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NEW: Markers to Identify Patients with NAFLD Whose Disease Will Progress Rapidly to NASH

Request Number N656701
Need details
Description

Pfizer Inc.’s Worldwide R&D organization is interested in establishing collaborations with clinicians, academic researchers and biotechnology companies working in the field of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). Pfizer specifically seeks to establish and progress collaborations with groups developing serum and/or imaging markers of NAFLD and hepatic fibrosis that reliably predict which patients have benign steatosis and which are at risk of rapidly developing hepatocellular injury and progressive fibrosis.

 

 

Background

NAFLD is a prevalent cause of liver disease. Although the progression from NAFLD to NASH, and the development of fibrosis, increases the risk of cardiovascular and liver-related death, the identification of patients at-risk of progression remains clinically challenging.  Advancing age and parenchymal or portal inflammation (as identified by liver biopsy) are independent predictors of progression to advanced fibrosis in NASH.  Yet these factors have not been verified as predictors of progression over time, rather they have only been verified using cross-sectional analysis of patients based upon initial biopsy findings.  There is a strong clinical need for novel imaging and serum-based assays that can predict the presence of NAFLD/NASH, fibrosis, and/or inflammation as it is not feasible to recommend liver biopsy in all patients who are at risk for NAFLD.

 

 

Key Success Criteria

To be successful, proposals must seek to identify, or have identified, sensitive and specific non-invasive biomarkers that track progression from NAFLD to NASH and that have the potential to supplant liver biopsy as the primary means of diagnosis.  Proposals must be based upon, or utilize, datasets that contain detailed information on diagnosis, biomarkers, and clinical follow-up.

Datasets should contain:

  • Well-phenotyped cohorts of adult patients with biopsy-proven NAFLD who have had longitudinal prospective assessment over a minimum period of three (3) years;
  • A sub-set of patients who have progressed from NAFLD to NASH or advanced fibrosis (stage 3 or 4) as confirmed by subsequent biopsy(s); and
  • Specific serum biomarkers and/or non-invasive markers (e.g. markers based on MRI or other imaging modalities) that can be validated using multivariate logistic regression models as independent predictors of subjects who are more likely to progress rapidly to NASH or advanced fibrosis.  For this cohort the diagnosis of NAFLD must be established with exclusion of other causes of liver disease.

 

Possible Approaches

Pfizer is interested in receiving proposals that leverage data from patients with histological diagnosis compatible with NAFLD on their initial biopsy, who received no intervention of proven histological benefit, and who have undergone two liver biopsies with a minimum intervening interval of one year.

 

A successfully executed collaboration will be measured by demonstrating statistically significant results for areas under the receiver operating characteristic curves (AUROCs), positive predictive value (PPV), negative predictive value (NPV), the percent correctly classified, sensitivity and specificity.

 

 

Approaches not of interest

Pfizer is NOT seeking proposals based upon:

  • Block funding that do not have specific/defined milestones that can reasonably be met within two (2) years;
  • Establishing new patient databases (analyzing existing patient samples may be considered);
  • Genetic data or validation of previously identified genetic loci such as TM6SF2 variants or PNPLA3 variants;
  • Validating or refining the NAFLD fibrosis score (NFS) (combining age, hyperglycaemia, BMI, platelet count, albumin and AST/ALT ratio) that is currently in use; or
  • Animal and in-vitro data only.

 

Preferred Collaboration types
  • Joint Development
  • Contract Research
Items to be submitted

Pfizer seeks to establish strong collaborative relationships that bring a high level of interaction between our R&D groups and appropriate partner organizations. In addition to the possibility of providing funding for appropriate opportunities, Pfizer may also provide access to key drug discovery and development resources, including bioinformatics and statistical support. Although Pfizer prefers to work with groups who have already generated the data specified in the key criteria above, funding for additional sample analysis may be considered.  Pfizer is particularly interested in identifying opportunities with academic institutions, research institutes or biotechnology companies based in China, Hong Kong, Japan, Korea, Taiwan, Singapore or India.  Proposals will be assessed upon how well they address the specific partnering needs detailed above, the likelihood of meeting key milestones within a two (2) year period and upon the track record of the Principal Investigators as demonstrated by a publication record and competitive grant funding.

 

Your proposal should be in the form of a concise non-confidential abstract/executive summary that describes the technical approach and provides information on technology performance and background on the applicant and their team (including related experience). To submit a proposal, please use the Respond button located on the Need page and complete the required Response Template. By submitting a proposal, you acknowledge and confirm that you have consulted with your Technology Transfer Office, Business Development Office or any other business and/or legal group as may be necessary and that you have all requisite approvals to submit the proposal. All personal information disclosed to Pfizer within a response will be utilized in accord with principles and polices as described at http://www.pfizer.com/general/privacy. By submitting a proposal, you also acknowledge that Pfizer, in its sole discretion, may select or reject a proposal or any portion thereof. Your NineSights community profile should contain all required information in order to provide Pfizer with appropriate contact information for your proposal. For questions about NineSights privacy and security, please feel free to post in the Community Help forum.

 

 

Point of Contact
Darren Coomber
Area of Interest
  • Pharmaceuticals
  • Pharmaceutical R & D
Organization
Pfizer
Due Date
November 30, 2015
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