Bioanalysis of Biotherapeutics

During my tenure at Wyeth, Pfizer, Sana, and Regeneron I have cultivated substantial expertise in strategically approaching the bioanalysis of biotherapeutics. I was fortunate to support development of monoclonal antibodies (mAb), antibody drug conjugates (ADC), enzyme replacement (ERT), fusion proteins, adeno-associated virus delivery (AAV), chimeric antigen receptor T-cell (CAR-T), siRNA and other modalities of biotherapeutics. I had opportunity to experience and apply bioanalytical approach that is anchored in considerations such as the developmental phase of the compound, the modality type, the clinical indication, and the regulatory landscape. Key questions revolve around determining the optimal PK assay, fine-tuning the timing and nature of immunogenicity assessments for various biotherapeutic modalities, preparing comprehensive regulatory submissions, and crafting thorough responses to regulatory inquiries.

I have also gathered an array of pragmatic solutions designed to streamline the process of PK, anti-drug antibody (ADA) and neutralizing anti-drug antibody (NAb) detecting assay development, transfer, and validation. These encompass guidelines for discerning assay readiness for production or identifying the need for adjustments. Over the years, my involvement has been pivotal in assessing immunogenicity risk factors and orchestrating data-driven strategies for immunogenicity assessment. My leadership of the Immunogenicity Expert Working group within the organization has afforded me a unique vantage point, exposing me to diverse biotherapeutic modalities, indications, and associated risks. 

Leveraging my extensive network within the industry, forged through direct engagements and active participation in esteemed organizations such as AAPS, EBF, EIP, and Industry IQ, I have consistently seized opportunities to contribute, co-lead, and spearhead initiatives aimed at advancing the frontiers of bioanalysis science.