The Brain on Drugs: Strategic Use of Cognitive Measures & Biomarkers in Early Phase CNS-Drug Studies скачать в хорошем качестве

The Brain on Drugs: Strategic Use of Cognitive Measures & Biomarkers in Early Phase CNS-Drug Studies

A complimentary webinar on how the inclusion of biologic and cognitive pharmacodynamic markers in early phase clinical trials can inform clinical development strategy and show that late phase studies are likely to produce meaningful results. Topics covered include: • The strategic information that may be provided by targeted use of cognitive markers early-on • How the inclusion of cognitive endpoints informs the design of clinical trials • The specialty studies that can help to make informed decisions regarding the clinical development path • The fundamentals of biomarkers inclusion in early phase trials • The validated biomarkers in neurology and inflammation Presented by Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, and Denise Milovan, Neuroscientist, Clinical Neuropsychologist. Dr Beatrice Setnik, Chief Scientific Officer at Altasciences Beatrice has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. She is currently the Chief Scientific Officer at Altasciences and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Beatrice 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. Dr. Denise Milovan, Scientific Manager, Biostatistics, Data Services at Altasciences Dr. Milovan joined Altasciences in 2020. In former Neuroscientist roles at 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. She has a strong interest in the adaptation and refinement of traditional neurocognitive as well as behavioural measures for computerized administration tailored to the specific requirements of early phase clinical trials. Dr. Milovan practices clinical neuropsychology in a variety of settings, including hospitals (neurology, traumatic brain injury), non-profit organizations, and private practice. She holds a PhD and a Master’s degree in clinical neuropsychology, and has also completed the requirements of Master’s degree in clinical pharmacology. As a member of the Council of the College of Psychologists of Ontario from 2015 to 2021, Dr. Milovan held various roles including that of Vice President. Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/ #Altasciences #ScientificResearch #ResearchAndDevelopment #ClinicalTrials #PharmaceuticalIndustry