Our Biomarkers & Diagnostics Ecosystem: Moving Treatments Towards Target Populations

7:50 am Chair’s Opening Remarks

8:00 am Translational Case Study: Translational Development of IACS-6274, a Potent and Selective Glutaminase (GLS1) Inhibitor in Phase 1 Trials for Molecularly-Defined Subsets of Patients with Advanced Solid Tumors

  • Tim Heffernan Executive Director, Oncology Research, MD Anderson Cancer Center- Translational Research to Advance Therapeutics & Innovation in Oncology
  • Kashyap Patel President, Community Oncology

Synopsis

  • IACS-6274 is a potent, selective inhibitor of GLS1, that has excellent physicochemical properties and demonstrates selective anti-tumor effects in subsets of ovarian cancer and non-small cell lung cancers
  • Through a comprehensive translational effort, we uncovered a reliance on GLS1 driven by unique cellular dependencies and identified clinically actionable patient stratification biomarkers
  • An integrated approach that leverages translational and clinical research at MD Anderson Cancer Center allowed for the successful development and deployment of these biomarker strategies in our Phase 1 clinical trial of IACS-6274

8:30 am The Rapid Expansion of Companion Diagnostics is Impacting Us All – How Roche is Transforming in Response

Synopsis

  • For pharmaceutical and diagnostics providers alike, the world of CDx is undergoing massive changes – new regulatory rules, new technologies, shorter time to response
  • Roche is responding with bold steps to meet the demands of this new era in precision medicine

9:00 am Practical Strategies for Implementing an Effective Neurodegenerative Biomarker Program into Your Clinical Trial and Diagnostic Transition

Synopsis

  • Deploying the right biomarkers, platforms, technology and reagents to drive context-of-use appropriate data delivery
  • Leveraging new biomarkers, platforms, strategies in Alzheimer’s Disease clinical trial design
  • How effective biomarker strategies utilized during drug development can inform future clinical care
  • Partnering models for drug/CDx co-development

9:30 am Equity & Diversity in Precision Medicine: Better Drugs for Disease Heterogeneity in Diverse Populations

  • Kashyap Patel President, Community Oncology
  • Kaye Foster Senior Advisor & Executive Coach, The Boston Consulting Group (BCG)

Synopsis

  • Highlighting societal healthcare disparities and the precision medicine opportunity to better treat diverse populations
  • Accessibility to precision medicines
  • Connecting the community, from regulatory, diagnostic and biopharma standpoint, on improving access to better, more varied, precision medicine

10:00 am Speed Networking Break

Moving Biomarkers Towards the Clinic

Moving the Needle in Immuno-Oncology

10:30 am Reliable & Accurate TMB Measurements by NGS Panels for Precision Oncology

  • Joshua Xu Branch Chief, National Center for Toxicological Research, US Food & Drug Administration

Synopsis

  • The development and use of reference samples to benchmark oncology panels, estimate TMB, and make
    reproducible findings
  • Comprehensive assessment of reproducibility and accuracy of TMB measurements
  • Recommendations for developing and validating oncology panels for TMB biomarker

11:00 am Can Investigating the Tumor Microenvironment Help Better Understand Disease Drivers & Response?

  • Travis Hollman Dermatopathologist Memorial Sloan, Kettering Cancer Center

Synopsis

  • Primary and secondary resistance to IO therapies derives from tumor-intrinsic factors and the complex interplay between cancer and its microenvironment
  • Can research leading to alteration in the microenvironment identify novel approaches to improve immunotherapy outcomes?

11:30 am Innovative Biomarker Whole-Slide Imaging for Comprehensive Tissue Immunophenotyping Analysis

Synopsis

  • The need to accurately predict drug and patient response: How incorporation of a high-throughput, high-plex multiplexed immunofluorescence assay enables improved precision medicine efforts to quickly identify the right treatment for the individual patient, and limit or prevent late-stage clinical trial failures
  • Whole-slide image analysis of the tumor microenvironment: Previous IHC-based techniques are often limited to 1-2 biomarkers, serving as single-marker approaches to multi-faceted problems. Picking multiple biomarkers, and the right biomarkers, while utilizing less biopsy material provides more answers for clinicians and pathologists. Ultimately, that arms clinical trials with more advanced information and better predicts how patients will respond to certain treatments.
  • How advanced image analysis can be applied to discover specific cell types, populations and morphological context: Spatial phenotyping is an increasingly important pathology research tool for investigating the highly complex biology of tumors and their respective microenvironments.

12:00 pm Partnering to Accelerate Biomarker Research and Validation Prior to Clinical Development

Synopsis

  • With the changes in IVD regulations, this talk from Abcam will explore the value of using commercially available antibody clones in biomarker studies as a way to build a broader set of data, that can support validation of clinical programmes, globally, through academic and commercial partnerships
  • We will discuss how Abcam can support Biopharma and their network of partners in making decisions on biomarker tools from early research through to clinical use by analysing what additional biomarker data can be generated using commercially available antibodies – helping minimize risks when developing, selecting and validating critical reagents at key clinical phases.
  • We will explore how to access and work within an ecosystem of expert partners supporting the biopharma industry from discovery, research and into the clinic, and how this can help deliver a smoother experience across different phases of clinical development

12:30 pm Reverse Translation: Accelerating Biomarker Discovery Using GeoMx Digital Spatial Profiling

  • Nicholas Confuorto Senior Director, Digital Spatial Profiling Business Unit, Global Marketing, NanoString

Synopsis

  • Immune Checkpoint Therapies have shown promise, but strongly predictive biomarkers have remained elusive, highlighting the new need for novel approaches to biomarker discovery
  • Here we introduce the Nanostring GeoMx Digital Spatial Profiler (DSP), which allows users to spatially resolve over 100 proteins and 22000 genes directly in archived FFPE tissue
  • Using this new capability, we highlight how GeoMx DSP can help accelerate biomarker discovery in new drug programs , while also gaining further insights into the underlying mechanisms of disease and response from past clinical trials

1:00 pm Panel Discussion: What’s Needed to Move the Needle in IO?

  • Jeanine Roodhart Oncology Specialist , UMC Utrecht
  • Shane Olwill Senior Vice President, Head of Translational Science, Pieris Pharmaceuticals GmbH
  • Diane Da Silva Associate Director of Translational Medicine, Parker Institute for Cancer Immunotherapy
  • Matt Davis Director of NGS, Gritstone Bio

Synopsis

  • Overcoming heterogeneity and resistance mechanisms – can technology approaches intelligently investigate this?
  • Discussing the utility of larger panels to better unpick disease drivers and identify predictive biomarkers
  • Validating biomarkers in a crowded market
  • What tools, such as computational pathology, can enable early biomarker decisions to influence downstream clinical success?

Clinical Biomarker & Assay Development

Early Biomarker Decision-Making for Time-Efficient Clinical Planning

10:30 am Incorporating Biomarkers in Early Clinical Development Strategy

  • Johan Baeck Senior Vice President Clinical Development & Medical Affairs, Jounce Therapeutics

Synopsis

  • Key is “the right treatment for the right patient”
  • The impact of successful planning on biomarker utility within a clinical trial
  • Fast-track hypothesis driven clinical development strategy via employing biomarker pro-active approaches

11:00 am Clinical Trial Assay & CDx Development in the Era of Precision Medicine – Planning for Success

Synopsis

  • Regulatory considerations for assay development, validation & commercialization
  • Choosing the right diagnostic partner: experience, ability to deliver, transparency & trust
  • Biomarker-led clinical trial assay and companion diagnostic development & validation challenges
  • Case study showcasing a recent Almac Biomarker Program with a large global pharma partner

11:30 am From the Clinic to CDx: Navigating the Path of Clinical Trial Assay Selection & CDx Options for Targeted Oncology Therapies in Mid-Stage Development

  • David Portman Chief Executive Officer, Chief Medical Officer, Sermonix Pharmaceuticals
  • Gary Riordan CDx Regulatory Consultant, Sermonix Pharmaceuticals

Synopsis

  • Describe how an optimal clinical trial assay may be selected and discuss reimbursement, dual marketing plans
  • Explain significant risk and non-significant risk determination, IDE and pre-Sub issues
  • Understand how aspects of a biomarker assay impact recruitment, study execution (including defining a clinical cut off strategy), and transition to a CDx and PMA and transition to a CDx and PMA

12:00 pm Liquid Biopsy of EGFR Mutations in NSCLC Patients Before and After Osimertinib Therapy

  • Evi Lianidou Professor of Analytical Chemistry, Clinical Chemistry; Head, Laboratory of Analytical Chemistry, ACTC Lab, University of Athens

Synopsis

Crystal Digital PCR exhibited high concordance rates in correlation with Roche’s FDA-cleared Cobas technology;
In some cases, Crystal Digital PCR was more sensitive than other methods in detecting the T790M mutation, which is the key resistance mutation found during treatment with first-line and second-line EGFR tyrosine kinase inhibitors;
The presence of EGFR mutations in paired CTC-derived gDNA revealed discrepancies between CTCs and tumor or cfDNA genotyping.

12:30 pm Panel Discussion: Preparation & Planning for Regulatory Assessment

  • Jennifer Dacpano- Komansky Director, Global Regulatory Affairs, Medical Devices, Novartis
  • Jörg Engelbergs Scientific-Regulatory Expert Targeted & Personalized Biomedicines , Paul-Ehrlich-Institut Federal Institute for Vaccines and Biomedicines
  • James Hewitt IVD Product Expert, TÜV SÜD
  • Steven Berman Science Policy Analyst, US Food & Drug Administration

Synopsis

  • Working with regulatory agencies in the US & EU to understand data package requirements for clinical planning
  • Proper preparation and outlining study plans to avoid delays for innovative treatment access to patients
  • What regulatory guidance is there to aid with planning
  • Utilization of US & EU clinical laboratories under the IVDR

Drug-Dx Co-Development

Clinical Strategies for Biomarker-Driven Trials

  • Mark Kiel Co-Founder & Chief Science Officer, Genomenon

10:30 am Translating Oncology Successes into Outside Disease Indications

Synopsis

  • How CDx approaches in oncology can be modified to enable development for Gene Therapy and Rare Diseases
  • Pathways to develop a CDx for Gene Therapy
  • Planning and timeline considerations when incorporating CDx into a clinical development plan
  • Considerations in selecting CDx partners for gene therapy drug development

11:00 am Panel Discussion: A Shared Vision: Building a Best-in-Class Model for Global CDx Clinical Trial Deployment

  • Trevor Page Chief Business Officer, Companion Diagnostics, Agilent Technologies
  • Shirin Hasan Associate Vice President, Head of Global Clinical Affairs, Agilent Technologies
  • Kristina McGuire Sr. Director and Head of CDx & Lab Operations, Regeneron
  • Alan Wookey Companion Diagnostics & Oncology Scientific Advisor, Q2 Solutions

Synopsis

  • Discuss the intricacies of the partnership between the pharmaceutical/biotechnology drug developer, the global central laboratory and the diagnostic company that lead to a successful global Dx/CDx launch
  • How has the field of companion diagnostics changed from the start of your program to the finish line?
  • What novel and creative approaches were needed to enable a successful CDx program?
  • How do you maintain the highest level of data integrity across multiple organizations on a global scale?

12:00 pm Utilizing a Multi-Omic Approach to Precision Medicine

Synopsis

  • Learn about the advantages of bringing a diagnostic test to market with an integrated approach from discovery to commercialization
  • Discover the utility of protein based biomarkers for diagnostics
  • Understand how a proteomic test can be used to enhance clinical guidance and treatment

12:30 pm Panel Discussion: Cross-Functional Communication

Synopsis

  • With a greater number of targeted therapy ventures, it’s important we address the different languages of stakeholders in CDx development
  • Combining assay performance and operational criteria to get effective tests to market
  • Engaging different business arms such as those in scientific and commercial functions including Marketing, Dx, Market Access and Clinical expertise
  • Particularly with complex NGS, how do we work together to enable solutions reach patients?

1:30pm | Virtual Exhibition Hall Break

Synopsis

Head to the resources section of the online platform where you can find downloadable papers, research and information on the latest regarding end-to-end biomarker-driven drug development
Helpfully organized by drug development stage, you can navigate easily to find exclusive resources showing the cutting edge of precision medicine, with concepts spanning discovery to commercialization

Novel Models to Progress from Preclinical

2:00 pm “Everything Works in Mice, Nothing Works in Humans”: How a Unified Systems Model can Enable Therapeutic Success

Synopsis

  • Current interventions fail to alter the clinical vectors of agerelated neurodegenerative diseases, e.g., Alzheimer’s
  • A unified systems model must encompass animal and human pathology (both histological and clinical), upstream risk factors (e.g., genetic risk factors, TBI, etc.), and downstream biomarkers (e.g., amyloid plaque, tau tangles, mitochondrial dysfunction, etc.)
  • A cell senescence model is consistent with all known clinical and pathological data, is predictively valid for all interventional studies, and offers an innovative and feasible point of effective intervention

2:30 pm The Personalis NeXT PlatformTM for Oncology Precision Medicine

  • Dawn McHugh Senior Director Strategic Business Development, Personalis
  • Erin Newburn Director, Field Application Scientist, Personalis

Synopsis

  • Overview of the Personalis NeXT PlatformTM
    – The augmented Whole Exome/Whole Transcriptome NGS solution, that leverages comprehensive, advanced analytics, and is future proofed for existing biomarkers, next generation biomarkers and CDx
  • NeXT Generation CDx with the Personalis NeXT Platform
    – Beyond panel based TMB: exome-wide TMB and composite biomarker analysis with NEOPSTM
    Known and novel gene fusion detection with transcriptome analysis

3:00 pm Utility of Patient-Derived Organoid & Xenograft Models in Lung Cancer Preclinical & Clinical Research

  • Ming Sound Tsao Professor & Senior Scientist, Princess Margaret Cancer Centre, University Health Network

Synopsis

  • Organoid cultures as preclinical models of non-small cell lung cancer (NSCLC)
  • Patient-derived xenografts as preclinical models to study the biology of NSCLC and new drug development
  • Contrast and compare challenges and utility across preclinical and later therapeutic deployment

Defining Your Patient Population

2:00 pm Use of NY-ESO-1 TCR T-Cell Therapy in Patients with Mixed Round Cell Liposarcoma Whose Tumors are NYESO-1 Positive

Synopsis

  • Letetresgene autoleucel (lete-cel; GSK3377794) is a T-cell receptor (TCR)
  • T-cell therapy specific to the NY-ESO-1 peptide-displaying antigen, a highly immunogenic cancer/testis antigen expressed in myxoid round cell liposarcoma that promotes an anticancer immune response
  • Early development of NY-ESO-1 immunohistochemistry detection suggests a companion diagnostic path forward for clinical development

2:30 pm Data Driven Companion Diagnostic Development

  • Marc Yoskowitz Executive Vice President & Chief Strategy Officer, Life Sciences, Tempus Labs
  • Don Bergstrom Executive Vice President and Head of Research & Development, Relay Therapeutics
  • Anne-Marie Martin Senior Vice President , Global Head of Experimental Medicine, GlaxoSmithKline
  • Roni Mamluk Chief Executive Officer, Ayala Pharmaceuticals

Synopsis

  • Tempus has assembled the largest multi-modal real-world dataset to empower AI-driven research to build the next generation of diagnostics and improve patient care.
  • Pharma experts will discuss how data is being used to deliver real-time, data-driven decisions to deliver personalized patient care
  • The evolution of biomarker discovery, CDx development, and delivery of optimized therapeutic options

3:00 pm Tumor-Derived Small EVs (Exosomes) as Promising Biomarkers in Immuno-Oncology

  • Theresa Whiteside Professor of Pathology, Immunology and Otolaryngology, UPMC Hillman Cancer Center, University of Pittsburgh Cancer Institute

Synopsis

  • Tumor derived exosomes (TEX) in cancer patients’ plasma carry a molecular signature that mimics that of a parent tumor cell.
  • TEX are emerging as key components of liquid tumor biopsy
  • TEX are enriched in immunosuppressive proteins and interfere with functions of recipient immune cells

Navigating a Fast-Growing Companion Diagnostics Market

  • Mark Kiel Co-Founder & Chief Science Officer, Genomenon

2:00 pm Finding a Compatible Partner in the CDx Space

  • Javier Perez Director, Precision Medicine, Companion Diagnostics, Regeneron Pharmaceuticals
  • Brian Baker Senior Director, Regulatory Affairs (CDx), Regeneron Pharmaceuticals

Synopsis

  • Selecting a partner suitable for your indication
  • Weighing up centralized Vs non-centralized testing considerations for partner selection
  • Asking the right questions to partner building in regulatory into the conversation early on
  • Considerations for building partnership/commercial conversations earlier on in development

2:30 pm Global Trials – Benefits of Utilizing a Single Assay Worldwide

  • Tom Li Head of Global Biopharma Business Development, Burning Rock Biotech

Synopsis

  • Global Trials – Strategy and Challenges
  • Single assay worldwide – Regulatory considerations, benefits, and considerations
  • Burning Rock Oncoscreen – Widely used, well validated assay, (SEQC2- Nature, April 2021) easily deployable around the world.

2:40 pm Panel Discussion: Flow Cytometry as a Tool for New Biomarkers and Companion Diagnostics Based on Single Cell Protein Expression

Synopsis

  • What is the importance and growth outlook for protein measurements at single cell level, in comparison to genomic measurements, particularly in the era of immunotherapies, for new predictive and monitoring biomarkers and CDx?
  • What are the established and emerging IVD and clinical trial applications for flow cytometry and how do these create opportunity for new clinical biomarkers and CDx?
  • What are the strengths and weaknesses of flow cytometry in relation to other CDx modalities for development of predictive and monitoring biomarkers in immunotherapy and complex disease?

3:30 pm Demo Area

Synopsis

  • Your opportunity to schedule 1-2-1 meetings with your fellow colleagues and our event partners to find out their scientific innovations, technology capabilities, and CDx co-development opportunities!
  • New to this space? Get in touch and we can facilitate a conversation for you!

Evidence Enabling Informed Biomarker Strategy Decision Making

4:00 pm Panel Discussion: How to Know When a CDx & a Predictive Biomarker is Needed for a Drug

Synopsis

  • Discussing criteria determining which drugs to progress for CDx selection to inform clinical strategy and investment plan
  • Changing requirements to implement a diagnostic in the early phase clinical trial Vs what’s needed for later approval
  • Engaging different arms of the business, to build trust for CDx development
  • Pre-empting bottlenecks in Dx development to de-risk investment

4:30 pm A Powerful Combination: Best-in-Class, Distributed Genomic Profiling Meets Gold-Standard HRD Testing

Synopsis

  • The importance of a gold-standard HRD signature assay
  • The innovation to combine Illumina’s CGP kit with Myriad’s HRD assay
  • The impact on patient lives by expanding clinical reach

5:00 pm Pathways for Multiplexed IF: Development Through Clinical Trials & Commercialization Considerations

  • Qingyan Au Principal Scientist, Director of Multiplexing Operations, Pharma, NeoGenomics Laboratories

Synopsis

  • MultiPlexing Technology: Higher and Lower order assays
  • Clinical trial utilization and validation
  • Commercialization considerations and pathways

5:30 pm Jemperli: End-to-End Companion Diagnostic Co-Development Indicated for Adult Patients with Recurrent or Advanced dMMR Endometrial Cancer and Solid Tumors

  • Stephane Wong Immuno-Oncology Companion Diagnostics Senior Director, GlaxoSmithKline

Synopsis

  • Partnering with diagnostic manufacturer
  • Development and commercial aspects of companion diagnostic

6:00 pm Chair’s Closing Remark & End of Day 1