Name
Lisa Beilke
Educational Degrees
BS, MPH, PhD
Certifications
DABT - Diplomate American Board of Toxicology, ERT - European Registered Toxicologist
Education
MSPH, PhD (pharmacology/toxicology)
Expertise
Carcinogenicity, Cardiovascular Toxicology, Drug/Pharmaceutical Development, Food and Food Additives, Genetic Toxicology and Cytogenetics, Hazard Communication, Hepatic Toxicology, In Vitro Toxicology, Industrial and Occupational Toxicology, Medical/Clinical Toxicology, MSDS And Labels (Hazard Communication), Product Safety Assessment, Regulatory Toxicology, Risk Assessment, Safety Pharmacology
Specialties
small molecule toxicology, in silico/computational toxicology, safety pharmacology, risk assessment
Experience
Classically trained toxicologist with over 20 years in the biotechnology industry working on small molecule therapeutics. Experience ranges from work at a CRO conducting in vivo GLP studies to work in industry (small and large pharma) as a project team toxicologist on early research and late stage development multidisciplinary teams. Five years as computational toxicologist review/evaluation of in silico results from DEREK, LeadScope Model Applier and MultiCASE, with in silico assessment of impurities submitted to FDA on several occasions chaired an in silico symposium at ACT Annual Meeting (2011) 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. Primary author of toxicology-related sections (2.6.2/2.6.3, 2.6.6/2.6.7) of five INDs Prepared toxicology section of annual IND/IB updates Prepared Safety Information Amendments to IND (chronic toxicity and reproductive study summaries) Primary responsibility for authoring Section 2.6.7 and non-clinical reviewer for a 4-product (QUAD) and a 2-product combination NDA/MAA filing Prepared Module 1.8.2 SPA package for rat carcinogenicity study Possess excellent oral and written communication skills and value teamwork in a highly collaborative, creative work environment.
Address 2
Ste 336
City
san diego
State
CA
Zip Code
92130
Telephone
6505042547
Mobile Number
6505042547