Investigator Sponsored Studies

Investigator Sponsored Studies (ISS)

Click Here to Apply

Alkermes seeks to support investigator research designed and conducted by independent physicians and scientists. Alkermes has supported more than 40 clinical trials since the beginning of the ISS program in 2008. Alkermes can provide VIVITROL®, ARISTADA® and/or placebo to the ISS programs it supports. In addition, there may be limited financial support available. In general, the research we support is based in the U.S. with experienced researchers who have an established history of successfully receiving independent funding.

Areas of Interest

Substance Use Disorders

  • Improving treatment initiation and adherence
  • Long-term treatment outcomes including real world data
  • Implementing medication for OUD/AUD into healthcare systems
  • Cognitive effects of OUD and medication treatments
  • Special Populations:
    • Adolescents/young adults
    • Pregnant women
    • OUD and co-occurring mental health or substance use disorders

Schizophrenia

  • Integration of Long-Acting Injectables (LAIs) into psychosocial strategies
  • Patient/Family or Clinician engagement strategies in LAI use
  • Demonstration of LAI benefits in special populations
  • Criminal justice
  • Schizophrenia with substance use disorder
  • ARISTADA use in early stages of illness
  • Patients transitioning across treatment services

ISS applications are reviewed by a cross functional team of medical and scientific staff to consider patient safety, operational feasibility, scientific merit, and alignment with Alkermes research goals and needs. Applications can be submitted in one of two ways:

  • A pre-protocol submission where your application will serve as your proposal, but you have not developed a protocol yet; or
  • A protocol submission where your protocol is already developed and ready for review. To complete an application, please login here.

Please be aware that Alkermes cannot guarantee support for ISS program applications and all decisions regarding such support will be made at Alkermes’ sole discretion. ISS submissions are accepted on a rolling submission basis.

Request for Proposals (RFPs)

Alkermes will announce a Request for Proposals (RFP) for research in key clinical areas where gaps in data have been identified. Each RFP will focus on areas where Alkermes support could potentially have the greatest impact on improved patient care and outcomes.

Grants awarded as a result of an RFP are awarded solely for the purpose of advancement of basic research or enhancement of disease understanding or clinical outcomes.

Please note that all submissions in response to an RFP should be in concept form. Full proposals will be requested once the initial review has been completed. Include “RFP” in the study title when submitting through the portal.

Financial support for the RFPs below is limited to $300,000 USD, inclusive of indirect costs.

Requests must be submitted online at https://ISS.Alkermes.com by the physician or scientist.

Submissions should be in concept form. Full proposals will be requested once the initial review has been completed. Select “Clinical – RFP” as the study type when submitting through the portal. Please be aware that Alkermes cannot guarantee support for RFP program applications and all decisions regarding such support will be made at Alkermes’ sole discretion.

The RFPs listed below support small, innovative research projects for up to 2 years. No preliminary data is required.

2019 RFP Application Cycle
Date: April 1, 2019 - July 31, 2019 Date: June 1, 2019 - September 31, 2019
Topic: Withdrawal Management Topic: Initiation & Retention
Research supporting the implementation of withdrawal management and antagonist induction regimens into practice Innovative approaches to initiate medication and improve treatment retention for AUD or OUD in the hospital, emergency, or outpatient setting

Please contact ISS@alkermes.com with questions on the program