Archives: Agenda

• Exploring patient collaboration and the benefits it can bring to the sponsor and the patient.
• Importance of good communication to the patients and how this can streamline trial timelines
• Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up.
• How to optimize collaboration with patient advocacy organizations
• Patient perspective ‘Pain Points’ throughout various trials

• The role of AI in dissecting disease pathogenesis
• Ways AI can improve success rates in neurodegenerative drug discovery and development
• Methods for accelerating CNS clinical trials with AI, enhancing patient journeys and drug accessibility

• Discussing the personal experiences of the patient
• Defining ‘patient centricity’
• Building clinical trials with the perspective of the patients in mind
• Patient access to the drug post study

• How early engagement will improve outcomes
• Speaking the same language – one size doesn’t fit all
• Simplifying the complex, in a world with an awesome amount of outsourcing options

• Importance of retention and growth of your team
• Openness to junior clinical team members
• Openness to bridge programs with your vendor partner
• Navigating these challenges in a hybrid environment

·       Do you stand out in a competitive market?

·       With the recent Project Optimus guidance, are you targeting the right number of sites for your study?

·       What non-US countries should you consider for quick activation and strong enrollment?

During this presentation, you will learn:

• How to be prepared for an FDA BIMO (or other) inspection.
• Learn about publicly available resources for use to prepare.
• Evaluate inspectional metrics and new information provided by FDA.
• Learn how to respond to an FDA-483 or discussion points.

• Combining the expertise and technology of a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO)
• Navigating the intricacies of bringing new therapies to market without the complications of working with multiple outsourcing partners
• Delivering speed, simplicity, and scalability to clinical trials, drug development, and manufacturing