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Investigator-Sponsored Research

Every day, we strive to make a life-transforming impact on the lives of patients with severe and life-threatening rare disorders. As part of this mission, Alexion is committed to supporting investigator-sponsored research (ISR) to advance medical and scientific knowledge about our products, product candidates, and therapeutic areas of interest. The global ISR program is open to all investigators who are interested in conducting their own independently sponsored research and assuming the legal and regulatory responsibilities of the study. At Alexion, ISR proposals are clinical (interventional or observational) studies only, including active research in patients and research utilizing patient samples, patient records, or patient chart review.

Alexion receives many requests for ISR support, and as such, carefully evaluates each ISR submission on a highly competitive basis, taking into account scientific rigor, methodological considerations, patient safety and ability to generate data that would meaningfully inform clinical practice, alignment with our strategic priorities, as well as redundancy with internal research efforts. Submission of an ISR proposal does not imply or guarantee approval.

Areas of Interest

Alexion encourages the submission of innovative proposals in rare diseases. Research support is awarded on a highly competitive basis, taking into account scientific rigor, statistical consideration, and ability to generate data that would meaningfully inform clinical practice, alignment with our strategic priorities, as well as redundancy with internal research efforts. Importantly, submission of research proposals in these areas of interest does not guarantee that support will be awarded.

We will consider research proposals in the following areas of interest:

  • Complement-mediated diseases (with focus on paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome)
  • Metabolic Diseases (e.g. lysosomal acid lipase deficiency, hypophosphotasia)
  • Neurology Diseases (e.g. myasthenia gravis)
  • Immuno-oncology (e.g. Hemato-oncology)

Submit Proposal

Investigators interested in submitting a concept proposal to Alexion for consideration will first have to register on the web-based system with their profile. Once you have registered in the system, you can submit a concept proposal electronically. Email submissions are not accepted. To complete the submission of your concept proposal, please specify the type of support you are requesting (funding, drug product or other), and include the following information:

  • Study Title
  • Contact Information
  • Therapeutic Area
  • Indication
  • Study Duration
  • Rationale
  • Objectives
  • Endpoints
  • Curriculum Vitae

 

 
Submit Here

For more information on the ISR process, hover on the steps below:

Alexion will review each ISR proposal to confirm patient safety, scientific merit, operational feasibility, strategic alignment and portfolio and budget fit. This is a multistep review cycle, which takes about 3 months for a decision. After the first step of the review cycle, you will be asked for more detailed information, leading from a concept to a full proposal.

Following the approval of the proposal, you will be asked to submit a full protocol, final study budget and final clinical supplies request within 60 days. Once this information has been reviewed and approved, you will receive a study start up package, including financial forms, contract, etc. Your Alexion local country/field medical contact will arrange a meeting, to ensure expectations are clear for study conduct.

Once a study is activated, any changes or updates to a study can be submitted via the web-based ISR system. Alexion requires quarterly online updates for studies. If an Alexion medication is part of the study, all adverse drug events must be reported promptly to Alexion in accordance with the reporting guidance provided by Alexion.

Alexion requires receipt of a final study report and reconciliation of all clinical supplies and finances provided in support of an investigator-sponsored research study, within approximately 90 days.

An expected outcome of the ISR study is a publication in a peer-reviewed journal. Following the conclusion of the study, a draft of the publication should be sent to Alexion for a 30 day courtesy review. Alexion funding must be disclosed in any publication.

Nonclinical Research

Nonclinical research, e.g. preclinical and basic science, is not considered an ISR and proposals should be submitted through the Discovery Partnerships page, where you can learn more about support of nonclinical projects.

For proposals that are a two-phase approach with a combination of clinical/patient and nonclinical research, please submit your proposal based on the type of research that would be conducted in Phase 1, i.e., clinical or nonclinical. If you have any questions please use the Request Help button above.