Cambridge Healthtech Instituteの第6回年次会議

Implementing Precision Medicine
(精密医療の導入)

コンパニオン診断とゲノム医療:臨床採用の実現

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。

3月6日(月)

Registration and Morning Coffee7:00 am

PLENARY KEYNOTE SESSION: Rx/Dx COLLABORATIONS: STRATEGIES FOR BRINGING TARGETED THERAPIES TO MARKET
基調講演・プレナリーセッション:Rx/Dxのコラボレーション:標的療法の市場投入戦略

8:00 am

Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition

8:05 am Plenary Keynote IntroductionPlenary Keynote Introduction

Paul Beresford, PhD, Vice President and General Manager, CDx, Diagnostics and Genomics Group, Agilent Technologies

8:15 am KEYNOTE PRESENTATION:

Precision Medicine, What's So Difficult? The Interplay & Complexities of Pharmaceutical & Diagnostic Partnerships to Deliver the Promise of Precision Medicine

Sarah Hersey, MS, MBA, RAC, Vice President, Precision Medicine, Bristol Myers Squibb Co.

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?

8:45 am PANEL DISCUSSION:

Rx/Dx Collaborations: Strategies for Bringing Targeted Therapies to Market

PANEL MODERATOR:

Edward Abrahams, PhD, President, Personalized Medicine Coalition

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.

PANELISTS:

Christopher Conn, PhD, Director, Diagnostics Strategy, Amgen

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.

David Fabrizio, Vice President, Translational Strategy, Foundation Medicine

Sarah Hersey, MS, MBA, RAC, Vice President, Precision Medicine, Bristol Myers Squibb Co.

Networking Refreshment Break9:30 am

COMPANION DIAGNOSTICS IMPLEMENTATION AND CLINICAL ADOPTION
コンパニオン診断の導入と臨床採用

9:45 am

Chairperson's Remarks

Lourdes Barrera, PhD, Executive Director, Global Medical Affairs, Merck

9:50 am

Patient Access to Testing and the Promise of Precision Medicine

Jennifer Quigley, Senior Director, Global Precision Diagnostics Hematology, Novartis Pharmaceuticals

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.

10:20 am

Unlocking the Potential of Novel HER2-Targeting ADCs

Patrik Vitazka, PhD, Senior Director, Companion Diagnostics, Daiichi Sankyo, Inc.

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.

10:50 am PANEL DISCUSSION:

Clinical Adoption of Companion Diagnostics: What’s Still Holding Us Back?

PANEL MODERATOR:

Lourdes Barrera, PhD, Executive Director, Global Medical Affairs, Merck

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.

PANELISTS:

Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.

Christopher Conn, PhD, Director, Diagnostics Strategy, Amgen

Jennifer Quigley, Senior Director, Global Precision Diagnostics Hematology, Novartis Pharmaceuticals

Alison Urvalek, Senior Director, Clinical Diagnostics, Loxo@Lilly

11:20 am Current and future precision diagnostics: what comes after the genome

Timothy Taxter, MD, Senior Medical Director, Algorithmic Diagnostics, Tempus Labs

This presentation will discuss our end-to-end technology platform and validated assays, in addition to a review of the current and future state of multi omic data integration for delivering precision medicine.

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
腫瘍学以外の精密医療

1:10 pm

Chairperson's Remarks

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.

1:15 pm

Challenges and Opportunities for Precision Medicine in Chronic Disease

Mark Fidock, PhD, Vice President, Diagnostic Development, Precision Medicine and Biosamples, R&D Oncology, AstraZeneca

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.

1:45 pm

Navigating the Regulatory Approval Process for Non-Oncology Diagnostic Tests

Meggan Czapiga, PhD, Director and IVD Lead, Global Regulatory Affairs Devices, UCB BioSciences

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.

2:15 pm PANEL DISCUSSION:

Precision Medicine Outside Oncology: A Whole New World

PANEL MODERATOR:

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.

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.

PANELISTS:

Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences, Inc.

Meggan Czapiga, PhD, Director and IVD Lead, Global Regulatory Affairs Devices, UCB BioSciences

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

Stephane Wong, PhD, Senior Director, Immuno Oncology Companion Diagnostics, GSK

Sponsored Presentation (Opportunity Available)2:45 pm

Networking Refreshment Break3:15 pm

30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: GENOMICS INNOVATION
30周年記念TRI-CON基調講演・プレナリーセッション:ゲノムイノベーション

3:40 pm

Chairperson's Remarks

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

3:45 pm FIRESIDE CHAT:

Sequences, SynBio, and Sailing: Three Decades of Adventure with J. Craig Venter

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

J. Craig Venter, PhD, Founder, Chairman, and CEO, J. Craig Venter Institute

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.

4:15 pm PANEL DISCUSSION:

30 Years of Genomics Innovation and the Future of Precision Medicine

PANEL MODERATOR:

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

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.

PANELISTS:

Euan Ashley, PhD, Professor, Genomics & Precision Health, Stanford School of Medicine

J. Craig Venter, PhD, Founder, Chairman, and CEO, J. Craig Venter Institute

Molly He, PhD, CEO & Co Founder, Element Biosciences

Alex Aravanis, MD, PhD, CTO, Senior Vice President, Head of Research and Product Development, Illumina

Welcome Reception in the Exhibit Hall with Poster Viewing5:00 pm

Close of Day6:00 pm

3月7日(火)

Registration and Morning Coffee7:30 am

30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: DIAGNOSTIC INDUSTRY TRENDS
30周年記念TRI-CON基調講演・プレナリーセッション:診断業界の動向

8:00 am

Chairperson's Remarks

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

8:05 am PANEL DISCUSSION:

Big Diagnostics: 30 Years of Impact

PANEL MODERATOR:

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

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.

PANELISTS:

Dave Persing, MD, PhD, Executive Vice President, CSO, Cepheid; CSO, Danaher Diagnostics Platform

Jay Wohlgemuth, MD, CMO and Senior Vice President, R&D, Medical and Population Health, Quest Diagnostics

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

Robert J. Bujarski, President and COO, QuidelOrtho Corporation

Cindy Perettie, Head, Roche Molecular Labs

Transition to Sessions9:00 am

PRECISION ONCOLOGY: EMERGING TECHNOLOGIES AND IMPLEMENTATION STRATEGIES
精密腫瘍学:新興技術と導入戦略

9:05 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

9:10 am

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.

9:40 am

Liquid Biopsy Use in Precision Oncology

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

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.

10:10 am Talk Title to be Announced

Speaker to be Announced

Presentation to be Announced10:25 am

Coffee Break in the Exhibit Hall with Poster Viewing10:40 am

11:25 am

Precision Medicine: Beyond NGS - Why Implementation Matters

Kenna R. Mills Shaw, PhD, Executive Director, Institute for Personalized Cancer Therapy, MD Anderson Cancer Center

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.

11:55 am

Precision Oncology in the 21st Century: Artificial Intelligence as a Tool to Reclassify Diseases

Sean Khozin, MD, MPH, Research Affiliate, Massachusetts Institute of Technology

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

* 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。

Choose your language
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