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.
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 |
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Pre-check & Submission |
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Mainly dependent on sponsor’s/ Investigator’s timeline |
Revew and Approval / Rejection |
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1.5 – 2 months |
Contracting |
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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 |
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Dependent on study |
Study Conclusion (or early termination) and Publication |
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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
- Please note: You will receive access to the IIR assessment templates after you have registered in Mont Blanc. If you have any further questions, please contact support.montblanc@bayer.com.
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