From the imperative to detect cognitive and functional changes as early as possible in the course of Alzheimer’s disease, through the importance of measuring cognitive and attentional effects of investigational drugs in clinical trials, to the quantification of cognitive deficits during the course of affective disorders, the need for accurate, specific, and cost-effective neuropsychological assessment methods has never been greater.
This webinar will briefly review:
- The evolution of neuropsychological testing
- The difficulties with variability and inter-rater reliability in paper-and-pencil tests administered by raters
- The limitations of traditional instruments for cognitive assessment
- Regulatory requirements for clinical trial endpoints of disease-modifying therapies
- The promise of computerized cognitive testing in accurately and reproducibly measuring performance while minimizing environmental and interpersonal factors of variability
- Examples of computer-based cognitive tests for measuring specific endpoints
- What neuropsychiatric tests are required for demonstrating safety and tolerability in neuropsychiatric clinical trials?
- What cognitive and functional endpoints are relevant clinically and for regulatory purposes to demonstrate the efficacy of disease-modifying drugs in dementing illnesses like Alzheimer Disease?
- What options are available and affordable in the marketplace for these purposes?
Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Dr. Thomas Laage is an experienced psychiatrist who helps design effective clinical trials and develops sound protocols for our customers. Specifically, he has written several ADHD protocols over the course of his career. He completed residencies in internal medicine and psychiatry and earned Board certification in both specialties (internal medicine and psychiatry and neurology). He has had clinical experience from his training and practice in internal medicine and psychiatry and also worked in emergency room settings for four years. For many years, he conducted a private practice in psychiatry with an academic appointment as Instructor in Psychiatry at the Harvard Medical School. He has treated many adult and adolescent patients with ADHD with the usual medications over the course of his career. In 2011, Dr. Laage completed a Master’s degree in Public Health (Quantitative Methods) at the Harvard School of Public Health in Boston, MA. He recently completed courses in Good Clinical Practice (Sept, 2011) and in Medical Device Submission and Compliance Strategies for the US Market (June, 2011) through the Regulatory Affairs Professional Society (RAPS), as well as in Drug Safety and Adverse Event Reporting (Sept, 2011) through the Drug Information Association (DIA).
Prior to joining Premier Research, he worked as an independent contractor for the consulting firm John Lehmann, LLC in medical writing and safety reporting for clinical trials and as an independent medical writer and editor for Edanz Group Ltd in China and Japan, for CE Outcomes LLC in Birmingham, AL, and for the American Physician Institute in Chicago, IL. He is a member of Phi Beta Kappa, Alpha Omega Alpha, the Massachusetts Medical Society, the Regulatory Affairs Professionals Society, the Society for Clinical Trials, and the Drug Information Association.
Matthew T. Healy, Senior Manager, Clinical Management, Premier Research
Matthew Healy is currently a Senior Manager in the Clinical Management department at Premier Research. Mr. Healy is responsible for all aspects of functional management supervision to the clinical management staff including, but not limited to, performance management, guidance on corporate policy, training and support.
Mr. Healy has over eighteen years of clinical research experience including; site coordination and management, clinical monitoring, clinical team management and clinical operations management. His experience includes, six years of coordinating and project management experience at the University of Pittsburgh Medical Center, Department of Psychiatry; clinically focused on Alzheimer’s disease, Geriatric Schizophrenia, Traumatic Brain Injury, and Late Life Depression studies. He has extensive training in Neuropsychological concepts from the Western Psychiatric Institute and Clinic, for the administration and interpretation of numerous Neuropsychological assessment instruments. Mr. Healy also has more than two years of experience coordinating Hepatology and Gastroenterology clinical trials. Within the CRO environment he has over ten years’ experience working in the capacity of a clinical research associate, clinical team manager, and clinical operations manager covering various CNS, GI, Hematology, and Oncology trials.
Mr. Healy holds a Masters of Education in Counseling Psychology from the University of Pittsburgh.
Who Should Attend?
VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
for pharmaceutical, biotechnology and medical device companies
Premier Research is a leading global contract research organization serving highly innovative biotech, Pharmaceutical and medical technology companies.The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia, neurology, cardiovascular, dermatology, oncology and medical devices.
Premier Research has 24 offices across the globe. It employs over 1,000 clinical professionals. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.