Whilst we can't meet in person in 2020, we've taken the conversation digitally @ the 1st Digital Clinical Biomarkers & World CDx (29 September – 01 October, 2020) - view more information here.

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.

7:50 am Chair’s Opening Remarks

Biomarker for Immunotherapies

8:00 am Neoantigen Targeted Cancer Immunotherapy in the Clinic


• Neoantigens are key tumor specific targets that may be targeted therapeutically
• Neoantigens can be identified for each patient using NGS and machine learning
• Immunoassays and ctDNA can be used to evaluate neoantigen immunotherapies in the clinic

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


• 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 How Can We Use Data More Intelligently to Improve Companion Diagnostic Commercialization?


• Discussing data requirements to commercialize CDx
• What gaps exist in the data?
• How can we fill in those gaps to ensure seamless test integration?
• Showcasing most effective uses for available testing data
• Leveraging data to drive ROI & improve patient care

9:30 am Panel Discussion: Women & Diversity in Precision Medicine


• Understanding the importance of female advocacy in the workplace
• Adopting a female support system
• Entering a post-COVID world: Building diverse teams and maximizing business creativity
• Recognising the female leads in the pandemic response
• Exploring HR metrics and laws surrounding salary renegotiation
• Actioning changes: How the entire community can make valuable differences to ensure an inclusive, supportive workplace for the future of precision medicine

10:15 am

Speed Networking & Morning Refreshments

10:45 am Identification of a Predictive Biomarker for an Immune Agonist; Lessons Learned from Vopratelimab


• Translation of preclinical predictive biomarker data into the clinic is challenging for immunotherapies
• A drug specific, treatment emergent, pharmacodynamic biomarker that was associated with clinical outcomes was critical to finding a predictive biomarker
• A predictive biomarker optimized for prediction of the drug-specific pharmacodynamic biomarker was associated with improved clinical outcomes and is being tested prospectively in a randomized clinical trial

11:15 am HalioDx Immunogram & Cancer Immune Atlas: Application in Immuno-Oncology


• 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

11:45 am Launching a Companion Diagnostic: Research & Development Through Commercialization


• New approaches to personalized medicine have made drug development more efficient, however drug development has simultaneously become more complicated. Drug developers find themselves responsible for not only developing a therapeutic, but also a quick, easily interpreted CDx compatible with standard laboratory practices. A well-functioning clinical trial assay may not necessarily meet these criteria
• In this presentation, we share our experience developing and deploying diagnostics for use in clinical trials and marketing CDx to hospitals, oncologists and pathologists
• We also highlight our experience developing CDx through different regulatory pathways and the pros and cons associated with the different technology and platform choices available
• We address the challenge of transitioning a CDx from clinical trials to commercial practice post-approval, where the incentives and reimbursement are starkly different than those in the CRO industry
• Given the large number of CDx available, we provide an overview into NeoGenomics’ decision process whether or not to offer a diagnostic on our commercial menu, or whether development of an equivalent laboratory developed test (LDT) may be warranted

12:15 pm Panel Discussion: A PD-L1 Case Study: Key Industry Stakeholders Perspective


• 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

1:00 pm

Networking Lunch

Early Biomarker Strategy Track

Informative Clinical Data Track

Drug-Dx Co-Development Track

Translating Molecular Biomarkers into Validated Clinical Assays

Clinical Strategies for Biomarker-Driven Trials

Strategies to Support Future Clinical Development & Market Access

2.00 Translating Genomic Discoveries into Biomarkers for Alzheimer’s Disease: Integration of Functional Genomic Knowledge to Refine Polygenic Risk Scores

  • Late onset Alzheimer’s disease (LOAD) is highly heritable and genome‐wide association studies (GWAS) have identified over 30 risk loci associated with LOAD
  • Several studies used LOAD-GWAS SNPs to generate polygenic risk scores (PRS) with the goal to develop diagnostic biomarkers. However, for many Alzheimer’s traits the additional effects of polygenic burden beyond the APOE locus are of minor nature
  • We seek to gain predictive power and have undertaken an innovative approach for refining LOAD PRS by integrating functional genomic datasets, we then evaluated the improvement in the PRS performance

Ornit Chiba-Falek, Professor, Chief, Division of Translational Brain Sciences, Department of Neurology & Center for Genomic & Computational Biology, Duke University Medical Center

2.00 Integrating Predictive Biomarkers in Clinical Trial Designs

  • Discussing clinical trial design strategies in the presence of predictive biomarkers in early-stage and later-stage drug development
  • Presenting how phase II trial design can identify early indications of efficacy and how this may be implemented to efficiently test multiple therapies
  • Exploring the strengths and weaknesses of different confirmatory phase III trial designs and recommending when specific trial designs are most appropriate
  • Introducing umbrella and basket trials that test multiple therapies simultaneously and identify biomarker-matched subgroups of patients who are mostly likely to benefit from novel targeted treatments

Antje Hoering, President & CEO, Cancer Research and Biostatistics (CRAB)

2.00 Challenges & Considerations for Drug-Diagnostic Co-Development Strategies

  • Discuss challenges to the co-development of Rx and Dx to support simultaneous submission and approvals
  • Highlight key considerations that must be address for successful co-development

Robert Loberg, Executive Director, Clinical Biomarkers & Diagnostics, Amgen

2.30 A Purpose Driven Approach to Biomarker Strategy & Planning: Hint.. It Begins Early & Evolves With the Program

  • Keep the Biomarker strategy tied to your goals
  • Data and Timing are everything

Robert Pomponio, Global Scientific Advisor, Biomarkers & Clinical Bioanalysis TMED, Sanofi

2.30 The Increasing Adoption of RNA-Seq as a Biomarker Discovery Tool & How to Solve the Complex Data Challenge

  • The opportunity of RNA-Seq as a biomarker discovery tool
  • Challenges in analysing and interpreting large volumes of complex RNA-Seq data
  • How Almac Diagnostic Services’ claraT report solves this challenge, simplifying the process whilst saving time & resource
  • Detailed overview of the claraT reporting solution, including cohort and sample report interpretation
  • Case Study: In a real world RNA dataset utilising claraT

Katarina Wikstrom, Head, US Operations, Almac Diagnostic Services

2.30 Liquid Biopsies in Cancer Drug Development & Clinical Use

  • 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

Rick Wenstrup, Chief Medical Officer, Epic Sciences

3.00 Afternoon Refreshments

3.00 ctDNA in Clinical Trial Design

  • Identify patients in greatest need and most likely to benefit based on biology
  • Sensitive disease detection or molecular response

Darren Hodgson, Global Project Leader & Head of Strategy, Translational Medicine, AstraZeneca

3.00 Supporting Clinical Utility Through Rx/Dx Co-Development Strategies

  • Evaluation for need for an IDE
  • Aspects around training and test sets used to develop scoring methods/cutoffs
  • Other high level concepts that regulatory agencies look out for in diagnostic submissions

Sid Mathur, Regulatory Affairs Director, Companion Diagnostics, Merck & Co.

3:30 pm

Afternoon Refreshments

Informing Pipeline Decisions with Early Biomarker Testing

Developing Therapeutic Strategy with Robust Clinical Data

Technologies for Drug-Dx Co-Development

Moderator: Robert McCormack, Independent

4.00 Safety & Pharmacodynamic Biomarker Strategy for Viral Immunotherapy for Cancer

  • Understanding Oncolytic Virus treatment modality for cancer and regulatory requirements for Translational Biomarkers
  • Translation of pre- clinical data into safety and PoC Biomarkers for the clinic

Tooba Cheema, Director, Translational Medicine & Biomarkers, Oncorus

4.00 Impact & Successful Planning for Oncology Clinical Trials Biomarkers in the Era of COVID-19 Crisis: The Sanofi Experience

  • Oncology Clinical Trials have been seriously affected by COVID-19 pandemic at multiple levels: Kick-off, enrolment, operations, visits, and timelines
  • Oncology biomarkers and related endpoints have also been at great risk and mitigation plans are on high demand
  • Here, we share our lessons learned, rapid responses and long-term mitigation plans for molecular oncology and immuno-oncology trials biomarkers

Vasiliki Pelekanou, Clinical Translational Medicine Lead, Oncology, Sanofi

4.00 Diagnostic Platforms Selection to Effectively Execute Biomarker Strategies

• Identifying diagnostic modalities for early drug development pipelines
• Ensuring diagnostic options allow candidates to meet key regulatory requirements
• Preparing for launch: Setting up an effective Rx-Dx strategy

Cecilia Schott, Head, Precision Medicine Strategy, Oncology Business Unit, Novartis

4.30 Development of a Blood-Based Clinical Dx for a ssPMA

  • 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

Gary Pestano, Chief Development Officer, Biodesix

4.30 Companion Diagnostics in Immuno-
Oncology: Global Commercial & Partnership Considerations

  • 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

Joseph Ferrara, President & CEO, Boston Healthcare

4.30 Deploying a Robust, Global Platform
to Improve the Quality of Multi-National
Registrational Trials

  • Strengths of immuno oncology precision trials on industry: ability to predict more accurately which treatment and prevention strategies to use for a particular disease that takes into account, individual variability
    • Pre-study preparations
    • Assuring quality during the clinical trial through closeout
    • Post study support
    • Future concerns for the industry for device support during the clinical trials

Karina Kulangara, R&D Director, Companion Diagnostics (CDx), Agilent Technologies

5.00 Predictive Biomarkers Guide Evaluation of a Novel Combination of MB-101 (IL13Ra2-CAR-T) With C134 Oncolytic Virus for the Treatment of Glioblastoma

  • Lessons learned from the biomarker studies in GBM
  • Biomarker based rationale for MB-101 and C134 Oncolytic virus combination

Ekta Patel, Head, Pre-Clinical & Translational Research, Mustang Bio

5.00 Biomarker Led Clinical Strategies for Targeted Therapeutics: Journey from Bench to Bedside

  • Proactive planning for targeted therapy with companion diagnostics
  • Translation of research to clinical trial to FDA approval
  • Learnings from using an NGS approach in CCA

Smitha Sivaraman, Senior Director, US Medical Affairs, Incyte

5.00 Challenges in Coordinating Drug & Diagnostics Development: Assay Validation Requirements for Implementation into Clinical Trials at Different Phases of Drug Development

  • Evidence required for selection of assays and platforms in early clinical development
  • Assay validation required in early clinical development and at different phases of drug development
  • Implementation of assays for enrichment, stratification, selection, pharmacodynamics in early clinical development and at different phases of clinical drug development

Julie Engel, Senior Director, Molecular Diagnostics, Cyteir Therapeutics

5.30 Panel Discussion: Biomarker Approaches to De-Risk Early Drug Development

  • Discussing the biomarker strategies key to reducing risk associated with translational studies
  • Exploring how bioanalytical approaches are ensuring drug developers are running informed trials and making the right biomarker decisions

Tooba Cheema, Director, Translational Medicine & Biomarkers, Oncorus

Gregory Preston, Director, Bioanalytical & Biomarker Development, Axial Biotherapeutics

5.30 Panel Discussion: Identifying Unmet Clinical Need to Direct Clinical Portfolios

  • Discussing the importance of patient-centric approaches to drug development
  • Exploring patient groups and maximizing inclusion in trial cohorts to allow larger, robust data build
  • Meeting the needs of all: finding a place for excluded patients and those areas with high unmet clinical need

Sarah Paul, Senior Scientific Manager & Biomarker Lead, Genentech

Jason Bradt, Head, Rare Disease North America Medical Affairs & Director, Medical Affairs Operations, Ipsen

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

5.30 Panel Discussion: Developing & Validating Biomarker Assays

  • Key considerations in assay development and validation to maximize therapeutic success
  •  Finding your right technology: How can we ensure it's right for us and how are we implementing it into trials?
  • How correct validation of assays enables the global commercialization of therapeutics and the strategic goals to include in your strategy

Hakan Sakul, VP & Head, Diagnostics, Pfizer

Julie Engel, Senior Director, Molecular Diagnostics, Cyteir Therapeutics

Omar Perez, Head of Diagnostics, Experimental Medicine Unit, GSK

6:00 pm Chair’s Closing Remarks