8:20 am Chair’s Opening Remarks

Leveraging Data & Trends in Biomarkers & Diagnostics

8:30 am Working Together to Enable Solutions to Reach Patients: Maximizing the Utility of Data

Synopsis

Working Together to Enable Solutions to Reach Patients: Maximizing the Utility of Data

  • The move towards molecularly characterizing patients and retrospective analysis
  • Designing guidance to appropriately share data internally and improve awareness of published information
  • Addressing industry concerns on big data and privacy and implications for improving pre-competitive data sharing

9:00 am Comprehensive Liquid Biopsy: Clinical & Commercial Use

  • Elena Helman Head, BioPharma Bioinformatics, Guardant Health

Synopsis

  • Emerging data on ctDNA in clinical trials
  • Using ctDNA for immunotherapy development
  • Maximizing patient access commercially

9:30 am A PD-L1 Case Study: Key Industry Stakeholders Perspective

  • Xiaolei Xu Director, Global Regulatory Affairs, Companion Diagnostics, Agilent Technologies

Synopsis

  • An inside look at the entire ecosystem that is required to achieve a successful regulatory CDx registration and approval
  • A regulatory case study from the perspective of a pharma, diagnostic and lab company

10:00 am Diagnostic Advances for Rare Diseases, Now, & in the Future

  • Tom Defay Deputy Head, Diagnostics Strategy & Development, Alexion Pharmaceuticals, Inc.

Synopsis

  • Overview of diagnosis in rare disease
  • Advances in genetics to increase clinical suspicion
  • Advances in phenotype characterization and screening to increase clinical suspicion
  • Combining genotype and phenotype to aid in diagnostics

10:30 am Speed Networking Break

Synopsis

Utilize this opportunity to make meaningful connections with some of the industry’s greatest minds to hear the latest thinking on biomarkers and diagnostics and identify new technologies with potential to innovate your pipeline

Moving Biomarkers Towards the Clinic

Broadening the Scope of Validated Biomarkers

11:00 am Driving Biomarker Discovery: The UK Biobank Pharma Proteomics Project

  • Chris Whelan Associate Director & Head of Translational Genetics, Biogen

Synopsis

  • Analysis of ~1,500 circulating proteins to be analyzed from 53,000 patient blood samples
  • Enabling better understanding of the association between genetic variation and circulating protein levels to support innovative drug development linking genetics and human disease
  • Providing pre-competitive data mapping the levels of human proteins traditionally difficult to identify and quantify at scale

11:30 am Leveraging Machine Learning & AI in Translational Medicine

  • Andrew Beck Co-Founder & Chief Executive Officer, Path AI

Synopsis

  • Prioritizing the improvement of patient outcomes with reliable AI-Powered technology to provide patients with the most accurate diagnosis and efficient treatments
  • Our translational platform identifies and analyzes new cellular and tissue patterns to find pathology-based features that are used to gain novel insights across all phases of drug development and therapeutic areas at scale
  • Eliminate observer variability and improve patient selection and stratification to ensure the right patient is included in every trial and to increase the probability of trial success

12:00 pm Reverse Engineering Translational Biomarkers For Novel Breast Cancer Subtypes

Synopsis

  • Strategic overview on logistics for high quality biomarker translation
  • Reverse engineering biomarker selection going from protein to gene expression
  • Identification of ‘upstaging’ ER+ subtypes which impacts therapy selection and outcome

Clinical Biomarker & Assay Development

Overcoming Complexities in New Biomarker Therapeutic Strategies

11:00 am The Use of Biomarkers to Confirm Mode of Action & Inform Combination Strategy for PRS-343 in Her2-Low Gastric Cancer in Combination with Tucatinib

  • Markus Zettl Senior Director of Immuno–Oncology, Pieris Pharmaceuticals GmbH

Synopsis

  • PRS-343, the first bispecific to enter the clinic engineered to specifically activate 4-1BB in the tumor microenvironment is well tolerated and demonstrated durable anti-tumor activity in heavily pre-treated patient population including patients with “cold” tumors
  • Biomarkers confirm the mode of action of PRS-343 with a clear dose-dependent increases in CD8+ T cells in the tumor and soluble 4-1BB in plasma
  • Preclinical in vitro experiments showed that PRS-343 activity can be enabled and enhanced by Tucatinib in the situations with low HER2 expression
  • Preliminary evidence of activity was also demonstrated in HER2 low patients

11:30 am Power of Tumor-Informed & Personalized Assays to Drive High Sensitivity

  • Andy Hadd Director of Regulatory Affairs, Natera

Synopsis

  • Why personalized tumor-informed assays optimize sensitivity and specificity
  • Latest publications and data including IMvigor 010
  • What clinical trial designs are possible with a personalized tumor-informed assay

12:00 pm Evaluating Neoantigen Immunotherapies in the Clinic

  • Roman Yelensky Executive Vice President & Chief Technology Officer, Gristone Bio

Synopsis

  • Utilizing advances in genomic analysis and interpretation for therapeutic development
  • Selection of therapeutically useful neoantigens for immunization
  • Integrating immune monitoring and cell free DNA (cfDNA) to evaluate immunotherapies clinically

Commercialization in the CDx Industry

CDx Development in Emerging Markets

11:00 am Panel Discussion: Identifying Diagnostic Approaches to Support Emerging Modalities

Synopsis

  • Setting up an effective Rx-Dx strategy in unchartered waters
  • Validation methods for confidence in diagnostic decision making
  • Building in cost-consideration into clinical assessment planning

11:30 am Addressing Complex Biology with a Tissue- Based CDx

  • Olga Colgan Global Marketing Director, Advances Staining & Imaging, Leica Biosystems

Synopsis

  • Advantages and applications of in situ RNA detection
  • Collaboration of key stakeholders for co-development of a drug and RNA-ISH diagnostic device
  • Regulatory and commercial considerations for new innovative technologies

12:00 pm Interactive Roundtable: Drug Dx Market Access Strategy: Success Story

Synopsis

  • How to effectively assess a market landscape for your indication
  • Identifying expertise to better manage patients in disease areas outside oncology

12:30 pm Regulation Roundtable: IVDR & Europe – How are you Planning Ahead?

Synopsis

This roundtable session will enable attendees to participate in discussions surrounding forward planning for IVDR measures being implemented in Europe in May 2022. With the potential to cause major disruption to CDx development and clinical trials, join with your peers to learn why the topic is so front-of-mind. You will have the opportunity to:

  • Discuss what IVDR means for clinical planning to inform your data collection and study design
  • Hear how your precision medicine industry are preparing for the soon-approaching deadline
  • Address predicted challenges post-IVDR to plan strategies to overcome these to fulfil global drug-dx expansion goals

Generating Evidence Data to Translate New Biomarkers to the Clinic

1:30 pm Overcoming Sample Quantity Limitations

Synopsis

  • Can biospecimen databases help overcome limited access to genomic & proteomic data?
  • Utilizing NGS and addressing privacy concerns challenging personalized approaches and overcoming challenges of a small patient population

2:00 pm A Spatial Biology Approach for Biomarker Studies In Immuno-Oncology

  • Gavin Gordon Vice President, Clinical Market Development, Akoya Biosciences

Synopsis

  • Current limitations of predictive biomarkers in immunooncology
  • Potential for multiplexed immunofluorescence to improve biomarker strategies in immuno-oncology
  • Partnering with Akoya to support translational and clinical research

2:30 pm Achieving Clinical ‘Buy In’ – Biomarker Strategy Integrated with Clinical Development

  • Lakshmi Amaravadi Vice President, Head of Translational Medicine, Boston Pharmaceuticals

Synopsis

  • How to develop a biomarker plan with clear goals that enable clinical development with objective endpoints
  • How much or what preclinical data can predict a biomarker’s utility in clinical development
  • Case studies from Metabolic and Autoimmune disease areas will be covered to demonstrate specific examples of use of biomarkers with in the clinical program for decision making

Early Intervention for Better Patient Outcomes

1:30 pm ctDNA Response as an Earlier Indicator of Benefit & for MRD Monitoring

  • Darren Hodgson Global Project Leader & Site Head Translational Medicine, AstraZeneca Oncology

Synopsis

  • How to measure and assess across a number of biomarkers
  • Integrating data to support confidence in conclusions
  • The value of prognosis prediction to determine and develop better treatment options

2:00 pm Liquid Biopsies in Cancer Drug Development & Clinical Use

Synopsis

  • Evaluating current evidence on innovative technologies including circulating tumor cell and circulating tumor DNA methods
  • Improving detection, prognosis, and disease monitoring as well as drug development

2:30 pm Creating Standardization Within Clinical Liquid Biopsy Application Analysis for Reliable Result Interpretation

  • Mark Stuart Vice President, Science Policy, Friends of Cancer Research

Synopsis

  • Highlighting industry collaboration to set industry standards to enable the correlation of biomarkers with clinical outcome
  • Enabling the analytical validation of liquid biopsies to define performance metrics needed for precise patient therapy decision making
  • Overcoming sensitivity and specificity assay challenges impacting liquid biopsy clinical utility

3:00 pm RaDaRTM – Enabling a Paradigm Shift in Oncology Clinical Trials with Ultra-Sensitive ctDNA Residual Disease & Recurrence Testing

  • Tim Forshew Head of Science and Innovation & Co-Founder, Inivata

Synopsis

  • RaDaR MRD liquid biopsy assay has industry-leading sensitivity – why is this important?
  • Using residual disease and recurrence opens new options for clinical trial design
  • Data from a recent NSCLC clinical trial

Ensuring Patient Access in Routine Practice

1:30 pm Identifying Clinician and Patient Barriers to Guideline-Concordant Biomarker Testing

  • Nikki Martin Director, Precision Medicine Initiatives, LUNGevity
  • Janelle Schrag Assistant Director, Research Programs, Association of Community Cancer Centers

Synopsis

  • Profile a multi-phase initiative that focuses on cataloging barriers to biomarker testing among underserved lung cancer patients and developing a patient-and-clinicianapproved intervention to bridge testing gaps
  • Learn about key findings from the provider and patient research
  • Hear more about how an intervention to address gaps in biomarker testing access can be utilized

2:00 pm Maximizing Patient Access to Unlock the Potential of Precision Medicine

  • Rudi Powels Founder Director, Chief Executive Officer, Biocartis

Synopsis

  • Discussing considerations and choice of CDx strategy for novel precision medicines
  • Evaluating and deciding upon the variety of diagnostic technologies
  • Deciding between solutions for centralized versus decentralized testing
  • Discussing the development of a full-automated, highlyaccurate MDx platform
  • Demonstrating the value of such a platform to the advancement of patient access to ensure the right treatment at the right time

2:30 pm Post Market Activities: Innovative Commercial Strategies for Rare Oncology Tumors

Synopsis

  • Real World Data to gain scientific credibility
  • Innovative strategies to broaden assay adoption and utility
  • Key stakeholders to engage through implementation cycle
  • Additional to education, what strategies can companies use to increase adoption?

3:00 pm Panel Discussion Demonstrating Clinical Utility to Engage with Payors & Secure Reimbursement

  • Eugean Jiwanmall Senior Research Analyst for Medical Policy & Technology Evaluation, Independence Blue Cross
  • Antonella Cardone Executive Director, European Cancer Patient Coalition

Synopsis

  • Highlighting reimbursement requirements needed to show clinical utility for patient response over survival indicators
  • Trial design to factor in payor requirements – resulting in lower costs and lengthy trial periods
  • Uniting payor, hospital testing labs, IVD sponsor perspectives for improved testing access

3:30 pm Networking Break

Synopsis

  • With over half of drugs now approved supported by a biomarker, remain connected with your CDx community with the opportunity for 1:1 networking to stay ahead of the curve on the technological advances that could take your drugs to market
  • If you are new to the CDx space and need advice, get in touch and we can facilitate!

Applying AI & Advanced Analytics to Progress Medicines

4:00 pm HalioDx Immunogram & Cancer Immune Atlas: Application in Immuno-Oncology

  • Corrinne Danan Executive Vice President, Partnerships Business Unit, HalioDx

Synopsis

  • Data integration of biomarkers from the tumor microenvironment (colon cancer proof of concept)
  • Application: Cancer Immune Atlas to guide pharma development
  • From the Immunogram Cancer Immune Atlas to CDx

4:30 pm Utilizing AI Tools for CVD & Rare Disease Drug Development

Synopsis

  • AI approaches to generate insight in rare disease where patient subsets are small
  • Addressing challenges to integrating AI systems into biological and pre-clinical workflows
  • Improving feasibility of AI for better disease modelling and drug targeting

5:00 pm Panel Discussion: Routine Predictive Genomic Profiling in Oncology: “In House” Or Centralized – Never Ending Debate?

  • Luca Quagliata Vice President, Global Head of Medical Affairs, Thermo Fisher Scientific

Synopsis

  • During this panel the pros and cons for both approaches will be discussed by representatives of key stakeholders including pharma, diagnostics industry, pathologists and oncologists

5:30 pm New Approaches to Develop Diagnostic & Prognostic Biomarkers

Synopsis

  • How can digital approaches accelerate diagnostic and prognostic biomarker development?
  • Emerging approaches to better diagnose inflammatory-driven CNS disease and rare indications
  • Leveraging big data to inform on multimodal biomarker strategies

6:00 pm Closing Remark & Close of the 11th World Clinical Biomarkers & CDx Summit 2021