*PLEASE NOTE: ALL TIMINGS LISTED AS FOLLOWS: EST | PST*
9.00 | 6.00 – Welcome Back to the Third & Final Morning Networking Session!
Navigating Regulatory & Technical Challenges for Wider Liquid Biopsy Patient Access
09.20 | 06.20 – Opening Remarks
09.30 | 6.30 – 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
10.00 | 7.00 Decentralized ctDNA Liquid Testing Bringing Treatment Decisions Closer to the Patient
Synopsis
- Examining the paradigm shift from centralized NGS testing to a decentralized global testing model
- Current global market access challenges for comprehensive genomic profiling
10.30 | 7.40 – Liquid Lessons Learned From 2020 – Regulatory, Supply Chain, Payer & The Patients
Synopsis
- Reflecting on recent FDA approvals– What are the key regulatory considerations for liquid biopsy
companion diagnostic tests? - Liquid biopsy application is making signification contribution in cancer care seen by patients, but what challenges need to be overcome and knowledge gaps filled to support future liquid biopsy applications?
- What can we learn from recent supply chain disruptions resulting from the coronavirus pandemic to reduce delays in diagnostics reaching patients
- Tying together key considerations for liquid biopsy development and integration into therapeutic
programmes, and the importance of keeping regulatory, supply chain, payer & the patient priorities front of mind from the beginning
11.15 | 8.15 – Speed Networking Break
11.45 | 8.45 – Establishing the Analytical Validity of Circulating Tumor DNA Sequencing for Precision Oncology
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
12.15 | 9.15 Power of Tumor-Informed and Personalized Assays to Drive High Sensitivity
Synopsis
• Why personalized tumor-informed assays optimize sensitivity and specificity
• Latest publications and data including IMvigor 010
• What clinical trial designs are possible with a personalized tumor-informed assay
12.45 | 9.45 Expanding Access to Precision Medicine Using Liquid Biopsies
Synopsis
- The use of liquid biopsies as part of a precision medicine initiative
- Clinical utility of liquid biopsies in patients with NSCLC
- Enabling access to liquid biopsy testing through national distribution channels
13.15 | 10.15 – Networking Break – Whilst Enjoying a Bite to Eat, You Can Take Part In:
Synopsis
- 121 Pre-Scheduled Meetings With Our Event Partners: Take part in 1:1 networking with market leaders pioneering exciting advances in the liquid biopsy space
- Group Networking: Join your fellow attendees for group discussions reflecting on the morning’s topics. Collaborate and connect to consider applying new ideas and innovations to propel your pipelines forward.
13.45 | 10.45 Panel Discussion: Global Market Access To Liquid Biopsies
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
14.15 | 11.15 Circulating Tumor Cells as Liquid Biopsy: From Discovery to Clinical Implementation
Synopsis
- How to detect and analyze single viable CTCs ?
- Clinical relevance of CTCs: the example of PD-L1 in Onco-immunology
- Challenges to establish CTC lines from metastasis-competent CTCs in colon cancer
14.45 | 11.45 Liquid Biopsy Assay Screening : A Payor’s Perspective
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?
15.15 | 12.15 Panel Discussion: Implementation and Validation of a Next Generation Sequencing Liquid Biopsy Assay for Confirmatory Testing
Synopsis
• Use of liquid biopsy assays in your testing strategy
• Common challenges and considerations in analytical validation
• Exploring differences in validation approaches