Investigator Initiated Studies (IIS)

The Boehringer lngelheim IIS Program is offered to all qualified academic and community-based scientists or consortia who are interested in independently proposing and conducting their own research. Boehringer lngelheim may provide financial support and/or drug product for an approved IIS. Boehringer lngelheim does not serve as the Regulatory Sponsor for IIS.

In general, IIS are not registrational studies and may be proof of concept or exploratory in nature. The budget for such studies should reflect fair market value for all costs, and cannot include direct salary support for the Principal Investigator.

Boehringer lngelheim requires Investigators to apply for support via an online application process. Investigator applications received through other means will not be considered for review.

While the research interests listed within the therapeutic areas are of focus to Boehringer Ingelheim, other novel research interests may be considered.

External Research Quick Reference Guide ClinicalTrials.gov

Cardiometabolism

Type 2 Diabetes

(Drug only requests are being considered. Financial funding is not being provided.)

Exploring the Effects of Empagliflozin on the Cardiovascular System

New insights in the mode of action, potential pleiotropic effects, biochemical pathways and clinical effects of SGLT-2 inhibition with empagliflozin focusing on micro and macro vascular function, heart failure, cardiovascular risk and other diabetic complications in T2DM and earlier stages of the disease

Exploring the Effects of Empagliflozin on the Renal System

New insights in the mode of action, potential pleiotropic effects, biochemical pathways and clinical effects of SGLT-2 inhibition with empagliflozin focusing on kidney pathophysiology in T2DM and earlier stages of the disease

SGLT-2 Inhibition with Empagliflozin in Combination with Other Mode of Actions

Investigation of SGLT-2 inhibition effects of empagliflozin, e.g. in combination with DPP-4 inhibitor linagliptin, on metabolic control and the cardio-renal-axis in T2DM and earlier stages of the disease

Oncology

Solid Tumors

For drug only support, a submitted synopsis will be evaluated on an ongoing basis for strategic interest. Where interested, Boehringer Ingelheim will request a full proposal submission. All proposals will be reviewed on an ongoing basis; generally monthly.

For requests involving financial support, Boehringer Ingelheim will evaluate a synopsis application on an ongoing basis for strategic interest. Where interested, Boehringer Ingelheim will request a full proposal submission.

Afatinib IIS & ECR Objectives

Safety and efficacy of alternate dosing regimens (e.g., lower starting dose, treatment holidays, etc.)
Tumors driven by dysregulation of ErbB family members other than EGFR (e.g., HER2, HER3, HER4)
- non-T790M acquired resistance to 1st/2nd generation EGFR TKIs
- acquired resistance to 3rd generation TKIs following either first or second line use

Established Products

Aspirin/extended-release dipyridamole IIS Objectives

Evaluate potential clinical and non-clinical investigations involving COVID-19 related matters including safety, clinical outcomes, antiviral effects, or antithrombotic benefits.

Respiratory

IIS

1. Evaluate potential clinical and non-clinical investigations involving LAMA or LAMA/LABA in COVID-19, including safety and clinical outcomes.

Biosimilars/CNS/Immunology

(Currently, proposals are not being accepted in this area at this time)

Cardiovascular

(Currently, proposals are not being accepted in this area at this time)

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