwards the request to the IIS Committee for Review
- The IIS Administrator notifies the Applicant whether or not the grant has been approved or denied. Approval is always on a conditional basis, subject to the execution of an Agreement, in a form acceptable to Eisai.
- If the application is approved, the IIS Administrator oversees the process of generating a written agreement between Eisai and the applicable requesting organization.
- Upon contract execution, IIS Administrator arranges for issuance of payment(s) and/or drug supply as per contract requirements.
- ALL MATTERS RELATING TO INVESTIGATOR INITIATED STUDIES (IIS) MUST BE DIRECTED TO AND HANDLED BY THE RESPONSIBLE IIS ADMINISTRATOR.
To begin your oncology IIS grant application, please click on this link. You will be directed to the Eisai Oncology IIS VisionTracker Portal for preparation and submission of an electronic application.
Please note that the following documents will need to be attached in the designated fields or attachment section of the system.
- Budget Spreadsheet using the Eisai Template available for download in the system
- Copy of Your CV
- Copy of Your Medical License (for Clinical IIS)
Link to Oncology IIS VisionTracker Portal: https://eisai.envisionpharma.com/ienv_eisai/visiontracker/portal/login.xhtml?pgm=IIS
Investigator Initiated Studies (IIS) Committee Meetings
The IIS Committee meets on a regular basis to review eligible applications. IIS applications will be reviewed in the order in which they are received. You will receive a notification once your application has been accepted and is scheduled for review.
Meetings for EPILEPSY occur every other month
Meetings for ONCOLOGY occur on a quarterly basis
Meetings for INSOMNIA occur every other month