Our Biomarkers & Diagnostics Ecosystem: Moving Treatments Towards Target Populations

8:00 am Successfully Implementing a Biomarker in the Clinic

Synopsis

• Bridging the preclinical and clinical gap to successfully implement a predictive biomarker in the clinic
• Hurdles throughout and how these were overcome
• What are the lessons learned which are now informing future studies?

8:20 am Chair’s Opening Remarks

8:30 am Overcoming Obstacles to Commercial Success Through a Pharma-Centric, Patient-Focused CDx Strategy

  • John McAuliffe Senior Director, CDx Partnering, Roche Molecular Solutions

Synopsis

  • Confronting the inherent challenges and tensions that arise between diagnostics and pharmaceutical development teams
  • Understanding the guidance and support required for successful local market execution on an aligned plan
  • Reaffirming the commitment to clinicians by partnering to ensure advocacy and accurate diagnosis of patients

9:00 am Biomarkers from Exploratory to Clinical Trials to Companion Diagnostics: Advantages of Planning Early

  • Mark Roberts Senior Director, Diagnostics Development, Covance by Labcorp

Synopsis

  • Selection of biomarker technology to correspond with intended use in a clinical trial
  • Paths from exploratory biomarkers: test results as inclusion criteria in clinical trials
  • A few emerging biomarker technologies

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 High-Definition Multiplexing for Biomarker Strategies & CDx Development

Synopsis

  • Unravelling the complexity of biological samples
  • Combining multiplexed detection with spatial resolution to analyze heterogeneous cell populations and colocalize multiple markers in scarce samples
  • Discussing the impact of multiplexing on tissue integrity and throughput

12:00 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
  • Patrick Ng Associate Director of Translational Medicine, Harpoon Therapeutics

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 Starting from Phase I: Evidence Supporting Precision Medicine Move Towards CDx Planning from Earlier Clinical Timepoints

Synopsis

  • The value of building prognostic and predictive biomarkers in studies and starting CDx planning early
  • Assay design and clinical result collection in tandem to support clinical progression and later CDx case

12:00 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 (National Competent Authority responsible for Biomedicines)

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

10:30 am Cross-Company Collaboration for CDx Development

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

Synopsis

  • Education needed to co-ordinate CDx development across biopharma and partner
  • Improving dialogue and planning alongside complex clinical activities to anticipate, recognize and address problems in CDx development whilst these remain manageable
  • Better defining realistic timelines and remaining nimble as data evolves

11:00 am Multiplex Immunohistochemistry for Precision Medicine

Synopsis

  • Discussing mIHC for the development of robust Biomarkers
  • Evaluating the challenges with mIHC from an implementation and clinical approval standpoint
  • Showcasing the benefits to the user community and what needs to be done to ensure market and regulatory approval of these platforms

11:30 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

12:00 pm Development of a Blood-Based Clinical Dx for a ssPMA

Synopsis

  • Evaluate key challenges with bringing a liquid biopsy from concept to commercialization
  • Understand the developmental timelines and execution to achieve clinical readiness
  • Discuss PMA/510k and distribution readiness for liquid biopsy assays

12:30 pm Panel Discussion: Cross-Functional Communication

  • Charles Koyias Associate Director, Global Medical Affairs, Oncology, AbbVie
  • Qing Kang-Fortner Associate Director - Translational Medicine, Syros Pharmaceuticals
  • Christine Blinco Global Director of Marketing, Oncology Diagnostics, GlaxoSmithKline
  • Andrea Stevens Global CoDx Market Access Director, Janssen Inc.
  • Krystin Meidell Associate Director, Global RegCMC Device Lead, Biogen

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?

1:00 pm Get Involved: Showcase Your Scientific Poster

Synopsis

Contribute to the conversation and share your cutting-edge research to your fellow Clinical Biomarker & CDx community to:

  • Communicate your breakthrough discoveries to a vast audience of experts
  • Learn how others are tackling similar challenges as you

Novel Models to Progress from Preclinical

1:30 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

2:00 pm Enabling the Expansive Interrogation of a Tumor & its Microenvironment from a Single Sample for Translational Research & Precision Medicine

  • Kedar Hastak Senior Field Applications Scientist, Personalis

Synopsis

  • While the success of checkpoint blockade has been hugely promising, it is increasingly apparent that predicting response to immunotherapies and developing new ones requires a more comprehensive approach to tumor immunogenomic profiling
  • The traditional means of generating information relating to multiple biomarkers involves the use of several assay technologies from various sources which is not only impractical given the often limited quantity of tumor samples, but also due to complexities associated with the integration and interpretation of disparate reporting formats, and can be prohibitively costly
  • In this presentation, we’ll present our solution to these barriers, ImmunoID NeXT™, a universal cancer immunogenomics platform that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its microenvironment, from a single sample

2:30 pm Overview & Perspectives for Translating Multi-Omics into Clinical Utility in Solid Tumors

Synopsis

  • Insights into Indivumed’s activities to build up a truly muli-omics database – The only global multi-omics cancer database for drug development and personalized Oncology
  • How we can utilize this data in cancer research and to treat patients better

2:40 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

1:30 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

2:00 pm 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

2:30 pm Panel Discussion: Innovative Regulatory Approaches to Co-Development

Synopsis

  • Addressing new FDA policies
  • Exploring new legislative changes
  • How does this affect your drug-Dx development?

Navigating a Fast-Growing Companion Diagnostics Market

1:30 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

2:00 pm Companion Diagnostics in Immuno-Oncology: Global Commercial & Partnership Considerations

  • Joseph Ferrara President & Chief Executive Officer, Boston Healthcare

Synopsis

  • The testing paradigm in immuno-oncology is growing increasingly complex, moving beyond PD-L1, to include mismatch repair, microsatellite instability, tumor mutational burden, and others
  • Key commercialization considerations for drug and test innovators, including balancing test access and quality, and embedding CDx global commercial considerations in pharma and diagnostic company partnerships will be highlighted

2:30 pm Overcoming Challenges of Running Clinical Trials in China & Implications for Global Trials

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

Synopsis

  • How to navigate the regulatory environment in China
  • What are the trends? What are the challenges and how can we adapt?
  • How does this fit with Global Trials?
  • How can we help with commercialization/reimbursement/Day 1 assay availability?

2:40 pm Addressing the Global Footprint of Today’s CDx Industry for New Market Entry

Synopsis

  • Comparison of global companion diagnostic markets to enable informed clinical decision making in market penetration potential
  • Keeping up with regulatory changes globally in a constantly evolving environment with particular emphasis on incoming IVDR and new CDx requirements in China

3:10 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

3:30 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

4:00 pm Illumina Tomorrow & The Future of Global Dx Strategic Partnerships

  • Matt Nelson Senior Director of Business Development CDx, Illumina

Synopsis

  • Beyond just creating a diagnostic product, we are focusing on developing an innovative end-to-end global solution – from sample to answer
  • Breaking the ‘siloed thinking’ and smoothen trials from non-registrational to registrational with single comprehensive genomic panel
  • Innovative commercial strategies designed to democratize genomic testing

4:30 pm Strategies & Considerations for CDx Development in Early Phase Oncology Studies

Synopsis

  • Best practices and key learnings from early CDx development
  • Timing to engage with a Dx manufacturer & considerations for earlier CRO interactions
  • Cut-off determination

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

  • Qingyan Au Principal Scientist, Director of Multiplexing Operations, Pharma Services, 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 Women with Recurrent or Advanced dMMR Endometrial Cancer

  • 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