Cambridge Healthtech Instituteの初開催

Multi-Cancer Early Detection
(多重がんの早期発見)

多重がんの早期発見と微小残存病変検査

2023年3月7 - 8日、PST(米国太平洋標準時)

 

多重がんの早期発見とがんの先端診断により、がん治療を変革し、命を救うことが期待されています。Cambridge Healthtech Instituteの初開催「多重がんの早期発見」会議では、主要な利害関係者が集まり、MCED・MRDの新興技術のほか、ビジネスモデル、償還・市場参入の課題、投資・パートナーの機会、大手製薬企業のがん治療モデルへの影響について議論します。

3月7日(火)

EVIDENCE GENERATION AND MARKET ACCESS FOR MULTI-CANCER EARLY DETECTION
多重がんの早期発見向けエビデンス生成と市場参入

2:00 pm

Chairperson's Remarks

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

2:05 pm

Goals and Design of a Pilot Screening Trial of MCED Tests

Paul Pinsky, PhD, Chief, Early Detection Research, NIH NCI

Multi-cancer early detection (MCED) tests show promise as cancer screening tools. However, rigorous evaluation, preferably in a randomized-controlled trial (RCT), is necessary to prove their clinical utility. Due to the novel nature of MCED tests, several issues need to be resolved before embarking on a large-scale, definitive RCT of MCEDs. For that purpose, the NCI is planning on launching a pilot trial to try to resolve these issues.

2:35 pm

Addressing the Cancer Epidemic with Multi-Cancer Early Detection

Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC

A targeted methylation-based MCED detects a shared cancer signal across many cancer types with a low false positive rate, and predicts the cancer origin to direct downstream diagnostic work-ups. The performance of this MCED as well as appropriate performance metrics specifically for multi-cancer tests, the underlying biology of the signal that results in a balance of detecting more aggressive cancers while minimizing the risk of over-diagnosis, and the potential impact of implementing MCEDs in conjunction with standard-of-care cancer screening will be discussed.

3:05 pm

Challenges Facing Multi-Cancer Early Detection Tests: A Perspective from the MCED Consortium

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

The MCED Consortium, a group of volunteers, advisors, and companies spanning a wide range of expertise in biomarker evaluation and implementation, with a special focus on clinical practice, health equity, and communication, are developing recommendations for the evaluation of test utility, appropriate population targets for screening or early detection, downstream actions in health systems, issues of health equity, and communication challenges related to this new, potentially revolutionary generation of tests.

Sponsored Presentation (Opportunity Available)3:35 pm

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

4:45 pm

Chairperson's Remarks

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

Sponsored Presentation (Opportunity Available)4:50 pm

5:00 pm PANEL DISCUSSION:

Evaluation and Implementation of Multi-Cancer Early Detection Tests

PANEL MODERATOR:

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.

PANELISTS:

Philip E. Castle, PhD, Director, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health

Tomasz Beer, MD, CMO, Multi-Cancer Early Detection, Exact Sciences

Omar Perez, PhD, Head, Medical Diagnostics, AstraZeneca

Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC

Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer, Inc.

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

8:00 am

Chairperson's Remarks

Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC

8:15 am KEYNOTE PRESENTATION:

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.

8:30 am PANEL DISCUSSION:

Diagnostics Innovation and Investment Trends

PANEL MODERATOR:

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.

PANELISTS:

Ajit Singh, PhD, Partner, Artiman Ventures

Nathan Davis, Analyst, RA Capital Management

John W. Czajka, PhD, MBA, Director, Strategy and Innovation, BD Integrated Diagnostic Solutions

Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Lead, NIH’s Rapid Acceleration of Diagnostic Technologies (RADx Tech) Program

Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation

Transition to Sessions9:15 am

LIQUID BIOPSY FOR EARLY CANCER DETECTION
がんの早期発見向けリキッドバイオプシー

9:20 am

Chairperson's Remarks

Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy

9:25 am

Liquid Biopsy for Early Cancer Detection: Promises and Perils

Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI

The speaker will address the varied needs of different cancers for liquid biopsy tests in early detection, with special emphasis on risk assessment. Important need for cancers for which screening is currently an option, is a personalized risk profile based on a combination of biomarkers and subject characteristics that would allow tailoring of screening according to risk. For other less common cancers for which screening in a general population setting is not practical, liquid biopsy tests would offer the opportunity to identify individuals at sufficiently high risk to initiate surveillance.

9:55 am

Single-Cancer vs Multi-Cancer Detection? That Is the Question

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

Much interest has emerged in multi-cancer early detection. However, such MCED tests are not conceived to replace current cancer screening modalities. The challenge of how to reconcile single-cancer vs multi-cancer screening will be addressed.

Sponsored Presentation (Opportunity Available)10:25 am

Coffee Break in the Exhibit Hall with Poster Viewing10:55 am

LIQUID BIOPSY FOR EARLY CANCER DETECTION (CONT.)
がんの早期発見向けリキッドバイオプシー(続き)

11:35 am

Chairperson's Remarks

Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy

11:40 am

Early Detection of Cancer by Use of Liquid Biopsies and Other Technologies

Gary J. Kelloff, MD, Special Advisor, Cancer Imaging Program, National Cancer Institute, NIH

Liquid biopsies are sources of biomarkers that provide early detection of cancer often prior to metastatic spread. The newer technologies reveal the tissue of origin primarily via measurement of methylation patterns. This talk will review the remaining challenges for further development, including studies to establish standards using the various analytes and use of the biomarker results. A review of recent data emerging from the many international studies will be provided.

12:10 pm PANEL DISCUSSION:

Liquid Biopsies for Early Cancer Detection: The Final Frontier?

PANEL MODERATOR:

Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy

The final frontier for cancer elimination may be early detection. Liquid (usually blood-based) biopsies may potentially identify early-stage cancer, allowing for simple curative interventions. Cell-free DNA, extracellular vesicles, and DNA methylation are transformative cancer screening methodologies. However, critical issues remain: addressing false-positives when large populations are screened; optimizing assays for a single cancer versus across cancers; assessing impact of lead-time bias on survival impact; and applications in high- versus lower-risk patients.

PANELISTS:

Jonathan Beer, Worldwide Precision Diagnostics Strategic Intelligence Lead, Novartis Pharmaceuticals

Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

Gary J. Kelloff, MD, Special Advisor, Cancer Imaging Program, National Cancer Institute, NIH

Sponsored Presentation (Opportunity Available)12:40 pm

Session Break1:10 pm

1:15 pm LUNCHEON PRESENTATION:Multi-Cancer Early Detection through Multi-Biomarker Class Liquid Biopsy Testing

Frank Diehl, PhD, Executive Vice President, Multi-Cancer Early Detection, Research & Development, Exact Sciences Corporation

Cancer is often detected too late. MCED liquid biopsy tests are designed to harness the power of a variety of biomarkers from various tumors to help detect cancer prior to symptom onset. We’ll share the current evidence for novel multi-analyte approaches to MCED testing that, in combination with standard of care screening, may have the potential to detect more cancers at earlier stages when they are more treatable.

Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing1:45 pm

POPULATION HEALTH IMPACT OF MULTI-CANCER EARLY DETECTION
多重がんの早期発見における公衆衛生の影響

2:25 pm

Chairperson's Remarks

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.

2:30 pm

Cancer Screening at an Inflection Point: Is Multi-Cancer Early Detection the Answer?

Ruth Etzioni, PhD, Professor, Public Health Sciences, Fred Hutch Cancer Center

Tests that can detect multiple cancers with a single blood draw are fast becoming a reality. Diagnostic performance studies indicate that these tests can identify some cancers early but the implications for population health remain unclear. Lessons learned from decades of early detection research can help to manage expectations and guide strategies for test evaluation in a new era of novel cancer diagnostics.

3:00 pm

MCED in LMICs - An Opportunity Now to Transform Tomorrow

Dan Milner, MD, MSc, MBA, Consultant Pathologist, ASCP

Multicancer early detection assays are available from multiple companies but adoption in the USA/Europe may lag due to integration and competing existing systems; however, implementation in emerging economies where little infrastructure exists could have immediate impact on morbidity and mortality. Engaging governments, academia, and industry partners to deploy, test, and validate these assays in low resources settings will leapfrog systems to a higher level of cancer care.

3:30 pm PANEL DISCUSSION:

Is MCED Ready for Primetime?

PANEL MODERATOR:

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.

When it comes to screening healthy people for disease, it’s extremely important to show that potential benefits of that screening outweigh any potential harms. Multi Cancer Early Detection (MCED) tests that screen for multiple types of cancer in otherwise healthy individuals have been under development. While the technology holds promise, there appear to be many unanswered questions. This multi-stakeholder panel will explore the current state of MCED in the marketplace and discuss the path for evidence generation.

PANELISTS:

Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health

Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC

Paul Pinsky, PhD, Chief, Early Detection Research, NIH NCI

Brooke Byrd, PharmD, Clinical Oncology Pharmacist, Enterprise Oncology, CVS Health

Close of Conference4:00 pm

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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English

カンファレンスプログラム

2023年3月6-7日

Implementing Precision Medicine

Digital Medicine

At-Home & Point-of-Care Diagnostics

Liquid Biopsy

Spatial Biology

2023年3月7-8日

Precision Health

Diagnostics Innovation and Market Access

Infectious Disease Diagnostics

Advanced Diagnostics for Precision Oncology

Single-Cell Multiomics