Michael J. Pellini, MD Diagnostics Pain management  Patients can fight more broadly F for sharing data and data exchange 80% patients do not access Academic Centers for treatment

Michael J. Pellini, MD surgery, chemo, radiation – cost, harmful, INEFFECTIVE, Dr. Reza Columbia Medical School Oncologist 35 years How are we doing with technology? Very remarkable Clinical Utility to the Payer Regulatory – a super star in ten years

Stephen L. Eck, Carl June, UPenn Beyond Cancer: Chronic diseases have systemic of specific immune or autoimmune components: CNS, neurodegenerative and Diabetes, Sickle cell anemia – treatment by cell therapy microphages

Stephen L. Eck, Carl June, UPenn Cost of cell transfection therapy: Cost of Goods, Cost of Labor – pay for performance,  Manufacture in NJ shipped to Europe – not effective

Stephen L. Eck, Carl June, UPenn Similarity between Transfusion Medicine industry and Cell therapy – Transfection of cells therapy  Manufacturing of Cells for transfection: Over regulation like in small molecules vs too little regulation

Stephen L. Eck, Carl June, UPenn engineering T cells life farming – innovation is the driver, FDA is evolving in handling patents involved in Cell engineering Regulatory science needs to evolve in light of gene therapy in Human cell line in China

Stephen L. Eck, Carl June, UPenn Children vs Adults 2011 reported better results in Adults, children’s immune system is evolving  In 2019 – 13 biotech companies in CAR-T cell therapies, Gene therapy is growing FDA, drug cycle T cells vs stem cells

15th Annual meeting is at a historic moment in Boston where Prof. Church launched the Human Genome Project and Eric Launder at MIT and the Cancer Genome Project. Genzyme conceived gene therapy sold to Sanofi for $ Billion  Foundation Medicine

Edward Abrahams, Ph.D., President, PMC 170 drugs with biomarkers, up 15% from 2000 in Biomarker strategy Gene therapy started in 2005, today personalized medicine is becoming standard of care. Science & Technology need additional friendly environment

Kenna R. Mills Shaw, Ph.D., MD Anderson Institute does not sequence genome of each patient unlike Dana Farber clinicians need to access information for decision making when disease progresses – what new test to order data sharing inside the institute

Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, PMC Genomic sequencing for a single test that covers many biomarkers Improve treatment efficiency Growing recognition of the need to demonstrate value, evidence for Payers to pay

Ammar Qadan, Vice President, Global Head of Market Access, Illumina Illumina is building evidence for Harvard Pilgrim on theirs patient data on risk pregnancies Illumina is expanding  building evidence for ALL rare diseases for all Test diagnostics

Roy J. Gandolfi, M.D., Medical Director, SelectHealth, UT is the Payer of Intermountain Healthcare, UT Regional approach vs National perspective medical policies requires experts for Payer to approve a treatment Consumer in the health plan

Lincoln Nadauld, M.D., Ph.D., Chief, Precision Health, Intermountain Healthcare, UT Precision Oncology Program: Need, study, analysis outcome, publish dataPharmacogenetics testing will be covered for all employees & Neonatal

Peter J. Neumann, Sc.D., Tufts Medical Center clinical utility evidence of value: saving by diagnostics cost for quality cost of diagnostics cost effectiveness – characterize utility cost effectiveness – study Value to families value of knowledge

Ammar Qadan, Vice President, Global Head of Market Access, Illumina Illumina is partnering with providers and Payer Illumina & Blue Cross Blue Shield 150 Million are covered for genomics 2500 genomics test done Under utilization educate physician

Mark P. Stevenson, COO Thermo Fisher Scientific Context: Therapy selection in personalized medicine navigate diagnostics in use and policies when implementations is considered Physicians need precise testing now Payers evidence of utility is needed