Join our webinar to explore how digital endpoint solutions accelerate breakthroughs in psychiatric drug development. Learn how electronic clinical outcome assessments (eCOA), medical imaging, and cardiac safety monitoring enhance trial accuracy, improve patient experience, and drive innovation in psychiatric clinical trials. Discover the impact of cutting-edge technologies on advancing mental health treatments.
- eCOA: As a commonly used primary endpoint in psychiatric drug development, reliable COA data collection is crucial. Attendees will get to learn how common challenges like placebo response, rater drift and poor patient selection can be successfully overcome through the utilization of science-led eCOA and complemented by rater training, in-stream data surveillance and patient education programs
- Medical Imaging: Psychiatric drug development requires precise characterization of disease state and its relation to brain biometry and function. Attendees will get to explore how functional magnetic resonance imaging (fMRI) is unlocking insights into brain activation patterns in disorders like major depressive disorder (MDD), post-traumatic stress disorder (PTSD) and schizophrenia, and how specific biomarkers enhance trial design and target engagement.
- Cardiac Safety: Many psychiatric therapies have off-target inhibitory effects on cardiac ion channels that produce electrocardiogram (ECG) changes, implicating a risk for proarrhythmia. Understand the importance of 12-lead and continuous ECG monitoring in managing cardiac risks associated with psychiatric therapies, including impacts on blood pressure, and on adverse cardiac events.
By integrating these advanced methodologies, researchers can overcome common challenges, improve data accuracy and enhance decision-making in psychiatric drug development.
The attendees will also get to learn about effective strategies to combat placebo responses and maximize trial success by implementing real-time data surveillance and developing tailored patient education programs to improve participant engagement and compliance.
Register for this webinar today to explore how digital endpoint solutions like eCOA, medical imaging and cardiac safety monitoring are revolutionizing psychiatric drug development.
Speakers
(Moderator) Dr. Todd Rudo, MD, Chief Medical Officer, Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Message Presenter
Dr. Prateek Verma, MD, Director, eCOA Science & Consulting, Clario
Dr. Prateek Verma is an MD with more than 20 years’ experience in clinical research. He has served as a Clinical Investigator in global neuro-psychiatry clinical trials. Dr. Verma has worked extensively in areas of AD, schizophrenia, MDD, bipolar, dementia, other behavioral disorders, infectious diseases and dermatology.
Dr. Verma has also held advisory position for NIHR research design services and primary mental health clinical trials unit (PRIMENT) whilst working for Medical Research Council, UK, and University College London. He presently oversees eCOA design, investigator training and outcome analysis activities in global psychiatric, neurology and non-CNS indications and serves as an expert presenter at global investigator meetings and mentors scientific staff too.
Message Presenter
Dave Scott, PhD, Vice President, Medical & Scientific Affairs, Neuroscience, Clario
David Scott, PhD, is Vice President, Medical and Scientific Affairs at Clario. His aim is to facilitate drug development through standardized measurement of the neural correlates of neurodegenerative and other centrally mediated diseases.
As a student at Johns Hopkins University and the University of Michigan, he employed multi-modal imaging approaches, including dynamic PET and functional MRI to study the neurobiology of placebo analgesia. At Omneuron, he developed real-time fMRI applications aimed at treating chronic pain, depression and addiction.
Read more...
Read Less...
Dr. Alain Gay, MD, Senior Cardiologist, Cardiology, Clario
Dr. Alain Gay, MD, is board-certified in cardiology. After completing his training as a Cardiologist at the Hopital Cardiologique in Lille, France, Dr. Gay practiced for 10 years in a community hospital and completed his training in cardiac electrophysiology and cardiac pacing.
Dr. Gay then moved into drug development and medical affairs studies for 15 years at Bayer. He contributed to establishing study standards in heart failure and contributed to the prelaunch and launch of both Xarelto® and Kerendia®. At Clario, Dr. Gay is a contributor to the ECG core lab, also reading Holters and other recording devices. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.
Who Should Attend?
This webinar will appeal to:
- CEOs/Chief Medical Officers/Chief Scientific Officers
- Clinical operations/Clinical development/Clinical research
- Clinical Pharmacologists/Clinical Scientists/Imaging Scientists
- Medical Affairs
- Medical Monitor
- TA Experts in Neuroscience
- TA Experts in major depressive disorder (MDD)
- TA Experts in psychiatric drug development
What You Will Learn
Attendees will learn about:
- How to improve data accuracy in psychiatric drug development with digital endpoints
- Discover strategies to tackle placebo response and rater drift using science-led eCOAs and expert rater training
- The use of fMRI for identifying biomarkers and understanding MDD, PTSD and schizophrenia
- How continuous ECG monitoring can help detect and manage cardiac risks in psychiatric therapies
Xtalks Partner
Clario
Clario is a leading healthcare research and technology company that generates the highest quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account