Using patient-centric trial design and biomarker insights to support confident development decisions
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.
This webinar will explore the opportunities and challenges associated with these strategies, highlighting examples from neurodegenerative disease therapeutics and discuss:
- Getting the basics right: Study objectives and population selection
- Bringing the patient voice into early development
- Biomarkers as decision-making tools in neurodegenerative development
Register for this webinar to learn how early clinical trial design, patient involvement and biomarker strategies can support more informed development decisions in neurodegeneration.
Speakers
Paula Kopschina Feltes, PhD, Senior Manager, Solutions Architect, ICON
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 studies 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 serves 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.
Message Presenter
Matthias Mohse, Dipl-Psych, Director of Drug Development Services, ICON
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.
Message PresenterWho Should Attend?
The session will benefit 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 optimization, and biomarker selection in first-in-human and early clinical development settings.
- Clinical Pharmacologists and Trial Designers working on neurodegenerative disease therapeutics
- Medical Scientists and Researchers specializing 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
What You Will Learn
Attendees will gain insight into:
- Optimizing study objectives and patient selection in early clinical trials
- Incorporating the patient voice into early development
- Using biomarkers to support development decisions
- Addressing ethical and tolerability challenges in first-in-human studies
Xtalks Partner
ICON
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, they advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. They develop new innovations, drive emerging therapies forward and improve patient lives. Their 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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