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Panelists

Panelists. Moderator: Edward Abrahams, Ph.D. , President, Personalized Medicine Coalition Panelists: Christine Cournoyer , Chief Executive Officer, N-of-One

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Panelists

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  1. Panelists Moderator:Edward Abrahams, Ph.D., President, Personalized Medicine CoalitionPanelists:Christine Cournoyer, Chief Executive Officer, N-of-One Rebecca Sutphen, M.D., FACMG, President and Chief Medical Officer, InformedDNATimothy Thompson, Chief Executive Officer, Intervention Insights

  2. Personalized Medicine: Emerging Business Models Timothy J. Thompson Chief Executive Officer Intervention Insights

  3. Intervention Insights Overview • Proprietary informatics platform for content curation & editorial process • Clinically actionable knowledgebase of medical evidence in molecular oncology • Information service that aligns a patient’s tumor profile with current medical evidence • … helping oncologists select molecularly targeted therapies aligned with evidence • … while helping payers ensure the clinical appropriateness of care Intervention Insights is a health information services company helping community oncologists incorporate molecular oncology into their practice, supporting the appropriate utilization of molecular diagnostics and targeted therapeutics

  4. PrimeInsights™ Product Suite TM TM TM COVERAGE REVIEW REPORTS A specialized information service for molecular oncology, supporting the delivery of high-quality, cost-effective care aligned with current medical evidence … guiding clients through the scientific complexities of molecular oncology … helping plan sponsors establish evidence-based coverage policies … supporting clinicians in the effective use of molecular testing and targeted therapies … helping payers evaluate the clinical appropriateness of care

  5. PrimeInsights™ Reporting Process Analyte Measures Drug/Marker Associations Report Assembly Report Delivery Multiplex Mol Dx Panel Pathology Lab Partner Intervention Insights BRAF EGFR KIT ALK AKT1 KRAS PIK3CA NRAS APC MAP2K1 PTEN CTNNB1 IDH1 NOTCH1 TP53 ROS1 Insights Engine Insights Knowledge Base Real time Clinical Evidence Alignment

  6. PrimeInsights™ Report Excerpts Panel Summary Clear indication of markers tested and alterations identified Therapy-Marker Associations Marker-associated therapeutic options listed along with level of evidence and payer coverage

  7. PrimeInsights™Value Proposition Supporting the appropriate utilization of molecular diagnostics and targeted therapies aligned with current medical evidence and payer coverage policies • Payer benefits • Establish and enforce evidence-based coverage policies in molecular oncology • Ensure policies are up-to-date with the rapidly evolving medical evidence • Support the effective use of molecular testing and targeted therapies across your provider network • Evaluate the appropriateness of care based upon current medical evidence • Practice benefits • Keep pace with the rapidly evolving science of molecular oncology • Align with payer coverage policies and clinical pathways • Streamline prior authorization processes and maximize payer reimbursement • Establish competitive differentiation within local market

  8. Personalized Medicine: Emerging Business Models Chris Cournoyer CEO N-of-One Therapeutics

  9. Precision Medicine Growth Drivers: Tremendous changes in science and medicine have lead to the opportunity and the need to personalize the delivery of cancer care. A recent UnitedHealth survey found that three quarters of its network contracted physicians believe that some patients in their practice would benefit from genetic testing, but have not yet been tested. United Healthcare, March 2012 • Approximately 75% of drugs used in cancer care are ineffective for the patients receiving them (Source of data: Brian B. Spear, Margo Heath-Chiozzi, Jeffery Huff, “Clinical Trends in Molecular Medicine) • Growing # of cancer therapeutics and clinical trials matched to NGS results: More than 40 FDA-approved targeted therapies many with an associated predictive biomarker (National Cancer Institute). • Technical hurdles for NGS are being addressed and cost of sequencing dropped dramatically.

  10. Clinical Interpretation – The Next Bottleneck A major goal of cancer genomics is identifying “actionable” mutations that drive a tumor and can be targeted with available therapy BUT… “Then you have a 5-inch-thick set of papers on your desk for the bioinformatics. That’s where the cost is.” (Gail Vance, Director of Diagnostic Genomics, Indiana U. School of Medicine) • Ever-increasing amount of data of growing complexity for physicians & patients to process • NGS data •MDx & pathology results • Growing body of cancer & biomarker literature • New targeted therapies • Combination therapy • Clinical trials New technologies 900+ therapeutics in clinical development 2000+ MDx tests NGS data (100s of genes to 6MB genome 3500+ novel treatment approaches 2.8M+ peer-reviewed papers on cancer 10,000+ ongoing clinical trials

  11. N-of-One: Mission N-of-One’s mission is to bring the power of precision medicine to the point-of-care for patients and physicians through the translation of molecular data into state-of-the art, clinically actionable insights. N-of-One provides the most important link between molecular data and the oncologist—expert, clinical interpretation—translating this data into clinical insights to support oncologists with additional treatment options for their patients today.

  12. N-of-One® Experience • Interpretation for 4000thTumor - 347 different cancer subtypes profiled to date, including solid tumors and hematologic malignancies • >70% of cases: significant therapeutic options beyond current standard of care revealed • N-of-One direct clinical experience : • 100’s of direct patient cases followed through treatment • ~ 35% of treating physicians made an immediate change to their therapeutic • strategy based on N-of-One’s clinical interpretation • N-of-One’s trial enrollment rate is 3x national average POWERING PRECISION MEDICINE

  13. N-of-One® Five Year Track Record of Clinical Interpretation: >4,000 sequenced tumors Clinical Interpretation Reports – across multiple tests and platforms delivered to medical institutions and diagnostic labs across the country World class team of Ph.D.-level Scientists and Oncologists supported by a world class scientific advisory board Leading proprietary framework - PrecisionWorks® enables the development and delivery of knowledge in a scalable manner Jennifer Levin Carter, M.D., M.P.H Founder and President N-of-One www.n-of-one.com Established partnerships with leading diagnostics companies, providers and CRO’s to provide clinical interpretation POWERING PRECISION MEDICINE

  14. N-of-One Therapeutics 400 Fifth Avenue, Suite 115 Waltham MA 02451-8706 617-202-9808 www.n-of-one.com THANK YOU

  15. Personalized Medicine: Emerging Business Models Rebecca Sutphen, MD, FACMG President & Chief Medical Officer

  16. Clinical Genetics Services Genetic Benefits Utilization Management

  17. Best Practices

  18. 2012 Standard

  19. Fast Facts • Largest independent genetic counseling provider network • Increase access to genetic specialists by delivering services via telephone or web • 40+ board-certified genetic counselors • Rigorously follow national guidelines and standards • Secure, compliant data and telecom networks • 75 million (+) lives under contract

  20. Current Partners

  21. Ø Travel • Day, Evening, Weekend Patient Benefits • Spanish, ASL and Other Languages • Expedited Appointments • Family Appointments • Genetic Sub-Specialists

  22. Provider Benefits • Follow Guidelines; Standard of Care • Clinical Decision Support • Retain Patient Stewardship • Genetic Test Facilitation • Personalized Summary Report • Limit Liability Exposure

  23. Quality Assurance • Standard operating procedures with rigorous quality control • All recommendations follow national guidelines

  24. CoC Expectations • Implement risk assessment at new patient intake (all new analytic cases) • Refer for genetic counseling when indicated • Evaluate and track numbers and address barriers if they exist • Refer for genetic testing when indicated • Report to Cancer Committee on volumes – risk assessment, counseling, testing

  25. Our Solution • Provide systematicrisk assessment tool for use at new patient intake • Provide genetic counseling when indicated • Coordinate genetic testing when indicated • Audit and provide annual reports to Cancer Committee on volumes – risk assessment, counseling, testing

  26. khall@informedDNA.com www.informedDNA.com

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