Utilizing the Measurement of Cognition to Determine Drug Safety in Late Phase Clinical Trials, Upcoming Webinar Hosted by Xtalks
Thursday, November 7, 2024
In this free webinar, explore the considerations for the use of cognition to guide decision-making about drug safety in late-phase trials. Attendees will be shown examples that highlight how detecting change in cognition is a valid indicator of central nervous system (CNS) safety of new drugs. The featured speaker will review the importance of using appropriate tools to measure cognitive safety in early and late phase development.
TORONTO, Oct. 30, 2024 /PRNewswire-PRWeb/ -- When considering impacts on the central nervous system (CNS), the side-effects of drugs in development are often evaluated through the assessment of their effects on specific aspects of cognition, such as attention, memory and executive function.
While this approach is obvious for drugs designed to influence CNS function -- such as those used in psychiatry or neurology -- it can be applied for drugs where CNS effects may be indirect. Decisions about CNS effects of drugs made in early-phase studies define adverse effects as the presence of a drug- or dose-related decline in cognition. This manifests as a decline from a pre-drug cognitive test performance hours or days after dosing. Compared to early-phase trials, the use of cognition to guide decisions about drug safety in late-phase trials conducted within a regulatory context is less understood and worth exploring.
In this webinar, the expert speaker will consider three use cases where American and European Regulatory authorities required sponsors to demonstrate the CNS safety of their drugs:
-- The first use-case considers how cognition was used to reassure
regulators and clinicians about the CNS safety of esketamine (Sparvato)
for use in adults with treatment-resistant depression
-- The second use-case considers how cognition was used to reassure
regulators that the extension of the use of evolocumab (Repatha) for the
treatment of familial hypercholesteremia to children did not result in
any disruption to neurodevelopment
-- The third use-case considers how cognition was used as the primary
safety endpoint in a study designed to demonstrate that treatment of
chronic heart failure with sacubitril and valsartan (Entresto) did not
lead patients to develop Alzheimer's disease as neprilysin inhibition
also promoted amyloid accumulation
Each of these use cases demonstrates how detection of change -- or stability -- in cognition over months or years of drug treatment is a valid, efficient and effective method for communicating information to patients, clinicians and regulators about the CNS safety of new drugs.
Register for this webinar today to explore how cognitive assessment plays a critical role in demonstrating CNS safety in drug development.
Join Paul Maruff, PhD, Chief Innovation Officer, Cogstate, for the live webinar on Wednesday, November 20, 2024, at 11am EST (4pm GMT).
For more information, or to register for this event, visit Utilizing the Measurement of Cognition to Determine Drug Safety in Late Phase Clinical Trials.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit https://xtalks.com
For information about hosting a webinar visit https://xtalks.com/why-host-a-webinar/
Media Contact
Soumya Shashikumar, Xtalks, +1 (416) 977-6555 x371, skumar@xtalks.com, https://xtalks.com
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