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U.S. Department of Health and Human Services

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Predictive Safety Testing Consortium (PSTC)

Public Health Context: 

Unexpected toxicity from marketed drugs continues to cause 2-3% of approved drugs to be removed from the market each year.  While companies individually develop newer safety testing methods, these are often proprietary, differ from company to company, and generally are not accepted by the FDA or European Medicines Agency (EMA) as proof of safety because they have not been systematically compared and evaluated.

The Critical Path Institute (C-Path) disclaimer icon created the Predictive Safety Testing Consortium (PSTC) disclaimer icon as a neutral ground where scientists from 16 pharmaceutical companies and academia can share and test new methods that are more reliable predictors of human safety. The ultimate goal is to develop sufficient evidence to qualify new predictive safety tests for regulatory use that may improve the safety of new drugs that reach the market. 
 

Mission & Program Objectives:

PSTC’s mission is to qualify new biomarkers for the detection and monitoring of drug-induced toxicity in preclinical and clinical studies.  Program goals include:

  • Qualification of biomarkers of toxicity to use as experimental systems to predict the possibility of toxicity in humans.
  • Sharing preclinical and clinical data for genomic, proteomic and metabolomic biomarkers of drug-induced nephrotoxicity, hepatotoxicity, vascular injury, and carcinogenicity for evaluation and comparison by members of the consortium.
  • Conducting prospective studies to generate biomarker qualification packages for evaluation by the FDA.

Accomplishments as of August 2010:

  • Critical Path Institute worked with the FDA to pilot the “qualification” process for evaluation of new biomarkers for a specific context of use.
  • In 2008, the first sets of biomarkers were submitted to the FDA and EMA by PSTC and were qualified by for use in testing for renal safety in rodents to detect drug-induced kidney injury in laboratory animals.
  • The Hepatotoxicity Working Group of PSTC submitted a briefing package to FDA for qualification of four biomarkers for detecting drug-induced liver toxicity.
  • The Nephrotoxicity Working Group (NWG) of PSTC is evaluating the expanded clinical utility of the previously qualified biomarkers (urinary cystatin C, β2-microglobulin, total protein, urinary clusterin, KIM-1, trefoil factor 3, and albumin) and others in human clinical research sponsored by the Foundation for the NIH.
  • The Myopathy Working Group has submitted a briefing package of data that support eight novel biomarkers for detecting and monitoring drug-induced skeletal muscle injury in the rat.
  • A PSTC database has been established.  A common lexicon, study design elements, and standardization of tissue and sample handling, as well as data reporting have been established to facilitate combining the data from multiple studies performed at multiple sites.
     

Operational Framework:

The consortium is comprised of sixteen pharmaceutical companies that have signed a legal agreement committing to share their pre-competitive safety testing methods, data and knowledge to advance safety assessments in medical product development.  The FDA and the EMA are active advisors and participants in the consortium.  Over 250 scientists participate regularly in six working groups that meet every month in conference calls and in face to face meetings every 3-4 months.  The working groups are focused in the areas of: carcinogenicity, kidney, liver, cardiac, muscle and vascular injury. C-Path serves as the "trusted third party" leading the collaborative process by collecting and summarizing the data.
 

Partners: 

Government:

U.S. Food and Drug Administration
European Medical Agency (EMA)
Japanese Pharmaceuticals and Medical
Devices Agency (PMDA)

Industry:

Abbott Laboratories
Amgen Inc.
AstraZeneca Pharmaceuticals LP
Boehringer Ingelheim Pharmaceuticals, Inc.
Bristol-Myers Squibb Company
ClinXus
Daiichi Sankyo, Inc.
Eli Lilly and Company
GlaxoSmithKline
Johnson & Johnson, LLC
Merck and Co., Inc.
Mitsubishi Tanabe Pharmaceutical Corporation
Novartis Pharmaceutical Corporation
Pfizer, Inc.
Roche Palo Alto, LLC
sanofi-aventis U.S., Inc.