Commercialization of Molecular Diagnostics

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Recommended Pre-Conference Short Courses*

Clinical Studies for the Development of Evidence-Based Diagnostics

Regulatory Compliance in Drug-Diagnostics Co-Development

Regulatory and Reimbursement Issues with Multiplex Molecular Assays/Next-Generation Sequencing

*Separate registration required

Scientific Advisory Board

Harry Glorikian, Founder & Managing Partner, Scientia Advisors LLC
Iain D. Miller, Ph.D., Founder, Healthcare Strategies Group

WEDNESDAY, AUGUST 21

11:00 am Registration

11:00 PLENARY KEYNOTE DISCUSSION

Perspectives on Evaluating Novel Diagnostics for Reimbursement

Moderator: Andrew C. Fish, Executive Director, AdvaMedDx

Levels of evidence needed to support novel diagnostics
Health economics
Analytical issues
CMS policy
Rate schedule

Panelists:

Aaron D. Bossler, M.D., Ph.D., Clinical Associate Professor, Director Molecular Pathology Laboratory and Molecular Genetic Pathology Fellowship Program, University of Iowa Hospitals and Clinics and Co-Chair, AMP Economic Affairs Committee

Dwight Denham, MBA, Director, Clinical Research, Beckman Coulter, Inc.

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

Lee H. Newcomer, M.D., Senior Vice President, Oncology, United Healthcare

12:30 pm Enjoy Lunch on Your Own

1:45 Chairperson’s Opening Remarks

Harry Glorikian, Founder & Managing Partner, Scientia Advisors LLC

1:50 Commercializing Diagnostic Services on a Global Platform

Michael Fannon, President, BioIT Solutions, Former CIO, Human Genome Sciences

Dx markets require sophisticated workflow management, outcome interpretation, and secure report preparation. Add regulatory, reagent supply-chain, and reimbursement issues and many diagnostics pioneers face critical business needs for real-time controls. Mike discusses practical guidelines for fast and cost-effective platform deployment to manage modern Dx services.

2:05 Genomic Testing for All Cancer Patients at Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Boston Childrens Hospital

Barrett J. Rollins, M.D., Ph.D., Linde Family Professor of Medicine, Harvard Medical School; CSO, Dana-Farber Cancer Institute

The landscape of genomic abnormalities in cancer is often unknown at the level of the individual patient, and the influence of specific genotypes on clinical behavior is often unclear. These are impediments to the development of a commercially viable clinical test. To address these deficiencies, we developed PROFILE, a project that obtains genomic and linked clinical information on all patients who come to our hospitals for cancer-related care.

2:35 Disruption of the Diagnostics Market by NGS Technologies

Dietrich Stephan, Ph.D., Founder & CEO, Silicon Valley Biosystems (SVBio)

The cost of next-generation sequencing and the changing reimbursement schema is forcing adoption of NGS by purveyors of DNA Diagnostic tests. The continued success of these organizations will rely on reducing COGs and streamlining internal workflows, thus optimizing margins. The successful transition to cheaper technologies will define the winners and losers in the new ecosystem of diagnostics.

3:05 Non-Invasive Prenatal Testing Using Circulating Cell-Free Fetal DNA: An Innovative High-Throughput Clinical Application of Next-Generation Sequencing

Dirk van den Boom, Executive Vice President, R&D & CTO, Sequenom, Inc.

The utility of cell-free fetal DNA present in maternal plasma of pregnant women has revolutionized the approach to non-invasive prenatal testing (NIPT) for fetal aneuploidies. This presentation will provide an overview of the development, implementation,and commercialization of MaterniT21 PLUS - a next-generation sequencing based laboratory developed test for detection of fetal trisomies 21,18,13 and sex aneuploidies; in addition, there will be a summary of almost two years of clinical testing.

3:35 Rapid IVD Instrument Development

Walter Gilde, Business Development Manager, KMC Systems, Inc.

Rapid IVD product development focuses on accelerated time to market and lower development cost. Understanding user requirements, selecting and optimizing the hardware and software architecture, and leveraging off-the-shelf technologies are essential elements for success. The timely application of these three strategies can minimize design change, speedtime to market, and allow OEMs to meet user needs at a reasonable cost.

3:50 Next Generation Sequencing vs. Individual Assays – Implications for Demonstrating Clinical Utility in the Context of Reimbursement Decisions