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Kimberly Chew on Muck Rack

Kimberly Chew

As seen in: Taylor & Francis Online, Law360, JD Supra, American Bar Association, Westlaw Today, Drug Science, LexBlog, Clinical Leader, Life Science Leader, Law360 UK and
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Articles

Designing Defensible Protocols: Documentation, Training, and Informed Consent for High-Risk Psychedelics

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By Kimberly Chew, Odette Hauke
| American Bar Association Verified
Summary For high-risk therapeutics with reasonably knowable safety liabilities, litigation following serious adverse events often turns on a simple question: Did the sponsor act reasonably before the foreseeable harm occurred? Using ibogaine’s cardiac risk profile as the case study, this article demonstrates how trials can be designed that are more likely to be viewed as reasonable exercises of the duty of care owed to research participants.
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FDA Draft Guidance Maps Payor Strategy For Psychedelics

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By Kimberly Chew
| Law360 Verified
By Kimberly Chew ( July 22, 2026, 5:18 PM EDT) -- In June, the U.S. Food and Drug Administration issued its first revision to the guidance governing manufacturer communications with payors in eight years.[1]... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.
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Building Litigation-Ready Safety Architecture for High-Risk Therapeutics: Lessons from Ibogaine’s Cardiac Risk

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By Kimberly Chew, Escalation Triggers
| American Bar Association Verified
Summary CHigh-risk therapeutics—compounds with known safety liabilities alongside meaningful therapeutic potential—present a fundamental challenge to sponsors and their counsel. Using the example of ibogaine, this article demonstrates how Data Safety Monitoring Boards and adverse event escalation pathways should be structured for both regulatory compliance and litigation resilience.
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