Lessons Learned in Neuroscience Drug Development: How Biomarker-based, Evidence-driven Decisions Enable Successful Outcomes

Register at https://xtalks.com/webinars/lessons-learned-in-neuroscience-drug-development-how-biomarker-based-evidence-driven-decisions-enable-successful-outcomes/, free of charge

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.

This webinar will benefit professionals in the following fields with the following job titles:

• 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

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