HUM-MOLGEN events: CNS Safety of Drugs in Late Phase Clinical Trials: Using Cognitive Information in Discussions with Regulators

Who Should Attend?

Executives, directors, scientists and managers from pharma, biotech and CROs responsible for the clinical development of hybrid or decentralized clinical trial solutions, including:

Research and Development

Clinical Operations

Clinical Science

Outcomes Research

Outsourcing and Procurement

Project Management

Clinical Trial Planning and Optimization

Medical Affairs

What You Will Learn

How to consider the use of cognitive tests to understand the CNS safety of new drugs

How consideration of drug-related cognitive decline differs for treated groups or individual subjects

How ensuring study designs for the measurement of cognition can be optimized to provide appropriate information to scientific and regulatory bodies

Speaker

Paul Maruff, PhD, Chief Innovation Officer, Cogstate

Professor Paul Maruff is one of the founders of Cogstate and served as Chief Science Officer before taking on the role of Chief Innovation Officer. He is a neuropsychologist with expertise in the identification and measurement of subtle behavioral and cognitive dysfunction. Paul’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision making in drug development and in clinical medicine. Paul remains an active researcher. He is appointed Professor at the Florey Institute for Neuroscience and Mental Health. He is currently clinical co-chair of the Australian Imaging Biomakers and Lifestyle (AIBL) study. Paul has published over 450 research articles in international peer-reviewed scientific journals and has co-authored 15 book chapters