7:00 am
Registration & Morning Coffee

7:55 am
Chair’s Opening Remarks

Elevating the Value of Diagnostics through Technology Innovations to Drive Clinical Development

8:00 am Value of Diagnostics in Drug Development – A Case Study in Multiple Myeloma (MM)


  • Identifying the genomic complexity of MM using diagnostics
  • Development of a novel CDx for MM treatment
  • Elevating the CDx value by incorporating novel technologies in MM testing

8:20 am Rapid, Decentralized NGS: CDx for the Future

  • Scott Myrand Director, Diagnostic Partnering, Clinical Next- Generation Sequencing, Thermo Fisher Scientific


  • Decentralized NGS provides a fast and easily accessible diagnostic solution to labs in more countries
  • Automated NGS solutions from Thermo Fisher Scientific provide a turnaround time as short as 1 day
  • Thermo Fisher Scientific has proven track record in NGS CDx development, establishing partnerships with pharmaceutical companies since 2015

8:50 am Accelerate Clinical Biomarker Development & Commercial Success with Accessible Liquid Biopsy Testing

  • Dejan Knezevic Senior Director Business Development, Guardant Health


  • Harness epigenomic insights for more effective cancer therapies: Identify the right patients and improve therapeutic response
  • Building the flexible CDx strategies and accelerating commercial success with data-driven insights
  • Expanding global access for clinical trials and liquid biopsy testing

9:20 am A New Paradigm Shift of Biomarker Innovation to Accelerate Oncology Clinical Development & Real-World Utilization of Novel Therapeutics

  • Zhen Su Chief Executive Officer, Marengo Therapeutics


  • Understanding the need for biomarkers to assist clinical development across different disorders
  • Translating biomarker development into patient benefit
  • Finding different treatment modalities through understanding the mutations and the biomarkers suitable for targeting oncology
  • Addressing the value proposition of CDx

9:40 am Leveraging Broad Adoption of the Signatera MRD Assay to Accelerate Clinical Development

10:10 am From Clinical Trials to Personalized Medicine: Harnessing navify Digital Technology to advance clinical Breakthroughs in Oncology and Neurology


  • Leverage Longitudinal Data and Insights, build confidence in crucial data and provide clarity for patients while optimizing engagement
  • Learn more about navify’s open Ecosystem approach; Digital Pathology, AI and Data Driven innovations
  • Explore the Benefits and impact of digital biomarker solutions in Neurology

10:40 am
Networking Break

Track A: Biomarker Discovery & Translational Development

  • Laura Lasiter Director, Translational Regulatory Affairs, Digital Health, AstraZeneca

Examining Trends in Spatial & Multimodal Modelling to Transform Biomarker Discovery

11:30 am Exploratory AI Pipeline to Identify Biomarkers in the Tumour Micro Environment Using Spatial Transcriptomics

  • Mario Flores Assistant Professor, Department of Electrical and Computer Engineering, University of Texas


  • Development of a computational pipeline for screening biomarkers in NSCL cancer
  • Development of strategy to increase details of the molecular composition of the TME using high-resolution spatial transcriptomic
  • Outlining the novel and innovative technologies to study heterogeneity in NSCLC

11:50 am Set Yourself Up for Success: Achieve More with Better Antibodies


  • Passionate about solving the ‘reproducibility crisis ’abcam has performance data available for antibodies used in research and clinical development programs. Our aim is to remove uncertainty and guarantee reproducible results with our proprietary, recombinant rabbit monoclonal portfolio.
  • In this presentation, abcam will present the industry-leading progress they have made to create highly validated and consistent antibodies. It will cover the implementation of biophysical quality control processes, knock-out and enhanced validation into their antibody portfolio. These quality commitments guarantee reproducible results, increase confidence and reduce risk for researchers and clinical development applications.
  • As a result, biopharma customers can be assured that they are selecting antibody tools that will support biomarker programmes from the outset and through to clinical trials. Abcam’s research products are the right choice at the start of something new. Because what starts well, ends well

12:20 pm Utilizing Multimodal Network-Driven Biomarker Discovery for Alzheimer’s Disease Diagnosis & Monitoring

  • Satya Saxena Director, Global Proteomics, Clinical Pharmacology and Translational Medicine, Eisai


  • Building modules of co-expressing proteins linked to various biological functions, organelles and specific cell types to facilitate network-driven biomarker discovery
  • Identifying novel proteomic alterations to help in deeper understanding of disease heterogeneity and pathophysiology of neurodegeneration
  • Developing biomarker signature(s) to facilitate clinical management of Alzheimer’s disease through precise disease staging and prediction of disease progression, response to treatment, and adverse effects.

12:40 pm Challenges in Biomarker Discovery: How to Avoid Missing Information About any New Biomarker Discussed in Literature and Patents


  • Perform complex and time-consuming scientific literature analysis in a real time 
  • Discover all proteins related to your specific disease setting
  • Get comprehensive insights driven by the biggest protein ontology in the field (more than 6M concepts and synonyms) 
  • Get aware about new biomarkers discussed in patents but not literature yet, and vice versa

Track B: Clinical Biomarker Development

  • Minakshi Guha LBx Strategy Lead, Companion Diagnostics, Takeda Pharmaceuticals

Defining & Identifying Patient Populations Using Biomarker Data to Validate Clinical Development

11:30 am Claudin18.2 Identifies a Previously Undefined Patient Population with Gastric/GEJ Cancer

  • Robert Getzenberg Medical Director, Diagnostics, Oncology, Astellas Pharmaceuticals


  • Claudin 18.2 is a tight junction protein that during transformation is retained and exposed for detection
  • Claudin 18.2 can be detected by IHC and is prevalent in a significant percentage of patients 
  • The biomarker Claudin 18.2 may guide treatment decisions in these patients

11:50 am Applying Learnings to Reimagine Biomarker Targets and Technologies that Drive Greater Patient Access


  • Increasing potential patient populations by exploring technology across standard, multi-omic and advanced therapy development platforms
  • Enhancing patient access to precision medicine with unique biomarkers beyond traditional targets
  • Driving greater patient access within oncology and expanding therapeutic indications including neurology, renal disease and NASH

12:20 pm Delving into Biomarker Selection & Validation for Clinical Use

  • Pratiksha Gulati Senior Scientist & People Enabler, Biomarkers & Bioanalytics, Roche


  • Gain valuable insights from a case study that sheds light on the process of biological CoU driven qualification of biomarkers
  • Employ the context of use as a guiding factor for making informed decisions regarding technology selection and method validation

12:40 pm Enabling Precision Medicine Through Digital Pathology

  • Tom Turi Chief Science Officer, Flagship Biosciences


  • Expanding the repertoire of biomarkers for patient stratification
  • Implementing digital pathology as an integral component of clinical trials
  • Validation of digital pathology solutions

Track C: CDx Development & Commercialization

  • Eugean Jiwanmall Senior Analyst - Research, Medical Policy & Technology Evaluation, Independence Blue Cross

Bridging Data Approaches to Achieve Faster Screening & Diagnosis for Accelerated Precision Medicine Treatments

11:30 am Leveraging Novel Newborn Whole Genome Sequencing to Enable Screening & Diagnosis of Disease

  • Thomas Defay Deputy Head, Diagnostics Strategy and Development, Alexion, AstraZeneca Rare Disease


  • Accelerating treatment of over 500 diseases by leveraging newborn sequencing technologies
  •  Achieving faster molecular diagnosis using whole genome sequencing
  • Bridging bioinformatics, data science, genomics and molecular sciences to bring newborn screening practices up to speed

11:50 am Accelerating Companion Diagnostics Development with Digital Pathology and AI

  • Hisani Madison Franchise Head of Precision Oncology, PathAI
  • Scott Ely Senior Scientific Director, Translational Pathology, Translational Sciences and Diagnostics/Translational Medicine/R&D, Bristol Myers Squibb
  • Pascal Bamford Senior Vice President, Research and Development and Laboratory Operations, Akoya Biosciences
  • Douglas P. Clark Chief Pathologist, Companion Diagnostics, Agilent Technologies


Moderator: Douglas P. Clark, MD, Chief Pathologist, Companion Diagnostics, Agilent

  • Addressing biopharma 'pain points' in CDx development with AI to improve efficiency and efficacy
  • Defining regulatory pathways/strategies for CDx/AI co-development
  • Utilizing multiplexing and image analysis to enhance precision diagnostics

12:20 pm Federated Data Approaches To Solve Precision Medicine Data Access Needs

  • Tine Lewi Senior Director, Platforms & Partnerships, Global Commercial Data Science, Janssen


  • Enabling precision medicine with multimodal data (omics/ nonomics) and privacy-preserving analytic methods
  • Delving into the complexities of forming public/private federated data networks for precision medicine
  • Why and when do we need a federated data approach for precision medicine

12:40 pm Keeping the Promises of Early Discovery Through the CDx Development Stages


  • Successfully delivering co-commercialisation & full sample journey traceability across global CDx launch.
  • Optimizing the IVD journey from RUO to CTA and CDx delivery to ensure assay robustness and effective CDx use
  • Stemming from targeted biomarker selection processes through consecutive exploratory rounds, highlighting how advanced technologies contribute to effective downstream project delivery.
  • Exploring the relevance of large-scale biomarker screening to accelerate translational developments of targeted Biomarker signatures for new therapies in selected cohorts.  

12:50 pm
Networking Lunch & Tech Demo

Evaluating the Promise of Multi-Omics in Revolutionizing Biomarker Data for Precision Medicine

1:50 pm Exploring Parallel & Drug-Dx Co-Development to Shape Effective Therapeutic Models

  • JD Schonhoft Senior Principal Scientist, Clinical Biomarker Lead, Repare Therapeutics


  • Understanding the implications and complexity of DDR loss of function 
  • Discussing the impact and challenge identifying DDR reversions in patients treated with next generation DNA repair inhibitors 
  • Next generation liquid biopsies for monitoring and diagnosing DDR LoF and resistance

2:10 pm Ultra-Sensitive Tumor-Informed ctDNA Monitoring of Molecular Residual Disease (MRD) & Response to Immunotherapy in the Advanced Disease Setting


  • Ultra-sensitive ctDNA assays are required for accurate classification of patient MRD status and treatment monitoring
  • Low ctDNA levels are commonly observed, even in late stage disease, with positive ctDNA detections in these studies occurring as low as 2.3 PPM
  • Detections down to low PPM levels correlate strongly with RECIST-derived classifications of response

2:40 pm Comprehensive Proteomics to Advance Biomarker Discovery & Validation for Precision Medicine

  • Towia Libermann Associate Professor of Medicine, Beth Israel Deaconess Medical Center & Harvard Medical School


  • Sharing our extensive experience with aptamer-based SomaScan proteomics of 7,000 proteins to accelerate novel biomarker discovery and translation to clinic
  • Addressing challenges in biomarker discovery when using population cohorts 
  • Recent development of non-invasive predictive protein biomarker signatures for early detection of cancer and therapeutic response efficacy 

3:00 pm Enabling Clinical Uptake of Higher-Plex Technologies in IHC/ISH


• Multiplex immunohistochemistry and in situ hybridization assays are used in early therapeutic development and are becoming increasingly pervasive within the diagnostic workflow

• More complicated clinical questions are arising that may require multi-omics-based clinical diagnostic assays

• Issues in translating diagnostic data from preclinical to translational to clinical use

• Transition points of the diagnostic strategy from translational and clinical therapeutic development stages to include system considerations, clinical trials, and regulatory considerations

• Future challenges & opportunities in Spatial biology to support a goal of a better precision medicine approach

More Speakers to be Confirmed, Leica

Utilizing Novel Tools & Technologies to Drive Diagnosis & Validation

1:50 pm Transforming Clinical Trials with Urine Assay Technology: A Promising Solution

  • Michelle Quiroz Scientific Director, Oncology Precision Medicine & Diagnostics (O-PMDx), Janssen Global Services, LLC


  • Detection in urine provides a non-invasive screening approach and mitigates certain challenges with tissue testing
  • Early detection with urine-based assays in bladder cancer can lead to earlier treatment, better patient outcomes, and potentially a higher chance of cure
  • Tumor markers in urine can also be utilized for disease monitoring and longitudinal response to treatment
  • Urine offers rapidity, simplicity, and sensitivity in the mission of personalized medicine in bladder cancer

2:10 pm Greater Precision in Targeted Therapy and Immunotherapy through Blood-Based Biomarkers


  • Enhancing clinical trials and treatment plans by integrating blood-testing alongside tissue-testing for a comprehensive and robust biomarker strategy
  • Harnessing liquid biopsy to identify patients for personalized treatment, targeted therapies, and clinical trials
  • Leveraging ctDNA for dynamic monitoring of treatment response, providing valuable real-time insights for personalized care
  • Learnings and advancements from recent collaborations in the biopharmaceutical industry

2:40 pm Panel Discussion: Harnessing AI/ML in Clinical & Diagnostic Workflows to Bring Biomarkers to the Clinic & Validate Them

  • Carl Barrett Vice President, Translational Science & Oncology, AstraZeneca
  • Zheng Feng Director, EMD Serono
  • Dishant Kalra Head of Precision Medicine, Astellas Pharmaceuticals
  • Scott Reid Vice President & Global Head of Diagnostics, Sophia Genetics


  • Analyzing how AI/ML can be exploited to diagnose disease early onscreen and diagnose disease 
  • Spearheading biomarkers to the clinic using AI/ML approaches
  • Understanding the art of validating biomarkers using AI/ML 

3:00 pm 3D Genomic Liquid Biopsy: Predictive, Prognostic & Diagnostic Biomarkers; From Immuno-Oncology to Early Screening of Populations at Risk


  • EpiSwitch® 3D Genomic blood-based platform: from fundamental epigenetic biology to systemic clinical biomarkers for disease diagnosis, prognosis and prediction of treatment response;
  • EpiSwitch CiRT (Checkpoint Inhibitor Response Test): Highly sensitive clinical blood test for prediction of systemic response to PD-1/-L1 immune checkpoint inhibitors;  
  • EpiSwitch PSE (Prostate Screening Test): novel, highly accurate, multivariant clinical blood test combining PSA with EpiSwitch biomarkers for  a breakthrough in prostate cancer screening

Exploring Parallel & Drug-Dx Co-Development to Shape Effective Therapeutic Models

1:50 pm Understanding the Current Regulations Underpinning Clinical Trials Harnessing CDx Tests for Clearer Guidelines on the Tests

  • Sid Mathur Executive Director, Regulatory Affairs & Companion Diagnostics, Merck & Co


  • Providing clarification on the regulatory status of CDx assays in clinical trials
  • Shifting attention to the regulations pertaining tests run in clinical trials – why is it important
  • What are some approaches used for biomarker testing in clinical trials and how do they pave the way for market access

2:10 pm Flow Cytometry for Patient Selection Assays, MRD, & CDx

  • Scott Bornheimer Associate Director, Biomarkers & CDx, Medical & Scientific Affairs, Medical Affairs, BD Technologies


  • Understand the rationale and utility of flow cytometry for patient selection, MRD, and CDx
  • Deep dive on MM-MRD
  • Learn about capabilities for global commercialization of IVD, IVDR, and CDx flow cytometry assays

2:40 pm Panel Discussion: Streamlining the Design & Implementation of Co-Development Plans to Shape Therapeutic Effectiveness

  • Aastha Kohli Senior Director, Global Regulatory Affairs, Precision Medicine Diagnostics, Gilead
  • Matt Houliston Senior Director, Diagnostic Marketing and Precision Medicine, Mersana Therapeutics
  • Elaine Joseph Director, Precision Medicine, Bristol Myers Squibb
  • Joseph Ferrara Chief Strategy Officer, Veranex


Moderator: Joseph Ferarra, Chief Strategy Officer, Veranex

  • Highlighting current challenges and on going efforts to address drug-DX development
  • Exploring the regulatory challenges of using multiple CDx from patient perspectives
  • Assessing the impact of co-development on patient trial design

3:00 pm Fireside Chat: Pharma Perspectives on the Past, Present and Future of Cancer Diagnostics


  • Past successes and future challenges
  • Promising technologies and solutions on the horizon
  • Data that supports your excitement
  • Advice for Pharma-Diagnostics collaborations

3:30 pm
Afternoon Networking Break

Supporting the Application & Certification of Novel Diagnostic Tests to Accelerate Clinical Adoption & Development of CDx

  • Eugean Jiwanmall Senior Analyst - Research, Medical Policy & Technology Evaluation, Independence Blue Cross

4:00 pm HER2 Stratification with a Novel Diagnostic Test


  • Discovering the potential of the APiS Breast Cancer Subtyping Kit for faster HER2 result turnaround without the need for reflex testing to iSH
  • Learning how to significantly reduce time for results interpretation with automatic results via validated software
  • The detection ability of lowly HER2 Stratification with a Novel Diagnostic Test
  • HER2 Stratification with a Novel Diagnostic Test

4:30 pm Liquid Biopsy in Precision Oncology

  • Jonathan Beer Senior Director Diagnostic Sciences, Bristol Myers Squibb


  • Successful implementation of Precision Medicine requires accurate and timely biomarker data to inform patient treatment strategies and although tissue remains the gold standard, liquid biopsy testing has many intrinsic advantages
  • The US FDA has approved 5 Companion Diagnostic with plasma as the sample type for use in identifying patients eligible for 15 unique precision medicine therapeutics across multiple solid tumor cancers including tumor agnostic and group class approvals and new applications such as molecular residual disease monitoring and early cancer detection are in development Barriers preventing greater use of liquid biopsy in clinical practice and what it will take to overcome them for increased patient benefit will be discussed

4:50 pm Biomarkers & Assays: A Landscape Review in Lung Cancer


  • An overview of the preclinical and clinical lung cancer biomarker landscape
  • A breakdown and analysis of the current lung cancer assay landscape
  • A review of the current regulatory landscape for lung cancer biomarkers and assays

5:20 pm Providing Clarity on the IVDR CDx Procedure: Lessons from the First CDx Product Certification

  • Anthony Kanavage IVD Product Assessment Regional Team Manager & Product Expert, TUV SUD Americas


  • Background on IVDR and differences in CDx definition between IVDR and US FDA
  • Summary of process
  • Key points & experience from the first CDx Product Certification
  • Partnerships between IVD manufacturers and Notified bodies to accelerate CDx Product Certification

5:40 pm Utilizing Liquid Biopsies for Women’s Health Diagnostics & Cancer Screening


  • Development of diagnostic and screening tests for ovarian and endometrial cancer
  • Development of a diagnostic test for pelvic pain and infertility-related conditions
  • Outlining the novel and innovative technologies in detecting non-blood-based biomarkers

6:00 pm AI/ML Enabled Precision Pathology in Drug Development  – Bridging Clinical Practice & Development  

  • Qing Li Director of Clinical Pathology, Moderna

6:20 pm
Chair’s Closing Remarks & End of the 13th Clinical Biomarkers & CDx Summit Boston

  • Eugean Jiwanmall Senior Analyst - Research, Medical Policy & Technology Evaluation, Independence Blue Cross