Cambridge Healthtech Instituteの第2回年次会議
Early Cancer Surveillance
2023年8月22 - 23日、EDT（米国東部標準時）
PLENARY SESSION Co-Organized by PMC
Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care
Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition
Many oncology patients who are eligible to receive high-value personalized treatments do not. Despite a lengthy history of targeted treatment availability in advanced non-small cell lung cancer (aNSCLC), a recent study found that 644 of every 1,000 newly diagnosed aNSCLC patients (64.4%) did not receive a personalized treatment due to clinical practice gaps in the delivery of precision oncology.
- What are the clinical practice and policy challenges related to diagnostic testing and the delivery of appropriate targeted therapies leading to a failure of patients to receive precision oncology strategies?
- What impact does each clinical practice gap have on the population-level delivery of precision oncology?
- How can we optimize biomarker testing and treatment decision-making to help best address clinical practice gaps?
- What policies and practices can help assure optimal and equitable delivery of appropriate high-value personalized medicines?
Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo Oncology, Inc.
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:30 pm
POLICIES, PERSPECTIVES, AND STRATEGIES FOR EARLY DETECTION
Challenges and Opportunities for Multi-Cancer Early Detection
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI
MCED tests are based on genomic signals that are usually interpreted by machine learning. The tests are designed either to complement existing screening modalities or as standalone tests. The tests are being developed and, in some instances, marketed to consumers, but are not FDA-approved or covered by health insurance plans. In order to show clinical utility, the test must undergo validation of analytical accuracy and reproducibility and rigorous clinical validation utilizing large prospective cohorts to demonstrate diagnostic performance. Once the test is matured and post-test analytics are locked down, the test must undergo a prospective, randomized trial to demonstrate the benefits of the test. Post-trial validation to demonstrate cost-effectiveness, benefit/harm ratio, and health economics will also be needed. The various aspects of MCED will be addressed and a risk-based MCED screening to improve positive predictive value (PPV) will be proposed.
Rethinking Risk Assessment within the Context of Multi-Cancer Early Detection
Alpa V. Patel, PhD, Director Cancer Prevention Study, Cancer Prevention Study, American Cancer Society
Risk assessment for cancer has typically been approached a single cancer type at a time. This approach helps both elucidate the etiology of each cancer type and assess risk to inform screening guidelines for that individual cancer. Newer technologies have the potential to target detection of several cancers in a single test, and this will require rethinking how we assess risk and inform screening guidelines. Specifically, it will be important to understand the populations who will most benefit from using multi-cancer early detection (MCED) tests and the risk factors associated with risk of developing any cancer to establish MCED screening guidelines.
NCI Perspectives on Clinical Trial Design for Evaluating the Use of Multi-Cancer Detection Assays for the Purpose of Cancer Screening
Lori M. Minasian, MD, Deputy Director Cancer Prevention, Cancer Prevention, NIH NCI
Multi-Cancer Detection assays have the potential to improve cancer screening by increasing the numbers and types of cancers detected. However, the unknown clinical benefits and harms necessitate the development and conduct of randomized clinical trials to determine clinical effectiveness. This talk will address the issues in trial design for such an RCT using MCD assays for cancer screening and the development of the pilot Vanguard Study.
Refreshment Break in the Exhibit Hall with Poster Viewing3:20 pm
How Many Contacts Can You Make in 30 Minutes? IN-PERSON ONLY
Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute
Bring yourself, your business or e-cards, and be prepared to share and summarize the key elements of your work in a short, two-minute sound bite. This session will be located in the exhibit hall and will be moderated.
POLICIES, PERSPECTIVES, AND STRATEGIES FOR EARLY DETECTION (CONT.)
Creating Consensus on a Lexicon, Standards, and Frameworks for Multi-Cancer Detection
Lauren Leiman, Executive Director, BLOODPAC Consortium
Stakeholder collaboration is critical for advancing the development and clinical implementation of multi-cancer early detection and screening. The Blood Profiling Atlas in Cancer (BLOODPAC), a nonprofit consortium composed of over sixty organizations within academia, industry, government, and the nonprofit sector, has launched efforts related to standards and framework development, education, and access coordination for MCED. The vision of BLOODPAC’s Screening and Early Detection Working Group includes (1) thinking creatively about how best to evaluate the impact of early detection strategies on morbidity and mortality resulting from rare and currently unscreened cancers; (2) engaging providers and patients in understanding and mitigating the barriers to implementation of blood-based cancer screening tests and provide recommendations for an equitable, resilient, and sustainable healthcare ecosystem that benefits people; and (3) engaging and collaborating with regulatory agencies to generate postmarket evidence to support the safety and effectiveness of blood-based cancer screening tests in real-world use. In this session, we will discuss progress to date on these initiatives, including our soon-to-be-published lexicon of standard terms for blood-based assays for the screening and early detection of cancer.
Early Cancer Surveillance: The Potential of Broad Cancer Screening of Undiagnosed Populations
Stephen Ezell, Vice President, Global Innovation Policy, ITIF IT & Innovation Foundation
Key findings from his report Seizing the Transformative Opportunity of Multicancer Early Detection will be presented. Why it’s time for a new cancer screening paradigm in the United States (and globally) and the significant individual, social, and economic benefits that a new approach to multi-cancer early detection (MCED) screening could provide will be discussed, as well as concerns about potential MCED misgivings. How public policy can facilitate greater levels of innovation and deployment of MCED solutions will also be presented.
New Non-Invasive, Non-Liquid Biopsy Methods for Early Cancer Detection
Mark Hiatt, MD, MBA, MS, CMO, RadSite
It is clear that blood-based liquid biopsies have the potential to have a significant and highly disruptive impact on early cancer detection, but it would be a mistake to think there are no other platforms that also offer potential. This panel will discuss several promising platforms that are also non-invasive but are not based on liquid biopsies. This includes elastography and Electrical Impedance. These approaches are less well developed than liquid biopsies and thus are initially focused on early detection of individual cancers, but their potential should not be overlooked.
Close of Day5:30 pm
Recommended Dinner Short Course6:00 pm
SC2: Translating CTCs, ctDNA, and Exosomes for Clinical Use
*Separate registration required. See short courses page for details.
Registration Open7:15 am
Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions page on the conference website for a complete listing of topics and descriptions.
Pre-Competitive Collaboration for Early Cancer Detection
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group, National Cancer Institute (NCI), NIH
- Opportunities for pre-competitive collaboration
- Examples of current collaborative efforts
- Challenges for commercial and non-commercial organizations
Legislative Update on Insurance Coverage for Early Cancer Screening
- Validation clinical trials for early detection could still take years
- Legislative efforts to promote or require coverage could be a game-changer
- Update on current and potential legislative initiatives
Differing Strategies; First Targeting Higher-Risk Patients or General Population Screening
- Algorithms for analysis are undergoing constant revision and improvement
- The end goal should be MCEDs that can be used in the general population
- Should testing in higher-risk cohorts be a stepping stone to broader general use?
MULTI-OMIC BIOMARKERS FOR EARLY CANCER DETECTION
Toward More Effective Strategies for the Early Detection of Common Cancers
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
Screening is currently available for five common cancers. However current screening modalities have limitations with respect to performance in the general population. For these cancers, blood tests for risk assessment have the potential to make screening more efficient by tailoring screening according to risk. For other less common cancers for which population-level screening is not practical, there is a need for blood tests to identify individuals at sufficiently high risk to be screened for these cancers.
Evolution of a Multi-Biomarker Class Approach to Multi-Cancer Early Detection Testing
Frank Diehl, PhD, Executive Vice President Multi Cancer Early Detection, R&D, Exact Sciences Co.
Multi-Cancer Early Detection (MCED) testing has the potential to be the paradigm shift needed to enable early detection for more cancers. Harnessing the power of a variety of biomarker classes in MCED test design has been shown to enhance test performance, especially in early-stage detection. We’ll share additional follow-up information from the DETECT - a study and the current data for a novel multi-biomarker class approach to MCED testing that, in combination with standard-of-care screening, may have the potential to detect more cancers at earlier stages when they may be more treatable.
Leveraging Multi-Omics and Machine Learning towards a Stepwise Approach to Multi-Cancer Screening
Jimmy ChengHo Lin, PhD, CSO, Freenome, Inc.
Early cancer discovery is challenging due to heterogeneity of different cancers and even within cancers from the same organ. In order to tackle this problem, Freenome has built a multi-omics discovery platform that looks for signals along the entire central dogma - DNA, methylation, RNA, protein, immunoprofiling, extracellular vesicles, circulating cells, among others. In order to featurize, train, and build the best models that are generalizable and robust, we have created our own machine learning platform incorporating different computational biological signals. All this is aligned with a step-wise investigation of cancers that can most benefit the population and make a difference to patients, starting with colorectal cancer and advanced adenoma. During this talk, we will discuss the clinical, scientific, and computational strategy that we think is important to create the best products to benefit the most patients.
Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing.10:00 am
MULTI-OMIC BIOMARKERS FOR EARLY CANCER DETECTION (CONT.)
Use of Exosomes in Blood to Detect Early-Stage Cancer
Paul R. Billings, PhD, CEO & Director, Biological Dynamics, Inc.
Exosomes are a class of extracellular vesicles that carry multiple, informative signals from DNA, RNA, proteins, and metabolites. They are present in biological fluids such as blood, urine, and saliva. Exosomes are constantly shed from both healthy and diseased cells, making them ideal targets for development of liquid biopsy tests for early disease detection. In this presentation, the CEO of Biological Dynamics, Paul R. Billings, MD, PhD, will review the company's proprietary Alternating Current Electrokinetic (ACE) technology used in their ExoVita exosome-based assays. The ExoVita assays are high-sensitivity and can distinguish between early-stage disease and control patient samples.
New Understanding of Natural History of Colorectal Cancer: Clinical Performance of a Multimodal-Screening Blood Test for Advanced Adenomas and CRC
John J. Sninsky, PhD, Chief Tech Advisor, CellMax Life
A new understanding of the natural history of colorectal cancer (CRC) informs the biological compartments that should be surveyed to develop a classifier for the continuum from advanced adenoma (AA) to CRC. We describe FirstSight, a blood-based multimodal test with a proprietary ‘probability risk function’ classifier that demonstrated high specificity with high sensitivity for CRC and modest sensitivity for AA in a train-test and cross-validation analyzed average risk screening study.
- How well does a cancer test need to perform to be 'disruptive?'
- Are there adaptive approaches to primary screening that may produce benefits in advance of primary population screening?
- What are the key challenges of pan-cancer screening tests?
Noninvasive Glycosaminoglycan Profiling (GAGomes) Using Mass-Spec for Multi-Cancer Early Detection: Update from Single-Cancer Studies
Francesco Gatto, PhD, CSO and Co-Founder, Elypta AB
Multi-cancer early detection (MCED) is an emerging paradigm to curb cancer mortality through a single test diagnosing all cancer types at an early stage. Liquid biopsies based on genomic biomarkers (like cell-free DNA) could make MCED realistic, but limitations include the inability to detect specific types like renal cancers.
In this talk, I will provide an update on the MCED potential of plasma and urine glycosaminoglycan profiles (GAGomes) as noninvasive biomarkers of tumor metabolism presenting data from several single-cancer studies on cancer types challenging to detect using cell-free DNA.
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:30 pm
Session Break1:30 pm
Networking Refreshment Break1:40 pm
SEQUENCING OF DNA AND METHYLATED DNA FOR EARLY CANCER DETECTION
Investment Perspectives for MCED
Mark Massaro, Managing Director & Senior Equity Research Analyst, BTIG LLC
Billions of dollars have been raised by labs that have developed early cancer detection tests, and great strides have been made - but will money continue to mark a significant barrier to entry? Our panel will discuss what some of the most successful companies to date have done, and we will discuss whether this is likely to be necessary going forward for the next generation of new entrants.
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 presented.
Genome-Wide cfDNA Fragmentation in Patients with Cancer
Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics
Cell-free DNA (cfDNA) consists of small nucleic acid fragments entering the bloodstream during apoptosis or necrosis. cfDNA fragmentation patterns detected by low-coverage whole-genome sequencing can be used to detect the presence of circulating tumor DNA (ctDNA) in a background of cfDNA mostly derived from hematologic cells. This presentation will describe the development of a blood-based, whole-genome, next-generation sequencing (NGS) test to detect early stages of cancer in asymptomatic individuals and to follow disease progression in cancer patients being treated with chemotherapy, targeted therapy, or immunotherapy.
Strategies and Approaches for Improving ECD Assays Development and Data Generation
Alexey Aleshin, General Manager, Early Cancer Detection; CMO, Natera, Inc.
The development and implementation of multi-cancer early-detection assays are accompanied by a unique set of challenges. Such challenges include defining an optimal set of biomarkers across multiple cancers, prioritizing performance specific features, and ensuring that the assay is not biased towards specific populations. This talk will address these challenges in the context of all stages of assay development, from development to validation in clinical trials.
Presentation to be Announced4:05 pm
Close of Summit4:35 pm
2023 Conference Programs