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Project Title: Predictive Safety Testing Consortium
Critical Path Goal: To Identify and Qualify Safety Biomarkers
Critical Path Priority: Biomarker Development and Qualification
Mechanism: Public/Private Consortium

Goal

The Predictive Safety Testing Public/Private Consortium was established as a collaboration of industry, academia, and government to identify and clinically qualify safety biomarkers¹ that will

• Improve our understanding of a compound’s safety profile before using the compound in people
• Develop novel tools for troubleshooting compounds that fail studies in preclinical drug safety assessment
• Identify early signals to be used in predicting and preventing post-marketing safety issues
• Speed and/or reduce the cost of preclinical drug safety evaluation

The Consortium intends to provide a venue whereby companies can share and clinically qualify their biomarkers cooperatively. The validation efforts will be conducted in the context of regulatory impact. The graphic below illustrates the planned steps involved in qualifying safety biomarkers.

Consortium

The Food and Drug Administration (FDA), the C-Path Institute (a non-profit institute), and others from academia, industry, and government have agreed to collaborate as part of this group.

Roles and Responsibilities

The Consortium will nominate safety biomarker qualification projects, create and review proposals, develop a discussion and ranking system (with internal Steering Committee review), and identify interested Consortium participants. In addition, the Consortium will refine study protocols, allow for outside scientific advisory board review, determine the best way to communicate findings (e.g., white papers or other publications), and conduct studies. The FDA will have substantial involvement and input in all scientific aspects of the Consortium.

The C-Path Institute² will facilitate the programmatic aspects of the Consortium such as, coordinate meetings, develop and disseminate reports and communication activities, execute contracts and other agreements and other required administrative functions.

Members of the Consortium have significant expertise and programs in safety biomarkers (i.e. neuro, muscle, kidney, liver). Members will also have a willingness to share data, knowledge, and intellectual property; commit internal resources for qualifying other members’ safety biomarkers; make available intellectual property to members of the Consortium under appropriate arrangements; and enter into cooperative agreements.

Steps for Qualifying Preclinical Biomarkers (Safety)

¹Biomarkers are measurable characteristics that reflect physiological, pharmacological, or disease processes in animals or humans. Changes in biomarkers following treatment reflect the response of the patient to the product.

²See the C-Path Institute at http://www.c-path.org/

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