April 6, 2023

Welcome to hubXchange’s East 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


  • Precision medicine in oncology drug development
  • Biomarkers for ADC drugs
  • Implementation challenges in getting from bench to bedside
  • Designing impactful CDx strategies for early clinical development of new IO and cell therapies
  • Is there a defined CDx strategy: Centralized vs decentralized model
  • Exploring Laboratory Developed Test (LDT) vs distributed kit approach
  • Using MRD to develop patient stratification approaches through tumor-informed or tumor-naive comprehensive insights
  • Exploring liquid biopsies for advanced clinical trials
  • Consideration of liquid biopsy implementation in next generation CDx in solid tumors

Full Xchange Agenda

Click on each track for detailed agenda

Clinical Biomarkers

Titles and Bullets
08:00 – 08:30
08:30 – 09:00

Opening Address & Keynote Presentation
Harnessing AI to develop better diagnostic algorithms

Artificial Intelligence (AI), and specifically machine learning (ML, a subset of AI), increasingly is being applied across the healthcare landscape. ML has become an essential tool in biomarker discovery, and promises to play a major role in diagnostic development. The adoption of ML in diagnostics and clinical decisions is not without risks, namely the potential to exacerbate existing biases that characterize patient datasets. On the other hand, ML also can be deployed to identify and mitigate these very same biases. Industry advocacy organizations, public-private dialogue, and informed policy-making are required to ensure the responsible adoption of AI/ML in healthcare.

Chief Executive Officer, Co-founder, Genialis

Rafael is CEO/co-founder of Genialis, a computational precision medicine company unraveling complex biology to find new ways to address disease. Rafael sits on the Board of the Alliance for AI in Healthcare. He earned his doctorate at Yale, and conducted postdoctoral research at LBNL and Baylor College of Medicine.

Rafael Rosengarten
09:05 – 10:05

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 Group Head of Translational Science Leaders at Bayer. Her team are responsible and accountable for the Integrated Translational Sciences strategy, orchestrating Precision Medicine strategy, Clinical Pharmacology strategy and Computational Biology, delivered to all Oncology projects at Bayer. Before the current role, she led the Immuno Oncology (IO)Precision Medicine group, overseeing Biomarker and CDx strategy across various stages of IO development. 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 Oncology. 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 – 10:40
1-2-1 Meetings/Networking Break
10:40 – 11:10
1-2-1 Meetings/Networking Break
11:10 – 11:20
Morning Refreshment Break
11:20 – 12:20

Developing CDx from complex signatures: promise, practice and pitfalls

  • Benefits and risks of developing CDx based on more complex analytes and signatures
  • Challenges of translating signatures from research to the clinic
  • Getting the most from RNA-seq in a clinical application
  • The future of multi-omics and multi-modal data in diagnostics

Chief Executive Officer, Co-founder, Genialis

Rafael is CEO/co-founder of Genialis, a computational precision medicine company unraveling complex biology to find new ways to address disease. Rafael sits on the Board of the Alliance for AI in Healthcare. He earned his doctorate at Yale, and conducted postdoctoral research at LBNL and Baylor College of Medicine.

Rafael Rosengarten
12:20 – 13:20
Networking Lunch
13:20 – 13:50

Spotlight Presentation
Immunotherapy with or without chemotherapy for advanced stage lung cancer? miRisk provides the answer.

Patients with advanced-stage NSCLC and high PD-L1 expression are eligible for treatment with immunotherapy, however there is debate as to who requires additional chemotherapy. Using an immunotherapy treated, advanced-stage NSCLC cohort, we have defined a blood-based biomarker (miRisk) specifically predictive of response to immunotherapy. miRisk is a myeloid-predominant, 5-microRNA signature, with predicted interactions to immunotherapy pathways including PD-L1 signaling.

miRisk may serve as a complementary diagnostic to objectively guide treatment in advanced-stage NSCLC, or more generally as a signature of non-response to PD- (L)1 monotherapy for multiple uses including the enrichment of patients for novel ICI combination trials.”


Vice President, Medical Sciences, Hummingbird Diagnostics

Timothy Rajakumar leads the immunotherapy biomarker development at HBDx. Prior to this he completed his Academic Foundation training at Oxford University Hospitals, making contributions to spatial transcriptomic analyses of prostate cancer. He gained expertise in small RNA biology during his Ph.D. studies in synthetic biology at the University of Oxford.

Timothy Rajakumar
13:55 – 14:25
1-2-1 Meetings / Networking Break
14:25 – 14:55
1-2-1 Meetings / Networking Break

15:00 – 16:00

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.

Rick Chu
16:00 – 16:10
Afternoon Refreshment Break
16:10  17:10

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
17:10 – 18:10
Evening Drinks Reception

Lead Partner


Oncology Companion Diagnostics Xchange | East Coast 2023