Assessing cognition and driving ability: examining simple and cognitive domains in clinical pharmacology studies
As world-class providers of cognitive assessments, Altasciences and Cognitive Research Corporation join forces to discuss the current industry standards in the field. This webinar will focus on when and how to use cognitive assessments as a safety tool in early development studies, as well as the critical nature of assessing potential driving impairment.
What will you learn?
- Details about the US FDA guidance and current trends from regulatory agencies for cognition in first-in-human studies
- The classes of drugs that require CNS assessments and methods for developing a robust CNS program in early-stage clinical development
- How to determine the need for a dedicated driving study
- Types of study designs used for cognitive assessments
- The differences between dedicated driving studies using standardized driving simulators and European on-the-road driving tests
- How to ensure your drug meets the regulatory requirements
Who may this interest?
- Drug development teams
- CNS researchers
- Clinical operations
- Outsourcing professionals
Gary G. Kay, Ph.D.
Cognitive Research Corporation
Gary G Kay is President of Cognitive Research Corporation, located in St Petersburg (FL, USA). He is an Associate Professor of Neurology at Georgetown University School of Medicine (DC, USA). Kay is the author and publisher of the CogScreen-Aeromedical test battery and a pioneer in computer-based cognitive testing and development of driving simulation methodology for evaluating the impact of drugs on driving. Kay received his PhD in neuro-clinical psychology from Memphis State University (TN, USA) and completed his clinical psychology internship at the US Naval Hospital in Bethesda (MD, USA). Kay is a diplomate of the American Board of Assessment Psychology and the American Board of Professional Neuropsychology. He is a Fellow of the National Academy of Neuropsychologists. He serves as a Senior Neuropsychology Consultant to the US Federal Aviation Administration and also serves as a consultant to airline medical departments, military medical organizations, other governmental agencies and to the pharmaceutical industry.
Vice President, Global Clinical Operations
Ingrid Holmes is Vice President, Global Clinical Operations at Altasciences (Laval, Canada). Ingrid’s responsibilities include oversight of all clinical pharmacology units, with 400 early-phase beds, a dedicated driving simulator unit with ten simulators on-site and purpose-built inhalation facilities. Ingrid is also responsible for the harmonization of clinical processes across Altasciences’ sites, and acts as Global Compliance Lead within the Quality Management System. Ingrid started her career in clinical research in 1995 at LAB Pharmacological Research. Ingrid has held management roles in various early-stage clinical operations, progressing to Director of Business Operations and Continuous Improvement, overseeing the financial and quality performance of five international clinical sites. She has extensive experience in early-phase trials, international regulatory requirements, business operations, quality management systems and Lean Six Sigma. Ingrid also provided consulting services for early-stage CROs and has successfully implemented company-wide management systems, including financial, client services and operational KPIs.
In association with
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, clinical monitoring, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.