Assessing Cognitive Safety of Drugs in Clinical Development

Cognitive impairment is increasingly recognized as a serious potential side effect of medication – both for central nervous system (CNS) and non-CNS compounds. Despite concerns voiced by physicians, regulators and consumers many drug development programs do not incorporate objective and sensitive cognitive assessments as part of the clinical characterization and decision-making process. Additionally, cognitive assessment is an essential tool for clinical trial research professionals for the evaluation of efficacy of many new medications being developed to address devastating diseases, including Alzheimer’s, depression, schizophrenia and ADHD.

Key Discussion Points:

• What is cognition and how is it best measured throughout the drug development process for both CNS and non-CNS indications?
• Why monitor cognition in drug development?
• Are there current or upcoming regulations that impact cognition assessment?
• What are desirable characteristics of cognitive assessment tools?
• What developments are on the horizon for cognitive assessment?

Spend 60 minutes with two industry experts and walk away with a firm understanding of why there is a need to assess cognitive safety in clinical development of compounds, the methodological considerations for cognitive assessment in clinical trials, approaches to the analysis and interpretation of cognitive outcome measures and how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.

Importance for Drug Development: The presenters will discuss why the accurate measurement of specific aspects of cognitive function is essential for the evaluation of cognitive safety of new medications being developed for various CNS and non-CNS indications. Recognizing that the ability to test, measure and monitor cognitive performance and potential impairment over time enables the identification of cognitive impairment of clinical relevance throughout the drug development process to improve decision making.

Value Across the Drug Development Cycle for All Therapies: Any drug that crosses the blood-brain barrier (BBB) can produce cognitive effects that can interfere with everyday functioning. Importantly, this includes drugs for both CNS and non-CNS indications (e.g. cardiovascular drugs; including statins, diabetes, oncology, HIV, pain, antihistamines, anticonvulsants and antimuscarinics). The presenters will explore strategies for measuring cognitive function during clinical drug development for all therapies and how this can help determine dose-response relationships, provide competitive differentiation, detect off-target pharmacological effects and assess the risk/benefit profiles.

Review of Methodologies, Study Design and Analysis: Learn how when assessing cognitive safety in a clinical trial, one also has to be aware of basic methodological principles, including study design and statistical analysis, from Phase I through to postmarketing as well as how best to interpret the magnitude of any identified effects, including comparison with benchmarks.

Speakers

Pradeep Nathan, MA, PhD, MRACI, CChem, FCP, Vice President Neuroscience Scientific Strategy Lead and Head, Neuroscience Center of Innovation, inVentiv Health

Pradeep Nathan is a cognitive neuroscientist with more than 20 years clinical research experience. He has held positions in both academia and industry, including most recent positions as Professor of Neuroscience (Monash University) and Senior Director and Director, Neuroscience Discovery Medicine at UCB Pharma and GSK, respectively. His primary research interests are in translational and biological markers of neurological and psychiatric disorders, cognitive neuroscience, functional neuroimaging and drug discovery.

Pradeep has published more than 200 research papers, and his research has been cited more than 7,000 times in academic journals. He also has worked on more than 10 clinical compounds in phase I-III for psychiatric and neurological indications. Prof. Nathan serves on the editorial board of a number of journals, including Drug Discovery Today and the International Journal of Neuropsychopharmacology.

Pradeep has received many research awards including the Australian Young Tall Poppy Science Award (2006), the Brain and Behaviour Foundation, Independent Investigator Award (2007) and the British Association for Psychopharmacology, Clinical Psychopharmacology Award (2008).

 

 

Message Presenter

Kenton H. Zavitz, PhD, Director of Clinical Affairs , Cambridge Cognition, Ltd.

Kenton Zavitz brings over 17 years of biotechnology and Pharmaceutical experience including involvement in all aspects of the industry from drug discovery and clinical development through pre-commercialization. Prior to joining Cambridge Cognition, Kenton served as Chief Scientific Officer for New Mexico-based biotech Zocere Inc. where he worked on developing a neuroprotectant drug designed to combat brain injury resulting from stroke. He currently serves on the Scientific Advisory Board for Exonate Limited, a start-up founded in 2013 at the University of Nottingham. From 1998 to 2012, Kenton worked at Myriad Pharmaceuticals, Inc. in Salt Lake City and served in a variety of roles including Senior Director of Clinical Affairs, Chief Scientist of the tarenflurbil clinical development program (an investigational drug for the treatment of Alzheimer’s disease, developed through Phase 3), Director of Neurodegeneration Therapeutics Discovery and Director of Strategic In-licensing and Scientific Evaluation.

Kenton received his PhD in Biochemistry and Molecular Biology from The Sloan-Kettering Division of the Weill Cornell Graduate School of Medical Sciences in New York City. He was a Postdoctoral Fellow at the UCLA School of Medicine and was awarded fellowships from the Leukemia Society of America and the Jane Coffin Childs Memorial Fund for Medical Research.

Message Presenter