Membership:

AstraZeneca; Bayer HealthCare AG; Bristol-Myers Squibb Company; Eisai Co., Ltd.; Eli Lilly and Company; GlaxoSmithKline; F. Hoffmann-La Roche Ltd.; Johnson & Johnson Pharmaceuticals; Merck & Company; Metabolex, Inc.; Novartis Pharmaceuticals Corporation; Novo Nordisk A/S; Perlegen Sciences, Inc.; Pfizer Inc.; Sankyo Co., Ltd.; sanofi-aventis; Servier Group; Takeda Pharmaceutical Company, Ltd.; Wyeth Research

Public Participation:

Eureda AB; Imperial College London; Indiana University School of Medicine; Instituto Nacional da Farmácia e do Medicamento (INFARMED); University of Nebraska Medical Center; University of North Carolina, Chapel Hill; US Food and Drug Administration (Center for Drug Evaluation and Research, National Center for Toxicological Research)

Activities:

The HESI PPAR Agonist Project Committee was established in 2005 by a group of pharmaceutical companies to advance research on and understanding of the modes of action and human relevance of this emerging rodent tumor data for PPAR agonists. 

During 2005, Co-Chairs were identified, and a Steering Team and Working Groups were formed.  The Project Committee developed a mission and work plan.  Each Working Group is currently developing a mode-of-action framework for human relevance on the tumor types of interest. 

In 2006, the PPAR Agonist Project Committee will sponsor two Pathology Working Groups (PWGs) to develop consensus on tumor diagnosis and consistency of diagnosis across multiple studies.  The PWGs will be conducted by Experimental Pathology Laboratories, Inc., Research Triangle Park, NC.

• The purpose of the PWG to Review Primate Urinary Bladder is to determine the presence of true hyperplasia in monkey urothelium vs. hyperplasia in the range of normal. 
• The PWG to Review Hemangiosarcomas in Mice or Hamsters and Liposarcomas/Fibrosarcomas in Rats will focus on establishing consistent tumor diagnostic criteria and assessing evidence of preneoplastic changes.

For both PWGs, the intent is to provide a substantial basis upon which to design future experiments to address the mode of action associated with PPAR agonists and establish, with greater certainty, the human relevance.  Consensus results from the PWGs will be published in a scientific, peer-reviewed journal.

Potential projects to be undertaken by the PPAR Agonist Project Committee in 2007 include the following:

• Share data among government, industry, and academic participants via a coded 
  mechanism which will protect proprietary information.
• Develop hypotheses and initiate experimental programs to explore the modes of actions of PPAR agonists.
• Conduct workshops to communicate project status and research results.
• Publish research results.