*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

  • Matt Nelson Senior Director, Companion Diagnostic Partnering , Illumina

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

  • Jami DeBrando- Palumbo Senior Vice President, Foundation Medicine
  • Darren Hodgson Global Project Leader and Site Head Translational Medicine , AstraZeneca Oncology
  • Daniel Simon Senior Vice President, BioPharma Business Development , Guardant Health
  • Mark Stewart Vice President, Science Policy , Friends of Cancer Research
  • Luca Quagliata Vice President, Global Head of Medical Affairs , Thermo Fisher Scientific
  • Debra Rasmussen Global Regulatory Affairs Diagnostic / Digital Leader, Janssen

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

  • 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

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

  • Taylor Jensen Strategic Director, Research and Development , Labcorp

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

  • 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?

15.15 | 12.15 Panel Discussion: Implementation and Validation of a Next Generation Sequencing Liquid Biopsy Assay for Confirmatory Testing

  • Kelli Bramlett Director R&D, Thermo Fisher Scientific
  • Umberto Malapelle Assistant Professor of Anatomic Pathology, Department of Public Health, University of Naples Frederico II
  • Geoffrey Bien Manager, Analytical Validation Services, Thermo Fisher Scientific
  • Meredith Berry Director, Lab Operations and Pharma Services , NeoGenomics Laboratories

Synopsis

• Use of liquid biopsy assays in your testing strategy
• Common challenges and considerations in analytical validation
• Exploring differences in validation approaches

15.45 | 12.45 – Chair’s Closing Remarks

  • Elizabeth Attias Chief Strategy and Development Officer , Sermonix Pharmaceuticals

15.50 | 12.50 – End of Day Three & Networking