Kimberly I. Chew

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.
• Provided analysis of company drug discovery regulatory files in order to provide a due diligence evaluation that would enable potential investors to understand potential risks involved that could impact the business.