Cambridge Healthtech Institute’s Seventh Annual
Commercialization of Molecular Diagnostics
Leveraging Winning Strategies for Success
August 16-17, 2017 | Grand Hyatt Washington | Washington, DC
Accumulating expertise for commercialization success is challenging in an environment of constantly changing market dynamics defined by regulation and reimbursement directives and a fiercely competitive landscape. Factors governing product success in molecular diagnostics will be outlined at the Seventh Annual Commercialization of Molecular Diagnostics meeting, ranging from adoption, reimbursement, approval, pricing, product launch and marketing. This comprehensive forum is now in its seventh year and attracts industry leaders to discover what determines success in a growing market that has the potential to improve access to and delivery of better quality healthcare.
Final Agenda
Scientific Advisory Board
Andrew C. Fish, J.D., Chief Strategy Officer, AdvaMed; Executive Director, AdvaMedDx
Harry Glorikian, MBA, Healthcare Consultant
Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates
Recommended Short Course(s)*
SC4: Commercialization Boot Camp: Manual for Success in Molecular Diagnostics
SC12: Regulatory Compliance in Advanced Diagnostics
*Separate registration required
WEDNESDAY, AUGUST 16
10:30 am Registration
1:05 pm Luncheon Presentation:Transitioning Emerging Research Tools into Clinical Diagnostics
Moderator:
David Cavanaugh, Partner, DeciBio Consulting
Panelists:
Anna Berdine, Vice President, Marketing, NanoString Technologies
Asia Chang, Senior Director, Oncology, Product Management, Clinical NGS Division, Thermo Fisher Scientific
Kyle Fieleke, Senior Director, Global Strategic Marketing, Luminex Corporation
Many innovative technologies struggle to make the leap from research to clinical applications. DeciBio Consulting partner David Cavanaugh will host a panel with KOLs and experienced stakeholders who have successfully navigated the transition to demystify the process and elaborate on the keys to success.
1:35 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
2:05 Chairperson’s Remarks
Scott Kopetz, M.D., Ph.D., FACP, Associate Professor, Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center
2:10 Evolution and Increasing Complexity of Cancer Biomarker Testing: Non-Small Cell Lung Cancer as a Model
David R. Gandara, M.D., Director, Thoracic Oncology Program; Professor and Senior Advisor to the Director, University of California, Davis Comprehensive Cancer Center
Recent studies such as those of The Tumor Genome Atlas (TCGA) have demonstrated the complexity of NSCLC at the genomic level, both differentiating it from less complex cancers as well as indicating a remarkable degree of inter- and intra-patient tumor heterogeneity. Although overall response rates in oncogene-driven NSCLC exceeds 60%, eventual emergence of acquired resistance and progressive disease is universal. Methodologies for identifying treatable abnormalities defined by predictive biomarkers at both the time of initial diagnosis and after the development of progressive disease have evolved rapidly over the last 5 years. This presentation will discuss this evolution and the increasingly complexity associated with therapeutic decision-making, including the use of next generation sequencing in tissue and plasma.
Chairperson’s Remarks
Gabriela Lavezzari, Ph.D., MBA, Senior Vice President, Business Development, Biocerna
2:40 Next-Generation Sequencing: Logistics from the Trenches
Gregory J. Tsongalis, Ph.D., HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center; The Audrey and Theodor Geisel School of Medicine, Dartmouth College
This session will discuss the impact of NGS on the implementation of precision medicine. Focusing on applications to oncology, the advantages of NGS over other molecular methods will be compared and contrasted. The limitations of NGS and alternative approaches to molecular oncology testing will be discussed.
3:10 Sources of Uncertainty in Developing Molecular Diagnostics
Robert Cook-Deegan, M.D., Professor, School for the Future of Innovation in Society, Consortium for Science, Policy & Outcomes, Arizona State University
Uncertainty pervades each of many steps in developing complex new molecular diagnostics. Some of the major sources are recent Supreme Court decisions that have constrained patentable subject matter, FDA’s proposed regulation and then partial walk-back, weak infrastructure and unreliable norms for data-sharing, annotation, curation, and interpretation of genomic variants, and lack of clarity about what criteria will be used to decide coverage and reimbursement, and who is responsible for generating the evidence for such decisions. I will illustrate these with a few examples, and point to policies that might reduce the uncertainty surrounding emergence of tests that build on advances in genomics.
3:40 Introducing a New Cost-Effective Model for Fast Track Diagnostic Technology Development and Commercialisation
Matt Pearce, Ph.D., President, Medtechtomarket Ltd.
From Corporation to Start-up, launching compliant products quickly, cheaply and with low risk is a universal goal. In other innovation-driven industries, outsourcing is Standard - reducing costs and risks by 90%, whilst decreasing cycle times and realizing technology assets. The IVD industry needs to follow Pharma in capitalizing this strategy.
3:55 Overcoming Barriers to Adoption of Molecular Products
Greg Richard, Senior Vice President, Interpace Diagnostics
There are several key challenges in convincing physicians to adopt molecular tests and incorporate them in to their protocols. These include patient billing, benefit plan design, threatening letters from payers, and most notably a lack of understanding of the value of molecular/DNA-based testing. Learn how to overcome these challenges.
4:10 Refreshment Break in the Exhibit Hall with Poster Viewing
5:00 Moderator’s Remarks
Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates
While next-generation sequencing has always involved large amounts of data and sophisticated processing, a new industry is emerging to facilitate the interpretation and clinical application of genomics. For example, as tumor mutation bioinformatics becomes more complicated, this capability may be outsourced or purchased rather than developed in-house. As another example, conventional laboratory information systems and hospital EHRs are not designed for storage and utilization of large amounts of genomic information. From a commercial and payer perspective, the revenue models for this digital industries are opportunities for systematic innovation. In this panel, leaders in the field discuss their perspectives, their 2-to-5 year outlook, and challenges presented by the legacy regulatory systems.
- Topics to be discussed:
- How will labs choose vendors?
- How will they get reimbursed?
- How does it fit into the LDT architecture?
- How does software fit into CLIA or CAP inspections?
- Will the software be regulated by the FDA?
5:10 Value in Evidence: Data-Driven Dx Development
Harry Glorikian, MBA, Healthcare Consultant
The most successful molecular diagnostics companies in the upcoming years are going to be the ones that have the science right, but have been able to break down silos and get the commercialization part right, too. Disruptive technologies get a lot of attention, but it takes more than press releases to drive business success in this ultra-competitive industry. With healthcare’s new paradigm focused on evidence and value, molecular diagnostics will have to demonstrate both. In my talk, I’ll describe how companies that are embracing a value-based, evidence-driven model are setting themselves up for success, for both regulators and consumers.
5:25 Precision Medicine Beyond the One-Gene One-Drug Paradigm Using Predictive Computational Modeling
Taher Abbasi, Co-Founder, Chief Design Officer, Cellworks Group Inc.
Precision medicine endeavors to avoid trial-and-error strategies by predicting clinical responses to treatments and design of personalized therapies. Modern sequencing technologies expose the full mutanome. However, current bioinformatics capabilities limit precision medicine to a one-mutation, one-drug paradigm. This paradigm fails to predict the holistic impact of cumulative genetic aberrations on drug response. Computational biology modeling incorporates a patient’s complete mutanome to generate bio-simulation models to further the precision medicine objective.
5:40 Delivering Precision Oncology through the use of Novel Clinical Decision Support Tools and Knowledge Resources
Manuel J Glynias, President & CEO, GenomOncology LLC
The use of precision oncology has been steadily growing, thus increasing both the volume and complexity of genomic/molecular data, and thereby threatening its effectiveness by overwhelming users. Use of clinical decision support tools to manage this data will enable physicians to deliver to patients the right treatments at the right time, improving the duration and quality of life.
5:55 Not Just Noise: Transforming Big Data into Smart Data
Brady Davis, Vice President, Strategy & Marketing, DNAnexus
Big Data is only a big deal when applied in context. Smart Data – the right data at the right time to the right person – helps enhance and inform healthcare. That’s the prize; and while everyone’s got their eyes on it, not everyone knows how to get their hands on it. This session will focus on the Informatics aspect of Genomics, and solutions that apply to all stages of the data lifecycle.
6:10 PANEL DISCUSSION
6:30 Close of Day
6:30 Dinner Short Course Registration*
6:45 – 9:15 pm Recommended Dinner Short Course(s)*
SC13: Regulatory and Reimbursement Issues with Advanced Diagnostics and Circulating Biomarkers
SC14: Liquid Biopsy: Technology, Applications, Regulations and Reimbursement
*Separate registration required
THURSDAY, AUGUST 17
7:30 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.
Exploring Novel Payment Models for Innovative Antimicrobial Diagnostics
Gabriela Lavezzari, Ph.D., MBA, Senior Vice President, Business Development, Biocerna
- Post-market challenges that affect market uptake and reimbursement
- Moving from fee-for-service to value-based payments
- Novel payment approaches to reward antimicrobial diagnostics
Commercialization of Next Generation Diagnostic Testing
Jing Xie, PhD, Vice President, Clinical Affairs, Medical Device Innovation Consortium (MDIC)
- Where does industry see key opportunities or areas for development in next generation diagnostic testing?
- What are the major opportunities and challenges for taking the next generation diagnostic testing to the market, regulatory, reimbursement?
- What are the specific areas multi-stakeholder (industry, regulator, payer, etc.) approach should be focus on to develop tools and approaches?
Co-organized with
8:25 Moderator's Remarks
David R. Hillyard, M.D., Professor, Pathology, University of Utah; Director, Molecular Infectious Disease Testing, Arup Laboratories
Point and Counterpoint:
- Overview of current environment
- Challenges and unmet needs
- Lessons learned
- Needs and utilization for microbial resistance testing
- How POCT is changing the landscape of testing
Panelists:
Kimberly Hanson, M.D., MHS, Associate Professor, Infectious Disease, University of Utah School of Medicine
Gregory A. Storch, M.D., Ruth L. Siteman Professor, Pediatrics; Professor, Medicine and Molecular Microbiology; Chief, Division of Pediatric Laboratory Medicine; Medical Director, Clinical Laboratories, St. Louis Children’s Hospital; Medical Director, Project ARK (AIDS Resources and Knowledge), Washington University School of Medicine
9:30 Commercialization of Novel Workflow Solution for DNA from Liquid Biopsy, FFPE Samples & Circulating Tumor Cells
Christoph Mauracher, Ph.D., Managing Director, Stratec Consumables GmbH
Circulating cell-free DNA (cfDNA) is one of the most rapid growing diagnostic procedures and has increased the demand for reliable and validated methods. In order to successfully commercialize this novel diagnostic method into the hospital laboratories devices, reagents and software from multiple manufacturers must be combined and validated by one vendor. Here we present such a complete and automated solution, from vein to brain, for the analysis of DNA extracted from liquid biopsies, histological preparations (FFPE) as well as an application for the extraction of mRNA from CTCs.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Moderator's Remarks
Stan Skrzypczak, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.
- What are critical factors that enable reimbursement?
- Improving safety through non-invasive biopsy
- Stratifying patients for optimal treatment
- Reducing costs of clinical trials when tissue is insufficient
- Value drivers for pharma
11:10 Lessons from the Field: Implementing Next Gen Sequencing Coverage Policies and Proving Value
Donna Messner, Senior Vice President, Center for Medical Technology Policy
This session will discuss the process of developing medical coverage policies for next generation sequencing, including the evidentiary requirements and the insurance concerns of first mover, adverse selection and asymmetry of information. We will review the initial two year experience with coverage for next generation sequencing and the impact or lack thereof on clinical decision making from the payer and provider perspectives.
11:20 Reimbursement from the CMS Perspective
James Almas, M.D., MolDX Medical Director, Palmetto GBA
This session will discuss CMS coverage (National Coverage Decisions, NCDs) and coverage by MACs (Medicare Administrative Contractors). Coverage under an LCD will be discussed along with the evidence needed to obtain such coverage.
11:30 Clinician’s Perspective: Interface of Cancer Therapeutics and Liquid Biopsy
David R. Gandara, M.D., Director, Thoracic Oncology Program; Professor and Senior Advisor to the Director, University of California, Davis Comprehensive Cancer Center
The field of biomarker diagnostics for cancer therapy is moving forward at an ever-accelerating pace. Non-small cell lung cancer is particularly applicable to this space due to both the genomic complexity and the presence of highly treatable oncogene-driven subsets. Recent guidelines emphasize needs for a broader scope of testing, simultaneous rather than sequential testing, and rapid turn-around times. Further, serial monitoring for early detection of acquired resistance is being incorporated into clinical management paradigms. Liquid biopsy technologies employing next generation sequencing achieve these goals and are increasingly recommended.
11:40 Value from the Perspective of the Oncologist
Scott Kopetz, M.D., Ph.D., Associate Professor, GI Medical Oncology, University of Texas MD Anderson Cancer Center
Balancing the competing information available from tissue and plasma, Dr. Kopetz will provide a perspective on the added value of ctDNA in the management of cancer patients, emphasizing clinical questions critical for solid malignancies.
11:50 Investment Perspective
Eli Casdin, Managing Member, Casdin Capital
As investors, we recognize that history does not repeat itself but often does rhyme. As such and in the context of DX, we are always on the lookout for examples of companies who have successfully navigated the daunting path towards reimbursement coverage and profitability. We will discuss a few case studies and highlight critical elements that should be considered for companies moving forward.
12:00 pm PANEL DISCUSSION
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:30 Session Break
2:00 Moderator’s Remarks
Andrew C. Fish, J.D., Chief Strategy Officer, AdvaMed; Executive Director, AdvaMedDx
2:05 Delivering Clinical and Economic Value through Sepsis Diagnostics
Rahul K. Dhanda, MBA, Senior Vice President, Corp Development, T2 Biosystems Inc
Sepsis is the most expensive inpatient disease in the United States. Through targeted therapy driven by transformative diagnostics, the disease can be managed to decrease both cost and mortality. T2 Biosystems has launched T2Candida and is in clinical trials for T2Bacteria, the first whole blood, culture-independent diagnostic solution that can detect sepsis causing pathogens with the accuracy and speed necessary to address the healthcare burden imposed by this severely undertreated condition.
2:35 Evidence Planning for Demonstrating the Value of Molecular Diagnostics
Dwight Denham, MBA, Vice President, Global Health Economics & Reimbursement/Market Access
Danaher Corporation, Life Science & Diagnostics Segment
Value Frameworks are developed and promoted by various interested parties. Yet the burden to interpret by an individual test developer requires thorough understanding of the multiple stakeholders in the clinical care pathway and numerous methodologies for conducting studies that address requirements of the stakeholders. This presentation includes concepts for considering different methodologies to address various stakeholder value perceptions, enabling broader panel discussions.
3:05 Use of Real World Evidence to Establish Value
Scott Pohlman, Associate Director, Outcomes Research, Hologic
Real world evidence is increasingly used to inform clinical, regulatory and health policy decisions. Several examples will be presented to demonstrate the impact of customer-level data and real world evidence in establishing a meaningful value framework.
3:15 PANEL DISCUSSION
4:05 Close of Conference
4:30 Symposia & Short Course Registration
RECOMMENDED CONFERENCE SYMPOSIUM:
Rapid Critical and Urgent Care Testing
Separate registration required