Regulatory hurdles, reimbursement, and market strategy are three main obstacles that must be overcome on the road to commercializing a diagnostic. And within each of these obstacles are a myriad of smaller details and issues to overcome. At this year's Commercialization of Molecular Diagnostics symposium, experts in product development and launch will come together to provide case studies and lessons learned from their experiences to achieve market success.
Final Agenda
Thursday, March 10
7:30 am Registration and Morning Coffee
9:00 Chairperson’s Opening Remarks
Lyssa Friedman, Consultant, Lyssa Friedman Consulting
9:10 The Economics of Molecular Diagnostics: Addressing the Challenges to Commercial Success
John Beeler, Ph.D., Vice President, Business Development, Inivata
This presentation will discuss the unique challenges of bringing molecular tests to market and review the current landscape and proposed initiatives to foster continued investment of innovative molecular diagnostic products.
9:40 Developing the Reimbursement Story: It’s Never Too Early
Lyssa Friedman, Consultant, Lyssa Friedman Consulting
A novel diagnostic is developed from a previously unimagined discovery. The market is untapped, the unmet medical need is vast. Yet, without a clear reimbursement story and the published studies needed to tell it, the business opportunity will likely fizzle. This session will explore study design to support the reimbursement case and strategies for addressing reimbursement early in the development process.
10:10 The Role of Cost Effectiveness in Health Technology Assessments - Overcoming Parti Pris in Payer Policy Determinations
John W. Hanna, MBA, Vice President, Endocrinology, Veracyte, Inc.
As pressure on healthcare costs increases laboratories must demonstrate that the addition of molecular diagnostics do more than add costs, that they change patient management and health outcomes. Molecular tests are perceived by payers to be expensive relative to traditional lab services. This talk will review how to overcome perceptions related to cost effectiveness when undergoing a health technology assessment with a healthcare payer.
10:40 Coffee Break with Exhibit and Poster Viewing
11:15 Leveraging Coordinated Care Technologies
to Achieve Healthcare Economics
Chrystal Adams, Associate Vice President, Product Line Management, Marketing, XIFIN, Inc.
Patricia Goede, Vice President, Clinical Informatics, XIFIN, Inc.
Recent studies reveal that physicians are not able to access the expertise and collaboration they require to ensure accurate diagnostics. As reimbursement patterns shift from fee-for-service to value-based care, achieving improved outcomes will require a continued digital transformation.
11:45 PANEL DISCUSSION: Business Models to Optimize Commercial Success
Moderator: John W. Hanna, MBA, Vice President, Endocrinology, Veracyte, Inc.
Panelists:
Bill Cook, Principal, Diagnostics Commercialization, WECA
Additional Panelists to be Announced
Topics for discussion include:
- Partnerships
- Economics of product development
- Reimbursement and regulatory hurdles
12:30 pm Session Break
12:45 Luncheon Presentation: CDx Commercialization - What You Need to Understand Before You Develop Strategy and What to Monitor When You Launch
Peter Keeling, Chief Executive Officer, Diaceutics Group
Pharma teams need to understand what analytics, insights and data are needed to inform strategy and ensure a successful target therapy launch. Diaceutics will share the company’s experience and learnings from more than 10 years of targeted therapy commercialization projects.
1:15 Session Break
1:50 Chairperson’s Remarks
Mara G. Aspinall, Executive Chairman, GenePeeks
2:00 Delivering on the Promise of Personalized Medicine Technologies
Josephine N. Harada, Ph.D., MBA, Senior Director, Strategic Alliances, 10X Genomics
While the diagnostic requirements of personalized medicine are increasingly well understood, significant limitations remain in the ability of conventional molecular diagnostic technologies to serve the clinical and commercial requirements of the field. This presentation will review how key challenges may be addressed by new technologies that disrupt the status quo and improve genome analysis in comparison to current diagnostic systems.
2:30 Companion Diagnostics – The Breakthrough that We Have Been Waiting For?
Mara G. Aspinall, Executive Chairman, GenePeeks
Diagnostics and Companion Diagnostics have finally emerged – or have they? Pharma is paying for them, scientists are improving them and venture capitalists are funding them. Yet, physicians are not using them regularly, medical schools are not teaching them, regulators are perplexed by them, and payors are looking for ways to pay less for them. What is happening? Will Companion Diagnostics bridge this real and perceived gap in respect and recognition?
3:00 Refreshment Break with Exhibit and Poster Viewing
3:30 Global Commercialization of Companion Diagnostics: Value Capture in Personalized Medicine
Joseph Ferrara, President, Boston Healthcare Associates
How can a global drug launch best embed companion test commercial considerations? Key commercialization factors for pharmaceutical and diagnostics innovators will be highlighted, including balancing test access and quality, effective commercial partnerships, and navigating evolving test funding models.
4:00 Business Strategies to Bring Diagnostics to Market
Keith F. Batchelder, M.D., CEO & Founder, Genomic Healthcare Strategies
Peter Miller, COO, Genomic Healthcare Strategies
Traditional business models for bringing diagnostics to market still work, but market changes make success difficult for developers, marketers, and investors. The traditional model is flawed: academic discovery of a biomarker, followed by licensing to a large firm or founding of a company to productize the biomarker, with the goal of finding bench space in a large reference lab. There are many more opportunities and paths today; routes to market access will be very different than in the past.
This talk focuses on business considerations and on strategy, not tactics.
We will discuss:
- Common approaches which often are not successful, with examples
- The difference between tactics and strategy
- A strategic process, with examples
- Necessary candidate characteristics
- Inertia and traditional practice
- Some discussion of the changes in roles of patients, payors, and providers will influence diagnostics
5:00 Reception with Exhibit and Poster Viewing
6:00 Close of Day
Friday, March 11
8:00 am Morning Coffee
8:25 Chairperson’s Remarks
Scott C. Palmer, Vice President, Life Sciences, Parthenon-EY, Ernst & Young LLP
8:30 Global Innovation and Advancement of NGS
Scott C. Palmer, Vice President, Life Sciences, Parthenon-EY, Ernst & Young LLP
As NGS transitions from the research bench to the clinic, NGS companies will need to develop new strategies while pharmaceutical companies will need to proactively develop partnerships in order to fully maximize the potential of personalized medicine. Lastly, established and emerging companies will need to innovate rapidly as next-next generation sequencing comes to fruition.
9:00 PANEL DISCUSSION: Implementing NGS: Commercial and Clinical Laboratory Challenges
Moderator: Scott C. Palmer, Vice President, Life Sciences, Parthenon-EY, Ernst & Young LLP
Panelists: Josephine N. Harada, Ph.D., MBA, Senior Director, Strategic Alliances, 10X Genomics
Additional Panelists to be Announced
The NGS space is evolving rapidly, with new tests and new technologies coming online at an ever-accelerating pace. According to Richard Klausner, Chief Medical Officer of Illumina, we are moving out of the era of companion diagnostics and into the era of companion therapeutics. This panel will address:
- Getting started with NGS: From cost to assays
- Technological limitations
- Integration into routine workflow
- Developing the infrastructure needed to sustain an NGS program
- Partnerships
10:00 Sponsored Presentation (Opportunity Available)
10:30 Coffee Break with Exhibit and Poster Viewing
11:00 Accelerating Molecular Diagnostic Programs
Bill Cook, Principal, Diagnostics Commercialization, WECA
The commercialization of molecular diagnostics from initial proof of clinical utility through commercial product launch and market development poses many hidden obstacles. We will explore the use of a Commercialization Roadmap to identify and address these critical issues.
11:30 Talk Title to be Announced
Chris Meda, Chief Business Officer, IncellDx, Inc.
12:00pm Close of Symposium