PSTC Member Presentations
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Title - Predicting Carcinogenicity in the Rat: Fact or Fiction? Presenter - Mark Fielden, PhD, DABT, Amgen Conference - Southern California Chapter of the Society of Toxicology 2010 Annual Meeting Date - October 8, 2010 |
Summary - The presentation will summarize the Predictive Safety Testing Consortium Carcinogenicity Working Group's preliminary evaluations of a QPCR-based genomic biomarker for predicting non-genotoxic hepatocarcinogens in the rat and understanding the mode of action to facilitate human risk assessment of carcinogens. |
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Title - Improving Screening and Biomarkers for Drug Induced Liver Injury Presenter - Gerry Kenna, AstraZeneca SAUK Conference - DIA 2010 Annual Meeting Date - September 2, 2010 |
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Title - C-Path's PSTC: Progress in Developing Evidentiary Standards and Regulatory Processes for Evaluating and Adopting New Safety Biomarkers Presenter - Eric Thompson, Ph.D., Critical Path Institute Conference - DIA 2010 Annual Meeting Date - June 17, 2010 |
Summary - Both regulatory agencies and the drug development industry recognize the opportunities for new safety biomarkers to enhance drug development success. Consortia such as the Critical Path Institute's Predictive Safety Testing Consortium have been created as a resource sharing precompetitive mechanism to generate the evidentiary standards that are needed to advance the qualification and acceptance of these biomarkers through a formal and transparent interface with worldwide regulatory agencies. Great strides have been made in 2009 and 2010 to expand the experimental basis for advancing mutual understanding of the performance characteristics of new safety biomarkers of drug-induced injuries to kidney, liver, and skeletal muscle. In the course of the experimentation and subsequent data sharing and data evaluation, critical issues have surfaced between industry and regulatory agencies that must be resolved for future efforts to succeed at a reasonable pace. The data that support the novel utility of these emerging new safety biomarkers, the issues that have surfaced, the different viewpoints and resolutions achieved, and the processes that have evolved for qualifying new safety biomarkers will be shared and discussed. |
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Title - Can the Regulator and the Regulated Work Together to Advance Drug Safety Science? Rules and Process to Achieve Scientific Consensus, Impartial Review and the Adoption of Best Science in Safety Assessment Presenter - Eric Thompson, Ph.D., Critical Path Institute Conference - Collaborative Innovation in Biomedicine Date - June 14, 2010 |
Summary - Critical Path Institute, an independent non-profit entity formed in 2005 to support FDA's Critical Path Initiative, facilitates several innovative consortia working to advance the drug development process and speed the delivery of safe, efficacious drugs to patients. C-Path's Predictive Safety Testing Consortium (PSTC) is a collaboration of 16 major pharmaceutical companies sharing safety biomarker data, assay information, and samples to deliver convincing datasets to the FDA, EMA, and PMDA on novel safety biomarkers that can be utilized in regulatory decision-making. The PSTC has worked closely with these regulatory agencies to pilot and refine a biomarker qualification process that enables their early input as advisors but ensures impartial, objective regulatory review once a dataset is formally submitted. Several critical factors that contribute to the success and challenges of this pre-competitive, public-private partnership of industry and these regulatory bodies will be highlighted. |