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Investigator-sponsored research

INVESTIGATOR-SPONSORED TRIALS (IST)

Program Description

Our Investigator-Sponsored Trials (IST) program provides support for external clinical research that advances medical and/or scientific knowledge about our products and clinical candidates to enhance patient care. Our current IST portfolio includes programs investigating:

  • Brentuximab vedotin
  • Enfortumab vedotin
  • Tisotumab vedotin
  • Tucatinib

The objective of our IST program is to provide funding and/or study drug for clinical research that will:

  • Address unmet medical needs with new scientific data
  • Support pilot studies that explore the feasibility of new investigational treatments

Innovation to Achieve Equity in Cancer Care IST   

Seagen is committed to improving the lives of people with cancer through innovative therapies in a diverse, equitable and inclusive manner. Recognizing that cancer health disparities persist, to achieve our mission of making meaningful differences in the lives of people with cancer, we are inviting you to propose and submit a concept to research actionable solutions to address health disparities.

Please click here for a complete description of the RFP. Please click here to access the portal for concept submission.

To discuss your proposed research or for questions about our process, please contact your regional Medical Science Liaison (MSL) or email us at IST@seagen.com for help identifying the MSL in your region.

Process Outline

  1. New IST concepts are accepted three times annually through our online portal (see submission deadline schedule below).
  2. A Seagen employee will present your concept to the Investigator-Sponsored Trial Review Committee (ISTRC).
  3. If the concept is approved, a full protocol and detailed budget are requested within 60 days, which will be reviewed by the ISTRC.
  4. Following ISTRC protocol approval, start-up regulatory and contracting activities may begin.
  5. Study activation must occur within 6 months of protocol approval or funding/approval may be at risk.

New IST Concept Submission Deadlines

March Review

Feb 15, 2022

July Review

June 15, 2022

November Review

Sep 30, 2022

 

For a detailed description of our program, processes, and applicant responsibilities, click Program Overview.

Program Overview

Application and Questions

To apply for an IST related to brentuximab vedotin, tucatinib, enfortumab vedotin (Canada only), or tisotumab vedotin (North America and EU-16 countries only), please submit your concept in our online portal.

Enfortumab vedotin
To apply for an IST related to enfortumab vedotin research (United States only), please visit the Astellas Investigator-Sponsored Research portal. Enfortumab vedotin proposals from United States investigators are reviewed jointly by Seagen and Astellas.

Tisotumab vedotin
To apply for an IST related to tisotumab vedotin research (Japan only), please visit the Genmab Investigator-Sponsored Research portal. All tisotumab vedotin proposals are reviewed jointly by Seagen and Genmab.

Please email IST@seagen.com with questions about our IST program.


TRANSLATIONAL RESEARCH AGREEMENTS (TRA)

Program Description

Our Translational Research Agreement (TRA) program provides support for non-clinical research projects.

Requests for materials transfer or sponsored research will be considered, with a limited number of projects supported each year. To discuss your proposed research or for questions about our process, please contact your regional Medical Science Liaison (MSL) or email us at translationalresearch@seagen.com for help identifying the MSL in your region.

Process Outline

Project will be reviewed within 90 days and the regional MSL will present the proposal internally.

For questions regarding our process, email us at translationalresearch@seagen.com.

Application and Questions

To apply for a TRA related to available programs and for enfortumab vedotin (Canada only), please submit your concept in our online portal. All tisotumab vedotin proposals are reviewed jointly by Seagen and Genmab.

To apply for a TRA related to enfortumab vedotin research (United States only), please visit the Astellas Investigator-Sponsored Research portal. Enfortumab vedotin proposals from United States investigators are reviewed jointly by Seagen and Astellas.

Please email translationalresearch@seagen.com with questions about our TRA program.

Access scientific and clinical resources

Healthcare professionals in the United States can access recent congress presentations, videos about our science, and more on our medical affairs website.

Explore the Medical Affairs Website