Associate Director, Biological Clinical Assay Lead
Pfizer
Susana received her Hon. B.Sc and M.Sc. in Biochemistry from Simon Fraser University, British Columbia, Canada. Right after graduation, Susana joined Merck Frosst Canada in Montreal as a biochemist. She supported protein characterization and assay development in various drug development programs and she also contributed to 17 scientific papers and 23 abstracts. With full support from both the Pharmacology and Biochemistry departments, Susana took the initiative and established the Pharmacology Analytical Service Group to support research project teams with GLP bioanalytical methods. Cycle time of data production was significantly reduced with Six Sigma guidelines.
After the close of Merck Frosst Canada in 2009, Susana continued her career in various CROs. As Operations Manager & Bioanalytical Principal Investigator at Algorithme Pharma, Susana set up the brand-new Large Molecule Bioanalysis Department. As Director of Analytical Operation in Immuni T Canada, Susana managed the analytical operations and lead external audits. In 2016, Susana transitioned to focus on biosimilar and joined Apobiologix, Apotex. As the Associate Director of Bioanalytics, Susana provided guidance to CROs for the develop immunogenicity assays. Susana also built and directed Apotex Research Private Limited (ARPL), the purpose-built bioanalytical laboratories at in Bangalore, India. During the 3 years in Apobiologix, Susana worked on numerous biosimilar programs: Epoetin alfa (Epogen®), Darbepoetin alfa (Aranesp®), Bevacizumab (Avastin®), Rituximab (Rituxan®), Trastuzumab (Herceptin®). She contributed to the timely submission to Health Canada, leading to approval of Lapelga™ (PEG-filgrastim) biosimilar to Neulasta® on 28th February 2019, first ever PEG-filgrastim biosimilar approved in any highly regulated market in world.
Susana joined Pfizer Clinical Assay Group in 2019 and supports large molecules global development. Also, Susana is an active member in American Association of Pharmaceutical Scientists (AAPS).
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Wednesday, January 12, 2022
3:30 PM – 4:30 PM ET
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