We pursue Externally Sponsored Research (ESR) in two forms.
The first is Investigator-Sponsored Research (ISR), which is defined as unsolicited research from an external sponsor where the investigator or the institution serves as the sponsor.
The second is Externally Sponsored Collaborations (ESC), which are research studies conducted in collaboration with an institution and involve joint decision-making authority.
The global ESR program is open to all investigators who are interested in conducting sponsored research and assuming the legal and regulatory responsibilities of the study. At Alexion, ESR 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 ESR support, and as such, carefully evaluates each ESR submission on a highly competitive basis, taking into account scientific rigor, innovation, ethics, methodological and statistical considerations, patient safety, and the ability to generate data in alignment with Alexion strategic priorities while avoiding redundancy with our internal research efforts. Submission of an ESR proposal does not imply or guarantee approval.
Research Areas of Interest
Alexion encourages the submission of scientifically sound and innovative research proposals in rare diseases.
Research support is awarded on a highly competitive basis, taking into account scientific rigor, innovation, ethics, methodological and statistical considerations, patient safety, and the ability to generate data in alignment with Alexion strategic priorities while avoiding redundancy with our internal research efforts.
We will consider research proposals in the following areas of interest:
- Complement-mediated diseases:
- Hematology, with focus on PNH (paroxysmal nocturnal hemoglobinuria)
- Nephrology, with focus on complement-mediated TMA, including aHUS (atypical hemolytic uremic syndrome)
- Neurology, with focus on gMG (generalized Myasthenia Gravis) and NMOSD
- Metabolic diseases
Importantly, submission of research proposals in these areas of interest does not guarantee approval and that support will be awarded.
How Our Sponsorship Process Works
Hover on the steps below to walk through the ISR process with Alexion
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 three 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.
Investigators interested in submitting a 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
- Study Duration
- Curriculum Vitae
Nonclinical research, e.g. preclinical and basic science, is not considered an ISR and proposals should be submitted through the Discovery Partnership 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.