Examining changes in cognition in clinical pharmacology studies, with an emphasis on the importance of starting early in clinical development. As world class providers of cognitive assessments, Cognitive Research Corporation and Altasciences Clinical Research join forces to discuss the current industry standards for cognitive assessments.
This webinar will focus on how to use cognitive assessments as a safety tool in first-in-human studies and as a measure of potential cognitive improvements or impairments in Phase II studies. It will also address the need for performing driving simulation studies to satisfy the FDA guidance.
What will you learn?
- FDA guidance and the trends seen so far from regulatory agencies for cognition in first-in-human studies
- What classes of drugs require CNS assessments and how to develop a robust CNS program in early stage clinical development
- How to determine when you will need a dedicated driving study
- What are the types of study designs used
- Comparing dedicated driving studies using standardized driving simulators and European on-the-road driving tests
- How to ensure your drug meets the regulatory requirements
- How to differentiate your drug from that of the competition
Who will this interest?
- Drug Development Teams
- CNS Researchers
- Clinical Operations
- Outsourcing Professionals
Meet our speakers
Cognitive Research Corporation
Gary G. Kay, PhD, 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). Dr. 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. Dr. Kay received his PhD in neuroclinical psychology from Memphis State University (TN, USA) and completed his clinical psychology internship at the U.S. Naval Hospital, in Bethesda (MD, USA). Dr. Kay is a diplomat 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 U.S. Federal Aviation Administration and also serves as a consultant to airline medical departments, military medical organizations, other governmental agencies and to the pharmaceutical industry.
General Manager, Montreal Clinical Operations
Altasciences Clinical Research
Ingrid Holmes joined Altasciences Clinical Research in 2011, as Vice President, Clinical Operations, at the Montreal (Canada) site, a facility currently housing seven clinical units with 265 early phase beds, and a dedicated driving simulator unit. She was promoted to General Manager, Montreal Clinical Operations, in 2018. In addition, Ingrid is responsible for the harmonization of clinical processes across Altasciences’ three sites, and acts as the Global Compliance Lead within the Quality Management System. Ingrid started her career in clinical research in 1995 at LAB Pharmacological Research. Over the years, Ingrid has held various management roles in early stage clinical operations, progressing to become Director of Business Operations and Continuous Improvement, overseeing the financial and quality performance of five international clinical sites. In her various roles, she has gained extensive experience in the conduct of early stage trials, international regulatory requirements, business operations, quality management systems and Lean Six Sigma. Prior to joining Altasciences, Ingrid provided consulting services for early stage CROs and has successfully implemented company-wide management systems, including financial, client services and operational key performance indicators in a number of organizations.
Chief R&D Officer
Altasciences Clinical Research
Dr. Wood joined Altasciences Clinical Research as Executive Vice President, Phase I Clinical Development, in November 2015. He was promoted in early 2018 to Chief R&D Officer. Dr. Wood oversees the scientific aspect of Altasciences’ operations, with a focus on bringing in new patient populations, procedures and technology, to best serve the needs of sponsors worldwide. Since 1999, his focus has been on early drug development, and more specifically on clinical pharmacology. Dr. Wood’s experience includes managing three new molecular entities from toxicology to Phase IIa, over 50 first-in-human studies and 30 proof-of-concept studies. In total, Dr. Wood has been involved in the design and conduct of over 600 clinical pharmacology studies with companies such as Phoenix International, MDS Pharma, Allied Research, Cetero and Altasciences. He also gained experience in running Phase II and III studies when he was CEO of Manna Research, a network of late-stage sites he built across Canada. Dr. Wood has a Ph.D. in Neurology and Neurosurgery from McGill University (Canada), and did a fellowship at the National Institute of Mental Health.