インタラクティブディスカッション

研究の進展や動向いま直面している課題について、業界のエキスパートや同業他社と共に徹底的に討論することができます。
インタラクティブディスカッション・グループでは、将来の協力相手とのネットワーク作りに不可欠な役割を果たします。このグループは、研究成果をシェアし、仲間とアイデアを出し合い、グループで問題解決に取り組む機会が提供されます。

インタラクティブディスカッションは対面形式でのみ実施されます。

TUESDAY, AUGUST 19

INTERACTIVE DISCUSSIONS

7:30 am Interactive 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.

Enabling Point-of-Care Diagnostics

BREAKOUT DISCUSSION: Best Practice Recommendations by the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine
James Nichols, PhD, DABCC, FADLM, Professor of Pathology, Microbiology, and Immunology; Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine

• Identify common types of personal health devices
• Describe the data collected by health devices
• Recognize the advantages of interfacing personal health data with a patient’s electronic medical record
• Debate the challenges of connecting health devices to an EMR

BREAKOUT DISCUSSION: Integrating AI and Machine Learning into IVD Products
Giles Sanders, DPhil, Head, Diagnostics, TTP plc
Lawrence Worden, Founder, Principal, IVD Logix
Even beyond the hype, we are seeing a technological shift enabled by AI and ML disrupting professions and whole industries. In vitro diagnostics will also see changes from the broader upheavals that AI will bring. This open breakout discussion looks to consider how AI may impact us in POCDX in the future. Areas we may touch on include:

• Where AI may be applied in the diagnostic development pathway
• How AI-enabled tools may enable better diagnostics
• How multianalyte and longitudinal data could be applied for personalization of diagnostic approaches
• Regulatory and other hurdles to overcome 

Early Cancer Surveillance

• Ways to improve comparability of MCED test performance for better matching to a patient’s individualized cancer risk
• Best options for workups when cancer cannot be imaged              

• The role of single-cancer tests as reflex for positive MCED result

• NIH-wide SBIR and STTR programs 
• Funding opportunities for Early Cancer Detection 

• Application tips and assistance for awardees and applicants

• Challenges around existing cancer screening rate data sources - inaccuracy, inaccessibility, incompleteness
• Impact of these challenges on early detection test development 
• Proposed solutions and opportunities to get involved

BREAKOUT DISCUSSIONS: What is the Optimal Number of Cancers for Which an MCED Should be Trained?
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

• Trade-offs between sensitivity and specificity           
• The pros and cons of broad vs. more narrow initial training                
• Accounting for patient risk for more targeted screening
  

Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Charlie Adams, Director, Global Market Access, Health Policy & Reimbursement Strategy, Beckman Coulter Inc.

• Aligning Coverage with Transformative Value: Given the rapid evolution of diagnostics science, how can Medicare's "reasonable and necessary" coverage standard evolve to more flexibly and proactively incorporate transformative diagnostics to reshape care pathways rather than reacting to established evidence?
• Addressing the "Paradox" for Prevention and Early Detection: For innovative diagnostics focused on early disease detection or risk stratification (e.g., blood-based neurobiomarkers in early Alzheimer’s Disease detection, host response to infection assays to determine the need for antimicrobial therapy), how can CMS better capture the short and long-term value in improved outcomes and avoidance of more costly downstream interventions? How could CMS “reward” manufacturers and other developers for these critical diagnostics innovations?
• Predictability vs. Flexibility: Striking the Right Balance for Innovation: How should Medicare's national and local coverage and payment determination processes offer greater predictability for diagnostic innovators to plan R&D investments, while simultaneously maintaining enough flexibility to adapt to breakthrough technologies and rapidly evolving clinical value?
• Adapting RCT Requirements for Diagnostic Paradigms: Given the unique characteristics of diagnostics - often impacting decision-making rather than direct intervention, coupled with the longer time horizon to demonstrate ultimate outcomes in Medicare populations -- how can Medicare’s general reliance on prospective randomized clinical trials be adapted to foster innovation without imposing unfeasible burdens? What alternative or complementary evidence generation approaches (e.g., real-world evidence, virtual clinical utility studies) should CMS and its Contractors accept when evaluating coverage for novel diagnostics when traditional RCTs are impractical or unethica

 

WEDNESDAY, AUGUST 20

INTERACTIVE DISCUSSIONS

7:30 am Interactive 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.

Advanced Diagnostics for Infectious Disease

BREAKOUT DISCUSSION: The Role of CRISPR Technology in the Future of Clinical Diagnostics
Gregory Brett Robb, PhD, Senior Scientific Director & Head, CRISPR Science, VedaBio, Inc.

• Sample preparation-is it needed?
• Selection of amplification versus amplification-free CRISPR methods
• Selection of the optimal Cas enzymes
• Selection and evaluation of guide sequences

BREAKOUT DISCUSSION: What Future Syndromic Panels Are Needed in the Clinical Laboratory?
Niaz Banaei, MD, Professor, Pathology and Medicine; Medical Director, Stanford Health Care Clinical Microbiology Laboratory; Director, Stanford Clinical Microbiology Fellowship; Associate Program Director, Stanford Clinical Pathology Residency Training, Stanford University School of Medicine

• Met needs for syndromic panels
• Unmet needs for syndromic panels
• Challenges for industry to develop future syndromic panels
• Regulatory changes for future syndromic panels

Clinical Biomarkers and Companion Diagnostics

BREAKOUT DISCUSSION: Have We Finally Reached a Tipping Point for Digital/Computational Pathology?
Gary Gustavsen, PhD, Partner & Managing Director, Health Advances
Liam Lee, PhD, Senior Director of Medical Diagnostics, US Lung Cancer Diagnostics Team Lead, AstraZeneca

• Novel computational biomarkers in oncology
• Pharma pipeline driving need for computational pathology
• Key stakeholders across the ecosystem

Liquid Biopsy for Disease Management

• NIH-wide SBIR and STTR programs 
• Funding opportunities for Early Cancer Detection 

• Application tips and assistance for awardees and applicants