Accelerating R&D to Commercialization by Leveraging Predictive Biomarkers & Clinical Diagnostics Evidence for Best Patient Outcomes in Target Populations
The 11th World Clinical Biomarkers & CDx Summit returns in 2021 as the only end-to-end industry-led meeting diving deep into the science of transitioning biomarkers to the clinic, their clinical validation and later commercialization with a CDx.
With over half of drugs approved by the FDA now supported by a biomarker and as new CDx collaborations are announced on an almost weekly basis, demand for diagnostic tools enabling earlier, more precise, therapeutic interventions is at an all time high. Join with 650+ key stakeholders across biomarker, translational, clinical, regulatory and commercial functions to tackle end-to-end challenges and deliver game-changing drug-Dx products to market.
Across 2 days of comprehensive content, 65+ global expert speakers will share fresh data paired with inspiring stories from innovative partnership collaborations to help you overcome your most pressing challenges and accelerate curative medicine for heterogeneous patient populations.
With 3-tracks addressing the entire lifecycle of biomarker-driven drug development, explore biomarkers and Dx movement within bioanalytical analysis, AI/ML application, data sharing and the regulatory and payer landscape. Covering immune-oncology, neurodegenerative, metabolic, autoimmune and rare indications, gain a diverse picture of today’s expanding personalized medicine ecosystem.
This is your unmissable event, bringing you the tools, insights and techniques to design a clinically robust biomarker and commercially competitive CDx!
Returning to a three-tracked format, World CB & CDx is designed to be your organization’s one-stop-shop for end-to-end insights across the spectrum of precision medicines drug development.
Here’s what you can get involved in:
- Identify and overcome obstacles in end-to-end CDx development
- Apply new digital approaches and accelerate diagnostic and prognostic biomarker development
Gold Track: Moving Biomarkers Towards the Clinic
- Leverage predictively valid disease models and advance biomarkers towards the clinic
- Develop validation plans predicting a biomarker’s utility in clinical development
Red Track: Clinical Biomarker & Assay Development
- Maximize clinical outcomes with earlier CDx planning and MRD monitoring
- Be prepared for regulatory assessment with defined patient populations, precise assay selection and clinical cut off points
Blue Track: Drug-Dx Co-Development & Commercialization
- Develop and commercialize a competitive Drug-Dx and maximize global access
- Demonstrate clinical utility and secure optimal reimbursement
Your Plenary Speakers
Gathered by the aim of getting the best option to the right patient as quickly and efficiently as possible, unite with the 1000+ of your precision medicine peers to explore precision medicine opportunity to treat diverse populations, end-to-end CDx development case studies, latest diagnostic interventions reaching the market and biopharma’s efforts to maximise the utility of data.
Moving Biomarkers Towards the Clinic Speakers
Support your early biomarker discovery and development through robust analytical validation and effectively validate and translate assays to make the clinical transition. Meet leaders challenging complex disease heterogeneity across immune-oncology, metabolic, autoimmune and neurodegenerative disease with NGS, organoid modelling, multi-omics and comprehensive data collection.
Global CoDx Market Access Director
Senior Director, Regulatory Affairs (CDx)
Executive Director, Head of CDx Marketing (US)
Senior Research Analyst for Medical Policy & Technology Evaluation
Independence Blue Cross
Director, Biomarker Sciences
Clinical Biomarker & Assay Development
Draw actionable insights from clinical data to establish an effective trial strategy and inform treatment decisions making an impact in target populations. Showcasing data from small molecules, T-cell therapies, bispecific antibodies and neoantigen studies, and featuring the latest on liquid biopsy and genomic analysis, determine your clinical cut-offs with confidence.
Chief Medical Officer
Chief Executive Officer, Chief Medical Officer
Head of CDx Cell & Gene Therapies Oncology
Director, Global Regulatory Affairs, Medical Devices
Senior Director of Immuno–Oncology
Pieris Pharmaceuticals GmbH
Develop, identify and validate the technologies you need to obtain optimal results from your trials then establish effective internal and external stakeholder collaboration to expedite drug-Dx commercialization whilst optimizing reimbursement. Apply expert practical knowledge to navigate the fast-growing CDx market delving into case studies across oncology in addition to emerging gene therapy and rare disease, and gain a picture of the real-world-evidence and patient perspectives broadening assay adoption.
Director, Pharmacology/ Translational Medicine
Associate Director & Head of Translational Genetics
Branch Chief, National Center for Toxicological Research
US Food & Drug Administration
Vice President, Head of Translational Medicine
President & Founder