The Brain on Drugs: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies
This webinar focuses on how the inclusion of biologic and cognitive pharmacodynamic markers in early-phase clinical trials can inform clinical development strategy, provide relevant data for dose and sample size determination, demonstrate feasibility, and show that late-phase studies are likely to produce meaningful results.
Examining cognition changes early helps identify subtle yet significant negative (or enhancing) effects on cognitive function. Data from these endpoints helps clarify the need for (or ability to waive) additional evaluations.
The use of exploratory biomarkers confirms relevancy for the drug’s purported MOA, toxicity, pharmacokinetics, etc., and the validation of planned analyses.
What will you learn?
- Discover strategic information that may be provided by targeted use of cognitive markers early-on
- Understand how the inclusion of cognitive endpoints informs the design of clinical trials
- Discover specialty studies that can help to make informed decisions regarding the clinical development path
- Understand the fundamentals of biomarker inclusion in early-phase trials
- Discover validated biomarkers in neurology and inflammation
Who may this interest?
- CNS drug development teams (preclinical, clinical, medical affairs)
- CNS research scientists
- Other professionals
Neuroscientist, Clinical Neuropsychologist
Dr. Milovan joined Altasciences in 2020. In previous Neuroscientist roles at INC Research/Syneos Health and DecisionLine Clinical Research, she provided expertise and oversight of Neurocognitive Early Phase programs dedicated to the assessment of the pharmacodynamic effects of CNS drugs. Dr. Milovan practices clinical neuropsychology in a variety of settings including hospitals (neurology, traumatic brain injury), non-profit organizations and private practice. She is currently the Vice-President of the Council of the College of Psychologists of Ontario. Dr. Milovan holds a PhD and Master degree in clinical neuropsychology.
Chief Scientific Officer
Dr. Setnik has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. Dr. Setnik is currently the Chief Scientific Officer at Altasciences and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. She has published numerous research articles in internationally recognized peer-reviewed journals and is a recognized expert in the field of human abuse and physical dependence potential evaluation.