Band 1
Provided by Kimberly Chew
Kimberly is a scientist-turned-attorney who helps life sciences innovators bring cutting-edge therapies to patients while navigating the complex legal and regulatory frameworks governing biomedical innovation. Her background in research science gives her a practical understanding of the scientific, operational, and funding realities facing biotechnology companies and academic researchers as they advance new therapies toward clinical use.
As co-founder and co-leader of the firm’s Psychedelics & Emerging Therapies practice, she guides clients through every stage of development, from clinical trial agreements and research collaborations to regulatory compliance and enforcement matters. She represents drug developers, biotechnology companies, and startups, often helping new ventures address early-stage challenges such as corporate formation, trademarks, and governance by collaborating with firm colleagues to deliver integrated legal solutions tailored to each client’s goals and stage of development.
In the emerging therapies space, Kimberly advises on evolving legal frameworks surrounding psychedelic therapeutics and other novel medical technologies, including regenerative stem cell therapies. She works with clinics and clinicians to develop best practices, prepare informed consent and operational documents, comply with state regulations, and navigate investigations by medical boards or enforcement agencies. She also counsels on clinic ownership and operational structures, helping clients achieve regulatory compliance while supporting their business objectives.
Her work spans research and development, clinical trials, product liability, and controlled substances regulation at the federal and state levels. She closely tracks emerging life sciences issues, including the growing role of artificial intelligence (AI) in regulatory review, and presents on how federal agencies use AI to analyze regulatory data. Kimberly also advises clients on best practices when deploying AI internally, working with vendors, or interacting with agencies that use AI-driven tools.
Her practice includes advising on FDA regulatory issues across a range of health-related products and services, with a particular focus on matters at the intersection of wellness and regulated medical products. Kim regularly helps clients assess when a product or service may begin to implicate drug or device regulatory considerations—work that draws directly on her scientific background, especially where clinical or development factors are involved. She advises on FDA regulatory exclusivity periods, clinical trial regulatory issues such as Institutional Review Board (IRB) authority and safety reporting, and suitability petitions before the Office of Generic Drugs. Kim also conducts regulatory due diligence for biotech SEC filings and has litigation experience in patent enforcement and defense, as well as Hatch-Waxman (ANDA) litigation.
Kimberly draws on 16 years of experience in research science, including roles in academia and four startup ventures, to understand the scientific and operational realities clients face. She appreciates the pressures of funding cycles, publishing requirements, and protecting intellectual property, and understands the priorities of small biotech companies building and safeguarding patent portfolios, as well as academic researchers balancing the desire to share discoveries with regulatory and commercialization realities.
A trusted partner for researchers, innovators, and clinicians, Kimberly listens attentively to clients’ challenges, anticipates potential obstacles, and helps prioritize resources and legal spend while managing risk and delivering high-quality, efficient work. Known for her strategic insight, practical guidance, responsiveness, and approachable manner, she communicates clearly, meets clients where they are, and ensures they feel supported and confident in their decisions.
American Bar Association, Health Law Section
American Health Law Association
State Bar of California
Alameda County Bar Association
Health Care Compliance Association
Psychedelic Medicine Association
Psychedelic Pharmacists Association
Women in Bio
Provided by Chambers
Kimberley Chew is recognised for her provision of legal compliance advice, particularly as it pertains to the use of ketamine in psychotherapeutic treatments.