GOROVITSCONSULT.COM

During my tenure at Wyeth and then Pfizer, I have built a significant expertise in strategic approach to Bioanalysis of Biotherapeutics that is based on the compound development phase, modality type, clinical indication and regulatory risks. Typical questions include the type of PK assay to develop, the nature and timing for the immunogenicity evaluation, how to prepare for a regulatory submissions, information to include when responding to inquires from regulators... I also have created a collection of tactical solutions that can simplify and streamline process of assay development, transfer and validation, questions to ask when determining whether the assay is ready for production or requires additional adjustments... Through the years, I have been actively involved in evaluation of immunogenicity risk factors and relevant and data driven design of immunogenicity assessment strategy. My leadership of the Immunogenicity Expert Working group within the company created solid..