Biomarkers are transforming the landscape of clinical trials, offering innovative solutions to enhance the accuracy, efficiency, and success of trials in neurodegenerative diseases such as Alzheimer’s and Parkinson’s. This webinar will explore innovative strategies and lessons learned for improving the success of clinical trials, including the integration of imaging, wet, genetic and digital biomarkers. Such objective data are revolutionising patient disease progression projection and find their way into optimized diagnostic research criteria for population enrichment. Nonetheless, clinical outcome parameters such as rating scales, but more and more also digital endpoints, are the gold standard as primary endpoints for marketing authorization. Clinical research sites are crucial in adapting to these advancements, from early phases of drug development for early decision making to pivotal trials, ensuring seamless integration of such tools and enhancing patient engagement.
What you’ll learn:
- Understand the role of biomarkers—including imaging, wet, genetic, and digital—in enhancing the accuracy and efficiency of clinical trials for neurodegenerative diseases.
- Explore strategies for integrating biomarkers into early-phase CNS clinical trials to improve patient diagnosis and treatment evaluation.
- Apply best practices to improve the success rates in trials, such as central readers, optimized scales, placebo-minimization and adherence to medication measures
- Identify the evolving role of clinical research sites in adopting and implementing such more holistic approaches.
Who should attend:
- Clinical Trial Managers / Directors
- Clinical Operations Leads
- Principal Investigators
- Medical Directors / Clinical Development Leads
- Neuroscience Researchers
- Biomarker Scientists
- Regulatory Affairs Specialists
- CNS Drug Development Professionals
- Patient Engagement Managers
- Pharmaceutical and Biotech Executives
Join our global experts as they discuss how these new innovations in CNS clinical trials are overcoming traditional high failure rates and accelerating drug development.
Speakers:
Dr. Peter Schüler, MD
Dr. Peter Schüler, MD, is board certified in Neurology, Neurophysiology and in Pharmaceutical Medicine and certified in Business Administration (Henley College, London). After his academic career at University Hospital Erlangen, Germany, he joined Pharmacia as Head Medical Affairs CNS for the German-speaking countries in 1995 and moved into the CRO business in 2000. In 2015 he was appointed Sr VP Drug Development Solutions Neurosciences at ICON.
He was involved in the design and conduct of various proof-of-concept, dose-finding and pivotal studies in nearly all CNS indications. He is editor of the Elsevier textbooks “Re-engineering clinical trials” in 2015 and in 2020 of “Innovation in Clinical Trial Methodologies”. He lectures Pharmaceutical Medicine at the ECPM of Univ. Basel, Switzerland and is Past-President of the German Society for Pharmaceutical Medicine.
Prof. Günther Höglinger
Tim Buchanan