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 A New Era of Molecular Medicine, Regulation & Globalization Calls for a New Model for CDx
Synopsis
- Molecular medicine is advancing so rapidly that the classic CDx model will need to evolve
- Rather than CDx being the end of a pharma-Dx journey, it is proving to be just the beginning, with far greater integration into the precision medicine ecosystem and a loop back into discovery
- We will share Guardant’s emergent Dx and data model and how it interacts with dynamics in regulation, reimbursement and market practices in Europe
9:30 am Panel Discussion: What is the Current State of Play for IVDR & Regulation Across Europe?
Synopsis
- Over the last year of IVDR, what challenges still persist?Â
- How are non-European-based companies working through IVDR? How is this different to Europe?
- What are the main hurdles are faced in clinical development phase for CDx?Â
- What are the main hurdles faced for CE-Marked certification?
- Where are we with the combine trial and what more needs to be done to advance the field forward?
10:00 am Overcoming Immunogenicity in AAV Gene Therapies
Synopsis
- The importance of AAV antibody testing in overcoming immunogenicity challenges, ensuring treatment safety, and efficacy
- Best practices for assay and companion diagnostic development, emphasizing early development, assay format selection, and regulatory expertise
- Quest Diagnostics' pioneering approach to AAV antibody testing: from assay development and validation to supporting strategic immunomodulation
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
Track Chair
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 Next-generation multi-omics: in minutes, without wet-lab assays
Synopsis
- Panakeia’s software offers multi-omics biomarker profiles in minutes, without need for wet-lab assays.
- This is achieved using an AI-driven software that analyses H&E stained images to determine molecular biomarkers directly from the tissue image.
- The company has offerings for both clinical and research use
12:10 pm 5 minute Q&A
12:15 pm Epigenetic Biomarkers, an Untapped Treasure for Cancer Diagnostics
Synopsis
- Highlighting the benefits of DNA methylation biomarkersÂ
- Novel technologies towards bimodal readout capturing both genetics and epigeneticsÂ
- Successful epigenetic biomarker applicationsÂ
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.
Virtual Talk
Track B: Companion Diagnostics & Commercialisation
Track Chair
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 Innovations in Companion Diagnostics: Challenges & Opportunities to Advance Precision Medicine
Synopsis
- Innovations that are impacting the evolution of complex companion diagnostics
- Challenges and solutions to implementing the innovations in CDx solutions (regulatory, commercialization, adoption, etc.)
- Implications for the collaborative CDx development model between pharma and IVD developers
Session Moderator
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 biopharma and diagnostics developers? How do you manage this from a biopharma perspective?
- In what ways can we be improving co-development relationship?
1:00 pm Highlighting the Utility of Liquid Biopsy in Clinical Research
Synopsis
Session Details TBA
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
Session Moderator
3:00 pm Panel Discussion: Accelerating our Ability to Unearth the Mechanism of Action of Biomarkers
Synopsis
- What are some of the major challenges for identifying and understanding biomarker MOA?
- How are researchers developing a better test earlier?Â
- How are we overcoming the upfront investment?
- What are the key challenges for validating different sets of biomarkers?
- Why is sampling so important?
- At what stage do we need to begin thinking about the CDx?
- 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 Unlocking Bacteriophages: Pioneering Diagnostics & Marker Discovery
Synopsis
- If diagnosed early, Lyme disease is relatively straightforward to treat.
- Currently, there is a lack of diagnostic methods for detecting early-stage Lyme disease.
- Bacteriophages are considered ideal biomarkers for identifying the bacteria that cause Lyme disease.
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 The Changing/Challenging Role of the Diagnostic Developer in the Biopharmaceutical Industry
Synopsis
- Where diagnostic use in the pharmaceutical industry has come from, and where it’s going
- Changing regulations impacting assays used for patient care in clinical trials
- Managing inconsistency from health authorities, IVD manufacturers and laboratories which can create roadblocks to patient care
4:00 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
Optimizing Novel Techniques for Biomarker Profiling to Promote Translational Success
4:30 pm Afternoon Break & Networking
4:45 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
5:15 pm 3D Genomic Liquid Biopsy: From Predictive, Prognostic & Diagnostic Biomarkers to Data Knowledge
Synopsis
- 3D Genomic EpiSwitch® blood-based biomarkers platform
- Blood-based clinical tests for early diagnosis, prognosis and prediction of response to treatment
- Actionable resolutions with 3D Genomic Analytics and Data Knowledge.
5:45 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