*PLEASE NOTE: ALL TIMINGS LISTED AS FOLLOWS: EST*

8:20 am Chair’s Opening Remarks

  • Pashtoon Kasi Director Colon Cancer Research; Precision Medicine Director for Liquid Biopsy Research , Weill Cornell Medicine; Englander Institute of Precision Medicine

Keeping Up with the Liquid Biopsy Landscape

8:30 am Reflecting on the Evolving Role of Liquid Biopsy in Precision Oncology: 2022 & Beyond

  • David Gandara Professor, Director, Thoracic Oncology Program; Chief Medical Officer, UC Davis Comprehensive Cancer Center; International Society for Liquid Biopsy

Synopsis

• The landscape is changing very quickly, with more entrants into the industry and increasingly promising data being announced on a regular basis
• As non-invasive testing comes to fruition, it’s important we recognise how the industry is evolving and identifying where liquid biopsy can permit the more comprehensive study of disease resulting in patient benefit and healthcare savings
• In NSCLC alone, there are increasing ways liquid biopsies are being applied to further our understanding of disease, with potential to see better treatments reach patients – Most recent progress and research in this area will be shared

9:00 am Comprehensive Liquid Biopsy Across the Continuum of Care: Are we There Yet?

  • Louis Levy Director, Business Development, Guardant Health

Synopsis

• Expanding use cases in late-stage cancer with molecular response
• Adjuvant and MRD opportunities using blood only
• Next stop: Early Detection

9:30 am The International Liquid Biopsy Standardization Alliance (ILSA) & Public-Private Research Partnership Development Through the FNIH Biomarkers Consortium Cancer Steering Committee

  • Dana Connors Scientific Program Manager, Cancer Research Partnerships, Foundation for the National Institutes of Health

Synopsis

• The FNIH supports public health and the mission of the NIH through publicprivate research partnerships, and Biomarkers Consortium projects bridge the gap between basic research and practical needs for advancing drug development and regulatory science

• The FNIH ctDNA QCM project will provide quality control materials that will help real-world users to develop ctDNA assays and monitor their performance

• The FNIH joins organizations that recognize the importance of working towards the global use of liquid biopsy and common reference standards in oncology in the International Liquid Biopsy Standardization Alliance to promote their use in the broader medical community

10:00 am Tempus’ Liquid Biopsy Offering and Emerging Trends in Clinical Development

  • Nike Beaubier Vice President, Head of Translational Medicine, Tempus Labs

Synopsis

• Overview of Tempus Labs’ biopharma offerings
• Updates to the xF liquid biopsy panel
• Case studies and emerging trends on how biopharma is leveraging liquid biopsy tests in clinical development

10:30 am Panel Discussion: Equity, Diversity & Inclusion in the Context of Clinical Disparities & Minority Representation in Patient Populations

  • Marjorie Petty Senior Director, Operations & Medical Development, Spectrum Pharmaceuticals
  • Daniel Simon Senior Vice President, BioPharma Business Development, Guardant Health
  • Julie Ramage Director of Precision Medicine Quality Initiatives & Partnerhips, AstraZeneca
  • Michel Reid Senior Director and Head, Global Demographics & Diversity, Global Clinical Delivery, Global Clinical Operations, R&D, GlaxoSmithKline
  • Jennifer Skenfield Director, Clinical Operations, Early Phase Oncology, Gilead Sciences

Synopsis

• Discussing importance, barriers, opportunities and key people who can make a difference in precision oncology clinical trial design and execution

11:00 am Structured Networking Break

Synopsis

• Take part to catch-up with your old friends, meet new faces and connect with those who can assist you with your precision pipeline progress
• New to this space? Get in touch here and we can facilitate a conversation for you!

Liquid Biopsy Applications

Chair:

  • Pashtoon Kasi Director Colon Cancer Research; Precision Medicine Director for Liquid Biopsy Research , Weill Cornell Medicine; Englander Institute of Precision Medicine

Cancer Biology & Biomarker Investigations

12:00 pm Advancing Liquid Biopsy Biomarker Discovery and Companion Diagnostics with PGDx elioTM Plasma Assays

  • Jennifer Jackson Director, Translational Science and Strategy, Personal Genome Diagnostics

Synopsis

• Advancing ctDNA-based tumor profiling towards clinical use
• PGDx’s focused and comprehensive liquid biopsy solutions
• Partnering opportunities for biomarker discovery, companion diagnostics and other emerging applications

12:10 pm Liquid Biopsy Using Nanotube-CTC-Chip

  • Balaji Panchapakesan Professor, Founding Director, Small Systems Laboratory, Department of Mechanical Engineering, Worcester Polytechnic Institute

Synopsis

• Bioanalytical methods for validation of circulating tumor cell assays
• Not all circulating tumor cells are metastatic cells
• Biophysical properties of circulating tumor cells enable new clues to metastasis

Developmental & Commercialization Pathways

Chair:

Commercial Considerations for Program Planning

11:30 am Liquid Biopsies & the Valuation of Drug Programs

  • Steven Rosen Scientific Innovation Leader In Healthcare, Wyss Institute, Harvard University

Synopsis

• How is non-invasive testing informing drug valuation estimations and how do diagnostics drive value in programs and additional informative characteristics of multi-technology approaches?

• Might promising data for ctDNA analysis to select patient therapy impact future pipeline decision making in oncology?

• The trend towards identifying patients earlier: the impact on drug development programs and the role liquid biopsy has in reaching patients in earlier settings

12:00 pm Evolving Trends of Liquid Biopsy Utilization in the Market

  • Lijoy Mathew Global Director, Medical Affairs, Oncology Biomarkers & Diagnostics, Merck

Synopsis

• Liquid biopsy has the potential to impact many areas of oncology, starting with treatment selection to screening for cancers
• Logistical and technical challenges remain that may limit aspects of ctDNA utilities
• The utilization of liquid biopsy technologies from feasibility concepts to test implementation in clinical practice is continuously evolving

12:30 pm Demo Area

Synopsis

• Your opportunity to schedule 1-2-1 meetings with your fellow colleagues and our event partners to find out their scientific innovations, technology capabilities, and assay development opportunities!
• New to this space? Get in touch here and we can facilitate a conversation for you!

1:00 pm Circulating Tumor Cell (CTC) Enumeration, Biomarker Expression & Kinetics in Response to Therapy in Patients With Gastrointestinal Malignancies

  • Pashtoon Kasi Director Colon Cancer Research; Precision Medicine Director for Liquid Biopsy Research , Weill Cornell Medicine; Englander Institute of Precision Medicine

Synopsis

• Understand the options from a research and/or clinical availability of some of the circulating tumor cells (CTC) platforms
• Understand the value and utility of what circulating tumor cells have to offer in comparison to circulating tumor DNA (ctDNA)
• Understand clinical and biological variables affecting CTC enumeration and analysis relevant to integration in clinical trial designs and clinic

1:30 pm Unbiased Enrichment of CTCs and Immune Cells via Parsortix Offers Multiple Downstream Applications

Synopsis

• Parsortix offers unbiased enrichment of CTCs and accompanying immune cells
• Parsortix enrichments are amenable to a wide array of downstream molecular, imaging and expression-based applications
• Endothelial-to-mesenchymal markers offer unique insight into cancer biology

2:00 pm AbbVie ctDNA Assay Successfully Performed in Large Cohort of Clinical Plasma Samples With High Quality Data Readout

Synopsis

• BRCA1/2 Reversions are molecular resistance mechanisms detected at time of disease progression in some treated patients and across clinical response types to PARPi or Pt-based Chemotherapy
• Members of MRN complex involved in HR repair, RAD50, NBN, and BLM among most dynamic mutated DNA repair genes in ctDNA over time
• RAD50 mutations are potentially enriched in a subset of patients with complete or partial response to treatment

1:00 pm Forward Planning for Integrating MRD Testing into Drug Development Programs

Synopsis

• What is the value of MRD monitoring and why is this being implemented in precision oncology programs

• Types of MRD biomarkers in differing cancer settings in current in-progress studies

• A look at what gaps need to be addressed in assay standardization and current planning guidance to improve the utility and reliability of MRD monitoring

1:30 pm Translating the Language of Glycoproteomics into Biological Insights and Biomarker Discoveries

  • Daniel Serie Chief Data Officer, InterVenn Biosciences
  • John Leite Chief Business Officer, InterVenn Biosciences

Synopsis

• Translating the language of glycoproteomics into biological insights and biomarker discoveries
• First Of Its Kind – A unique, powerful liquidbiopsy solutions by leveraging the rich diversity of glycoproteomics perspectIV™ collaboration platformAI-Based Biomarker discovery

2:00 pm How to Overcome the Challenges of Analytically Validating a ctDNA Clinical Trial Assay

  • Jim Williams IVD Development & Validation Manager, Almac Diagnostic Services

Synopsis

• Pre-analytical factors that influence the design of a ctDNA clinical trial assay
• Analytical considerations for platform selection and analysis pipeline based on the intended use of the assay
• Almac’s experience and approach to tackling the unique challenges of analytically validating ctDNA assays for investigational use

2:30 pm Virtual Exhibition & Poster Session

Synopsis

• Learn how academia and industry are progressing sensitive and specific liquid biopsy application
• Contribute to the conversation and share your cutting-edge research to your fellow precision oncology peers to – Submit your poster for review here!

Assay Validation to Enable Earlier Intervention

3:30 pm NeXT Personal: Next Generation MRD Testing for Solid Tumors

  • Dan Norton Associate Director, Product Management, Personalis, Inc.

Synopsis

• The ability to monitor and predict molecular recurrence at the earliest timepoints during or after curative therapy in patients previously diagnosed with cancer may inform precision treatment regimens, or spare patients from costly side effects
• Here we discuss NeXT Personal, an advanced next generation MRD platform optimized for sensitivity to detect cancer at the earliest timepoints

4:00 pm Panel Discussion: Exploring the Sensitivity & Specificity of Liquid Biopsies in Disease Detection

  • Partha Das Medical Director, CDx & Biomarker Strategy, Amgen
  • Pashtoon Kasi Director Colon Cancer Research; Precision Medicine Director for Liquid Biopsy Research , Weill Cornell Medicine; Englander Institute of Precision Medicine
  • Darren Hodgson Global Project Leader and Site Head Translational Medicine , AstraZeneca Oncology
  • Minetta Liu Research Chair, Department of Oncology; Consultant, Department of Laboratory Medicine and Pathology, Mayo Clinic
  • Jennifer Elliott Senior Director Business Development, Oncology & Precision Diagnostics, Qiagen

Synopsis

• What is the importance and distinction between sensitivity and specificity?
• How can technology be qualified for purpose?
• Which sequencing methods show enhanced accuracy to detect clinically actionable mutations?
• Is analysis of DNA alternations sufficient or should we expand to other biomarker sources in earlier settings?

4:30 pm Chair’s Closing Remarks

  • Pashtoon Kasi Director Colon Cancer Research; Precision Medicine Director for Liquid Biopsy Research , Weill Cornell Medicine; Englander Institute of Precision Medicine

Commercial Considerations for Program Planning

3:00 pm Partner Selection: Choosing the Right Technology & Expertise for Your Program

Synopsis

• Key determinants and strategies when planning your study partners
• Considerations surrounding sensitivity, selectivity, and differing market language to describe capabilities
• Example of technology selection in practice: The Amivantamab story

3:30 pm Panel Discussion: Setting up Global Clinical Trials with the End in Mind

  • Libby Barksdale Director of Regulatory Affairs and Scientific Policy, LUNGevity Foundation
  • Steven Piccoli Head of Clinical Biomarkers, SPARC
  • Kenna Anderes Vice President Translational Medicine & Companion Diagnostics, Mirati Therapeutics
  • Benoit Destenaves Executive Director, Head of Biomarkers & Companion Diagnostics, H3 Biomedicine

Synopsis

• Is the evolving regulatory landscape requiring greater generation of relevant and reliable real world evidence to prove pre-market clinical performance?

• How do analytical parameters of precision medicine testing influence and augment clinical utility and outcome?

• Differentiators between US & EU locations for supporting streamlined drug and companion diagnostic regulatory strategy execution and submissions

4:30 pm Chair’s Closing Remarks