Cambridge Healthtech Instituteの第14回年次会議

Advancing Novel Frameworks for Companion Diagnostics
(コンパニオン診断(CDx)の新規枠組みの進展)

進化する情勢の世界の展望

2023年8月21 - 22日、EDT(米国東部標準時)

コンパニオン診断(CDx)の開発は、今なお衰える気配がありません。この分野が成長し続ける中で、周囲の情勢もそれに合わせて進歩することが重要です。医療がますます個別化されるにつれて、製薬企業と診断企業間のパートナーシップは、質の高いケアと患者の転帰につながる可能性があります。新規の開発経路や進化する規制要件は、製薬企業や診断企業の方向性にも重要な影響を与えます。Cambridge Healthtech Instituteの第14回「コンパニオン診断(CDx)の新規枠組みの進展」年次会議では、最前線でこれらの問題を明確にし、製薬企業と診断企業間のコラボレーションを促進し、経営幹部、ビジネス専門家、規制当局、科学者、臨床医、コンパニオン診断(CDx)、医薬品・診断の共同開発、プレシジョンメディスン(精密医療)に関与するその他の関係者間で意見が異なる分野、意見が一致する分野について検証します。

8月20日(日)

Registration Open1:00 pm

8月21日(月)

Registration and Morning Coffee7:15 am

ADAPTING TO CHANGE IN THE GLOBAL AND DOMESTIC REGULATORY LANDSCAPE
世界・国内の規制情勢における変化への適応

8:25 am

Chairperson's Remarks

Eunice Lee, PhD, Vice President, Global Regulatory Affairs, Guardant Health

8:30 am KEYNOTE PRESENTATION:

Companion Diagnostic Test Development and Review: Supporting Patients and Innovation

Mark Stewart, PhD, Vice President, Science Policy, Friends of Cancer Research

Diagnostic tests are increasingly used in cancer care to match patients to targeted therapies based on a patient’s own molecular data. Given the critical role of diagnostic tests in cancer care, regulatory frameworks should enable patient access to innovative tests, while ensuring quality and reliability. Establishing performance metrics and streamlined processes can help clarify expectations and promote development and review of high-quality companion diagnostic tests.

9:00 am

Impact of Global IVD Regulatory Requirements on Co-Development

Eunice Lee, PhD, Vice President, Global Regulatory Affairs, Guardant Health

Regulatory frameworks for in vitro diagnostics have advanced and continue to develop across the globe. Companion diagnostic development can often be impacted, as highlighted by the implementation of IVDR in the European Union, and steps should be taken to avoid significant disruption and maintain coordinated activities with therapeutic products, while meeting evolving regulatory expectations. Best practices and strategies for navigating the regulatory environment when developing multi-regional co-development plans will be discussed.

9:30 am

Companion Diagnostics:  A CDRH Perspective

Brittany W. Schuck, PhD, Deputy Office Director, OHT7: Office of In Vitro Diagnostics, CDRH, Food and Drug Administration (FDA)

As personalized medicine continues to advance rapidly, in vitro diagnostics (IVDs) are increasingly being used as the primary driver for patient treatment decisions. When an IVD is essential for safe and effective use of a therapeutic, accurate and reliable IVDs are critical for optimal treatment decisions. CDRH’s policy, regulatory review, and vision of the future for such IVDs will be discussed.

Coffee Break in the Exhibit Hall with Poster Viewing10:00 am

10:45 am PANEL DISCUSSION:

Critical Implications of EU IVDR for Companion Diagnostics

PANEL MODERATORS:

Vihanga Pahalawatta, PhD, Associate Director, Regulatory Affairs Device and Combination Products, AbbVie, Inc.

Jai Pandey, PhD, Head, Global Device Regulatory IVD/CDx and Digital Health, Sanofi

Transitioning to IVD Regulation (EU) 2017/746 aims to ensure the placement of IVDs into markets and setting standards for the quality and safety of IVD devices. This panel will discuss strategic approaches for a successful Companion Diagnostics program under IVDR and explore potential solutions to unresolved pain points, including:

  • Challenges for co-development of medicines and CDx
  • Uncertainties in CDx consultation procedures result in conformity assessment delays
  • Best practices on navigating IVDR challenges
PANELISTS:

Heidi Naderi, Senior Medical Regulatory Consultant, Lecturer, Compliant Medical Devices Ltd.; External Partner, an EU Notified Body

Eunice Lee, PhD, Vice President, Global Regulatory Affairs, Guardant Health

Seamus Kearney, MSc, CEO, Principal Consultant, ARC Regulatory Ltd.

11:45 am Talk Title to be Announced

Speaker to be Announced

12:00 pm Talk Title to be Announced

Speaker to be Announced

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:15 pm

Session Break1:15 pm

THE PRESENT AND FUTURE OF COMPANION DIAGNOSTICS
コンパニオン診断(CDx)の現状と将来

1:30 pm

Chairperson's Remarks

Neeraj Adya, PhD, Head, Diagnostics, Genmab

1:35 pm

The Scope & Significance of Recent Advancements in Personalized Medicine

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

While the health care system moves beyond the immediate ramifications of the COVID-19 pandemic, the frontiers of personalized medicine are rapidly advancing with the efficient approval of new diagnostic tools and treatments that will expand the field with implications for patients with rare genetic diseases, cancers, and some common diseases. New diagnostic tools and trends involving liquid biopsy, tissue agnostic oncology indications, and early detection, as well as newly approved molecularly targeted drugs and cell-based and gene therapies will be highlighted to provide a look at where the field is and where it is going.

2:05 pm

Leveraging Dx/CDx as a Core Strategic Consideration in Drug Development

Neeraj Adya, PhD, Head, Diagnostics, Genmab

Precision or personalized medicine (PM) covers multiple initiatives, including the use of diagnostic (Dx)/companion-diagnostic (CDx) in drug development. A PM-driven approach can expedite and de-risk new drug launches while simultaneously improving clinical efficacy. This presentation will focus on the strategic applications of diagnostics in drug development and tactical consideration to successfully implement and deliver value through a PM-driven approach. 

Presentation to be Announced2:35 pm

Refreshment Break in the Exhibit Hall with Poster Viewing3:05 pm

3:45 pm

Companion Diagnostics and Intellectual Property: Navigating the Challenges to Ensure Business Success

Melissa Hunter-Ensor, PhD, Shareholder, Co-Chair, Global Patent Prosecution Group, Greenberg Traurig LLP

Precision medicine has been gaining traction.  Diseases that appear similar in pathology often arise from distinct underlying etiologies. These differences have consequences for patients and for companies.  Patients may suffer and clinical trials may fail when therapeutic agents are administered to the wrong patients. Companion diagnostics ensure that therapies are administered only to patients who can benefit from them. Current trends in patent law pose challenges to the protection of innovative technologies. This presentation will provide actionable strategies for the protection of innovations in the companion diagnostic and precision medicine arenas. 

4:15 pm PANEL DISCUSSION:

Strategies for Applying Companion Diagnostics to Drug Development

PANEL MODERATOR:

Neeraj Adya, PhD, Head, Diagnostics, Genmab

Sponsored Presentation (Opportunity Available)4:45 pm

Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing5:15 pm

Close of Day6:30 pm

8月22日(火)

Registration Open7:15 am

7:30 amInteractive Discussions with Continental Breakfast

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.

BREAKOUT DISCUSSION:

Putting Together a Wishlist for Alternative US FDA CDx Regulations

Dun Liang, PhD, Executive Director, Regulatory Affairs, Companion Diagnostics, Loxo@Lilly

  • What are the major challenges and pain points within the current CDx regulatory framework?
  • Will the proposed FDA/OCE CDx pilot program effectively address the existing pain points?
  • What practical aspects should the CDx pilot program consider to improve patient access to the testing while ensuring reliability and accuracy?

PHARMACEUTICAL REGULATORY STRATEGY
薬事戦略

8:25 am

Chairperson's Remarks

Albine K. Martin, PhD, Executive-in-Residence, BioHealth Innovation; Entrepreneur-in-Residence, Johns Hopkins University

8:30 am

Challenges and Implications of Current and Proposed CDx Regulations: A Pharma Perspective

Dun Liang, PhD, Executive Director, Regulatory Affairs, Companion Diagnostics, Loxo@Lilly

Presentation will address the challenges of current CDx regulation from a pharmaceutical industry perspective, using examples such the necessity of CDx for genetic tests accepted as standard of care, the use and review of local lab tests by the FDA, and the process of study risk determination and IDE planning and execution. The presentation will also compare the current CDx regulation with the proposed FDA CDx pilot program and explore the implications of the landscape changes. Finally, the speaker will identify some key hurdles for the new framework to roll out and invite more discussion.

EMERGING TECHNOLOGIES IN COMPANION DIAGNOSTICS
コンパニオン診断(CDx)の新興技術

9:00 am PANEL DISCUSSION:

Embarking on the Path of CDx: Key Considerations

PANEL MODERATOR:

Albine K. Martin, PhD, Executive-in-Residence, BioHealth Innovation; Entrepreneur-in-Residence, Johns Hopkins University

This panel will discuss key considerations and the integration of novel and foundational technologies for advancing  companion diagnostics to market. The impact of selected technologies on regulatory and partnership strategies will be considered. These impacts will be considered through case studies including trial design, and early strategic priorities.

PANELISTS:

Lori M. Minasian, MD, Deputy Director Cancer Prevention, Cancer Prevention, NIH NCI

Hannah MacLeod, PhD, Senior Scientist, Accelevir Diagnostics

Sponsored Presentation (Opportunity Available)10:00 am

Coffee Break in the Exhibit Hall with Poster Viewing10:30 am

Transition to Plenary Panel Discussion11:15 am

PLENARY SESSION Co-Organized by PMC
基調講演(PMCによる共催)

11:30 am PLENARY PANEL DISCUSSION:

Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care

PANEL MODERATOR:

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?
PANELISTS:

Robert H. Dumanois, Director, Reimbursement Strategy, Thermo Fisher Scientific

Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo Oncology, Inc.

Apostolia-Maria Tsimberidou, MD, PhD, FASCO, FAASS, Professor of Medicine, Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:30 pm

Close of Advancing Novel Frameworks for Companion Diagnostics Conference1:30 pm

Recommended Dinner Short Course6:00 pm

SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward

*Separate registration required. See short courses page for details.

* 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。

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