Jeffrey Barbon is a Senior Scientist at AbbVie in the department of Global Biologics. He has over 20 years of University, biotech and large pharmaceutical company experience. He currently supports antibody development programs that span across multiple human diseases. His expertise lies in supporting these antibody generation campaigns by identification, design, optimization and support of functional bioassays.
Xiao-Yan Cai is a graduate of the basic medicine division and obtained her medical degree from Beijing Medical University in China in 1984. She obtained her Ph.D.from the Department of Microbiology & Molecular Genetics of University of Medicine and Dentistry of New Jersey (UMDNJ) in 1991. She has over 20 years of experience working in pharmaceutical industry. She is currentlya director at Merck Biologics Bioanalytical Development division. She has extensive experience developing and validating immunogenicity assays to support preclinical and clinical studies for therapeutic protein and peptide programs.
Shawn Fernando is currently the lead scientist for method development/troubleshooting biochemical and immunological assays under GLP conditions to evaluate pharmacokinetics and immunogenicity analysis in support of preclinical and clinical studies of biologics. He recently assumed the role of Principal Scientist in order to take responsibility of the technical conduct of a bioanalytical study as well as for the interpretation and analysis, documentation, and reporting of results in support of preclinical and clinical studies.
Cecile Geuijen is the director of oncology at Merus BV
Brad Greenfield joined Theraclone in January 2012 as a Scientist 2, Biology and manages the Assay Development/Screening functions. He has over 22 years of R&D experience in large and small bio-Pharma and academic research institutions. His experience spans basic discovery, protein Antibody and small molecules, assay development, automation and screening technologies. Prior to joining Theraclone, Brad Greenfield worked 13 years at Immunex/Amgen in the Assay Development/Screening group within the Inflammation Department. Brad was responsible for assay design, optimization and technology development efforts for the transfer of assays from discovery to screening within the Inflammation department. Brad earlier worked at MDS Pharma services as a Scientist/Group Leader heading up a large DNA Array contract project for a large Pharma client and developed processes/protocols for industrializing DNA prep, sequencing and QC for array chips. Earlier in his research career, Brad worked several years at Bristol-Myer Squibb, The Fred Hutchinson Cancer Research Center and Seattle Biomedical Research Institute. Mr. Greenfield holds a B.Sc. in Biology from Willamette University in Salem, Oregon, with graduate research studies at Colorado State University in Fort Collins, Colorado.
Barbara Hebeis, Ph.D., has over 13 years experience in cell based and biochemical bioassays, first in an academic environment, characterising antiviral immune responses and investigating signalling in and activation of B cells. She then moved to GSK Infectious Diseases CEDD, establishing cell based signalling assays and leading discovery programmes for small molecules enhancing anti-viral immune responses via Toll-like receptors. She then continued working on discovery of biologicals for inflammation and immune mediated therapeutics for oncology, first at GSK Biopharm and later at BoehringerIngelheim.
In 2011 she joined NDA Analytics leading the development team in the Bioassay department. The group can provide custom assay, design, development and validation. Activities are Bioassays to GMP, enabling development, GLP, GMP and GCP projects/studies, training and scheduling resource to ensure deliverables are met. Examples of assays developed and validated are cell based Bioassays measuring cytotoxicity, cytokine release and cell proliferation. Barbara also regularly supports all types of cell based and Bioassay related enquiries, working with clients assessing their requirements and planning implementation of their projects.
Jenny Hu is a scientist in Clinical Immunology at Amgen. She has been involved in developing assays for the detection of neutralizing antibodies against protein therapeutics for the past 12 years in Amgen. Prior to that, she worked on the discovery research in the field of oncology. She obtained a Bachelor of Science degree on Biology from FuDan University in China and a Master of Science degree on Molecular Biology from University of Southern California. She has extensive knowledge on ADA assay development, optimization and validation.
Janet L. Lathey is currently Director of Immunology and Assay Validation at Emergent BioSolutions in Gaithersburg, MD. Primary work areas are Toxin Neutralization assays, ELISA, and ELIspot. Previously, she was Deputy Director for Global Clinical Immunology at Sanofi Pasteur, Swiftwater, PA. As a Project Representative she was involved with standardizing assays for influenza clinical trials and efficacy studies. Before moving to Sanofi, Janet was director of Virology and Immunology at SeraCare in Gaithersburg, MD. Here she was responsible for developing an ELIspot kit for market and setting up proficiency testing using ELIspot for HIV and Cancer programs. At ZYCOS in Lexington, MA, Janet was group leader for clinical immunology and developed bioassays for the evaluation of Phase I and II cancer clinical trials.
Before moving to industry, Dr. Lathey was an Associate Research Scientist at University of California, San Diego in the department of Pediatrics. She was heavily involved in developing assays for evaluating HIV clinical trials. She was the leader of nationwide assay working groups for both virological and immunological assays for the AIDS Clinical Trial Group (ACTG). Janet completed a post doctorial fellowship in Viral pathogenesis at Scripps Clinic and Research Foundation, La Jolla, CA. after receiving her Ph.D. in Viral Immunology from the University of Tennessee in Knoxville, TN.
Patrick Liu is currently a Senior Director of the Global Bioassays and Technologies at Teva. He is also the Global Head who is managing multiple sites around the globe in support of product biological evaluation, PK/PD and immunogenicity assessment for both innovative biologics and biosimilars development. Prior to joining Teva, Dr. Liu was an Associate Director at Genentech and a Director at Tanox, where he had played leadership role in bioanalytical sciences for the development and commercialization of biological new molecule entities (NMEs) in the fields of oncology, hematology, immunology, allergy and infectious diseases, with numerous patent applications and publications. Dr. Liu had practiced medicine with specialty in Endocrinology and PhD in Molecular Biology.
Tina Morris is Vice President, Biologics and Biotechnology, USP-NF in the Global Science and Standards Division at USP, which she joined in 2003. She coordinates all standard-setting activities in the division related to biologics and biotechnology for the US-based compendia and manages the scientific staff responsible for the relevant Expert Committees, the development of biological reference materials, and the biologics laboratory at USP Headquarters.
Before joining USP, Dr. Morris’ industrial experience includes major biotech companies in the areas of analytical development, especially mass spectrometry, and recombinant protein characterization. Dr. Morris is the holder of several United States patents in the areas of virology and mass spectrometry assay development. She is the author of many publications in peer-reviewed journals and a frequent invited speaker at national and international scientific conferences.
Surendran Rajendran is presently a Senior Research Investigator at Bristol-Myers Squibb. He started his research career at University of Texas Medical Branch at Galveston. He has been successful in academia, big Pharma as well as small biotech companies and involved in drug discovery and development, new technology innovation and basic research. He has made over 30 publications, many presentations and successful contribution of taking many compounds (both large and small molecules) from discovery to successful clinical trial.
Jane Robinson works at the National Institute for Biological Standards and Control (NIBSC), a centre of the Medicines and Healthcare products Regulatory Agency (MHRA) and a World Health Organization (WHO) International Laboratory for biological standards. She has responsibility for control and standardization of polypeptide growth factors of therapeutic and diagnostic potential, advises regulatory authorities and other organizations on bioassay design for a variety of types of biologicals and leads collaborative projects to develop WHO international standards and reference reagents. These activities have provided her with an overview of bioassay use in different organizations and the problems which can be encountered. Prior to joining NIBSC, Dr. Robinson worked at the University of Warwick, UK, and at the Institute for Cellular and Molecular Pathology (ICP), Brussels, Belgium. She received her Ph.D. degree in chemistry from the Katholieke Universiteit te Leuven, Belgium.
Alexis Rossignol studied Cellular Biology and Immunology in the University of Poitiers, France. During his Ph.D. (defended in 2007), he worked on the interactions between human dendritic cells and invariant natural killer T cells and their role in the antitumoral response, particularly during chronic myeloid leukemia.
Dr. Rossignol then moved to the field of therapeutic antibodies, joining the team of Pr. Hervé Watier and Pr. Gilles Paintaud in Tours (France), specializing in immuno- and pharmacogenetics of therapeutic antibodies. After its discovery of the role of FCGRIIIA-158V/F genotype in the clinical response to rituximab, this team had just found a second genetic factor influencing therapeutic antibodies' response. He joined Pr. Watier's team to develop cellular assays exploring this new mechanism and acquired great experience in cellular bioassays (ADCC, CDC…).
Dr. Rossignol was recruited in 2011 to manage the development of potency bioassays at Clean Cells, particularly ADCC assays based on highly standardized exclusive CD16-expressing T cells. He is also the coordinator of the "PremiumADCC" project, a private-academic scientific partnership led by Clean Cells, aiming to improve the tools for measuring ADCC and develop a standardized, non-radioactive method that complies with current regulatory standards.
Max Tejada, Ph.D., is a QC Senior Scientist and Group Leader in the Biological Technologies group at Genentech. He leads a team of scientists and research associates focused on the development, optimization and validation of receptor and cell-based biological methods used in support of GMP lot release potency testing and characterization of clinical products including large molecules and antibody-drug conjugates. His group also supports potency method transfers to collaborators and contract manufacturers. Prior to joining the Biological Technologies group, he was a Postdoctoral Fellow in the laboratory of Napoleone Ferrara where his research interests included the role of the microenvironment in tumor growth.
Baolin Zhang is a Senior Investigator and a Product Quality Reviewer at the Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). He has over 12 years regulatory experience in the quality review (Chemistry, Manufacturing and Control) of new therapeutic proteins under investigational new drug applications (INDs) and biologic license applications (BLAs). He also leads a research team in the conduct of FDA mission related research program, including the development of bioassays for evaluation of oncology drug products. His scientific expertise lies in the areas of protein biochemistry, cell death regulation, cancer drug action and resistance mechanisms, and cancer biomarkers, as evidenced by over 60 peer-reviewed articles. He serves as an Editorial Board member or reviewer for numerous peer-reviewed journals. Prior to joining FDA in 2001, he was a Senior Research Scientist at University of Tennessee, College of Medicine. He had also served as Professor and Deputy Director at the Beijing Center for Biologics Development and Research, and Associate Professor at Nanjing University. He earned his Ph.D. in chemistry from Peking University in 1992. He has received many awards including the 2010 FDA/CDER Scientific Achievement Awards for Excellence in Laboratory Science and the 2011 FDA/CDER Excellence in Leadership and Mentoring.
Xianzhi Zhou graduated with a Ph.D. in Biochemistry from Albert Einstein College of Medicine in 1999, worked at Pfizer from 2000 -2010, and moved on to Medimmune in 2010 where he is a senior scientist working on statistical approaches to bioassay bridging and transfew