EVENT POSTPONED TO 2021
To safeguard against COVID-19, we have taken the decision to postpone this event. We are working with the venue to schedule new dates in 2021. Register your interest here to get updates.

8:50 am Chair’s Opening Remarks

Biomarker & Diagnostic Operations

9:00 am Supporting Drug-Dx Commercialization with Effective Go-to-Market Strategic Framework

  • Jeffrey Emch Vice President, Global Commercial Diagnostics Strategy, Oncology, GSK

Synopsis

• Defining a Strategic Framework for Oncology Drug and Diagnostic Combinations
• Lessons learned in diagnostic integration across an oncology portfolio
• Effectively integrating commercial with medicine and diagnostic developmental and regulatory strategy

9:30 am Data Analytics & Real World Evidence for Design of CDx Studies

  • Mark Roberts Senior Director, Diagnostics Development, Covance

10:00 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

10:30 am

Morning Refreshments

11:00 am Developing Successful Clinical Trials in Cell & Gene Therapies

  • Jennifer Herring Executive Director, Head, Clincial Scientists, Cellular Therapy, Global Development, Bristol Myers Squibb

Synopsis

• The journey of a CAR T cell – from the patient and back again, understanding what it takes to execute a Cell Therapy Clinical Trial
• Designing feasible trials with a combination of efficacy and surrogate biomarker endpoints
• Monitoring of patients for acute and long term toxicity, how can biomarker data inform the clinical team

11:30 am Delivering Successful Companion Diagnostics Programs: A Large Global Central Laboratory’s Experience

  • Alan Wookey Scientific Advisor, Oncology & Companion Diagnostics, Q2 Solutions

Synopsis

• Describing some of the trends in the data to support companion diagnostic submissions and approval, seen by a Central Laboratory, that is supporting over 100 CDx clinical trials
• Other approaches required to maximize the potential of predictive biomarker assays, given the small number of CDx approvals since the first 20 years ago
• Trends and best practice will be described on how CDx assays are supporting clinical development in China

12:00 pm Keynote Panel Discussion: Routine Predictive Genomic Profiling in Oncology: “In House” Or Centralized – Never Ending Debate?

Synopsis

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

12:45 pm

Networking Lunch

Early Biomarker Strategy Track

Informative Clinical Data Track

Drug-Dx Co-Development Track

R&D Informatics: Driving Biomarker Insight

Tissue-Based Biomarkers in Digital Pathology

Driving Market Access & Commercialization

1.45 Molecular Markers of Response to BCMA CAR T Therapies

  • We aimed to study the relationship between drug product composition and durability of response by performing molecular profiling of the drug product using cyTOF and RNAseq
  • We identified molecularly defined subgroups that are correlated with response and durable response
  • These data suggest that early memory phenotypes may lead to a robust peak expansion and sustained response

Hans Bitter, Vice President, Data Sciences, bluebird bio

1.45 The Impact of Digital & Computational Pathology on Biomarker Discovery & Development

  • Utilization of AI, data science and pathology to enhance biomarker discovery
  • How to identify image-based biomarkers using algorithms?
  • Computational tools to understand how the tumor microenvironment changes due to therapy

Jason Hipp, Senior Director, Head of Pathology Data Science & Innovation, Translational Medicine, AstraZeneca

1.45 Commercialization Strategies for CDx in Precision Medicine in the US: Pitfalls & Considerations

  • Considerations of the CDX test diagnostic partner versus sole source lab
  • Build a JSC prior to launch with commercial
  • Diagnostic SME support
  • Reimbursement considerations and goals
  • Field support who and how drives uptake of testing in the field
  • Education and Medical intervention driving uptake in partnership
  • Driving testing drives therapy! Were in this together

Julie Ramage, Director, Precision Medicine Quality Initiatives & Partnerships, AstraZeneca

2.15 Data, Data Everywhere and Not Enough Time to Think: Deploying a Bayesian Approach To Identify Causality in OMICS Data For Population Health and Precision Medicine

  •  Engaging a Bayesian inference approach to identify actionable biological targets and biomarkers for precision medicine and population health
  • Use of adaptive omic technologies to identify the right patient at the right time based on patient biology

Michael Kiebish, Chief Precision Medicine Officer & Vice President, Systems Medicine, BERG Health

2.15 Addressing Complex Biology with a Tissue-Based CDx

  • 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

Keith Wharton, Senior Medical Director, Leica Biosystems

2.15 Establishing Effective Rx-Dx Partnerships

  • Forming partnerships with biopharma to deliver commercially successful drug Dx products
  •  Developing diagnostic lead on a dementia therapeutic
  • Finding patients for robust diagnostic development

Elizabeth Somers, Diagnostic Pathway Lead, AD Franchise, Eisai

2.45 Leveraging Machine Learning & AI in Translational Medicine

Speaker confirming from, PathAI

2.45 Patient Selection & Stratification from Early to Late Stage Development: Cost, Risk & Quality Considerations

  • Patient Selection and Stratification in early clinical development and is a balance of cost considerations and risk mitigation that requires forward thought and planning.  Options will be presented with relevant risks outlined.
  • Once the trial has started, global clinical trials require consideration of local and country specific patient care for patient selection and stratification and to identify patients who are eligible for the trial. Risk of local tests, central testing, sample processing and documentation are all important considerations

Kristina McGuire, Senior Director, Regeneron

2.45 Panel Discussion: Multidimensional Biomarkers & Machine Learning Based Approaches for Precision Medicine

  • Discussing the utility of multidimensional biomarkers in the translational and clinical space
  • Distilling down complex biological signals into actionable biomarkers utilizing machine learning
  • Evaluating the enhanced role of multiplexing in early biomarker selection

Brought to you by Cofactor Genomics

3:15 pm

Afternoon Refreshments

Evaluations, Validations & Verifications of Diagnostic Tests

3.45 Science to Medicine: Using Biomarkers & Genetics for Indication Selection & Prioritization in Drug Development

  • We are in the era of “molecular medicine”; indication selection and prioritization for targeted therapies
    requires scientific evidence of target activation related to disease pathogenesis
  • Dupilumab clinical development has utilized biomarkers and molecular signatures to prioritize indications and
    provide translational insights into IL-4 an IL-13 pathway biology
  • Advancements in molecular and data analytical tools provide an opportunity to transform drug development

Jennifer Hamilton, Executive Director & Head, Precision Medicine, Regeneron

Guiding Clinical Treatment Decisions

3.45 Understanding Disease Mechanisms & Response Outcomes Through Biomarker Analyses: A Case Study in NSCLC & Treatment with Pembrolizumab

  • Uncovering biomarker selection to better predict responders and non responders
  • Disease mechanisms and response pathways based on biomarker analyses in context of monotherapy and combination treatment options
  • Tying it all together: How these findings inform future drug development and trial design

Ellie Corigliano, Global Director Medical Affairs, Oncology, Thoracic & Pan Tumor Biomarkers & Diagnostics, Oncology
Global Medical Affairs, Merck & Co.

Demonstrating Clinical Utility with Regulatory & Patient-Centric Strategies

3.45 Innovative Regulatory Approaches to Co-Development

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

Lauren Silvis, Senior Vice President, External Affairs,Tempus

4.15 Multiplex Immunohistochemistry for Precision Medicine

  • 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

Courtney Nicholson, Director, Business Development, Abcam

4.15 High Definition Multiplexing for Biomarker Strategies & CDx Development

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

Philippe Mourere, Senior Vice President, Commercial Operations, Ultivue

4.15 Maximizing Patient Access to Unlock the Potential of Precision Medicine

  • 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 fully automated, highly accurate MDx platform
  • Demonstrating the value of such a platform to the advancement of patient access to ensure the right treatment at the right time

Vishal Sikri, US General Manager, Biocartis

4.45 Development & Use of Whole Blood Flow Cytometry Assays to Support First-in-Human Studies for CCR4 Antagonists

  • Chemokine receptors represent a challenging class of therapeutic targets with exciting therapeutic potential
  • Quantification of target engagement is especially important for novel targets
  • Challenges with flow-based functional assays and results from FIH studies will be presented

Paul Kassner, Senior Vice President, Quantitative & Computational Biology, RAPT Therapeutics

4.45 Biomarker-Driven Next-Generation Non- Viral CAR-T in Treatment of Multiple Myeloma

  • Predictive biomarkers are well established in oncology, particularly when a drug specifically targets an oncogenic driver. In CAR-T therapies, it has been quite challenging to find truly predictive markers
  • In this mode of therapy, it is essential to fully characterize the immune system, tumor and the CAR-T product of each patient
  • The field is being paved by extraordinary results; much remains to be done to improve CAR-T cells

Majid Ghoddusi, Senior Director, Clinical Biomarkers, Poseida Therapeutics

4.45 Navigating the Regulatory Pathway for Early & Late Stage Clinical Development of CDx Assays

  • Development of several targeted therapies in oncology is streamlined by the early adoption of diagnostic assays into clinical trials
  • Key regulatory requirements for contemporaneous approval of Cdx and therapeutic drug product
  • Overcoming clinical hurdles and mitigating regulatory risks for therapeutic drug and diagnostic approval

Jayanthi Menon, Senior Manager, Regulatory Affairs, Regeneron Pharmaceuticals

Irene Bacalocostantis, Senior Manager, Regulatory Affairs, Regeneron Pharmaceuticals

5.15 Exploring Biological Pathways to Identify Novel Therapeutic Opportunities

  • Leveraging biomarker co-localization to uncover disease mechanism of action
  • Identifying biomarkers of clinical relevance
  • Exploring the technology applied to identify immune cells, track the expression of payload and the influence of armouring on surrounding tumors

Darrell Borger,Associate Director, Translational Sciences, ODDU Takeda

5.15 Developing Global Diagnostic Assays

  • Further details shortly confirming

Russell Garlick, Chief Scientific Officer, LGC Clinical Diagnostics

 

5.25 Detecting Patient Response & Risk of
Disease Relapse or Progression to Inform Future Strategies

  • ctDNA testing for patients of gastrointestinal cancer
  • Incorporating liquid biopsies both as correlatives as well as predictive markers to clinical trials
  • ctDNA and novel therapeutics
  • Closing the gap on unmet clinical need for patients through liquid biopsy

Pashtoon Kasi, Assistant Professor, College of Medicine & Oncology, University of Iowa

5.15 Commercialization of Precision Diagnostics: Challenges & Opportunities

  • Challenges exist when introducing new precision diagnostic tests into the European market which impact rate of test adoption
  • To deliver an effective European wide test access strategy, different approaches needs to be considered on a market by market basis
  • Opportunities for centralized vs de centralized testing approaches will be discussed with emphasis on access, TAT and quality

Hans-Christian Pedersen, Director, Business Development, Unilabs Denmark

5.45 End & Close of 11th Clinical Biomarkers & World CDx Boston 2020

5.55 Progressing Precision Medicine in the Non-Oncology Space

  • Outline the application and need for precision medicine in the non oncology space
  • Share examples of the development and delivery of precision medicines in a range of non-oncology disease indications
  • Drawing on experiences and lessons learnt from recent pipeline developments

Maria Orr, Head, Precision Medicine, Biopharmaceuticals, AstraZeneca

5.45 Improving the Effectiveness of Patient Care Treatment Pathways through Diagnostics

  • Choosing the right drug right away can be life or death for some cancer patients
  • How diagnostics can lessen the financial toxicity of ineffective treatments

Elizabeth O’Day, CEO & Founder Olaris

6.25 End & Close of 11th Clinical Biomarkers & World CDx Boston 2020

6.15 End & Close of 11th Clinical Biomarkers & World CDx Boston 2020