7:00 am Registration & Welcome Coffee
7:20 am Chair’s Opening Remarks
When Companion Diagnostics are Needed
7:30 am Next-Generation Biomarkers & Companion Diagnostics in the Era of Combination Cancer Immunotherapy
Synopsis
• bTMB CDx case study
• Biomarkers from liquid biopsies
• Exploration of biomarkers for combination of drugs in oncology
8:00 am The Digital Transformation of Pathology: Enabling Digital Pathology with a Platform Ecosystem
Synopsis
- An overview of Roche’s approach to digital diagnostics
- Why broad Digital Pathology adoption is at a tipping point
- How Roche is enabling digital pathology with an innovative platform ecosystem
8:30 am Validating a Digital Biomarker
Synopsis
• AI & wearable technology approaches being used to advance non-invasive means of biomarker testing to select a patient population
• How can we look at large datasets to identify risk factors for disease earlier on and develop predictive diagnostics to better understand the digital fingerprint of patients?
• Digital biomarker validation showing concordance with physical samples of biomarker readouts – achievements in validating biomarkers by collecting digital pieces of information and looking at correlations between liquid and digital readouts
9:00 am Pharma & Diagnostics for the Future of Precision Medicine: Together we can do More
Synopsis
• The importance of strategic partnerships & how to partner right
• How to choose the right diagnostic partner to enable broader patient access to the right therapeutics
• The key areas for consideration when developing a precision medicine & CDx strategy including IVDR, market access, broad patient access & technology longevity
9:30 am Panel Discussion: Diversity & Inclusion in Precision Medicine
Synopsis
• In the fast-paced precision medicine industry where innovation is key, this panel discussion will shed light on the efforts of precision medicine leaders to create and maintain diverse and inclusive workplace cultures
• With the exchange of experience and knowledge, all can tap in to the diverse talents and perspectives which propel innovations towards patients
10:00 am Structured Networking Break
Synopsis
• An opportunity to network, discuss and collaborate with precision medicine leaders passionate about advancing patient-centric progress within the field
Regaining Clarity from European Regulatory Expectations
10:45 am IVDR Implementation
Synopsis
• As we enter a new transition period, what is the current status of IVDR implementation?
• How can future regulatory changes enable co-approval and development of companion diagnostics?
• Connecting clinical and commercial planning to avoid delays to IVD-enabled innovative therapies reaching European citizens
11:15 am Impact of EU/UK IVD Regulatory Changes on Precision Medicine Development for the Pharmaceutical Industry
Synopsis
• How will the incoming EU and UK regulatory changes for IVDs and CDx impact precision medicine development?
• How will the UK will be aligned with Global and EU IVD and CDx Regulations?
• How will these changes be implemented and who is going to pay for them?
• How can internal pharma R&D and commercial teams prepare for compliance with these new regulatory changes?
11:45 am From Translational Research to CDx Development
Synopsis
• Veracyte Biopharma ATLAS: How to guide Biopharma’s biomarker strategy?
• How to identify predictive and/or toxicity signatures
• CDx development: How to integrate the new IVDR regulation?
12:15 pm The IVDR for Diagnostic Laboratories: Implications, Compliance Strategy & Useful Interactions
Synopsis
• Implication of IVDR Art. 5.5 for diagnostic laboratories
• Preparatory actions for diagnostic laboratories to reach IVDR compliance
• Useful interactions between IVD manufacturers and diagnostic laboratories regarding innovation, IP, clinical evidence and product portfolio
12:30 pm Diversity & Inclusion Networking Lunch
Synopsis
In the highly competitive precision medicine industry, it’s now more important than ever to prioritise D&I as a strategic objective to drive innovation. Join this networking lunch to hear how your industry’s efforts are making a difference on an individual & organisation-wide basis, then network with academic, biopharma & diagnostic leaders to discuss next steps to foster and recruit diverse leadership teams in addition to the next generation of diverse talent
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