Cover REGISTER TODAY! Next Generation Summit

1 Cover REGISTER TODAY! Conference-at-a-Glance Sixth Annual Short Courses next Generation Summit Enabling Point-of-Care Diagnostics Moving Assays to the Clinic August 19-21, 2014. Capital Hilton, Washington, DC. Predictive Cancer Biomarkers The next Generation Dx Summit brings together all of the major players in the evolving areas of diagnostics Companion Diagnostics: Strategy and Partnerships CONFERENCE PROGRAMS. August 19 - 20 August 20 - 21. Inherited Disease Diagnostics Enabling Point-of-Care Diagnostics Molecular Diagnostics for Infectious Disease NGS-Based Assays in the Clinical Setting Predictive Cancer Biomarkers Companion Diagnostics: Technology Companion Diagnostics: Strategy & Reimbursement Molecular Diagnostics for Infectious Disease & Partnerships Commercialization of Molecular Diagnostics Companion Diagnostics: Inherited Disease Diagnostics NEW! Clinical Application of Cell-Free DNA NEW! Technology & Reimbursement NGS-Based Assays in the Clinical Single-Cell Sequencing NEW!

2 Commercialization of Setting NEW! Molecular Diagnostics Clinical Application PLENARY SESSION: Think Tank on next - Generation Sequencing Diagnostics of Cell-Free DNA. Discussion: regulatory Review of Clinical Sequencing Assays Moderator: Harry Glorikian, Healthcare Consultant Single-Cell Sequencing Guest Speaker: Jennifer Dickey, RAC, , Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration Sponsor & Exhibit Opportunities Co-Organized with next - Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement Hotel & Travel Information Moderator: Elaine Lyon, , Medical Director, Molecular Genetics, ARUP. Case Presenters: Registration Information Andrea Ferreira-Gonzalez, , Professor, Pathology;. Director, Molecular Diagnostics Lab, Virginia Commonwealth University Click Here to Madhuri Hegde, , FACMG, Professor, Human Genetics;. Executive Director, Emory Genetics Laboratory, REGISTER Online! Emory University School of Medicine Premier Sponsors Organized by Cambridge Healthtech Institute next Generation Dx Summit | 1.

3 Cover Event-at-a-Glance Conference-at-a-Glance DETECTION BIOMARKERS BUSINESS & STRATEGY GENOMIC ANALYSIS SEQUENCING. Monday Pre-Conference Short Courses*. Short Courses Enabling Point-of-Care Companion Diagnostics: NGS-Based Assays in the Tuesday AM Predictive Cancer Biomarkers Inherited Disease Diagnostics Diagnostics Strategy and Partnerships Clinical Setting Enabling Point-of-Care Diagnostics Enabling Point-of-Care Companion Diagnostics: NGS-Based Assays in the Tuesday PM Predictive Cancer Biomarkers Inherited Disease Diagnostics Diagnostics Strategy and Partnerships Clinical Setting Predictive Cancer Biomarkers Wednesday Enabling Point-of-Care Predictive Cancer Biomarkers Companion Diagnostics: Inherited Disease Diagnostics NGS-Based Assays in the AM Diagnostics Strategy and Partnerships Clinical Setting Companion Diagnostics: Plenary Keynote Session Strategy and Partnerships Wednesday Molecular Diagnostics for Companion Diagnostics: Commercialization of Clinical Application of Single-Cell Sequencing PM Infectious Disease Technology and Reimbursement Molecular Diagnostics Cell-Free DNA.

4 Inherited Disease Diagnostics Dinner Short Courses*. NGS-Based Assays in the Molecular Diagnostics for Companion Diagnostics: Commercialization of Clinical Application of Thursday AM Single-Cell Sequencing Clinical Setting Infectious Disease Technology and Reimbursement Molecular Diagnostics Cell-Free DNA. Molecular Diagnostics for Thursday PM. Molecular Diagnostics for Companion Diagnostics: Commercialization of Clinical Application of Single-Cell Sequencing Infectious Disease Infectious Disease Technology and Reimbursement Molecular Diagnostics Cell-Free DNA. *Separate Registration Required Companion Diagnostics: Technology & Reimbursement About the Summit Premier Sponsors Commercialization of Access to next Generation diagnostics will Molecular Diagnostics only be gained through careful creation and management of partnerships in Clinical Application the community around development, of Cell-Free DNA commercialization, reimbursement and Corporate Sponsors regulation. This year's next Generation Single-Cell Sequencing Dx Summit will showcase advances in personalized medicine through a comprehensive program encompassing Sponsor & Exhibit companion diagnostics, infectious disease, Opportunities cancer molecular markers, point-of-care, inherited disorders, cell-free DNA and Hotel & Travel Information single-cell sequencing.

5 This event has become the meeting Registration Information place for major players in the expanding arena of diagnostics. It will showcase key Click Here to components of their successful adoption in the clinic and advancement to the market. Transgenomic . Advancing Personalized Medicine REGISTER Online! Please join the leaders in the community for Corporate Support Sponsor another exceptional year. Organized by Cambridge Healthtech Institute next Generation Dx Summit | 2. Cover Conference-at-a-Glance Short Courses*. MONDAY, AUGUST 18 (9:00AM-12:00PM). Short Courses SC1: Overcoming Challenges of Working with FFPE Samples W. Fraser Symmans, , Professor & Director, Research Operations, Pathology, UT MD Anderson Cancer Center Enabling Point-of-Care Sidney W. Fu, , , Professor & Associate Director, Genomic Medicine and of Medicine, Microbiology, Immunology and Tropical Medicine, George Washington Diagnostics University School of Medicine and Health Sciences Professor Beatrice S. Knudsen, , , Director, Translational Pathology, Cedars Sinai Medical Center Assay development and understanding pre-analytic effects on RNA gene expression Predictive Cancer Biomarkers Profiling microRNA expression FFPE DNA quality control and its correlation with NGS data Companion Diagnostics: SC2: Leading Product Innovation Strategy and Partnerships John C.

6 Carrano, , President and Founder, Paratus Diagnostics, LLC. Raising capital for your company or your project; pitching new ideas and writing a winning proposal, product development processes for FDA QSR. Inherited Disease Diagnostics Mathematics of cost-benefit analysis to establish a value proposition ISO 13485 and leadership and management techniques NGS-Based Assays in the SC3: NGS Data Analysis Determining Clinical Utility of Genome Variants Clinical Setting Heather McLaughlin, , MB(ASCP)CM, Instructor of Pathology, Massachusetts General Hospital and Harvard Medical School and Assistant Laboratory Director, Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine Molecular Diagnostics for Erica Ramos, MS, CGC, Clinical Genomics Specialist, Certified Genetic Counselor, New and Emerging Opportunities, Illumina, Inc. Infectious Disease Gabe Rudy, Vice President, Product Development, Golden Helix Review advances in NGS, identify genetic variants to link sequence data with disease and explore genetic data science Learn how to determine informed healthcare decisions Companion Diagnostics: Technology & Reimbursement MONDAY, AUGUST 18 (2:00-5:00PM).

7 Commercialization of SC4: Microfluidics for POC:Technologies, Applications and Products Molecular Diagnostics Holger Becker, , Founder & CSO, microfluidic ChipShop GmbH. Understand the role of microfluidics technology in the development of new products and the current state of the markets and obstacles in the commercialization process; and Clinical Application the different microfabrication methods for low and high volume production of Cell-Free DNA Learn about development strategies in product development and about examples of successful and unsuccessful microfluidic product introductions Get an overview on existing microfluidics-enabled products in the POC market Single-Cell Sequencing SC5: NGS as a Diagnostics Platform Madhuri Hegde, , FACMG, Associate Professor, Human Genetics; Executive Director, Emory Genetics Lab, Emory University School of Medicine Jennifer Morrissette, , Scientific Director, Clinical Cytogenetics Laboratory; Clinical Director, Center for Personalized Diagnostics (CPD), University of Pennsylvania Sponsor & Exhibit School of Medicine Opportunities Justin Zook, , Biomedical Engineer, NIST.

8 Technical aspects, tremendous power and pitfalls of NGS. Hotel & Travel Information NGS for cancer genomic analysis and companion diagnostics Risks of genetic discrimination and impacts of gene patents, government regulation, and direct-to-consumer marketing Registration Information Standardization of NGS assay development Click Here to REGISTER Online! *Please visit the event website for more details. Separate registration is required. Organized by Cambridge Healthtech Institute next Generation Dx Summit | 3. Cover Short Courses*. Conference-at-a-Glance SC6: Clinical Trials to Establish the Value of Diagnostic Tests: Design and Management Adrienne Bambach, Manager, Scientific Affairs; Acting Director, Clinical Affairs NanoSphere, Inc. Short Courses Anita Borek, Senior Manager, Clinical Affairs & Specimen Mgmt., Nanosphere, Inc. Scott Powell, Clinical Marketing Manager, Nanosphere, Inc. Enabling Point-of-Care Sponsored/Investigator-Initiated-Study clinical diagnostics processes Diagnostics Specimen Acquisition and Management who from, how to acquire, when to acquire, what to acquire and management best practices Clinical study publication planning and execution microbiology molecular diagnostic test case presented from market development studies through clinical outcomes/cost-effectiveness studies Predictive Cancer Biomarkers SC7: Sample Prep Methods for Liquid Biopsy and POC Molecular Diagnostics Michael J.

9 Heller, , Professor, Bioengineering and Nanoengineering, UCSD. Companion Diagnostics: Isolation of circulating cell-free DNA, ccf-RNA and exosomes from blood, plasma, serum and other clinical samples Strategy and Partnerships Isolation of circulating tumor cells from blood and of bacteria and virus from blood and other clinical samples New seamless sample to answer devices and finding needles in a haystack Inherited Disease Diagnostics MONDAY, AUGUST 18 (DINNER 5:30-8:30PM). NGS-Based Assays in the SC8: Use of CLIA-Waived POC and Rapid Diagnostic Tests in Community Pharmacies Clinical Setting Michael E. Klepser, , FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy Donald G. Klepser, , MBA, Assistant Professor, Pharmacy Practice, University of Nebraska Medical Center College of Pharmacy Molecular Diagnostics for Allison Dering-Anderson, ,RP, Clinical Assistant Professor, Pharmacy Practice, University of Nebraska Medical Center College of Pharmacy Infectious Disease Community pharmacies and how it is a growth market for diagnostics Legislation and state practice acts regarding the use of CLIA-waived POC and RDTs in community pharmacies Companion Diagnostics: Developing a sustainable business using POC and RDTs in community pharmacies Technology & Reimbursement SC9: regulatory Compliance in Drug Diagnostics Co-Development Commercialization of Tracy Bush, , Director & Global Coordinator, Companion Diagnostics, regulatory Affairs, Roche Diagnostics Molecular Diagnostics Pamela L.

10 Swatkowski, Director, regulatory Affairs, Abbott Molecular, Inc. Sabah Malek, Associate Director, Global regulatory Affairs, Eisai, Inc. Clinical Application requirements and processes; government oversight of diagnostics, diagnostic clearance and approval pathways of Cell-Free DNA Co-development process & timelines and integration of Rx and Dx development plansl navigating the development process and co-development examples and lessons learned Diagnostics regulation in the EU, Japan, China and other complex emerging markets; developing a successful CDx global regulatory strategy Single-Cell Sequencing WEDNESDAY, AUGUST 20 (DINNER 6:30-8:30PM). SC10: regulatory & Reimbursement Issues with NGS and Multiplex Assays Sponsor & Exhibit Melina Cimler, , Vice President, Head, Global Quality Illumina, Inc. Opportunities Danielle Scelfo, Director, Government Affairs, Genomic Health Part 1: NGS applications and implications; Current regulatory pathways; Things to consider in developing NGS applications for clinical use; NGS in companion diagnostics roles Hotel & Travel Information of pharma and diagnostic partners Part 2: Coding, coverage, policies and payment fees for NGS assays; Medicare /CMS view; How to generate cost effectiveness data; Clinical utility data Registration Information SC11: NGS for Infectious Disease Diagnostics Samia Naccache, , Associate Specialist, Laboratory Medicine, UCSF.