Biopharma session
About the session
No Digital PCR Festival would be complete without exploring the use of digital PCR in biopharmaceutical manufacturing. Discover how scientists apply dPCR in cell and gene therapies where precision and sensitivity are of highest importance.
- Opening remarks from QIAGEN
- PCR in Biopharma - Past, Present, and the Future
Speaker: Prof Dr. Mikael Kubista, Institute of Biotechnology, Czech Academy of Sciences, Czech Republic - Digital PCR Empowers Liquid Biopsy for Comprehensive Solid Tumor Management: Integrating Circulating Tumor Cells and Extracellular Vesicles
Speaker: Prof Dr. Hsian-Rong Tseng, David Geffen School of Medicine at UCLA, USA - Multiplex dPCR offers quantitative viral vector genome integrity evaluation
Speaker: Assist. Prof. Dr. David Dobnik, Niba Labs d.o.o. , Slovenia - Digital PCR Applications for Gene Therapy Products Including AAV Quantitation
Speaker: Mr. Stuart Nelson, Eli Lilly and Company, USA - Quantifying AAV vector genome titer in process ̶ intermediate samples by digital PCR and digital droplet PCR (d/dPCR)
Speaker: Mr. Chieme Kennedy Okechukwu, National Resilience, USA - Closing remarks from QIAGEN
Speakers
Professor, Czech Academy of Sciences & MultiD Analyses AB
Dr. Kubista obtained his Ph.D. in chemistry at Chalmers University of Technology in Göteborg and did postdocs at La Trobe University, Melbourne, Australia, and Yale University, New Haven, USA. He invented the light-up probes for nucleic acid detection in homogeneous solution, which led to the foundation of LightUp Technologies AB as Europe´s first company focusing on quantitative real-time PCR (qPCR) based diagnostics. In 2001 Kubista set up the TATAA Biocenter as a center of excellence in qPCR and gene expression analysis. In 2014, Kubista introduced non-invasive prenatal testing (NIPT) in Sweden and started Life Genomics AB. In 2020 Kubista co-founded SimSen Diagnostics for liquid biopsy analyses. Kubista co-authored the MIQE guidelines for qPCR analysis, which is the most cited paper in molecular diagnostics, and he is a member of the CEN/ISO working group developing guidelines for molecular diagnostics. Most recently, Kubista’s team invented Two-Tailed PCR, arguably one of the most sensitive and specific methods for analyzing short nucleic acids and most suited for dPCR. Since 2007 Kubista has headed the Laboratory of Gene Expression at the Institute of Biotechnology, BIOCEV, Czech Academy of Sciences and is among the world’s 2 % most cited researchers. During the SARS-Cov-2 pandemic, Kubista’s team was one of the first in Europe to start testing on February 3, 2020.
Professor of Molecular and Medical Pharmacology, UCLA
Prof. Hsian-Rong (HR) Tseng is a Molecular & Medical Pharmacology Professor at the David Geffen School of Medicine at UCLA. On the UCLA campus, he also holds joint memberships in the California Nano Systems Institute, Crump Institute for Molecular Imaging and Jonsson Comprehensive Cancer Center. At the UCLA Liquid Biopsy Laboratory, which he co-directs, Prof. Tseng and his team develop in vitro diagnostics (IVD) technologies for use in oncology and perinatology. He founded CytoLumina Technologies Corp. and Eximius Diagnostics to commercialize these platform technologies. Under Prof. Tseng's leadership, CytoLumina's NanoVelcro Chips was recognized as a Success Story by the National Cancer Institute (NCI) Innovative Molecular Analysis Technologies (IMAT) program in October 2019. Prof. Tseng earned his Ph.D. in Chemistry from National Taiwan University in 1998 and completed a postdoctoral fellowship in UCLA Chemistry under the supervision of Professor Sir Fraser Stoddart, the 2016 Nobel Laureate in Chemistry.
Co-founder and Chief Scientific Officer, Niba Labs
From 2016, David Dobnik has been closely working with companies in the field of gene therapy (such as AveXis [now Novartis Gene Therapies]) to develop and apply methods for precise quantification of viral vectors (e.g. dPCR), observation of viral particles (electron microscopy), and for identification and quantification of impurities (e.g. nucleic acids by high-throughput sequencing [HTS/NGS] or PCR-based methods). David has been leading the development and tech-transfer projects for pharmaceutical companies focused on the field of gene therapy, helping their process development efforts with characterizations of viral vectors. Lately, most of his work has been focused on new approaches for genome integrity evaluation.
Technical Lead, Eli Lilly and Company
Stuart Nelson is a Technical Lead of Analytical Control Strategy at Eli Lilly. Stuart has over a decade of industry experience in drug development for several biologic modalities. He joined Prevail Therapeutics in 2018 (acquired by Lilly in 2021), holding increasing levels of responsibility over the last 5 years. His most recent contributions were as part of the Gene Therapy CMC and analytical development teams, helping advance multiple programs from pre-IND to clinical dosing. Prior to Prevail, Stuart held positions at Kanyos Bio (Merged with Anokion) and MassBiologics.
Principal Scientist, National Resilience
Mr. Chieme Kennedy Okechukwu is currently a Principal Scientist, Analytical Development at National Resilience in Waltham, Massachusetts. He holds a Master of Science in Medical Genetics and Developmental Medicine from University of Glasgow. Mr. Okechukwu has years of experience with biopharma research in various companies.