SC1: Preclinical and Clinical Immunogenicity Bioanalysis: ADCs, Multi-Domain Biotherapeutics and New Modalities
SUNDAY, APRIL 30, 2017
MORNING 10:00 AM - 1:00 PM
Instructors:
Darshana Jani, M.S., Senior Manager, Pfizer, Inc.
Priya Sriraman, Ph.D., Principal Investigator, Biotherapeutics Development, Celgene Corp
Seema Kumar, Ph.D., Associate Director, EMD Serono
Corinna Krinos Fiorotti, Ph.D., Business Development Manager, Bioagilytix
Topics will include:
Screening
Confirmatory assays
- Confirmatory cut-point determination
- Metrics and interference
- Specificity
Neutralizing antibody assays
- Assay format selection
- Sensitivity
- Specificity
Detailed Agenda:
10:00 Moderator’s Remarks:
Darshana Jani, M.S., Senior Manager, Pfizer, Inc.
10:15 Immunogenicity Mapping for Emerging Modalities
Priya Sriraman, Ph.D., Principal Investigator, Biotherapeutics Development, Celgene Corp
Immunogenicity assessments for new modalities goes beyond the conventional anti-drug antibody (ADA) assays. Approaches to understanding domain specificity of the ADA response and further attempts with epitope mapping can support engineering efforts in producing de-immunized versions, or help avoid immunogenicity in the next generation of molecules. Approaches to understand the nature of the immune response and correlation to clinical findings will also be discussed.
11:00 Refreshment Break
11:15 Talk Title to be Announced
Seema Kumar, Ph.D., Associate Director, EMD Serono
12:00 Antibody-Drug Conjugate Bioanalytical Assay Development: Where are the Challenges?
Corinna Krinos Fiorotti, Ph.D., Business Development Manager, Bioagilytix
12:45 Q&A with Audience
1:00 Close of Course
Instructor Biographies:
Darshana Jani, M.S., Senior Manager, Pfizer, Inc.
Darshana Jani has nearly 25 years of practice in the academic and biotechnology field. Throughout her tenure at Genzyme, Medimmune, BiogenIdec until present employment as Senior Manager at Pfizer she has supported clinical and pre-clinical trials, in addition to post marketing studies inclusive of Safety, Immunogenicity, PK, Efficacy, and Biomarker analysis. Darshana has risen from the ranks, at the outset developing and applying boianalytical methods, while assuming numerous responsibilities germane to regulatory compliance of the validation and application of group procedure. She has guided bioanalytical lab groups, held responsible for overseeing all phases of drug recovery and development; a task which incorporated product characterization, potency determination, immunogenicity testing, as well as surrogate maker discovery.
Priya Sriraman, Ph.D., Principal Investigator, Biotherapeutics Development, Celgene Corp
Priya Sriraman is a Principal investigator at Celgene in NJ. Her group is responsible for immunogenicity, bioanalytical and pharmacokinetic support for biotherapeutic and cell therapy programs. Prior to Celgene, Priya was at Roche Pharmaceuticals.
Seema Kumar, Ph.D., Associate Director, EMD Serono
Seema Kumar has recently joined Global Early Development (GED) division at EMD Serono Inc. (Merck KGaA, Germany) as an Associate Director and a Quantitative Pharmacology & Drug Disposition- New Biological Entities (QPD-NBE) Program Representative. In her role, Dr. Kumar manages overall nonclinical drug disposition contribution to NBE projects including support for ADME, bioanalytical (BA), immunogenicity strategy, and scientific oversight of outsourced large molecule programs, through the different discovery and development stages. Previously, Dr. Kumar led regulated BA group in Pharmacokinetics and Dynamics Metabolism (PDM-NBE) department at Pfizer. The group provided regulated (GLP/GCP) BA support including assay development, validation and sample analysis for the Pharmacokinetics (PK) and immunogenicity (ADA and Nab) assessments for pre-clinical and clinical development of Pfizer’s large molecule programs. Dr. Kumar also provided oversight to Core Automation Team (CAT) engaged in automated large-molecule bioanalysis using Hamilton robotic liquid handlers. Prior to joining Pfizer, Dr. Kumar had served at roles of increasing responsibility as Director of Quality Control and Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc. Dr. Kumar holds a Ph.D. in Biophysics/Biophysical Chemistry from Johns Hopkins University and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar sits in Advisory Board of scientific meetings, and has also given numerous talks in various national and international scientific conferences and meetings. Dr. Kumar has a special interest in Pharmacokinetics and Drug Disposition of ADCs.
Corinna Krinos Fiorotti, Ph.D., Business Development Manager, Bioagilytix
Corinna Fiorotti obtained her Ph.D. in Microbiology and Immunology in 1999 from the University of New Hampshire where she investigated bacterial pathogenesis of Legionnaires disease. She attended Harvard Medical School to complete a post-doctoral fellowship where she was awarded several NIH grants to investigate bacterial polysaccharide genetics of Bacteroides fragilis abscess formation. Her work was featured as a cover story in the journal Nature. She was promoted to the faculty at Harvard where she taught medical students while continuing her research in bacterial genetics and immune evasion. In 2003 she joined Eyetech Pharmaceuticals and investigated the mechanism of disease in age related macular degeneration and was involved in the approval of Macugen®. In 2005 she joined Pfizer (formally Wyeth) where she was in the Pharmacokinetic, Dynamics and Metabolism Group responsible for developing cell based assays for the detection of neutralizing antibodies in addition to developing ADA and PK assays for both clinical and pre-clinical support in a GLP laboratory. She joined BioAgilytix Labs in October of 2015 and serves as the Business Development Director for the Northeast Region.