Regulatory hurdles, reimbursement, and market strategy are three main obstacles that must be overcome on the road to commercializing a diagnostic. While traditional business models for bringing diagnostics to market still work, market changes make success difficult for developers, marketers, and investors. Significant limitations remain in the ability of conventional molecular diagnostic technologies to serve the clinical and commercial requirements of the field. 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.
Thursday, February 23
7:00 am Registration and Morning Coffee
8:25 Chairperson’s Opening Remarks
Noa Ghersin, Analyst, Lux Research, Inc.
8:30 Disruptive and Open Innovation in Market Strategies for Precision Medicine
Winston Patrick Kuo, D.M.Sc., Chief Technology Officer, Head, Global Business Development, CloudHealth Genomics, Ltd.
The goal of President Obama’s Precision Medicine Initiative was to enable disruptive technologies like next-generation sequencing (NGS) and innovations to improve patient care, diagnose disease at the early onset, using big data to guide therapies and therapeutics - bringing the American healthcare ecosystem into the 21st century. However, many important issues pertaining to the FDA remain unaddressed; NGS, on the FDA’s regulatory purview, Laboratory Developed Tests (LDTs), pending FDA guidelines and reimbursement for NGS-based LDTs. Predicine’s innovative marketing strategy is organized around engaging/leveraging the global community including and not limited to academia/industry, government and strategic partnerships. Predicine will shed some insight in overcoming some of these issues, and yet, providing value to the American market.
9:00 Advanced Diagnostic Laboratory Test (ADLT) Commercialization in a Post-PAMA Era
John Hanna, Vice President, Marketing & Managed Care, Veracyte, Inc.
The PAMA final rule sets specific criteria for New ADLT designation beginning in 2018. This session will cover considerations of the criteria for the ADLT designation, Medicare coverage and coding requirements, and commercialization strategies to effectively synchronize these activities.
9:30 Development of Decentralized Multiplexed Molecular Diagnostics for Precision Oncology
Sean Ferree, Ph.D., Vice President, Diagnostic Development, Nanostring Technologies, Inc.
10:00 Novel Diagnostic Technologies: Coverage Today and Coverage in the Future
Kyle Fetter, MBA, Vice President & General Manager, Diagnostic Services Operations, MDx Support Services, XIFIN, Inc.
Early stage and wearable diagnostic device companies face great hurtles to commercialization and reimbursement. The combination of clinical research, market adoption, and reimbursement challenges make it imperative to synch up efforts. Understand the tools necessary tools with information on current challenges and how diagnostics companies are positioning themselves for success.
10:15 Sponsored Presentation (Opportunity Available)
10:30 Coffee Break with Exhibit and Poster Viewing
11:15 Molecular Diagnostics & Reimbursement: Lessons, Opportunities, and Challenges. The Clinical Laboratory Perspective
Thomas Neuwerth CQA(ASQ), MB(ASCP)CM, Quality Assurance, Intermountain Precision Genomics
Precision medicine has unique challenges and opportunities. Discussion will include the status of reimbursements in advanced diagnostics, evolving standards from accrediting/standards issuing agencies, economic impact data from an Intermountain Healthcare retrospective patient study, and the impact of MolDx on large panel somatic oncology tests from a laboratory research and development and validation perspective as part of the larger regulatory and reimbursement conversation within the precision medicine community.
11:45 Show Me the Money: Navigating the Reimbursement Process for Molecular Diagnostics
Lon Castle, M.D., CMO, Molecular Genetics, Specialty Drug and Personalized Medicine, eviCore healthcare
Analytic Validity…check. Clinical Validity…check. Clinical Utility…check. You’ve checked all the boxes as you launched your new test, so what’s left to do? Plenty—if you want to get paid. Learn about the nuances of the reimbursement process and what to expect once your test is moved from “I&E” to “covered.”
12:15 pm Sponsored Presentation (Opportunity Available)
12:30 Session Break
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
1:50 Chairperson’s Remarks
Lon Castle, M.D., CMO, Molecular Genetics, Specialty Drug and Personalized Medicine, eviCore healthcare
2:00 The Practical Effect of Myriad on Patent Claims
John Liddicoat, Ph.D., Philomathia Research Fellow, Faculty of Law, University of Cambridge
I will present a detailed quantitative study of how the Supreme Court decision of Association for Molecular Pathology v. Myriad Genetics Inc. has affected claims to naturally occurring nucleotides as composition of matter. This study focuses on patent applications that were pending when the case was decided and how the applicants have amended their claims to comply with the holding in Myriad. A descriptive statistical analysis of how claims have changed post-Myriad will be presented, as well as several case studies demonstrating these changes.
2:30 How Can We Go from Innovative Research to an FDA-Approved Diagnostic Test in the Market Place?
Debra J. Rasmussen, MBA, Global Regulatory Affairs Diagnostic Leader, Janssen Pharmaceuticals
Now is the time when increased innovation and novel healthcare models are driving a new way of addressing global health. One of the challenges is the transition from innovative research to an FDA-approved commercial product. This presentation will highlight regulatory considerations in Companion Diagnostics and explore strategies to move from research through feasibility, investigational trials, FDA approval/clearance, and market access.
3:00 Diagnostic Inventions – Dilemmas for Protection and Enforcement of Patent Rights
Erica Pascal, Ph.D., J.D., Partner, Intellectual Property & Technology, DLA Piper LLP (US)
Patent protection for diagnostics can be tricky. Methods claims may include steps carried out by a collection of entities – including the manufacturer, the healthcare provider, patients and data collection and analyses intermediaries. Where more than one party is involved in carrying out the steps, it may be difficult to enforce patent rights when an infringer comes on the scene. Protection for diagnostic assays and reagents may also raise questions as to how to extract the value from these inventions through licensing, enforcement and other manners of IP protection. This talk will explore the interplay between evolving IP laws and business considerations.
3:30 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall
4:15 Effective Companion Diagnostic Partnerships with a Focus on Drug Approvals
Dan Snyder, President & CEO, Executive Management, MolecularMD
Applying traditional approaches of IVD development and commercialization to a companion diagnostic (CDx) program is not likely to result in a successful outcome for the corresponding drug development program. Collaborators need to be reminded that there is no commercialization of the companion diagnostic without the approval of the targeted therapy. In drug diagnostic co-development, the requirements for the diagnostic must be fully aligned with the investigational therapeutic clinical indication. The early stage alignment of the co-development strategy is pivotal in the overall success of the program. Case studies and insights will be shared that will illustrate and highlight best practices in forging effective partnerships between biopharma and diagnostic assay developers.
4:45 Companion Diagnostics for Immunotherapy – The Man Behind the Curtain
M. Allen Northrup, Ph.D., FRSC, CEO, MIODx
Ideally, one would have a 100% predictive companion diagnostic to ensure that a therapy would work to save money, time, and the patients that be can selected. In clinical trials, it would be best to de-select patients that don’t respond, smoothing the path to FDA approval. However, is there a simple gene or other marker to accurately predict a response to a therapy in such a complex and dynamic system as the human immune system? In any case, some degree of trial and error must be followed to even get to the ability to pre-diagnose responding patients. In the absence of a precise and predictive companion diagnostic, to prevent unforeseen negative effects or ineffective treatments, and to understand the biological response, immunotherapies benefit from real-time patient immune system monitoring.
5:15 Commercialization of Companion Diagnostics- Critical Success Factors and Lessons Learned
Reinhard Ortmann, Director, Companion Diagnostics, QIAGEN
Development of Companion Diagnostics (CDx) has been extensively analyzed; however, commercialization is often put aside until the registrational study begins. Getting a CDx developed and approved is indeed a critical and necessary step for commercial access; however, implementing the newly approved Companion Diagnostics is equally important. This presentation will discuss the importance of preparation for the successful launch and implementation of a newly approved Companion Diagnostic into the clinical laboratory
5:45 Reception with Exhibit and Poster Viewing
6:45 Close of Day
Friday, February 24
7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Registration Open
8:25 Chairperson’s Remarks
William Pignato, Founder and Principal, W. J. Pignato & Associates
8:30 PANEL DISCUSSION: Recent Thinking, Development, and Initiatives
Moderator: William Pignato, Founder and Principal, W. J. Pignato & Associates
Panelists: Laura T. Housman, MPH, MBA, CEO, Founder, Access Solutions Consulting
Patricia Carrigan, Ph.D., Head,Translational Assay Technology, Pharmaceuticals Division, Bayer Pharma
Peggy Carter, Ph.D., Global Head, Drug Regulatory Affairs, Novartis Companion Diagnostics
This panel will cover:
- Regulatory issues
- Breakthrough therapies
- Timing of CDx integration
- Pre- and post-marketing challenges
- Implications of new technologies (e.g., NGS, “liquid biopsy”)
- FDA-centric approach vs. global CDx initiatives
- Central CLIA lab vs. IVD platform choices
10:00 PD-L1 Testing as a Model for the Impact of Biomarker Adoption on Drug Launch Success.
Peter Krein, Ph.D., Managing Director, Diaceutics
Due to the variety of antibodies and testing methodologies, as well as interpretation variation, the introduction of testing for PD-L1 expression presented numerous challenges, not only for pathologists, but also for clinicians intending to treat patients with I-O therapies. A better understanding of the specific factors that influence biomarker testing adoption for each country, and implementation of programs to overcome these barriers, would improve access to novel biomarker testing and streamline the therapy launch. This in turn would increase the number of patients eligible for precision therapies and help to eliminate variability in access to new therapeutics.
10:30 Coffee Break with Exhibit and Poster Viewing
11:15 Precision Immunotherapy: The Challenge of Converting Complex Predictive Biomarkers into Practical Companion Diagnostics
Kenneth Emancipator, M.D., Executive Medical Director, Translational Medicine, Companion Diagnostics, Merck & Co.
Early immunotherapies have produced dramatic results for some patients, but future immunotherapies likely need to be guided by diagnostics to benefit more patients. Properly targeting immunotherapy requires incorporating into clinical practice complex diagnostics which can assess host immune response in addition to cancer biology itself. “Precision Immunotherapy” requires discovery of appropriate predictive biomarkers and incorporating them into practical companion diagnostics which will be adopted by practitioners.
11:45 Establishing Companion Diagnostics for Immunotherapies Including OPDIVO® (Nivolumab)
Neeraj Adya, Ph.D., Director, Pharmacodiagnostics Research and Development, Bristol-Myers Squibb
Clinical utility of single biomarker-based companion diagnostics (CDx) to select patients has been effectively demonstrated for mutation-targeted therapies. An effective CDx for immunotherapies like OPDIVO® will likely require a set of biomarkers that serves as a surrogate for identifying immune status in patients. These biomarkers will need to meet the same analytical rigor as for a single biomarker. This talk leverages lessons learned from PD-L1 towards future CDx development.
12:15 pm Companion & Complementary Diagnostic Strategies for Cancer Immune Therapies
J Andrew Williams, Ph.D., CDx Franchise Leader, Cancer Immune Therapies, Genentech
This presentation highlights diagnostic strategies for cancer immune therapies.
Based on a 2017 publication (Scheerens et al. 2017 Clinical and Translational Sciences, DOI:10.1111/cts.12455) considerations for companion and complementary diagnostics will be discussed with potential for broader application across other diseases. Relevant data from the 2016 approval of atezolizumab (Tecentriq) in NSCLC will be covered. Immunhistochemistry (IHC) and molecular assay data will be presented, along with key learnings from assay comparisons.
12:45 Close of Symposium
