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This presentation outlines a novel framework for expanding the reach and impact of precision medicine in cancer care, focusing on a case study in non-small cell lung cancer (NSCLC). We will explore strategies for driving scalable adherence to NCCN guidelines, facilitating their adoption, and fostering innovation beyond the capabilities of world-renowned cancer centers.

Key topics include leveraging network-based approaches to accelerate innovation and ensure world-class diagnostics and treatments are accessible outside tertiary and quaternary centers of excellence. This framework is designed to address critical issues of health equity, including access to cutting-edge care in rural and underserved areas, reducing disparities in cancer treatment outcomes.

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Synopsis: To propel precision medicine into its next phase of advancement, we must overcome formidable challenges extending beyond scientific and technological barriers. Our current reliance on single-gene and single-protein diagnostics is a bottleneck, limiting our predictive capabilities and thereby impeding the improvement of clinical outcomes and reduction in health care costs. The future of diagnostics lies in an evolution towards NextGen solutions characterized by algorithmic-driven patient care derived from artificial intelligence-based methodologies applied to extensive, longitudinal, multimodal patient datasets. This evolution will require holistic integration of clinical, demographic, laboratory/imaging, sensor, and molecular data. However, this transformation to NextGen diagnostics is impeded by a lack of alignment in our biomedical ecosystem and non-scientific barriers (e.g., regulatory, legislative, economic, reimbursement, clinical practicalities, data availability, scale of research).

This town hall will:

• Identify non-scientific forces holding back the next quantum leap in precision medicine, with a focus on predictive biomarkers.
• Identify and understand root causes of the forces that represent roadblocks to progress.
• Brainstorm potential approaches to solving roadblocks. How might we create a “tipping point?”
• Develop a strategy for a white paper to define the problem and market it to the masses with the aspiration of provoking changes required to advance precision medicine.

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Synposis coming soon.

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Synposis coming soon.

Recent advancements in next-generation sequencing (NGS) workflow automation have significantly improved both speed and ease of use. With the Ion Torrent Genexus System, NGS results are now obtainable in as fast as 24 hours and can be implemented in virtually any molecular laboratory due to the workflow simplicity and minimal hands-on time requirement. During this panel presentation, the speakers will explore the application of next-day NGS, with perspectives from a community research lab with limited experience as well as those from investigators in the NCI myeloMATCH trial, highlighting the transformative potential of rapid results for the future of precision oncology.

Synposis coming soon.

Synposis coming soon.

Topics:

• Research, development, commercialization pathway
• Rise and fall in Dx companies – trends in WHs, digital health, fall of NIPT bubble
• What do we need to succeed? clinical utility, regulatory, reimbursement, policy, partnership
• What can we learn from other areas?

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The 2022 ‘Practice Gap paper’* published in JCO and gained significant attention when revealing that as many as 64% of patients in aNSCLC were not receiving the most appropriate drug for their genetic profile.

Since then, several efforts have been initiated to better understand the 7 gaps identified and how the ecosystem around precision medicine collaboratively can work to close these.

In this talk several of these initiatives will be addressed as well as providing deep dives into some of the practice gaps to better understand the specific challenges. A view on where we are today and whether the efforts are making a difference for patients will be presented.

* Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non-Small-Cell Lung Cancer – Link to publication: Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer | JCO Precision Oncology (ascopubs.org)

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Liquid biopsies measuring circulating tumor DNA (ctDNA) have been used to identify therapeutic targets for a number of years, but recent evidence suggests a major role in monitoring the extend of disease. It is possible that measuring minimal residual disease (MRD) after treatment (e.g. surgery, radiation, or chemotherapy) may allow de-escalation of therapy in those cases where disease has been molecularly eradiated or escalated in those with disease that remains. However, disease burden has traditionally been identified by imaging, and how this is related to MRD remains unclear, albeit evidence suggests that MRD is more sensitive. However, if a patient has a molecular recurrence and/or is MRD positive but without positive imaging this creates new paradigms for treatment. This panel will discuss new data related to MRD and its use in escalating and de-escalating therapy.

Synposis coming soon.

Synposis coming soon.

Single cell: current practices and latest advancements in the field

Multiomics: single cell as multiple modalities from DNA to RNA to protein

Spatial profiling: when to use it and how does it compare to single cell
Challenges of adopting spatial omic technology

Computation: data analysis, pipelines, integration , normalization, scaleability

Single cell/spatial: is this population ready? Individualized care ready?

Synposis coming soon.

Synposis coming soon.

Despite latest breakthroughs in single cell sequencing that revealed cellular heterogeneity, differentiation, and interactions at an unprecedented level, the study of multicellular systems needs to be conducted in the native tissue context defined by spatially resolved molecular profiles to better understand the role of spatial heterogeneity in biological, physiological and pathological processes. In this talk, I will begin with discussing the emergence of a whole new field – “spatial omics”, and then focus mainly on a new technology platform called Deterministic Barcoding in Tissue (DBiT) for spatial omics sequencing developed in our laboratory over the past years. We conceived the concept of “spatial multi-omics” and demonstrated it for the first time by co-mapping whole transcriptome and proteome (~300 proteins) pixel-by-pixel directly on a fixed tissue slide in a way compatible with clinical tissue specimens including FFPE. It has been applied to the study of developing mouse brain, human brain, and human lymphoid tissues associated with normal physiology, disease, or aging. Recently, our research enabled another new field – “spatial epigenomics” – by developing multiple DBiT-based spatial sequencing technologies for mapping chromatin accessibility (spatial-ATAC-seq), histone modification (spatial-CUT&Tag), or further combined with transcriptome or proteins for spatial co-profiling. These new technologies allow us to visualize gene expression regulation mechanisms pixel by pixel directly in mammalian tissues with a near single cell resolution. The rise of NGS-based spatial omics is poised to fuel the next wave of biomedical research revolution. Emerging opportunities and future perspectives will be discussed with regard to human biology research, aging, disease, clinical biomarker discovery and therapeutic development.

We present Single-Cell Transcriptomics Analysis and Multimodal Profiling (STAMP), a novel and scalable approach for high-throughput single-cell analysis. STAMP integrates transcriptomics and proteomics via imaging-based platforms, enabling comprehensive RNA and protein profiling without sequencing, significantly reducing costs. The method is highly flexible, accommodating single-modal and multimodal experiments with diverse sample types, including PBMCs, cancer cells, and stem cells, across hundreds to millions of cells. STAMP demonstrated utility in Immunophenotyping, identifying rare cell populations like circulating tumor cells, and supporting large-scale perturbation studies. This versatile platform sets a new benchmark for cost-effective single-cell genomics, offering wide-ranging applications for research and clinical diagnostics.

Synposis coming soon.

Synposis coming soon.

Topics:
– The role of unbiased analytics in revealing personalized disease pathways
– Combining spatial data with genomic and clinical insights to advance precision medicine
– How spatial biology and advanced analytics can drive more effective, patient-specific treatment strategies in clinical trials

Synposis coming soon.

Synposis coming soon.

Synposis coming soon.

Synposis coming soon.

This panel will emphasize the critical role of CMC in ensuring the safety, efficacy, and quality of gene therapy products. It opens the floor for discussions on overcoming regulatory hurdles, scaling up manufacturing, ensuring quality control, and maintaining product consistency—all essential topics for a successful gene therapy launch.

Panel Theme Overview:
• Discuss the critical role of CMC in ensuring the safety, efficacy, and quality of gene therapy products.
• Identify quality control considerations from CMC perspective on Gene Therapy product development
• Highlight best practice and regulatory considerations within the rapidly evolving Gene Therapy landscape.

Synposis coming soon.