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)
https://funding.boehringer-ingelheim.com/welcome/us
Research must align to one or more of the following areas of ILD research:
- Studies investigating the natural course of the disease in patients with pulmonary fibrosis, (including risk factors for development of ILD and predictors of disease progression) with and without treatment with approved antifibrotics.
- Studies investigating digital tools or programs to support management of patients with ILDs or studies evaluating interventions (including digital) aiming to support/improve early diagnosis of ILD.
- Studies that investigate the interconnected roles of inflammation and fibrosis in the pathogenesis of pulmonary fibrosis.
- Studies that investigate impact of early diagnosis and treatment of patients with pulmonary fibrosis
- Studies investigating non-pharmacological management of patients with pulmonary fibrosis including supportive and palliative care (e.g., home monitoring programs, telemedicine, nurse support, rehabilitation, physical training, oxygen use, and other innovative digital tools)
- Studies to support the development and evaluation of tools (including digital) that assess patient reported outcomes in patients with pulmonary fibrosis.
- Studies supporting novel imaging tools or algorithms for diagnosis of IPF, PPF, SSc-ILD
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
FAQs
- 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.