2023 Conference Day 2

8:00 am Morning Networking Coffee

8:55 am Chair’s Opening Remarks

  • Clare Balendran Vice President of Translational Development, Novo Nordisk

Streamlining the EU IVD Regulatory Process to Accelerate New CDx Approvals

9:00 am CDx Certifications Under IVDR: State of Play

  • James Hewitt IVD Business Line Manager & Senior Specialist (CDx), TÜV SÜD

Synopsis

  • State of play IVDR with viewpoint on CDx
  • Understanding interactions with EMA
  • Lessons learnt and takeaways from first certification projects

9:30 am Session Reserved for Guardant Health

10:00 am Experiences & Challenges on the Co-Development of Personalised Medicines & CDx

  • Joerg Engelbergs Scientific-Regulatory Expert Targeted & Personalised Biomedicines, Paul-Ehrlich-Institute

Synopsis

  • Update on the European regulatory framework
  • Current experiences and challenges to streamline co-development
  • Role of the CDx in pharmaceutical studies

10:30 am Morning Networking Break

11:00 am Session Reserved for Quest Diagnostics

11:30 am Panel Discussion: Taking Control of Your IVD Regulatory Submissions to Turbocharge the Future of CDx

  • Julien Senac Global Director, IVD Focus Team & Strategic Account Manager, TÜV SÜD
  • Hugues Malonne Director General, DG "Pre-authorization", Federal Agency for Medicines and Health Products
  • Stephen Lee Director, Diagnostics Regulation, Association of British Healthcare Industries Ltd. - ABHI
  • Fatima Bennai-Sanfourche Senior Director of QA & RA Compliance for Medical devices, Combination products, & eHealth, Bayer

Synopsis

  • Addressing European frameworks and the need of industry collaboration
  • Discussing how to best optimise regulatory process to avoid it being a barrier to finding new precision medicines in Oncology, NASH and Neurodegenerative disorders

12:00 pm Session Reserved for NeoGenomics

12:30 pm Lunch & Networking Break

TRACK A: Clinical Biomarker Development

  • Lynn Durham Chief Executive Officer & Founder, Stalicla S.A.

Patient Enrichment & Stratification for Further Clinical Benefit

1:30 pm Patient-Derived Tissue Models to Support Personalised Safety

Synopsis

  • Usage of micro-physiological systems in pre-clinical drug discovery and clinical development
  • Case examples of precision medicine and personalised medicine: Cancer Immunotherapy and immune-related adverse events, paediatric drug development and support of trial design and clinical decision making

2:00 pm Enquire About Partnership Opportunities

Bioanalytical Assay Validation Approaches to Enhance Precision Medicine Clinical Trials

2:30 pm Standardisation of Biomarker Validation for Implementation in Clinical Trials: Oncology & NASH as Case Studies

  • Radha Krishnan Executive Director, Clinical Pathology Lead, CDx, MSD

Synopsis

  • General guiding principles for biomarker development
  • Best practices for the development and fit-for-purpose validation of biomarkers across a range of therapeutic areas, including NASH and oncology
  • Addressing the challenges in developing and implementing biomarker use in clinical trials and clinical practice
  • How are regulatory agencies addressing the need for validated biomarkers?

3:00 pm Aligning Biomarker Assay Validation Strategies for Successful Implementation in Clinical Trials

  • Stephanie Traub Associate Director, Bioanalytical Scientific Manager, Translational Biomarkers & Bioanalysis, UCB S.A.

Synopsis

  • Discussing the appropriate timing for validation
  • Determining how to improve bioanalytical validity of a biomarker assay
  • How to achieve more robust and comprehensive biomarker readouts

TRACK B: Drug-Diagnostics & Commercialisation

  • Michael Palmer Vice President - Translational Oncology, Bicycle Therapeutics

Opening the Way to a Better-Defined Commercialisation Pathway

1:30 pm New Era of Precision Medicine in Life-Threatening Diseases

  • Julie Hart MHRA IVD Expert Advisory Group Member, Oxford Academic Health Science Network & University of Reading

Synopsis

  • Why is there such a clinical need in the critical care space?
  • Differences between marketplace payer and regulatory steps in different European countries
  • Lessons learnt and how to apply to other non-oncology modalities

2:00 pm VUCA-N: Variable, Uncertain, Complex, Ambiguous, but Necessary: Discovering the Trials & Tribulations of Precision-based Diagnostics from a Pharma Perspective

Synopsis

  • Addressing some of the inherent challenges facing a pharma company developing a global precision-based oncology therapeutic product and companion diagnostic portfolio
  • From early clinical to post-commercialisation

Unravelling Reimbursement Challenges to Maximise Access to Precision Medicines

2:30 pm Precision Medicine in Cardiovascular & Metabolic Diseases

  • Alix Berton VP, Head of Disease Understanding & Precision Biomarkers, Bayer

Synopsis

  • Where are we today?
  • Realisation of precision medicine outside of oncology: dream or reality
  • Call to arms in CV space: what are the next steps?

3:00 pm Roundtable Discussion: CDx Market Strategies to Ensure Widespread Access to Approved Medicines

  • Julie Hart MHRA IVD Expert Advisory Group Member, Oxford Academic Health Science Network & University of Reading

Synopsis

  • Understanding the importance and value of the technology with payers
  • How does reimbursement look like in different countries?
  • Can the biomarker be separated from the treatment to which they are associated to?

3:30 pm Afternoon Networking Break

Shaping the Future of CDx to Ensure Precision Medicine Access for All

4:00 pm How to Handle IVDs in Clinical Trials: Sponsor Responsibilities According to the IVDR Requirements

  • Fatima Bennai-Sanfourche Senior Director of QA & RA Compliance for Medical devices, Combination products, & eHealth, Bayer

Synopsis

  • Addressing regulatory landscape changes and sponsor responsibilities
  • Discovering IVDs used in drug clinical trials
  • Deciphering clinical trial submission including IVDs

4:30 pm IVDR impact on Clinical Trials for Oncology & Non-Oncology Diseases

  • Francesca Cipolli Associate Director, Precision Medicine & Digital Health, Global Regulatory Sciences, BMS

Synopsis

  • Understanding CTR and IVDR interfaces
  • How to apply for a performance study and strategies for market adoption
  • Defining a better framework to ensure access to precision medicines

5:00 pm Chair’s Closing Remarks & End of 13th Annual Clinical Biomarkers & CDx EU Summit 2023