Generating meaningful clinical insights as early as possible is a growing priority in neurodegenerative disease development. To support faster and more informed decision-making, sponsors are increasingly implementing innovative first-in-human study designs that integrate multiple objectives, streamline development pathways, and enable earlier evaluation in patients. These approaches can also help address ethical and tolerability challenges that may limit traditional healthy volunteer studies.
In this webinar, we will explore the opportunities and challenges associated with these strategies, highlighting examples from neurodegenerative disease therapeutics and discussing:
- Getting the basics right: Study objectives and population selection
- Bringing the patient voice into early development
- Biomarkers as decision-making tools in neurodegenerative development
Speakers
Paula Kopschina Feltes, Ph.D.
Paula is a Senior Manager, Solutions Architect at ICON. Before joining ICON, Paula was a researcher in brain PET imaging at the University Medical Center Groningen (UMCG) in The Netherlands, holding a double-PhD in the field. She has worked on many investigator-initiated research as well as partnerships with the industry in clinical trials for major pharma companies. Within ICON, Paula performs feasibility assessments for early phase clinical trials and acts as a subject matter expert in Nuclear Medicine, where she provides guidance and consultancy for customers on optimal trial design, clinical conduct and scientific advice.
Matthias Mohse, Dipl.-Psych
Matthias is a Director of Drug Development Services at ICON. He provides drug development guidance to customers, including trial design optimisation, dose selection, advice regarding safety, PK and PD, eligibility criteria, risk mitigation, and practical aspects of the study conduct. Matthias has a strong neuroscience background, extensive CNS research methodology experience, and a passion for experimental disease models and their utilisation for proof of mechanism.
Target audience
The target audience for this webinar includes clinical researchers, drug development professionals, and scientists involved in early-phase clinical trials focused on neurodegenerative diseases. It is particularly intended to raise interest and stimulate innovation in patient engagement strategies, study design optimisation, and biomarker selection in first-in-human and early clinical development settings.
Ideal attendees
- Clinical pharmacologists and trial designers working on neurodegenerative disease therapeutics
- Medical scientists and researchers specialising in CNS disorders and biomarker development
- Patient engagement and advocacy professionals seeking to improve recruitment and retention in early trials
- Regulatory affairs specialists interested in strategic biomarker implementation for trial approval
- Pharmaceutical and biotech industry professionals involved in early clinical development and feasibility assessments
- Clinicians and translational researchers focusing on patient-centric trial methodologies and outcomes