Investigator-Initiated Studies
In general, IIS are not registrational studies, and they may be proof of concept or exploratory in nature. The budget for these studies should reflect fair market value for all costs, and cannot include direct salary support for the Principal Investigator.
Boehringer Ingelheim may provide financial support and/or drug for an approved IIS. Boehringer Ingelheim does not serve as the regulatory sponsor for IIS. Investigators are required to apply for support via an online application process.
While the research interests listed within the following therapeutic areas are of focus to Boehringer Ingelheim, other research interests may be considered.
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Drug only request:
Explore the effects of empagliflozin on diseases of the cardio-renal-metabolic systems in under-represented populations.
- Studies investigating the natural course of the disease in patients with GPP (including risk factors; predictors, triggers, frequency and impact of flares; symptoms between flares; systemic symptoms; mortality)
- Studies investigating frequency and impact of extracutaneous manifestations and comorbidities (Anxiety/Depression, Cardiovascular Disease) in patients with GPP
- Studies to support the development, evaluation and/or validation of tools that assess patient-reported outcomes in patients with GPP
- Studies investigating the limitations (residual symptoms, incomplete/delayed flare resolution etc) of therapies based on other MOAs used to treat GPP
- Studies investigating pathogenesis of GPP
- Studies investigating incidence and/or prevalence of GPP
- Studies investigating management of patients with GPP, including treatment patterns, supportive and/or interventions to support/increase adherence to treatments (e.g., home programs, nurse support, other innovative digital tools)
Schizophrenia
- Evaluate patient assessment, symptom evaluation, and diagnosis patterns for negative symptoms
- Evaluate patient assessment, symptom evaluation, and diagnosis patterns for cognitive symptoms
- Assess the treatment landscape and trajectory of disease progression for cognitive and negative symptoms
Post-Traumatic Stress Disorder
- Evaluate patient assessment, symptom evaluation, and diagnosis patterns
- Assess the treatment landscape and trajectory of disease progression
- Evaluate disease progression with respect to index event
Digital Therapeutics
- Increase the clinician's awareness of the current unmet medical needs and burden of disease in patients with schizophrenia, including cognitive and negative symptoms associated with schizophrenia as well as the potential utility of digital therapeutics in psychiatry, including schizophrenia.
- Improve the clinician's understanding of the management and limitations of treating cognitive and negative symptoms of schizophrenia, as well as ongoing developments in clinical research in schizophrenia and digital therapeutics in psychiatry.
Major Depressive Disorder
- Evaluate patient assessment, symptom evaluation, and diagnosis patterns
- Assess the treatment landscape and trajectory of disease progression
Proposals in the following areas are not being considered:
Biosimilars, Fibrosing ILDs
FAQs
Yes. Boehringer Ingelheim requires applications to be submitted online via our Grants and Funding portal. Applications received through other means will not be considered.
Yes. You may apply on behalf of the Sponsor-Investigator, providing the Sponsor-Investigator’s information within the application as requested.
In general, grant funding to support clinical (interventional and non-interventional) and health outcomes research studies are all acceptable proposals. Requests for Proposals (RFPs) may include more specificity.
Required documents include a fully executed contract between Boehringer Ingelheim and the investigator’s institution, regulatory documents (IND or exemption), and a copy of the institutional review board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval.
You do not need to complete the entire application in one session. You are able to save your work by clicking “Save Draft.” You can make changes to the application prior to submitting. However, once you submit your application, it will be locked from editing.
- Please submit a detailed Excel budget sheet.
- Budgets must be developed based on activities, services and consumable supplies directly related to the project. Direct support for Principal Investigator salary will not be accepted. Cost effectiveness of the project will be considered in the overall evaluation. If your application is approved, as part of the fair market value assessment, applicants may be asked to provide written justification for facilities and administrative costs.
- Overhead rate – BI will support a maximum overhead rate of 50%.
- This 50% cap is intended to provide greater funding to support proposed research activities.
- The overhead rate is only applicable to total direct study costs and will not be paid on indirect study costs.
- If your institution’s overhead rate exceeds 40%, BI will require a copy of the exemption letter.
