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 revolutionizing patient disease progression projection and finding their way into optimized diagnostic research criteria for population enrichment. Nonetheless, clinical outcome parameters such as rating scales, but 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.
Join the featured speakers as they discuss how these new innovations in CNS clinical trials are overcoming traditional high failure rates and accelerating drug development.
Register for this webinar to learn how biomarkers and digital tools are improving clinical trials in neurodegenerative diseases.
Speakers
Dr. Peter Schüler, MD, Senior Vice President, Drug Development Services, ICON
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 Senior 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 the 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 the Past-President of the German Society for Pharmaceutical Medicine.
Message Presenter
Prof. Günther Höglinger, Munich Center for Neurosciences
Prof. Günter Höglinger is the Director of the Department of Neurology at Ludwig-Maximilians-Universität (LMU). He also serves as Senior Scientist at the German Center for Neurodegenerative Diseases (DZNE) and is a Principal Investigator at the Cluster of Excellence for Systems Neurology (SyNergy) in Munich, Germany.
Previously, he was Deputy Director of Neurology at Philipps University of Marburg and held the Chair of Translational Neurodegeneration at both the Technical University of Munich and DZNE Munich. He also led the Department of Neurology at Hannover Medical School. Dr. Höglinger serves on the Scientific Advisory Board (SAB) of the CurePSP Foundation and is chair of the SAB for the German Parkinson Foundation.
His research focuses on neurodegenerative diseases characterized by pathological protein aggregation, including alpha-synuclein-related conditions like Parkinson’s disease, Lewy body dementia, and multiple system atrophy, as well as tauopathies like frontotemporal dementia, progressive supranuclear palsy, and corticobasal degeneration. His work emphasizes understanding susceptibility and resilience factors, identifying biomarkers, and developing therapeutic interventions. He is a leading expert in clinical trial design, focusing on evaluating the safety and efficacy of disease-modifying molecular interventions.
Message Presenter
Who Should Attend?
This webinar will appeal to:
- 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
What You Will Learn
Attendees will:
- 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 more holistic approaches
Xtalks Partner
ICON
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.
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