Confidential 1 TM 2010 Strategic Health IT Advanced Research Projects SHARP Face-to-Face Meeting Project 3: High-Throughput Phenotyping Introduction to.

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Presentation transcript:

Confidential 1 TM 2010 Strategic Health IT Advanced Research Projects SHARP Face-to-Face Meeting Project 3: High-Throughput Phenotyping Introduction to Centerphase Solutions, Inc. June 21, 2010

Confidential 2 TM Centerphase Overview Centerphase offers technology-enabled services to address critical needs of the biopharmaceutical industry through collaborations with premier academic medical centers and healthcare systems, starting with the Mayo Clinic Clinical trial design and execution: initial focus Comparative effectiveness, post-marketing studies Safety surveillance, early detection Pharmacoeconomics, health outcomes, meaningful use

Confidential 3 TM Centerphase Team Management Gary Lubin – Chief Executive Officer Jeff Tarlowe – Chief Operations Officer Beth Harper – Chief Clinical Officer Experience More than 60 years of industry experience Focus on operational efficiencies in healthcare Expertise in starting and managing healthcare technology companies (co-founded Merck Capital Ventures) Passion for optimizing clinical trials performance Board & Strategic Advisors Per Lofberg (Chairman), CEO Caremark Ken Getz, Tufts Center for Drug Development David Hardison, SAIC & SHARP advisor

Confidential 4 TM Centerphase Background Five years ago, Merck Capital Ventures explored creation of joint venture with a leading medical records company to develop secondary EHR applications Determined that market was not ready to take advantage of these applications: technology immature, data was under-scaled and deficient, and customer support was limited Initiated discussions with Mayo Clinic in early 2009 regarding development of market offerings around Mayo’s longitudinal patient data repository Mayo’s goals included access to improve medical care, generate new revenue streams, realize cost efficiencies and strengthen relationship with the biopharma industry Successfully launched company with Mayo at the beginning of 2010

Confidential 5 TM Centerphase Collaboration with Mayo Founding investor and clinical services provider Proprietary access to de-identified patient information from the electronic data trust Priority status given to Centerphase studies - faster IRB, contracting and budgeting review and approval processes Access to its network of main sites, community clinics, patients, physicians, researchers and scientists Dedicated staff to support Centerphase, e.g., CMO, Project Management, Legal, IRB, Finance, Biostatistics and IT

Confidential 6 TM Design executable protocols Place the studies at the “right” sites Activate sites efficientlySet sties up for success Systematic and structured evaluation of study executability from site and patient perspective Quantitative and qualitative analyses Clearly define the protocol-specific “must have” site characteristics Validate enrollment potential for each site Streamlined SOPs Well coordinated team structure and resources Master clinical trial agreements Proactive recruitment and retention action plan Translate the protocol into practice via study implementation plan What Does Centerphase Deliver Today? Initial Focus Is on Clinical Trials

Confidential 7 TM Industry Median = 120 days* Industry Median = 90 days* Site Selection Decision (Reg. Doc. Pkg. Sent) Site Activation First Patient Enrolled (FPE) days* <30 days Centerphase Approach Time savings of 4 to 5 months to achieve First Patient Enrolled! * Varies depending on sponsor turnaround time Protocol executability and informed site selection Streamlined SOPs for site set up and enrollment FPEActivationSelection What Does Centerphase Deliver Today?

Confidential 8 TM Centerphase’s Vision Establish hub for connecting the biopharmaceutical industry with premier health systems to perform high quality, predictable, timely clinical services Centers of excellence / super-sites in key therapeutic areas – special focus on phase I / phase II studies Large pool of diverse patient/candidates to recruit for trial work Broad clinical capabilities to develop, evaluate and execute clinical trial Building a worldwide network of clinical information sources and providing extensive analytical services for both prospective and retrospective comparative effectiveness and health outcome studies

Confidential 9 TM High Throughput Phenotyping Team The project team deliverables will be open-source tools for generation of CDISC compliant queries and cohort datasets. Centerphase will serve to validate the commercial viability of these core tools in the market and supplement them with proprietary products and services (acknowledging the SHARP contributions). Health systems can decide at their option to avail themselves of these products and services through separate commercial discussions with Centerphase. SQL Generation Eligibility Criteria ETL Process Set Query (Input) Pull and Store Data Report (Output) CDISC Compliant Phenotyping Team Source Health Systems Organization Health System 3 EHR Health System 2 EHR Health System 1 EHR Health System 3 EHR Health System 2 Extract Health System 1 Extract Bridge to Individual EHRs Aggregate Cohort Dataset Analytics & Reporting

Confidential 10 TM Centerphase Solutions, Inc. 600 E. Crescent Avenue - Suite 205 Upper Saddle River, NJ (973) Gary Lubin Mobile: (973) Jeff Tarlowe Mobile: (201) Beth Harper Mobile: (817) TM We Are Looking Forward to Working Together