Lisa D. Beilke
MSPH, PhD, DABT, ERT

Profile Overview
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Full CV

Classically trained toxicologist with over 20 years in the biotechnology industry working on small molecule therapeutics. 

Broad experience in toxicology encompasses work at a CRO conducting GLP studies and work in industry (small and large pharma) as a project team toxicologist on early research and late stage development multidisciplinary teams. Independent consultant since 2012.

  • Over ten years as computational toxicologist, with in silico assessment of impurities submitted to FDA on numerous occasions; chaired an in silico symposium at ACT Annual Meeting; author of several in silico-related publications

  • Performance of risk assessment strategies for large and small molecule impurities, degradants, starting materials, etc, as well as leachable and extractables for device related products

  • Conducted various pharmacology/toxicology studies including safety pharmacology (CNS, respiratory, cardiovascular, Langendorff), genotoxicity (Ames, chromosome aberrations, micronucleus), repeat dose chronic toxicity and reproductive (Seg I, II) studies

  • Regulatory writing:

    • Primary author of toxicology-related sections (2.4, 2.6.2/2.6.3, 2.6.6/2.6.7) of several INDs across various therapeutic areas

    • Prepared toxicology section of annual IND/IB updates and DSUR

    • Primary responsibility for authoring Section 2.6.7 and non-clinical reviewer for two successful drug combination NDA/MAA filings; 4-product (QUAD) and a 2-product combination

  • Possess excellent oral and written communication skills and value teamwork in a highly collaborative, creative work environment.

 

Selected Professional Experience


Toxicology
Solutions, Inc.

President/CEO

TSI is an independent consulting company focused on providing non-clinical toxicology services for the development of small molecule therapeutics from early discovery through product registration. Specialty services include risk assessment and in silico toxicity predictions using 3 major predictive software programs (DEREK Nexus, Leadscope Model Applier, MultiCASE).

2012— Present,  San Diego CA


Responsibilities included overall management of drug safety, including impurity-related CMC and regulatory activities, as well as toxicology and associated activities (management of CROs, protocols, reports, summaries, regulatory submissions, etc.). Involved in strategic decision making, and responsible for authorship of any documentation and conduct of any activities appropriate to support decisions.

2015,  South San Francisco

Tricida, Inc.

Sr. Director, Drug Safety 


Aragon Pharmaceuticals

Principal Scientist

Aragon Pharmaceuticals was a privately held, small-molecule drug discovery company focused on developing breakthrough medicines for the treatment of hormonally-driven cancers. As the sole toxicologist for the company, I was responsible for the design and conduct of all non-clinical toxicology studies in support of breast and prostate cancer projects from discovery through registration. Lead author of toxicology sections for all regulatory filings with input/review of all other sections to ensure proper integration of toxicology conclusions. Collaborated with Regulatory and Clinical on the strategy of filings (e.g., combo INDs, presentation/interpretation of data). Served as Project Leader for SERD program, was responsible for coordination of all project-related activities from Chemistry, Biology and Drug Safety groups, including budget, API needs, timelines, etc. Additional responsibilities included hazard characterization of early research compounds, process chemicals, and impurities; MSDS development and review; lead computational toxicologist. Company was acquired by Johnson & Johnson without acquisition of employees.  

2012 — 2013,  Del Mar CA


Gilead Sciences

Research Scientist II, Drug Safety Evaluation

Independent design and conduct of non-clinical toxicology studies in support of anti-viral drug discovery and development projects. Lead protocol review discussions concerning scientific and procedural aspects of toxicology study design. Independently design and conduct various in vitro and in vivo studies to include general, single and repeat dose toxicology, safety pharmacology, genetic and reproductive toxicology, ion channels, receptor binding, and kinase screening. Oversee procedural and scientific aspects of studies throughout duration of study. Data review and interpretation of toxicology study reports. Prepare study protocols, amendments, and other documents as needed. Ensure quality studies are conducted and reported in a timely manner. Preparation and review of regulatory documents, annual reports, INDs, Investigator Brochures and NDAs/MAAs. Represent department on multifunctional project teams. Strategic decision making to anticipate obstacles and difficulties to ensure goals are met. Possess working knowledge of pre-clinical drug discovery and development, along with adherence to appropriate regulatory requirements of study conduct and industry standards of Good Laboratory Practices as well as Gilead SOPs. Additional responsibilities including hazard characterization of early research compounds, process chemicals, and impurities; MSDS development and review; lead computational toxicologist. 

2008 — 2012,  Foster City CA


Pfizer Global R&D

Sr. Associate Scientist

Formerly Agouron Pharmaceuticals, prior to acquisition by Pfizer. Responsible for managing Chemistry, Manufacturing, and Control (CMC) toxicology functions within Drug Safety Evaluation (DSE) Department. Primary responsibilities included independent design, conduct and interpretation of toxicology and worker safety studies, provided support to Pharmaceutical Sciences Dept. for drug substance and drug product issues (e.g., impurities, degradants, solvents, vehicles/excipients, etc.), liaison to EHS for hazard communication (provided hazard/risk assessments, MSDSs), DSE expert for excipients and vehicle safety. Participated as toxicology representative on project teams to facilitate the development of innovative and highly valued drug candidates. Additionally, acted as the department Safety Officer representing the department on various Safety sub-committees, ensuring departmental compliance with regulations, and evaluating impact of new technologies. Participated as toxicologist on global Vehicles Safety Task Force for evaluation of data and maintenance of vehicle/excipient database and evaluation of novel excipients.

2000 – 2006, La Jolla Ca.