Investigator-Initiated Studies

Veloxis is committed to improving the lives of transplant patients by advancing the science of transplantation. As a part of this commitment, our Investigator-Initiated Study Program serves as a basis of support for studies brought forward by members of the transplant scientific community to address relevant scientific questions.

Program Overview

The Investigator-Initiated Study (IIS) Program involves the review and consideration of support for independently-developed, unsolicited research proposals in which the investigator serves as the sponsor of the research study. As such, the investigator, in conjunction with their institution, assumes responsibility for the design, initiation and management of the study. Veloxis may support IISs in the form of financial support, provision of drug product, or both.

Review of IIS proposals will be conducted by a multidisciplinary committee at Veloxis. Numerous factors impact the decision to fund a study, including alignment of the IIS proposal with Veloxis strategic research initiatives and resource availability.

Veloxis welcomes submission of any prospective, retrospective, or real-world evidence study proposals that evaluate the research interests below.

ENVARSUS XR (tacrolimus extended-release tablets)

  • Evaluations of dosing
    • Studies exploring novel dosing strategies and/or drug exposure
  • Differentiation from immediate-release tacrolimus formulations
    • Studies evaluating differences in clinical outcomes between immediate-release tacrolimus formulations, including adherence, drug interactions, as well as long-term outcomes.
  • Use in non-renal populations
    • Studies focusing on the use of ENVARSUS XR in non-renal transplant recipients, including non-solid organ transplant applications.
  • Use in high-risk populations
    • Studies analyzing the use of ENVARSUS XR in transplant recipients identified as high risk or in populations where limited data exist.

VEL-101

  • VEL-101 related IIS proposals will be assessed on a case-by-case basis through a multidisciplinary committee.

Substantial Unmet Needs in Transplantation

  • Studies generating evidence to inform the patient journey, transplant patient disease progression, and advancements in the field; or studies generating evidence to support the unique challenges faced by transplant recipients.

Submissions will be evaluated in the order they are received, and funding is not guaranteed. For more information about the IIS Program and submission of proposals, please contact your local Medical Science Liaison or submit your request for information to medinfo@veloxis.com.

Application Process

Application Process

Disclaimer

Submission of a proposal does not imply nor guarantee approval. Financial and/or product support is contingent upon receipt of all required documentation and full execution of the research agreement by both parties.

Previous support by Veloxis does NOT guarantee future support as each proposal is evaluated on scientific merit, alignment with strategic initiatives, and available funding. If you have any questions, please contact your local Medical Science Liaison.