Conference Day Two

Thursday 18th July 2024

8:00 am
Check-In & Coffee

8:55 am Chair’s Opening Remarks

Gain Clarity on the IVDR Pathway to De-Risk Submissions for Accelerated Approvals

9:00 am Fireside Chat: Strategising for Routine Adoption of Liquid Biopsy Testing by Addressing IVDR, Reimbursement Issues & Other Challenges to Enhance Commissioning

  • Philip Beer Chief Scientific Officer, Step Pharma
  • Flora Berisha Global Head of Diagnostics Partnering & Development & Precision Medicine, Janssen Pharmaceuticals

Synopsis

• How does the recent European IVDR landscape needs to ensure regulatory alignment whilst addressing unmet patient needs?

• How to expand the application of liquid biopsies beyond special cases, where the value would be significant in bringing the right treatment to the patients faster?

• How to address the ever-growing reimbursement challenges for the routine usage of liquid biopsies?

• How to address the lag between a drug being launched and a diagnostic being reimbursed to ensure patient care is not compromised in the process?

10:00 am
Morning Networking Break

Enhancing Consensus & Collaboration to Reduce Fragmentation Through Shared Guidelines for Broader Adoption of Liquid Biopsy Assays Across Europe

11:00 am Overcoming Challenges in Clinical Adoption of Liquid Biopsies across Europe Through Innovative Strategies to Enhance Test Utilization & Patient Access

Synopsis

• What are the main challenges in clinical adoption of liquid biopsies across European countries?

• How to tackle fragmentation: How to create cohesion across countries to ensure that differences do not slow down innovation?

• How to collect clinical data to sustain the usage of liquid biopsies across Europe?

11:30 am Demonstrating the Need for Multidisciplinary Collaboration to Combat Lack of Physician Awareness & Call for Local & National Advocacy & Policy to Promote the Adoption of Liquid Biopsies

Synopsis

• Analysing how oncologists and frontline clinicians may lack familiarity with liquid biopsy technology, its benefits, and its implications for patient care

• Establishing multidisciplinary cross functional groups within hospitals to facilitate consensus building and decision making for the integration of liquid biopsy into patient care

• Building consensus among healthcare professionals and establishing protocols for incorporating liquid biopsy into clinical practice

12:00 pm Optimising Liquid Biopsy Access Through Inclusive Payment Models, Sample Handling Solutions & Global Access Strategies

  • Lutz Garbes Diagnostic Manager DACH, Stemline Therapeutics

Synopsis

• Integrate multiple payers into the payment structure such as the health insurer, the taxpayer, the patient, private health, public health

• How to overcome the single site testing reluctance to send samples outside of clinical sites?

• Navigating whether samples need to be shipped outside of a country or outside of the EU and what are the barriers in access?

12:30 pm
Networking Lunch

Optimising Pre-Analytics & Sample Handling for Reliable Molecular Analysis to Improve Patient Management

1:30 pm Roundtable Discussion: Empowering Precision Medicine by Integrating Novel Biomarkers & Strategic Approaches for Enhanced Cancer Patient Management & Treatment Optimization

Synopsis

• Engage in discussions on strategies to standardize pre-analytics handling of liquid biopsy samples, ensuring uniformity and reliability in molecular analysis across diverse clinical settings

• Dive deep into the development of agnostic assays utilising innovative techniques such as DNA fragment analysis and methylation markers, exploring their potential to enhance cancer patient follow-ups and treatment outcomes

• Delve into the validation process of circulating tumor DNA (ctDNA) as a pivotal marker for patient management across multiple cancer types, discussing its utility, challenges, and implications for precision oncology

2:30 pm Developing New Strategies & Biomarkers for Cancer Patient Follow Ups

  • Valerie Taly Director & Group Leader - Translational Research & Microfluidics, University Paris Descartes

Synopsis

• Ensuring appropriate pre-analytics handling of LB samples

• Developing appropriate agnostic assays based on DNA fragment analysis and methylation markers.

• Validation of ctDNA as a pertinent marker for patient management/ patient follow up in several cancers

3:00 pm Advancing Liquid Biopsy Assays for Workflow Standardization & Early Detection to Generate Consistency in Results & Empower Precision Treatments

  • David Crosby Head of Prevention and Early Detection Research, Cancer Research UK

Synopsis

• Harmonising liquid biopsy assays and processing protocols to address variations in sample handling timeframes

• Investigating how to enhance the stability and longevity of ctDNA samples for reliable molecular analysis

• Enabling broad access to liquid biopsy assays and global harmonization of regulatory requirements

3:30 pm Chair Closing Remarks

3:45 pm End of 1st Liquid Biopsy for Precision Medicine Summit Europe