A panel of expert speakers will outline current policy and regulations governing pr ecision oncology, and the initiatives being implemented to further advance its clinical reality in their specific countries, including a discussion on the following aspects:

• Identifying the current legal, regulatory and practical obstacles still restricting the advancement of precision medicine and exploring solutions to key implementation challenges
• What progress is being made in developing national and cross-border infrastructures for data storage, registries and data sharing programmes?
• Exploring what changes are needed to current disease and drug classification and reimbursement approaches
• Assessing the readiness of HTA bodies to really value the benefits of innovative precision oncology (histology-independent / tumour agnostic) drugs
• Determining what needs to be done to improve patient access to precision oncology

The discovery and development of innovative biologically & clinically relevant biomarkers, including multi-omics biomarkers, and then integrating these, supported and justified by reliable evidence, to become part of routine clinical care is crucial to the advancement of precision oncology.  This session looks at recent advances in the development and integration of new biomarkers and diagnostic tools to improve the understanding of cancer biology, including:

• Effectively using multi-omics analyses in precision oncology to better understand tumour development and devise appropriate treatment pathways
• Understanding the role of epigenetics and other signatures in precision oncology
• Implementing novel molecular characterisation strategies beyond tumour DNA sequencing, eg transcriptomics, immunophenotyping, and single-cell analyses
• Liquid Biopsy: Circulating tumour DNA & blood-borne biomarkers as precision diagnostic tools
• Successfully leveraging the information derived from digital biomarkers and assessing their use as diagnostic tools in practice
• Usefully interpreting increasingly complex laboratory and test reports and developing an effective clinical trial biomarker strategy

This session is intended to give participants the opportunity to discuss a specific topic in a more informal, participative format. Delegates may choose one roundtable to attend, and each table will be led by a facilitator who will outline some structured points for discussion and encourage optimum debate and exchange of ideas.

Each roundtable facilitator will briefly share the key learning points from their table discussion with the audience.

The clinical and molecular heterogeneity of tumours and their evolution after diagnosis and treatment presents major challenges to effective cancer therapy. Understanding what 'steps' a cell must take to become cancerous, as well as the influence of external factors such as inherited genetic factors, metabolic profiles, and lifestyle factors and being able to unravel the mechanisms of drug resistance are all fundamental to the development of precision oncology strategies. Molecular Tumour Boards play an increasingly critical role in cancer diagnosis and treatment and advances in these, including the development of virtual molecular tumour boards (vMTB), will further enable the development of new solutions in oncology clinical practice.

New approaches to clinical trials have the potential to accelerate research and drug development so that the right therapies can rapidly be delivered to the right patients. However there are a number of issues affecting progress such as regulatory and reimbursement constraints due to the cost and complexity of clinical trial design. This session will explore key issues including:

• The latest thinking in clinical trial design: platform, umbrella, basket, histology-agnostic and incorporating AI into trial design
• What changes need to be made to current trial design to better enable a precision approach
• Integrating real-world data with other information sources to select the “right” patients
• What payers need to see in order to fund and support access to targeted therapy.
• Patient empowerment in the clinical trial and drug development process

A vital step in the advancement of precision oncology is the effective analysis and interpretation of real-life data, extracting meaningful information from large volumes of complex data in order to give the clinician a carefully refined list of targets and actionable insights, thus aiding their decision-making. This session will discuss best practice in the collection, analysis and management of data and exploiting new data tools in order to drive real change in clinical practice.

• Identifying the most useful types of data to collect, and the key obstacles to effective access and sharing: overcoming the challenges of harmonising biomarker data
• Exploring the use of real-world data (RWD) and learning from patients who do not respond as expected
• Discussing the potential of AI for analysing patient and clinical data
• Overcoming the complexity of reporting actionable targets

There are huge expectations for cancer immunotherapies and their potential to manipulate the patient’s own immune system in order to fight tumour cells and treat the disease. Whilst much progress has been made in this area, there have also been set-backs and the price, hope and hype associated with cancer immunotherapy places a lot of pressure on clinicians. This session will explore new approaches for  optimising response and minimising resistance to cancer immunotherapies.

• Assessing the type of cancer to which immunotherapy will be most beneficial and implementing it in a personalised approach:
  • developing different therapies for different patients and cancers
  • determining likely time-scales for regulatory guidance for actively personalised immunotherapies
• Exploring the evolution and development of CAR-T cells for effective immunotherapy and precision oncology:
  • identifying novel targets for CAR-T cells
  • Increasing their effectiveness for solid tumours
• Examining the potential of neoantigens for cancer immunotherapy

This final audience discussion brings together many of the points discussed throughout the 2 days into some parting thoughts: how can we overcome the challenges of bringing molecular and genomic research & testing into routine clinical care and facilitate the journey from bench to bedside?