*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
10.05 | 7.05 – Regulatory Guidance for Liquid Biopsy Applications in Clinical Programs
- Gideon Blumenthal Vice President of Global Regulatory Affairs for Oncology, Merck
- 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
- Senior Representative , 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?
- Amit Deshpande Director, Nuvalent
- 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?