Investigator-Initiated Studies

The following IIS study types may be considered for support:

• Prospective clinical or preclinical studies involving Galderma products
• Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease
• In vitro and in vivo studies

We do not provide support for the following:

• Proposals that are not aligned with our current areas of interest
• Studies that have already started or are completed
• Proposals that are conditioned upon past or future prescriptions or purchases of Galderma products
• Requests that create a conflict of interest for Galderma

The following information is required for a concept proposal:

• Study Title
• Study Type
• Indication/Therapeutic Area
• Scientific Background & Rationale
• Primary & Secondary Objectives and Endpoints
• Study Design/Methodology
• Study Duration
• Type of Support Requested (funding, study product, or both)
• Contact Information for the Sponsor, Investigator, and Study Coordinator
• Curriculum Vitae for the Sponsor, all Investigators, and the Study Coordinator (to include publications, trainings on ICH GCP, and clinical trials)
• Medical Licenses for all Investigators

Please note that changes may occur to our requirements as we periodically update our process.

If the initial concept is approved, a follow-up request for a full proposal and protocol will be issued. The following information is required for a full proposal:

• Further Details of Study Drug, Treatment and Comparator (if applicable)
• Timeline and Schedule of Events
• Study Endpoint Analysis
• Safety Plan
• Statistical Plan
• Data Management Plan
• Publication Plan
• All-Inclusive Itemized Budget Based on Fair Market Value (FMV) Costs (if funding is requested)
• Detailed Protocol

Please note that changes may occur to our requirements as we periodically update our process.

If the full proposal is approved, a contract will be sent for execution between the sponsor, investigator, and Galderma. Support is contingent upon a fully executed contract, compliance with the terms and conditions of the contract, and submission of the following required documentation:

• IRB/EC Approval Letter and Final IRB Approved Protocol
• IND/IDE Application Submission to FDA, if applicable
• Registration on ClinicalTrials.gov, if applicable
• Institutional Sub-W9

We will consider reasonable requests for funding in support of an IIS. All full proposal submissions must include an itemized budget with costs based on fair market value (FMV) evaluations to ensure that the amount of support is appropriate. Requestors may use their own template or the Galderma template that is provided here. Line item allocations should be specified for each aspect of the study, such as study start-up fees (e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs (e.g., medical writer).

For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of choice. Please note that we do not provide support for the following:

• Salary and/or benefit payments for Investigators or study staff
• Education/training activities
• Costs that are deemed in excess of fair market value
• Capital equipment purchases (associated rental fees will be considered)
• Construction funds to build new facilities

Galderma accepts requests for monetary and/or in-kind product support for IISs. Researchers may request support for the following types of studies:

• Prospective clinical or preclinical studies involving Galderma prescription, consumer, or aesthetic products;
• Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease; or
• In-vitro and in-vivo studies.

Galderma supports multi-site studies. However, it is the responsibility of the Investigator to coordinate shipment of study product to other investigational sites.

Galderma may provide in-kind product in support of an IIS. To view our current portfolio of products that are available for request, please visit www.galderma.com/us.

• Support or payments made directly to HCPs or other individuals
• Salary and/or benefit payments for Investigators or study staff
• Education/training activities
• Costs that are deemed in excess of fair market value
• Proposals that are not aligned with Galderma areas of interest
• Capital equipment purchases (associated rental fees will be considered)
• Studies that have already started or are completed
• Proposals that are conditioned upon past or future prescriptions or purchases of Galderma products
• Requests that create a conflict of interest for Galderma
• Non U.S.-based HCPs or research

Galderma accepts requests for support on an ongoing basis.

You will receive a notification email confirming the submission of each request for support (i.e., after the submission of a Concept Proposal, and after the submission of a Full Proposal)

You may log into the Portal at any time to check the current status of each submitted request.

Once you complete each phase of the submission, no changes can be made. However, if the internal committee requires clarification or has questions about a Concept or Full Proposal, a "Request for Additional Information" will be issued.

Review times vary. Typically, each phase of the process (i.e., Concept Proposal and Full Proposal submissions) takes a minimum of 12 weeks. Additional processing time may also be needed around company and national holidays. Please note that Grant Requests may be declined due to insufficient processing time.

A "Request for Additional Information" is sent when additional information is needed in order for the internal committee to make a determination regarding support. If the additional information provided is insufficient or not received in a timely manner, the request may be denied.

Academic and community-based clinician-scientists who are interested in conducting their own research may apply for IIS support. Qualified individuals should have basic knowledge of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) Good Clinical Practice (GCP) as evidence by training on ICH GCP, have recent, prior clinical research experience as a Primary or Sub-Investigator, as well as have recent publication or presentation experience involving the results of clinical research.

The following information is required to submit a Concept Proposal:

• Study Title
• Study Type
• Scientific Background & Rationale
• Primary & Secondary Objectives
• Primary & Secondary Endpoints
• Study Design/Methodology
  • Study Design
  • Study Setting
  • Study Population
  • Number of Subjects with Rationale
  • Inclusion/Exclusion Criteria
• Indication/Therapeutic Area
• Study Duration
• Number of Study Visits
• Name of IRB
• Type of Support Requested from Galderma (monetary support, study product, or a combination of both)
• Curriculum Vitae for the Sponsor, all Investigators, and the Study Coordinator (to include publications, trainings on ICH GCP, and clinical trials)
• Medical Licenses for all Investigators

Please note that changes may occur to our requirements as we periodically update our process.

Following the review of the Concept Proposal, Requestors are notified of the decision from the committee. If a Concept Proposal is of interest, a follow-up request for a Full Proposal (i.e., protocol) will be issued. In addition to expanding upon the components of the Concept Proposal, the following information is required to submit a Full Proposal:

• Further Details of Study Drug, Treatment and Comparator (if applicable)
  • Description
  • Treatment/No Treatment Regimen
  • Permitted/Prohibited Concomitant Medications
• Timeline and Schedule of Events
  • Study Visits and Procedures
  • Duration of Enrollment
  • Duration of Treatment
  • Duration of Follow-up
• Primary and Secondary Endpoint Analysis
• Safety and Adverse Events
  • Adverse Events of Special Interest
  • Reporting Procedures
• Statistical Plan
• Sample Size and Power Analysis Justification
• Publication Plan
• Specific Support Requested from Galderma
• All-Inclusive Itemized Budget Based on Fair Market Value (FMV) Costs (if monetary support is being requested)
• Detailed Protocol

Please note that changes may occur to our requirements as we periodically update our process.

Galderma will consider reasonable requests for funding in support of an IIS. All Full Proposal submissions must include an itemized budget with costs based on fair market value (FMV) evaluations to ensure that the amount of support is appropriate. Requestors may use the Galderma template that is provided here, however other templates are accepted as well. Line item allocations should be specified for each aspect of the study, such as study start-up fees (e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs (e.g., medical writer).

For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of choice. Please note that the following costs will not be supported by Galderma and should not be incorporated into study budgets:

• Salary and/or benefit payments for Investigators or study staff;
• Education/training activities;
• Costs that are deemed in excess of fair market value;
• Capital equipment purchases (Associated rental fees will be considered); or
• Construction funds to build new facilities.

Following the review of the Full Proposal, Requestors will be notified of the decision from the committee. If the Full Proposal is approved, a Letter of Agreement (LOA) will be sent for execution between the Sponsor, Investigator, and Galderma. Support from Galderma is contingent upon a fully executed LOA, compliance with the terms and conditions of the LOA, and submission of all required documentation as listed below:

• IRB/IEC Approval Letter and Final IRB Approved Protocol;
• IND/IDE Application Submission to FDA, if applicable; and
• Registration on www.clinicaltrials.gov, if applicable.
• Please note that the study Sponsor and Investigator(s) must agree to conduct the study in accordance with ICH GCP Guidelines and all applicable local, state, federal laws, rules and regulations.

The study Sponsor and Investigator must ensure that the study is conducted in accordance with ICH GCP Guidelines and all applicable local, state, federal laws, rules and regulations. The Investigator must assume all regulatory responsibilities including, but not limited to, obtaining all IRB/IEC approvals and re-approvals, regulatory approvals including IND/IDE submissions, and all safety-reporting obligations to local regulatory authorities, as well as, to the FDA and Galderma. Investigators are also required to:

• Register the study on www.clinicaltrials.gov, as well as, provide status updates and post-study results, (for trials involving human subjects);
• Clearly label all product, "For Investigational Use Only" so that the product is clearly identified as product being used in a clinical study and is not for commercial use;
• Immediately notify Galderma of any protocol amendments submitted to the IRB/IEC;
• Notify the FDA, IRB, and Galderma of any severe adverse event possibly related to a study product for any study within 24 hours of receiving notification of such an event;
• Submit frequent progress reports to Galderma regarding study status;
• Submit all study close-out documentation to Galderma within 90 days of study completion;
• Submit the results of the study for publication within six (6) months of study completion, whether or not the results are favorable to Galderma or any Galderma Product; and
• Comply with all terms, conditions, and requirements of the LOA.

The Investigator must submit the following updates to Galderma while the Study is ongoing:

• Amendments to Study Approval;
• Safety Reporting;
• Pre-Publication Review; and
• Progress Reports.

The Investigator is contractually obligated to provide Galderma with all study closeout documentation within ninety (90) days of study completion. If Galderma does not receive the required study closeout materials, you will not be eligible to apply for future support. Additionally, for research support that includes funding, the final milestone payment is dependent on proof of submission for publication or presentation of study results within 6 months of study completion. Study closeout documents include:

• Study Report;
• Budget Reconciliation;
• Product Reconciliation;
• Adverse Event Reconciliation; and
• Evidence of Submission for Publication.

The Investigator will immediately notify Galderma of any action to amend the study protocol, and of any required periodic updates from regulatory authorities.

The Investigator will ensure that all adverse events whether related or unrelated to study product, are reported according to the terms of the study protocol. The Investigator will report all serious adverse events (SAE) to the FDA, IRB, and Galderma. The Investigator will also provide a complete reconciliation of all adverse events as part of the study closeout documentation.

Selection and submission for publication/presentation is at the discretion of the Investigator; however, submission to a peer-reviewed journal is required to receive support from Galderma. All publications should comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors.

A copy of all draft publications that report the results of Galderma supported IISs must be sent to Galderma at least thirty (30) days in advance of submission for publication to allow Galderma to conduct a courtesy review. Additionally, Galderma must receive evidence of submission for publication no later than six (6) months following completion of the study. For research support that includes funding, the final milestone payment is dependent on submission for publication or presentation of study results.

Reports noting study progress and/or reaching any major milestones (e.g., IRB approval, first subject in, last subject in, last subject out, etc.) will be sent to Galderma by the study Investigator. Progress report timing will be dependent on the length of the study and may be monthly, bi-monthly, or quarterly. A failure to provide progress reports or provide notification of attaining a major milestone may be interpreted as a lack of study progress and could result in support being withdrawn.

The Sponsor will provide Galderma with written report of the Study results in accordance with the ICH Guidance for Structure and Content of Clinical Study Reports.

Reports certifying that all support was used in accordance with the study and declaring any unused funds or product to return/destroy will be sent to Galderma following the completion of the study. The Sponsor will be required to refund unused grant funds, or return/destroy unused or partially used product after the study is completed.

By submitting materials for review, you agree that the information is not confidential, nor proprietary, and may be referred to a number of different persons at Galderma to determine the level of interest in supporting your request. A Confidential Disclosure Agreement (CDA) will be executed between parties for each submitted concept.

Publications or other presentation of data derived from the IIS must be marked with an acknowledgement that the study was conducted with financial and/or in-kind support from Galderma, as a collaborator.