Cambridge Healthtech Instituteの第2回年次会議
Diagnostics Innovation and Market Access
（診断イノベーションと市場参入）
先端診断向け投資、規制、償還、市場参入戦略
2023年3月7 - 8日、PST（米国太平洋標準時）
COVID-19のパンデミックは、先端診断における爆発的なイノベーション、投資、市場機会に拍車をかけています。Cambridge Healthtech Instituteの第2回「診断イノベーションと市場参入」年次会議では、ポストパンデミック時代における先端診断向け投資、規制、償還、市場参入戦略について紹介します。新興技術の展示では、厳選された次世代の分子診断検査、AI・デジタルプラットフォーム、ポイントオブケア（POC）診断・在宅診断などに焦点を当てています。
3月7日（火）
PARTNERING STRATEGIES FOR EVIDENCE GENERATION AND MARKET ACCESS
エビデンス生成と市場参入向けパートナー戦略
Payers 301: An Upper-Level Class
Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare
How do you get a Payer’s attention? Hint: e-mail, LinkedIn and TikTok won’t do it. To have meaningful conversations with a Payer, you have to get to know them. This session will review the different types of payers, what they are likely to find interesting and the types of risks they are willing to take. Passing this course should help you find common ground for partnerships.
An Innovative Partnering Model to Generate Evidence and Increase Access to Genomic Medicine
Stacey DaCosta Byfield, PhD, MPH, Vice President, Genomic Health Economics and Outcomes Research, Optum Labs
Illumina and Optum Genomics started collaborating in 2021 with the vision to accelerate the evidence-based application and coverage of genomic testing and connect impact of genomics to the Quadruple Aim. Projects span: Core Market Access application value dossier reviews; real-world data evidence assessments; implementation studies - TCOC measurement; stakeholder engagement; and the newly formed Clinical Catalyst Program is a critical industry node to progress test acceleration by supporting innovative applications.
Payer Partnerships: Urban Myth or Golden Ticket?
Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare
New tests can provide great value to payers - particularly when the test addresses a specific area of interest. In the words of Rick Blaine, a partnership in these areas can be “the beginning of a beautiful friendship.” But how does a lab gauge a payer’s interest? Our panel will discuss how their organizations identify partners for pilots and value-based contracts that benefit both the lab and the payer.
Diagnostic Coverage in the Digital Era: A Comparative Case Study of a Traditional RCT vs. a Simulated-Patient RCT
Randy David, PhD, Vice President, Life Science, QURE, a TRC healthcare brand
Clinical utility evidence is increasingly integral to establishing a diagnostic test or other commercial medical product as worthy of payer coverage and reimbursement. Study design and execution is often resource-intensive and time-consuming, with favorable results dependent on many external, non-scientific variables. Simulated-patient RCTs are a clinically-validated method of engaging physicians in scientific research, to quickly and affordably establish the requisite evidence for payer coverage and reimbursement.
Talk Title to be Announced
William Page, MD, Senior Scientific Director, Diagnostics, Ciencia, Inc.
Our Centinela diagnostics platform has demonstrated extraordinary accuracy, precision, and cost efficiency in diagnosing very complex infectious conditions (Lyme,Covid). Leading research universities (SUNY Poly, UConn) and hospitals to collaborate on both bench research projects targeting high complexity/high cost diseases, and as a novel POC solution for an array of complex iconditions. We seek commercial collaborations to further expand our offering, and create licensing opportunities.
Refreshment Break in the Exhibit Hall with Poster Viewing4:05 pm
PLENARY KEYNOTE SESSION: MULTI-CANCER EARLY DETECTION
基調講演・プレナリーセッション：多重がんの早期発見
Sponsored Presentation (Opportunity Available)4:50 pm
Evaluation and Implementation of Multi-Cancer Early Detection Tests
Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium
Multi-cancer early detection promises to improve cancer diagnosis, treatment and patient care. However, introducing MCED technologies into clinical care requires evaluation and assessment of benefits and risks, potential outcomes, costs, and value. The multi-stakeholder expert panel will address how MCED will impact clinical care, outstanding challenges in evidence generation, test reimbursement, market adoption, and equitable patient access.
Close of Day5:45 pm
3月8日（水）
Registration and Morning Coffee7:30 am
30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: DIAGNOSTICS INNOVATION AND INVESTMENT TRENDS
30周年記念TRI-CON基調講演・プレナリーセッション：診断イノベーションと投資動向
Failure: The Best Way to Learn
Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation
The thought of failure creates fear. The reality of failure creates opportunity. We must embrace failure and all it can teach. As Arianna Huffington said: “Failure is not the opposite of success - it’s part of success.” We will discuss how to think differently about failing - how to motivate yourself and your teams.
Diagnostics Innovation and Investment Trends
Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC
Diagnostics investing experts will review what is hot and what is not in the field. Technological trends and white spaces will be identified, and entrepreneurs will be given best practices to maximize chances for successful financing. The panel will also provide guidance to founders to optimize operational success post-financing and what to do in the event of a stumble, the dreaded pivot, or in dealing with failure.
Transition to Sessions9:15 am
INNOVATIVE PARTNERSHIPS TO ACCELERATE NEXT-GENERATION MOLECULAR DIAGNOSTICS
次世代の分子診断を加速させる革新的なパートナーシップ
Overcoming Challenges to Enhance Commercial Success of Advanced Diagnostics
Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI
An overview of key considerations for advanced diagnostic innovators to achieve reimbursement success in a competitive environment. This presentation will provide insights into how reimbursement planning can be incorporated into test development to optimize coverage and payment, observations on market access strategies that work and ones that don’t, and pitfalls to avoid when launching molecular diagnostics in the marketplace.
CVS Health and Tempus: Successful Partnerships are Built on Aligned Incentives
A case study that explores the use of comprehensive Tempus sequencing for oncology patients in the CVS transform oncology program. The session will explore the motivating factors for both CVS Health and Tempus to enter into the partnership and how they stayed focused on shared incentives as the program moved forward.
Sponsored Presentation (Opportunity Available)10:25 am
Coffee Break in the Exhibit Hall with Poster Viewing10:55 am
INNOVATIVE PARTNERSHIPS TO ACCELERATE NEXT-GENERATION MOLECULAR DIAGNOSTICS (CONT.)
次世代の分子診断を加速させる革新的なパートナーシップ（続き）
Horizon & Adaptive Biotechnologies: A Collaboration to Optimize Therapy for Multiple Myeloma
Steven R. Peskin, MD, MBA, MACP, Senior Advisor, ADVI; Associate Clinical Professor, Medicine, Rutgers RWJ Medical School; Course Director, Internal Medicine Grand Rounds, Penn Medicine Princeton Healthcare
A case study to explore use of the ClonoSEQ test for minimal residual disease to optimize therapy for multiple myeloma patients. This session will explore both the payer and laboratory perspectives on why this collaboration was established, how it was implemented, and learnings for future collaborations.
Key Factors to Building Successful Partnerships
Sherie Smalley, MD, Vice President & Medical Director, ADVI
Experts will present ideas on how to collaborate to demonstrate the value of advanced diagnostics and precision medicine. Panelists will share insights on the innovative partnerships they have established and the goals each aims to achieve.
Sponsored Presentation (Opportunity Available)12:40 pm
Session Break1:10 pm
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:15 pm
Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing1:45 pm
REIMBURSEMENT STRATEGIES FOR ADVANCED DIAGNOSTICS
先端診断向け償還戦略
PAMA Reform: Ongoing Efforts and Pathways Forward
Nicholas Halzack, Director, Health Policy, Roche Diagnostics
Since implementation of new Medicare Clinical Laboratory Fee Schedule rate-setting methodologies under PAMA began in 2017, there have been consistent efforts to delay and/or reform the underlying statute. Most recently, the Saving Access to Laboratory Services Act (SALSA) was introduced in 2022 which endeavored for long-term reform. This session will address some PAMA policy history, the contents of SALSA, ongoing reform efforts, and what might come next.
Medicare's Transitional Coverage for Emerging Technology - Something Old and Something New
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
Despite the confusion of reversing policies between the Trump and Biden administrations, Medicare remains committed to better pathways for new technologies. For 2023, the new title for these efforts is "TCET - Transitional Coverage for Emerging Technologies." CMS has held town halls and associations have chimed in with positions or webinars. TCET may flag renewed CMS interest in Coverage with Evidence Development, which is controversial with industry.
Demystifying Molecular Diagnostics Coverage and Reimbursement in Medicare: MolDX
Close of Conference4:00 pm
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