Cambridge Healthtech Instituteの第6回年次会議
Implementing Precision Medicine
2023年3月6 - 7日、PST（米国太平洋標準時）
20年前にヒトゲノムプロジェクトが完了して以来、精密医療のアプローチにより、個人の遺伝的表現型に合わせた新しい発見と治療が行われてきました。ゲノム医療、コンパニオン診断、精密腫瘍学、その他の個別化医療技術の臨床採用を可能にするために、発見から導入戦略へと重点が移りつつあります。Cambridge Healthtech Instituteの第6回「精密医療の導入」年次会議では、精密医療の主要な利害関係者が再び集まり、臨床採用、ビジネスモデル、償還と市場参入、健康の公平性への影響、腫瘍学以外の応用、コンパニオン診断・分子診断における進歩を含む、導入戦略についてブレインストーミングを行います。
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
COMPANION DIAGNOSTICS IMPLEMENTATION AND CLINICAL ADOPTION
Patient Access to Testing and the Promise of Precision Medicine
Biomarker testing enables precise therapeutic decisions, from timely and accurate diagnoses through treatment selection and monitoring. As our medicines and technologies become more sophisticated, capable of curing or controlling disease, we envision a world in which most diseases are cured and no longer a threat to living our best lives. However, widespread patient access to testing is critical to realizing this vision. We need creative solutions and collective efforts.
Unlocking the Potential of Novel HER2-Targeting ADCs
Antibody-drug conjugates (ADCs) are one of the fastest growing classes of anticancer therapeutics in recent years. The unique design of ADCs, comprising a specific antibody conjugated to a cytotoxic payload via a linker, enables efficient and specific drug delivery to antigen-expressing tumor cells. Trastuzumab deruxtecan is a novel HER2-directed ADC that has been evaluated as a treatment for several HER2-expressing cancers. Here we provide an update on the recent companion diagnostic (CDx) approvals for this novel ADC agent, including the first CDx approval for the HER2-low metastatic breast cancer and the first NGS-based approval for the HER2- mutated NSCLC.
Clinical Adoption of Companion Diagnostics: What’s Still Holding Us Back?
Although companion diagnostic tests are the keystone of personalized medicine, there are still many roadblocks to their practical implementation. Among others, regulations for each diagnostic differ drastically, uncertainty surrounding the coverage by payers of diagnostic tests, some doubt as to how cost-effective they are as well as clear quality standards. We will reflect on this and other barriers and identify potential drivers to overcome them.
Sponsored Presentation (Opportunity Available)11:35 am
Session Break11:50 am
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own11:55 am
Session Break12:55 pm
PRECISION MEDICINE OUTSIDE ONCOLOGY
Challenges and Opportunities for Precision Medicine in Chronic Disease
The presentation will focus on the delivery of precision medicine for chronic diseases with case studies drawn from indications associated with respiratory & immunology and cardiovascular, renal & metabolism. These will illustrate the opportunities within chronic disease to rewrite the textbooks on how we treat patients with these indications improving outcomes.
Navigating the Regulatory Approval Process for Non-Oncology Diagnostic Tests
Despite significant challenges, drug companies have been increasing their investment in the discovery and implementation of patient selection biomarkers that focus on non-oncology areas. Outside of oncology, this path is not well paved including in the regulatory space. This talk will highlight the principles for co-development of a CDx with a non-oncology therapeutic product, communication strategies for coordinating investigational CDx tests with the FDA, and will address some of the current challenges for co-drug/device development programs in rare disease and cell and gene therapy programs.
Precision Medicine Outside Oncology: A Whole New World
When we hear Precision Medicine and CDx, we think of oncology drugs, but Precision Medicine is becoming an essential component of drug development in other therapeutic areas. This session will focus on the opportunities and challenges faced developing precision medicines in chronic, rare, and inflammatory diseases.
Sponsored Presentation (Opportunity Available)2:45 pm
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
PRECISION ONCOLOGY: EMERGING TECHNOLOGIES AND IMPLEMENTATION STRATEGIES
Liquid Biopsy in the Clinic: The Newest Precision Medicine Frontier
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 single cancer versus across cancers; assessing impact of lead-time bias on survival impact; and applications in high-versus lower-risk patients.
Liquid Biopsy Use in Precision Oncology
Precision medicine therapies have demonstrated benefits for cancer patients but are dependent on biomarker results for prescription. Four key barriers to optimal precision oncology treatment exist: Awareness, Availability, Adoption, and Access. Each hurdle will be examined through the lens of how LBx tests in today's healthcare system are well-suited to overcome some, but disadvantaged in other barriers, including examples of clinical utility from PADA-1 and DYNAMIC trials.
Presentation to be Announced10:25 am
Coffee Break in the Exhibit Hall with Poster Viewing10:40 am
Precision Medicine: Beyond NGS - Why Implementation Matters
This talk will cover how challenges in biomarker testing in the cancer patient population are influencing progress, or lack thereof, in the implementation and promise of appropriate use of targeted, matched therapies in the cancer patient population. This talk will review current issues in the field and opportunities for improving options for patients and clinicians.
Precision Oncology in the 21st Century: Artificial Intelligence as a Tool to Reclassify Diseases
Despite the recent progress in the development of new anticancer therapies, many patients do not derive optimal benefit from available therapies and most cancers in the advanced stage remain incurable. Catalyzing the next wave of biomedical breakthroughs requires a paradigm shift in the classification of oncological diseases, moving to more objective methods derived from quantitative assessments closer to underlying mechanisms of disease by leveraging advances in AI and machine learning.
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