Bioanalytical Aspects in Biological Therapeutics
Bioanalytical Aspects in Biological Therapeutics
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Description
Xiaohui Xu, PhD, is Director at Daiichi-Sankyo Inc. She is actively serving in the American Association of Pharmaceutical Scientists (AAPS) PK Assay Group and IQ Consortium Metabolite Working Group. She has extensive experiences in regulated bioanalytical field including global submissions, covering small molecules, biologics and new modalities. She has extensive publications and 2 book chapters. She received her Doctorate in Pharmaceutical Analysis from College of Pharmacy, the University of Georgia.
Weifeng Xu, PhD, is Director at Merck & Co., Inc. He is an active member and leader in the AAPS and the European Bioanalysis Forum’s (EBF) immunogenicity community and has published multiple papers on immunogenicity assay development and validation. He is also co-leading the IQ Consortium Bioanalytical Considerations and Challenges for Cell Therapies subgroup. More recently Weifeng also became Bioanalytic lead to multiple vaccine projects within Merck including COVID-19 and pneumococcal to oversee all clinical immunogenicity assays.
Xiaohui Xu, PhD, is Director at Daiichi-Sankyo Inc. She is actively serving in the American Association of Pharmaceutical Scientists (AAPS) PK Assay Group and IQ Consortium Metabolite Working Group. She has extensive experiences in regulated bioanalytical field including global submissions, covering small molecules, biologics and new modalities. She has extensive publications and 2 book chapters. She received her Doctorate in Pharmaceutical Analysis from College of Pharmacy, the University of Georgia.
Weifeng Xu, PhD, is Director at Merck & Co., Inc. He is an active member and leader in the AAPS and the European Bioanalysis Forum’s (EBF) immunogenicity community and has published multiple papers on immunogenicity assay development and validation. He is also co-leading the IQ Consortium Bioanalytical Considerations and Challenges for Cell Therapies subgroup. More recently Weifeng also became Bioanalytic lead to multiple vaccine projects within Merck including COVID-19 and pneumococcal to oversee all clinical immunogenicity assays.