Short Courses*

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.

Weifeng Xu, PhD, Principal Scientist & Group Leader, Bioanalytical, Merck

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.

Ang Liu, PhD, Senior Principal Scientist, Bristol-Myers Squibb

Dr. Ang Liu is currently a Senior Principal Scientist at Bristol-Myers Squibb. Ang joined the Department of Bioanalytical Sciences at BMS in 2012 with experience in regulated bioanalysis at Tandem Labs (now Covance) and experience in protein bioanalysis at Yale University. Ang received her Ph.D. from University of Illinois at Chicago in 2009. Ang has extensive experience in regulated bioanalysis of small-molecule and large-molecule drugs, and new treatment modalities in support of PK and immunogenicity using LC-MS based and LBA based technologies. Ang has authored or co-authored a book chapter and over 15 scientific publications in peer-reviewed journals. She also serves as a reviewer of a number of journals. Ang has served on the organizing committee of Applied Pharmaceutical Analysis (APA) Conference since 2016.

Kavitha Akula, PhD, Senior Scientist, Bristol-Myers Squibb

Dr. Kavitha Akula is currently a Senior Scientist at Bristol-Myers Squibb (BMS) in the Non-clinical Disposition and Bioanalysis Group. Kavitha joined BMS in 2019 with about five years of experience in regulated bioanalysis from different contract research organizations (CRO). Kavitha received her PhD from Temple University, Philadelphia in Organic Chemistry in 2017. Kavitha has extensive experience in regulate bioanalysis of large molecule drugs and new treatment modalities in support of PK and Immunogenicity. She also serves as a member of the Early Career Bioanalytical Scientists (ECBS) sub-team in AAPS.

Nanda Balasubramanian, Senior Principal Scientist, NDB, Bristol-Myers Squibb

Nanda Balasubramanian is a Sr, Principal Scientist at BMS providing bioanalytical support for gene therapy and biologics. Nanda brings 10+ years of immunoassay and bioanalytical experience. Prior to BMS, Nanda was at AstraZeneca, where he provided scientific, bioanalytical and operational oversight of regulated bioanalytical assays and strategies in support of oligonucleotide therapeutics and biologics. Prior to AstraZeneca, Nanda held similar roles, with increasing responsibility, at Pfizer and Alexion Pharmaceuticals. He did a postdoc at Yale University School of Medicine applying DNA repair, high-throughput screening, anti-sense oligos, nanoparticles, and gene therapy.

Soumi Gupta, PhD, Senior Director, Head of Immunogenicity Assessment, 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.

David Lansky, PhD, President, Precision Bioassay, Inc.

David Lansky has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 30 years. This includes Searle/Monsanto/Pharmacia (10 years) and as the owner of Precision Bioassay, Inc. (since 2002). David has been and is still an active participant in the work to revise the USP bioassay chapters. His education includes a year of Electrical and Computer Engineering (University of Michigan), a BS in Botany (San Francisco State), an MS in Entomology (Cornell) and finally both an MS and Ph.D. in Biometry (both Cornell).