Jim Bland Executive Director, CRIX International CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned Jim Bland Executive Director, CRIX International

What is CRIX? CRIX International Stands for “Clinical Research Information eXchange” (CRIX). A shared infrastructure for exchange of regulated clinical research information. A community interested in realizing this vision of a shared infrastructure through a public-private partnership. Anticipated delivery of platform and initial services by year end 2007 Platform Operator Service Module Developers & Operators Service Module X Service Module Y Users

December 2006 – CRIX International Association History (2003-2004) Industry SEBIX 2005 - caBIG Regulatory Data Exchange Steering Committee (formerly CRIX Steering Committee) December 2006 – CRIX International Association Convergence of initiatives NCI stewardship with broad stakeholder support and participation FIREBIRD pilot Building upon the visionary work of the Regulatory Data Exchange Steering Committee Has potential for public-private partnership 2003 - US Gov’t FDA/NCI IOTF

The Planned CRIX Community International Community Patients & Patient Advocates Contract Research Organizations Public Sector Hospital Groups Industry Service Providers CRIX International provides a voice for small bio-pharma, the public, academic researchers An information exchange reduces infrastructure burden Shared infrastructure is more cost effective Shared implementation tools lower cost of conversion into a fully electronic business and regulatory process Agreement / use of common standards reduces costs Potential to bring new treatments to market more quickly by leveraging CRIX International capabilities Academic Research Centers Trade and Standards-Setting Organizations Key: = Organizations involved with CRIX = Planned involvement

Value of Information Exchange Point-to-Point Architecture: Low cost for simple implementations Limited Scalability Complex as connections grow “Enterprise Software” from an Industry perspective Value-Added Hub and Spoke Architecture: Requires initial planning Lowest cost as the model scales Maximum standards leverage “Value-Added hub” from an industry perspective

Potential Industry Services CRIX International future services could: Enable patients to identify clinical trials they are eligible for Provide drug safety monitoring and reporting Facilitate a collaborative review environment (e.g. for the Structured Product Label (SPL)) Potential value to the healthcare community is: To enable significant process enhancements in the delivery of new therapies to patients To gain workflow efficiencies and lower process and resource costs, allowing for increased scientific investment Improved safety surveillance processes Accelerated adoption of standards

An Illustration: Clinical Trial Matching Database 2. System matches patient to clinical trials (24X7, continuously) Personal Health Records Trial Criteria 1. Patient self-reports Personal Health Record Matching Rules 3. Investigator Registry provides contacts to the patient Authoritative Investigator Registry 4. Patient contacts research site: Calls research site Sends Personal Health Record via Secure Message Center. Leveraging Shared Infrastructure / Accelerate Clinical Trial Enrollment 5. Patient Visits Research Site: Research staff/investigator determine patient eligibility Patient elects whether or not to enroll

CRIX - Current Status & Lessons Learned

Operational Partner Selected: NG CRIX Milestones: 2007 DEC ‘06 JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC CRIX Int’l Founded Began Operations Enhancements to the NCI’s FIREBIRD application Pfizer Amgen FDA RFI Response Novartis CRIX Collaborative Platform Adverse Events Reporting System Operational Partner Selected: NG Patient Matching MySignature Book

CRIX Platform – Year-end 2007 Established Repositories & Registries Study Registry Sponsor Registry Patient Registry Service Provider Registry Content Repository Clinical Data Repository Business Components (Applications) Functionality User Interface Experience CRIX International Portal CRIX User Registry Cert Registry The CRIX Platform will provide: Single-sign on capabilities SAFE credentials for PKI A unified user experience through a portal Established, standards-based repositories Business components Add application functionality to meet business requirements Can leverage and extend repositories Can be accessed seamlessly if the provider leverages the CRIX services User Information & Credentialing Single Sign-On

Lessons Learned Integration with government regulatory agencies presents challenges Developing the correct organizational structure to allow regulatory involvement Technical development of the platform will require building interfaces to legacy systems and a gradual migration toward CRIX services In order to address the needs of the European Community, CRIX will need to develop services specifically tailored to EU participants sooner than anticipated Despite some challenges, CRIX is moving ahead faster than anticipated and building momentum in the healthcare community in the US

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