Clinical trials for central nervous system (CNS) conditions have historically been notoriously difficult for a myriad of reasons with a failure rate for new drugs being very high relative to other therapeutic areas. This has caused the industry to think long and hard about remaining or entering this space. Yet the need for novel therapies to slow down or halt disease progression has never been more urgent.
Using a variety of neuroscience tools and techniques at the Phase I or first-in-human (FIH) phase of the drug development pipeline, it is possible to gather the data and insights needed to build a detailed picture of the CNS effects of drug candidates. This data can help to build a business case for future CNS clinical trials.
This webinar will provide an overview of the utility of neuroscience techniques, specifically electrodiagnostic markers (EDMs), for measuring target engagement in FIH clinical trials. The speakers will use examples to discuss the application of neuroscience techniques to measure and record target engagement and measure dose response in clinical trials investigating CNS-active drugs.
Register for this webinar to learn about the practical considerations of building neuroscience into CNS clinical trials.
Dr. Roisin McMackin, Postdoctoral Fellow, Academic Unit of Neurology, Trinity College Dublin
Now a postdoctoral fellow at Trinity College Dublin’s Academic Unit of Neurology, where she works within the Signal Analysis team, Dr. Roisin McMackin obtained her PhD in Clinical Medicine for investigating electrophysiological biomarkers of ALS and is a junior non-clinical research fellow of the UK Motor Neurone Disease Association.
Roisin’s research applies the use of EEG and TMS to investigate the change in neural networks in ALS, build on current understanding of the mechanism of ALS and enhance categorisation of different clinical presentations of ALS. Her research and the use of TMS-EEG has broader application in measuring changes in other neurodegenerative diseases and the development of therapeutic drugs.
Dr. Simon Hutchings, Director of Pharmacology, Simbec-Orion
Dr. Simon Hutchings has over 15 years of experience in the drug development process, including preclinical pharmacology/toxicology, Phase I (including first-in-human) pharmacology/PK studies and investigator-led Phase II and Phase III trials. In addition to undergraduate and postgraduate qualifications in pharmacology, Simon also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine (Royal College of Physicians) and a Certificate in Regulatory Affairs, University of Hertfordshire.
Tonia Smreczak, Managing Director, The Science Behind
Tonia is the Managing Director of The Science Behind, a company that helps CROs and sponsors meet some of the challenges of CNS clinical trials. By combining neuroscience, neurology and psychology expertise with access to hardware, The Science Behind brings innovative methods for studying the effects of CNS-active drugs in early-phase clinical trials.
Who Should Attend?
This webinar will appeal to:
- Chief Medical Officers
- Project Managers/Directors
- Clinical Operations Managers/Directors
- Heads/Directors of Clinical Development
What You Will Learn
The audience can expect to learn:
- An overview of the utility of neuroscience techniques, specifically electrodiagnostic markers (EDMs), for measuring target engagement in FIH clinical trials
- What EDMs are, how to measure them and what they can indicate
- Some of the practical considerations of building neuroscience into clinical trials
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Simbec-Orion offers clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post-marketing studies. With a focus on tailormade and scalable solutions, Simbec-Orion adapt delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives.