Lessons Learned in Neuroscience Drug Development:
How Biomarker-based, Evidence-driven Decisions Enable Successful Outcomes
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About this webinar
Early-phase neuroscience trials have traditionally focused primarily on establishing safety and tolerability. From Alzheimer’s disease to psychiatry, early development strategies can also generate meaningful evidence of target engagement and potential drug efficacy to inform future investment decisions. While trials in these indications enroll distinct populations with distinct challenges, both require the same fundamentals: understanding and demonstrating meaningful target engagement to build confidence in future development decisions. This webinar explores how evidence-driven biomarker and endpoint strategies can strengthen early neuroscience clinical trials and inform development decisions.
The featured panelists will explore how lessons learned in recent drug approvals for Alzheimer’s disease can be applied across other areas of neuroscience, including psychiatric development. Incorporating the right clinical assessments, along with sensitive biomarkers, as part of a comprehensive endpoint strategy enables insight into treatment effects, even in an early-phase study with limited participants.
Novel biomarkers can also play a critical role in identifying sub-populations most likely to respond to a particular drug mechanism, further enabling proof of target engagement in small, early development studies. The featured panelists will discuss how innovative early evidence strategies can help sponsors evaluate whether a therapeutic approach is having the intended effect, refine endpoint and patient-selection strategies and make more informed decisions before advancing into larger, more costly studies.
Through perspectives spanning clinical trial endpoints in Alzheimer’s disease and psychiatry, attendees will gain practical insights into how thoughtful early development strategies can holistically provide safety and tolerability data, reduce uncertainty in drug efficacy and build a stronger foundation for later-phase neuroscience development.
Register for this webinar to learn how biomarker-supported endpoints and evidence-driven strategies can strengthen neuroscience clinical trials and support earlier development decisions.
Who should attend
- CEOs/Chief Medical Officers/Chief Scientific Officers
- Clinical Data Managers/Clinical IT/Clinical Monitoring
- Clinical Operations/Clinical Development (early phase)
- Clinical Research/Clinical Pharmacologists/Clinical Scientists
- Data Science
- Digital Health/Innovations/Operations
- Health Economics and Outcomes Research
- Imaging Scientists/Medical Affairs/Medical Monitor/Head of Development for Program
- Neuroscience Clinical Trials Professionals
- PK Experts/Protocol Managers/Regulatory Affairs
- Professionals in the field of Neuroscience
- Sr. Managers, Trial Initiation
What you will learn
- Understand the value of identifying clinically meaningful, biomarker-supported evidence of target engagement early in neuroscience clinical development
- Review practical examples of endpoints, biomarkers and outcome assessments that can detect treatment effects with greater sensitivity
- Identify opportunities to optimize study design and sample size while improving statistical power through more informed endpoint strategies
- Validate a drug’s mechanism of action and therapeutic potential earlier in development
- Make more confident go/no-go decisions prior to investing in larger and more expensive late-phase trials
- Mitigate development risk by leveraging high-quality neurobehavioral, cognitive and digital measures
Featured Speakers
Todd Rudo, MD
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.
David Scott, PhD
David Scott 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.
Since joining Clario in 2012, David’s focus has been to enable MRI and molecular imaging solutions toward safety, eligibility and therapeutic efficacy endpoints. He works with radiologists, physicists, software engineers and operational specialists on the design, execution, analysis and interpretation of neuroscience clinical trial imaging data. His motivation is to enable neuroimaging to accelerate the delivery of therapeutic benefit to patients around the world.
Mark Opler, PhD, MPH
Dr. Mark Opler is Chief Research Officer, eCOA Neuroscience at Clario. In this role, he directs scientific research and leads ongoing studies in psychiatry, measure development, psychometric validation and other areas of neuroscience.
Dr. Opler is the Executive Director of the PANSS Institute and has served as a faculty member in the Departments of Psychiatry at New York University School of Medicine and in the Department of Neuroscience at Columbia University, College of Physicians and Surgeons. His academic research focuses on the etiology, phenomenology and treatment of serious and persistent mental disorders. He is a co-author and developer of several clinical assessment tools, including the SNAPSI, CGI-DS and NY-AACENT. He is also a contributor to the latest edition of the PANSS Manual.
Vrutangkumar V. Shah, PhD
Dr. Vrutangkumar V. Shah is a scientist with over 13 years of experience in clinical research. He is currently working as a Director, Data Science and Biostatistics at Clario, a global data and technology company that helps with decentralized clinical trials. He consults with sponsors and CROs in developing the Statistical Analysis Plan (SAP) package for Phase I-IV clinical studies. His expertise includes but not limited to data analytics, biostatistics, machine learning, and time-series analysis to develop digital biomarkers for clinical trials.
Partner for this event
Clario
Clario, part of Thermo Fisher Scientific, is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence-generation solutions that combine medical imaging, eCOA, precision motion, cardiac and respiratory endpoints.
For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have been deployed over 30,000 times to support clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2012.
For more information, go to Clario.com or follow us on LinkedIn.