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

10.05 | 7.05 – Regulatory Guidance for Liquid Biopsy Applications in Clinical Programs


  • 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

10.35 | 7.45 – Panel Discussion led by Foundation Medicine

11.15 | 8.15 – Establishing the Analytical Validity of Circulating Tumor DNA Sequencing for Precision Oncology

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


  • 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

11.45 | 8.45 – Speed Networking Break

12.15 | 9.15 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


  • 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

12.55 | 9.55 – Interactive Roundtable Session Could Liquid Biopsies Be More Cost Effective?


  • 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

13.35 | 10.35 – Liquid Biopsy Assay Screening in: A Payor’s Perspective

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


  • 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?

14.05 | 11.05 – Chair’s Closing Remarks

14.10 | 11.10 – End of Day Three & Networking