Bayer Support of Investigator Initiated Research

IIR

Welcome to the Bayer Pharmaceuticals website for Investigator Initiated Research (IIR). Bayer is committed to the improvement of healthcare by the support of independent research proposals, which further increase knowledge and understanding of different disease areas and treatment options.

Bayer will have no role in the planning or conduct of the study. Bayer will support suitably qualified Investigators / Institutions in pursuing their own research interests, which are of scientific merit and promote legitimate research goals.

Due to certain country specific regulations, in certain countries investigators are asked to submit proposals via their local affiliates.

This site can not be used to report adverse events or product related quality complaints

IIR Definition

Investigator / Institution Initiated Research (IIR): Investigator Initiated Research encompasses any research activity both initiated and conducted by a party outside of Bayer Pharmaceuticals. The requirements applicable to this external party are those applicable to an Investigator and a Sponsor as required by applicable law and regulations. The research may include clinical or non-clinical activities.

Investigator: The Investigator is an individual, a company, institution, or organization responsible for the initiation, management, and conduct of the research activity. If the research activity is conducted by a team of individuals, the Investigator is the responsible leader of the team and may be called the Principal Investigator. The Investigator(s) is / are external from Bayer Pharmaceuticals.

Sponsor: In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial but does not actually conduct the investigation.

GCP: Good Clinical Practice (GCP) is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies.

General

Bayer Areas of Interest for IIR

The information on therapeutic area interests are outlined below. Please note that Bayer can only support IIRs which are in line with Bayer´s IIR strategy for each therapeutic area and which contribute to the generation of valuable data.

Pulmonology: Pulmonary Hypertension including Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH).

Infectiology: in vitro resistance, animal models of infection pharmacodynamics and pharmacokinetics, in vitro and animal models studies addressing specific mechanisms of resistance and non-clinical and clinical research in Chagas’ Disease.

Diagnostic Imaging: Studies using Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Angiography, Positron Emission Tomography (PET).

Hematology: Hemophilia A, bleeding disorders.

Multiple Sclerosis: Treatment adherence and biomarkers.

Oncology: All indications would be considered based upon scientific rationale and strategy of the compound/product. IIRs requests using niclosamide will not be considered.

Ophthalmology: Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Central Retinal Vein Occlusion (CRVO), Macular edema secondary to branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).

Thrombosis: Venous thromboembolism prevention (including orthopaedic surgery, treatment of venous thromboembolism, Stroke Prevention in Atrial Fibrillation, Secondary Prevention of Acute Coronary syndrome.

Cardiorenal: Patients without ACEi/ARB, Combination therapies (except ACEi/ARB), Mechanistic studies regarding Mode of Action, Proof of concept studies in Kidney Transplant, Pulmonary Fibrosis, NASH & Chronic Dialysis.

Women’s Health: Oral and intrauterine contraception, endometriosis and fibroids.

IIR Process Overview with Timelines

PROCESS STEP	INVESTIGATOR ACTIVITIES	BAYER ACTIVITIES	TYPICAL TIMELINE
Pre-check & Submission	Develop study idea Potentially initiate proposal pre-check Mont Blanc is Bayer's IIR electronic approval and tracking system Register account access in Mont Blanc here Submit complete proposal via Mont Blanc after registration is complete Please refer to the Checklist for Submission section for more details	Potentially pre-check general feasibility of study prior to submission Provide information upon request Acknowledge received submission	Mainly dependent on sponsor’s/ Investigator’s timeline
Revew and Approval / Rejection	Confirm final proposal, provide missing information as required (followed by re-submission)	Evaluate proposal, typically on country and global level Clarify questions and provide recommendations Report on decision of internal review process (fully/partly agreed or denied)	1.5 – 2 months
Contracting	Involve legal sponsor of the study (institution) to negotiate contract (template will be provided by Bayer) and conclusion (including ethical and regulatory approval)	Negotiate contract with the study’s legal sponsor/ institution.	First draft of agreement after 15 calendar days; response expected in following 15 calendar days; total duration of contracting process depends on intensity and pace of negotiations
Study Realization	Conduct study Provide status update Adverse Event (AE) reporting as needed	Monitor study progress (e.g. milestone checks) Maintain dialogue with sponsor/ Investigator and provide ongoing support as needed	Dependent on study
Study Conclusion (or early termination) and Publication	Complete study Develop complete clinical study report and publish results	Follow up on publication status Process study conclusion/ early termination	Dependent on study & resources; the final study report or publication manuscript should be submitted to Bayer within 1 year after study conclusion

Tools

Checklist for Submission to Mont Blanc:

In the Mont Blanc electronic approval and tracking system you will be asked to provide the following:

Create a study concept in Mont Blanc
Attach one of the below IIR assessment templates
- Clinical
- Pre-Clinical
Please attach the investigator's Curriculum Vitae

Checklist for Contracting:

Complete study synopsis
Feasibility of study site for confirmed
Intellectual Property (IP) requirements
Adverse event reporting to be confirmed
Safety reporting requirements
Regulatory requirements
Milestones and payments to be agreed
Early termination agreements
Publication requirements
Signature from legal sponsor/institution supporting the study

Checklist for Study Conclusion

Final study report or a final draft for study publication
Publication (ideally in a peer review journal in a timely fashion)
Final payment within a year of study completion

Local Bayer medical affiliates will support the investigator with the IIR submission process as needed.
Please contact your local point of contact for any concerns and questions throughout the submission process.

Assessment Criteria List

Evaluation Criteria
Please be aware that acceptance is dependent on a number of factors. The most important ones are:

IIR Medical Value

Medical value of the study – addresses area of medical need unmet
Alignment with company therapeutic areas of interest
Value of Scientific output – generates peer reviewed publication

IIR Technical Quality

Sound study design
Investigator experience
Structural feasibility – adequate sample size, appropriate resource outlined in proposal.
Appropriate compliance with relevant regulations.

*Please note that the approval of studies is dependent on availability of budget

Requirements for Successful Collaboration

Prior to Study Start:

Plan timelines realistically
Diligently plan budget based on Fair Market Values and use the “request for financial support of IIR” template to request financial support
Clarify availability of internal resources
Ensure study site is appropriately resourced for study feasibility
Obtain necessary approvals as applicable
Ensure that submission is complete – take advantage of a pre-check
Contact legal sponsor/ institution early on

During Study Conduct:

Changes to the original proposal, including requests for financial support, cannot be changed during study conduct without re-submission and Bayer internal re-assessment of the changed details
Provide regular updates to Bayer and contact your local point of contact early on with any questions or concerns
Ensure full documentation
Send proof of services for initiation of payments

Contact

In case you would like to get in contact with a Bayer representative for questions or clarifications, please submit your request via the support.montblanc@bayer.com.