Short Courses*

Shan Chung, PhD, Associate Director & Principal Scientist, Bioanalytical Sciences, Genentech

Dr. Shan Chung is currently an Associate Director and Principal Scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. Shan received his Ph.D. in Molecular Biology from University of Pennsylvania and completed his postdoctoral training in Protein Engineering at Harvard University. Shan has more than 20 years’ experience in research and development of pharmaceutical products, specifically in the areas of preclinical and clinical development of therapeutic antibodies. An expert on Fc effector functions, bioanalytical assays, and immunogenicity of biotherapeutics, Shan serves on the USP Fc Function Expert Panel, and is an active member of the AAPS Working Group on Immunogenicity Risk Assessment and Mitigation. Shan joined Genentech in 2006, and currently leads the Effector Function and Cell Biology group in BAS. The responsibilities of his group include biological characterization of clinical candidates, development and validation of bioanalytical assays, and evaluation of immunogenicity potential of antibody products.

Jim McNally, PhD, Principal, McNally Bioanalytical Consulting

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Weifeng Xu, PhD, Principal Scientist & Group Leader, PPDM, Merck Research Labs

Weifeng has been in the field of immunogenicity for biologics for about 10 years. He had developed cell-based neutralization Ab assays for multiple key product at BMS including Opdivo and Yervoy. He is an active member in AAPS NAb work group as well as EBA NAb team; he is also co-leading the NAb assay drug tolerance subteam at AAPS. After join Merck at the end of 2018, Weifeng is now leading Cell Assay group within PPDM Regulated Immunogenicity to develop neutralizing assays for both biologics and vaccines.

Jim McNally, PhD, Principal, McNally Bioanalytical Consulting

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Lynn Kamen, PhD, Senior Scientist, BioAnalytical Sciences, Genentech Inc.

Lynn Kamen is a Senior Scientist in the BioAnalytical Sciences department at Genentech. She earned her Ph.D. in Immunology at the University of Michigan and completed a postdoctoral fellowship in immunology at the University of California San Francisco. Following her postdoctoral fellowship, Lynn transitioned into industry working in early drug discovery of both small and large molecules at several biotech companies including Portola Pharmaceuticals and Alector. Since joining Genentech, Lynn has supported the in vitro biological characterization of large molecules and lead the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. She is co-lead of the AAPS NAber working group and member of the AAPS NAb drug tolerance sub-team.

Johanna Mora, PhD, Associate Director, Bristol-Myers Squibb

Dr. Mora is currently an Associate Director in the Non-clinical Disposition and Bioanalysis Group at Bristol-Myers Squibb (BMS). She received a Bachelor of Science degree in Chemistry from the University of Costa Rica in 1999 and a Ph.D. in Analytical Chemistry from the University of Kansas in 2004. At BMS she is the PK and immunogenicity Lead for innovative medicines development (IMD) assets and leads a team of scientists in the development of methods to support bioanalysis and bioanalytical strategy of small, macromolecular, and new modality therapeutics. She is a mentor to her team, is an author of over 15 scientific publications and has served in several cross functional teams within BMS. She is an active member of AAPS, has served in the Emerging Technology and the Therapeutic Product Immunogenicity Focus groups and is a member of Applied Pharmaceutical Analysis Regulated Bioanalysis Committee.

Angela Yang, PhD, Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.

Angela Yang is a Scientist in the Bioanalytical Sciences department at Regeneron. She received a Ph.D. from the University of North Carolina at Chapel Hill, where she studied interactions between PEGylated nanoparticles and the immune system. At Regeneron, Angela has worked on the development and validation of PK, ADA, and neutralizing antibody assays in support of clinical and non-clinical studies, as well as developing tools for data analysis of immunogenicity assays.

Soumi Gupta, PhD, Director, Translational Sciences, BioMarin Pharmaceutical

Soumi Gupta received her Ph.D. in Microbiology from University of California, Davis in 2003, where the focus of her research was aimed at furthering our understanding of the immune correlates of protection towards a successful AIDS vaccine. She pursued post-doctoral training in Immunology at Chiron Corporation where she investigated anti-HIV T and B cell-mediated responses following mucosal immunization with alphavirus-based replicon particles encoding for HIV-Gag, Pol and Env. Following her post-doctoral training, she worked at Monogram Biosciences as a scientist in research and development, developing assays to characterize genotypic and phenotypic resistance to HIV antivirals. Soumi joined BioMarin in February of 2015 as a Director in Immunogenicity Assessment where she provides immunologic expertise to drug programs across developmental stages and develops immunogenicity and safety strategies for novel biologic therapeutics, including enzyme substitution therapies and AAV-mediated gene therapies.

Jim McNally, PhD, Principal, McNally Bioanalytical Consulting

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow and lead for the Immunogenicity Discipline at Pfizer, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.