Cambridge Healthtech Instituteの第14回年次会議
Advancing Novel Frameworks for Companion Diagnostics
2023年8月21 - 22日、EDT（米国東部標準時）
Registration and Morning Coffee7:15 am
ADAPTING TO CHANGE IN THE GLOBAL AND DOMESTIC REGULATORY LANDSCAPE
Companion Diagnostic Test Development and Review: Supporting Patients and Innovation
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.
Impact of Global IVD Regulatory Requirements on Co-Development
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.
Companion Diagnostics: A CDRH Perspective
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
Critical Implications of EU IVDR for Companion Diagnostics
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
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:15 pm
Session Break1:15 pm
THE PRESENT AND FUTURE OF COMPANION DIAGNOSTICS
The Scope & Significance of Recent Advancements in Personalized Medicine
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.
Leveraging Dx/CDx as a Core Strategic Consideration in Drug Development
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
Companion Diagnostics and Intellectual Property: Navigating the Challenges to Ensure Business Success
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.
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
Registration Open7:15 am
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.
Putting Together a Wishlist for Alternative US FDA CDx Regulations
- 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
Challenges and Implications of Current and Proposed CDx Regulations: A Pharma Perspective
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
Embarking on the Path of CDx: Key Considerations
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.
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
Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care
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?
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.