Droplet Digital PCR World 2021

Dr. Ren is currently Director of Analytical Science & Technology, Global QC in Novartis Gene Therapies. Dr. Ren was medically trained and later received his PhD in Molecular Biology from the University of Oxford. He started bio‑analytical career in 2008 when he developed a PCR clamp technology for rare mutation detection. Dr. Ren has rich experience in PCR assay development & validation, and in testing operation management. In the recent years, he is focused on the QC analytics for AAV Production. Today he will talk about the application of ddPCR technology in AAV Production QC.

Pete joined Biogen in 2012, and for 7 years he was a member of the Bioassay and Gene Therapy group within the Analytical Development department (PO&T). There he supported the characterization and development of clinical stage protein biologic and AAV vector‑based gene therapy programs. He is now a Scientist in the Gene Therapy Accelerator Unit within the Biotherapeutics and Medicinal Sciences department (R&D). There he continues to focus on vector analytics for preclinical programs and platform initiative with expertise in in vitro method development. Within the GTxAU he also supports portfolio, platform, and technology development. Over the past 5 years Pete has gained extensive experience with the ddPCR technology, developing and qualifying multiple methods on the platform. He is a recognized ddPCR expert at Biogen and SME for its applications, particularly in AAV vector characterization. Pete holds a Bachelor’s degree in Biology from Boston College and a Professional Master of Science degree in Biotechnology from Northeastern University.

As part of the gene therapy revolution at bluebird bio, Russell is blending his expertise in biochemistry and molecular virology with QC and drug development experience to recode the way we develop genetic medicine. At bluebird, he has supported efforts ranging from late-stage vector platform analytics to the development of novel assays for the next generation of CAR‑T therapies.

Russell earned his PhD from Emory University in 2017 where his research focused on discovering and characterizing cellular factors that restrict HIV replication. He established a CRISPR platform within the lab to validate the role of DNA repair enzymes and innate immune sensors in viral transduction of cells critical to HIV persistence.

Before pursuing his graduate degree, Russell was part of a lean and dynamic Quality Control & Analytical Development team at Synageva Biopharma where he validated and executed a wide panel of assays that supported the successful development of Kanuma for lysosomal acid lipase deficiency.

David Dobnik, PhD in biotechnology has been working at NIB for 12 years. His main focus area is development of new nucleic acid detection/quantification approaches. He started with development of novel isothermal amplification methods for detection and quantification of DNA targets. He developed innovative system of simultaneous multiplex isothermal amplification and detection of DNA and RNA targets (Dobnik et al., 2014). Lately majority of his work has been focused on digital PCR. As first in the world, he and his colleagues reported a high‑level multiplex absolute quantification with Droplet Digital PCR (Dobnik et al., 2015; 2016) and one of the developed methods (Bogožalec Košir et al., 2017) is now on the list of accredited methods for GMO detection under ISO 17025. He has been in close contacts with companies for gene therapy, helping in process development with characterizations of viral vectors. He also conducted training workshops for digital PCR and executed a digital PCR tech transfer to pharmaceutical company. He continues to work in the field of gene therapy in cooperation with virus vector manufacturing companies.

Deborah is a Senior Scientist at Tessa Therapeutics where her work focuses on developing and qualifying molecular assays for characterization or lot release of Tessa's cell therapy products targeting a wide range of cancer indications. Before joining Tessa, Deborah worked at MSD, where she utilized her diverse experience in genetics and genomics to identify novel targets and to validate exploratory and clinical biomarkers across different therapeutic areas. Deborah holds a Ph.D. in Molecular Microbiology and Microbial Pathogenesis from Washington University in Saint Louis (USA).

Dr Edmund Ang is currently a Principal Scientist with MERCK BioReliance® Biosafety Testing Services providing scientific and technical support and thought leadership on biologics safety testing to biopharma in the Asia Pacific region. He has extensive life science research and development experiences from both academic and industrial settings. He obtained his PhD in Cell Biology from the University of Edinburgh, Scotland, UK, followed by postdoctoral research on cell signalling at Stanford University, California, USA, and at the National Cancer Centre Singapore, before joining Ionis Pharmaceuticals and Eli Lilly working on cancer drug and biomarker discovery programs. He also has commercial experience with biotech companies including Roche Diagnostics and Thermo Fisher Scientific in the areas of cellular analysis, applied markets and bioproduction

David Dobnik, PhD in biotechnology has been working at NIB for 12 years. His main focus area is development of new nucleic acid detection/quantification approaches. He started with development of novel isothermal amplification methods for detection and quantification of DNA targets. He developed innovative system of simultaneous multiplex isothermal amplification and detection of DNA and RNA targets (Dobnik et al., 2014). Lately majority of his work has been focused on digital PCR. As first in the world, he and his colleagues reported a high‑level multiplex absolute quantification with Droplet Digital PCR (Dobnik et al., 2015; 2016) and one of the developed methods (Bogožalec Košir et al., 2017) is now on the list of accredited methods for GMO detection under ISO 17025. He has been in close contacts with companies for gene therapy, helping in process development with characterizations of viral vectors. He also conducted training workshops for digital PCR and executed a digital PCR tech transfer to pharmaceutical company. He continues to work in the field of gene therapy in cooperation with virus vector manufacturing companies.

Professor Dobrovic heads the Translational Genomics & Epigenomics Laboratory at University of Melbourne Department of Surgery. His laboratory is at the forefront of a translational research ‑ clinical implementation interface that translates laboratory research findings into affordable diagnostics to benefit the patient population. Prof. Dobrovic has made a particular contribution to innovative methodology in cancer molecular diagnostics. He has authored more than 200 publications in leading scientific journals.

Dr Simona Soverini is an Assistant Professor at the Department of Experimental, Diagnostic and Specialty Medicine of the University of Bologna, in Italy. She graduated with a degree in Biological Sciences in 1999 and subsequently earned a PhD in Clinical and Experimental Haematology from the University of Bologna. She currently works in the Molecular Biology Unit of the Institute of Hematology “Lorenzo e Ariosto Seragnoli”, where she coordinates the Myeloid Leukemia Research group. Since 2003, her main interests lie in the biology and therapy of chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoblast leukaemia (ALL), with a particular focus on the mechanisms of resistance to tyrosine kinase inhibitors. In this field, she has worked with many internationally renowned scientists and has earned honours and awards. Over the past years, Dr Soverini has also cultivated a growing interest in the application of novel technologies as diagnostic tools.

Professor Sandi Deans is a Consultant Clinical Scientist and the Director of Genomics Quality Assessment (GenQA) part of the UK National External Quality Assessment Service (UK NEQAS) which is based in the Royal Infirmary of Edinburgh, UK. The EQA Scheme delivers assessment of molecular genetics, molecular pathology and cytogenomic testing, newborn screening, prenatal diagnosis, preimplantation genetic diagnosis and variant interpretation. Sandi holds a chair as Professor of Clinical Genomics at the University of Edinburgh. She also is the National Scientific and Laboratory Lead of the NHS England Genomics Unit embedding the National Genomic Medicine Service for rare disease and cancer including whole genome sequencing within the NHS and collaborates closely with Genomics England to deliver high quality whole genome sequencing for both the rare diseases and cancer programmes. From March 2020, Sandi has been part of the UK national COVID‑9 response team and is Head of Laboratory Validation and Quality Assurance for SARS‑CoV‑2 testing for mass testing.

Dr. Paweletz is head of the Translational Research Laboratory (TRL) of the Belfer Institute for Applied Cancer Science at Dana Faber Cancer Institute in Cambridge, Massachusetts. He joined from Merck & Co., Inc., where he most recently served as principal scientist, externalization lead, and proteomics site lead for the Department of Molecular Biomarkers at the Merck Research Laboratory in Boston.

At Merck, Dr. Paweletz successfully built platforms to look at disease biomarkers in body fluids and oversaw research activities spanning the spectrum from early‑stage discovery to the clinic. Prior to that, he was a postdoctoral fellow in the Department of Physiology at the Uniformed Services University School of Medicine in Bethesda, Maryland and a research fellow in the Laboratory of Pathology at the National Cancer Institute, National Institutes of Health (NIH). Dr. Paweletz earned his PhD with honors from Georgetown University and his Bachelor of Science Degree from Baldwin Wallace College.

Keiko Shinjo, M.D., Ph.D., is an associate professor of the Nagoya University Graduate School of Medicine. She received her Ph.D. from Nagoya University Graduate School of Medicine in 2012 and subsequently conducted her research as a faculty member of Aichi Cancer Research Institute. She became the assistant professor of the Nagoya City University Graduate School of Medical Sciences in 2014. From 2017, she is a faculty member of Nagoya University Graduate School of Medicine. Her research has been focused on the dynamic regulation of gene expression by epigenetic mechanisms in human cancers. She applied ddPCR technique to detect aberrant DNA methylation in circulating free DNA for diagnose cancer.

In 2006, Fernando joined the Laboratorio Estatal de Salud Pública as Clinical technician. There, he supported the molecular characterization of virus like Rabies and Zika resulting in scientific publications and the development of a strong molecular biology team. After his stay in CDC USA, he started his research in SARS‑CoV‑2 supporting the implementation of the molecular diagnosis and new technology like ddPCR. Thanks to his great experience, now he is leading SARS‑CoV‑2 research in collaboration with scientist groups in Mexico to get better understanding of the COVID‑19 infection in qPCR negative cases, anti‑drug activity of some compounds and multi‑infection cases. Fernando holds a Bachelor’s degree in Pharmaceutical Chemist Biologist from Universidad Autónoma del Estado de Morelos, a Master of Health Science and a PhD in Medicine Research from Instituto Politécnico Nacional.

Dr. Huggett is a Science Fellow at the UK National Measurement Laboratory, LGC in Teddington and a Visiting Professor at the School of Biosciences & Medicine, University of Surrey. He is a molecular biologist specialising in the application of measurement science to nucleic acid analysis. Dr Huggett has led a team at one of the world leading national measurement institutions supporting the development of high accuracy, traceable molecular measurements in areas such as metagenomics, precision medicine and clinical microbiology. He advises governments and international organisations (ISO, CCQM) on measurement accuracy and standardisation for routine application of molecular methodologies such as in vitro diagnostics.

Dr. Driscoll received his PhD from Virginia Tech in 2013 in Genetics, Bioinformatics, and Computational Biology after eight years as an independent science media producer. His research group at West Virginia University studies the ecological and evolutionary dynamics of zoonotic and vector-borne pathogens, with a particular focus on Rickettsia. In 2020, his group began testing wastewater on campus for the presence of SARS‑CoV‑2 using Droplet Digital PCR, and are currently expanding their efforts state‑wide.

Dr. Qiu obtained his Ph.D. degree in School of Life Sciences at Fudan University, Shanghai, China, after which he continued his research as a postdoctoral fellow at Fudan University. He currently serves as Senior Scientist of GeneWell Biotechnology Co., Ltd., an innovative life science company focused on accelerating the standardization of diagnostic testing. Dr. Qiu has been leading the development of a variety of molecular diagnostic standards, such as COVID‑19 RNA reference material, IHC quantitative control, HRD reference standards etc., all of which have been developed with the collaboration of world‑class IVD companies to provide better solutions for quality control in clinical laboratory.

Dr Chen is engaged in the research of replication and pathogenesis of medical viruses such as coronavirus and virus control, analyzing the functions and structures of SARS coronavirus RNA methyltransferase, main protease and N protein and their mechanisms of action, and developed four targeted anti-coronavirus inhibitors. During the SARS‑CoV‑2 outbreak, he was part of the investigation team to complete the pathogen identification and the whole genome sequencing on January 7, 2020. Subsequently, Dr Chen identified the aerosol novel coronavirus load and transmission characteristics by developing a highly sensitive nucleic acid detection method based on Droplet Digital PCR. The studies show ddPCR could largely minimize the false negatives reports resulted by qRT‑PCR. Dr Chen has published more than 40 papers with more than 4800 citations in Nature, Molecular Cell, Nature Immunology, Nature Ecology & Evolution, PNAS, PLoS Pathogens, Emerging Microbes & Infections, Journal of Virology