As a former life sciences researcher, Kimberly advises industry clients on regulatory and legal liability issues. She has a keen interest in biotech endeavors and advises entities on research and clinical trial matters.
Prior to attending law school, Kimberly began her career with 16 years as a research scientist, working for both government agencies and biotech companies. She served as a lab manager, overseeing experimental design and conducting her own experiments as part of the Human Genome Project; performed small animal surgeries for immunological studies; and assisted with the drug development pipeline. Kimberly published frequently in peer-reviewed scientific journals and submitted information for patent applications. Her scientific studies encompassed genomic studies/analysis, gene expression studies, tissue grafting, tissue culture, DNA extraction, stem cells and regenerative medicine, and genomic sequencing in humans and model organisms in support of many medical conditions such as breast cancer, glioblastoma, and muscular dystrophy.
Kimberly’s background in biotech startups gives her a unique perspective on legal matters in the life sciences industry. She understands drug development, technology licensing, and clinical trials from both a legal standpoint and a scientific one, and she readily grasps the science of clients’ projects in detail. She also knows the great promise of clients’ research and the potential their discoveries have to improve people’s lives, and she is passionate about serving as a problem solver and regulatory compliance advisor for innovators and clinicians engaged in the research and commercialization of novel therapies.
As a co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is particularly inspired and motivated by the potential use of psychedelic therapeutics to treat debilitating mental health conditions such as PTSD. She offers experienced guidance through the web of legal complexities at the state and federal levels as these novel therapies proceed through the clinical trial process.
Kimberly has advised clients in matters of research and development of potential therapies, clinical trials, product liability, environmental matters, and legal matters regarding Schedule I controlled substances that involve laws such as the Controlled Substances Act, healthcare and research study regulations under the California Business & Professions Code, requirements relating to DEA licensing and registration of controlled substances, CERCLA/Superfund, RCRA, California Proposition 65, and other alleged solid and liquid hazardous waste violations in response to federal and state agency inspections. In addition to her psychedelics focus, Kimberly is experienced with other emerging medical technologies, such as regenerative stem cells. While she primarily practices in the regulatory arena, she also supports litigation related to novel therapies, including Medicare audits. Kimberly is also qualified to assist with allegations of research misconduct.
Alongside her life sciences practice, Kimberly works with the firm’s innovative and award-winning Asbestos Litigation team, helping clients manage their risk profiles and defending large national dockets. Businesses, academic and medical research centers, premises owners, contractors, and manufacturers are among those who rely on Kimberly’s broad range of litigation and regulatory experience. As national coordinating counsel, she has coordinated the discovery for thousands of cases.
Knowledgeable and energetic, Kimberly is known for identifying key strategies in challenging cases, then easily communicating those ideas to clients and legal teams in order to move forward with the best solutions.