Conference Day One
Wednesday - 24 April, 2024
7:00 am Check in & Morning Coffee
8:15 am Chair’s Opening Remarks
Streamlining the IVDR Process to Deliver Compliant Assays & Drugs Faster
8:30 am How to Continue Running Clinical Trials in EU Under IVDR
Synopsis
- Overview of the new requirements for clinical studies
- Impact of the EU IVDR regulation on drug clinical trials in Europe
- A case study on pharma’s response to IVDR – lessons learned and best practices
9:00 am Session Reserved Guardant
Synopsis
Talk Details TBA
9:30 am Panel Discussion: What is the Current State of Play for IVDR & Regulation Across Europe?
Synopsis
- How are non-European-based companies working through IVDR?
- How close are we with the combine trial and what impact will it have on the field?
- What are the main hurdles are faced in clinical development phase for CDx and C certification from notified bodies and agencies?
- What are the main hurdles for co-development for CDx?
10:00 am Session Reserved Quest Diagnostics
Synopsis
Talk Details TBA
10:30 am Morning Break & Speed Networking
Synopsis
An opportunity to network, discuss and collaborate with precision medicine leaders passionate about advancing patient-centric progress within the field. Plus a bespoke dedicated networking session to encourage conversation amongst peers and potential new business partners.
Track A: Biomarker Discovery & Development
Developing New Biomarkers for Disease Progression & Patient Stratification in Immunology
11:30 am Spotlighting the Need for Better Tools for Biomarkers of Inflammation
Synopsis
- Biomarkers for inflammation diagnosis requires a multibiomarker approach
- Diagnosing chronic low-grade inflammation will require new technology combining proteomics and genomics
- Biomarker signatures will allow early detection and treatment to prevent the progression of disease, tissue damage and aging
12:00 pm Project Managing Biomarker / CDx Programmes with Pharma – A Diagnostic Company’s Perspective
Synopsis
- Aligning the ‘value proposition’ and defining a clear biomarker strategy from the outset
- Agreement on timelines and project delivery
- The importance of selecting the appropriate technology
- How to successfully run clinical trials and Regulatory requirements for global territories
- Areas for future improvement and better collaboration
12:30 pm Molecular Glue Degraders for Non-Oncology Indications
Synopsis
- Introducing molecular glue degraders (MGDs) as a targeted protein degradation (TPD) approach
- Leveraging the application of MGDs in non-oncology indications, such as diseases associated with autoimmunity and inflammation
- Illuminating the main utility of Biomarkers in Targeted ProteinDegradation
1:00 pm Single-cell multi-omics for discovery, translational, and clinical development
Synopsis
- Dissect molecular heterogeneity, characterize disease-driving clones, and identify molecular mechanisms of relapse.
- Track clonal changes to measure therapeutic efficiency and changes throughout the course of disease.
- Perform predictive biomarker screening to identify responders vs non responders and improve patient stratification.
Track B: Companion Diagnostics & Commercialisation
Forging Strong Precision Medicine Strategies to Optimize Market Access
11:30 am Evidence Generation to Support Novel Biomarker Access Strategy: A Case Study
Synopsis
- Demonstrating the true frequency of the novel biomarker in the patient population and which diagnostic method is most appropriate to optimize detection
- Identifying the barriers to patients getting appropriate testing and evidence generation to support improved access
- Exploring how Precision Medicine stakeholders are working together to address diagnostic access barriers
12:00 pm Session Reserved for Agilent Technologies
Synopsis
Session Details to be Confirmed
12:30 pm Panel Discussion: Building a Better Dynamic Between Biopharma & Diagnostics Developer to Deliver Drugs to Patients Faster
Synopsis
- How are regulations impacting CDx and assay manufacturers? How are they impacting biopharma?
- What are the performance limitations of current instruments and assays used/needed routinely by biopharma?
- What are the cultural differences between large pharma partnership structures and biotech? How does this impact timelines for CDx development?
- In what ways can we be improving co-development studies?
Enquire Today About Your Speaking Partnership Opportunity!
1:30 pm Networking Lunch Break
Synopsis
An opportunity to grab some lunch, liaise with your peers, and hear first-hand how diagnostics developers and partners are employing novel technologies to transform your workflows.
Utilizing New Technologies to Realize the Potential of Using Biomarker Combinations
2:30 pm Biomarker Discovery & Diagnostic Development Using Whole Genome Sequences Paired with Clinical Data
Synopsis
- Recruiting participants from the NHS with rare diseases and cancer, to enable molecular diagnosis and best treatment opportunities, paving the way for the first national WGS standard of care offering in the world
- Deidentifying whole genome sequences linked with longitudinal clinical data, to accelerate genomic research and advance R&D into the clinical indications represented in this dataset
- Analysing data together (along with additional multiomic and multimodal data) gives context to the genome and supports researchers in characterising diagnostic variants, identifying biomarkers and elucidating novel drug targets/opportunities
3:00 pm Fireside Chat: Accelerating our Ability to Unearth the Mechanism of Action of Biomarkers
Synopsis
- How are companies developing a better test earlier due to new guidelines? How are they overcoming the upfront investment?
- Overcoming reluctance to go to Europe to conduct clinical trial with IVDR
- Shedding light on importance of correct sampling
- What is the need to begin working with companion diagnostics company earlier?
- What platforms are being used and are they compliant?
3:30 pm Protica Bio Empowering Cancer Immunotherapy with AI-enhanced Proteomics
Synopsis
- Pinpointing the clinical unmet need for IO predictive biomarkers
- Harnessing Protica’s platform: ground-braking proteomic technology for biomarker identification
- Achieving proof of concept in Head and Neck cancer
4:00 pm Session Reserved for OHMX Bio
Synopsis
Session Details to be Confirmed
Overcoming Challenges with Conducting Clinical Trials in Europe Using IVDs to Maximize Market Access & Garner Commercial Success
2:30 pm Challenges in Conducting Clinical Trials Involving Medicinal Products with Medical Devices or IVDs
Synopsis
- Introducing the categories of devices used in the drug clinical trials and the regulatory pathways to be followed.
- Understanding how to conduct clinical trials with CE marked devices
- Where are we now with the Combined trials?
- Unearthing current challenges for the sponsor of Combined Trials and how to overcome these challenges
3:00 pm Bio-Techne: Your Companion Diagnostic Partner of Choice
Synopsis
- Leading IVD partner selection in a global setting
- Demonstrating the importance of alignment between your partner’s IVD process and your therapeutic journey (or clinical development)
- Collaboration is key!
3:30 pm Change Management: How to Integrate Changes in Diagnostic Testing to Yield a Positive Change for Clinical Trials & Patient Care
Synopsis
- Changing regulations impacting assays used for patient care (LDT/IVD) are driving towards a better future state both for patient care and clinical trials.
- Understanding of the intent of the regulators and the released changes in regulatory guidance is key to identifying a future state
- Navigating change for management of the testing landscape has impacted device manufacturers and laboratories significantly.
- Managing inconsistency from health authorities, IVD manufacturers and laboratories which can create roadblocks to patient care.
- Working collectively with drug developers, regulators, laboratories and insurance/reimbursement on a global scale to promote success
4:00 pm Session Reserved for Panakeia
Synopsis
Session Details to be Confirmed
4:10 pm Afternoon Break & Networking
Optimizing Novel Techniques for Biomarker Profiling to Promote Translational Success
4:40 pm Genome Wide cfDNA Methylome Profiling as a Tool in Precision Oncology
Synopsis
- Highlighting benefits of using cfDNA for biomarker analyses
- Using a genome wide screen to pinpoint all potential biomarkers
- Applying technique to broad range of oncological conditions
5:10 pm Session Reserved for Oxford BioDynamics
5:40 pm Harnessing Multiomics to Transform Autism Spectrum Disorder Diagnosis
Synopsis
- Early diagnosis of ASD enables early intervention, improving treatment efficacy and lifelong outcomes.
- Customizing MULTIOMICS to be disease specific, based on scientifically novel and selective molecular mechanisms.
- An urgent need for an accurate, objective, and scalable tool for the early detection of autism