7:30 am Breakfast & Networking

8:20 am Chair’s Opening Remarks

Innovations in Biomarker-Driven Clinical Trials to Inform Clinical Decision-Making & Future Drug-Dx Strategy

8:30 am Genomics: The Changing Landscape of Precision Medicine

Synopsis

  • How to harness the vast genomic and clinical data in the UK
  • Use data to stratify and find patients
  • Combining data from different countries

9:00 am Data Analytics & Real World Evidence for Design of CDx Studies

  • Mark Roberts Senior Director, Diagnostics Development, Covance

Synopsis

  • Additional information shortly confirming

9:30 am Comprehensive Liquid Biopsy: Clinical & Commercial Use Cases

Synopsis

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

10:00 am Routine Predictive Genomic Profiling in Oncology: “In House” Or Centralized – Never Ending Debate?

  • Luca Quagliata Global Head, Medical Affairs, Clinical NGS & Oncology Division, Thermo Fisher Scientific
  • Michael Schubert Editor , The Pathologist Journal

Synopsis

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

10:45 am Morning Refreshments

Enhancing Clinical Trial Design & Development for Improved Patient Outcomes

Chaired By: Christopher Peters, Clinical Senior Lecturer & Consultant Upper GI Surgeon, Imperial College London

Stepping into a Complex

Chaired By: Christopher Peters, Clinical Senior Lecturer & Consultant Upper GI Surgeon, Imperial College London

11.15 Maximizing Clinical Success With Effective CDx Strategies

  • Enabling successful clinical development of therapeutics
  •  Driving companion diagnostic strategy while mitigating risk associated with diagnostic implementation
  • Streamlining biomarker-CDx co development

Javier Perez, Director, Precision Medicine Companion Diagnostics, Regeneron

11.15 Personalized Medicines: European Regulatory Landscape & Challenges for the Co- Development of Drugs & Predictive Biomarker- Based Assays (Companion Diagnostics)

  • Regulatory considerations for drug and assay co-development
  • Analytical and clinical validation aspects from phase I-III
  • The new role of drug regulators in the CE marking process
  • Assurance of diagnostic assay quality during clinical drug-assay co-development and clinical routine testing
  • EMA / HMA initiatives, tools and guidelines

Jörg Engelbergs, Scientific-Regulatory Expert, Biomedicines & CDx, Paul-Elrich-Institut, Federal Institute for Vaccines & Biomedicines

11.45 Lung Cancer: An Exemplar for Creating a Paradigm Shift in Precision Medicine Trials

  • Findings from setting up national NGS testing within the NHS and running a large adaptive lung cancer trial
  • Forward look into the challenges and opportunities for patient stratification

Rowena Sharpe, Director, Precision Medicine Trials, University of Birmingham

11.45 Taking a Look at MDR: What Lessons Can We Learn?

  • Applying learnings from MDR in submission times and issuing certificates
  • Acting now to meet crucial deadlines

Julien Senac, Global Director, IVD Focus Team, TÜV SÜD

12.15 Utilizing Automated Image Analysis
Solutions for Clinical Trials

  • Exploring analytical validation of algorithms, retrospective analysis and prospective stratification with image analysis-powered clinical trial assays
  • Discussing partnering for CDx commercialization
  • Learnings from PD-L1 analysis

Florian Leiss, Director, Digital Tissue Biomarkers, AstraZeneca

12.15 Understanding the Latest Regulatory
Advancements

  • What clinical evidence is required and what changes will be required in trials to design accordingly?
  • Understanding current guidance documents and what to expect next
  • Discussing the new submission process under IVDR

Stay Tuned: Announcing Speaker in February 2020!

12:45 pm Networking Lunch

Streamlining Data Analysis & Integration for Informed Clinical Decision Making
Chaired By: Christopher Peters, Clinical Senior Lecturer & Consultant Upper GI Surgeon, Imperial College London

Navigating Fragmented Payer Requirements Across Europe
Chaired By: Christopher Peters, Clinical Senior Lecturer & Consultant Upper GI Surgeon, Imperial Colleg

1.45 Utilizing Clinical Patient Data to Inform Future Drug Development

  • Allowing for future use of clinical data through thorough patient consent
  • Integrating clinical data to future trials to inform target identification and patient stratification in complex diseases
  • Linking clinical data to analytical data to improve future drug development

Caoimhe Vallely-Gilroy, Head, Data Analytics & Strategy, CEO Office Healthcare, Merck KGaA

1.45 Establishing the Cost-Effectiveness of Drug-Dx Products

  • Understanding how the cost effectiveness of Drug-Dx products will be established and the potential impact this could have on pricing
  • An overview of the reimbursement process of Drug-Dx products in the UK

Will Green, Project Director, York Health Economics Consortium

2.15 Novel Biomarkers for Change in Renal Function in People With Dysglycemia

  • Application of the Luminex technology (Myriad RBM Inc, Austin/TX) to measure 237 protein biomarkers/subject in > 8000 subjects
  • Identification of panel of biomarkers, which are better than clinical models to predict eGFR decline

Sibylle Hess, Senior Clinical Biomarker Expert, R&D, Translational Medicine & Early Development, Biomarkers & Clinical Bioanalyses (TMED-BCB), Sanofi

2.45 How to Take Benefit of Metagenomics Data in the Clinical Care?

  • Generating assumptions using full shotgun sequencing metagenomics data
  • From full shotgun sequencing metagenomics to an easier-to-use technology
  • Predicting patients’ status with machine-learning techniques using the easier-to-use technology data

Guillaume Desachy, Senior Biostatistician, Enterome

2.15 Understanding the Diagnostic Pathway to Reimbursement & Pricing

  • Understanding the key considerations for Dx industry and the effect of this on co-development timelines
  •  Establishing effective pricing structures
  • Key considerations for global Dx development and maximizing global drug-Dx adoption

Stay Tuned: Announcing Speaker in February 2020!

3.15 Afternoon Refreshments 

2.45 Afternoon Refreshments 

3:45 pm Roundtable Discussion: Evaluating the Global Impact of a Shifting European Landscape on Clinical, Diagnostic & Commercial Outcomes

Synopsis

  • How can we optimise trial design to meet external requirements, from payers to regulators?
  • To what degree will regulatory guidance dictate internal strategy, across biopharma and diagnostic companies alike?
  • What is the impact on the shifting European landscape to non-oncology disease indications in a very different development stage?
  • How do different evidence requirements across key European states impact overall drug development, trial design and co-development timelines?

4:30 pm Chair’s Closing Remarks

4:35 pm End & Close of 11th Clinical Biomarkers & World CDx Europe 2020