Value through InnovationApril 24 2014

Hepatitis C Virus

The following areas are of research interest for the Hepatitis C Virus (HCV):

  • Studies of anti-HCV treatment in special patient populations with unmet medical needs
  • Studies of novel anti-HCV non interferon (non-IFN) containing regimens for the most difficult to treat patient types
  • Studies assessing adherence and / or supportive therapy during anti-HCV treatment
  • Studies assessing the epidemiology of host factors impacting HCV treatment
  • Studies evaluating non-hepatic effects of HCV
  • Studies evaluating unique delivery systems for IFN or direct acting antiviral (DAA) combination containing HCV regimens

While the research interests listed within the therapeutic areas are of focus to BIPI, other novel research interests may be considered. 

A brief synopsis must be submitted to BIPI for consideration of interest.

The following items are required for submission of the synopsis:

  • Proposed title of the study
  • Name and contact information of the principal investigator and institution
  • Brief scientific background and study rationale
  • Study Objectives
  • Study Design
  • Curriculum Vitae

Once/If BIPI confirms interest in the synopsis, additional details in the form of a full proposal must be submitted.  The following information will be required in the proposal:

  • Full title of the study
  • Name and contact information of the principle investigator and institution
  • Background and Study rationale
  • Study objectives
  • Study design
  • Study flowchart 
  • Study procedures and duration
  • Statistical methods (please include sample size and power analysis justification)
  • Data Management Plan/System
  • Requested Support (Drug only, Funding or both)
  • Drug Supply Request (BIPI Drug and/or non-BIPI Drug) Note: If drug requested, please provide name of drug(s), dosage and quantity
  • Itemized Budget (including Total Direct and Indirect and Pass-through Fees) Note: BIPI does not pay principal investigator salaries 
    • IIS grants are typically less than 1.0 million US dollars 
    • BIPI limits allowable Institutional Facilities & Administration Overhead (F&A)
  • Associated/relevant literature citations
  • Publication plan

Submission of a preliminary Proposal does not imply or guarantee approval. All proposals will be reviewed based on scientific merit and available funding. 

Please click on the link below to access BI’s online submission site.
https://bi.envisionpharma.com/vt_bi_iis/#Login

Investigators outside of the United States interested in Virology IIS are encouraged to visit http://www.boehringer-ingelheim.com/clinical_trials/iis_virology.html.

To contact Boehringer Ingelheim Pharmaceuticals, Inc., Medical IIS Office, please call 877-757-7354.