SC1: PRECLINICAL AND CLINICAL ASSESSMENT OF IMMUNOGENICITY: FOCUS ON NEW MODALITIES INCLUDING BI- AND TRI-SPECIFIC ANTIBODIES, OLIGONUCLEOTIDES, GENE THERAPY AND CAR T
SUNDAY, APRIL 7 | 10:00 AM - 1:00 PM (Federal Complex)
WHAT YOU WILL LEARN:
- Screening assays
- Confirmatory assays
- Confirmatory cut-point determination
- Metrix interference
- Specificity
- Neutralizing antibody assays
- Assay format selection
- Sensitivity
- Specificity
- Immunogenicity Assays for Gene therapy and CAR-T Therapies
COURSE AGENDA:
10:00 Chairperson’s Opening Remarks
Darshana Jani, MS, Senior Manager, Pfizer, Inc.
10:10 Immunogenicity of Oligonucleotides - Practical Considerations
Rama Boyanapalli, PhD, Director, Bioanalytical and Biomarker Development, Wave Life Sciences
10:50 Immunogenicity Assessment in Support of Gene Therapy Program-Use of ELISPOT Technology
Magdalena Tary-Lehmann MD, PhD, Chief Scientific Officer, Cellular Technology Limited; Adjunct Associate Professor of Pathology, Case Western Reserve University
11:30 Refreshment Break
11:40 Impact of Immunogenicity on PK/PD Relationships of Biologics
Kosalaram Goteti, PhD, Director, Site Head of Pharmacometry (Billerica), EMD Serono
12:20 Hybrid LC-MS Approach to Overcome Drug Interference in Immunogenicity Assays
Linzhi Chen, Senior Research Fellow & Bioanalytical Group Leader, Boehringer Ingelheim Pharmaceuticals
Very recently, immunocapture-LC/MS has been developed for ADA analysis in support of immunogenicity assessment. This novel approach enables simultaneous ADA isotyping and semi-quantitation. Immunocapture-LC/MS could be used as an alternative ADA assay
platform in cases where traditional ligand binding ADA assays suffers from drug or target interference. This talk presents immunocapture-LC/MS ADA assay development and a case study to overcome drug interference in monkey ADA analysis.
1:00 Close of Short Course
INSTRUCTOR BIOGRAPHY:
Rama Boyanapalli, PhD, Director, Bioanalytical and Biomarker Development, Wave Life Sciences
Rama has a PhD in Biology from Bowling Green State University, Bowling Green, Ohio and Postdoctoral fellowship in immunology and Biochemistry, University of Colorado, Boulder, Colorado. Currently working in department of Bioanalytical and Biomarker Development at Wave Life Sciences, Rama leads a group assessing immunogenicity of oligonucleotides. Before joining Wave, Rama worked for three years at Shire Pharmaceuticals, Lexington, Massachusetts, seven years at Nivalis Therapeutics, and three additional years at RoMonics and Boulder Diagnostics, Boulder, Colorado. He held various positions of increasing responsibilities working on immunogenicity, immunogenicity impact assessment, PK and PD assay development.
Linzhi Chen, Senior Research Fellow & Bioanalytical Group Leader, Boehringer Ingelheim Pharmaceutical
Dr. Chen obtained his PhD degree in organic chemistry from the University of Mons, Belgium. After postdoctoral training, he joined 3M Pharmaceuticals and then Boehringer Ingelheim Pharmaceuticals and has worked primarily on metabolite profiling/ID and
bioanalysis in support of small molecule drug development. In recent years at Boehringer Ingelheim, he has led a group to provide LC/MS-based bioanalytical support to biotherapeutic development programs, and developed a number of LC/MS assays for
quantitation of various biotherapeutic proteins such as nanobodies, Fabs, bispecifics, mAbs, etc. His group also developed immunocapture-LC/MS methodology for simultaneous ADA isotyping and semi-quantitation. His recent research focuses on LC/MS determination
of in vivo biomodifications of biotherapeutics and their impact on PK/PD. Dr. Chen has more than 30 publications in peer-reviewed journals.
Darshana Jani, MSc, Associate Director, Global Lead Biologics, Clinical Assay Group, Global Product Development, 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.
Kosalaram Goteti, PhD, Director, Site Head of Pharmacometry (Billerica), EMD Serono
Dr. Goteti is a Pharmacist by training and holds a BS in Pharmacy, Birla Institute of Technology, India., and a PhD in Pharmacokinetics, University of Utah. Kosalaram has nearly 14 years of experience in pharmaceutical industry. After his PhD, he
successively was research assistant at Roche (Nutley, NJ), Senior Scientist DMPK at Astra Zeneca (Boston, MA), Senior Clinical Pharmacologist at MedImmune (Gaithersburg, MD) and Associate Director Clinical Pharmacology at Pfizer (Cambridge, MA).
Since 2017 Dr. Goteti is the site head of pharmacometry at EMD Serono (A buisness of Merck KGaA) in Billerica. He has experience in both large and small molecule drug development. His expertise is in clinical pharmacology, PK & PD modeling
and simulation across the drug development paradigm. He is also member of Journal of Pharmaceutical Science's Editorial Advisory Board (EAB).
Magdalena Tary-Lehmann, MD, PhD, CSO, Cellular Technology Limited (CTL); Adjunct Associate Professor of Pathology,
Case Western Reserve University (CWRU)
Dr. Magdalena Tary-Lehmann is Co-Founding Scientist and Chief Scientific Officer for Cellular Technology Limited (CTL). Dr. Tary-Lehmann received her M.D. and Ph.D., both from the University of Tübingen, Germany. Her postdoctoral training in
Immunology was at the University of California, Los Angeles. She moved thereafter to Case Western Reserve University, where she was awarded tenure and appointed as Associate Professor in the Department of Pathology. As Chief Scientific Officer
for CTL she oversees the performance of immunology assays in CTL’s GCP, GLP- and CLIA compliant contract laboratory for various pharmaceutical and biotechnology clients.