Moving molecular diagnostics to the market involves demonstrating the value proposition of the test while carefully managing resources and expertly navigating the constantly changing environment. With increasing pressure from rising healthcare costs, molecular testing will need to demonstrate that it can improve outcomes of patients while saving healthcare dollars. This year’s expert faculty will share best practices and case studies for handling regulatory approval, clinical adoption and market access to achieve commercial success.
Scientific Advisory Board
Andrew C. Fish, J.D., Executive Director, AdvaMedDx
Harry Glorikian, Healthcare Consultant
John W. Hanna, MBA, Vice President, Endocrinology, Veracyte
Julie Lynch, Ph.D., MBA, RN, Principal Investigator, Veterans Health Administration
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
WEDNESDAY, AUGUST 19
10:30 Registration
1:25 Refreshment Break in the Exhibit Hall with Poster Viewing
1:50 Chairperson’s Opening Remarks
Scott M. Kahn, Ph.D., CSO, Oncostem Biotherapeutics, LLC.; Adjunct Associate Research Scientist, Urology, Columbia University; Chairman, Biomarkers Council, International Cancer Advocacy Network
2:00 KEYNOTE PRESENTATION: Precision Medicine for Adult Volunteers
C. Thomas Caskey, M.D., FACP, FACMG, FRSC, Professor, Molecular & Human Genetics, Baylor College of Medicine
Forty-five physicians and eighty-five Young Presidents’ Organization members volunteered to participate in an educational program studying utility of whole genome sequencing. The study matched a molecular diagnosis to their medical history in 29% of volunteers. The utility and acceptance will be illustrated.
2:30 Private Payer Evaluation of Diagnostic Tests – A Survey of 50 Medical Directors and an Insider’s Perspective on the Health Technology Assessment Process
John W. Hanna, MBA, Vice President, Endocrinology, Veracyte, Inc.
Melissa K. Bennett, MS, CGC, Clinical Director, Laboratory Management Program, CareCore National
This session presents results of a published study surveying 50 payer medical directors and evaluating their perceptions of the value of molecular diagnostics, understanding of diagnostic test evidence including clinical utility, and use of standardized health technology assessment (HTA) processes. CareCore will also discuss their standard processes for molecular test evaluation and the growing interest among private payers to outsource HTAs.
- Perception of the value molecular diagnostic
- Understanding of diagnostic study design
- Understanding of diagnostic test evidence evaluation, and in particular clinical utility
- The use of standard tech assessment groups like Hayes, etc. in evaluating products
3:30 Capture and Molecular Characterization of Viable Circulating Tumor Cells using a Novel Epitope Independent Micro-Fluidic Platform
Shane Booth, Ph.D., CTO, Research and Development, ANGLE plc
4:00 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Regulatory Panel:
Moderator: 
Andrew C. Fish, J.D., Executive Director, AdvaMedDx
This session will review current issues related to FDA oversight of laboratory developed tests (LDTs) and offer perspectives from key stakeholders, including regulators, laboratories, manufacturers, and clinicians. The panel will discuss topics including the status and content of FDA proposed guidance on LDT oversight, any legislative and policy updates, evidence expectations regarding analytical and clinical validity, and compliance challenges.
Panelists:
Katherine Serrano, Ph.D., Biomedical Engineer, Chemistry & Toxicology Devices, FDA CDRH
Elissa Passiment, Executive Vice President, American Society for Clinical Laboratory Science (ASCLS)
Roger D. Klein, M.D., J.D., Medical Director, Molecular Oncology, Cleveland Clinic Foundation (Chair, Professional Relations Committee, Association for Molecular Pathology)
Richard L. Schilsky, M.D., FACP, FASCO, CMO, American Society of Clinical Oncology
6:15 Close of Day
6:00 Dinner Short Course Registration
THURSDAY, AUGUST 20
7:30 – 8:25 am Problem-Solving Breakout Discussions with Continental Breakfast
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
ACCESS AND VALUE OF NGS DATA: Driving Clinical Decision Making Across Disease Areas
Han Liang, Ph.D., Associate Professor and Deputy Chair, Bioinformatics and Computational Biology, R. Lee Clark Fellow, The University of Texas MD Anderson Cancer Center
- What are the key standards for making clinical decisions based on NGS data
- How to build the efficient infrastructure for supporting the applications of NGS data in clinical decision
- How to standardize and share the knowledge related to NGS-based decisions in a community
The Protecting Access To Medicare Act Of 2014 (PAMA): What Do These New Regulations Mean For Stakeholders?
Roger D. Klein, M.D., J.D., Pathologist, Molecular Pathology, Cleveland Clinic Foundation
- What are the implications of CMS’ definition of “laboratory”?
- Unique HCPCS codes, what will these mean for manufacturers and laboratories?
- CMS’ and Medicare Administrative Contractors (MACs), where do we go from here?
ACTIONABILITY IN CANCER AND NGS: How Should We Be Viewing This Space
Carl Morrison, M.D., DVM, Executive Director, Center for Personalized Medicine; Director, Roswell Park Cancer Institute
- Pathways, genes, exons, codons, and single nucleotides, which is the right fit?
- Independent google search versus engine rules to define actionability, which is optimal?
- Is there a framework for evidentiary standards to define actionability?
Smart Consumables, Hybrid Consumables – What’s Needed Next in the Healthcare Market Continuum?
Ali Tinazli, Ph.D., Vice President, Head, Business Development & Sales, Sony DADC Biosciences
- Emerging Technologies
- Function integration
- Commercialization
8:25 Chairperson’s Opening Remarks
Harry Glorikian, Healthcare Consultant
8:30 A New Business Model in Laboratory Testing – Sharing Data
Carl Morrison, M.D., DVM, Executive Director, Center for Personalized Medicine; Director, Roswell Park Cancer Institute
Prior models of revenue streams for laboratories have been almost exclusively from 3rd party payers for laboratory services provided. As laboratories move from traditional single analyte testing to comprehensive multi-analyte platforms the ability to generate 2nd and 3rd uses of this data has the ability to generate additional revenue streams. Dr. Morrison will present how his group is using this new business model to achieve new avenues of commercialization for laboratory testing through the OmniSeq program.
8:45 NGS: Filling in the Gaps
Erynn Gordon, MS, LCGC, Medical Marketing Director, 23andMe
The use of Sanger sequencing and array based testing over the past few decades has made genetic testing available to patients with clear Mendelian disorders. However, the cost and time involved has been a burden to patients and many have been left without answers. NGS has shifted the genetic testing paradigm allowing many, if not all, genes to be queried at once.
9:00 New Knowledge from NGS and Big Data
Felix W. Frueh, Ph.D., Executive Partner, Opus Three LLC
The ability to integrate NGS in larger contexts of diverse health care data provides the opportunity to interpret the human genome at increased precision. Such interpretation creates the foundation for new knowledge (e.g. associations between genome-level data and clinical manifestations) that will drive clinical decision making in molecular medicine.
9:15 Improve Cancer Treatments by Incorporating the NGS Data of Tumor Samples
Han Liang, Ph.D., Associate Professor and Deputy Chair, Bioinformatics and Computational Biology, R. Lee Clark Fellow, The University of Texas MD Anderson Cancer Center
An important task in cancer research is how to accurately identify biomarkers and use them to predict the prognosis or drug responses of cancer patients. Using the genomic data from large-patient cohorts, we evaluated the power of diverse types of molecular data in predicting patient survivals and annotated the functional effects of mutational hotspots in clinically actionable genes across tumor types.
9:30 Cross-Industry Partnerships to Foster Innovation and Decrease Manufacturing Time to Market in the Biomedical Business
Ali Tinazli, Ph.D., Vice President, Head, Business Development & Sales, Sony DADC Biosciences
Smart Consumables based on polymer materials with microscale or supreme optical features are prerequisites for emerging applications in the biomedical markets as in in vitro diagnostics. The increasing complexity of such new product, including CMOS hybrid consumables, requires new manufacturing technologies.
9:45 Sponsored Presentation (Opportunity Available)
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:50 PANEL DISCUSSION:
Moderator: Harry Glorikian, Healthcare Consultant
- What are the value creation points for the data? How does the data make a difference in how someone is treated?
- Ensuring access to and organizing and managing data
- How are partnering deals structured? What are some key issues?
- How do you monetize the value of the data?
- Is the data more valuable than the technology that creates it?
Panelists:
Carl Morrison, M.D., DVM, Executive Director, Center for Personalized Medicine; Director, Roswell Park Cancer Institute
Erynn Gordon, MS, LCGC, Medical Marketing Director, 23andMe
Felix W. Frueh, Ph.D., Executive Partner, Opus Three LLC
Han Liang, Ph.D., Associate Professor and Deputy Chair, Bioinformatics and Computational Biology, R. Lee Clark Fellow, The University of Texas MD Anderson Cancer Center
12:20 pm Sponsored Presentation (Opportunity Available)
12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:20 Session Break
2:00 PANEL DISCUSSION: Clinical Informatics Needed to Ensure Implementation of Your Test
Moderator: Julie Lynch, Ph.D., MBA, RN, Principal Investigator, Veterans Health Administration
- How do you meet informatics requirements for your test
- Linking test results to pharmacy and EHR
- Guidelines for HIPAA compliance of your test with requirements
- How do you ensure utilization of test?
Panelists:
Terah B. Collins, Genomics Strategist, Cerner Corporation
Valentina I. Petkov, M.D., MPH, Health Scientist/Program Officer, Surveillance Research Program, Division of Cancer Control and Population Sciences National Cancer Institute
Danielle Chun, MPH, Genomics Informaticist, VINCI Services, VA
Scott Kulich, M.D., Ph.D., Associate Professor, Pathology, Division of Pathology and Division of Neuropathology, VA Pittsburgh Healthcare System (VAPHS)
3:30 Chairperson’s Remarks
Ali Tinazli, Ph.D., Vice President, Head, Business Development & Sales, Sony DADC Biosciences
3:35 CLOSING KEYNOTE: Commercializing Personalized Medicine: It’s All About the Value Proposition
Daryl Pritchard, Ph.D., Vice President, Science Policy, Personalized Medicine Coalition
A key barrier to the commercialization of personalized medicine products involves an unclear value proposition. Many factors are involved in value assessments, but determining what are the most important value drivers depends on who you are asking.
4:05 Close of Conference