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"Kimberly has represented our company for a number of years, streamlining defense. After taking the matter over from another law firm, she kept us up to date on what was going on and kept costs contained. Kimberly is the best attorney that I have worked with."

Bud Krohn, Former President, Automotive Consumer Lending Company

Overview

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.

"Kimberly has represented our company for a number of years, streamlining defense. After taking the matter over from another law firm, she kept us up to date on what was going on and kept costs contained. Kimberly is the best attorney that I have worked with."

Bud Krohn, Former President, Automotive Consumer Lending Company

Industries

Services

Recognition

  • National Law Journal’s Emerging Therapies/Life Sciences Trailblazers
  • The Global Top 200 Psychedelic Lawyers, Policy & Regulation Experts, 2023

Education

  • J.D., Golden Gate University
    • Top 10%
    • CALI Award, professional responsibility
    • Moot Court Board
    • Environmental Law Moot Court Board
    • Asian-Pacific Law Association
    • Witkin award for Real Property, highest grade in course
  • B.S., University of California, Davis
    • Biological Sciences
    • Laboratory research assistant – asbestos fiber imaging in lung tissue

Admissions

  • California
  • U.S. District Court, Central District of California
  • U.S. District Court, Northern District of California
  • U.S. Court of Appeals, Ninth Circuit

Professional Memberships and Certifications

  • 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-present
  • Alameda County Bar Association, 2008-2015; Executive Committee of the Environmental Section, 2010-2015
  • Health Care Compliance Association
  • Psychedelic Pharmacists Association


*Contact Kim to set up an in-person consultation by appointment in the Oakland office.
Experience

As Research Scientist

  • Served as laboratory manager, leading research and development laboratories for genomics and regenerative biology companies in the generation of higher quality differential gene expression profiling based database products and services offered to biotech and pharmaceutical clients for their drug and biomarker discovery and validation efforts across various disease areas. The database products were used for academic research and clinical medicine.
  • Characterized and mapped genes to human chromosome 19 in a high-throughput manner utilizing laboratory instrumentation and analysis of genomic databases for Human Genome Project.
  • Developed assays and processes utilizing laboratory instrumentation to examine gene expression in various health conditions in order to identify likely candidates for therapeutic intervention including microarrays, restriction enzyme differential display and qRT-PCR for gene expression analysis, standardized RT-PCR, and fluorescent DNA sequencing for breast cancer, Unverricht-Lundborg disease (a form of epilepsy), myotonic dystrophy, and cataractogenesis.
  • Performed small animal surgeries to graft human immunological tissues into mice for efficacy testing of anti-viral treatments includingimmunohistochemical testing and characterization.
  • Performed genetic engineering; supervised cloning and construction of cDNA libraries to support sequencing of human genome.
  • Offered analysis and interpretation of sequence database hits using algorithms such as BLAST (basic local alignment search tool) and FASTA to compare subject nucleotide sequences with a database of sequences.
  • Identified competitive start-up products and services and opportunities for in-licensing of technologies for genomics/molecular diagnostics based disease intervention testing and monitoring for the early detection and prediction of human cancers and mental illnesses.
  • Worked in R&D related to stem cells derived from adult adipose tissues; developed and characterized stem cell lines (human and murine mesenchymal cells); characterized skeletal muscle derived stem cells into cardiomyocytes. Project sought to differentiate the cells into cardiac cells.
  • Identified, assessed, and evaluated strategic genomics technologies including microarray, sequencing, or PCR based pharmacogenomic/genetic analysis platforms.
  • Drafted standard operating protocols relating to assays, cell handling and propagation, and tissue culture laboratory procedures.

Product Liability and Toxic Tort

  • Advised business in advance of a planned product launch in the United States as to compliance and liability issues with federal and state controlled substance laws and product liability issues.
  • Serves as national coordinating counsel for asbestos client, managing the discovery program.
  • Counseled manufacturer and retail clients on regulatory compliance issues and in defense of lawsuits involving California's Proposition 65, which requires warnings to Californians about significant exposures to chemicals that allegedly cause cancer, birth defects or other reproductive harm.
  • Assisted in defense of product manufacturer in a class action suit requiring detailed analysis of voluminous evidence related to the manufacturer's product recall.

Environmental

  • Audited client facilities and operations and update environmental management programs to ensure compliance with applicable environmental health and safety regulations.
  • Negotiated reduced settlements in regulatory enforcement actions.
  • Represented family dry cleaning business in federal and California Department of Toxic Control Substances (DTSC) allegations of groundwater contamination and related cleanup costs. Argued for equitable allocation in consideration of nearby fuel retailer with underground storage tanks.
  • Represented manufacturer when DTSC inspections identified alleged environmental violations related to electroplating process; remedies included training and hazardous waste storage policy upgrades.
  • Represented component part manufacturer when DTSC inspection revealed alleged violations including chemical processing, hazardous waste storage and recordkeeping. Remedies included policy and training upgrades.
  • Advised out-of-state trucking company regarding diesel emissions in an enforcement action brought by the California Air Resources Board.

Life Sciences, Healthcare, Psychedelics, & Emerging Therapies

  • Advised higher education client on federal regulations and California law governing who is able to prescribe, administer and dispense controlled substances under California law, information needed for DEA licensing requirements, and clinic licensing requirements for human studies involving psychedelic substances.
  • Advised distributor as to the liability risks of importation of certain products as related to drug paraphernalia laws.
  • Advised venture capital firm as to liability risks associated with proposals that could implicate international treaties on psychedelics.
  • Advised author as to liability issues related to contract with publisher and drafted disclaimer language for author's book related to psychedelic-assisted therapy.
  • Provided advisory services related to developing a ketamine clinical network.
  • Assisted physician in navigating audit and investigation by Medicare Administrative Contractor (MAC) to seek a reduction in overpayment claims through analysis and rebuttal of technical and clinical positions of auditor.
  • Prepared informed consent documents to comply with healthcare regulations for therapy practice utilizing new technology.
  • Advised healthcare practitioner as to the liability risks involved with proposed harm reduction therapies.
  • Represented healthcare practitioner to negotiate and resolve claims associated with a therapeutic instrument.
Podcast | September 12, 2023
Psytelligence Podcast
Articles | June 23, 2023
Beyond the Psychedelic Renaissance
Articles | June 23, 2023
Conducting Psychedelic Clinical Trials
Articles | September/October 2022: | Volume 39, Issue 5
GPSolo Magazine: Legal Developments in Psychedelic Therapeutics
Articles | June 2022 | Volume 34, Number 5
The Health Lawyer: Legal Developments in Psychedelic Therapeutics
News Releases | February 17, 2023
Husch Blackwell Authors Amicus Brief in Ninth Circuit's Psilocybin Rescheduling Dispute

Husch Blackwell prepared and filed an amicus curiae brief on behalf of nearly 30 end-of-life and palliative care clinicians, urging the U.S. Court of Appeals for the Ninth Circuit to compel the U.S. Drug Enforcement Agency to initiate proceedings that could lead to a rescheduling of psilocybin for use in the end-of-life clinical setting.

News Releases | March 15, 2022
Husch Blackwell Launches Psychedelics and Emerging Therapies Practice Group

Husch Blackwell is pleased to announce the formalization of its Psychedelics and Emerging Therapies practice group, making it the first Am Law 100 firm to establish such a practice.

News Releases | April 01, 2021
Husch Blackwell Expands California Footprint
Outside the Office

Kimberly is a proud mother of twins and a group fitness enthusiast, having once been certified by the Aerobics and Fitness Association of America for cardio dance formats. She’s also an avid gardener, with a backyard greenhouse, and enjoys reading horticulture books and magazines.

Psychedelic Therapeutics

Kimberly Chew follows the research and development of these medicines for psychiatric conditions such as PTSD and treatment-resistant depression.

While psychedelic drugs such as MDMA, psilocybin, LSD and DMT are currently federally illegal Schedule 1 substances, the FDA is currently overseeing Phase I, II and III studies exploring the potential therapeutic benefit of these drugs. Members of the Husch Blackwell psychedelic law team are closely following this progress and concurrent proposed state legislation in multiple jurisdictions, and are positioned to help clients navigate what will no doubt be highly complex and novel legal issues.