Investigator-initiated and Sponsored Research (IISR)

At this time, Upsher-Smith is not accepting proposals for IISR grants. Please check back for updates.

Definition:

Investigator-initiated and Sponsored Research (IISR) is generally defined as unsolicited, independent, clinical research where the investigator or the institution (academic, private or government) serves as the Sponsor and Upsher-Smith provides support in the form of study drug and/or funding. Upsher-Smith’s IISR program supports innovative clinical studies that address important medical and scientific questions in our therapeutic areas of interest.

What is supported:

Upsher-Smith is interested in supporting independent research that will address scientific gaps related to marketed USL products and/or therapeutic areas of interest, namely epilepsy/seizure disorders, and which generates outcomes information that is intended to enhance patient care.

Timelines:

Concept forms can be submitted to Upsher-Smith at any time. A notice of receipt of the concept form will be provided. The IISR Review Committee (IISR-RC) will review concept form submissions on a monthly basis. Allow approximately 4 to 6 weeks for Upsher-Smith to respond.

Submitters will be informed of the IISR-RC’s decision within 5 working days of the decision. If the concept is accepted for full review, a full proposal check list will be sent and the submitter will be required to provide all information requested in the full proposal check list.

Full proposals will be reviewed on a quarterly basis. Information outlined in the Full Research Proposal Checklist must be provided by the dates below in order for the proposal to be reviewed at a quarterly meeting.

Quarter 1 review: March 1 deadline
Quarter 2 review: June 1 deadline
Quarter 3 review: September 1 deadline
Quarter 4 review: December 1 deadline

A notice of receipt of a complete Full Proposal will be provided. Submitters will be informed of the IISR-RC’s decision within 5 working days of the decision.

Expectations:

  • Research outside U.S. Food and Drug Administration (FDA) approved indications will require an Investigational New Drug Application (IND) or approval for IND exemption.
  • Upsher-Smith is committed to compliance with all applicable laws, regulations, and industry standards and policies for the commercial support of IISR.
  • IISR are awarded at Upsher-Smith’s sole discretion. We reserve the right to decline any IISR request.

Contact Information:

You can contact our IISR Grant Department at medinfo@upsher-smith.com with any questions or if you need assistance.