DAY TWO AGENDA

7:00 am Morning Registration & Welcome Coffee

8:00 am Chair’s Opening Remarks

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

Establishing a Footprint in Competitive Global Markets

8:10 am Creating Clarity on IVDR: Advancing our Understanding of the EMA Consultation Procedure for CDx Devices

Synopsis

• Bringing the global precision medicine community up to speed with the latest developments for CDx consultations under IVDR
• Creating awareness of the requirements for the summary of safety and performance and instructions for use under IVDR and learnings from initial EMA consultations
• Commercial implications and practical implementation of IVDR from the eyes of IVD manufacturers and Notified Bodies

8:35 am Panel Discussion: Data-Driven Companion Diagnostic Development

  • Brian Tunquist Director of Diagnostics , Pfizer
  • Giulia Fabbri Senior Director, Translational Medicine Oncology Strategy , AstraZeneca
  • Lauren Silvis Senior Vice President of External Affairs, Tempus Labs, Inc

Synopsis

• Overview of Tempus’ companion diagnostics offering and multi-year, strategic data collaborations with pharma
• Optimizing biomarker discovery/refinement and companion diagnostic development using multimodal data and artificial intelligence
• Utilizing broad panel NGS panels for clinical trial enrollment and companion diagnostics

9:05 am Co-development of biomarkers from the tumor micro-environment, from early phase clinical trials to successful CDx commercialization

Synopsis

• Learn more about our platforms and capabilities to accelerate precision medicine
• Veracyte’s long-term partnerships with pharma from biomarker discovery to CDx
• Ensure global reach and successful commercialization with a proven CDx platform

9:35 am Comparison & Contrast of CDx in APAC – Route to Success

  • Dun Liang Director, Regulatory Affairs, CDx, Loxo Oncology at Lilly

Synopsis

• Critical regulatory updates in APAC & specifically China for precision drug developers to factor to in to biomarker & diagnosticenabled drug development program design in 2022/3
• Navigating and assessing the regulatory landscape in APAC & specifically China to define the compliments new drug and diagnostics will bring to this competitive landscape
• Using current guidance to inform and reveal efficiencies in portfolio planning in line with regulatory and compliance expectations

10:00 pm Morning Networking Break

Synopsis

An opportunity to network, discuss and collaborate with like-minded leaders accross the continuum of biomarker-driven & diagnostic enabled drug development

Biomarker Discovery & Translational Development

Track Chair:

Tools & Techniques Driving Efficiencies in Biomarker Discovery

10:40 am Panel Discussion: Tissue is the Issue

  • John Yi Senior Director, Translational Medicine, G1 Therapeutics
  • Espy Anguiano Scientific Market Development, BioPharma, NanoString Technologies
  • Joshua Rusbuldt Scientist, Oncology Translational Research, Immuno-Oncology, Janssen
  • Qing Li, MD, PhD Head of Clinical Biomarker & CDx Strategy, H3 Biomedicine
  • Steve Anderson Consultant, Precision Medicine & Oncology

Synopsis

• Logistics & tools to gain the most information from scarce samples
• How can we limit the challenges associated with sample storage?
• What tools and approaches are being used today to maximize biomarker information gained from scarce samples?
• Combining both logistical and scientific expertise and considerations to maximize output in discovery settings
• Is AI biomarker technology really the answer to extracting the most amount of data from biological samples?

11:25 am Breast Cancer as a Model for the Marriage of Biological Understanding and CDx

  • Rebecca Ann Previs Director of Medical Affairs, Labcorp Oncology & Adjunct Faculty, Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, Duke University
  • Steve Anderson Consultant, Precision Medicine & Oncology

Synopsis

• Emergence of HER2 low as a biomarker for patients with breast cancer and treatment implications.
• Landscape of NCCN guideline-driven biomarkers: HER-2, Ki67, PIK3CA as well as emerging biomarkers
• Rise of ADCs as potential treatments and in combination with check point inhibitors

11:55 am Clinical Biomarkers Require a Multi-Omics Partnership Approach

  • Guy Afseth Assistant Vice President - North America, MiRXES Corporation

Synopsis

• Informative and robust biomarker discovery for early disease detection from liquid biopsies remains challenging
• MiRXES has utilized comprehensive miRNA profiling to identify early detection signatures across multiple disease states and launched the first miRNA based IVD for early gastric cancer detection
• For multicancer early detection (MCED) a multi-omics approach will be required, and MiRXES is partnering with global clinical and industry leaders to identify, validate and commercialize the next generation of early detection tests

12:05 pm Drive Clinical Uptake of Emerging Technologies by Leveraging Foundational Biomarker Use-Cases and Clinical Diagnostic Evidence

Synopsis

• Enabling novel technologies to answer clinical questions in the translational medicine space
• Transition to CDx development and regulatory submission
• Importance of clinical evidence to commercialization

12:35 pm Emerging Solutions for Non-Invasive Cancer Monitoring

Synopsis

•Discuss the current state, advantages, and limitations of non-invasive liquid biopsies in oncology
• Introduce Blocker Displacement Amplification and Quantitative Amplicon Sequencing technologies and how these technologies can improve liquid biopsies
• Highlight applications of these technologies in non-invasive longitudinal monitoring

Clinical Biomarker & Assay Development

Track Chair:

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

Gaining a Strategic Advantage Through the Implementation of Latest Patient Stratification Approaches

10:40 am Driver Mutation Variant Allele Frequency (VAF) in Circulating Tumor DNA and Association with Clinical Outcome in NSCLC Patients with EGFR- and KRAS-Mutated Tumors

  • Meijuan Li Vice President, Head of Biostatistics, Oncology Group, Eisai

Synopsis

• Is ctDNA a good potential surrogate endpoint for
survival time?
• How can we implement ctDNA testing in trials in terms of
surrogate endpoint monitoring?

11:05 am Oncomap ExTra with Xerna TME, Moving Beyond CGP to Better Guide IO Tx Selection

  • Mark Landers Vice President of BioPharma Partnerships, Exact Sciences

Synopsis

• As immune oncology agents and combinations move through the clinic into practice, more complex biomarker testing is required to effectively guide therapy selection
• The Oncomap ExTra germline subtracted whole exome + whole transcriptome with Xerna TME score enables better clinical decision making from a single tumor sample
• Reporting Xerna TME phenotype along with clinically actionable variants (SNV, CNV, fusions) , TMB, MSI, HRD and PD-L1 status on a single test report not only identifies patients likely to benefit from approved targeted and ICP therapies but can better select those more likely to respond to your next generation ICP therapies and combinations in clinic development

11:35 am Optimizing Rare Disease Diagnosis with Curated Variant Content

  • Mark Kiel Chief Scientific Officer, Genomenon

Synopsis

• Identify how a combination of AI-based indexing and expert, manual review is used to produce disease-specific curated content
• Examine how integration of disease-specific curated content into the variant interpretation workflow can increase diagnostic and treatment rates
• Discover a novel way to connect patients and their physicians with upcoming trials and commercial therapeutic strategies

11:45 am Standardization of Complex Biomarker Assays in Oncology to Advance CDx

Synopsis

• Ongoing challenges in NGS oncology assay development
• Approaches to addressing standardization of NGS workflows for CDx application
• Example case studies of progress

11:55 am Next-generation multi-omics: in minutes, without wet-lab assays

  • Pahini Pandya Co Founder, Chief Executive Officer , Panakeia Technologies

Synopsis

• Panakeia’s software offers multi-omics biomarker profiles in minutes, without need for wet-lab assays.
• This is achieved using an AI-driven software that analyses H&E stained images to determine molecular biomarkers directly from the tissue image.
• The company has offerings for both clinical and research use.

 

12:05 pm Utilizing ctDNA Dynamics to Guide Early Drug Development

  • Victoria Rimkunas Senior Director, Head of Translational Medicine, Repare Therapeutics

Synopsis

• Considerations and limitations when using ctDNA to detect genomic alterations in DDR genes
• Early ctDNA dynamics to assess drug activity in early phase clinical trials
• How early clinical trial results showing an interesting biological link between ctDNA levels & drug activity create questions for understanding tumor pathophysiology

12:30 pm Late Breaking Advancements in How to use Tissue and Liquid Biopsy for Pharma and Commercialization Strategies

Synopsis

• Discuss how to incorporate liquid and tissue comprehensive genomic profiling (CGP) in clinical trials to maximize detection of biomarker-positive patients
•  Review the latest data on single test or reflex testing approaches to effectively use tissue or liquid CGP to detect NCCN biomarkers
• Compare and contrast various sampling strategies to ensure accurate and actionable biomarker identification
•  Explore approaches for integrating ctDNA molecular response

Commercialization in the CDx Industry

Track Chair

  • Susanne Rhoades Senior Director, Diagnostic Development, Loxo Oncology at Lilly

Drug-Dx Commercialization & Maintaining Stong Market Access

10:40 am Rx and CDx Co-Development of Retevmo and Oncomine Dx Target Test in Japan

  • Susanne Rhoades Senior Director, Diagnostic Development, Loxo Oncology at Lilly

Synopsis

• In Japan, Retevmo is approved for the treatment of RET-positive non-small cell lung cancer and RET-positive thyroid cancers with the Oncomine Dx Target Test as the companion diagnostic
• This presentation will discuss these recent co-approvals and unique considerations for co-development
• For the development timeline, is the goal co-approval or co-launch?
• What are essential elements of the bridging study design?
• What steps can be taken to facilitate the regulatory review?

11:05 am Policy Opportunities to Improve Patient Access to Comprehensive Biomarker Testing

  • Hilary Gee Goeckner Senior State and Local Campaigns Manager, Access to Care, American Cancer Society Cancer Action Network

Synopsis

• Current barriers to patient access to comprehensive biomarker testing
• Policy solutions to expand equitable access to biomarker testing and biomarker-driven therapies
• Opportunities for patients, health care professionals and industry to support efforts to advance equitable access to biomarker testing through state policy change

11:30 am Panel Discussion: Coverage and Reimbursement for Companion Diagnostics for IHC and Liquid Biopsy NGS

  • Dana Dilbeck Senior Director, Market Access, Reimbursement and Pricing, Agilent
  • Chris Capuano Senior Director, Global Market Access, Oncology, Sanofi
  • Lynn Replogle Senior Director, Precision Medicine, Veranex
  • Sam Hong Director, Global Health Economics and Outcomes Research, Agilent

Synopsis

Importance of education and awareness in an increasingly complex landscape of biomarkers and targeted therapies Alignment with pharma partner for streamlined process to ensure access to the CDx and drug Considerations for developing a robust evidence package and value communication tools to address payer priorities

12:00 pm The New Era of Blood Digitizers: Enabling Near Patient CDx Through Blood Morphology Markers

Synopsis

  • An introduction to Sight OLO – an AI and digital microscopy based near patient blood analyzer
  • The opportunity of blood morphology markers in developing and implementing accurate CDx assays
  • Selected use cases for incorporating image data into clinical decisions

12:10 pm Panel Discussion: Driving Patient Enrollment and Stratification through a CDx Partnership

Synopsis

• Companion diagnostics (CDx) have the extraordinary power to connect a patient’s unique genetic profile to a promising, personalized treatment option
• Accurately diagnosing, selecting and predicting response in patients require novel technologies and information-rich diagnostic testing strategies
• Learn about how a diagnostics-enabled approach can facilitate the clinical, reg

12:40 pm Biopharma’s Commercial Go-to-Market Strategy for CDx

  • Partha Das GMD Precision Medicine and Pipeline, The Janssen Pharmaceutical Companies of Johnson & Johnson

Synopsis

• Pharma’s jump to Targeted treatments by leveraging Precision Medicine
• Alignment between internal/external stakeholders for synchronized Drug-Dx launch
• Raising testing awareness. No test – No treatment

1:05 pm Networking Lunch

Synopsis

Uncover novel technologies and strengthen relationships with experts to define your precision pipeline strategy in 2022 & beyond

Next Generation Biomarker Discovery

2:05 pm Novel Global Peptidome-Driven Strategies for Biomarker Discovery and Translation

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

Synopsis

PRESENTING VIRTUALLY

• Mass spectrometry based ultra-deep peptide profiling to accelerate novel biomarker discovery and translation to clinic
• Identification of peptide-level alterations for deep molecular characterization of disease subtypes
• Development of predictive biomarker signatures by combining unique disease stage or subtype-linked peptide profiles

2:30 pm Streamlining research from discovery to the clinic: how Abcam’s enhanced antibody validation and partnering ecosystem enables biopharma companies

Synopsis

• How enhanced validation, biophysical characterization and improved reagent quality though knock-out validation help minimize risks when developing, selecting and validating critical reagents from the earliest stages of biomarker programs
• Case study: enhanced validation using an Abcam Claudin 18.2 antibody
How Abcam leverages its ecosystem of expert partners in discovery, research and IVD development to support the frictionless transition of critical reagents across the different stages of clinical development phases.

3:00 pm Clinical need for rapid molecular testing in lung cancer patient management

  • Dr Alison Finall Consultant Histopathologist, Swansea Bay University Health Board
  • Michael Steele Vice President, Business Development Pharma Partnering , Biocartis

Synopsis

• Eighteen per cent (18%) of stage 4 NSCLC patients with non-squamous, NSCLC histology are at risk of rapid clinical deterioration and ¾ of these have a performance status 0, 1 or 2 at first MDT discussion.

• Turnaround times for reporting somatic mutations in EGFR could be improved by using rapid, automated PCR-based testing that can yield results in as little as 3 hours.

• Rapid PCR testing on the Idylla™ platform could be integrated alongside IHC and NGS for optimum patient management, due to its low tissue consumption and excellent performance. Consideration should be given to the wider genomic testing context and whether to extend rapid testing to cover other actionable variants such as KRAS and gene fusions in lung cancer

Gaining a Strategic Advantage Through the Implementation of Latest Patient Stratification Approaches

2:05 pm Applying Machine Learning in Patient Subgroup Identification and Predictive Gene Signature Development: A Case Study in a Late Phase Oncology Trial

  • Jie Cheng Senior Director, Statistical and Quantitative Sciences, Takeda Pharmaceutical Company

Synopsis

• The utility and application of ML for exploratory patient subgroup identification from clinical trial data
• Applying ML in parsimonious gene signature development
• Good practice guidelines for applying machine learning based predictive models

2:30 pm Panel Discussion: AI-Powered Digital Pathology in Clinical Development: Opportunities, Challenges, & Solutions

Synopsis

• AI-powered digital pathology opens up new opportunities in both clinical development and diagnostic development
• Hear from key precision medicine opinion leaders across the drug development continuum on how they are unlocking more impactful therapeutic strategies for patients through AI digital pathology
• Learn how to address emerging challenges in AI-driven medicine, such as privacy, bias, and accuracy

3:00 pm High Quality Liquid Biopsies in Cancer Clinical Biomarker Discovery & Global Trials

  • Xinru Mao Vice President Pharmaceutical Business Development, Burning Rock Dx

Synopsis

• Advances of ctDNA testing and clinical scenarios
• Burning Rock OncoCompass Target – Widely used, well validated assay, (SEQC2- Nature Biotechnology, April 2021) easily deployable around the world
• Global Trials – How Burning Rock empowers multiregional clinical trials through dual CLIA & CAP certified labs Located in China and USA

Ensuring Access in Routine Practice

2:05 pm Partnering in Practice: Co-Development with a CDx Partner Through the Eyes of a Biopharma

  • Minghao Song Director, Precision Medicine Lead, AstraZeneca

Synopsis

  • Understand capabilities and needs in the process for a partner selection and considerations
  • Maturity of the technology through the lens of CDx Climbing up regulatory mountains
  • Readiness for the clinical trial and commercial launch
  • Initiating partnership to develop a CDx important to pipeline progression
  • Advise for smaller biotech firms with their first CDx venture

2:30 pm Working with Patients to Improve the understanding of Bio-Marker Testing and Access

Synopsis

• How can healthcare groups better work with patients and advocates to enable greater access to testing?
• Education, awareness, and resources needed to work towards coverage and improved testing uptake
• How emerging biomarker testing & analysis technology, including AI-based approaches, can result in patient benefits to help make more informed treatment choices
• Sharing patient perspectives on industry progress to accelerate the delivery of next-generation precision medicines and testing technology to market

2:55 pm Early Detection, Earlier Intervention, and Higher Impact: Access and Value in an Evolving Precision Medicine Landscape

  • Amit Jain Vice President, Commercial Strategy & Market Access , Veranex
  • Avneet Heer Senior Manager, Commercial Strategy & Market Access , Veranex

Synopsis

• This presentation highlights the clinical and economic implications of our ability to detect and treat cancers at earlier stages of disease, with a particular focus on the recent evolution of testing
for targeted therapies in early-stage tumors
• Key topics that will be discussed include: The need for clinical practice change, challenges in identifying patients for earlier treatment, and hurdles for achieving payer coverage and valuebased payments for NGS tests
• Implications for key stakeholders (e.g., providers, payers, biopharma, test manufacturers, etc) will be explored, as well as a call to action plan

3:30 pm Afternoon Networking Break

Synopsis

Your final opportunity exchange business cards to takeaway meaningful and long-lasting connections beyond this year’s event – We look forward to hearing about your progress next year!

Collectively Progressing Precision Medicine

Track Chair:

  • Meijuan Li Vice President, Head of Biostatistics, Oncology Group, Eisai

3:55 pm A Semi-Automated Digital Pathology Algorithm for Quantifying Predictive Biomarkers for Cancer Immunotherapies

  • Qi Tang Director, Digital & Data Sciences , Sanofi

Synopsis

PRESENTING VIRTUALLY

• Cancer immune phenotype is known as biomarker for predicting patients’ responses to cancer immunotherapies
• Developed a novel digital pathology algorithm to quantify cancer immune phenotypes based on immunofluorescence images
• Increased the possibility of the development of a CDx for cancer immune phenotypes

4:20 pm From Bench to Bedside: A CDx Odyssey

Synopsis

• Supporting development of new diagnostics from early research inception to use by community oncologists and pathologists
• Development of novel biomarker assays with an eye towards development as a CDx and commercialization
• Guidelines and key stakeholders through the pathologist lens
• Commercialization strategies that work

4:50 pm Regulatory Considerations for a Successful Companion Diagnostic

  • Vijay Walia Senior Program Director, Companion Diagnostics, Quest Diagnostics

Synopsis

When, where, and how to expertly navigate the FDA regulatory process
• Pathway considerations
• Pre-submission
• Testing
• Submission
• Commercialization

5:20 pm Reducing Time to Treatment Initiation in Precision Oncology: The Impact of Fast NGS Testing

  • Matthew Beer Head of NA Medical Affairs, Clinical Next-Generation Sequencing and Oncology, Thermo Fisher Scientific

Synopsis

• ThermoFisher Scientific solutions for CDx in precision oncology
• Importance of short turn around time in delivering molecular profiling
• Enabling HCPs to improve current clinical patient management

5:50 pm Best Data Practices and Strategies for Biomarker CDx Development

Synopsis

  • The advantages of data planning for prospective, retrospective and concordance CDx/IVD projects
  • Complexities and solutions: Biomarker data types and strategies for large clinical trials
    Working collaboratively with third parties to ensure proper data formatting, data transfer security and data QC across multiple laboratories in global locations

6:15 pm Chair’s Closing Remarks & Close of the 12th World Clinical Biomarkers & CDx Summit 2022

  • Meijuan Li Vice President, Head of Biostatistics, Oncology Group, Eisai