7:00 am Registration & Welcome Coffee

7:20 am Chair’s Opening Remarks

  • Isabella Gashaw Principal Clinical Biomarker Lead, Cardiometabolism, Boehringer Ingelheim

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

  • Michael Rivers Vice President and Lifecycle Leader, Digital Pathology, Roche Tissue Diagnostics

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

  • Matt Nelson Senior Director, Companion Diagnostic Partnering, Illumina
  • Flora Berisha Head of Dx Strategic Partnering, Oncology, Janssen, Global R&D

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

  • Patrick Fivey Director of Precision Medicine Policy, AstraZeneca

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

  • Fabienne Hermitte Senior Vice President, Global Quality & Regulatory Affairs & Head of Medical Affairs, Immuno-Oncology, Veracyte

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

  • Chris Bray Head Global Regulatory Affairs, Precision Medicine and Companion Diagnostics, Merck KGaA

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

  • John Simmons Global Vice President, Biopharma Business Development, Natera

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

  • Gillian Livock Senior Vice President & GM, Connected Sensors and Digital Measures, Medable

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

  • Sari Pesonen Co-Founder & Chief Scientific Officer, Valo Therapeutics

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

  • Jonathan Dry Vice President, Scientific Discovery, Tempus
  • Una Pipic Senior Vice President, International Oncology , Tempus Labs

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

  • Clément Gay Director of Business & Corporate Development, Stilla Technologies

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.