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

9.30 | 6.30 – Welcome Back to the Third & Final Morning Networking Session!

10.00 | 7.00 – Opening Remarks

The Changing Regulatory Environment for Liquid Biopsies

10.10 | 7.10 – Regulatory Guidance for Liquid Biopsy Applications in Clinical Programs

Synopsis

  • Data assembly considerations for regulatory review
  • Regulatory considerations for varying LBx applications and profiling technologies
  • Endpoint considerations in clinical trial design
  • Establishing ctDNA changes as a surrogate marker in the metastatic and adjuvant settings

Improving Patient Access to Liquid Biopsies: Implementing Testing Into Routine Care

10.40 | 7.40 – Establishing the Analytical Validity of Circulating Tumor DNA Sequencing for Precision Oncology

  • Joshua Xu Branch Chief, U.S Food & Drug Administration

Synopsis

  • A multi-site, cross-platform evaluation of analytical performance among industry-leading ctDNA assays
  • Sensitivity was highly variable for mutations present at variant allele frequencies below ~0.5%, especially when input material was limited
  • Missed mutations (false-negatives) were more common than erroneous candidates (false-positives), indicating that the reliable sampling of rare ctDNA fragments is the key challenge for ctDNA assays
  • Provided best-practice guidelines, standardized reference samples, a vital dataset for precision oncology

11.10 | 8.10 – Speed Networking Break

11.45 | 8.45 – Longitudinal Monitoring of Melanoma Patients Receiving Checkpoint Inhibitor Immunotherapies Using Cell Free MiRNA

  • Dave Hoon Director, Center of Translational Molecular Medicine, Professor of Genomic Sequencing Center, John Wayne Cancer Institute

Synopsis

  • Profiling of cf miRNA by NGS to identify signatures in metastatic melanoma patients of stage 3 and 4
  • Identification of cf miRNA signatures that correlate to checkpoint inhibitor immunotherapy responses
  • Early detection of progression disease failure during immunotherapy failure

12.15 | 9.15 – How Can You Accelerate & Support Precision Oncology Drug Developers? Position Yourself as the Partner of Choice in This Fast Paced & Expanding Industry

Synopsis

  • How are you ensuring technologies are sensitive and selective enough to help integrate LBx into clinical programs with confidence?
  • Developers want to hear from you
  • Enquire today to find how you can get involved!

12.45 | 9.45 – Interactive Roundtable Session Could Liquid Biopsies Be More Cost Effective?

Synopsis

  • Identifying and assessing current cost obstacles to the wider industry application liquid biopsies
  • Can industry better work together to better demonstrate the clinical utility of testing to show payers and patients this should be part of routine care?
  • Which innovations and workflow efficiencies are lowering the cost of running NGS technologies?
  • Improved technology trends: Downstream effects of enhanced sensitivity and selectivity / multiple biomarker identification in a single draw
  • Addressing investment in the early detection setting for lowering costs through detecting disease in the later stages

13.30 | 10.30 – Liquid Biopsy Assay Screening in: A Payor’s Perspective

  • Mark Nunes Division Chief, Medical Genetics, Kaiser Permanente LAMC

Synopsis

  • The critical importance of assay sensitivity and specificity to act as a decision maker, not descriptive assets
  • How can clinical utility of translational genomics be better
    demonstrated to payors?
  • Kaiser Permanente assay approval process: what are payors looking for to cover assays within policy?
  • Where are cell free tumor DNA assays most needed clinically?

14.00 |11.00 Panel Discussion: Global Market Access To Liquid Biopsies

  • Catherine Alix-Panabières Associate Professor & Principal Investigator, The University of Montpellier
  • Marielena Mata Director & Diagnostic Lead, Pfizer
  • Yutaka Matsumoto Senior Manager Clinical Science, Oncology Early Clinical Development Department Translational Research Division, Chugai Pharmaceutical Co., Ltd. Roche Group

Synopsis

  • Looking at regulatory and reimbursement across different geographies for liquid biopsy implementation into the clinic
  • Where are we seeing the greatest adoption and why are there variations between geographies?
  • What is needed to highlight the value of these assays and further the delivery of precision medicine in different geographies?
  • How can drug developers successfully launch drug and assay in global markets to see a greater commercial return?
  • What are the major restraints to the wider application of liquid biopsies globally and how can these be addressed

14.45 | 11.45 – Chair’s Closing Remarks

14.55 | 11.55 – End of Day Three & Networking