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Galderma Laboratories, L.P. Medical Grants Portal

Galderma Laboratories, L.P. (Galderma) recognizes the importance of supporting activities that enhance and develop the knowledge, skill set, and proficiency of healthcare professionals. We are committed to supporting the medical community and advancing the science of skin health to address patients’ needs. We do this through a variety of mechanisms, such as providing medical grants in the form of funding and/or in-kind product, for Medical Education Activities, clinical research activities, and residency program trainings.

Investigator-Initiated Studies

Galderma Laboratories, L.P. (Galderma) recognizes the importance of supporting Investigator-Initiated Studies (IISs) that have the potential to improve patient outcomes, can advance medical and scientific knowledge about our products, as well as generate promising medical advancements. Results of such research may lead to greater understanding of our therapies and their potential applications, improved patient care, and new ideas for further research.

We accept unsolicited requests for research grants to conduct IISs from academic and community-based clinician-scientists who are interested in conducting their own research. Support is awarded based on the scientific merit of the study, Investigator qualifications, study budget, alignment with Galderma objectives, and site feasibility as reviewed through a formal evaluation process. Galderma may provide funding in the form of monetary support, study product, or a combination of both. While Galderma may provide support, Galderma is not the study Sponsor and will not assume any obligations of the study Sponsor.

Submit a Request

Galderma is interested in research with the potential to improve patient outcomes, can advance medical and scientific knowledge about our products, as well as generate promising medical advancements. Proposals for IISs must align with the company’s defined areas of strategic interest. Currently these include:

  • Prescription
    • Acne
    • Rosacea
  • Aesthetics
    • Hyaluronic acid fillers
    • Poly-L-lactic acid (PLLA)
    • Neuromodulators
  • Consumer Skincare
    • Moisturizers
    • Cleansers
    • Acne Medications

For further information on Galderma’s areas of interest, please visit www.galderma.com/us.

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.

Galderma will not consider requests in support of the following:
  • 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
IIS

Requests for support are submitted in a two-phase process: (1) a Concept Proposal (synopsis) and (2) a Full Proposal (protocol). All requests for support must be submitted through Galderma’s Medical Grants Portal (“Portal”). Requests submitted through any other means will not be accepted. The steps of the 2-phase submission process are further detailed below:

  1. Concept Proposal Submission: A Concept Proposal is submitted in the Portal by an Investigator.
  2. Concept Review: The Concept is routed to an internal committee for review and a written notification of the committee’s decision is sent.
  3. Request for Full Proposal: If the Concept Proposal is approved, a follow-up request for a Full Proposal (i.e., protocol) is issued.
  4. Full Proposal Submission: A Full Proposal is submitted in the Portal.
  5. Full Proposal Review: The Full Proposal is routed to an internal committee for review and a written notification of the committee’s decision is sent.
  6. Letter of Agreement: If the Full Proposal is approved, a Letter of Agreement (LOA) is executed 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 detailed in the LOA.
  7. Provision of Support: Once a LOA is executed and Galderma receives all required documentation, Galderma provides support for the study and the study may start.
    1. Payment: Study payments are broken down into milestones. Once a milestone is completed, the Investigator may submit an invoice for completion of the milestone for the corresponding amount. Milestone payments will vary from study to study. Payments will be made by electronic funds transfer (EFT) to the study Sponsor.
    2. Product: Product will be shipped directly to the Investigator before the study begins. It is the responsibility of the Investigator to notify Galderma of when the first subject is anticipated to receive treatment and request that study product be sent.
  8. Study Completion: The Investigator is required to provide all reconciliations and a study report, within ninety (90) days of study completion. The Investigator must also 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.

Please note that changes may occur as we periodically update our Process.

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.

All requests for IIS support must be submitted through the online portal. Submissions or requests through any other means will not be accepted. An internal committee will review and approve or deny all requests for IIS support; the decision will be communicated directly to the requestor with a notification through the portal. Upon approval of a Concept Proposal, a follow-up request for a Full Proposal (i.e., protocol) will be issued. If the Full Proposal is of interest, a Letter of Agreement (LOA) will be sent to the requestor for execution between the Sponsor, Investigator, and GLLP. Support from GLLP is contingent upon a fully executed LOA and submission of all required documentation. Once the study begins, payments will be made to the Sponsor upon completion of pre-determined study milestones. Upon study completion, the Investigator is required to provide all study closeout documentation including a study report within ninety (90) days, as well as submit the results of the study for publication within six (6) months, whether or not the results are favorable to GLLP or any GLLP product. Please note that changes may occur to our requirements as we periodically update our grants process.
GLLP accepts requests for IIS support on an ongoing basis.
Review times vary; however, typically each phase of review (i.e., Concept Proposal and Full Proposal submission) takes a minimum of 8 weeks.

Requests for support are submitted in a two-phase process: (1) a Concept Proposal (synopsis) and (2) a Full Proposal (protocol). All requests for support must be submitted through Galderma’s Medical Grants Portal (“Portal”). Requests submitted through any other means will not be accepted.

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 Investigator is responsible for ensuring that the study is approved by and subject to continuing oversight by an IRB constituted and operating in accordance with 21 CFR Part 56, and will submit all re-approvals as required by local laws and regulations to Galderma.
The Investigator is responsible for all matters and reporting related to Investigational New Drug Application (“IND”) requirements and Investigational Device Exemption (“IDE”) requirements in coordination with the FDA and an IRB. Upon full execution of a Letter of Agreement (LOA), Galderma may provide a “Right of Reference” letter to the FDA on behalf of the Investigator, as a requirement of the application process.
The Investigator is responsible for registering the study on www.clinicaltrials.gov for any study involving human subjects. The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research efforts, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Also, The International Committee of Medical Journal Editors (ICMJE) requires trial registration for certain drugs and medical devices as a condition of the publication of research results generated by clinical trials.

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.

Galderma is committed to maintaining integrity in all of our professional relationships. We operate under the highest ethical standards and in full compliance with all applicable laws, regulations, industry codes, and guidelines. Approval of funding is never related to or conditioned upon past or future prescriptions or purchases of Galderma products. Furthermore, Galderma does not offer, or provide funding to encourage or to reward the prescription, purchase, ordering, or recommending of Galderma products.

Our grant review and approval process is in full accordance with the recommendations and the guidance of the US Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers Association (PhRMA), the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interaction with Health Care Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Providers, and National Physician Payment Transparency Program: Open Payments “Physician Payment Sunshine Act,” as well as internal Galderma policies.

Research grant support for IISs is never based on or linked to the prescribing, formulary, purchasing, or reimbursement policies or practices of Galderma. In other words, Galderma does not use research grants to generate or reward business from the entity receiving the grant. Galderma does not provide support as a means to:

  • Give preference to high prescribers or purchasers;
  • Fulfill a customer’s business needs;
  • Respond to a customer’s request for product discounts; and
  • Meet a gap with respect to competitor product pricing.

Furthermore, Galderma also may not receive anything of value in return for providing research grant support, which includes but is not limited to:

  • The opportunity to select participating sites or Investigators; and
  • The opportunity to design the study.

Galderma operates in compliance with all applicable laws, regulations, and guidelines, such as the National Physician Payment Transparency Program: Open Payments “Physician Payment Sunshine Act,” the Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers Association (PhRMA) guidelines, as well as internal Galderma corporate policies.

When you submit proposals for review, the information you submit will be used for the sole purpose of evaluating your request for support. 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.

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

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