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
RSVP to Reserve Your Seat
Hear and discuss a case study from Pfizer – The Gender Pay Gap is Made for Closing!
Synopsis
- Breakthroughs that change patients’ lives is our purpose and central to everything we do at Pfizer.
- We strive to create a workplace that attracts and retains the best talent and allows every colleague to flourish.
- Closing the gender Pay Gap plays a big role in this and Dagmar will share Pfizer’s strategy, how they measure the progress made and how they inspire and engage their colleagues
Followed by focused networking over lunch on championing ED&I in all that you do.
12:30 pm Expo & 121 Meetings
Synopsis
An opportunity to meet and converse with industry’s leading solution and service providers. Gain first-hand insight to enable the better identification of partners with capabilities to advance your end-to-end biomarker development
Interactive Roundtable Sessions: IVDR & Planning Your Next Steps
Synopsis
Hear from experts on IVDR implementation clinical and commercial considerations, then join roundtable discussions to converse with your peers on planning your next steps in a changing regulatory landscape.
1:30 pm IVDR Requirements for Performance Studies: Planning for Clinical Studies with New Regulations on the Horizon
Synopsis
• Submitting an application for a performance study
• Performance studies that require authorisation
• Potential impacts on clinical studies (both running and new)
• Other strategic considerations
Developing Biomarkers to Define Your Patient Population with Superior Efficacy
Intervening Earlier via More Accessible Biomarker Testing
Track Chair: Rafael Rosengarten, Chief Executive Officer, Genialis
2:15 pm Oxidised Macrophage Migration Inhibitory Factor (oxMIF): A Novel Biomarker & ImmunoOncology Therapeutic Target for Precision Medicine
Synopsis
• OxMIF is the disease-related isoform of macrophage migration inhibitory factor (MIF) and an exciting drug target for cancer diagnosis and immunotherapy
• Key concept: a strategic companion diagnostic approach to enhance the success of clinical development plans by co-development of a therapeutic anti-oxMIF antibody and a radioimmune diagnostic to treat patients with solid tumours
• Candidate antibodies were engineered on key features, such as efficacy, tumour penetration, pharmacokinetics and dosimetry
2:45 pm Combining the Power of ctDNA and Real-World Data to Optimize Clinical Development
Synopsis
• How a circulating tumor DNA (ctDNA) assay can be used in clinical trials to (1) stratify and enrich for patients most likely to benefit from additional therapy and (2) monitor therapy response for early prediction of efficacy
• Latest case studies combining ctDNA and real-world data to optimize and accelerate clinical development and maximize likelihood of clinical trial success
3:15 pm Ultrasensitive ctDNA Analysis in Monitoring Treatment Efficacy: Technical & Clinical Aspects
Synopsis
• Many cancers lack recurrent mutations, rendering generic hotspot panels unsuitable for disease monitoring using liquid biopsies
• Ultrasensitive sequencing and patient-specific ctDNA panels allow sensitive and robust longitudinal monitoring of disease- and treatment progression
• Multiomic approaches improve sensitivity and specificity to detect disease
1:30 pm
Minimising Impacts of IVDR on Your Portfolio
Synopsis
• How can future regulatory changes enable co-approval and development of companion diagnostics?
• What is important to streamline device approval with a notified body?
• Key learnings from CDx approval projects so far in Europe
Regaining Clarity from European Regulatory Expectations cont.
Track Chair: Isabella Gashaw, Principal Clinical Biomarker Lead, Cardiometabolism, Boehringer Ingelheim
2:15 pm Navigating Global Regulatory Compliance for Companion Diagnostics in Precision Medicine Studies
Synopsis
• Understanding and meeting local Dx regulations
• Considerations for LDT’s used for patient selection
• How to conduct Study Monitoring for successful submissions
Preparing the Market for New Biomarkers
2:45 pm Creation & Implementation of Diagnostic Strategies to Bring Innovative Therapies Towards the Clinic
Synopsis
• Fostering close industry collaborations with diagnostic partners
• Designing market-leading CDx strategies for launch in Europe
• Align drug and CDx labels globally
3:15 pm Clinical Trial Assay Development & Validation: Strategies for Success
Synopsis
• Key considerations in the development & validation of CTAs for clinical stratification
• The importance of adequate specimen collection & stabilisation
• Major factors influencing platform selection
• The requirement of bridging studies and lessons learned
• Challenges of demonstrating adequate analytical performance of panels
• Considerations for data analysis pipelines
3:45 pm Afternoon Networking Break
Synopsis
• Utilise this opportunity to converse with tech leaders & meet your discovery, translational, clinical, commercial, regulatory & market access peers you weren’t able to catch up with earlier!
Enhancing Clinical Trial Design & Tools to Expedite Regulatory Approvals
4:15 pm Identifying Predictive Biomarkers for Immuno-Oncology Therapeutics
Synopsis
• Given the large number of novel IO agents and combination clinical trials being run, what is needed to harmonize biomarkers for the medical community?
• Where is progress being made in developing analytically and clinically validated assays?
• What impact does new predictive biomarker identification have on commercial potential of novel therapeutics?
4:45 pm Panel Discussion: Incorporation of Artificial Intelligence into Clinical Development Strategy: Best Practices & Pitfalls
Synopsis
• What are some potential advantages that AI can confer to clinical development programmes?
• When might an AI algorithm work better than a traditional statistical approach as a diagnostic, and when might it be unnecessary or inappropriate?
• What additional work or risks are involved in developing an AI-based algorithm to support clinical development?
• How do regulatory bodies consider AI within diagnostic devices, and how is this perspective evolving?
• If we get it right with AI, what does that mean for the future of diagnostics and clinical development?
5:15 pm Enabling Digital Biomarkers Through a Regulated Platform
Synopsis
- How new digital biomarkers and endpoints may deliver previously unharnessed insights
- How deploying a regulated platform approach can integrate sources of biomarker data to develop validated solutions
- Best practices on how one may leverage clinical relevant data to adhere to regulatory obligations
- How to employ the mechanism and framework necessary to align stakeholder input
5:45 pm Developing a DKK1 RNAscope Biomarker Assay for DKN-01 Patient Stratification
Synopsis
• Justifying the mechanistic rationale for neutralising DKK1 in oncology
• Delving into the development of a DKK1 RNAscope biomarker assay
• Sharing results from Leap Therapeutics’ DisTinGuish clinical trial
6:15 pm First-in-Human Clinical Trial with Intratumoral PeptiCRAd-1 in Combination with Pembrolizumab: Assessment of Safety & Immunological MoA
Synopsis
• PeptiCRAd technology combines OV and peptide vaccine providing a flexible therapeutic vaccine platform focused on generating cytotoxic T cell responses
• First-in-human clinical trial in combination with PeptiCRAd-1 and pembrolizumab starting early 2022
• Extensive immune monitoring planned for the assessment of MoA and biomarker identification
Emerging Technologies Entering Global Markets
4:15 pm Fireside Discussion: Emerging Trends in the Use of Multimodal Data, & how Pharma is Leveraging it Across Different Stages of Clinical Development
Synopsis
• Overview of Tempus’ life science offering and multi-year, strategic collaborations with pharma
• Transforming cancer drug discovery and clinical development using vast amounts of multimodal data and artificial intelligence
• Taking a data-driven approach to gain critical insights that will deepen our understanding of complex tumor biology
4:55 pm Getting Decentralised Testing into Routine Clinical Oncology Using High-Performance Genetic Multiplexing
Synopsis
- Digital PCR is an accessible, easy-to-use technology that deploys seamlessly across labs in the liquid biopsy space
- Assay standardization democratizes this tool for the absolute quantification of ctDNA, supporting the practical clinical development of biomarkers
- Fast turnaround times, higher multiplexing, and increased sensitivity – all without the need for outsourcing of samples – can bring uncompromised real-time oncology diagnostics
5:25 pm Regulation Panel Discussion: Scaling a Biomarker Test to Global Markets
Synopsis
• Discussing the nuances in regulatory approvals and launching drug & diagnostic products in different markets (US, EU, APAC)
• The importance of China as a market and why industry should come together more to discuss streamlining infrastructure planning and data handling protection to lower costs and planning time when launching biomarker-driven drug programmes
6:45 pm
Drinks Reception: Introducing the 12th Clinical Biomarkers & CDx Summit Awards!
Synopsis
The inaugural Clinical Biomarkers & CDx Summit Awards is an opportunity to recognise and celebrate the best ground-breaking work across biomarker-driven and diagnostic-enabled drug development. Celebrate rising stars from the most innovative assay development to most novel diagnostics transforming the precision medicine industry! With a panel of expert judges shortlisting finalists, you can have your say to award commendations to the companies, teams and individuals whose work you admire.
