7:00 am Registration & Welcome Coffee

7:40 am Chair’s Opening Remarks

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

7:50 am Next-Generation Biomarkers & Companion Diagnostics in the Era of Combination Cancer Immunotherapy

  • Mohini Rajasagi Senior Director Translational Oncology & Clinical Biomarkers, MSD

Synopsis

• bTMB CDx case study
• Biomarkers from liquid biopsies
• Exploration of biomarkers for combination of drugs in oncology

When Companion Diagnostics are Needed

8:20 am Precision Medicine Beyond Oncology

  • Maria Orr Head of Precision Medicine Biopharmaceuticals, AstraZeneca

Synopsis

• Outline the application and need for precision medicine in the non-oncology space
• Share examples of the development and delivery of precision medicines in a range of non-oncology disease indications
• Drawing on experiences and lessons learnt from recent pipeline developments

8:50 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

9:15 am With Additional Plenary Expertise Talks By:

9:20 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

Session Chair:

  • Claudia Dollins Executive Director, Regulatory Affairs, Companion Diagnostics & Precision Medicine, Bristol Myers Squibb

10:00 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

10:30 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?

11:00 am The IVDR for Diagnostic Laboratories: Implications, Compliance Strategy & Useful Interactions

  • Bart Lubbers Project Manager, European Scientific Foundation for Laboratory Hemato Oncology

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

11:15 am 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

11:15 am 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

12:15 pm 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.

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

1:00 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

1:30 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

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

Drug-Dx Co-Development & Commercialisation Planning for Maximised Access

Preparing the Market for New Biomarkers Track Chair: Isabella Garshaw, Principal Clinical Biomarker Lead, Cardiometabolism, Boehringer Ingelheim

1:00 pm Are Markets Ready to Accept New Biomarker Developments Outside Oncology?

Synopsis

• The increased interest in biomarker application in precision medicine beyond oncology – what does this mean to regulatory agencies and clinical guideline updates?
• Planning education and awareness programmes to establish biomarkers when these aren’t normally tested for
• Comparison between biomarker implementation in oncology, highlighting distinctions between planning and key learnings from established biomarkers

1:30 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

2:00 pm Tech Slam: Live Demonstrations Featuring Today’s Cutting Edge Biomarker Tech

Synopsis

• Hear latest biomarker discovery, development & diagnostic solution advancements in a succession of quick demonstrations followed by networking
• Get acquainted with the newest innovations to remain up to speed with latest progress and technologies reaching the market

2:30 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

3:00 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?

3:30 pm Developing a DKK1 RNAscope Biomarker Assay for DKN-01 Patient Stratification

  • Michael Kagey Senior Director of Translational Medicine, Leap Therapeutics

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

4:00 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

4:15 pm Additional Biomarker Development Talks by:

Emerging Technologies Entering Global Markets

3:00 pm Regulation Panel Discussion: Scaling a Biomarker Test to Global Markets

  • Philipp Schatz Regulatory Strategist IVD, Bayer
  • Svetlana Mukhina Associate Director, Global Regulatory Affairs, CDx, Merck KGaA
  • Claudia Dollins Executive Director, Regulatory Affairs, Companion Diagnostics & Precision Medicine, Bristol Myers Squibb
  • Nathalie Pechoux Global Oncology Marketing Director, Portfolio Companion Diagnostic Strategy, GlaxoSmithKline

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

“Fantastic organisation along with facilitation of effective networking. Conference content well thought through covering major discussion points within the field of Companion Diagnostics & Clinical Biomarkers.”

Additional Drug-Dx & Commercialisation Pathway Talks by:

4:30 pm
Welcome to 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.