LEO Pharma Medical Grant and IIS Portal

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Investigator-Initiated Studies

At LEO Pharma, we are committed to advancing medical knowledge and improving patient care through research. Our Investigator Initiated Studies (IIS) program is designed to support independent research that aligns with our mission and therapeutic areas of interest.

What are Investigator Initiated Studies?

Investigator Initiated Studies are research activities conceived and conducted by independent Investigators or academic institutions. These studies play a crucial role in exploring new scientific insights, treatment approaches, and patient outcomes.

Our Commitment

LEO Pharma is dedicated to fostering innovation and scientific excellence. We support IIS through funding and/or study drug supply. The value of Investigator-initiated research is key to complementing LEO Pharma-sponsored studies, helping us better understand the benefit/risk profile of our therapies and explore new opportunities to address unmet medical needs. Our goal is to empower researchers to pursue novel ideas that can lead to significant advancements in dermatology and other therapeutic areas.

Research Requirements

LEO Pharma is committed to supporting ethical, independent clinical and non-clinical research conducted by qualified Investigators. Proposed research must offer meaningful scientific objectives and be supported by a valid study design. Additionally, the privacy rights, safety, and welfare of patients and animals must be fully secured.

Types of IIS eligible for support:

• Clinical studies of approved and investigational uses, involving marketed LEO Pharma drugs (interventional studies phase ii to iv)
• Clinical observational studies, real world evidence (non-interventional studies)
• The following types of support are out of scope:
  • Non-clinical studies requests
  • Requests for compassionate use

The sponsor/investigator has to fulfil (or agree to) the following requirements:

• Have the scientific, technical and operational capabilities to conduct a study as a sponsor, including adequately trained staff to execute a study (GCP, GMP, etc.)
• Have expert statistical support
• Submit a scientifically well designed and well-written study proposal
• Deliver to agreed timelines
• Be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final study report and manuscripts etc.)
• Deliver a written report of the final study results to LEO Pharma
• Publish the study in a peer reviewed scientific journal
• Agree to safety reporting to health authorities and to LEO Pharma
• Agree to provide study updates to LEO Pharma

Areas of Research Interest​ (click to see full list)

How to apply for IIS support

Researchers interested in submitting a proposal for an Investigator Initiated Study can follow these steps:

1. Prepare your proposal: Include a detailed study plan, objectives, methodology, and budget.
2. Submit your proposal: Either reach out to your local LEO Pharma representative or send your proposal to IIS_program@leo-pharma.com, please indicate your country of residence/conduct of the IIS
3. The proposals will be reviewed on a quarterly basis, with the following schedule:
   • Q1 Review: Proposals due by February 28, feedback and decision expected by March 31.
   • Q2 Review: Proposals due by May 31, feedback and decision expected by June 30.
   • Q3 Review: Proposals due by August 31, feedback and decision expected by September 30.
   • Q4 Review: Proposals due by November 30, feedback and decision expected by January 31.

Feedback and decisions will be provided directly to you according to this schedule.

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