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.
Prior to embarking on her legal career, Kimberly dedicated 16 years to the field of research science, contributing significantly to government agencies and biotech companies. Her journey began as a lab manager, where she not only supervised experimental design but also conducted groundbreaking experiments for the Human Genome Project. Her diverse skill set includes performing small animal surgeries for immunological studies, contributing to the drug development pipeline, and publishing prolifically in peer-reviewed scientific journals. Kimberly's scientific knowledge spans genomic studies/analysis, gene expression studies, tissue grafting, DNA extraction, and genomic sequencing, all aimed at addressing medical conditions such as breast cancer, glioblastoma, and muscular dystrophy.
With a unique perspective gained from her experience in biotech startups, Kimberly seamlessly combines legal acumen with scientific insight. She comprehends the complexities of drug development, technology licensing, and clinical trials, offering clients a comprehensive understanding of their projects from both perspectives. Passionate about fostering innovation and improving lives, she serves as a problem solver and regulatory compliance advisor for those engaged in the research and commercialization of novel therapies.
As the co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is particularly inspired by the potential of psychedelic therapeutics to address mental health conditions like PTSD. She skillfully navigates the legal intricacies surrounding these therapies, providing guidance through the clinical trial process at both state and federal levels.
Kimberly's legal practice extends beyond psychedelics, encompassing emerging medical technologies such as regenerative stem cells. Her experience includes advising on research and development, clinical trials, product liability, environmental matters, and legal issues related to controlled substances. She navigates laws such as the Controlled Substances Act, healthcare regulations, and DEA licensing, demonstrating proficiency in handling federal and state agency inspections.
In addition to her regulatory focus, Kimberly supports litigation related to novel therapies and is qualified to address allegations of research compliance. As a trusted advisor, Kimberly is exceptionally qualified to navigate intricate issues related to research integrity, ensuring ethical conduct and regulatory adherence in a variety of contexts. Her background allows her to assist with issues relating to root cause investigations and corrective actions, research integrity, risk assessments and mitigation strategies, privacy, data management and data security issues in research, drug diversion concerns, research compliance auditing, compliance considerations for decentralized clinical trials, various regulatory requirements, and guidelines, covering FDA operations, product development, pharmacology/toxicology, and Good Clinical Practices.
Kimberly is knowledgeable about Document Management Systems, Quality Management Systems, Good Documentation Practices, and technical writing techniques, and the importance of Good Laboratory Practices (GLP) regulations. She holds a certificate in regulatory affairs, showcasing her proficiency in Good Manufacturing Practices, GLP, and data integrity. This credential reflects her commitment to staying at the forefront of industry standards, in order to assist clients in navigating the complex intersection of law and biotech research. Her multifaceted skill set, combined with a nuanced understanding of the legal and ethical dimensions of research, positions her as a trusted partner for researchers, innovators, and clinicians alike, whether addressing issues of research misconduct, international collaborations, or decentralized clinical trial.
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 proceed with the best solutions.