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8:50 am Chair’s Opening Remarks

Executing Clinical Trials to Effectively Prove the Clinical Utility of Liquid Biopsy & Inform Patient Treatment Decisions

9:00 am Demonstrating Clinical Utility of Blood Testing

  • Sarah Paul Principal Scientific Researcher & Biomarker Lead , Genentech

Synopsis

• Genentech’s innovative BFAST trial: Goals, design, and future directions of a blood-only 1L NSCLC trial

• Clinical results from BFAST Cohort A: Blood-identified ALK+ patients treated with alectinib

9:30 am Early Monitoring of cfDNA in Lung Cancer: What Can We Learn from the ALK+ NSCLC case?

  • Jean-Francois Martini Senior Director, Translational Oncology & Lead, Global Product Development , Pfizer

Synopsis

• Decreased cfDNA dVAF at 6 weeks was associated with response

• Deeper decreases in cfDNA dVAF at 6 weeks were associated with more prolonged PFS and OS

• Early cfDNA dynamics may predict lorlatinib efficacy in ALK-positive metastatic NSCLC

10:00 am Morning Refreshments

10:30 am Liquid Biopsy in the Clinic: Lessons from Use in Clinical Care & Clinical Trials

  • Mark Routbort MD, Professor, Hematopathology , University of Texas MD Anderson Cancer Center

Synopsis

• Become familiar with the ‘compartment of origin’ challenge for liquid biopsy interpretation

• Compare sensitivity and positive predictive value considerations for liquid biopsy

• Review established and emerging genomic mechanisms of resistance for targeted therapy for solid tumors and the ability of liquid biopsy to detect them

11:00 am Session Q+A

  • Sarah Paul Principal Scientific Researcher & Biomarker Lead , Genentech
  • Jean-Francois Martini Senior Director, Translational Oncology & Lead, Global Product Development , Pfizer
  • Mark Routbort MD, Professor, Hematopathology , University of Texas MD Anderson Cancer Center

Synopsis

Bringing together the perspectives of the session’s expert speakers, this is your chance to challenge viewpoints, ask any pending questions or bring new discussion points key to advancing clinical trial design, execution and clinical utility demonstration.

• How can we maximize patient enrolment in large clinical trials?

• Exploring strategies to navigate the analysis of large datasets to analyse relevant, applicable data and draw actionable conclusions to prove utility

• What lessons have been learned from published or unpublished comparative trials to inform end-end drug development?

• Establishing a set of minimal reporting and analysis criteria to be introduced to better understand your study’s quality

12:00 pm Networking Lunch

Meeting the Needs of the Clinician to Improve Patient-Centricity & Standard of Care

1:30 pm The Oncologist Perspective: Exploring Current Limitations to Implementing & Utilizing Liquid Biopsy in the Clinic

  • Howard Scher Co-Chair, Head, D. Wayne Calloway Chair & Attending Physician , Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College

Synopsis

• Real-world examples on how liquid biopsy has aided patient diagnosis and monitoring

• Moving away from the “gold-standard” of tissue biopsy: Exploring healthcare’s hesitations

• What’s required?: Discussing how healthcare and developers can navigate existing challenges from education to complex price challenges

2:00 pm Reducing Liquid Biopsy Results to (Routine) Clinical Practice

Synopsis

• Liquid Biopsies have become the preferred sample type in treatment decisions formany cancer patients

• Interpretation of Liquid Biopsy results remain problematic for many technical and administrative reasons, delaying a more rapid uptake for clinical decision-making

• The early results reported here are from an FNIH Consortium to validate commercial ctDNA control material to FDA-requirement levels, enhancing confidence in ctDNA results

2:30 pm Roundtable Discussion: Liquid Biopsies In the Clinic

Synopsis

• How are perceptions on liquid biopsy beginning to shift in healthcare? Where does future opportunity lie?

• Is liquid biopsy becoming more widely accepted in pathology?

• How do we combat the cost challenges associated with large randomized clinical trials?

• How can effective partnerships and wider industry advancements help drive patient-centricity in personalized therapeutics?

3:30 pm Chair’s Closing Remarks & End of 4th Liquid Biopsy for Precision Oncology Summit 2020