Elena Trepakova
Senior Principal Scientist @Sanofi
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WORK HISTORY
Senior Principal Scientist @Sanofi
Morristown, NJ, US
Provide scientific leadership within Preclinical Safety. Serve as a Nonclinical Safety Lead on multi-functional integrated Project Teams for small molecules, biotherapeutics, oligonucleotides, and other modalities: support the development of new products by designing and implementing the nonclinical toxicology and safety pharmacology strategies; design toxicology studies; review reports and other documentation authored by internal personnel and/or external contract laboratories and provide the nonclinical safety scientific perspective; ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies; contribute to writing regulatory documents such as IBs, INDs, CTAs NDAs/BLAs, Pediatric Investigation Plans, and others; perform integrated nonclinical risk assessments; interact with internal and external partners and global regulatory agencies. Provide scientific input on design and analysis of research activities, including evaluations of external opportunities for in-licensing as appropriate, and ensure activities are completed with highest scientific standards. Provide internal expertise for global nonclinical safety pharmacology issues by serving as a member of internal Safety Pharmacology Expert Group.
EDUCATION
Institute of Cell Biophysics, Russian Academy of Sciences
Ph.D., Biophysics/Cell physiology/Pharmacology
Yaroslavl Demidov State University
B. Sc., Environmental Toxicology, Physiology
SKILLS
ABOUT ELENA TREPAKOVA
Senior scientist and Preclinical Drug Safety Compound Leader with substantial industrial experience in preclinical safety support of compound development from Discovery through post-marketing; nonclinical cardiovascular safety, in vitro model development and solid academic training in cardiovascular ion channel physiology and pharmacology. Strong skills in people managing/coaching and talent development. Particularly interested in nonclinical safety aspects of drug candidate development and strategic planning.Specialties: Nonclinical compound development;Nonclinical drug safety;Nonclinical in vitro cardiac safety;Project management;21 CFR Part 58;21 CFR Part 11
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