August 23-26, 2016, the Next Generation Dx Summit will bring together more than 1,000 international diagnostic professionals to exchange key insights on a wide range of topics including NGS data considerations and interpretation, cell-free DNA, immunotherapy biomarkers, coverage and reimbursement, business strategy, and much more.

As a long time sponsor of the summit, Slone Partners is proud to support leaders and contribute to the success of organizations in the diagnostics space who are shaping the future of healthcare.

This year, the Next Generation Dx Summit has an incredible list of panel discussions, breakout sessions and symposia covering the diagnostics space. With so many valuable topics to choose from, we are providing you our list of 10 Must See Talks at Next Generation Dx Summit 2016.

1. Implementing President Obama’s Precision Medicine Plan at the FDA and Changing the Current Paradigm to Make Use of Targeted Studies Involving a Patient’s Specific Genetics, Health History and Lifestyle

Keynote | Wednesday 11:20 am | Elizabeth A. Mansfield, Ph.D., Director, Personalized Medicine, Office of In Vitro Diagnostics & Radiological Health, FDA CDRH

2. Disruptive Innovation in Laboratory Medicine: Game-Changing Technologies and Approaches

Keynote | Wednesday 11:50 am | Moderator: Ted E. Schutzbank, Ph.D., D(ABMM), Technical Director, Specialized Testing and Microbiology, Laboratory Services, St. John Providence Health System

Disruptive innovation is a new, emerging technology or approach that unexpectedly displaces an established one. Examples in laboratory medicine include next-generation sequencing, early cancer detection, direct-to-consumer testing, point-of-care assays and liquid biopsies. Scenarios incorporating such disruptive innovations will be presented by the moderator to a panel of experts to provoke discussion on the impact on laboratory medicine.

3. Precision Medicine and Personalized Solutions: Perspectives from a Healthcare Player, Janssen Diagnostics (Johnson & Johnson)

Companion Diagnostics | Tuesday, 8:40 am | Werner Verbiest, Global Head Janssen Diagnostics

The global healthcare market, and with it the pharmaceutical industry, is in a significant state of flux and change. Increased innovation and novel healthcare models will drive a new way of addressing global health. Janssen is committed to transforming the way diseases are treated and where possible even prevented or intercepted. In all therapeutic focus areas, Janssen is passionate to enhance patient outcome by bringing innovative medical solutions to practice. Janssen Diagnostics, an integrated part of Janssen, is focused on enabling precision medicine concepts and heavily relies on external partnerships to bring customized diagnostic solutions. This presentation will highlight Janssen’s vision and unique business model in addressing current and future opportunities.

4. Facing Challenges Regarding the Reimbursement Paradigms for Advanced Diagnostics

Reimbursement | Tuesday, 9:10 am | Lee Hilborne, MD, MPH, Professor, Pathology and Laboratory Medicine, David Geffen School of Medicine UCLA HealthSystem, Senior Medical Director, Medical Affairs, Quest Diagnostics, Health Policy Researcher, Global Health, RAND

Advanced diagnostics are critically important to improving the value of medicine. New and innovative strategies to improve patient care have outpaced current systems to appropriately reimburse providers for the costs of services and the value provided. At the same time, the Institute of Medicine estimates that 30% of U.S. healthcare is duplicative or unnecessary. Inappropriate or over-utilized medical tests account for $250 to $300 billion in U.S. medical expenses annually. The challenge must be to quickly establish both clinical validity AND clinical utility for new diagnostic services while taking responsibility for effective utilization of both new and existing diagnostic services.

5. Luncheon Presentation: Managing Risk: A Pragmatic Approach for the Successful Co-Development of Drugs and Diagnostics

Companion Diagnostics | Tuesday, 1:00 pm | Dan Snyder, President & CEO, MolecularMD

A greater biological understanding of disease has been catalyzed by the advent of powerful genomic applications and techniques. Over 800 candidate compounds are in clinical testing for cancer; 73% have the potential to be personalized medicines. Opportunities to improve healthcare outcomes are unprecedented but not without financial constraints and a high degree of uncertainty. Risk mitigation and a pragmatic, strategic approach to managing the clinical trial and commercialization are key to a successful drug-diagnostic approval.

6. Point-of-Care Diagnostics in a Retail Health Setting

Pharmacy | Wednesday 2:30 pm | Alexander Sbordone, Manager, Operations, MinuteClinic, CVS Health

As retail health continues to grow, clinics are looking to increase their service offerings. The expansion of services in clinics should include point-of-care (POC) diagnostics that will assist with the proper diagnoses and treatment of patients. This presentation will review current testing utilized at MinuteClinic, how expanded POC testing may allow for additional services in the retail setting, and the challenges that POC testing presents in this environment.

7. Keynote Presentation: From Volume to Value in Healthcare: A New Business Model for Diagnostics?

Molecular Diagnostics | Wednesday, 4:45 pm | Glenn D. Steele, Jr., M.D., Ph.D., Chairman of the Board, xG Health Solutions, Inc.

A combination of transformative changes in how health care is delivered and paid for will impact the business models of all stakeholders including device manufacturers and molecular diagnostic companies. As value of care to patients is emphasized, and as more targeted diagnosis and therapy become the norm, where care is given, who gives care, who makes product buy decisions, and how the product’s cost benefit is evaluated will all change.

8. How LDT Labs and Manufacturers are Being Impacted by Payor Consolidation, ACO Arrangements, and Managed Lab Benefit Programs 

Molecular Diagnostics | Thursday, 8:25 am | Moderator: John Hanna, Vice President, Endocrinology, Veracyte, Inc.

The laboratory market is facing a changing payor landscape including consolidation among private payers and Medicare MAC contractors, a greater push for ACO arrangements and P4P incentive programs, and the introduction of laboratory benefit management programs to control molecular diagnostics spend and utilization. Experts in this session will discuss the challenges these dynamics present to labs and manufacturers in participating in payer networks, launching new products, and demonstrating cost-effectiveness as a diagnostic test provider.

9. Implementing Genomic Testing into a Wellness Program

Genomic Health Screening | Friday 2:05 pm | Karen L. Huyck, M.D., Ph.D., Assistant Professor, Occupational and Environmental Medicine, Geisel School of Medicine, Dartmouth College

The Dartmouth-Hitchcock Weight and Wellness Center (WWC) Biorepository is being developed to archive comprehensive datasets including but not limited to: genomic, microbiomic, clinical, demographic, anthropomorphic, and psychosocial data, wellness and lifestyle data, and functional brain imaging information from patients with obesity. Much like the beginning of our nascent understanding of cancer, when rudimentary treatments were not targeted to specific types of tumor cells, obesity is often treated with a “one size fits all” approach. Effective treatment for obesity will benefit from organized, large-scale study, and precision research approaches.

10. Keynote Presentation: The Future of NIPT: Cell-Free DNA vs. Intact Fetal Cells vs. Invasive Diagnostic Testing

NIPT | Friday, 8:30 am | Ronald J. Wapner, M.D., Professor, Obstetrics and Gynecology, Vice Chair, Research, Director, Reproductive Genetics, Columbia University Medical Center

Noninvasive prenatal testing is constantly evolving. The use and application of currently available technology will be explained and compared with what is on the horizon. Next-generation sequencing and new technologies along with their indications will be explored.

For more information and a full list of talks at the Next Generation Dx Summit 2016, please visit, or download the brochure here.

Slone Partners is an active participant in the diagnostics space, providing counsel and delivering premier talent to the industry’s most innovative, world-class organizations. To learn more about how to bring on leaders to grow your organization or to schedule a meeting at NGDx 2016, please contact us.

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