Lessons Learned in Neuroscience Drug Development: How Biomarker-based, Evidence-driven Decisions Enable Successful Outcomes
Join us for this webinar as our featured panelists discuss lessons learned in recent drug approvals for Alzheimer’s disease that can be applied across other areas of neuroscience, including psychiatric development. They will also examine how 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. Register to learn how an integrated, phase-appropriate endpoint strategy can help teams identify meaningful signals earlier, reduce development uncertainty and generate stronger evidence for regulatory review and product differentiation.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 03:00 p.m. – 04:00 p.m. GMT (UK)
- 04:00 p.m. – 05:00 p.m. CET (EU-Central)
Register for this webinar to learn how biomarker-supported endpoints and evidence-driven strategies can strengthen neuroscience clinical trials and support earlier development decisions.
In this webinar, attendees will:
- 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
Speakers
Todd Rudo, M.D.
EVP, Chief Medical Officer at Clario, a part of Thermo Fisher Scientific
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, a part of Thermo Fisher Scientific, 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, Ph.D.
VP, Medical and Scientific Affairs at Clario, a part of Thermo Fisher Scientific
David Scott is Vice President, Medical and Scientific Affairs at Clario, a part of Thermo Fisher Scientific. 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.
Brian K. Rundle, Ph.D.
Scientific Advisor at Clario, a part of Thermo Fisher Scientific
Brian Rundle is a Neuropsychologist and Scientific Advisor within Clario’s eCOA Science & Consulting team, where he helps pharmaceutical and biotechnology sponsors optimize the collection of patient-centered and cognitive outcomes data in clinical trials. His work focuses on the design and implementation of research technology that balances regulatory compliance, scientific rigor and intuitive user experiences to maximize data quality and participant engagement.
With expertise spanning neuroscience, cognitive assessment, metabolic disorders and connected devices, Brian works closely with sponsors to develop fit-for-purpose solutions for complex clinical research programs. Leveraging a unique blend of scientific, technical and project management experience, he provides strategic guidance on study design, endpoint selection and clinical trial technologies that support successful drug development.
Mark Opler, Ph.D., M.P.H.
Chief Research Officer, eCOA Neuroscience at Clario, a part of Thermo Fisher Scientific
Dr. Mark Opler is Chief Research Officer, eCOA Neuroscience at Clario, a part of Thermo Fisher Scientific. 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, Ph.D.
Director, Data Science and Biostatistics, Precision Motion at Clario, a part of Thermo Fisher Scientific
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 supports 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 is not limited to, data analytics, biostatistics, machine learning and time-series analysis for developing digital biomarkers for clinical trials.