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Pre-Competitive Collaboration in Clinical Trials

Pre-Competitive Collaboration in Clinical Trials

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Pre-Competitive Collaboration in Clinical Trials

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  1. Pre-Competitive Collaboration in Clinical Trials June 10, 2013

  2. Mission Statement for TransCelerate “TransCelerate BioPharma will develop shared industry research and development solutions to simplify and accelerate the delivery of innovative products to patients. Our non-profit, pro-competitive model will be based on a results-oriented approach, emphasizing increased quality in clinical trials and improved patient safety, enabled by broad participation and collaboration across the global research and development community.”

  3. TransCelerate was incorporated to drive pre-competitive collaboration opportunities into implementation Existing collaboration organizations within the life sciences industry were evaluated for their ability to successfully execute the selected opportunities in clinical trial execution and it was determined that no existing vehicles met the necessary criteria. Therefore a dedicated implementation organization will be formed to promote a high-level of member accountability and a results-driven approach.

  4. Specific to pre-competitive areas, five opportunities in clinical trial execution were prioritized for near term pursuit Initiate Immediately Deferred Start (subject to change) Value to R&D Highest • End-to-End Data Flow 6 • Provide comparator drug (marketed products used in clinical trials) • Deliver Label / Drug Information via Mobile Device 4 5 1 8 • Clinical Data Standards 2 • Placebo/Standard of Care Data Sharing • Standard Approach for High Quality, Risk-Based Monitoring 3 Metrics and Performance Data Sharing 7 • Investigator / Site Portal 9 • Centralize / Share Site Qualification and Training • Develop Investigator Networks & Minority Population Site Recruitment 10 Lowest Q4 2012 to now Later (2013/2014) Timing

  5. The intent is to work with the overall eco-system to bring these opportunities into implementation Industry Initiatives • External Engagement with the Larger Ecosystem • Outside organizations, including regulatory, public, government and industry-based entities, are/have being engaged. Patient Advocacy TransCelerate BioPharma Inc. Research and CRO Community Regulatory Bodies