Speaker Biographies

CELL CULTURE TO BIOPRODUCTION

CELL LINE TO PROTEIN EXPRESSION

CONTINUOUS PROCESSING FOR BIOPHARMACEUTICALS

RECOVERY AND PURIFICATION

CELL THERAPY CMC AND MANUFACTURING

GENE THERAPY CMC AND MANUFACTURING

ANALYTICAL CHARACTERISATION

FORMULATION, STABILITY AND AGGREGATION


Cell Culture to Bioproduction

Josephine Adams, PhD, Professor, Cell Biology, Biochemistry, University of Bristol
Prof. Adams has a Ph.D. in Cancer Biology from the University of London. After post-doctoral research at Imperial Cancer Research Fund and, as an EMBO Fellow, in the Vascular Research Division at Brigham and Women’s Hospital, Harvard, she began her laboratory in 1994 as a Wellcome Trust Senior Fellow at the MRC-LMCB, University College London. She is now Professor of Cell Biology in the School of Biochemistry, University of Bristol. Prof. Adams’ laboratory researches on the molecular basis of cell interactions with extracellular matrix and extracellular matrix assembly. Interests are in normal tissue processes and the contributions of extracellular matrix proteins in fibrosis and carcinoma metastasis. The evolution of extracellular matrix and protein families such as thrombospondins is a parallel interest. Prof. Adams is the current Editor-in-Chief of AJP-Cell Physiology, a Journal of the American Physiological Society.

Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

Giovanni Campolongo, Market Segment Manager Process Analytics, Hamilton Bonaduz AG
Business development professional with experience in Biopharma, Chemical and Food Industry in the Business Unit Process Analytics by Hamilton Bonaduz AG. Segment Manager with focus on development, manufacturing, and customization of PAT solutions for upstream processes. This includes an active partnership with private industry and public organizations to optimize the fermentation processes of Hamilton’s customers.   

 

Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU), and Co-Founder and CEO, Novasign GmbH
With more than 10 years of experience, Mark is a passionate scientist in the field of biopharmaceutical process development. He worked together with several Top 25 Pharma companies targeting their needs in process development and understanding. Together with his team, he is developing a PAT and QbD software solution for both up and downstream processes. This software utilizes artificial intelligence learning from data and human process models in so called hybrid models to quickly predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization is accelerated significantly while simultaneously a better process understanding is gathered. From this research project the company Novasign was founded in 2019 offering this unique software solution.

Krist Gernaey, PhD, Professor and Head, Process and Systems Engineering Center (PROSYS), Chemical and Biochemical Engineering, Technical University of Denmark (DTU)
MSc (1993) and PhD (1997) from Ghent University (Belgium). First associate professor at DTU Chemical Engineering (2005-2012), then Professor in Industrial Fermentation Technology ("The Novozymes professor") since 2013. Head of the Process and Systems Engineering Center (PROSYS) since 2014. CEO of Bioscavenge ApS, a BIOPRO startup with focus on resource recovery, since 2017. Scientific lead of BIOPRO, a research cluster within bio-based production processes (www.biopro.nu).
Current research focuses on large-scale fermentation, mathematical modelling, investigation of mass transfer issues across scales, application and development of computer-aided tools for elucidation of (bio)process kinetics, Process Analytical Technology (PAT), continuous production, resource recovery, process simulation.

Jarka Glassey, PhD, Professor, Chemical Engineering, Engineering, Newcastle University
Jarka Glassey is a Professor of Chemical Engineering Education at Newcastle University. She also chairs the Education Special Interest Group of the Institution of Chemical Engineers, She is an Executive member of the IChemE Education and Accreditation Forum with responsibility for pedagogical development, a secretary of the Working Party of Education of the EFCE as well as the Editor in Chief of the Education for Chemical Engineers journal. Her main pedagogical research interests are in the areas of curriculum design, active learning and employability skills in chemical engineering education. Currently she coordinates iTeach, an Erasmus Multilateral Projects sponsored project, aiming to develop a robust framework for the evaluation of the effectiveness of pedagogical approaches used in core chemical engineering knowledge and employability competency delivery. Her research interests are in the area of bioprocess development, modelling, process optimisation, Quality by Design and Process Analytical Technologies.

Christoph Herwig, PhD, Professor and Head, Biochemical Engineering, Chemical Environmental and Bioscience Engineering, Technical University of Vienna (TU Wien)
Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec addressing data science solutions for the biopharma life cycle

Inês Isidro, PhD, Scientist, Computational Biotechnology, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
Inês Isidro is a scientist in computational biotechnology of animal cells. She holds a PhD in Bioengineering and her current work combines proven tools from systems biology, computational modelling, machine learning and process analytical technologies to improve production processes and increase metabolic understanding in animal cell technology applications. Ongoing research includes the development of insect cell-based platforms for production of viral vectors for gene therapy and the deployment of metabolomic approaches to human stem cell-derived and cancer cell models.

Lisa Alexandra Pieper, PhD, Associate Director, Cell Culture, Bioprocess and Analytical Development, Boehringer Ingelheim Pharma GmbH & Co. KG
After having studied Biotechnology at the RWTH Aachen, Lisa A. Pieper performed her PhD at the Institute of Cell Biology and Immunology (University of Stuttgart) in cooperation with Boehringer Ingelheim. Lisa joined Boehringer Ingelheim in 2017 as Postdoc in the group of Early Stage Bioprocess Development, focusing on the upstream development of cell culture processes within the context of an integrated state-of-the art process platform for the production of high-quality biologics. Subsequently, she worked as Scientist in the upstream development and assumed project responsibility for the development of New Biological Entities. In 2019, Lisa started as Associate Director in the Contract Manufacturing Business, heading a cell culture laboratory in the department of Bioprocess- and Analytical Development at Boehringer Ingelheim.

Stefan R. Schmidt, PhD, MBA, COO, Head, Operations, BioAtrium AG
Dr. Stefan R. Schmidt MBA, currently serves as Head of Operations/COO at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that, he was CSO at ERA Biotech in Barcelona, directing the company’s R&D efforts. Prior to that, he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

Anupam Singhal, PhD, Technology Development, Marketing, Berkeley Lights, Inc.

Anupam Singhal earned his PhD from the University of British Columbia and has over 15 years of experience in nanotechnology and microfluidics at UBC, the University of Toronto and Stanford University.  His work has been cited over 600 times and resulted in several patents for molecular disease diagnosis, antibody discovery, and development of production cell-lines for biologics.  At Berkeley Lights, Anupam leads the development of next-generation platforms for the discovery and development of antibody therapeutics.

 

Wolfgang Sommeregger, PhD, Research & Development, Bilfinger Industrietechnik Salzburg GmbH
Wolfgang Sommeregger, R&D Supervisor, is currently leading the development team of the advanced process monitoring and control software Qubicon at Bilfinger Industrietechnik Salzburg. He holds a Ph.D. in Biotechnology from University of Natural Resources and Life Sciences in Vienna. His research interests are cell biology, bioprocessing and advanced process control.

David Stewart, MSc, Senior Director, Site Quality Lead, Next Generation Manufacturing, Biogen
Dave Stewart joined Biogen in Luterbach, Switzerland in June 2018 and is Director of Quality Assurance. He is responsible for quality of the production processes. Originally from Pittsburgh, Pennsylvania in the USA, Dave served in the United States Marine Corps and has worked in the production of biopharmaceutical products for more than 20 years. He held leadership roles in Technology, Process Engineering, Manufacturing Sciences and Automation, most recently at Genentech (a subsidiary of Hoffman-La Roche) in California. Dave lives with his wife near the town of Luterbach and has three grown daughters. In his spare time, he enjoys exploring the beauty of Switzerland by hiking and biking with family and colleagues.

Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
Associate Professor at the Department of Biotechnology (BOKU), head of the working group microbial fermentation and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

Moritz von Stosch, PhD, Head, Process Systems Biology and Engineering Center of Excellence of Technical R&D, GSK Biologicals
Moritz von Stosch leads the Process Systems Biology and Engineering Center of Excellence, as Senior Manager at Technical R&D of GSK Biologicals, Belgium. He also is a co-founder of NovaSign, a company that provides commercial hybrid modeling solutions and services. Dr. von Stosch is a process systems engineer by education with a Diplom in Chemical Engineering from the RWTH-Aachen University and PhD in Biochemical Engineering from the University of Porto. Before joining GSK, he worked as a Lecturer at the School of Chemical Engineering and Advanced Materials at Newcastle University, where his research focused on the development of novel hybrid modeling methods and their application to enable more efficient process operation/design.

Johannes Wirth, MSc, Scientist, BioProcess Science, Rentschler Biopharma SE
After completing his studies in Pharmaceutical Biotechnology at the University of Ulm (MSc), Johannes Wirth joined Rentschler in 2017 as a scientist and is currently working the department of Process Science. The department is engaged in all aspects of modern bioprocess development with a focus on implementing new technologies and approaches to improve upstream bioprocesses.

Cell Line to Protein Expression

Niall Barron, PhD, Professor, Principal Investigator, Cell Engineering, National Institute for Bioprocessing Research and Training (NIBRT)
Niall Barron obtained a BA(Mod) in Microbiology from Trinity College Dublin and PhD in Applied Microbiology/Biochemistry from the University of Ulster. He spent three years at Baylor College of Medicine as a postdoctoral scientist working on genome engineering strategies to study nuclear steroid receptor function. He then returned to Ireland to work on stem cell engineering at Dublin City University. Subsequently, as a senior scientist in DCU, he was instrumental in growing the mammalian cell engineering group with a specific focus on the production of recombinant therapeutic proteins. He was appointed NIBRT Principal Investigator and Professor of Biochemical Engineering in the School of Chemical and Bioprocess Engineering in UCD in 2017.

Martin Bertschinger, PhD, Deputy Director, Cell Sciences, Ichnos Sciences, Inc.
Martin Bertschinger completed his PhD at the EPFL in Lausanne (Switzerland) in the Laboratory of Professor Florian Wurm. After finishing his PhD in 2006, Martin joined Glenmark Pharmaceuticals SA (Switzerland) in order to build teams for protein expression and cell line development. In 2019, Glenmark Pharmaceuticals span out its R&D unit into Ichnos Sciences. At Ichnos Sciences, Martin is leading the Cell Sciences section (Cell Line Development, Medium Development and Upstream Process Development).

Mark Mao Xiang Chen, PhD, Manager, Cell Line Development and Cell & Gene Therapy, GlaxoSmithKline
Mark (Mao Xiang) leads the Cell Line Development group in GSK’s Cell and Gene Therapy Product Development for the establishment of viral vector stable producer cell lines. Prior to this role he worked on biological reagent generation and assay development for multiple therapeutic targets in GSK, following accademic research in signal transduction at the MRC Protein Phosphorylation Unit at the University of Dundee and the Genetics Department at the University of Leicester.

Tsafi Danieli, PhD, Head, Protein Expression Core Facility, Wolfson Center for Applied Structural Biology, The Hebrew University of Jerusalem
Tsafi Danieli is the head of the Protein Expression Core Facility at the Wolfson Centre for Applied Structural Biology at the Hebrew University of Jerusalem, Israel. The core facility functions as a biotechnology research center for the development and implementation of novel technologies in recombinant DNA, molecular biology and protein production. It also operates as a training centre supporting individual research projects and conducting workshops and courses for scientists from academic institutes and from the Biomed & Biotech industry. Dr. Danieli is also the founder and director of “BioGiv”, a specialised university-based center for promoting and supporting entrepreneurs and inventors to translate ideas into new products and bring new technologies to market, while using the infrastructure of the Hebrew University in Jerusalem. Dr. Danieli holds a BSc in Biology and MSc in human genetics from Tel Aviv University, and a Ph.D. in molecular virology from the University of California, San Francisco Pharmacology Department, in collaboration with the Biochemistry Department at Tel Aviv University.

Bert Devriendt, PhD, Scientist, Virology, Parasitology, Immunology, Physiology, Ghent University
Dr. Bert Devriendt is a postdoctoral fellow at the Laboratory of Immunology, the Faculty of Veterinary Medicine, Ghent University. In 2010 he obtained his PhD in Veterinary Sciences on the interaction between virulence factors of enterotoxigenic E. coli with intestinal epithelial cells and dendritic cells in a piglet model. During his postdoctoral research, he focuses on host-pathogen interactions and how the gained insights might be used to accelerate the development of oral vaccines to prevent enteric diseases. In that context, a strategy was developed to boost uptake of oral vaccine antigens by the gut epithelium via antibody-mediated selective targeting to epithelial aminopeptidase N. Dr. Devriendt also investigates the evasion of immune cell functions by alpha herpes viruses in large animal models.

Vicky Goralczyk, PhD, Director, Cell Line and Bioprocess Development, Glycotope GmbH
Doctoral thesis on development of a perfusion bioreactor for cells grown on ceramics at Berlin University for Technology; deepening business knowledge for 5 years as a product manager for fertility products; 2016 scientist in up stream process development at Glycotope; promoted to head of bioprocess group in 2018.

Gabriela Kozejova, MSc, Senior Scientist, Protein and Cellular Sciences, R&D Platform Technology & Science, GSK Medicines Research Centre
I studied Applied Biology at the Slovak University of Agriculture and Biomedicine at University of London where I focused on investigation of cell lipid rafts and their function. I started with GSK as a Senior Scientist in Cellular Technologies group within the Protein & Cellular Sciences department in 2016. My focus has been on the generation and validation of clonal tool cell lines expressing a variety of genes encoding antigens, ion channels and reporter systems in a range of mammalian cell lines to support both, small molecule and biopharmaceutical programs. 

Nicolas P. Mermod, PhD, Professor & Director, Biology & Medicine, University of Lausanne
Nicolas Mermod is Professor of Biotechnology at the Faculty of Biology and Medicine of the University of Lausanne, and a co-founder of Selexis SA, a biotech company. Nic completed his PhD at the University of Geneva in environmental biotechnology, followed by post-doctoral studies at the University of California at Berkeley, USA, in the laboratory of Professor Robert Tjian. Nic then joined the University of Lausanne as an Assistant Professor of the Swiss National Science Foundation, to become full Professor and the director of the Institute of Biotechnology. Nic has gained recognition in the field of gene expression in biotechnology by publishing over 100 papers in peer reviewed renowned journals and by authoring a number of patents on epigenetic regulatory elements, heterologous gene expression and cell line engineering.

Cristina Parola, PhD, Scientist, Biologics Research, Sanofi-Aventis Recherche & Développement, Sanofi
Cristina Parola obtained her M.Sc. degree in Medical Biotechnology at the University of Torino, Italy, and subsequently moved to Trondheim, Norway, for an internship in the company GeneSeque. She then completed her Ph.D. at ETH Zurich, in Switzerland, in the Department of Biosystems Science and Engineering located in Basel. During her doctoral studies, she was part of the Laboratory of Systems and Synthetic Immunology of Prof. Sai Reddy, where she worked on developing a mammalian cell platform for antibody engineering. She is now a postdoctoral research scientist at Sanofi, Biologics Research, in the Paris area, where she is working on mammalian display as part of the Enabling Technologies team.

Eva Pekle, PhD, Associate Scientist, Process Development, Achilles Therapeutics, Ltd.
Final year PhD student with AstraZeneca and the University of Kent, working on improving the cell line development process through novel screening methods and novel host cell line generation.

Yves Poitevin, MSc, Head, Bioprocessing Unit, Light Chain Bioscience (a brand of NovImmune SA)
I obtained a MSc degree in Molecular and Biophysical Chemistry Sciences at the University of Orleans, France. Then I joined IBF BIOTECHNICS in 1984 where I developed a new formulation for a serum substitute for cell culture (Ultroser™ G). In 1988, I have worked at TRANSGENE S.A in the viral field for 14 years focusing on the development and optimization of a safe retroviral vector system and a HEK-293 packaging cell line for tumor gene therapy. In 2000, at the “Centre d’Immunologie Pierre Fabre” I developed a recombinant yellow fever viral vector expression system for vaccination and cancer immunotherapy. In 2002, and until now, I have taken the responsability of the bioprocessing unit at NOVIMMUNE SA. Our main activity is to produce mAbs for in vitro and in vivo needs as well as assess the early developability of future mono and bispecific therapeutic antibody candidates for multiple projects.

Arnaud Poterszman, PhD, Research Director, Integrated Structural Biology, Institut de Génétique et de Biologie Moléculaire et Cellulaire (IGBMC)
After studying at ENS Cachan, Arnaud Poterszman completed his PhD at the age of 28 years from Strasbourg University and joint the CNRS one year later. He holds a CNRS Research Director position and performs his studies in the Department of Integrated Structural Biology at IGBMC, Illkirch France. He has a dual expertise in Structural and Molecular biology with insights on expression technologies and sample preparation. His research is focused on eukaryotic multi-protein complexes involved in transcription regulation and DNA repair by, particularly, the 10 subunits transcription/DNA repair factor TFIIH and its partners from the nucleotide excision pathway.

Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
Associate Professor at the Department of Biotechnology (BOKU), head of the working group microbial fermentation and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

Mark Trautwein, Dr. rer. nat., Senior Scientist, Research & Development, Pharmaceuticals, Expression Technologies, Bayer AG
Mark Trautwein obtained his doctorate in biochemistry from University of Tübingen, Germany. Mark joined Bayer in 2008 to establish transient & stable mammalian protein expression platforms for protein therapeutics. In his current position, Mark leads the Expression Technologies group and is involved in antigen and antibody expression as well as cell line development. In his project leadership role, he has been advancing projects with different degrees of maturity within oncology as well as ophthalmology, comprising mAbs, antibody drug conjugates, radioimmunoconjugates and various other formats.

Rico Uhler, MSc, Scientist, Cell Line Development, Octapharma Biopharmaceuticals GmbH
Rico is currently performing his Ph.D. in cell line development and engineering at the Mannheim University of Applied sciences in cooperation with Octapharma Biopharmaceuticals and the university of Heidelberg. His aim is to alter protein post-translational modifications generated by the HEK 293-F cell line in order to improve pharmacokinetics of recombinant protein drugs produced by it. Before his Ph.D. he obtained a MSc of biotechnology at the Mannheim University of Applied Sciences and worked in the Cell Line Development group of Octapharma.

Bjørn Voldborg, MSc, Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark (DTU)
Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was teamleader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of proteinbased drug candidates. From this he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and since 2012 Bjørn has been heading the CHO Cell Line Engineering project at the NNF Center for Biosustainability at the Technical University of Denmark, a project dedicated to the engineering of improved protein production cell factories.

Continuous Processing for Biopharmaceuticals

Dejan Arzenšek, PhD, Principal Scientist, Global Drug Development, Technical R&D, Novartis
I have spent last ten years working for a biopharmaceutical company Lek d.d., a Novartis company. Currently I am working as a Principle Scientist in Downstream Process Development Department. My PhD degree in physics gave me a strong background in physical principles of protein ssociation/aggregation, along with additional skills in mathematical modelling, statistical analysis and experimental biophysics. I am currently responsible for new technology development and implementation in downstream processing. Majority of my work responsibilities is the nextBioPharmDSP project of EU Framework Program for Research and Innovation “Horizon 2020” for which the goal is to drive drug process development towards Continuous Processing in Biopharmaceutical Manufacturing. I am leading new technology project of process analytical technology (PAT) as part of Quality by Design (QbD) approach implementation on integrated processes using Advanced Process Control (APC) control strategies, where APC control system is building.

David Garcia, PhD, Advanced Process and Manufacturing Technologies, Novartis Pharma

Vicky Goralczyk, PhD, Director, Cell Line and Bioprocess Development, Glycotope GmbH
Doctoral thesis on development of a perfusion bioreactor for cells grown on ceramics at Berlin University for Technology; deepening business knowledge for 5 years as a product manager for fertility products; 2016 scientist in up stream process development at Glycotope; promoted to head of bioprocess group in 2018.

Stuart Jamieson, PhD, Principal Scientist, Upstream, Downstream and Analytical, CPI Biologics
Stuart is a Principal Scientist and Head of the Technical team at CPI Biologics. He has over 17 years experience in process development, scale up and clinical manufacture for early to late phase products. Stuart joined CPI in 2014 to help establish the new National Biologics Manufacturing Centre and build the downstream science technical team. Stuart now leads the technical development team encompassing upstream, downstream and analytical development.

Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology
Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from BOKU. He is head of the Institute of Process Science and Engineering at BOKU. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering and is study director of the Ph.D. program Bioprocess Engineering. He also acts as area head of Bioprocessing Engineering and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioprocess engineering of proteins, plasmids and viruses. He has published 340 papers on recombinant protein production, bioseparation and advanced materials for bioprocess enginering, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor of Biotechnology Journal. He acts also as the vice president of research of the European Society of Biochemical Engineering Science.

Martin Lobedann, PhD, Protein Purification Technology Expert, Bayer AG
Study of Bioprocessing at TU Dresden; PhD in isolation of antibodies from transgenic tobacco; Joined Bayer in 2010;  Development of continuous downstream processes with focus on plant design, automation and process control and PAT

Duarte L. Martins, PhD Student, BOKU/ACIB, Laboratory of Protein Technology and Downstream Processing, Department of Biotechnology, University of Natural Resources and Life Sciences (BOKU)
Duarte L. Martins earned a MSc in Biotechnology in 2013 from NOVA University of Lisbon (Portugal). In 2014 he joined Novasep CMO (Belgium) where he developed purification processes for vaccines and gene therapy vectors. Since 2016 he is PhD student at University of Natural Resources and Life Sciences in Wien (BOKU)/ACIB and has been focused on continuous processing and continuous viral inactivation.

Massimo Morbidelli, PhD, Professor, Chemical and Bioengineering, ETH Zurich
Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in chemical reaction engineering, with particular emphasis on polymer reactions and colloidal engineering. This has evolved over the years in developing new processes for the production of polymer particles, ranging from the micro to the nano scale, exhibiting various types of functionalities and physico-chemical characteristics, including bio compatibility and degradation kinetics. Applications in various areas are considered including drug delivery, composite materials and treatment of oil reservoirs.

Ozan Ötes, Purification Engineer, Bioprocess Engineering, Sanofi-Aventis Deutschland GmbH
In the last three years Ozan Ötes worked in the role of a process development engineer in a DSP Development lab at Sanofi-Aventis Germany, contributing to the development of purification processes for biologics. He was involved in the tech transfer for continuous protein A chromatography from Development to GMP at Sanofi Frankfurt. Since January, he is mainly responsible for the tech transfer of biologics from development to GMP production scale. Ozan holds a Master degree in Bioengineering from the KIT (Karlsruhe Institute of Technology), Germany

Marcel Ottens, PDEng, Associate Professor, Bioprocess Engineering, TU Delft
Marcel Ottens obtained a PhD in Chemical Engineering from Amsterdam University, and currently holds a position at Delft University of Technology, the Netherlands. He teaches engineering courses in Biotechnology programs. He is course leader and board member Annual International Post Graduate Advanced Course on Downstream Processing, Delft; board member of the DPTI (Delft Process Technology Institute) and editor of Food and Bioproducts Processing. Marcel Ottens published over 90 papers, various books and book chapters and holds several patents, presented dozens of (invited) lectures at international conferences. His current research interests are micro bio systems technology and micro fluidics, biologicals separation and purification, fast conceptual bio(pharma)process design (High Throughput Process Development), process chromatography of biologicals and nutraceuticals, continuous bioprocessing (e.g. Simulated Moving Bed technology), general phase behavior of biomaterials, including crystallization and precipitation, and more in general transport phenomena and bioseparation science.

Jérôme Pezzini, PhD, Scientist, DSP Breakthrough Technologies Skill Center, Biopharma Development, Sanofi, Lucrèce Nicoud, PhD, Project Manager, Ypso-Facto
Jerome Pezzini is a principal Scientist at Sanofi working in the DSP Breakthrough technology skill center who helps to drive innovation and new technology assessment in the field of purification of biologics. Jerome has previously worked in process development and held various positions within the biopharmaceutical industry since completing his doctorate in biochemistry.

Michael Sokolov, PhD, Lecturer, Institute of Chemical and Bioengineering, ETH Zurich; COO and Co-Founder, DataHow
Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

Andrew Sinclair, President & Founder, Biopharm Services Ltd.

Yan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur
Dr. Yan-ping Yang received PhD in Biochemistry from the University of Missouri-Columbia, USA, and has 28 years of experiences in vaccine research and development with Sanofi Pasteur. She has been with the R&D department since 1989, involved in various bacterial and viral vaccine development projects with numerous patents, publications and presentations. Over the years Yan-ping has had increasing responsibilities within the company and currently, is the Head of Bioprocess Research & Development North America, overseeing a department of ~100 staff in its efforts to develop manufacturing processes to provide materials for preclinical and clinical studies up to phase III.

Recovery and Purification

Raquel Aires-Barros, PhD, Professor, Bioengineering, Instituto Superior Técnico
Raquel Aires-Barros is a Full Professor in the Department of Bioengineering (DBE) at Instituto Superior Técnico (IST), Universidade de Lisboa, and researcher at the Institute of Bioengineering and Biosciences (IBB). Chair of the Section Downstream Processing of the European Society of Biochemical Engineering Sciences (ESBES); Vice-President of the Portuguese Society for Biotechnology and editor of Separation and Purification Technology Journal. Current research interests include the development of new separation processes with high performance and efficiency for purification biopharmaceuticals and the development of devices- "Lab-on-a-Chip" - for biomolecules purification.

Bill Barrett, PhD, Product Specialist, Chromatography, Gore & Associates, Inc.

William Barrett, PhD is a Product Specialist with over 20 years of experience in biotechnology, chromatography and the medical device industries. Most recently at Gore, Bill’s focused on affinity purification chromatography.  Previously, Bill worked at Agilent on affinity depletion devices used in biomarker discovery and proteomics. His PhD in Biochemistry is from the University of Illinois and his fellowship was at the Laboratory of Biochemistry at the National Health, Lung and Blood Institute at the NIH.

 

Gregory Dutra, PhD Student, Department of Biotechnology, BOKU
Gregory Dutra is a PhD student supervised by Professor Alois Jungbauer at BOKU. He is one of the 15 PhD students in the Analytics for Biologics (A4B) project, a Europe-wide innovative training network (ITN). His investigation topic is the continuous separation of recombinant antibodies by non-chromatography methods.

Philip Corner, PhD, Scientist, Technical Lead, CPI Biologics
Philip is a pharmacist with academic and industrial research experience in drug development. He graduated from the University of Sunderland with an MPharm degree in 2012, and after undertaking pre-registration training between hospital and industrial pharmacy, completed a PhD at Durham University focusing on co-crystallisation as a technique to improve the properties of drugs. Following a post-doc position in the Northern Institute for Cancer Research (NICR) at Newcastle University developing a peptide based pro-drug, Philip is now based within the biologics downstream processing team at CPI. He is currently contributing to projects involving the development of an automated, integrated, continuous downstream process, and development and scale-up of a continuous non-chromatographic purification stage for monoclonal antibodies.

Hani El-Sabbahy, PhD, Biopharmaceutical Application Engineering Specialist, Separation and Purification Sciences Division, 3M United Kingdom PLC, 3M
Dr El-Sabbahy is a Life Science Application Engineer for 3M Separation and Purification Sciences Division UK and Ireland. Prior to joining 3M, he worked as a Senior Downstream Process Development Scientist at Actavis Biologics where, as well as developing DSP for Biologics, he gained significant experience on continuous chromatography and single-pass tangential-flow filtration.

Daniel Fleischanderl, Head, Upstream Process Development Austria, R&D Pharmaceutical Sciences, Takeda
I graduated from the University of Applied Life Sciences Vienna (Biotechnology) and started my career as a cell culture scientist at Polymun. I joined Baxter 2006 as a development scientist and spent the last years developing multiple animal cell culture processes for blood clotting factors, antibodies, proteases and other complex proteins in fed batch, chemostat and perfusion mode. In 2015 Baxter spun off Baxalta, which was acquired by Shire. Later, Shire became part of Takeda in early 2019. Currently I am heading Upstream Process Development Austria within Pharmaceutical Sciences at Takeda.

Rainer Hahn, PhD, Associate Professor, Department of Biotechnology, BOKU
Rainer Hahn holds a PhD in Biotechnology and currently is Associate Professor for Bioprocess Engineering at the Department of Biotechnology at the University of Natural Resources and Life Sciences (BOKU Vienna, Austria). His general field of research is processing of biomolecules from fermentation broths covering a full range of unit operations like centrifugation, homogenization, filtration, ultrafiltration and chromatographic techniques. Research key activities are preparative separations as well as mechanistic modelling and engineering aspects with a special focus on chromatographic separation of proteins and other biomolecules.

Sophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology
Sophia Hober is Professor of Molecular Biotechnology at KTH, Stockholm, Sweden. The focus of her current research group is development of predictable and robust systems for protein purification and detection by protein design and various selection methodologies. Her key scientific achievements includes design and development of gene fusion systems for selective ion-exchange purification and improvements of the alkaline tolerance of protein A and protein G for industrial purification of IgG/HSA (Currently a product sold by GE-Health care). Moreover, small bispecific protein domains with ability to strongly and selectively bind to two different proteins recently have been developed.

Daniel Kronberger, PhD, Head, Downstream Pilot, Process Science, Boehringer Ingelheim
I have a degree in mechanical engineering and a master degree in biotechnology. In my current position I am now for more than four years. Before I was responsible for tech transfers and developments of customer projects as a project leader in the CMO business.
Together with my wife and our two kids I live in Vienna. On weekends I love to go mountain biking.

Daniel Komuczki, PhD Candidate, Institute of Bioprocessing Science and Engineering, Working Group Jungbauer, BOKU
Daniel Komuczki received a Master of Science in Biotechnology at Wageningen University and a Double Degree (MM.Sc) in Material and Energetic Exploitation of Renewable Raw Materials (NAWARO) from BOKU and the Technical University in Munich (TUM). He is currently a PhD Candidate at BOKU in the group of Alois Jungbauer and embedded in the Marie Sklodowska-Curie ITN “Analytics 4 Biologics” (A4B). His research is focused on fully integrated continuous bioprocessing of recombinant proteins using mammalian cells. Thereby, he emphasizes on the improvement of up- and downstream processes using rapid prototyping by the means of 3D-printing.

Karolina Les, PhD, Scientist II, R&D Biopharmaceuticals, Purification Process Scientist, AstraZeneca
Karolina Alicja Les is a Scientist in Purification Process Sciences group in BioPharmaceuticals Development Unit at AstraZeneca. Her primary focus area is design and optimisation of purification processes and their transfer into manufacturing facilities to support early clinical trials. Karolina is also working at the research/development interface providing CMC input to early stage projects. Prior to this, she had worked on half-life modulations of biopharmaceuticals and characterisation of antibody-drug conjugates (ADCs) at Abzena Company. Karolina obtained her PhD from School of Pharmacy of University College London.

Lukas Marschall, Exputec GmbH
Lukas is a Sr. Consultant at Exputec and project lead in innovative lighthouse projects. He holds a MSc in Biochemical Engineering from the University of Technology Vienna. Over the last 5 years he was involved in basic engineering, process optimization and process validation projects. Always running at the exciting interface between data science and process engineering he masters both languages (statistics and process technology) fluently. Currently he has the lead on several process validation projects and helps top-tier pharmaceutical companies on reaching their goal of successful submission.

David O’Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin
I am a research scientist who is deeply fascinated by the behaviour of proteins in cells, in living systems and in recombinant engineered systems. The junction of biology, chemistry and physics is of particular interest to me and is manifest in my many collaborative relationships in Europe and the US. I am also a Science Foundation Ireland funded investigator with BEACON, the Bioeconomy Research Centre, that enables me to use my expertise in protein engineering to drive creation of value in the circular economy, ensuring that excellent science creates products and technologies with sustainable properties, and to further enhance the reputation of UCD as Ireland’s number one university.

Hector Osuna, Head of Biotech Modeling, Ypso-Facto

Rui Oliveira, PhD, Associate Professor, Faculty of Science and Engineering, Universidade Nova Lisboa
Prof. Rui Oliveira is currently Associate Professor of Chemical and Biochemical Engineering at the Universidade Nova de Lisboa (UNL), Portugal, and the head of the Systems Biology and Engineering lab. He develops research activity mainly in the field of computational systems biotechnology with emphasis on the use of hybrid systems theory to integrate the different “omics” platforms in a common computational framework. He has been also deeply involved in innovation, where he has founded several start-up companies operating in the Systems Biotechnology arena.

Cristina Peixoto, PhD, Head, Downstream Processing Laboratory, IBET
Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology) New University of Lisbon and she holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biológica (ITQB) from New University of Lisbon. Working in Animal Cell Technology field since 1996, her PhD contributed to the establishment of several scalable purification processes for complex biopharmaceuticals, mainly virus and virus like particles for vaccine and gene therapy. Cristina coordinated several research contract projects with Industrial partners, some of the processes developed are nowadays in GMP for phase I and II and she published over 60 manuscripts in refereed international journals.

Oliver Spadiut, PhD, Associate Professor, Integrated Bioprocess Development, TU Wien
Oliver Spadiut completed his PhD in Biotechnology at BOKU University, Vienna, Austria, in 2008 before doing a 2-years PostDoc at KTH, Stockholm, Sweden. Since 2010 he has been employed as University Assistant in Biochemcial Engineering at TU Wien, Vienna, Austria. In March 2015 he got his Habilitation in “Biotechnology” and is currently Associate Professor and PI of the research group “Integrated Bioprocess Development”. He has published more than 90 papers in reputed journals and is serving as a peer-reviewer for 69 scientific journals.

Anne Tscheließnig, PhD, Head, Downstream Development II, Biopharma Process Science Austria, Boehringer Ingelheim

Cell Therapy CMC and Manufacturing

Fouad Atouf, PhD, Vice President, Global Biologics, USP
Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics including advanced therapies.. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the development of cell-based therapies for the treatment of diabetes. Dr. Atouf earned his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Jean-Charles Epinat, PhD, Head, Process Development, Cellectis
Jean-Charles Epinat, graduated from the University Pierre and Marie Curie, Paris, France as yeast geneticist. He received his PhD Degree at the Pasteur Institute, Paris, France, followed by a Post Doctoral fellowship at Boston University. Jean-Charles joined Cellectis in 2000 and developed a high throughput screening platform for engineered homing endonucleases based on functional activity testing in yeast and mammalian cells. He put in place an automated TALEN® synthesis platform to support the strategic focus of Cellectis on TALEN®-based gene edited cell therapies. Since 2015, he is the Head of the Process Development group and responsible for developing production methods for scalable manufacture of UCART product candidates and other allogeneic therapy products of Cellectis portfolio. Such processes have been transferred for clinical manufacturing.

Carol Knevelman, PhD, Vice President, Head, Process R&D, Oxford Biomedica
Dr Knevelman is the Vice President and Head of Process R&D at Oxford Biomedica (OXB), providing specialist expertise in all aspects of process development throughout her eight years with the company.  Her main areas of responsibility include early and late phase process development activities encompassing platform process design & optimisation, scale-up, process characterization and technical support in the area of viral vector production/purification development for cell and gene therapy applications. The department works across multi functions to support both OXB’s internal and third party collaborator product development pipeline. Prior to joining OXB, Carol worked for several years for Lonza Biologics both in the UK and US. Carol has an Eng.D in Biochemical Engineering from University College London (UCL).

Juan Pablo Labbrozzi, PhD, Principal Scientist, Process Development, Kiadis

Anne-Sophie Lebrun, PhD, Head, Manufacturing, Bone Therapeutics
After completing my PhD in Molecular Biology, I joined Bone Therapeutics in 2010 in the Quality Assurance Department. At that time, we had to face several challenges like the validation of an autologous production process and an allogeneic production process in order to start our first clinical trials. After reaching these miles stones, I had the opportunity to join the production and optimization department. We had to tackle other challenges such as the robustness, increase the yield and scale of our production process. We are currently at a turning point in the evolution of our company where we must think about the future and commercialization of our product.

Athanasios (Sakis) Mantalaris, PhD, Professor, W.H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University
Athanasios (Sakis) Mantalaris is Professor in the W.H. Coulter Department of Biomedical Engineering at Georgia Tech & Emory. Prior, he was Professor of BioSystems Engineering in the Department of Chemical Engineering at Imperial College London. He received his PhD (2000) in Chemical Engineering from the University of Rochester.  His expertise is in modelling of biological systems and bioprocesses with a focus on mammalian cell culture systems, stem cell bioprocessing, and tissue engineering. He has published over 170 original manuscripts, co-edited one book, and holds several patents with several more pending. He has received several awards including the Junior Moulton Award for best paper by the Institute of Chemical Engineers (IChemE) in 2004. In 2012, he was elected Fellow of the American Institute for Medical & Biological Engineering and in 2013 he was awarded a European Research Council (ERC) Advanced Award. In 2015, he was awarded the Donald Medal by the Institution of Chemical Engineers (IChemE) for his contributions to biochemical engineering.

Ali Mohamed, PhD, Vice President of CMC, Immatics US, Inc.
Ali Mohamed, PhD, Vice President, CMC, Immatics US Inc. Formerly the senior director of manufacturing operations/ manufacturing development at PCT (Now HCATS). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical stage companies including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a PhD in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in neuroscience and neurobiology from the Georgetown University.

Mustafa Mohamed Munye, Lead Scientist, Industrialisation, Cell and Gene Therapy Catapult
Mustafa obtained a PhD from University College London focused on non-viral gene therapy for airway diseases. He subsequently spent time working in academia and industry developing novel cell and gene therapy products at different stages of the drug development pathway. This has included establishing bioprocesses for manufacture and analytics of cell and viral. Since joining CGT Catapult Mustafa has led the establishment of closed and automated bioprocesses for manufacture of cell and gene therapy products and analytical development of release and process analytical technologies for immunotherapy, viral vector and stem cell products. Mustafa also leads CGT Catapult’s Stem Cells program providing strategic direction towards controlled, closed and automated bioprocesses for affordable manufacture of stem cell therapies.

Christiane Niederlaender, PhD, Director, AMBR Consulting; Former Senior Quality Assessor for MHRA; Former Member, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA)
Christiane has spent 12+ years in medicines, tissue, cell and gene therapy regulation, last with the MHRA, where she worked until August 2019. She was the UK representative at the EMA committee for advanced therapies (CAT). Christiane was the Rapporteur/ Co-Rapporteur for several advanced therapy medicinal products (ATMPs) and many other biological product applications, including biosimilars. She acted as the Rapporteur and drafting group member for CAT guidelines. Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European Tissues and Cells Directive as an assessor and inspector. She has a Ph.D. and research background in cell-signalling, cancer and stem cells and obtained a law degree in 2005. Christiane has set up her own consultancy company in September 2019.

Florence Salmon, PhD, Portfolio Lead Regulatory Affairs CMC, Cell and Gene Therapies, Novartis Pharma AG
Florence holds a PhD in Molecular and Cellular Biology from Strasbourg University. She started her career in the area of Product Safety moved to DMPK and PK modelling, and later into building early development packages for innovative medicines at TNO in Leiden/Zeist (the Netherlands).  She gained considerable experience in product development and regulatory affairs, bringing many of the early cell and gene therapies from the bench to the clinic.  She joined uniQure (Amsterdam, Netherlands) in 2009 where she was instrumental in the approval of Glybera (first gene therapy in the EU) in 2012 and supported the development of a number of AAV-based gene therapy vectors for various disease areas.  She joined Novartis in 2014 as Director Global Regulatory Affairs CMC Cell and Gene Therapies, where she led the submission and approval of Kymriah (first CAR-T product) for the treatment of acute paediatric leukaemia and adult lymphoma in the US, Europe, Japan and many other regions. 

Mark Tomishima, PhD, Executive Director, Platform & Process, BlueRock Therapeutics
Mark Tomishima is the Executive Director of Platform & Process at BlueRock Therapeutics. He has almost 20 years of experience in pluripotent stem cell biology. As a postdoc in Lorenz Studer’s Lab, he developed novel transgenic technologies that helped to define the optimal stage for Parkinson’s transplantation. Dr. Tomishima then built and managed the SKI Stem Cell Research Facility for a decade, where he acquired more extensive experience in reprogramming, genome engineering and directed differentiation, resulting in authorship on over 30 publications. His lab participated in Lorenz Studer’s New York State (NYSTEM)-funded contract to manufacture midbrain dopamine neurons from PSCs for Parkinson’s treatment. Dr. Tomishima and his team transitioned a research-grade protocol to a clinically compatible bioprocess. In 2016, he led the GMP manufacture of around 1000 human doses of the product called DA01. This product and process is now BlueRock Therapeutics’ lead pipeline product, and Dr. Tomishima will continue to help advance BlueRock’s portfolio of cellular medicines at BlueRock.

Maitane Ortiz Virumbrales, PhD, Senior Scientist, Cell Therapies, Takeda
Dr. Maitane Ortiz Virumbrales is senior scientist at Cell Therapies department at Takeda. Before joining industry Maitane worked on modeling of Alzheimer disease using iPSC at the Mount Sinai Hospital and The New York Stem Cell Foundation. At Takeda she is leading research projects on characterizing the role of adipose derived mesenchymal stem cells (ASC) in immunomodulation, to develop relevant assays for process and product characterization. Also, she is coordinating efforts to improve the ASC production process and create a new robust automated closed system to meet the clinical and commercial demands while preserving the critical quality attributes (CQA) of the cells.

Gene Therapy CMC and Manufacturing

Eduard Ayuso, DVM, PhD, Team Leader, Innovative Vectorology; Scientific Director Translational Vector Core (CPV), Translational Gene Therapy for Genetic Disorders, Inserm, University of Nantes
Eduard Ayuso, DVM, PhD. He is currently senior scientist at the INSERM unit “Translational gene therapy for genetic diseases” in the University of Nantes (France). He leads a research team focused on innovative vectorology and viral vector manufacturing and is the scientific director of the translational vector core. He obtained the degree in Veterinary medicine at the Autonomous University of Barcelona in 2001 and the PhD in biochemistry and molecular biology at the same university in 2006. He has expertise in several viral vector platforms for gene therapy, such as adenoviral vectors, helper-dependent adenoviral vectors and adeno-associated vectors and he has made significant contributions to field of in vivo gene transfer in small and large animal models of diseases.

Marian Bendik, PhD, Site Lead Orth, Gene Therapy Center Austria, Biologics Operating Unit, Technical Operations, Takeda
Marian Bendik holds a Master’s degree in Biochemistry from the University of Chemistry and Technology, Prague, Czech Republic. He then worked as an immunoassay research scientist in academia and later in industry. Afterwards, he occupied different process and manufacturing expert roles with increased responsibilities in the cell-based vaccines business unit at Baxter Bioscience. In 2014, he joined gene therapy process development team to support developing of the AAV manufacturing platform in Austria. Currently, he holds accountability for gene therapy manufacturing and acts as Site Lead Orth for Gene Therapy Center Austria at Takeda.

Gregory Berger, PhD, Lead Scientist, Cell and Gene Therapy Catapult
Greg has been at the cell and Gene Therapy Catapult since early 2017 and brings a wealth expertise in viral vector/cell line development, vector production in bioreactors and development of appropriate analytical tools for characterization and functionality assessment. Greg obtained his PhD in Virology and Immunology from the Ecole Normale Superieure de Lyon (ENS Lyon) in France, focusing upon the development of new Lentiviral vectors for the development of Dendritic cell-based immunotherapy. He then joined the department of Immunobiology and Infectious Disease at King’s College London as a post-doctoral researcher where his work focused predominantly on viral vector integration and immune cell dysfunction upon transduction. At CGTC, Greg is currently working with the process and analytical team to address the current challenges regarding viral vector manufacturing

Clare Blue, PhD, Director, Analytical Development, Biogen

Ana Sofia Coroadinha, PhD, Lab Head, Health & Pharma Division, Animal Cell Technology Unit Cell Line Development and Molecular Biotechnology Lab, IBET
Dr. Ana Sofia Coroadinha has a Degree in Biochemistry (University of Lisbon) and a PhD in Gene Therapy performed at Généthon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009 is the Head of Cell Line Development and Molecular Biotechnology Lab at iBET and ITQB-NOVA. She has over 20 years of experience in recombinant viruses and animal cell culture, areas where she has published over 50 peer reviewed papers. Dr. Ana Sofia Coroadinha group research focus on applied virology developing recombinant virus and molecular tools supporting the areas of gene therapy, vaccine development and virology.

Rénald Gilbert, PhD, Team Lead, Department of Bioprocess Engineering, NRC Canada
Rénald Gilbert is the team leader of Viral Vector Production at the National Research Council Canada (NRC) in Montreal. He is also an adjunct professor in the department of Bioengineering of McGill University.  His research interests embrace the optimization of viral vectors for the development of vaccines and for cell and gene therapy applications, as well as the manufacturing process of these complex biologics. R. Gilbert completed his Ph.D. in Biochemistry at McMaster University (Hamilton Ontario) in 1994.  Before starting his career as research officer at NRC in 2002, he trained as a postdoctoral fellow in the department of Cell Biology of Weill Cornell Medical College (New York City) and in the department of Neurology in Neurosurgery at the Montreal Neurological Institute of McGill University.

Alan Griffiths, PhD, Director, Viral Vector Development, MeriaGTX

Jean-Philippe Combal, PhD, Co-Founder and CEO, Vivet Therapeutics
Jean-Philippe has 26 years of experience in the pharma & biotech industries. He is a highly skilled senior executive with a broad range of experience leading global development and a successful track record of innovation and development in the area of Orphan Drugs. While Chief Operating Officer of GenSight Biologics (2014-2017), he successfully contributed and participated to investment round of more than 80M$, including a successful IPO and piloted the advancement of two major gene therapy programs from non-clinical to phase 3 pivotal trials, as well as regulatory and launch readiness strategies. Prior to his GenSight experience, from 2011 to 2014, he was Strategic Therapeutic Area Leader at Galderma extending from the preclinical stage through launch readiness activities and assessment of business development opportunities and prior to that held the role of Vice President of Drug Development at Sanofi (Ophthalmic Division after Fovea Pharmaceuticals acquisition; 2006-2011). During his early career, from 1990 to 2006, Jean-Philippe was a key leader in the research and development departments at Servier, Pierre Fabre, Fournier-Pharma/Solvay, Exonhit Therapeutics. Jean-Philippe earned his PhD in Toxicology and Pharm.D from Paris XI University and holds a Master in Strategic Marketing from ESCP Paris as well as a General Management Program from center of executive development at INSEAD.

Christine Le Bec, PhD, Head of CMC Analytical, Technology Development, Genethon
Christine Le Bec joined Genethon in 1997 as a scientist and currently heads the CMC Analytical Department. She is responsible for the analytical activities in the characterization and release testing of gene therapy products at early stage development, stability studies, and interface with CMO for method transfer and validation, analytical/QC testing. She also assists in the response to CMC questions from regulatory agencies query. She has a strong expertise in the development and qualification of analytical methods based on biochemical, biophysical and cell based assays to assess identity, potency, impurity profile, and safety. Before joining Genethon, she obtained her PhD in Bio-Organic Chemistry from Université Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, US) and then at Institut Pasteur (Paris, France) in the field of synthesis, structural analysis and in vitro evaluation of antisense DNA as therapeutic agents for cancer and AIDS.

Janneke Meulenberg, PhD, MBA, COO, Arthrogen
Janneke Meulenberg has over 25 years of experience in the Biopharmaceutical industry. She graduated cum laude from the University of Groningen, received a PhD in Biochemistry from the University of Amsterdam and holds an MBA from RSM Erasmus University. Janneke Meulenberg started her career in industry at ID-Lelystad, where she headed a world leading R&D team developing veterinary vaccines in collaboration with Boehringer Ingelheim. She joined the management team of Amsterdam Molecular Therapeutics (now UniQure) in 2000, where she was responsible for developing Glybera® from research to registration studies. Glybera® is the first gene therapy that has received market approval in the Western World. Between 2008 and 2015, Janneke Meulenberg was CEO of ORCA Therapeutics B.V., a biopharmaceutical company developing innovative oncolytic adenoviruses and sinds 2015 she is CEO of ViciniVax BV, a company developing immunotherapeutic cancer vaccines. In 2015, Janneke Meulenberg was appointed COO of gene therapy company Arthrogen BV. She is author of numerous peer-reviewed publications, book chapters, and inventor on several patents.

Robert Pletzenauer, Head, Process Analytics, Takeda Gene Therapy Process Development
I started my professional career in 1997 with a chemical lab technician apprenticeship in a small pharmaceutical company. After my master’s degree in 2014 I started to work at Baxter, Baxalta Shire, Takeda where I am now responsible for the Analytical Development combined with a dedicated Process Analytics part at Takedas´ Gene Therapy Hub in Orth.

Francis Poulin, PhD, Director, Analytical Development, Sanofi
Francis Poulin is a Director of Analytical Development at Sanofi in Framingham, Massachusetts, where he is responsible for the development, qualification and validation of bioassays and molecular assays to support the release of biologics in preclinical and clinical development, including gene therapy products. Prior to joining Sanofi, Francis was a postdoctoral fellow at HHMI/University of California, Berkeley and the Lawrence Berkeley National Laboratory. Francis received his PhD in Biochemistry from McGill University.

Kamila Pytel, PhD, Lead, CMC Analytical Development, Gyroscope Therapeutics Ltd.

Matthew Roach, Process Development Engineer, Precision Biosciences
Matthew Roach is a Process Development Engineer at Precision BioSciences focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matthew completed his Bachelor's degree in Biological Sciences at North Carolina State University and his Master's degree at the University of Florida.

James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx
Dr. Warren has more than 25 years of experience in the pharmaceutical and biotechnology industry, with a focus in bioprocess development and manufacturing of viral vectors, viral vaccines, and biologics. At Ultragenyx, he leads a team of 50 scientists and engineers, responsible for all early and late stage Process and Analytical Development of viral vector products as well as Pilot Scale Manufacturing in the Woburn, MA Pilot Plant.  Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, and Shire. Earlier in his career, Jim spent 16 years at Merck & Co., Inc., where he led process development, technology transfer, and manufacturing sciences teams responsible for development of several clinical vector and vaccine candidates and the licensure of multiple commercial vaccines (RotaTeq®, Varivax®, ProQuad®, and Zostavax®).  Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a Ph.D. in Molecular and Cellular Biology from Lehigh University.

Analytical Characterisation

Dan Bach Kristensen, PhD, Principal Scientist, Symphogen
Dan Bach Kristensen holds a Ph.D. in biology and B.Sc. degree in chemistry. Dan is specialized in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research in Japan and later in Denmark. For the last 15 years Dan has been working with analytical development in the biopharmaceutical industry, on projects ranging from early discovery through to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases and oncology. Dan currently works as a Principal Scientist at Symphogen, which is specialized in the development of antibodies and antibody mixtures for the treatment of cancer.

Eric Bishop, Vice President, Research and Development, Cygnus Technologies
Eric has worked within the Biotechnology industry for 21 years. Eric was hired at Cygnus Technologies in, 2010 as the Vice President of Research and Development. His current responsibilities at the company include business development, technical support, new product development, custom services, along with being the Head of Research and Development Laboratory. Prior to joining Cygnus, Eric worked for MedImmune from 2002-2010. His responsibilities included: Analytical Representative on CMC teams guiding projects from IND to BLA submissions, Head of New Technology Development group, In-house host cell protein expert, Supervisor of 9 scientists in Immunoassay laboratory, and development, validation, Tech transfer of HCP and other analytical assays. Eric also worked for CropTech Development from 1998-2002. Eric has a Masters of Science in Biotechnology from The John Hopkins University in Baltimore, MD., and a Bachelors of Science in Biology, with a Minor in Chemistry, from Radford University in Radford.

 

Jonathan Bones, PhD, Principal Investigator, CCL, National Institute for Bioprocessing Research and Training (NIBRT)
Jonathan received his PhD in Analytical Chemistry from Dublin City University in 2007. Jonathan then moved to NIBRT - The National Institute for Bioprocessing Research and Training, working under the mentorship of Prof. Pauline M. Rudd within her GlycoScience Laboratory. In 2010, Jonathan was appointed the John Hatsopoulos Research Scholar within the Barnett Institute of Chemical and Biological Analysis at Northeastern University, Boston, working under the mentorship of Prof. Barry L. Karger. Jonathan returned to NIBRT in 2012 and is the Principal Investigator of the NIBRT Characterization and Comparability Laboratory and an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin.

Jianwen Feng, PhD, Director, Quality Control, Massbiologics, Umass Medical School
Dr. Jianwen Feng is a director at MassBiologics of Umass Medical School. His main interest includes protein (antibody) characterization, assay development/validation and formulation of mAb, AAV gene therapy and vaccine products. Jianwen has over 13 years of experience in QC, development and discovery of antibody, gene therapy and vaccine. He completed his Ph.D. in Biochemistry/Enzymology from Boston College, and did PostD research in Dana-Faber Cancer Institute, Harvard Medical School. Since 2006, Jianwen has worked in manufacture (MassBiologics), process development (Lonza), and discovery (Shire and Jounce Therapeutics) with increasing roles and responsibilities. He has established various platforms in protein characterization, antibody developability and manufacturability assessment and formulation to accelerated drug discovery and development.

Gerald Gellermann, Senior Fellow, Analytical Development, Novartis
Gerald currently holds a position as Senior Fellow and Analytical Project Leader in Analytical Development at Novartis. Prior to joining Novartis in 2015 he was working at Roche where he was among other responsibilities analytical lead the first biotech project with a globally approved design space. Before joining Roche in 2008 he gained professional experience as a scientist in neuroscience research and later in the diagnostic division at Abbott. Gerald holds a Master’s degree in Biology from the University of Constance (Germany) and a PhD in Molecular Biology from the University of Jena (Germany).

Bruno Genet, Lab Head Mass Spectrometry, Sanofi
After several years in a proteomics team to support innovative projects, I joined the BioDevelopment department to take in charge the lab of characterization by MS of Biologics in the R&D site of Vitry. Our transversal activity covers early and late phase of biotherapeutic projects, up to the industrial affairs.

Christoph Herwig, PhD, Head Research Area Biochemical Engineering, TU Vienna
Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec addressing data science solutions for the biopharma life cycle.

Alistair Kippen, PhD, Vice President, BioPharmaceutical Development, Ipsen
Alistair heads CMC Development of novel Biopharmaceuticals at Ipsen Biopharm; incorporating Bioprocess, Formulation and Analytical development groups, managing product supply, specification setting & regulatory submissions, through to manufacturing & commercial lifecycle support. Previously, he was Director & Global Head of Analytical Sciences at MedImmune, the Biologics division of AstraZeneca; incorporating Product Characterisation, Potency, Stability, In-Process/Residuals & Quality Control (QC) groups as part of Biopharmaceutical Development. He was also Development lead for Cardiovascular & Metabolic Diseases therapies, CMC project leader and lead for various European Biotechnology Industry-Regulatory forums. Alistair gained his PhD from Cambridge University (with studies on Enzyme Structure & Mechanism with Prof. Sir Alan Fersht at the MRC LMB), and held various previous academic & industrial positions as: Research Scientist at the Geneva University Medical Centre; Senior Scientist at PolyMASC Pharmaceuticals; and Associate Director of Biotechnology-Protein and Immunochemistry at Covance Laboratories.

Diane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia
Dr. McCarthy is a Senior Manager in USP’s Global Biologics Department. Diane leads a team that focuses on development of new standards that can help address bottlenecks in the biotechnology industry. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

Miroslav Nikolov, PhD, Senior Scientist & Lab Head, Roche Pharma Research and Early Development (pRED)
Miroslav grew up in Bulgaria, and before joining Roche in 2017, he spent multiple years working on mass spectrometry-based proteomics approaches, protein biochemistry and lab automation. At the mass spectrometry department in Large Molecule Research (LMR) at Roche Innovation Center Munich (RICM), he leads an MS lab, focused on automation, data management and software. Besides that, his lab and department cover MS analytics and are responsible for characterization of molecules from early research to entry into clinical development. Outside of work, he gets excited about music, technology innovation, gadgets and fast cars.
Sandra Prior, PhD, Senior Scientist, National Institute for Biological Standards and Control (NIBSC, a centre of the MHRA)
Sandra Prior joined the National Institute for Biological Standards and Control (NIBSC, Potters Bar, UK) as a Senior Scientist in 2015. She works on the development of bioassay standards for therapeutic monoclonal antibodies and the investigation of structure-function in relation to the safety and efficacy of monoclonal antibody products. She is also currently a member of the European Directorate for the Quality of Medicines and HealthCare (EDQM) monoclonal antibody expert committee and Official Medicines Control Laboratory (OMCL) monoclonal antibody testing group. Formerly she obtained her PhD from the University of Navarra (Spain) and then moved to the UK where she initially worked in NIBSC investigating safety and protective mechanisms of bacterial combination vaccines. In 2010 she joined Lonza Biologics (Cambridge, UK) working on bioactivity and immunogenicity assessment of biotherapeutics. Sandra has over 15 years’ experience in applied immunology and in vitro cell-based assay development.

Alan G. Ryder, PhD, Professor, Nanoscale Biophotonics Laboratory, National University of Ireland Galway
Prof. Alan G. Ryder directs the Nanoscale Biophotonics Laboratory (NBL) which is based at the National University of Ireland, Galway (NUIG).  He has a B.Sc. and Ph.D. (1989) in chemistry from NUIG.  After a stint as a postdoctoral researcher in UCC, he rejoined NUIG in 1997 to work on developing quantitative Raman spectroscopy-based methods for measuring illicit narcotics.  In 2003, he formed the NBL which applies photonics and chemometrics technologies to applications in the life and physical sciences.  In 2006 obtained tenure in the School of Chemistry at NUIG as senior lecturer and was promoted professor there in 2016.  He has two core research areas: Analytical Sciences and Photonics which cover a wide range of applications.  In the Analytical Sciences domain, his main research area is developing of rapid, quantitative analytical methods for the analysis of complex materials with particular focus on biopharmaceutical manufacturing and cell culture media analysis.  He has collaborated with a wide range of biopharmaceutical manufacturing industries since 2004.  He has authored more than 95 publications, generated 3 patents, graduated 17 PhD students.

Gerard Scheppink, Scientist, Product Characterisation/Analytical Development, Janssen Vaccines
Gerard Scheppink is a scientist within the Analytical Development Department of Janssen Vaccines and Prevention. He studied Biomedical Sciences and holds a MSc in Neuroscience and Cognition from the University of Utrecht, The Netherlands. He has worked on the analytical development of virus-based vaccines for over 8 years. Initially he was responsible for bioanalytical method development and validation. In his current position he is responsible for criticality analysis, product characterization and comparability studies of virus-based vaccines.

Helge Schnerr, PhD, FortéBio - Molecular Devices (Germany) GmbH
Dr Schnerr has spent +20 years in research and development focused on chemical biology, biochemistry and molecular biology. Before joining Fortébio in 2016, he worked for the largest sequencing service provider in Europe. He has experience in R&D, product management and marketing with a focus on leading interdisciplinary teams in life science industry focusing on product development and commercialization. He holds a Ph.D. from TUM and a Diploma in Chemistry from TU Dresden, Germany.

 

Gwen Shi, Senior Scientist, Analytical R&D, Pfizer
M.S Drexel University Analytical Chemistry B.S Shanghai Jiao Tong University Applied Chemistry 4/2010~Current Scientist ARD Provide bio-analytical assays support (e.g., LC/MS, SDS-CE, SEC, IEX, iCE280, peptide mapping, N-glycan etc.) for bioprocess development and formulation development for antibodies and fusion proteins; Perform LC/MS analysis of forced degradation samples for late stage mAb projects and assist BLA writing for regulatory filing. 08/2005 – 03/2010 Research Scientist II ARD Performed analytical method development and qualification associated with process related impurities, buffer components, and excipients during process purification and manufacturing of clinical biopharmaceutical products Investigated and identified the abnormal materials found in bioprocess equipment and drug substances.

David Spencer, Characterisation Manager, Ipsen Biopharm
David has >15 years of experience in biopharmaceutical R&D supporting many pre-clinical and clinical development programs for therapeutic proteins.  David joined Ipsen in 2016 where he leads the Characterisation group as part of Biologics Pharmaceutical Development. David formerly worked at MedImmune/AstraZeneca both in the UK and the US.  David’s analytical responsibilities and interests span from protein engineering (developability by design) to bioprocess/formulation development and manufacturing.  David gained his BSc in Biochemistry/Biotechnology from the University of Sheffield, UK. 

Sabrina Vollers, PhD, Senior Research Officer, Bioanalytical Development, Ichnos Sciences
Dr. Sabrina Vollers joined Glenmark 2 years ago in order to help create the Bioanalytical Development group, bringing expertise in SPR and cell-based assays, with previous experience in analytical method validation from Genzyme Corporation. She earned her PhD in biochemistry and molecular pharmacology from the University of Massachusetts Medical School (USA), broadening her 11 years’ experience in protein biochemistry with postdoctoral research in diabetes and physiology at the University of Lausanne (CH), and protein design and vaccinology at the EPFL (CH), which was supported by a Novartis fellowship. Dr. Vollers has authored multipe successful research grants, a book chapter, and has ~10 publications in high impact journals (JBC, PNAS).

Formulation, Stability and Aggregation

Zahir Akhunzada, PhD, Research Scientist, Drug Product Science Development, Bristol-Myers Squibb
Dr. Zahir Akhunzada is a PPD Consultant at Bristol-Myers Squibb Company. Prior to joining PPD, he worked for Schering-Plough/Merck, KACST, King Saud University and as a guest Investigator at the GI Research Institute of the VA Hospital, NJ. He earned his Doctorate degree in Chemistry from the H. E. J. Research Institute, Karachi, Pakistan. He did Post-Doc in Tubingen, Germany and gained research experience in Phamacognosy, at Leiden University, the Netherlands. He has several research publications and co-Authored a Textbook,” Stereoselective Synthesis in Organic Chemistry”, Springer Verlag, USA. He has a broad range of expertise in R&D, specializing in spectroscopy, organic synthesis, flow imaging and wet analytical techniques. More recently, he has focused his expertise on characterizing biologics. Dr. Akhunzada is the recipient of several awards and recognitions, including Certificate of Honor (New York Academy of Sciences), several Bravo (STAR) Awards (BMS/PPD), ELN Champion Award (BMS) and Shining Performance Awards (Schering Plough/Merck).

Tudor Arvinte, PhD, CEO, Therapeomic; Professor of Biopharmaceutics, University of Geneva
Tudor Arvinte studied physics at University of Jassy, Romania, and received his Ph.D. in biophysics from University of Düsseldorf, Germany. He held numerous research positions in Europe and the USA at: Max-Planck Institute, Germany; C.N.R.S., France; Cornell University, New York; Texas A&M University; Ciba-Geigy U.K., Novartis, Switzerland. T. Arvinte worked with more than 200 biopharmaceuticals, three of his formulations reached the market, has over 90 publications and 15 patents. He is Titular Professor at Geneva University and CEO of Therapeomic, Inc. Basel Switzerland, a contract research biotech company focused on the characterization and formulation of biopharmaceuticals.

Nadine Binai, PhD, Scientist Product Characterization, Janssen Vaccines
Nadine Binai is a scientist in the Analytical Development department within Janssen Vaccines. Within the Product characterization team, Nadine works on comparability assessments, criticality analysis and characterization of product stability. Her broad background in analytical technologies, such as mass spectrometry as well as molecular methods helps her to contribute to develop vaccines that can potentially save millions of lives.

Matthew Brown, PhD, Applications Manager, AMEC, Malvern Panalytical
Matt Brown completed his PhD at the University of London, and followed this with Postdoctoral Fellowships at Harvard Medical School, in Boston, USA. Prior to joining Malvern Panalytical, Matt worked in the biopharmaceutical sector, employing a range of biophysical and biochemical methods to support bioprocess development and commercial manufacturing operations. Currently, Matt is the Bioscience Applications Manager for the US, specializing in the Biopharmaceutical sector.

Robin Curtis, PhD, Senior Lecturer, Chemical Engineering and Analytical Science, Manchester University
Robin Curtis joined the Chemical Engineering and Analytical Science School at University of Manchester in 2003.  Previously he did his PhD at the University of California at Berkeley and post-doctoral training at University of California Los Angeles and Rice University.  His current research is focused on understanding the fundamentals of protein solution behaviour with an emphasis on elucidating non-specific protein-protein interactions and how they depend upon protein structural properties and the solution components including excipients.  The approach relies on using a combination of light scattering methods (dynamic and static light scattering, electrophertic light scattering) as well as computational approaches based on structural informatics and molecular modelling.  Current projects are focused on formulation issues such as protein phase behaviour, aggregation, and solution rheology. 

Sachin Dubey, PhD, Head of Formulation, Analytical and Drug Product Development, Glenmark Pharmaceuticals SA
Dr. Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland as deputy director and head of formulation, analytical and drug product development unit. His current responsibilities include designing and executing product development and characterization strategies for both early and late stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He have ~ 8 year of experience in biopharmaceutical formulation and combinational product development. Twelve products developed by him and his team are currently in different clinical trial. He have extensive experience with regulatory submissions in USA, EU and India. He have 9 PCT patent applications, ~ 20 publications in high impact journals like Journal of Controlled Release etc., 6 book chapters and ~ 60 presentations to his credit. He also have received 19 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International biocamp) and Swiss Society of Pharmaceutical Sciences (Best publication).

Jan Jezek, Chief Scientific Officer, Arecor
Jan Jezek is the Chief Scientific Officer at Arecor Ltd. He has been trained as a biophysical chemist. He was the principal scientist at Insense Ltd, leading the development of a range of novel medical devices from the proof-of-concept all the way to market. During his time at Insense, he and his team developed a novel formulation platform to achieve superior stability of proteins and other biological molecules. His inventions related to protein stabilization led to inception of Arecor Ltd as a separate company focusing on commercialization and further development of the stabilization platform.

Dimitrios Lamprou, PhD, Reader in Pharmaceutical Engineering, Queen's University Belfast
Dimitrios Lamprou (Ph.D., MBA) is Reader in Pharmaceutical Engineering and MSc Programme Director at the School of Pharmacy in Queen's University Belfast (UK) and Visiting Researcher at University of Strathclyde (Glasgow, UK). Dimitrios has experience of teaching in Higher Education, conducting research (70+ publications, 200+ conference abstracts, 80+ Oral/Invited Presentations) and securing national and international funding (£2M+). He is Secretary at the United Kingdom and Ireland Controlled Release Society (UKICRS), Ph.D. examiner for UK and International Institutions, and referees for journals, publishers and research funding bodies. His group is applying Nano and Microfabrication Techniques in Pharmaceutical and Medical Device Manufacturing. More specifically, his areas of interest include: Additive Manufacturing (3D Printing & Bioprinting), Electrospinning (Melt & Solution), and Microfluidics (Particle Formulation & Chip Manufacturing).

Íris Luz Batalha, PhD, Research Associate, University of Cambridge
Iris L. Batalha is currently a joint Research Associate at the Nanoscience Centre and Molecular Immunity Unity, University of Cambridge. She received her PhD degree in Bioengineering Systems from the MIT-Portugal program in 2014. From 2014 to 2017, she worked between the Department of Chemical Engineering and Biotechnology, University of Cambridge, and the biopharmaceutical company MedImmune/Astrazeneca, followed by a brief experience as a healthcare/pharmaceutical consultant. In 2018, she was appointed as a Research Associate at Peterhouse College in Cambridge, while simultaneously becoming a Course Director at the University of Cambridge Institute of Continuing Education, where she teaches healthcare nanobiotechnology for the International Summer Program.  Her research interests and expertise lie on medical and pharmaceutical research and development, particularly in the fields of nanobiotechnology, bio-inspired materials, downstream processing, formulation and drug delivery. 

Paul Matejtschuk, PhD, Section Head Standardisation Science, NIBSC (National Institute for Biological Standards & Control)
Dr Paul Matejtschuk leads the Standardisation Science Section at NIBSC, part of the UK’s Medicines & Healthcare products Regulatory Agency, formulating and freeze drying a range of biologicals, many as part of the development of WHO International Standards for bioactivity assignment. He has over 30 years post-doctoral experience in downstream processing and formulation of biologics and has co-supervised a number of PhD students and published and lectured widely on freeze drying and other topics, including editing “Lyophilization/Freeze drying of Pharmaceuticals & Biologicals –New Technologies & Approaches” with Dr Kevin Ward for Springer Press (2019).

Kevin Mattison, PhD, Principal Scientist, Malvern Panalytical
Dr Mattison completed his doctorate from Purdue University in 1999, where he studied the effects of formulation additives on enzyme stability and activity.  From there he joined Protein Solutions as the Applications Development and Technical Support Manager.  In 2002 Dr. Mattison joined Malvern Instruments, where he served as Applications Manager, Product Manager, and Director of Customer Support, prior to assuming his current position as Principal Scientist in the Malvern Panalytical Biosciences group. 

Mark McCoy, PhD, Principal Scientist, Screening, Target and Compound Profiling, Merck & Co
Mark McCoy is currently a Principal Scientist in the Discovery Chemistry group at Merck & Co, Inc.   where he uses structural biology and biophysical studies to understand details of protein structure, function and behavior. His early discovery work on PD-1-antibody interactions provided the first understanding of Keytruda’s mechanism of action. His most recent research is on understanding details of weak intermolecular interactions of therapeutic proteins which has discovery applications to developability and design as well as development applications that include formulation and coformulation.  Prior to joining Merck, Mark worked at the Wistar Institute, the University of Pennsylvania and at the Sterling-Winthrop Pharmaceutical Research institute. He has a Ph.D. from Princeton University and carried out postdoctoral research at ETH-Zürich.

Jennifer McManus, PhD, Head of Department, Chemistry, Maynooth University
Dr. Jennifer McManus is the Head of the Department of Chemistry at Maynooth University and leads the Soft Matter and Biophysical Chemistry Group there. She is also a Funded Investigator in SSPC, the SFI Research Centre for Pharmaceuticals. She completed a BSc and PhD in Chemistry at UCD, also spending time at the Max Planck Institute for Polymer Research in Mainz. Following her Ph.D., she spent a year at the University of Fribourg before moving to MIT as a postdoctoral associate. In 2008 she became the Science Foundation Ireland Stokes Lecturer in Chemistry and established a research group at Maynooth.

Rajsekhar Paul, PhD, Fellow, Drug Product Development, Novartis
Dr. Rajsekhar Paul is currently working as a Fellow in Late Phase Pharmaceutical Development Biologics in Novartis Basel. He is a Biologics R&D scientist with 15+ years of experience in Biological sciences and 11+ years of industry experience in pharmaceutical development for parenteral dosage forms of biologics for the clinics, market and for lifecycle products. Raj works in end-to-end development of various dosage forms, interpretation of patents and design of formulation development strategies from pre-formulation to development including optimization and validation for Injectable Biologics products and Lyophilized Product of IV Parenteral Dosage Forms. Raj expertise in product development, process development and optimization, biopharmaceutics and biophysical methodologies and related analytics, formulation development, process scale up, process technology transfer for clinical supplies and commercial scale. In 2008, Raj started his industry career in F. Hoffmann La Roche Basel as a Postdoc in biophysical characterization of monoclonal antibodies and moved to a lab head role in pre-formulation development in Biologics liquid parenteral forms. Later, he joined Novartis in 2012 as a Principal Scientist in Biologics late phase Development department. Over last years, he moved to a functional lead role (Drug product lead), handled several biologics projects (phase 2b/3 molecules) in prefilled syringe and vial formats. Raj is a Chemist by education and holds a PhD from Max Planck Institute of Biophysics, Frankfurt, Germany.

Anacelia Ríos Quiroz, PhD, Scientist, Group Leader Particle Lab, Pharma Technical Development Europe, Roche
Anacelia Ríos Quiroz did her University studies as Industrial Pharmaceutical Chemist in the Polytechnic National Institute (IPN) of Mexico City. Afterwards, she did her Master studies in Pharmacology in the Centre of Research and Advanced Studies (CINVESTAV-Mexico City) on the field of Bioinorganic Chemistry. In 2012, she started her PhD studies in Pharmaceutical Technology in collaboration with Basel University and F. Hoffmann-La Roche Ltd., in Switzerland. She worked in the field of sub visible protein particles and has become an expert on particle counting characterization techniques. Her research increased the understanding on the applicability of emerging technologies as analytical tools for the pharmaceutical industry and serve as guideline for the implementation of related analytical methods and quality control strategies. After a Post Doc in the field of evaluation of the immunogenicity of protein particles, she joined in January 2016 the Analytical Department of Roche where she leads the Particle Lab unit.


Renee Tobias, Director, Marketing, Halo Labs
After earning her Masters in Cell and Molecular Biology, Renee worked several years in drug discovery research at companies like Tularik (Amgen), Bayer, and Schering-Plough. She eventually left the bench to pursue more customer-facing roles in applications and product management for life science analytical tools. She is passionate about promoting new, innovative solutions to accelerate biopharmaceutical development, and her current role as Director of Marketing at Halo Labs enables her to do just that.

Riccardo Torosantucci, PhD, Section Head Formulation and Process Development, Sanofi-Aventis
Riccardo received his Master´s degree in Chemistry and Pharmaceutical Technologies from the University of Rome La Sapienza and his PhD from the University of Leiden. During his PhD studies, performed between Leiden University and the University of Kansas, he worked on the relationship between protein oxidation, aggregation and immunogenicity of several therapeutic proteins. Since 2013 he covered different roles between Coriolis-Pharma and Sanofi-Aventis Deutschland, focusing on the early and late stage formulation development of biologics.

Annette Vinther Heydenreich, PhD, Senior Scientist, Symphogen
Annette Vinther Heydenreich holds a M.Sc. in pharmacy. Annette is specialized in formulation development of biopharmaceutics, initially working with gene delivery (oligonucleotides and DNA vaccines) and later vaccine-adjuvant formulations at small biotech companies. For the last 6 years Annette has been responsible for formulation and drug product development of peptides and protein (including mAbs) for parenteral administration on projects ranging from pre-clinical development to product registration. Annette currently works as a Senior Scientist at Symphogen, which is specialized in the development of antibodies and antibody combinations for the treatment of cancer.

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