Cambridge Healthtech Instituteの第13回年次会議
2023年3月6 - 7日、PST（米国太平洋標準時）
リキッドバイオプシーは、疾患の早期発見、患者の層別化と治療選択、治療反応性のモニタリング、疾患の再発の発見に対する成熟技術です。Cambridge Healthtech Instituteの第13回「リキッドバイオプシー」年次会議では、CTC、cfDNA、循環細胞外RNA、エクソソーム、マイクロベシクルの検出と分子特性評価における最新技術とともに、診断・医薬品開発におけるリキッドバイオプシーの応用について探求します。
Registration and Morning Coffee7:00 am
PLENARY KEYNOTE SESSION: Rx/Dx COLLABORATIONS: STRATEGIES FOR BRINGING TARGETED THERAPIES TO MARKET
Precision Medicine, What's So Difficult? The Interplay & Complexities of Pharmaceutical & Diagnostic Partnerships to Deliver the Promise of Precision Medicine
Numerous dynamic intricacies exist between pharmaceutical and diagnostic industries which require careful consideration when deploying precision medicine solutions. This, coupled with technological advances and an evolving regulatory landscape, results in significant complexity. From the push to try to incorporate precision medicine earlier in drug development, through commercialization, what are the potential opportunities as well as hurdles to overcome to enable more effective collaborations to deliver targeted therapies?
Rx/Dx Collaborations: Strategies for Bringing Targeted Therapies to Market
This session will explore challenges and strategies to discover and develop personalized medicines from the points of view of both the diagnostic and pharmaceutical industries.
Networking Refreshment Break9:30 am
ULTRASENSITIVE DETECTION TECHNOLOGIES FOR MINIMAL RESIDUAL DISEASE
Plasma cfmiR Utility in Assessing Multiple Solid Tumor Detection and Progression
Cell-free microRNA (cfmiR) assessment of blood offers opportunities to monitor early detection of cancer and monitor cancer patients during progression and treatment. We have used a platform assessing >2000 miR using an NGS-based assay. The assay demonstrated the sensitivity and specificity of the cfmiR detection in multiple types of solid tumors that include GBM, melanoma, renal, breast, and prostate cancers. cfmiR provides an alternative molecular biomarker to assess MRD in early- and late-stage solid tumor progression. These cfmiR analyses offer alternatives to cancer cfDNA patient analysis in detection of MRD.
Measurable Residual Disease Biomarker Development in ALL and Multiple Myeloma through the FNIH Biomarkers Consortium and Ongoing Efforts in AML
This session will provide an overview of the FNIH Biomarker Consortium’s Measurable Residual Disease (MRD) projects, including successes in Acute Lymphoblastic Leukemia and Multiple Myeloma, and new programs in Acute Myeloid Leukemia and MGUS. MRD will be discussed in context of FNIH efforts to support widespread use of liquid biopsy, including the design and development of quality control materials for ctDNA testing. Efforts to support effective clinical research and therapeutic decision-making, and coordination with regulatory oversight, will be discussed in coordination with the International Liquid Biopsy Standardization Alliance (ILSA) and the development and objectives of this FDA recognized Collaborative Community.
Injectable Priming Agents and Sequencing Technology Innovations for Enhanced Liquid Biopsy Testing
Liquid biopsies could improve cancer care but require higher sensitivity. Here, I will describe our team’s efforts to push DNA sequencing to its limits and overcome the massive in vivo bottlenecks that constrain cancer detection. I will present (i) clinical validation of MAESTRO mutation enrichment sequencing for MRD, (ii) development of CODEC 'single duplex' sequencing, and (iii) proof-of-principle for the first liquid biopsy priming agents: injections to improve cancer detection.
Session Break11:50 am
Introducing the GenoCTC®, a novel CTC enrichment device, which relies on immune-magnetophoresis and microfluidics.
Presenting two clinical studies facilitated by the DeNovo® CTC scanning system:
- Feasibility study in advanced non-small cell lung cancer patients which demonstrated 94% CTC detection rate.
- Study evaluating EpCAM positive CTCs and c-MET positive CTCs in hormone receptor positive metastatic breast cancer patients (mBC).
Please join us to learn more about our exciting studies results.
Session Break12:55 pm
BLOODPAC'S ROADMAP FOR MOLECULAR RESIDUAL DISEASE IN SOLID TUMORS
Value of Collaboration and Standardization to the Integration of Molecular Residual Disease into Drug Development Programs
ctDNA-based MRD has many utilities for solid tumor indications across the patient journey and in supporting drug development. Currently, challenges remain to integrating MRD in a clinical setting, including gaps in existing guidance and a lack of standardization around assays and studies. The efforts of consortia can provide value in moving the validation, implementation, and standardization of MRD assays forward in the clinical setting.
Molecular Residual Disease Testing: Is It Minimal if It’s Measurable?
Minimal residual disease (MRD) is defined as evidence for the presence of persisting cancer cells below the threshold of conventional methods for disease detection. While MRD testing has clear prognostic utility and is increasingly adopted as a surrogate endpoint for drug efficacy, modalities, thresholds, and standards vary considerably. Here, we focus on the landscape of molecular MRD testing, utility in drug development, and efforts to standardize such as through BloodPAC.
Strategic Collaboration: Reaching Molecular Residual Disease as an Early Endpoint for Solid Tumors
A discussion with BLOODPAC members representing drug and assay development to discuss the value of strategic collaborations to advance the implementation of MRD and its validation as an early endpoint in solid tumors.
Fundamental changes in the epigenome underpin changes in disease biology. One such change is afforded through DNA demethylation events, as identified by 5-hydroxymethylation cytosine. Evidence shows that 5hmC enables a powerful way of measuring epigenomic control. We have built discrete classifiers for the detection of early-stage pancreatic and ovarian cancers directly from 5hmC events on cfDNA, also allowing for measurement of patient response to drug therapy.
Networking Refreshment Break3:15 pm
30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: GENOMICS INNOVATION
Sequences, SynBio, and Sailing: Three Decades of Adventure with J. Craig Venter
Since his riveting publication on expressed sequence tags in 1991, which galvanized a revolution in genomics, J. Craig Venter has been a dominant figure in the world of genomics and biotechnology. As the first human to have his personal genome completely sequenced, and as the co-founder of Synthetic Genomics and Human Longevity, he is routinely one step ahead of his peers. As we celebrate 30 years of TRI-CON, we’re thrilled to host Dr. Venter who will discuss his life, his many accomplishments, and his vision for the future of precision medicine and the biotech industry.
30 Years of Genomics Innovation and the Future of Precision Medicine
Over the past three decades, genomic medicine has been transformed from a distant dream to a clinical reality. With patients suffering genetic diseases and cancer now cured thanks to advances in genomics, cell therapy, genome editing, and computing, the future is bright - but by no means assured. In this TRI-CON keynote panel, we discuss the scientific highlights of an extraordinary journey for practitioners of precision medicine and anticipate where the field is headed.
Welcome Reception in the Exhibit Hall with Poster Viewing5:00 pm
Close of Day6:00 pm
Registration and Morning Coffee7:30 am
30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: DIAGNOSTIC INDUSTRY TRENDS
Big Diagnostics: 30 Years of Impact
Healthcare depends on diagnostics. We all know that diagnostics is the glue that holds the healthcare together and that 70% of medical decisions are informed by a diagnostic - but does that say enough? More than 3.5 million people work in diagnostic industry. The number of companies is at an all-time high. COVID showed the world how valuable a test can be. But with all the changes of the last few years - there have been constants - the industry’s largest players. From the labs to manufacturers, from services to products, there are a few companies that have seen it all. In this panel, we talk to them about the good and bad, challenges and opportunities and most importantly, the impact of the last 30 years.
William G. Morice II, MD, PhD, President & CEO, Mayo Clinic Laboratories; Professor & Past Chair, Mayo Clinic Department of Laboratory Medicine and Pathology; Chair, American Clinical Laboratory Association Board of Directors
Transition to Sessions9:00 am
CLINICAL ADOPTION OF ctDNA TESTING
Match Maker, Match Maker, Make Me a Match: Deciding Factors for Selecting Assays/Technologies for Clinical Validation
The precision medicine era has ushered in an abundance of analytically valid assays for tumor-specific biomarkers. This profusion of novel assays confounds the selection of the optimal technologies to advance towards clinical validation, the dedicated sequence of trials needed to demonstrate that the biomarker for the purpose of a specific context of use. Deciding factors include an assay’s performance and potential utility for the patient population with the unmet need.
ctDNA Clinical Testing Adoption: Current State and Expected Evolution
Circulating tumor DNA (ctDNA) has become the focal point of molecular diagnostics development in oncology due to its various clinical applications in cancer care management and its relative ease of sample collection and use. Regulatory-approved liquid biopsies using ctDNA have been available for several years, but they have not been widely adopted in clinical practice. We will review the current and expected clinical adoption of this practice-changing cancer diagnostics tool.
Sponsored Presentation (Opportunity Available)10:10 am
Coffee Break in the Exhibit Hall with Poster Viewing10:40 am
Clinical Applications of ctDNA in Oncology
Significant advances have been made in ctDNA detection in oncology. ctDNA analysis offer advantages such as minimally invasive collection, easily repeatable collection, being representative of all cancer lesions and representing tumor heterogeneity. This presentation will focus on various clinical applications of ctDNA as a biomarker with examples and discuss opportunities and challenges of integrating ctDNA-based biomarkers into clinical trials with respect to patient selection, patient stratification, response, and resistance monitoring.
Early ctDNA Dynamics to Monitor Treatment Response in Patients with ALK+ Advanced Non-Small Cell Lung Cancer
Circulating tumor DNA (ctDNA) has been used for prognostication and treatment monitoring. We evaluated ctDNA as potential biomarker for response to lorlatinib, a third-generation ALK inhibitor in patients with previously untreated ALK-positive advanced NSCLC in the ongoing Phase 3 CROWN study (NCT03052608). Molecular responses were calculated using mean variant allele frequency (VAF), longitudinal change in VAF, and ratio to baseline, and analyzed for association with clinical outcome parameters (progression-free survival [PFS]). Comparing molecular responders vs non-responders to lorlatinib, responders had longer PFS (HR, 0.37; 95% CI, 0.16-0.85). Early ctDNA dynamics predicted better outcomes with lorlatinib.
Sponsored Presentation (Opportunity Available)12:25 pm
Session Break12:55 pm
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:00 pm
Refreshment Break in the Exhibit Hall with Poster Viewing1:30 pm
Close of Conference2:00 pm