Phase III clinical trials are required to prove the effectiveness and safety of a drug in a larger population. After decades of research, Alzheimer’s disease still has no disease-modifying drug that is approved as many of the drug development programs fail in later-stage phases. Phase III Alzheimer’s clinical trials face several challenges within imaging operations due to the complexity of the disease and the larger-scale studies. This webinar will address practices to reduce limitations within these operational processes, including:
- Site qualification optimization
- Investigator training
- Patient recruitment
- Radiological reads
Data management is particularly complex when dealing with large and complex data sets within Phase III trials; therefore, an effective data management platform is required to streamline the processes. This webinar will present the advanced TrialTracker platform for scaling-up processes and systems to manage imaging data, from radiological read workflow to imaging data analysis. Optimised analysis of imaging data is vital for ensuring that the outcomes of the clinical trials are accurately measured and significantly impacts the success and progression of the clinical study. Therefore, this webinar will additionally cover the AI-driven LEAP platform.
Speakers
Roger Bullock, Chief Medical Officer, Oryzon
Dr. Roger Bullock completed his pre-clinical medical training at Keble College, Oxford University, gaining a BA (Hons) in Physiological Sciences in 1978 (converted to MA in 1985). This was followed by clinical medical training at St Bartholomew’s Hospital in London where he gained the MB.BS in 1981. In 1990, he specialized in psychiatry, gained membership of The Royal College of Psychiatry and undertook postgraduate psychiatric training including higher specialist training in geriatric psychiatry which concluded in 1993.
Dr. Bullock is considered a world KOL in the space of neurodegenerative diseases. He has extensive experience as clinical researcher, having participated in more than 70 clinical trials in Alzheimer’s disease and other CNS conditions. Over his 30-year research career, he has authored and co-authored more than 100 peer-reviewed publications and book chapters in this domain and presented at numerous conferences. Recently he has been working as a consultant for companies active in the CNS space, including Lilly and Merck.
Message Presenter
Shona Clegg, Associate Director Client Services, IXICO
Shona Clegg has over 17 years MRI research/clinical trial experience, spanning all four phases of clinical trials. Previously worked at the Dementia Research Centre, University College London (UCL) gaining experience in analysis of MR imaging and team leadership, including thorough understanding of imaging trials and the potential confounding factors/complications.
Clegg joined IXICO in March 2016, managing projects including MRI, dMRI/ DTI, functional MRI, and PET imaging across a range of Alzheimer’s, Progressive Supranuclear Palsy and Parkinson’s disease studies. Clegg is also the lead project manager for wearables studies at IXICO. As a Portfolio Lead, Clegg maintains study oversight for her assigned portfolio to ensure study deliverables are met within the agreed timelines and budget.
Message Presenter
Richard Joules, Imaging Science Manager, IXICO
Richard Joules has over seven years’ experience working in imaging both in an academic and commercial setting. Holds a PhD from Kings College London in neuroimaging, assessing the application of machine learning to pharmacological resting state fMRI.
Joules has worked in a range of therapeutic areas, such Alzheimer’s Disease, Huntington’s Disease and Progressive Supranuclear Palsy, to develop methods for biomarker detection and disease monitoring. As the current imaging science manager at IXICO, he is responsible for the deployment and monitoring of analysis solutions in clinical trials.
Message PresenterWho Should Attend?
This webinar is suitable job titles in the following departments:
- CMO, CSO, CIO
- Heads of: R&D, Clinical Research, Clinical Development, Clinical Operations
- TA Head/Lead
- Clinical Lead
- Clinical Scientists
- Imaging Scientist
- Biomarkers Scientists
- Study/Project Manager
- Protocol Manager
- Study Startup
- Procurement/Outsourcing
What You Will Learn
- An overview of imaging biomarkers in Alzheimer’s clinical trials
- Addressing the challenges in imaging operations for Phase III Alzheimer’s clinical trials
- Streamlining imaging operations: from site qualification to data management
- Harnessing LEAP AI technology to advance segmentation and volumetric analysis
Xtalks Partner
IXICO
IXICO is a medical data company, providing data management and advanced analytics to the clinical trials market. Established in 2004, IXICO has firmly established itself as a trusted partner to the global pharmaceutical industry developing new therapies for neurological conditions such as Alzheimer’s, Parkinson’s and Huntington’s diseases.
Our purpose is to advance medicine and human health by turning data into clinically meaningful information, providing valuable new insights in neuroscience and our goal is to be a leading proponent of artificial intelligence in medical image analysis. We will achieve this by developing and deploying breakthrough data analytics, at scale, through our remote access technology platform, to improve the return on investment in drug development and reduce risk and uncertainty in clinical trials for the pharmaceutical industry.
Our integrated technology offering encompasses every stage of clinical drug development through to post market assessment and we continue to invest in infrastructure and innovation to support our ambitious growth strategy. We are dedicated to addressing complex unmet needs in clinical development by partnering and collaborating with clients and academic experts early in the drug development cycle to identify and validate promising new imaging and digital biomarkers and to support the clinical development of new drug assets all the way through to commercialisation.
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