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At Bioverativ, we believe in supporting medical research that advances the scientific knowledge in hemophilia and are committed to improving patient care.

Medical Research

Medical research

At Bioverativ, we believe in supporting medical research that advances the scientific knowledge in hemophilia and are committed to improving patient care.

Areas of interest

The following areas of research are currently being considered to support studies related to hemophilia A and B, and Fc fusion technology:

Preclinical and basic science studies

  • Mechanisms of immunogenicity and immune tolerance
  • Biomarkers and novel assessments of sub-clinical bleeding, bleed resolution, inflammation and joint health
  • Mechanisms of dysfunctional hemostasis
  • Studies of Fc fusion clotting factors, including tissue distribution

Clinical Research

  • Studies of immunogenicity, immune tolerance, and immune tolerance induction
  • Biomarkers and novel assessments of sub-clinical bleeding, bleed resolution, inflammation and joint health
  • Studies of alternate dosing regimens based on patient characteristics
  • Effectiveness in patients undergoing surgical procedures (e.g. wound healing)
  • Effectiveness in special populations such as hemophilia carriers
  • Outcomes related to co-morbidities in the hemophilia population

Real world qualitative and quantitative studies

  • Studies of adherence and compliance, and how those are associated with clinical outcomes and quality of life
  • Studies of the economic burden and resource utilization in hemophilia
  • Assessment of patient and caregiver reported outcomes, such as quality of life, psychosocial function, pain, mental health, depression, physical activity/mobility, productivity and treatment preference
  • Women with bleeding disorders
  • Clinical and economic burden in treatment of patients with inhibitors

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded.

Bioverativ supports research in a number of research areas. A complete study proposal must be submitted online to Bioverativ for review by our cross-functional committee. It should contain a well thought out study rationale, clear primary objective with supporting endpoints, cohesive study design, statistical analysis plan and sample size calculation, and study and publication timelines.

A template is available to assist in drafting your study concept (download here). Once your concept is drafted, it must be entered into the online portal for review by the committee.

Careful consideration should be given to the following sections:

  • Proposal type (Investigator Initiated Trial versus Sponsored Research Agreement)
  • Study type (Clinical Interventional, Clinical Non-Interventional, versus Nonclinical)
  • Type of support (drug, funding, medical writing, data management, statistical analysis, etc.)
  • Projected study milestones/timeline (Total study duration, Final Data Availability, Planned Study Start, Planned Enrollment per month, etc.)

An Investigator-Initiated Trial (IIT) is an unsolicited preclinical, clinical, outcomes- or disease state-related study. An investigator independently generates a research proposal and Bioverativ may only provide support in the form of funding, study drug, or a combination of the two.

A Sponsored Research Agreement (SRA) is a collaboration between Bioverativ and an investigator on a research proposal. Bioverativ and the investigator collaborate on the design and the interpretation of the results. Bioverativ may support the research beyond funding and/or study drug. Publication and authorship will be based on ICMJE criteria.

For both IITs and SRAs, the investigator, or his/her institution, remains as the study regulatory sponsor. The sponsor assumes responsibility for initiating and conducting the study, directing the administration of study drug (if applicable), and ensuring compliance with all local laws and regulatory requirements.

A complete study concept is necessary for the Review Committee to correctly assess a proposal. This includes not only the scientific and medical aspect, but also the request made to Bioverativ for support.

We provide forms to help you submit your proposal to our Review Committee. Only complete submissions will be reviewed and if your submission is incomplete, we may contact you to ensure appropriate revisions are made. Note that a complete concept submission includes a completed concept form (download here), and budgets (download here) using Bioverativ’s templates entered into the online portal.

This can include, but is not limited to, financial support, supplying study drug, medical writing, data management, and/or statistical support. Once your support request and budget are drafted, they must be uploaded into the online portal for review by the committee. No proposal will be reviewed without a clear outline of the support required.

For clinical studies, Bioverativ will only fund reasonable and customary services rendered (e.g. EDSS, MRI, Statistical Analysis, Publication Fees, Laboratory Tests, etc.) that are Non-Standard of Care. Personnel costs must be expressed as an hourly rate per function. Regardless of study type, Bioverativ will not cover the cost of travel to conferences and capital equipment requests.

The Bioverativ Review Committee will review each submitted proposal according to the following evaluation criteria:

  • The proposed research is legitimate and scientifically rigorous:
  • The proposed research is aligned with Bioverativ’s research objectives and established areas of interest.
  • Requested support is justified and reasonable, and budget is commensurate with fair market value

Study proposals are reviewed on a rolling basis. All study proposals are represented to the Bioverativ Review Committee by appropriate local medical and/or scientific personnel. Therefore, it is highly recommended that prior to submitting a study proposal, investigators contact their local Bioverativ medical representative to address any questions and to ensure the proposal and associated budget are complete and compliant. 

Following the approval of the study, including a developed protocol for appropriate/clinical studies, Bioverativ’s legal department drafts an agreement and engages in negotiations with you and your institution. These contract negotiations typically take 3-4 months to finalize, but can take longer depending on the study circumstances (e.g. the type of study, intellectual property clauses, indemnification, and the complexity of the study). 

For both Investigator-Initiated Trials (IITs) and Sponsored Research Agreements (SRAs), the investigator and/or his/her institution retain regulatory sponsorship for the study. However, due to the collaborative nature of SRA studies, Bioverativ implements a transfer of responsibilities document as part of the contracting process. This document clearly outlines the responsibilities of both Bioverativ and the investigator throughout the course of the study.

We believe in improving the quality of patient care by supporting medical research that advances scientific knowledge of disorders relevant to our therapeutic portfolio and products. We therefore strive to ensure studies progress according to plan and help investigators set appropriate and achievable milestones, for which we require regular updates.

We also encourage investigators to publish their research for the benefit of the scientific community and to fulfill established data and/or knowledge gaps. Investigators who wish to publish or publicly disclose any information, data, results or details about their study shall provide a full and complete text copy of the disclosure to Bioverativ for review at least 30 calendar days prior to the submission to a third party for review, its publication, or other disclosure.

Sponsored Research Agreement studies are collaborations between the investigators and Bioverativ. As such, publications resulting from these studies will be developed jointly and authorship will be determined according to International Committee of Medical Journal Editors (ICMJE) recommendations, and all authors will be required to acknowledge and agree to the final publication before submission.

Should the Investigators not wish to publish or disclose the information gathered in their study, a final study report will be required by Bioverativ to close out the study.

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded.

For investigators outside of the US or Japan

Please contact the Bioverativ local medical representative in your country/region. If you do not know who your appropriate Bioverativ representative is, please contact us at medicalresearch@bioverativ.com.