Sr. Director
Merck & Co., Inc.
West Point,, Pennsylvania
I have accumulated 16 years of invaluable experience in the Pharmaceutical Industry, specializing in regulated bioanalytical (BA) testing of biologic therapeutics. Throughout my career, I have focused on the development and validation of pharmacokinetic (PK), immunogenicity (ADA), and neutralizing antibody (NAb) assays. My work has been instrumental in supporting numerous preclinical and clinical studies for critical programs. I have played a vital role in multiple successful IND and BLA submissions, meticulously preparing bioanalytical sections for regulatory filings. As part of these endeavors, I have actively engaged with regulatory agencies, providing scientific strategy and responding to inquiries from health authorities. Currently, I am a Sr. Director at the Regulated Bioanalytics Group of Merck. In this role, I lead a team of dedicated scientists who are involved in the development of PK and ADA assays. Additionally, we provide critical immunogenicity assessment strategies enabling the development and licensure of biotherapeutics.
Disclosure information not submitted.
Bioanalytical Strategies for New Modalities - Part 2
Tuesday, July 23, 2024
1:30 PM – 3:10 PM CST