ONCOLOGY COMPANION DIAGNOSTICS XCHANGE
EAST COAST
Boston
April 5, 2023​

Welcome to hubXchange’s West Coast Oncology Companion Diagnostics Xchange 2023, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing oncology companion diagnostics.

Discussion topics will cover Clinical Biomarkers, Clinical Development, Liquid Biopsies and Next Generation CDx.

Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Venue Details: Hilton Boston Woburn Hotel, 2 Forbes Road, Woburn MA 01801

Clinical Biomarkers

Time
Titles and Bullets
Facilitator
8:00 – 8:30am
Registration 
8:30 – 9:00am

Opening Address & Keynote Presentation

9:05 – 10:05am

Precision medicine in oncology drug development

  • Decision Enabling Biomarkers
    • Patient Enrichment Strategies
    • Proof of Mechanism
  • Tools to deliver Decision Enabling Biomarkers (e.g. Reverse Translation; Digital Pathology, Radiomics and AI/ML; Real World Omics Data)

Vice President, Immuno Oncology Precision Medicine, Bayer

Amanda Wang is the Vice President and head of Immuno Oncology Precision Medicine at Bayer. Her team is responsible for Biomarker and CDx strategy across various stages of IO development, from target identification & validation to early development, late development and life cycle management. Before joining Bayer in 2019, Amanda worked at Novartis for over nine years, where she focused on biomarker development in autoimmune, Oncology and additional disease areas. Amanda has in-depth experience of translational science and clinical development in IO. Amanda received an PhD degree in Biochemistry and Molecular Biology from the University of Virginia. She also received a Master degree in Biostatistics from Boston University.

Amanda Wang
10:10 – 10:40am
1-2-1 Meetings/Networking Break
10:40 – 11:10am
1-2-1 Meetings/Networking Break
11:10 – 11:20am
Morning Refreshment Break
11:20am – 12:20pm

Sponsor-led Roundtable

12:20 – 1:20pm
Networking Lunch
1:20 – 1:50pm

Spotlight Presentation

1:55 – 2:25pm
1-2-1 Meetings / Networking Break
2:25 – 2:55pm
1-2-1 Meetings / Networking Break

3:00 – 3:30pm

Poster Session

3:30 – 3:45pm
Afternoon Refreshment Break

3:45 – 4:45pm

Biomarkers for ADC drugs

  • ADC targets in solid tumor vs liquid tumor
  • Target expression level vs efficacy
  • Target mutation status
  • ADC resistance mechanism
  • ADC combination therapy

Senior Director, Translational Medicine, Cogent Biosciences

Dr. Chu has more than 20 years of research and development experiences in the pharmaceutical
industry. He joined Sanofi in 2000, headed research teams in proteomics, anybody drug discovery, biomarker and clinical bioanalysis. He proposed several novel drug targets and led successful antibody discovery programs, including IL33 currently in clinical phase 3. His team was instrumental in the FDA approval of Hydrashift 2/4 isatuximab CDx. Before joining Cogent, he headed the clinical biomarker team at Luzsana Biotech (Hengrui USA), supported anti-Her2, -Her3, -Trop2, and -Claudin 18.2 antibody drug conjugate (ADC) clinical development programs.

Photo_Oscar Segurado_N1c
4:50  5:50pm

Implementation challenges in getting from bench to bedside

  • Can a clinical biomarker hypothesis be generated during early during drug discovery? What are the challenges associated with the use of pre-clinical models to test biomarkers of response and/or efficacy in human clinical trials?
  • How can analytical validation of testing methodology be achieved to generate uniform and consistent data across subjects? Turnover times from sample collection to assay analysis leading to outputs? How to regulate pre-analytics of sample collection and sample handling prior to biomarker analysis?
  • Can Clinical Trials be designed to generate proof of concept data for an exploratory biomarker? Is the clinical validation of biomarker prone to fluctuations due to patient heterogeneity, timepoints and drug pharmacology? Can real world evidence data help?
  • Do we need extensive clinical data to establish full clinical utility? What are the challenges associated with transition into CDx? Regulatory hurdles?”

Director of Biology, Pre-Clinical and Translational R&D, Partner Therapeutics

Ila Joshi
5:50 – 6:50pm
Canape / Drinks Reception

Lead Partner

Partners

Oncology Companion Diagnostics Xchange | East Coast 2023
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