Cambridge Healthtech Instituteの第3回年次会議

Digital Medicine
(デジタル医療)

精密医療における次なるフロンティア

2023年3月6 - 7日、PST(米国太平洋標準時)

 

デジタル技術の進歩は、既存の治療に新規のデジタル治療やデジタルコンパニオンデバイスを導入し、患者中心の臨床意思決定と研究を可能にし、コネクテッド診断で患者にポイントオブケア(POC)をもたらし、最終的に患者の転帰に影響を与えることによって、医薬品の提供を革命的に変化させることが期待されています。第3回「デジタル医療」年次会議では、デジタルヘルスのソートリーダーが集まり、急速に進化するデジタル医療の分野における最新の技術、応用、導入戦略について議論します。

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

PATIENT-CENTRIC DIGITAL INNOVATION
患者中心のデジタルイノベーション

9:45 am

Chairperson's Remarks

Luca Foschini, PhD, President & CEO, Sage Bionetworks

9:50 am

What Does Gold Standard Patient Engagement Look Like in a Digital Age?

Alicyn Campbell, Vice President, Head of Digital Health for Oncology R&D, AstraZeneca

This presentation will cover: 1) treating patients as equal partners when building digital health solutions by engaging them in the development from the start of the process, to ensure the solutions designed fit well into their lives; 2) leveraging the connection between technology and our partnership with patients, to drive innovation in the most meaningful areas to manage their disease; 3) enabling better outcomes for patients and supporting them in having a more positive experience during treatment.

10:20 am

Advancing Clinical and Translational Science through the Decentralization of Clinical Trials

Christopher M. Hartshorn, PhD, Chief, Digital & Mobile Technologies Section - CTSA Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health

An evolving trend in clinical and translational science has been their CT decentralization. The benefits are clear, the ability to decrease burden(s) to trial participants, improve recruitment and retention to enable interventions to succeed or fail faster without early termination, and offer more robust, rigorous medical evidence from broader demographics and diverse participants. This talk will discuss challenges and benefits in terms of existing NIH-funded efforts to advance.

10:50 am PANEL DISCUSSION:

The Business Case for Individual Engagement, Learnings across Industries

PANEL MODERATOR:

Luca Foschini, PhD, President & CEO, Sage Bionetworks

For online, direct-to-consumer services, user engagement is measured by frequency, timespan, and quality of interactions with an application which is often directly related to monetization, thus business metrics. In contrast, in healthcare and life science, purchase decisions are usually not made by the end user, so their engagement does not immediately relate to business KPIs. Is there still a business case for increasing individual engagement in the health industry?

PANELISTS:

Christopher M. Hartshorn, PhD, Chief, Digital & Mobile Technologies Section - CTSA Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health

Alicyn Campbell, Vice President, Head of Digital Health for Oncology R&D, AstraZeneca

Sponsored Presentation (Opportunity Available)11:20 am

Session Break11:50 am

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own11:55 am

Session Break12:55 pm

DIGITAL TOOLS AND WEARABLES FOR REMOTE PATIENT MONITORING AND PRECISION MEDICINE
遠隔患者モニタリング・精密医療向けデジタルツールとウェアラブル

1:10 pm

Chairperson's Remarks

Luca Foschini, PhD, President & CEO, Sage Bionetworks

1:15 pm

Wearables for Monitoring Health and Detecting Disease

Michael Snyder, PhD, Stanford W. Ascherman Professor & Chair, Department of Genetics, Director, Center for Genomics & Personalized Medicine, Stanford University

Early detection of disease is crucial for early intervention. Nowhere is this more evident than in the detection of infectious disease. We have built a scalable real-time smartwatch-based alerting system for the early detection of aberrant physiological signals associated with early infection onset and other stressors. We also perform continuous glucose monitoring for detecting glucose dysregulation.

1:45 pm

The Future of At Home Patient Monitoring and Care

Catherine Liao, Chief Strategy Officer, CardieX

The future of health and wellness lies in remote patient monitoring and digital health. By adapting to remote technology, industry leaders can aid in prevention, prediction and early detection. Throughout my presentation, I’ll discuss how remote patient monitoring can increase accessibility to healthcare, and how it is a critical first step toward tackling heart disease and improving overall vascular health.

2:15 pm

Remote Monitoring for High-Risk Perinatal Conditions

Mika Eddy, Founder & CEO, Malama Health

Malama enables remote monitoring for high-risk perinatal conditions, beginning with diabetes in pregnancy which affects nearly 1 in 5 women globally. Malama's fully HIPAA compliant platform makes it easy for patients to track glucose data and receive actionable insights, and for providers to reduce likelihood of adverse events.

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

ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING (ML) FOR IN VITRO DIAGNOSTICS (IVDs)
体外診断(IVD)向け人工知能(AI)と機械学習(ML)

9:05 am

Chairperson's Remarks

Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, Medical Device Innovation Consortium

9:10 am

Regulatory Science Approaches for Addressing Iterative Improvements in AI/ML-Enabled IVDs

Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, Medical Device Innovation Consortium

The Artificial Intelligence (AI) and Machine Learning (ML) for in vitro Diagnostics (IVDs) Working Group was established to address iterative improvements to AI/ML-enabled medical devices, including IVDs. This session will discuss the development of a regulatory framework to incorporate the use of Real-World Data (RWD) with the specific goals to develop a predetermined change control plan (PCCP) with templates for Software Pre-Specifications (SPS) and an Algorithm Change Protocol (ACP).

9:40 am PANEL DISCUSSION:

Fostering Responsible Innovation in AI/ML-Enabled IVDs

PANEL MODERATOR:

Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, Medical Device Innovation Consortium

Experts from industry and FDA will discuss regulatory science tools aimed at supporting AI/ML-enable IVDs, including an Algorithm Change Protocol (ACP) and a Software Pre-Specifications (SPS) template along with a common glossary developed as part of MDIC’s Artificial Intelligence (AI) and Machine Learning (ML) for in vitro Diagnostics (IVDs) Initiative. The discussion will include how these tools can facilitate and accelerate innovation in the application of AI/ML to IVDs.

PANELISTS:

Pat Baird, Head, Global Software Standards, Philips Healthcare

Jeffrey Ballyns, PhD, Associate Director, Regulatory Policy, BD

Nathan Carrington, PhD, Vice President, Global Regulatory Affairs, Agilent Technologies

Daniel Nichita, MD, Senior Product Marketing Manager, Beckman Coulter

Sponsored Presentation (Opportunity Available)10:10 am

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

DIGITAL PATHOLOGY IN DIAGNOSTICS AND PRECISION MEDICINE
診断・精密医療向けデジタル病理学

11:25 am

Precision Pathology to Accelerate Precision Medicine

Esther Abels, MSc, BioMedical Regulatory Health Science Expert; Past President, Digital Pathology Association

It’s crucial in this era of digitization to bring innovative devices, emerging products, and effective treatment to patients. Digitization is a required element for scalable and sustainable healthcare. Advancement in digital pathology, computational pathology, and artificial intelligence expand the network of brainpower for diagnostic, prognostic, and predictive pathology in precision medicine.

11:55 am

Computational Pathology: The Next Revolution in Cancer Diagnosis

J. Carl Barrett, PhD, Vice President of Translational Science, Oncology, AstraZeneca Pharmaceuticals

The first companion diagnostic for oncology precision medicine was HER2 over 20 years ago using IHC and FISH. IHC is semiquantitative and poor at measuring spatial heterogeneity in tumors. We have developed a deep learning computational pathology method that scores HER2 and other IHC markers at low expression levels, quantitates expression of each cancer cell, and allows scoring of spatial heterogeneity of positive and negative cells. Application of this method called Quantitative Continuous Scoring of IHC better predicts response to ADCs.

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