Cambridge Healthtech Institute’s Eighth Annual
Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic
Driving the Emerging Digital Genomics Revolution
August 22-23, 2018 | Grand Hyatt Washington | Washington, DC
Commercializing molecular diagnostic tests requires comprehending the changing landscape of diagnostic testing, taking stock of reimbursement and regulatory conditions, gaining traction with key opinion leaders and building a successful product launch. The Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic track at the Next Generation Dx Summit brings together thought leaders with a timely agenda that features case studies and real-world examples to highlight how molecular diagnostics is being implemented in various settings and impacting outcomes.
Final Agenda
Recommended Short Course*
SC8: Commercialization Boot Camp: Manual for Success in Molecular Diagnostics
Harry Glorikian, MBA, Healthcare Consultant; Author, Commercializing Novel IVD’s Content
Stan Skrzypczak, MS, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.
*Separate registration required
Scientific Advisory Board
Harry Glorikian, MBA, Healthcare Consultant
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Stan Skrzypczak, MS, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.
WEDNESDAY, AUGUST 22
7:45 am Registration and Morning Coffee (Independence Foyer)
8:25 Chairperson’s Opening Remarks
Harry Glorikian, MBA, Healthcare Consultant
8:30 KEYNOTE PRESENTATION: Thriving in the New Data-Driven Healthcare Market
Harry Glorikian, MBA, Healthcare Consultant
What are the goals of this data-driven revolution and how far are we from starting to achieve them? Will a completely new business paradigm emerges for next-generation health systems to optimize operations and patient care? Is there room for disruptive entrepreneurs alongside existing companies to succeed in data-driven drug discovery and development? Roll up your sleeves and get ready to discuss what is working and what is getting in the way of flourishing in the world of MoneyBall Medicine.
Attendees may be interested in Commercializing Novel IVDs: A Comprehensive Manual for Success, written by Harry Glorikian.
9:00 Predicting Disease Using Clinical Diagnostics
Jason Bhan, MD, CMO & Co-Founder, Prognos
Artificial intelligence (AI) is driving a paradigm shift in healthcare, powered by increasing availability of healthcare data and rapid progress of analytics techniques. AI can be applied to various types of Clinical Diagnostic data (structured and unstructured). Major disease areas that use clinical diagnostic results and AI tools include Oncology and Rare Diseases. We will review in more details how we can predict diagnosis and major disease events earlier in these areas. The specific applications are in early detection, intervention, and outcome prediction.
9:15 Harnessing the Inherent Utility of Bayesian AI Solutions for Target Discovery, Population-Based Diagnostics, and Health Economics
Niven R. Narain, President & CEO, Berg Pharma
9:30 Panel Discussion
10:00 Biostatistics in Clinical Research -- What Can Make or Break Your Product's Commercialization
Benjamin Brown, PhD, Senior Medical Research Biostatistician, IVD, NAMSA IVD
As an integral part of clinical research, a sound biostatistical strategy is essential in achieving commercialization. No matter what markets you plan on launching into, who the intended user is, or the purpose of your product, there is one design element that needs to be the center of your strategy. Learn what this is and how to apply it to your clinical research, data management, and biostatistical reports to facilitate market approval.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
11:15 Genomic Medicine for the University of Vermont Health Network
Debra G.B. Leonard, MD, PhD, Chair, Pathology and Laboratory Medicine, The University of Vermont Health Network and the Robert Larner, M.D. College of Medicine, University of Vermont
The Department of Pathology and Laboratory Medicine is developing clinical genomic testing for the University of Vermont Health Network. Clinically, the vision is genomic sequencing for all patients. Education focuses on preparation of medical students, healthcare providers and the public. Research is on genomic value, implementation science and functional genomics. This program is being implemented in an evolving global payment model for population health management.
11:35 Quality, Consistency, and Utilization in Diagnostic and Proactive Genetic Testing
Stephen E. Lincoln, Head of Scientific Affairs, InVitae
Advances in technology have made clinical genetic testing more accessible and affordable, leading to the rise of many new laboratories and genetic tests. However, this can lead to physician and patient confusion as the different tests can have remarkably different clinical validity and clinical utility, which is not currently thoroughly addressed by the existing standards and regulatory bodies. New international collaborations are playing a significant role in defining standards and best practices which can help make robust implementation of precision medicine a reality.
11:55 Implementing Personalized Medicine in a Community Health System
John Deeken, MD, COO, Inova Translational Medicine Institute, Senior Vice President, Inova Health System; Associate Professor, Virginia Commonwealth University
The opportunities and challenges to initiate a personalized medicine program are significant. Given rapid improvements in technology, genetic sequencing is getting easier and cheaper. Unfortunately, health care reimbursement, and physician changes in practice habits, have slowed the implementation of personalized medicine. In this presentation, I will discuss how a community health system envisioned and implemented a PM program, and lessons on what we learned along the way.
12:15 pm PANEL DISCUSSION: What Does It Take to Really Integrate into the Clinic?
- Clinician education
- Integration with EMRs
- Hospitals - What they must insource, outsource
- Resourcing precision medicine (PM)
- Ensuring quality - PM resources should be comprehensive, standardized
- Community-based oncology practices - every patient getting PM?
- How do you scale up sales force and reach the market?
- How do you commercialize PM when patients are thinly distributed?
12:45 Luncheon Presentation: Devil's Advocate: Contrarian Viewpoints in Dx Trends
Moderator: David Cavanaugh, MBA, Partner, DeciBio Consulting
Panelists: Allison Ballmer, Vice President, Corporate Development, Agilent Technologies
Amanda Murphy, MBA, Senior Equity Research Analyst, Diagnostic Services and Life Sciences, William Blair
Stephane Mouradian, PhD, Venture Partner, New Leaf Venture
As with many industries, diagnostics industry stakeholders can have a tendency to run wild with the latest trends. David Cavanaugh hosts a panel discussion covering some of the unconventional or unpopular opinions in clinical diagnostics in an attempt to inject a sense of realism and pragmatism to the conversation.
1:15 Session Break
Moderator: Larry K. Wray, PhD, Wray IVD Consulting
1:45 Connectivity And Data Aggregation Components
Robert Havasy, MS, Senior Director, HIS, HIMSS North America
1:55 Individuals as Research Partners Powered by Blockchain
Dawn Barry, President & Co-Founder, Luna DNA
2:05 Open Access, Patient Involved, Collaborative Model for Research and Clinical Trials with Multiple Myeloma
Christopher Williams, Vice President, Business Development, Multiple Myeloma Research Foundation
2:15 Panel Discussion:
- What are some promising technologies?
- What are some exciting new applications for remote monitoring?
- What are some current obstacles and concerns?
- What are the unmet needs?
2:50 Precision Medicine in Diabetes - Commercialization Challenges and Opportunities
Eric Button, MSc, MBA, President & Managing Director, NeoMark Ventures
Precision Medicine has the potential to provide novel insights about diabetes on an unprecedented scale. Significant efforts are underway to develop information on genetic and environmental factors important for pathogenesis of diabetes that may be incorporated into personalized approaches to prevention and treatment. Commercialization opportunities and challenges will be discussed.
3:05 Sponsored Presentation (Opportunity Available)
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
Moderator: Stan Skrzypczak, MS, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.
4:00 Medicare Coverage of Next Generation Companion Diagnostics
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Laboratory diagnostic tests using Next Generation Sequencing hold promise for patients with advanced cancer in identifying genomic alterations that will lead to a targeted therapy. However, many of these tests have not yet been formally validated or may not have sufficient published evidence on clinical utility. The presentation will discuss the framework used by CMS and FDA in its final national coverage determination published in Spring 2018 and will also examine the local coverage process in effect through the MOL DX program where carrier discretion is enforced for non-FDA tests and the technology assessment process.
4:15 New Innovation and Molecular Diagnostics: What Do Payers Want?
Mark D. Hiatt, MD, MBA, MS, Radiologist; Former Executive Medical Director, Regence BlueCross BlueShield; and Vice President of Medical Affairs, Guardant Health
From his experience working for a multi-state health plan, Dr. Mark Hiatt clarifies evidentiary expectations of payers to demonstrate the clinical utility of molecular diagnostic testing. Dr. Hiatt can also elucidate how payer conceptions of clinical utility and study outcomes influence evidence requirements and perceptions of value for innovative technologies from his experience with value-based reimbursement models, and can address safety considerations of biopsies in general from his experience as a physician performing conventional percutaneous biopsies.
4:30 Oncology Practices in Value-Based Payment Models
Stuart Goldberg, MD, Chief Scientific Officer, COTA Inc
Value has been roughly defined as outcomes divided by costs. Yet most oncology practices (and even insurers) have trouble measuring either component and therefore may not be prepared for value-based payment reforms. Although NGS testing may enable precision medicine, and thereby, reduce wasteful spend on ineffective therapy, the monitoring of both quality (such as adherence to testing guidelines) and clinical outcomes by oncology practices is required to practice value-based medicine. This session will explore how mining real world datasets from electronic health records might improve care. A case example from a previously published liquid biopsy study will be presented and discussed in context of the current OCM model with emphasis toward value demonstration for payers and providers.
4:45 Real Time Molecular Monitoring Using cfDNA
Timothy Cannon, MD, Clinical Director, Inova Schar Cancer Institute; Assistant Professor, Virginia Commonwealth University
Medical Oncologists and patients are often frustrated with the difficulty of following treatment response, given the constraints of imaging and traditional tumor-marker assays. The use of cfDNA in real-time monitoring of response to treatment is an exciting development, that can provide an early and accurate assessment of responses to personalized therapy.
5:00 PANEL DISCUSSION
• What are critical success factors that enable reimbursement for liquid biopsy?
• Improving patient safety metrics through non-invasive biopsy
• Stratifying solid tumor oncology patients for optimal treatment
• Implications of liquid biopsy utilization toward value-based reimbursement models (physicians, hospital systems, payers)
5:30 Networking Reception in the Exhibit Hall with Poster Viewing (Independence Ballroom)
6:30 Close of Day
THURSDAY, AUGUST 23
7:15 am Registration (Independence Foyer)
7:30 Problem Solving Breakout Sessions with Continental Breakfast (Independence F-I)
Recent FDA Feedback, Tips and Trends for IVDs
Gail Radcliffe, President, Consulting, Radcliffe Consulting, Inc.
- De Novo submissions: timing and benefit/risk
- Next-Gen Testing: regulation snafu
- CLIA Waiver: simple and low risk of erroneous result
- IHC, ISH, Digital Pathology: study designs
Patient Engagement in Healthcare
Larry K. Wray, PhD, Wray IVD Consulting
- What do me mean by "patient engagement in healthcare"?
- What changes are taking place and/or anticipated?
- How is this changing the healthcare system, e.g. manufacturers, providers, payers, etc.
- What new products and services are or will be entering the marketplace?
- What are the major obstacles to overcome to reach the desired end result?
Moderator: Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA
8:25 Regulatory Perspective
Eric F. Donaldson, PhD, Clinical Virology Reviewer, Co-Chair of the FDA Genomics Working Group Division of Antiviral Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
8:35 Assay Development Perspective
Timothy D. Minogue, PhD, Chief, Molecular Diagnostics Department, Diagnostic Systems Division, USAMRIID
8:45 Clinical Implementation Perspective
Gary W. Procop, MD, Director, Molecular Microbiology, Parasitology, Virology Laboratories; Co-Chair, Enterprise Laboratory Stewardship Committee, Medical Operations; Processor of Pathology, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic
8:55 Bioinformatics Perspective
Tom Slezak, Distinguished Member of the Technical Staff, Global Security Program, Lawrence Livermore National Lab
9:05 PANEL DISCUSSION
• What is the status of quantitative NGS as it is being used in the clinic?
• What is the role of bioinformatics?
• How to mitigate the issue of long, expensive assays
• Point-of-care
• Antimicrobial resistance
9:30 Implementing a Prior Auth Program – Choosing the Right Strategy for Your Lab
Walt Williams, Director, Revenue Optimization & Strategy, Revenue Cycle Services, Quadax
Policies have changed and understanding these changes is critical to choosing the right prior auth strategy for your lab. This presentation will compare the prior auth service models offered by a variety of vendors and, explore their impact on the claims adjudication and revenue cycle process for genetic/molecular claims subject to the prior authorization programs of Anthem and UnitedHealthcare. We will explore strategies for navigating prior auth that are most likely to get you paid, with the least disruption to your current processes. We will share analytic insights based on actual reimbursement trends that compare claims processing both with and without prior auth (including the increasing failure rate of appeals and overall reduction in reimbursement). The presentation will also highlight the latest payer trends including policy changes. New data and information is now available as these programs continue to evolve.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
11:15 am Chairperson’s Remarks
11:20 am - 12:00 pm TECHNOLOGY PANEL: Disruptive Technologies in Lab Medicine
Moderator: Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth
- What is appropriate test utilization?
- How do you ensure both user and patient safety?
- How are tests implemented in the clinical setting?
- How do they get regulated?
- How do results get reported?
- How do you enforce quality control in implementation?
- How does it impact emerging applications such as liquid biopsies, infectious disease outbreaks, and POC diagnostics?
Panelists:
Rakesh Nagarajan, MD, PhD, Chief Biomedical Informatics Officer, PierianDx
Greg Richard, Chief Commercial Officer, Interpace Diagnostics
Crystal R. Icenhour, PhD, CEO, Aperiomics, Inc.
Additional Panelists to be Announced
12:00 - 12:45 pm Changing Approaches to Sustainable Funding in Diagnostics
Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether government or private, what drives the final difficult decisions and how can companies raise their chances of success? This session features leaders from several different channels of funding for innovators, including the NIH, other federal programs, and corporate and traditional venture investors.
Panelists:
Alex DeWinter, PhD, Managing Director, GE Ventures
Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division of CBRN Countermeasures, BARDA
Todd Haim, PhD, Program Director, National Cancer Institute SBIR Development Center
Wouter Meuleman, PhD, Director, Venture Investments, Illumina Ventures
12:45 pm Luncheon Presentation: Maneuvering Through Disparate Technology Assessment Processes (Franklin/McPherson)
Greg Richard, Senior Vice President, Interpace Diagnostics
Traditionally most payers conducted their own Technology Assessment for emerging, molecular tests, using their own internal Medical resources. A significant evolution in this area has transpired, making the process of securing coverage for new technologies more complex and less expeditious. Numerous payers have delegated this process and the overall management of the molecular testing to third parties, many of whom have disparate policies and requirements. Learn about methods that can be used to secure coverage and reimbursement for molecular diagnostics whether working with payers directly or via their selected intermediaries.
1:15 Close of Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic
Recommended Short Course*
SC10: Leveraging Key Opinion Leaders (KOLs): Building a Bridge Between R&D and Commercialization of Companion and Non-Companion Diagnostics
Lawrence J. Worden, Principal, IVD Logix
Charles Mathews, Principal, ClearView Healthcare Partners
Peggy Robinson, Vice President, Angle PLC
*Separate registration required