Band 1
Provided by Kimberly Chew
Kimberly is a seasoned professional with a rich background in biotech research, leveraging her extensive experience to guide clients through the intricate landscape of clinical trials and academic research compliance.
Her experience extends to analyzing FDA regulatory exclusivity periods, providing regulatory analysis related to clinical trials such as Institutional Review Board's (IRB) scope of authority and safety reporting, and drafting suitability petitions to the Office of Generic Drugs, as well as conducting regulatory due diligence for SEC filings in the biotech sector. Kimberly's litigation skills extend to patent enforcement and defense and Hatch-Waxman (ANDA) litigation, further solidifying her role as a comprehensive advisor in the biotech and pharmaceutical industries.
Kimberly's scientific background, including her 16-year tenure in research science, enhances her understanding of drug development, genomic studies, and medical conditions like cancer and muscular dystrophy. Her perspective as a research scientist turned attorney allows her to combine legal knowledge with scientific insight, offering clients a comprehensive view of their projects.
As co-founder of the firm's Psychedelic and Emerging Therapies practice group, Kimberly navigates the legal intricacies of psychedelic therapeutics and emerging medical technologies, such as regenerative stem cells. Her practice spans research and development, clinical trials, product liability, and controlled substances, and she is knowledgeable about both federal and state regulations. She is enthusiastic about the potential of AI tools in life sciences and their impact on intellectual property, compliance, and liability. She is also keenly aware of how mental health parity rules will shape the future of healthcare.
Kimberly's commitment to innovation and compliance extends to risk assessments, data integrity and management, and regulatory adherence. Her regulatory affairs certification underscores her dedication to industry standards, as she assists clients in navigating the intersection of law and biotech research. Known for her strategic insights and clear communication, Kimberly is a trusted partner for researchers, innovators, and clinicians and is adept at addressing complex issues in research and commercialization.
American Bar Association, Health Law Section
American Health Law Association
State Bar of California, 2007-present; Environmental Legislation Committee, 2008-2015; Litigation Section, 2018-present
Defense Research Institute, 2021-2023
Alameda County Bar Association, 2008-2015; Executive Committee of the Environmental Section, 2010-2015
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.
Provided by Chambers
Kimberly has great efficiency and quality in her turnarounds. She is very impressive in all aspects.
Kimberly is a very responsive and supportive attorney.
Kimberly has great efficiency and quality in her turnarounds. She is very impressive in all aspects.
Kimberly is a very responsive and supportive attorney.
