Cognitive Safety: Satisfying Regulatory Requirements in a Competitive Landscape

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical Regulation,
  • Wednesday, June 05, 2019 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Regulators, physicians and patients are all concerned by the potential impact of new drugs on cognition, as any drug that crosses the blood-brain barrier (BBB) can have detrimental effects.

Common disease states, environmental toxins, certain medications and the aging process itself can all compromise the integrity of the BBB. Accordingly, both central nervous system (CNS) and non-CNS therapeutics (e.g. for cardiovascular disease, diabetes, cancer, pain) can present significant challenges for cognitive safety in their target patient populations.

Consequently, recent regulatory guidance recognises the critical importance of monitoring cognitive function throughout the drug development process in order to adequately assess the safety and risk profile of new compounds, and make appropriate label claims.

This webinar will provide participants with a firm understanding of how the computerized delivery of objective and sensitive cognitive assessments can enhance the clinical development process. These assessments facilitate early decision-making, profile safety and tolerability and satisfy current regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.

Speaker

Kenton Zavitz, PhD, Director of Clinical Affairs, Cambridge Cognition

Dr. Kenton Zavitz has over 20 years of biotechnology and pharmaceutical experience with involvement in all aspects of the industry from drug discovery and clinical development through to pre-commercialization.

Prior to joining Cambridge Cognition, Kenton served as Chief Scientific Officer at New Mexico-based biotech Zocere Inc. where he worked on developing a neuroprotectant drug designed to combat brain injury resulting from stroke. From 1998 to 2012, Kenton worked at Myriad Pharmaceuticals, Inc. where he served as Chief Scientist of the tarenflurbil clinical development program (an investigational drug for the treatment of Alzheimer’s disease, developed through Phase 3). 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

Who Should Attend?

Biopharmaceutical researchers and CRO professionals who are working in:

  • Drug development
  • Medical affairs
  • Clinical operations
  • Clinical trial management
  • Clinical outcomes
  • Pharmacovigilance

What You Will Learn

Participants of this free webinar will gain insights on:

  • The value of monitoring cognition during drug development for CNS and non-CNS indications
  • Optimizing the drug development process by employing computerized cognitive testing
  • Navigating current regulations that will impact cognitive assessment in clinical trials
  • Lessons learned from conducting a cardiovascular safety trial at scale: case study

Xtalks Partner

Cambridge Cognition

Cambridge Cognition is a neuroscience digital health company which develops & markets gold standard medical software products and expert scientific services to accelerate the development of safe and effective treatments and quantify cognitive health in patients worldwide.

The company provides products and services to the world’s leading pharmaceutical and biotech companies as well as globally renowned academic institutions.

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