Bioanalysis Rising Star Award finalist: Emily Werth
Nominated by: Lin-Zhi Chen, Sr Research Fellow at Boehringer Ingelheim (NY, USA)
Supporting comments:
“Emily started working in my group at Boehringer Ingelheim in January 2020, focused on developing highly sensitive instrumentation platforms for bioanalytical assays in the drug development pipeline. Through this effort, technical achievements include developing and implementing a highly sensitive micro-flow LC–MS assay delivering a 5-fold increase compared to regular UPLC/MS assays for numerous programs in the pipeline. Her work uses state-of-the-art techniques for LC–MS biomarkers, including anti-peptide-antibody reagents, with results included in regulatory documents and used to support the company’s decision-making on clinical and preclinical programs. Notably, her achievement in clearly demonstrating target engagement in complex biological systems succeeded where ELISA assay techniques failed, providing accurate total biomarker levels in vivo for improved PK/PD modeling. Throughout her professional development, Emily has advocated for and pursued leadership opportunities including her new role as a lab head responsible for GLP-compliant PK assays for tox studies and clinical trials. She has excelled in a fast-paced environment with the capacity and technical expertise to advance within her field.”
Describe the main highlights of your bioanalytical work
As a DMPK lab head and DMPK project representative, my contribution to drug programs begins at the start of development lasting until launch. My group is focused on best-serving programs through robust PK assays for toxicological studies and clinical trials. This includes support on mAb, bi-specific, oligo and ADC drugs in the pipeline. A key highlight from this is understanding drug disposition following intravitreal injection by characterizing the PK profile across ocular tissues and understanding target engagement. A microflow HPLC strategy and SISCAPA (stable isotope standards and capture by anti-peptide antibodies) workflow for ocular tissue PK was used to inform the project team on how the drug disperses throughout ocular tissue following treatment. This double immunocapture approach provided 100 pg/mL detection levels in plasma and low ng/mL LLOQs for a wide array of ocular tissues, a technical achievement delivering 5-fold increased sensitivity over traditional methods.
I have supported intravitreal programs, among others, by characterizing the PK profile across ocular tissues and measured target engagement to better inform cross-functional teams to answer regulatory questions. Results from my work led to the formation of an ocular biodistribution working group within the department supporting numerous programs through our expert panel.
