Yanyan C. serves as a Senior Scientist at Wave Life Sciences, where she plays a pivotal role in the development of oligonucleotide therapeutics. With a robust background in drug metabolism and pharmacokinetics (DMPK), Yanyan is responsible for designing and executing DMPK activities that are critical...
Yanyan C. serves as a Senior Scientist at Wave Life Sciences, where she plays a pivotal role in the development of oligonucleotide therapeutics. With a robust background in drug metabolism and pharmacokinetics (DMPK), Yanyan is responsible for designing and executing DMPK activities that are critical for Investigational New Drug (IND), Investigator's Brochure (IB), and New Drug Application (NDA) filings. Her extensive knowledge of current regulatory guidance ensures that all studies meet the stringent requirements set forth by regulatory agencies.
In her current role, Yanyan leads key projects that involve pharmacokinetic (PK) and pharmacodynamic (PD) analysis for discovery studies, as well as non-compartmental analysis (NCA) modeling for clinical studies. She expertly manages bioanalytical activities, including bio-analysis of PK and biomarker samples, utilizing advanced techniques such as Liquid Chromatography-Mass Spectrometry (LC-MS) and Enzyme-Linked Immunosorbent Assay (ELISA). Her proficiency in identifying oligonucleotide metabolites both in vivo and in vitro is instrumental in understanding the drug's behavior in biological systems.
Yanyan also excels in cross-functional collaboration, working closely with various teams to ensure seamless integration of bioanalytical data into the drug development process. Additionally, she is responsible for qualifying and recruiting service providers, including Contract Research Organizations (CROs), to support the expanding needs of Wave Life Sciences. Her expertise in the pharmaceutical industry, coupled with her skills in data analysis software such as WinNonlin, positions her as a key contributor to the advancement of innovative therapies in the life sciences sector. Through her dedication and technical acumen, Yanyan C. is making significant strides in the field of oligonucleotide drug development.