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Hermine Achard, MS, Biotechnology Engineer, R&D, Sanofi

No bio available.

AnalysisMode

Belma Alispahic, Head of Business Development, AnalysisMode

Belma's unique blend of AI knowledge and biotech expertise positions her at the forefront of bioprocessing innovation. She leverages this deep understanding to develop practical AI solutions that address the industry's complex challenges. As AnalysisMode's Co-Founder and Head of Business Development, she drives the integration of AI technologies, shaping a transformative approach to biopharmaceutical development. Her leadership ensures the industry's resilience and readiness for the future. 

Mayo Clinic Center for Regenerative Medicine

Julie G. Allickson, PhD, Michael S. and Mary Sue Shannon Family Director, Mayo Clinic Center for Regenerative Medicine, Member, ISCT

Julie Allickson, PhD , Chief Manufacturing Development Center Officer, Wake Forest Institute for Regenerative MedicineDr. Allickson has 30 years of experience in clinical translation of regenerative medicine products. Translational experience includes regulatory affairs, laboratory/cleanroom management, business management and board directorship. Experience as an executive officer with a publicly traded company building services for cellular banking including licensure of technology. Dr. Allickson heads the clinical translation team streamlining development to create a robust pipeline of products in development and early phase clinical trials including cell therapy, gene therapy, tissue engineered organs and tissues, biomaterials and devices. Prior to the Institute she was the Vice President of Research and Development and Laboratory Operations for Cryo-Cell International Inc. and held leadership roles at the University of Miami Diabetes Research Institute and the American Red Cross. Dr. Allickson is on the Board of Directors for AABB and the Regenerative Medicine Outcomes Foundation as a scientific advisor, Editorial board of CELLR4 and Journal of Translational Medicine, Vice Chair for Cord Blood Association Quality Committee, Technical Advisory Board for Tissue Engineered Products under ICCBBA, grant reviewer for state funded initiatives such as CIRM and serves on the ISCT Commercialization Committee.

ValGenesis

Rui Almeida, Director, Product Lifecycle Management Services, ValGenesis

Rui Almeida, a biological engineering graduate with a master's in engineering management, brings nearly 18 years of pharma industry experience. His roles span technical services, quality assurance, and project management in both small and large companies. Formerly head of PMO in a CDMO, he now leads Consultancy Service in Product Life Cycle Management at ValGenesis integrating science, engineering, and digital solutions for Industry 4.0 requirements.

Cell & Gene Therapy Catapult

Amna Anwar, Associate Senior Scientist, Downstream Processing, Cell & Gene Therapy Catapult

Amna Anwar is a downstream bioprocessing specialist with over 7 years experience in the gene therapy sector. Currently an Associate Senior Scientist at the Cell and Gene Therapy Catapult where she is working on the development of scalable manufacturing processes for AAV-based gene therapies, with a focus on tech transfer up to a 200L production scale. Furthermore, she is involved in the ongoing optimisation of filtration and chromatographic processes whilst utilising automation capabilities for development of these processes at a small scale.

Boehringer Ingelheim Pharma GmbH & Co. KG

Sabine Arnold, PhD, Senior Scientist, Upstream Process Development, Boehringer Ingelheim Pharma GmbH

Sabine has more than 20 years of experience in mathematical modelling of microbial and mammalian bioprocesses. She is currently a Senior Scientist at Boehringer Ingelheim in the cell culture process development group within Development Biologicals. Her main focus is on application of advanced data analytics and mathematical models for process and media optimization in upstream bioprocess development. She received her PhD in Biochemical Engineering from the University of Stuttgart, Germany.

Fouad Atouf, PhD, Senior Vice President, Global Biologics, USP

Fouad Atouf, PhD, is Senior Vice President, Global Biologics, at the United States Pharmacopeia (USP) where he oversees standards development, stakeholder engagement, and industry collaborations in support of the quality and safety of biological medicines. Dr. Atouf has been at USP for over 15 years and served in multiple leadership roles developing quality tools for biologics and establishing relevant reference material programs. In addition to leading the modernization of compendial standards, Dr. Atouf launched and implemented the biologics strategy focusing on technologies to support manufacturing and testing biological medicines. He has implemented new engagement models and collaboration approaches with academia, biopharma industry, and global government agencies. Dr. Atouf has a strong background in the regulation and standardization of pharmaceutical products including biologics and advanced therapies. Dr. Atouf is the author of numerous publications and is a frequent speaker at national and international pharmaceutical and regulatory scientific events. He holds a PhD in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Siegfried DINAMIQS

Eduard Ayuso, DVM, PhD, CEO, DINAMIQS; Chairman of Manufacturing, European Society of Gene and Cell Therapy

Dr. Eduard Ayuso is the CEO of Siegfried DINAMIQS, a CDMO providing manufacturing services, process development, quality control and analytics solutions. He is also serving as chairman of the Manufacturing committee of the European Society for Gene and Cell Therapy. He is an expert in the field of gene therapy using viral vector platforms, including their design, manufacture, and purification. He was previously the CTO at DiNAQOR, a genetic medicine platform company. He also served as Head of Innovative Vectorology at INSERM, and as the Scientific Director of the Translational Vector Core at the University of Nantes. Dr. Ayuso earned his Ph.D. in Biochemistry and Molecular Biology and his degree in Veterinary Medicine from the Autonomous University of Barcelona.

University of Augsburg

Janina Bahnemann, PhD, Professor, Cell Culture and Microsystems Technology, University of Augsburg

Dr. Janina Bahnemann is Full Professor and the Department Head of “Technical Biology” at the University of Augsburg. She obtained her PhD from Hamburg University of Technology and joined the California Institute of Technology (USA) as a postdoc in 2015. Afterwards, she led an independent Emmy Noether (DFG) research group at Leibniz University Hannover, and held a substitute professorship at Bielefeld University. Her research focuses on cell culture and microsystems technology and the development of biosensors for biotechnological and biomedical applications.

Resolution Therapeutics

Christopher Baldwin, Vice President, Manufacturing and Supply, Resolution Therapeutics

Chris Baldwin is the VP, Manufacturing & Supply at Resolution Therapeutics, a clinical development company focusing on autologous and allogenic macrophage cell therapy products. Prior to joining RTx, he was the Supply Chain Director for Cell & Gene Therapy Products at GSK with accountable for the vein to vein supply chain for T-Cell Immuno-Oncology products covering a network of apheresis collection centers, manufacturing sites and treatment centers. His team covered forecasting processes, logistics, labelling, Chain of Identity tracking, site on-boarding and coordinating the cellular supply chain across sites for clinical supply and building the strategy for commercial supply. In previous roles, he has lead teams to design and build supply chains for complex biological products including mRNA vaccines, Biosimilars and Antibody Drug Conjugates. Chris holds a PhD from University of Cambridge and a Masters from University College, London.

Norwegian University of Science and Technology

Nadav Bar, PhD, Professor, Chemical Engineering, Norwegian University of Science and Technology

W. L. Gore & Associates, Inc.

William Barrett, PhD, Product Specialist, PharmBIO, W. L. Gore & Associates, Inc.

William Barrett, Ph.D. is a Product Specialist with Gore & Associates.  He has over 20 years combined experience in biotechnology, chromatography and the medical device industries.  Most recently at Gore, Bill’s focused on affinity purification chromatography with membranes.  He received a Ph.D. in Biochemistry from the University of Illinois and completed his fellowship in the Laboratory of Biochemistry at the National Heath, Lung and Blood Institute at the NIH. 

Natl Institute for Bioprocessing Research & Training NIBRT

Niall Barron, PhD, Principal Investigator, National Institute for Bioprocessing Research & Training (NIBRT)

Niall Barron obtained a B.A. (Mod) in Microbiology from Trinity College Dublin and Ph.D. 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.

Regeneron Pharmaceuticals

Marilia Barros, PhD, Principal Scientist, Regeneron Pharmaceuticals

Dr. Barros is a biophysicist with expertise in biomolecular interactions working in drug product development. She received her PhD from Carnegie Melon University Physics where she studied biomolecular interactions and structure of proteins at lipid membranes. During her graduating studies she became a Guest Researcher at NIST Center for Neutron Research where she conducted neutron scattering experiments. After her PhD, she joined Dr. Yueming Li at MSK as a postdoc to lead and develop the lab biophysics research for studying the mechanisms of action of proteins that have implication in both cancer and Alzheimer disease. Currently, she works for Bristol Myers Squibb as a Research Investigator investigating the colloidal stability of biotherapeutics to support drug development and new strategies of drug product formulation.

Institute for Bioengineering of Catalonia (IBEC)

Iris L. Batalha, PhD, La Caixa Junior Leader, Molecular Bionics, Institute for Bioengineering of Catalonia (IBEC)

Iris L. Batalha is currently a Junior Leader Research Fellow at the Institute of Bioengineering of Catalonia (IBEC) in Barcelona, a Panel Tutor in Nanotherapeutics at the University of Cambridge Institute of Continuing Education, a freelance Senior Innovation Consultant at Inspiralia (Spain and USA), a Co-Founder, Director and Editor-in-Chief of the non-profit organisation Women Ahead of Their Time (WATT), and a Research Associate at Peterhouse College. From 2017 to 2020, she was a joint Research Associate at the Department of Engineering Nanoscience Centre and Department of Medicine Molecular Immunity Unit, University of Cambridge. From 2014 to 2017, she worked at 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. Her research interests and expertise lie in medical and pharmaceutical research and development, particularly in the fields of nanobiotechnology, bio-inspired materials, downstream processing, formulation, and drug delivery.

Benjamin Bayer, PhD, Scientist CMC, Biotherapeutics Technology Development & Implementation, Takeda

Benjamin received his PhD in bioprocess engineering, specialized in hybrid modelling and quality by design implementation in upstream processing. Now, he works as a scientist with his main emphasis on upstream bioprocess modelling and data science to identify bottlenecks and to develop as well as implement the right technologies to resolves these, leveraging process development work.

Novartis Pharmaceutical Manufacturing GmbH

Karl Behler, PhD, Senior Scientist, MS&T, DSK, Novartis Pharmaceutical Manufacturing GmbH

Dr. Karl Behler studied Biochemistry and Industrial Biotechnology at the Technical University of Munich (TUM) before he started his doctorate in Biochemical Engineering. He finished his thesis in 2022, shortly before taking up his current position as Senior Scientist in Manufacturing Science and Technology (MS&T) at Novartis in Kundl, Austria.

Purespring Tx

Mark Bell, Principal Bioprocessing Scientist, Purespring Therapeutics

Mark is the leader of upstream process development at Purespring Therapeutics and has 15 years of industrial experience within the cell and gene therapy sector. Mark leads a team of experienced scientists within the viral gene development, delivering robust manufacturing processes, supported by rapid, high-resolution characterization tools to enhance the production of AAV based gene therapies. Mark's team also supports the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture. Prior to his work at Purespring, Mark spent 7 years at the Cell and Gene Therapy Catapulting supporting the development of ATMP processes suitable for GMP as well as consulting for the Janssen group advising on the manufacture of its lead ocular gene therapy.

Technical University of Munich

Sonja Berensmeier, PhD, Professor, Bioseparation Engineering Group, School of Engineering and Design, Technical University of Munich

Prof. Sonja Berensmeier has led the Bioseparation Engineering Group at the Technical University of Munich since 2009. Previously, she worked as a group leader at the Karlsruhe Institute of Technology in the area of biofunctional surfaces. She meets the challenge of integrating molecular biology, biotechnology, particle technology, and process engineering. Her current research focuses on process intensification by adsorptive and extractive separation methods. In the field of adsorbents, she specializes in magnetic and conductive materials and their translation into new process designs. Berensmeier gained international experience at MIT, ETH, and Iowa State University. She is well established in the scientific community and is a member of the scientific committees of the international conferences PREP and ISPPP.

Beam Therapeutics

Siddharth Bhoraskar, PhD, Senior Scientist, Beam Therapeutics

Siddharth Bhoraskar is currently working as a senior scientist at Beam Therapeutics with the Analytical Research & Development team based in Cambridge, MA. He has been involved in early-stage LC/LC-MS characterization of lipids, mRNA, sgRNA, and lipid nanoparticles and supporting research, as well as CMC teams in driving Beam’s molecules from preclinical to clinical stage. He received his PhD in Chemistry from University of Massachusetts Lowell, Masters in Pharmaceutical Sciences from Northeastern University, and Bachelors in Pharmacy from Devi Ahilya University in Indore, India.

Steven Binninger, Head of Collaborative Technology Development & Commercialisation, Sartorius; PDM Committee Member, ISCT

Experienced in developing, commercializing, and implementing new manufacturing and QC technologies applicable across the drug development spectra. Focused on enabling others to deliver medicines at-scale.

Cygnus Technologies

Eric Bishop, Vice President of Research and Development, R&D, Cygnus Technologies

Eric Bishop is the Vice President for Research and Development at Cygnus Technologies. Eric leads the research and development team and is responsible for new product development and custom development services. Eric has 25 years of experience in HCP analytics.

Eric joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies.

 

National Institute for Bioprocessing Research and Training

Jonathan Bones, PhD, Principal Investigator, Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training (NIBRT), Ireland

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.

TU Dortmund University

Christoph Brandenbusch, PhD, Assistant Professor, Bioprocess Separations & Biologics Formulation Development, TU Dortmund University

Dr. Christoph Brandenbusch studied Chemical Engineering at the Department of Biochemical and Chemical Engineering at TU Dortmund, (Germany) 2003-2007. He finished his Ph.D. thesis in the field of downstream processing in biocatalysis in 2011. Since 2012 he works as a group leader and assistant professor at the Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund (Germany). His main research fields include: Novel strategies for protein purifications in pharmaceutical bio-processes as well as the development of liquid and lyophilized biopharmaceutical formulations. The methods used include analytical techniques as well as coarse-grained modeling approaches for predictive formulation screening.

Merck KGaA

Stefan Braun, Head of Laboratory, Liquid Formulation R&D, Merck

Stefan Braun is a laboratory head within Merck´s Liquid Formulation R&D and holds an MS in bioprocess development. In the last years he was mainly focusing on high-concentration formulations and resulting challenges as attractive interactions. An instrumental part of his work was to develop Merck´s Viscosity Reduction Platform.

Consulting on Advanced Biologicals Ltd.

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

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

Boehringer Ingelheim RCV GmbH & Co KG

Cecile Brocard, PhD, Director Downstream Development, Bioprocess Science, Boehringer Ingelheim RCV GmbH & Co. KG

Cecile Brocard is a trained biochemist and molecular cell biologist. She earned her degree in Biochemistry and Molecular Cell Biology in France and went on to obtain a PhD in Biochemistry from the prestigious University of Vienna, Austria. Currently, Cecile serves as the Director of the Downstream Development in the Process Science department at Boehringer Ingelheim Regional Center Vienna. In this role, she leads a talented team responsible for developing downstream processes for a wide range of recombinant proteins expressed in microbials. The team's work is crucial for clinical supplies for Phase I, II, and III trials, as well as overseeing the tech transfer to production. Cecile's team comprises two downstream development units and a non-GMP pilot plant. Under her leadership, the team has been instrumental in driving technology programs and strategic initiatives within the organization. Cecile is dedicated to fostering innovation and improving process flows. As a speaker and participant in international conferences, Cecile Brocard aims to bring her knowledge and experience to the forefront, contributing to the advancement of biotechnology on a global scale.

Christopher D. Brown, PhD., Chief Product Officer and Co-founder, 908 Devices

Prior to founding 908 Devices, Chris was a platform architect at Apple leading investigations into future-gen hardware/software technologies. Prior to Apple, he headed Product Development and Engineering at Ahura Scientific, establishing the company’s core embedded analytics and chemometrics capability, and later at Thermo Fisher Scientific, which acquired Ahura. Prior to Ahura, Chris held leadership roles at InLight Solutions developing multiple biodiagnostic products across a range of imaging and spectroscopic modalities.

Blood Centres of America

Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America

Lee is an experienced senior executive and corporate director with deep commercial expertise in the biotechnology sector. His management experience includes as CEO and VP of public and private biotech companies, as well as providing management and strategic consulting services to public and private bio-pharma companies in Canada, the United States, Middle East, Japan, and Europe. Lee’s deepest expertise is in the cell therapy and regenerative medicine sector having lead several transformative transactions including multinational investment and licensing deals involving companies in North America, Europe, and Asia. Lee has particular experience in Canada, the United States, and Japan. Lee holds a Bachelors of Education and a JD from the University of British Columbia.

Department of Biotechnology, University of Natural Resources and Life Sciences

Johannes Felix Buyel, PhD, Head, Institute for Biochemical Engineering, University of Natural Resources and Life Sciences (BOKU)

Prof. Dr. Johannes Buyel is a biotechnologist and bioprocess engineer and by training and received his Bachelor of Science from the RWTH Aachen University in Aachen (one of Germany´s Excellence Universities) in 2006. He continued his master studies in Molecular Biotechnology with stays abroad in Sweden (Lund University, ERASMUS schoolarship) and the USA (Fraunhofer Center for Molecular Biotechnology, Newark, Delaware). Finishing his Masters with honours in 2009 he was awarded the Springoroum Coin. Johannes conducted his PhD at RWTH Aachen University during which he was a visiting scientist at the Rensselaer Polytechnic Institute (Troy, NY, USA) and Karlsruhe Institute of Technology (KIT) (Germany) for several months. He received his PhD with honours and was awarded the Borchers Medal. In 2014 he joined Fraunhofer IME as a group leader and became head of the Bioprocess Engineering department the year after. In parallel, Johannes started a second PhD in Bioprocess Engineering at the KIT, which he finished in 2017. Between 2018 and 2020 he conducted his habilitation and was an Associate Professor at the RWTH between 2020 and 2023. Johannes is an active member of the German Biotechnology Association (DECHEMA), and member of the Editorial Boards of Frontiers in Bioengineering and Biotechnology, Frontiers in Plant Science as well as Transgenic Research, where he is Editor-in-Chief since 2021. In 2022, he joined the University of Natural Resources and Life Sciences, Vienna (BOKU) as a Full Professor for Downstream Processing. Johannes has 15+ years of experience in the development of tailor-made upstream production and downstream processing for 50+ recombinant proteins, small molecules and DNA in different expression systems such as E. coli, yeast, plant cell cultures and whole plants both under GMP and non-GMP conditions. He is also focussing on integrated processing, i.e. the use of residual biomass for cascading use. Johannes was/is involved in international projects like PHARMAPLANT, FUTURE-PHARMA and RESILIANCE. Amongst others, he received a €2.5 million Fraunhofer Attract grant for a project to establish a model-driven high-throughput expression and purification platform for recombinant proteins (FAST-PEP). Johannes was a principal investigator (PI) in the tumor-targeted drug delivery graduate school of the German Research Foundation (DFG; 2018-2022) as well as the International Center for Networked Adaptive Production (ICNAP; 2016-2022) for which he has so far received funding of €0.9 million and €1.8 million respectively. His work is strongly inter- and cross-disciplinary, combining research in, for example, biotechnology, bioprocess engineering, informatics, mathematics, data science, oncology, cosmetics and nutrition. He has currently more than 80 publications (h-index 27, i10-index 51, 2333 citations as of August 2023).

Evaluating Biopharma Events

Brian J. Caine, Co-Founder, Evaluating Biopharma

Hamilton Bonaduz AG

Giovanni Campolongo, Senior Market Segment Manager, Process Analytics, Hamilton Bonaduz AG

Senior Market Segment Manager at Hamilton Bonaduz AG's Process Analytics Business Unit. Giovanni specializes in business development across Biotech, Pharma, and Food sectors. His multifaceted role spans product portfolio development, sales coaching, and key accounts support. As a GMP coach, Giovanni guarantees that process analyzers align with key regulations, including GAMP 5 and CFR 21 Part 11.

Octomera and Orgenesis

Vered Caplan, CEO, Octomera and Orgenesis

Vered Caplan CEO Orgenesis Inc, a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. Orgenesis identifies promising new therapies and leverages its POCareTM Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Prior to Orgenesis, Vered has been CEO of Kamedis, a company focused on utilizing plant extracts for dermatology purposes. From 2004 to 2007, Ms. Caplan was CEO of GammaCan, a company focused on the use of immunoglobulins for the treatment of cancer. During the previous five years, Ms. Caplan has been a director of numerous companies in the biotech industry, among them: Inmotion Ltd., a company involved with self-propelled disposable colonoscopies; Nehora Photonics Ltd., a company involved with non-invasive blood monitoring and others. Ms. Caplan has a M.Sc. in biomedical engineering from Tel Aviv University specializing in signal processing; management for engineers from Tel Aviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion-Israel Institute of Technology specialized in software and cad systems.

Benjamin Cappe, Dr, Field Applications Specialist, Sales, Refeyn

No bio available.

Antonio G. Cardillo, PhD, Scientific Lead Associate Director, TRD-DS Global Innovation Centre, GSK Vaccines

Antonio Gaetano Cardillo, Senior Scientist in Drug Substance Technical Research and Development, GSK Vaccines. Holds a master’s degree and PhD in Chemical engineering. Thesis on: Process intensification at University of Bologna. Started in GSK Vaccines (formerly Novartis Vaccines) in 2015 as scientist, where he held product development positions of increasing professional responsibility until 2019. Lead of the process modelling Centre of excellence (2017 - 2019). Since September 2019, member of the Global Innovation Centre for Drug Substance Technical Research and Development and Automation and Robotics transversal lead. Interest to apply in GSK Pharma 4.0 framework for digital strategies to the unique contexts of pharmaceutical manufacturing.

Natl Institute for Bioprocessing Research & Training NIBRT

Sara Carillo, PhD, Team Lead, Application Development, National Institute for Bioprocessing Research & Training (NIBRT)

Dr. Sara Carillo is the applications development team leader in the Characterisation and Comparability Laboratory in NIBRT, Ireland. Sara completed her PhD in Chemical Science at the University of Naples in 2013 working on bacterial glyco-conjugates structural characterisation. In 2015, Sara joined Dr. Jonathan Bones’s research group in NIBRT, working on CHO cell glycome and development of analytical workflows for biotherapeutics characterisation.

Loic Chappuis, PhD, Scientist, Upstream Processing, Merck

Loic Chappuis is a scientist at Merck Serono SA (an affiliate of Merck KGaA, Darmstadt, Germany) in the Process Technology Innovations group within the Global Drug Substances Development department. He has been working for 5 years on the development and optimization of the perfusion process platform. Loic leads and supports different projects ranging from prototype testing to implementation at lab-scale and tech transfer to pilot-scale. Prior to this role Loic contributed to the design and implementation of perfusion cell cultures at pilot and manufacturing scale for clinical material production. He holds a master's degree in chemical engineering and biotechnology from EPFL.

Helen Cheek, Global Product Manager, Marketing, Cytiva

Helen has a background in Chemistry with a BSc from Imperial College London.

Previously she worked in R&D on small molecule drug discovery and then on development of Fibro products joining Cytiva in 2019.

She moved into Product Management in 2022, where she is focusing on bringing the Fibro offering to the market, working with multiple functions to establish a platform that is capable of growing alongside the developments in biopharmaceuticals.

KTH Royal Institute of Technology

Veronique Chotteau, Professor, Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, Industrial Biotechnology, KTH Royal Institute of Technology

Veronique Chotteau, Professor, Leader of the Cell Technology group, Dept. Industrial Biotechnology, School of Engineering Sciences in Chemistry, Biotechnology, and Health, KTH (Royal Institute of Technology), Stockholm, Sweden; Education: BSc Eng. Sciences, MSc Electrical Engineering, MSc Biotechnology, PhD Automatic Control/Modelling/Biotechnology (University of Louvain, Belgium); V. Chotteau has 30 years of experience in mammalian cell culture including more than 10 years in biopharmaceutical industry (at Pharmacia Upjohn/Biovitrum, Stockholm, nowadays Swedish Orphan Biovitrum). She is the Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, and Coordinator of iConsensus, EU IMI2 project. She joined KTH in 2008, when she was offered to lead the animal cell cultivation activities. Her group is focusing on cell-based processes for biologics production, high cell density perfusion of CHO and HEK293 cells, mathematical modelling, and production of viral vectors. Her group was the first to publish cell densities higher than 200 millions cells/mL in CHO cell perfusion process.

Natl Institute for Bioprocessing Research & Training NIBRT

Colin Clark, PhD, Principal Investigator, NIBRT; Associate Professor, University College Dublin

Colin Clarke holds a MSc and PhD in Bioinformatics from Cranfield University, UK. He leads the Bioinformatics and Data Analytics Laboratory at the National Institute of Bioprocessing Research and Training, Dublin, Ireland and is an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin. The goal of Colin’s systems biology research is to enhance our understanding of CHO cell factories to enable more efficient production. Colin’s team also have an active research programme focussed on harnessing big data technologies for biopharmaceutical manufacturing. He was awarded the Martin Sinacore Outstanding Young Investigator Award at Cell Culture Engineering in 2014 and selected as the Young Leader of the Year at the 2017 Irish Laboratory Awards.

Cryoport Systems

Dominic Clarke, Vice President of Technical Operations, IntegriCell; PDM Committee Chair, ISCT

Dr. Clarke is an executive level technical leader and has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is currently Vice President of technical operations, IntegriCell, Cryoport Systems. Previously he was a partner and Chief Strategy Officer for Orange County Bio a dedicated cell & gene therapy marketing operations and consulting company where he led the development and execution of the business strategy. Dominic also served as Chief Technical Officer, Cell & Gene Therapies at Discovery Life Sciences providing leadership, direction and development for their cell & gene therapy products and services. Additional roles and experience include Director of Global Cell Therapy Strategy & Innovation at Charles River Laboratories, Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies, Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research & Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards educating and developing best practices for translating research and process development from bench to clinic.

iBET Instituto de Biologia Experimental Tecnologica

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 Genethon, 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.

iBET Instituto de Biologia Experimental Tecnologica

Ricardo Correia, PhD, Postdoctorate Researcher, Cell-Based Vaccines Development Lab, iBET Instituto de Biologia Experimental Tecnologica

Ricardo Correia is a Biological Engineer from IST (Portugal), graduated in 2014. From 2015 to 2017, he was a junior researcher at the Animal Cell Technology at iBET / ITQB-NOVA (Portugal), being involved in the upstream processing of a universal Influenza vaccine candidate. Ricardo got his PhD degree within the MIT Portugal - Bioengineering Systems doctoral program in 2022, working at iBET / ITQB-NOVA. He is author of 16 scientific manuscripts in peer-reviewed journals, has supervised 4 MSc and 2 PhD students, made 5 oral communications and >10 poster communications. His research focuses on the development of novel bioprocess engineering approaches for the improved production of vaccine candidates against infectious diseases such as Influenza and malaria.

Dark Horse Consulting Group

Stephan Croft, Senior Principal, Head of Quality, Dark Horse Consulting Group

Kite Pharma, a Gilead Company

Christopher Crowell, Vice President Operations, Site Head EU Manufacturing and Managing Director, Kite Pharma, a Gilead Company

Experienced CMC Operations Executive focused on bringing innovative medicines through the commercialization process to positively impact patients lives. Proven track record on delivering transformational results that enables Organizations to reach their full potential, while passionately focused on developing future leaders within the Health Care Industry.

Stuart M Curbishley, PhD, Chief Manufacturing and Development Officer, adthera bio

Stuart was awarded his PhD by the University of Birmingham in 2005 after which his group developed a programme of immune based therapies for liver disease and liver cancer. Forging a successful academic career, he undertook a variety of first-in-human, early-phase clinical trials. Whilst at the University of Birmingham, Stuart led the development of cell therapy based around dendritic cell vaccination for primary liver cancer. Following this success, the University invested in the building and licensing of an ATMP manufacturing facility which he directed until leaving academia at the end of 2022. Since then, Stuart has been operating as Chief Manufacturing Officer and Chief Development Officer of adthera bio, a newly formed commercial CDMO. adthera is positioning itself as the partner of choice for innovative, optimised-quality, high-technology, cell & gene therapy-focussed development and manufacturing. adthera bio develops clients' cell therapy ideas and makes them into workable medical interventions for patients, all in a regulatory-compliant and quality managed system, to get it right the first time. Based on brilliant ideas and curious capable minds, they partner with biotech and academic centres to bring novel ATMP therapies to market and thus to patients who urgently need them.

Cocoon Bioscience

Romy Moreno Dalton, PhD, COO, Cocoon Bioscience

Romy M. Dalton has a PhD in Molecular Biology and Virology, and more than 23 years of experience in the field, with 14 scientific publications in peer reviewed journals. She has dedicated 16 years of her professional life to virology applied to biotech, 8 of them in biotech operations management. Currently, she is the COO at Cocoon Bioscience, managing operations of the unique CrisBio® technology, in which development she has been involved for the last 8 years.

Nicholas J Darton, PhD, Associate Director, AstraZeneca

Nicholas J. Darton has worked in biopharmaceutical formulation development for 11 years. Following a Biochemistry Ph.D. and Chemical Engineering and Biotechnology Post doctorate at the University of Cambridge, Nicholas started in formulation at the Unilever spin-out company, Arecor. Following 8 years of formulation technology development at Arecor he moved to Astrazeneca in 2020. Now as an Associate Director in Astrazeneca’s Dosage Form, Design and Development Department of the BioPharmaceutical Development Division he is responsible for leading R&D collaborations and CMC formulation development. Nicholas is an honorary Professor at Nottingham University and part of the MIBio international formulation conference series organisation committee.

Fresenius-Kabi Biopharma

Vincent Dechavanne, Master 2 of Science, Senior Scientist II, DSP Process Development, Fresenius-Kabi Biopharma

Vincent Dechavanne, Master 2 of Science, Senior Scientist II, Fresenius-Kabi Biopharma

Joined Fresenius Kabi SwissBiosim GmbH in December 2019

Senior Scientist II, DSP Process Development

Over 28 Years of experience in the field of DSP within several Biotech International companies

Strong experience in Research & Development, Manufacturing, MSAT & Tech Transfer

Miltenyi Biotec B.V. & Co. KG

Johann Christoph Dettmann, PhD, Senior MSAT Clinical Products, Lentiviral Vector Manufacturing, Miltenyi Biotec B.V. & Co. KG

 

 

Johann-Christoph Dettmann, PhD, earned his doctorate from the University of Bielefeld, focusing on the development and optimization of production processes for lentiviral vectors. Currently a Senior MSAT at Miltenyi Biotec, he specializes in providing critical data analysis support for lentiviral vector manufacturing in CAR T-cell therapy. Leveraging advanced statistical methods, Dr. Dettmann ensures GMP compliance and contributes significantly to the advancement and robustness of this innovative bioprocessing at Miltenyi Biotec.

 

University of Beira Interior

Cristina M. Dias-Cabral, PhD, Professor, Chemistry, University of Beira Interior

Cristina Dias-Cabral holds the position of Assistant Professor at the Department of Chemistry, University of Beira Interior in Covilha, Portugal. Additionally, she is an integrated member of the Biopharmaceuticals and Biomaterials Development Group at the CICS-UBI - Health Sciences Research Center within the same university. Currently, her research focuses on characterizing large biomolecules in the context of downstream processing. Her expertise lies in investigating the fundamental aspects of biomolecule adsorption on diverse chromatographic supports, with the goal of understanding the interaction mechanisms between biomolecules and these supports. She places particular emphasis on optimizing and scaling up chromatographic units. Since 2010, she has been leading a Flow Microcalorimetry laboratory at CICS-UBI, where she conducts thermodynamic characterization of these adsorption mechanisms. This research is carried out collaboratively with various national and international research groups.

Leiden University Medical Center

Elena Dominguez Vega, PhD, Assistant Professor, Center for Proteomics and Metabolomics, Leiden University Medical Center

Dr. Elena Dominguez Vega received her Ph.D. degree on analytical chemistry in 2011 at the University of Alcala (Spain). After joining the Biomolecular Analysis group at Utrecht University (The Netherlands) in 2012, she worked on the development of new electrophoretic methods for the analysis of biopharmaceuticals. In 2013 she continued as postdoctoral researcher at VU University where she focused on the study of protein heterogeneity, conformation and affinity. In May of 2017, Dr. Dominguez Vega joined the Center for Proteomic and Metabolomics at the LUMC as assistant professor were she continue her work on the characterization of glycoproteins of clinical and pharmaceutical interest. Furthermore she has expanded her research focus to the development of innovative analytical platforms for the analysis of gene therapy products. Over the years, Dr. Elena Dominguez Vega has closely collaborated with several pharmaceutical companies and has received multiple grants and awards in support to her research.

Novartis Pharma AG

Zorica Dragic, PhD, Director, Cell Line Screening and Development, Novartis Pharma AG

Zorica leads Cell Line Screening and Development Unit at Novartis NIBR Biologics Center, responsible for development, engineering and characterization of various cell lines for research discovery purposes, and biologics manufacturing cell lines from early development and pre-clinical, up to commercial. During 17 years at Novartis, Zorica assumed different roles at the R&D interface - within early technical development and research as line function and project management. leading CMC teams, and cell line development unit.

Procelys by Lesaffre

Benoit Drogue, Ph.D., Global Innovation Manager, Global Innovation, Procelys by Lesaffre

Benoit Drogue holds a PhD in Microbial Ecology and has over 10 years of experience in Research and Innovation. He has successfully led numerous scientific projects at the intersection of the market and industry, and his expertise extends to the development of innovative solutions in the field of biotechnology."

Mark Duerkop, CEO, Novasign GmbH

Leading Novasign as CEO, Mark is passionate to improve bioprocesses for the production of biopharmaceuticals, enzymes and substitutes for animal-derived proteins. With his team, he is developing a hybrid modeling software for both up and downstream processes. This software utilizes artificial intelligence applied to process data and first principle models (hybrid models) to not only accelerate bioprocess optimization but also to reuse these models for model predictive control strategies. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.

Halo Labs

Paul Dyer, PhD, Field Application Scientist, Halo Labs

Paul Dyer obtained his PhD in Cell Biology and Drug Delivery Strategies from the University of Greenwich. Following a period in academic research, Paul joined Halo Labs Ltd as an application scientist covering UK and Europe. Building upon his extensive background in medical science, he has been focusing on the development of new applications of particle analysis within the area of biologics, in particular cell therapies, resulting in the release of a new product, the Aura CL™.

Swansea University

Kadie Edwards, PhD, Post Doc, Swansea University

Biochemist by background, chemist by fire (PhD) focusing on improving cancer therapy through nanomedicine-enabled drug delivery. Currently working on bespoke polymers for gene therapies!

Jean-Charles Epinat, PhD, Director, Process Development, Cellectis

PhD from Pasteur Institute in Paris and Post Doc at Boston University working on NF-kappa B transcription factor. Joined Cellectis in 2000 right after the creation of the company. Developed functional high throughput screening methods in yeast for Meganuclease and TALEN engineering. Became CTO of the company. Led the Tools & Services subsidiary before turning to CAR-T process development when the company focused on clinical approaches.

Jose Escandell, PhD, Senior Scientist, Animal Cell Technology Unit, iBET

Jose Escandell did his doctoral degree in Valencia (Spain) at the Faculty of Pharmacy in the field of drug discovery. He received postdoctoral training at various prestigious research institutes, such as the Gray Institute at the University of Oxford. In 2019 he joined the Animal Cell Technology Unit at Instituto de Biologia Experimental e Tecnologica (iBET) as a senior scientist. His current research interests are in the area of gene therapy, including streamlining the cell line development processes and optimizing production systems by improving the cell hosts through cell engineering approaches.

University of Natural Resources & Life Sciences

Touraj Eslami, PhD, Automation Engineer, Downstream Processing, Institute of Bioprocess Science and Engineering, University of Natural Resources & Life Sciences

The aging of chromatography columns can significantly impact process efficiency, but it is often not accounted for in traditional fixed protocols. A novel approach that combines model predictive control (MPC) and an extended Kalman filter (EKF) has been developed to address this issue. By constantly monitoring the resin capacity and adjusting the loading volume and velocity gradient, this system is able to maintain high resin utilization and productivity while reducing buffer consumption. This approach also enables automation of the chromatographic unit operation, ensuring a stable, long-term process.

Lara Fernandez-Cerezo, PhD, Associate Principal Scientist, Merck

Lara Fernandez Cerezo graduated from University College London with a Masters of Engineering in Biochemical Engineering in 2014. She then pursued an Engineering Doctoral degree, a 4-year industrial PhD program with Merck focusing on scale-down filtration technologies of high concentration mAbs. Upon graduation, she established the ambr® crossflow high throughput system as a process characterization/development UF/DF tool in the Merck process development teams. In 2019 she transitioned to continuous manufacturing (CM) in biologics gaining ‘hands-on’ experience in both non-GMP 50L development scale and GMP 500L clinical scale. Since moving back to the development group in the US in 2021, Lara continues to influence the GMP continuous manufacturing teams at Merck by providing recommendations for the design of our next-generation commercial CM facility including a customized SPTFF/ILDF Skid. Lara now leads the downstream biologics continuous manufacturing team in the Enabling Technology group at Merck. Other activities she is involved with include co-leading a Merck / Penn State Collaboration focusing on scale-up depth filtration challenges; and leading a IQ sub-group focusing on the use of UF/DF for post-conjugation steps in antibody-drug conjugates (ADCs).

University of Copenhagen

Vito Fodera, PhD, Associate Professor, Biophysics, University of Copenhagen

Vito Fodera received his Ph.D. in Physics (2009) from the University of Palermo (Italy), with a project focused on (in)stability and self-assembly mechanisms of peptides and proteins. In 2009 he was appointed as a Research Associate at the Cavendish Laboratory at the University of Cambridge (UK). In 2012 Vito was awarded the Marie Curie IEF for Career Development grant that allowed him to join the Dept. of Drug Design and Pharmacology (University of Copenhagen). In 2016 he became tenured Associate Professor of Biophysics at the Department of Pharmacy, University of Copenhagen, where he established his research group. His main focus is on protein self-assembled structures and he aims at translating the fundamental knowledge on these systems into novel high-impact applications in advanced materials for nanomedicine, protein drug formulations and protein-related neurodegenerative diseases. In 2018 he is recipient of the Villum Young Investigator award and is the PI of the related 5-year initiative “ProSmart”, focused on the understanding of structural heterogeneity in protein self-assembled materials via advanced microscopy approaches and X-ray and neutron techniques. Vito´s group works in close connection with both international collaborators in academia, large-scale facilities and national and international industrial entities. He is author of > 60 manuscripts.

Numab Therapeutics AG

Bastian Franke, PhD, Associate Director and Group Leader, Downstream Processing, Numab Therapeutics AG

Bastian Franke works at Numab Therapeutics AG as a group leader USP/DSP and leads a team of research associates responsible for the manufacturing of multispecific antibody-based therapeutics, process development and technical transfer to C(D)MOs, as well as implementation of automated and novel purification workflows. Prior to Numab he gained first industry experience at DSM as a scientist in downstream processing after a postdoctoral fellowship at the University of Basel, Switzerland, where he developed novel isotopic labelling techniques for NMR applications and automated multicolumn purification schemes in collaboration with Cytiva. Bastian Franke received his PhD in structural biology from the University of Queensland, Australia.

Austrian Centre of Industrial Biotechnology

Aleksandra Fuchs, PhD, Senior Scientist, Austrian Centre of Industrial Biotechnology

Aleksandra Fuchs (nee Andryushkova) received her PhD in Molecular Biotechnology at the Technical University of Graz in 2010, working on yeast as an expression system for recombinant proteins. Since then she worked in basic science on yeast metabolism, and later moved to a more applied science at the Austrian Centre of Industrial Biotechnology. She presently focuses on projects in connection with alternative protein production, specifically in the area of medium optimization for cultivated meat and fish, on protein engineering and expression of growth factors, and on production of aroma components using conventional and alternative yeast species.

Rajiv Gangurde, PhD, Vice President, Technical Operations, Parexel

Rajiv Gangurde, PhD, Vice President of Technical Operations for Cell and Gene Therapy at Parexel, has over 18 years of industry experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Most recently, Rajiv served as Chief Technology Officer at SparingVision, an ocular gene therapy company, where he led all activities related to bioprocess and analytical development, manufacturing, and quality. Before SparingVision, Rajiv was Senior Director and Head of Chemistry, Manufacturing and Controls (CMC) at Voyager Therapeutics. In this role, he was responsible for CMC strategy and management of the company’s entire gene therapy portfolio. Prior to Voyager, Rajiv was Director of Bioprocess Development and Manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as Head of Protein Sciences at LakePharma, leading therapeutic protein production efforts for pre-clinical studies. Rajiv obtained his PhD in Life Sciences from Mumbai University in India and did postdoctoral research at the Department of Biochemistry at the New Jersey Medical School, and at the Department of Molecular and Cellular Biology at Harvard University. Rajiv is based in Massachusetts, USA.

Novartis Pharma AG

Gerald Gellermann, PhD, Scientific Officer, Analytical Development, Novartis

Gerald currently works as Scientific Officer at Novartis Technical Research and Development (TRD) Biologics. Prior to joining Novartis, he gained professional experience in CMC and analytical development during his time at Roche and AbbVie.

Kathryn Golden, SVP Technical Operations & Cell Manufacturing, Tech Operations & Cell Mfg, bit bio

Chemical engineer experienced in upstream and downstream process development of mammalian cell culture and bacterial fermentation, including PER.C6®, HEK, CHO, hybridoma, lentivirus, and E. coli, in fed-batch and perfusion systems to produce novel and biosimilar fusion proteins and antibodies. PMP-certified CMC project leader experienced in shepherding drug candidates from discovery stage to pivotal trials via project team representation, regulatory submission drafting, and management of CMOs. MIT Sloan MBA keenly interested in biotechnology entrepreneurship.

University College London

Stephen Goldrick, PhD, Lecturer, Digital Bioprocess Engineering, University College London

Stephen is a lecturer in Digital Bioprocess Engineering specialising in the application of advanced data analytics and mathematical modelling to the biotechnology sector. His key areas of focus is related to digitalisation of biopharmaceutical operations through development of advanced data analytics, process analytic technology and advanced control solutions.

iBET - Instituto de Biologia Experimental e Tecnologica

Ricardo Gomes, PhD, Senior Researcher, Mass Spectrometry Unit, iBET-Instituto de Biologia Experimental e Tecnologica

Ricardo Gomes is a Biochemist with a PhD in Biochemistry Regulation from the University of Lisbon, Faculty of Sciences. His PhD and post-doctoral studies gave him a solid and significant expertise in the field of mass-spectrometry and proteomics. Since 2015, Dr. Gomes is a Senior Research Associate at the Mass spectrometry Unit of iBET, Portugal. iBET is a private non-profit research intensive institution in the area of Biotechnology and Life Sciences. iBET acts as an interface between academic institutions while also creating and organizing autonomous knowledge and expertise. In the MS facility at iBET Dr. Gomes is particularly focused on the biologics characterization, namely, multiple attribute methodology, host cell protein analysis, and SWATH workflows. Dr. Gomes is the author of 28 scientific articles and 4 book chapters.

Parameswari Govindarajan, PhD, Senior Scientist, Process Development, CSL Behring GmbH

Dr. Parameswari Govindarajan is currently working as Manager / Senior scientist at CSL Behring Innovation GmbH Marburg in upstream process development team focusing on cell line development, bioreactors and process optimization. She has completed PhD in stem cell research related to bone remodeling followed by Post-Doc of nearly 4.5 years in brain tumor related cell and gene therapy research, focusing on vector construction, cell line development, and gene editing technologies in Germany. Originally from India, and has moved to Germany for perusing higher studies / PhD.

Charlotte Graham, PhD, Team Leader, Analytical, Ctr for Process Innovation Ltd

No bio available.

Phoenestra GmbH

Klaus Graumann, PhD, CEO, Phoenestra GmbH

Klaus has a degree in Biotechnology (BOKU, Vienna AT) and spent 20 years in the biopharmaceutical industry (Boehringer, Novartis / Sandoz) in the area of CMC development. Since 2018, he is active as a Biotech Consultant and since 2019 he is CEO of Phoenestra GmbH, a startup developing technology platforms for stem cells and stem cell-derived products.

ERIDIA GmbH

Gero Grieve, Head, Project Development, ERIDIA GmbH

Gero is the Head of Project Development at Eridia. Gero looks back on 11 years of experience in designing fermenters and bioreactors. During this time, he engaged extensively in the sustainable protein production space and developed tissue reactors and equipment for continuous fermentation processes. Gero provides support to the cell ag and fermentation space in designing their scale-up journey and shaping up- and downstream processes for the food and feed industry.

Sartorius Stedim Biotech

Mario Grunberg, PhD, Senior Scientist DSP, Modalities & Analytics, Sartorius Stedim Biotech

Mario Grunberg is Separations Technology Application and Testing Scientist at Sartorius. He is part of the development and verification of systems and consumables for the DSP of various Modalities. The focus is also on process development with subsequent analytics. During his PhD, he established chromatographic purification processes for human signal proteins. Prior to joining Sartorius, he worked as CDMO Process Engineer in DSP process development and GMP production of Protein-based Therapeutics.

Leiden University

Christoph Gstoettner, PhD, Postdoctoral Researcher, Center for Proteomics and Metabolomics, Leiden University Medical Center

Dr. Christoph Gstottner obtained his PhD in 2021 at the Leiden University Medical Center (Netherlands) under the supervision of Prof. M. Wuhrer. His PhD research was focused on the development of electrophoretic but also chromatographic methodologies for the in-depth characterization of biopharmaceuticals such as monoclonal antibodies or newer antibody formats. In his postdoc, he focuses on the development of new CESI-MS methods for the functional characterization of biopharmaceuticals and their affinity to Fc receptors.

Cell & Gene Therapy Catapult

Juline Guenat, Associate Lead Scientist, Technology & Process Innovation, Cell & Gene Therapy Catapult

Juline Guenat is a scientist with over 10 years of experience in biotechnology and pharma. She has an Engineering degree in Biotechnology from the National School of Biomolecules Bordeaux (ENSTBB). Currently an Associate Lead Scientist at the Cell and Gene Therapy Catapult in the UK, Juline leads a team developing scalable manufacturing processes for cell and gene therapies. Her work has been focused on applying novel bioprocessing solutions and developing closed end-to-end platforms to facilitate advanced therapy manufacture, bridging the gap between research and commercialization.

TaRGeT UMR1089

Laurence Guianvarch, Head, Viral Vector Process Development, TaRGeT UMR1089

I'm currently Head of Bioprocess Development at TaRGeT, a French academic unit (Nantes, France) dedicated to translational gene therapy. Before joining TaRGeT, I had the opportunity to lead the upstream development group at Genethon (Evry, France) for 6 years and to collaborate in supporting several projects through to clinical development. I was involved in lentiviral and AAV projects from small-scale to large-scale (up to 200L) through to technical transfer to various CDMOs. In 2019, I joined Novartis (Basel, Switzerland) as Viral Vector Drug Substance Group Head, then as Associate Director Cell & Viral Vectors Process Development, leading 16 talented scientific experts and DS and DP development for several cell and gene therapy projects. I had the chance to support both early- and late-phase projects (AAV, LVV, CAR T, autologous cell therapy, etc.) and to bring new therapeutic strategies to patients. At the end of 2022, I decided to join TaRGeT to lead the process development (USP & DSP) for AAV projects from small- to pilot-scale. This opportunity brings me back to the scientific heart of a multidisciplinary team.

Priyanka Amba Gupta, Senior Scientist, Gene Therapy, Upstream, UCB

Priyanka earned her Master's degree in Chemical and Biochemical Engineering from the University of Maryland in Baltimore County, USA. With over a decade of experience, her expertise encompasses upstream process development, optimization, scale-up, and technology transfer for the production of mammalian cell culture-based bio therapeutics. Priyanka presently holds the position of Senior Scientist within UCB's Gene Therapy department, where she is a member of the upstream team. In her current role, she is primarily responsible for the development of upstream manufacturing processes aimed at producing recombinant Adeno-Associated Viruses (rAAVs).

Claes Gustafsson, PhD, Chief Commercial Officer & Co-Founder, ATUM

As ATUM’s Co-Founder and CCO, Dr. Gustafsson oversees most of the company's external communications. Prior to co-founding ATUM, Dr. Gustafsson led, managed and collaborated with key strategic teams at Maxygen Inc. Before Maxygen, Dr. Gustafsson worked as a scientist at Kosan Biosciences, a number of research, teaching, and post-doctoral positions at UCs Santa Cruz and San Francisco, and at University of Umea. He received his Ph.D. in Molecular Biology/Biochemistry from the University of Umea, Sweden.

Markus Haindl, PhD, Global Head, Gene Therapy Technical Development, Roche Diagnostics GmbH

Markus finished his PhD in 2008 in Molecular Cell Biology at the Max-Planck-Institute of Biochemistry in Munich. He subsequently joined McKinsey & Company as a consultant taking over international strategy and operations projects for clients within the Pharma, Biotech and High-Tech industry. By the end of 2010 Markus joined Roche at the Biotech Centre in Penzberg. Since then he was holding positions as Group Leader and Department Head in Bioprocess Development and Analytical Development & New Technologies before he took over the Lead for Roche’s efforts towards Technical Development for in vivo Gene Therapies.

University College London

Petra Hanga, PhD, Lecturer, Biochemical Engineering and Cellular Agriculture, University College London

Dr Petra Hanga is a Lecturer in Biochemical Engineering - Cellular Agriculture at University College London and also the co-founder and Chief Scientific Officer of Quest Meat Ltd, a start-up based in Birmingham, UK. Dr Hanga holds a BEng in Biochemical Engineering and a PhD in Regenerative Medicine. She has >14 years of hands-on experience in bioprocess development for manufacturing cells for different applications including cultivated meat since 2019. To date, she delivered >30 invited talks and seminars on her work in the cultivated meat space. Petra sits on numerous committees including Industrial Biotechnology Leadership Forum (IBLF), and she is the winner of the inaugural ESACT-UK Chris Hewitt Rising Star Award.

Cees Haringa, PhD, Assistant Professor, TU Delft

Cees Haringa is currently assistant professor of bioprocess engineering at Delft University of Technology. His main research interest is to study impact of cell - environment interactions on bioprocess performance. For this, he develops integrated hydrodynamic - biokinetic simulations using computational fluid dynamics. Additionally, he studies the hydrodynamics of real broths to improve CFD models of bioprocesses. Previously, he worked as scientist in the bioprocessing industry at the DSM Biotechnology center. He holds a PhD and MSc. in Chemical Engineering from Delft University of Technology.

Cell and Gene Therapy Catapult

Jahid Hasan, PhD, Lead, Technical, Cell and Gene Therapy Catapult

Jahid is a Lead Scientist with 10 years of experience at the Cell and Gene Therapy Catapult. He has extensive experience developing processes across cell and gene therapy and leads the development of automated differentiation processes on the Allogeneic Cell Therapies programme. Jahid specialises in bioprocess translation with a strong focus on process automation and scale-up. His background is in Biochemical Engineering and he has a PhD in Tissue Engineering from the University of Leeds which focused on the decellularisation of porcine bone-meniscus-bone for use as a meniscal replacement.

Benedikt Haslinger, Bioprocess Modelling Engineer, Novasign

Benedikt holds a Master's degree in Biotechnology from the University of Natural Resources and Life Sciences, Vienna, with a specialization in Bioprocess Engineering. At Novasign, he is actively engaged in customer projects while pursuing a PhD. His research centers on developing an end-to-end model for continuous bioprocessing, encompassing various unit operations.

Christoph Herwig, PhD, former Professor, Bioprocess Engineering; CPO, Fermify GmbH; Senior Scientific Advisor, Korber Pharma Austria

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Korber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Korber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

CEPI Coalition for Epidemic Preparedness Innovations

Renske Hesselink, PhD, CMC Technology Lead, Mfg & Supply Chain, CEPI Coalition for Epidemic Preparedness Innovations

Dr Renske Hesselink is a biochemist with a background in the vaccine industry, who is currently working as CMC Technology Lead at CEPI, the Coalition for Epidemic Preparedness Innovations. At CEPI, she works on technology innovations that enable the rapid development and suitably scaled manufacturing of equitably accessible vaccines for outbreak response. Prior to joining CEPI, Renske worked in the pharmaceutical industry for over 10 years, mainly in formulation, analytical, and drug product development for various vaccines and biologics. She contributed to the Ebola vaccine developed by Janssen during the outbreak in West-Africa, scaling up the process and making vaccine doses available as soon as possible for clinical trials and containment of the epidemic. She also worked on the stabilization of protein- and viral vector-based vaccines against e.g., RSV and HIV. Renske holds an MSc degree in Molecular Sciences from Wageningen University, the Netherlands, and a PhD in Membrane Biology from the University of Leeds, UK.

Budapest Univ of Technology & Economics

Edit Hirsch, PhD, Research Assoc, Organic Chemistry & Technology, Budapest Univ of Technology & Economics

Edit Hirsch completed her Ph.D. in 2019 at the Budapest University of Technology and Economics (BME, Hungary). She is currently a research associate and a member of the FirePharma research group at BME. She gained expertise in pharmaceutical biotechnology by leading research projects and participating in industrial collaborations.

Boehringer Ingelheim Pharma GmbH & Co. KG

Chi-Ting Ho, PhD, Process Expert, Development Operation, Boehringer Ingelheim Pharma GmbH & Co. KG

Chi-Ting Ho is a process expert in the Development Operation Group at Boehringer Ingelheim and joined the company in 2018. He makes contribution in NBE process development and builds knowledge in process understanding and molecule understanding. Prior to his current role, he was a scientist in the analytical development department, leading analytical topics of various CMC stages, including method development, molecular characterization, and comparability strategies. Chi-Ting holds a PhD of biochemistry from the University of Heidelberg, Germany.

Ping-Wei Ho, PhD, Upstream Field Application Specialist, Customer Support, Cytiva

Ping-Wei Ho is serving as an Upstream Field Application Specialist covering EMEA at Cytiva.

Driven by a passion for translating research findings into practical applications, Ping provides expert application and technical support on cell culture bioprocesses, specializing in Cytiva's upstream devices and systems.

This role involves delivering advanced pre- and post-installation consulting, along with hands-on training for customers, ensuring they maximize the benefits of Cytiva's cutting-edge technologies.

KTH Royal Institute of Technology

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 include design and development of gene fusion systems for selective ion-exchange purification and improvements of the alkaline tolerance of protein A for industrial purification of IgG (currently a product sold by GE-Health care). Also, a novel ligand for affinity purification of proteins has been developed that displays a calcium dependent binding, enabling mild elution from the column. Moreover, small bispecific protein domains with ability to strongly and selectively bind to two different proteins recently have been developed for use in diagnostic and therapeutic applications.

Ulysse Consult

Margit Holzer, PhD, Owner, Ulysse Consult

Margit Holzer is a biochemical engineer with extensive expertise in the development and implementation of biochemical/technological production processes. She holds a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer Ingelheim and Novasep, she held various positions in R&D, production and manufacturing, quality, and technology, including several executive positions such as Technology Director. Amongst other achievements, she has led a successful FDA inspection on a pharma and biopharma production site as Quality Director. She has been involved in the process development of more than 50 different biopharmaceuticals of different origins (recombinant and non-recombinant cell cultures, yeasts, microorganisms, viruses, plants, and fluids from vertebras). Currently, she works as Scientific Director at Ulysse Consult.

Patrick M. Hossler, PhD, Senior Director, Pharmaceutical Development, Ultragenyx

Patrick Hossler is the Senior Director of Pharmaceutical Development at Ultragenyx. He leads an extended team of scientists who are accountable for gene therapy drug substance and drug product development across an extensive early- and late-stage pipeline. He has leadership experience of over 17 years participating and leading protein and gene therapy teams across the drug lifecycle. Pat received his PhD in Chemical Engineering at the University of Minnesota, and his B.S. from Rutgers University.

Upstream Applied Science

Simon Hubbard, PhD, Consultant Engineer & Owner, Upstream Applied Science

Simon has been running his solo consulting business for almost four years, focussing primarily on the development and application of computational models in the cellular agriculture space. Prior to starting Upstream, Simon spent time in the motorsport, high-tech product development, and technology consulting sectors. He has broad experience in computational simulation and mathematical modelling, with a focus on fluid dynamics simulation tools and applications.

Politecnico di Milano

Francesco Iannacci, PhD Candidate, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano

Francesco Iannacci graduated (MSc.) in Chemical Engineering in 2022, with a 110/110 final grade at Politecnico di Milano. Currently, Francesco is involved in a PhD project regarding the continuous biomanufacturing of oligonucleotides, whose final aim consists of an optimized and integrated continuous production system at bench-scale volumes. Specifically, he is carrying out ongoing studies about upstream optimization and scale-up validation, through perfusion cultures of transfected and native bacteria strains, and chromatography-based purification steps, exploiting the Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) technology. In addition, he contributes to projects regarding 3D bioprinting applications.

University of Sheffield

David C. James, PhD, Professor, Bioprocess Engineering, University of Sheffield

David James is Professor of Bioprocess Engineering in the Department of Chemical and Biological Engineering and Director of the Advanced Biomanufacturing Centre at the University of Sheffield. Previously held academic positions at the Australian Institute of Bioengineering and Nanotechnology, University of Queensland and the University of Kent. Current research and development in collaboration with UK and US bioindustrial partners focuses on engineering cellular manufacture of next generation biological medicines using functional genomics, computational modelling and synthetic biology.

Arecor Ltd

Jan Jezek, CSO, R&D, 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.

Yan Jiang, PhD, Principal Scientist, Biologics Development Bioanalytics, Sanofi

Yan Jiang received her PhD in Chemistry from Boston University. Since joining Sanofi in 2013, she has been working on the development of analytical methods for the release and characterization of therapeutic proteins, with a focus on the PTM characterization to support developability assessment, clone selection, formulation development, and comparability assessment.

DPS Group Global

Stephen Judd, Process Subject Matter Expert, Biologics, Cell and Gene Therapy, DPS Group Global

Stephen is an experienced Technical Manager and Principal Process Engineer with more than 15 years’ experience in process engineering, mainly in Biotech projects in all stages from Feasibility study through to Commissioning and Qualification. He has extensive experience with facility design, and process technology selection for hard-piped and single-use systems and his focus area is Cell and Gene Therapy.

University of Natural Resources & Life Sciences

Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

Aalborg University

Stefan Junne, PhD, Associate Professor, Bioscience and Engineering, Aalborg University

Current position: Associate Professor, Bioprocess Engineering, Dept. of Chemistry and Bioscience, Aalborg University Esbjerg, Denmark Main fields of interest: - bioprocess development for the microbial production of fine and commodity chemicals, food and feed - scale up and down of bioprocesses - application of process analytical technologies for monitoring physiological and morphological features and stress response, mostly on a single-cell level, for improved monitoring and control - single-use bioreactor design, scale up and application for microbial bioprocesses, e.g. filamentous organisms, plant cells, algea, and co-cultivation - circular bioeconomy concepts, life cycle and economic analysis Education: 2010 Ph.D. Bioprocess engineering, TU Berlin 2003 Degree as Diplom-Ingenieur of Chemical Engineering 1997-2003 Studies of Chemical Engineering at the University of Erlangen-Nurnberg, Germany, and Northwestern University, Evanston, IL, USA.

Takeda Pharmaceuticals

Japneet Kaur, PhD, Senior Scientist, CMC, Takeda Pharmaceuticals

Japneet is currently working as a Senior Scientist in the Biologics Drug Product Development group at Takeda. She has several years of experience in formulation, manufacturing, tech transfer, and scale-up of different modalities like proteins, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and microbiomes. She received her PhD in Pharmaceutical Sciences from University of Connecticut working on formulation of high concentration proteins. In her free time, Japneet enjoys playing Sudoku and board games, singing, and spending time with her family.

The Good Food Institute Europe

Seren Kell, Senior Science and Technology Manager, The Good Food Institute Europe

Seren’s background is originally in biochemistry, with a focus on cellular senescence and the fundamental processes underlying human ageing. Over the last few years she has been involved in both the cultivated meat space (focusing on cell culture media, and then co-founding Cellular Agriculture UK), and external innovation more generally - previously working at IN-PART, a startup that connects R&D-focused companies with academia to encourage greater collaboration. Now at the Good Food Institute Europe, Seren leads our science and technology team to build a strong, open-access sustainable protein research and training ecosystem across Europe.

Purespring tx

Tony Bou Kheir, PhD, Head, Analytical Development and QC, Purespring Therapeutics

Tony Bou Kheir leads the analytical development and Quality Control programme at Purespring Therapeutics; developing new analytics to support product characterisation and release. Tony has over 10 years’ experience in the design, development, and application of novel analytics to support product characterisation. Tony leads a team focused on improving AAV manufacture through the design and application of new technologies for in-process testing, and the development of more accurate and robust assays for product release. Tony’s team also oversees assay qualification and technology transfer to 3rd party GMP facilities and CDMO’s.

Takanori Kigawa, PhD, Senior Scientist, RIKEN Center for Biosystems Dynamics Research

Takanori Kigawa, Dr. Sci., is Senior Scientist of RIKEN Center for Biosystems Dynamics Research (BDR), Japan. He graduated from Graduate School of Science, the University of Tokyo in 1994 and started his professional career as a research scientist in RIKEN. He has developed a variety of technologies related to the cell-free protein synthesis system and NMR-based structure biology, and most of them were patented and commercialized.

Vienna Univ of Technology

Julian Kopp, PhD, Postdoc Researcher, Chemical & Environmental & Biological Engineering, Vienna University of Technology

Julian Kopp conducted his Bachelor and Master studies at the University of Natural Resources and Life Sciences (BOKU), Vienna, in the field of Biotechnology between 2011-2017. During his studies, he did multiple internships at SANDOZ GmbH and AGES GmbH giving him an insight in (bio-)pharmaceutical industry and control authorities. After graduation, he performed his PhD Thesis at TU Wien in chemical engineering. He developed diverse cultivation modes and analytical tools to facilitate E. coli bioprocessing. After completing his PhD Thesis in August 2020, Julian started as Post-doctoral researcher in the Integrated Bioprocess Development group of Prof. O. Spadiut. Currently, he uses multivariate data approaches to improve inclusion body downstream processing.

Astrazeneca

Rakesh Koppram, Senior Scientist, Astra Zeneca

Sandra Krause, Lab Engineer, Biodevelopment Microbial Platform, Sanofi

Sandra started her career after her apprenticeship at Hoechst AG in Frankfurt. For 10 years she worked at the Paul-Ehrlich-Institute in the research field of “Modified Vaccinia Virus Ankara” (MVA) and there worked on her bachelor thesis: “Construction and Characterisation of recombinant MVADE3L-LacZ. 2007 she changed to Sanofi. Since then, she works as a Lab Engineer and was focused on the protein purification process development. Her master’s thesis describes the validation and implementation of qPCR-based monitoring of retrovirus-like particles. Currently, she supports Sanofi’s digital transformation, focusing on the implementation of a globally deployed paperless lab system. She supported creation of experiment templates, connection to visualization tools (data lake) as well as inter-site alignment to switch to a digital way of lab working including the connection of lab equipment for an automated data transfer.

Novartis Pharmaceutical Manufacturing GmbH

Emanuel Kreidl, PhD, Senior Expert, Science & Technology, Technical Research & Development, Novartis Pharmaceutical Manufacturing GmbH

Emanuel received his PhD from the University of Vienna after conducting basic research in the lab of Jan-Michael Peters working on the mammalian cell cycle. This was a followed by a postdoc in the lab of Michael Hemann at the Massachusetts Institute of Technology establishing a high-throughput 3D cell culture system to perform CRISPR screens in spheroids. He used his skills gained during this endeavor by contributing to the establishment of The Antibody Lab, a start-up in the field of CHO cell line development using a novel approach for transgensis. Since 2019, Emanuel hast been a senior scientist in the upstream process development group at Ichnos Sciences focusing on media development and process optimization for bi- / multi-specific antibodies expressed in CHO.

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 17 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.

Queen's University Belfast

Dimitrios Lamprou, PhD, Chair of Biofabrication and Advanced Manufacturing, Queen's University Belfast

Dimitrios Lamprou (PhD, MBA) is Full Professor (Chair) of Biofabrication and Advanced Manufacturing, and Director at MSc Industrial Pharmaceutics at Queen’s University Belfast (QUB). He is also the Chair at United Kingdom and Ireland Controlled Release Society (UKICRS) and the Chair of the Academy of Pharmaceutical Sciences (APS) Emerging Technologies Focus Group. Dimitrios is the author of over 150 peer-reviewed publications, has over 400 conference abstracts, has given over 150 Invited Talks in institutions and conferences across the world, and has secure Funding more than £5M. Dimitrios has been recognized as world leader in 3D Printing & Microfluidics. PubMed-based algorithms placed him in the top 0.1% of scholars in the world writing about 3D Printing and on the top 0.07% of scholars in the world writing about microfluidics in the past 10-years. Moreover, PubMed-based algorithms placed him in the top 0.6% of scholars in the world writing about nanofibers. Dimitrios has also been named in the Stanford University’s list 2021 & 2022 of World’s Top 2% Scientists, for his research in Pharmaceutics and Biomedical Engineering. His research and academic leadership have been recognized in a range of awards, including the Royal Pharmaceutical Society Science Award and the Scottish Universities Life Sciences Alliance Leaders Scheme Award. For more info, please visit www.emergingtechnologieslab.com.

Bruno Cell S.r.l.

Stefano Lattanzi, PhD, CEO, BrunoCell

Stefano Lattanzi holds an academic background in social sciences and an Executive MBA. He is a serial entrepreneur, focused on the food processing industry. Due to ethical and environmental reasons, he entered the cultured meat field since the very beginning, in 2009. In 2019, he founded the first Italian cultivated meat startup, Bruno Cell, aiming to obtain technology to scale-up cultured meat production.

Technical Univ of Denmark

Andreas H. Laustsen, PhD, Center Director & Professor, Center for Antibody Technologies, DTU Bioengineering, Technical University of Denmark

Professor Andreas Hougaard Laustsen-Kiel (1987) heads the Center for Antibody Technologies at the Department of Biotechnology and Biomedicine at the Technical University of Denmark (DTU) and is specialized in antibody technologies. He is also the CTO of Bactolife A/S, responsible for nanobody technology and discovery in this company. Andreas is a Fellow of the Danish Academy of Technical Sciences, the Young Academy of Denmark, the Young Academy of Technology, Science, and Innovation, and the Young Academy of Europe. He holds a PhD from the University of Copenhagen and an M.Sc.Eng. from DTU. Andreas is a co-founder of the eight biotech companies, Biosyntia, VenomAb, Antag Therapeutics, Chromologics, VenomAid Diagnostics, Agrobiomics, Combotope Therapeutics, and Bactolife. He is recognized as Denmark’s Coolest Engineer (Engineer The Future), was listed on Forbes 30 under 30 in 2017, and was a Top 35 Innovator under 35 by MIT Technology Review 2017. Andreas is scientifically known for being the first to characterize a number of venoms from different snakes with proteomics, including the notorious black mamba, being the first to develop human monoclonal IgG antibodies against animal toxins (snakes and spiders), and being the first to develop broadly-neutralizing and oligoclonal antibody mixtures against animal venoms. Today, he focuses his research efforts on developing methodologies for the discovery of antibodies with special binding properties (e.g., pH-sensitive binding), nanobody technology, envenomings, infectious diseases, and microbiome engineering using antibody technology.

Sensorion Pharmaceuticals

Christine Le Bec, PhD, Head, CMC Gene Therapy, Sensorion

Christine Le Bec joined Sensorion early this year and is responsible for all CMC-related activities in process development and manufacturing with internal teams and external partners to support preclinical development through clinical development. Before, she was at Genethon for over 20 years as a scientist and headed the CMC Analytical Department. She has strong expertise in the characterization and release testing of gene therapy products, stability studies, interface with CMO for method transfer and validation, and analytical/QC testing. She has extensive experience 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 Ph.D. in Bioorganic Chemistry from Universite Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, PA, 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.

Taylor's University

Khai Wooi Jason Lee, PhD, Senior Lecturer, School of Biosciences, Taylors University

Dr. Lee obtained his PhD in Nanobiotechnology in 2012 from Universiti Putra Malaysia. He is currently a senior lecturer at Taylor's University, Malaysia. He is also a member of the University's Medical Advancement for Better Quality of Life Impact Lab, where his research focuses on the production and application of nanoparticles for vaccine development and targeted delivery of drugs and genes to specific cells.

TU Braunschweig

Nina Lehmler, Researcher, Biotechnology, TU Braunschweig

Nina Lehmler is a dedicated researcher in the field of Biotechnology, holding a Master's degree obtained from TU Braunschweig in 2022. Currently, she is pursuing her PhD within the Department of Biotechnology at the same university. Nina's PhD project is focused on the development of a highly sensitive mix-and-measure magnetic immunoassay designed for the detection of SARS-CoV-2. Her work involves the baculovirus-free production of antigens, antibodies and Virus-Like-Particles (VLP) in insect cells.

Atova Regulatory Consulting

Hannah Lester, PhD, CEO & Principal Consultant, Atova Consulting

Dr. Hannah Lester is the founder and CEO of Atova Regulatory Consulting. Prior to founding Atova, Hannah worked for Pen & Tec Consulting as their Scientific Director and later, their CEO. Hannah has over 18-years’ experience in regulatory affairs, helping clients worldwide obtain regulatory approval for veterinary medicines, animal feed, and human food in the EU and other global markets. Hannah is a leading expert in alternative proteins and innovative food and feed technology and along with assisting Atova´s clients, she also supports industry associations, non-governmental organizations, and governmental agencies to help them develop new approaches for the risk assessment and risk management of alternative proteins and innovative foods, and drive policy change. Hannah is on the board of Cellular Agriculture Europe, where she is actively working with stakeholders to pave the way for a smoother and more predicable approval process for novel foods in the EU.

LenioBio

Maja Lieven, Dr, Head of Protein Solutions, Protein Solutions, LenioBio

Maja Lieven is the Head of LenioBio's Protein Solutions team. Prior to joining LenioBio in 2021, she earned her PhD at the Novo Nordisk Foundation Center for Biosustainability, specializing in protein production technologies. As co-founder and Chief Technology Officer of Mycropt, a biotech startup, Maja played a pivotal role in driving technological innovation. Now at LenioBio, she continues to lead with a focus on advancing protein solutions.

Erik Martinsson, CEO, ArgusEye

Dr. Erik Martinsson is the CEO and co-founder of ArgusEye, a young Swedish company developing novel sensor systems for real-time bioprocess monitoring. Prior to his current position, Dr. Martinsson worked as a researcher at Linkoping University, conducting scientific research on optical sensors based on nanoplasmonic detection. He holds an MSc in Chemical Biology and received his PhD degree in Molecular Physics from Linkoping University in 2014.

Andrea Martorana, PhD, Lead Scientist, Analytical Development, AviadoBio

Dr. Andrea Martorana is lead scientist in analytics and downstream development at AviadoBio, a London pharmaceutical company developing transformative gene therapies for diseases including frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). Andrea started his career in Leiden (Netherlands) at Pharming as Scientist Process Development, developing protein replacement therapies for rare diseases, before relocating to the UK. In the UK, he worked on the lentivirus program at GSK before being approached by Catapult to join their Cell and Gene Therapy program. Andrea holds a PhD in chemistry and a postdoc in Physical Chemistry at the Weizmann Institute of Science (Israel).

Purolite, An Ecolab Company

Alain Medina, Field Application Scientist, Bioprocessing, Purolite, An Ecolab Company

Alain Medina is an experienced professional with 18+ years of diverse skills in healthcare, bioprocessing, and life sciences. He currently serves as a Field Application Specialist at Purolite, providing technical sales support to customers in Southern Europe and other European regions. Alain is committed to maintaining the business's "Technically Differentiated" status by providing direct technical activities to important accounts and sustaining customer relationships. 

 

Univ College London

Martina Micheletti, PhD, Professor, Bioprocess Fluid Dynamics, University College London

Martina is a Professor of Bioprocess Fluid Dynamics in the department of Biochemical Engineering at University College London. She has a first degree in Chemical Engineering from University of Pisa and a PhD in Mechanical Engineering from King’s College London and has been at UCL since 2004. Martina leads research in mixing and fluid dynamics applied to bioprocesses, and has applied her novel techniques and rigorous approach to obtain fundamental understanding of single-use bioreactor technologies and in increasingly important sectors like cell and gene therapy products, continuous production of monoclonal antibodies and vaccine manufacture. She has received several industrial awards and led collaborations with companies like Pfizer, MSD, AstraZeneca, among others. Since 2018 she has been Director of the UCL-Oxford Future Research Vaccine Manufacturing Hub (Vax-Hub) with Professor Dame Sarah Gilbert, aimed at developing lost-cost vaccines for low- and middle-income countries. Martina is currently the Director of the recently awarded EPSRC Manufacturing Hub for a sustainable future (2023-2030) aimed at development of vaccines for pandemic preparedness.

Anika Mijakovac, PhD, Researcher, University of Zagreb

Dr. Anika Mijakovac is a young researcher working at Genos Glycoscience Laboratory since 2023. She studies the regulatory mechanisms of protein glycosylation, with a main focus on immunoglobulin G (IgG) antibody. Her main expertise encompasses molecular cloning methods, cell culture techniques, CRISPR/dCas9 technology, gene expression analyses and transposon systems. She is also extensively involved in teaching and writing. Anika received her PhD degree at the Faculty of Science, University of Zagreb in 2023. She conducted her PhD research in Professor Zoldos Group for Epigenetics where she successfully developed IgG-secreting CRISPR/dCas9 cell lines and utilized them to study the genetic regulation of IgG glycosylation. She is currently expanding her research to other glycosylated proteins and is developing new cell lines to gain a deeper understanding of processes that regulate glycosylation.

AstraZeneca

Rahul Mishra, PhD, Senior Analytical Scientist, AstraZeneca

Rahul holds a PhD in Biological Sciences and Bioengineering from Indian Institute of Technology Kanpur. Following doctoral study, he worked as a Research Scientist in Analytical Development Lab of Intas Biopharma Ahmedabad, characterizing Biosimilars, from Jun 2016- Aug 2020. Since Sep 2020, he started working as a Senior Analytical Scientist in Biopharmaceutical Development division of AstraZeneca at Cambridge . He spent most of his time as an Electrophoresis SME, responsible for the development of analytical methods and characterizing innovator Biologics products. In addition to this also contribute significantly towards the progress of analytical stategy for CMC of Biologics products.

Immatics US Inc

Ali Mohamed, PhD, Vice President, CMC, Immatics US, Inc.

Ali Mohamed, Ph.D., Vice President, CMC, Immatics US Inc. was 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 Ph.D. in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in Neuroscience and Neurobiology from Georgetown University.

University College Cork

John Morrissey, PhD, Professor, Microbiology, University College Cork

John Morrissey is professor of yeast biotechnology and director of the SUSFERM Centre for microbial fermentation and bioprocess engineering at University College Cork in Ireland. He is a member of the board of the microbial biotechnology division of the European Federation of Biotechnology and is Editor-in-Chief of the yeast community journal, FEMS Yeast Research. His research interests span microbial evolution and biotechnology, with an emphasis on yeast biotechnology for food and biochemical applications. He is especially interested in the application of synthetic biology to increase engineering access to non-traditional microbes, notably non-conventional yeasts. He has coordinated several large European projects in the area of rational strain engineering, yeast biotechnology, and precision fermentation, and has excellent experience of working with industrial partners across the sector.

Genmab B.V.

Marija Mucibabic, PhD, Senior Scientist, Downstream Processing, Genmab

Marija Mucibabic obtained her PhD from Leiden University in 2016 and has worked at MSD, Abbott, DSM specializing in Protein Separations. She has worked as a Scientist within Protein Separations group, Chemistry, Manufacturing and Control, at Genmab since 2019 specializing in downstream processing of Genmab’s DuoBody® clinical candidates.

Unchained Labs

Andre Mueller, PhD, Marketing Manager, Biologics Solutions, Marketing, Unchained Labs

Andre is the Marketing Manager for Biologics Solutions at Unchained Labs supporting the development of new biologic drugs. His expertise covers fluorescence, static light scattering, and dynamic light scattering for biophysical characterization of proteins and viral vectors. His research experience spans from structural biology to plant physiology and across labs in Germany, Sweden, Denmark, and USA.  Andre earned his PhD at Carlsberg Laboratory and had a post-doc appointment at Stanford University.

Daniel Myatt, PhD, Senior Analytical Scientist, Biologics, Center for Process Innovation Ltd.

Daniel is a Senior Scientist in the analytical group at the Centre for Process Innovation (CPI, UK). He has a degree in Biochemistry and a PhD in Biophysics from the University of Manchester (UK). He has experience of a variety of biochemical and biophysical techniques gained from working in Biopharma, academic and at large scale facilities.

Peter Neubauer, PhD, Lab Head, Bioprocess Engineering, TU Berlin

Professor Neubauer is head of the Bioprocess Engineering Laboratory at TU Berlin which is leading in bioprocess scale-up and automated bioprocess development. He leads the KIWI-biolab which was selected as an International Future Laboratory in AI for bioprocess development. He is co-author in more than 300 publications and 20 patents and cofounder of the companies BioNukleo, Enpresso, and Cell-tainer. In 2023 he obtained the prestigious Thought Leader Award from Agilent.

Fraunhofer Institute for Biomedical Engineering IBMT

Julia Neubauer, Head of Department, Cryo & Stem Cell Technology, Fraunhofer Institute, IBMT

Dr. Julia C. Neubauer (Fraunhofer IBMT) is CEO of the Fraunhofer Project Center for “Stem Cell Process Engineering” and Head of the department “Stem Cell & Cryo Technology”. Among others, she is deputy coordinator of the imi-funded project EBiSC2. She studied Biology at the Julius-Maximilians-University of Wurzburg and received her PhD in 2012 after joining Fraunhofer IBMT five years before. During these years she spent also some time abroad, visiting the University of Stellenbosch/South Africa and the University of Coquimbo/Chile for research stays. Since 2012 she was leading the work group “Cryopreservation & Cell Culture Automation” at Fraunhofer IBMT in St. Ingbert. Since 2015 Julia Neubauer was appointed Head of Department and 2017 CEO of the Fraunhofer Project Center. Her main research topics are focused on establishing new automation procedures for the optimization of stem cell workflows using suspension bioreactors and robotic/microfluidic platforms in combination with new biomaterials. She is the author of more than 30 publications focused on cryopreservation of therapeutic relevant cells and automation of stem cell screenings. She has been a key scientist in all stem cell related projects of Fraunhofer IBMT.

Miroslav Nikolov, PhD, Senior Scientist & Laboratory Head, Roche

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.

AstraZeneca

Gunilla Nilsson, MSc, Associate Director, Advanced Drug Delivery, Pharmaceutical Sciences, AstraZeneca

Gunilla Nilsson holds a Master of Science from Chalmers University of Technology, Gothenburg. After graduation, she joined AstraZeneca, where she has held various roles within analytical chemistry and drug product development. In 2014, she transitioned to the New Modalities research area, working mainly with analytical development and strategies in the mRNA field. Her expertise is analytical science with focus on separation techniques such as liquid chromatography and capillary electrophoresis. In her current position as Team leader in Advanced Drug Delivery, AstraZeneca, Gunilla is responsible for the CMC analytical development of biomolecules such as oligonucleotides, peptides and mRNA/LNP drug products in early clinical phase.

Forschungszentrum Julich

Stephan Noack, PhD, Group Leader, Quantitative Microbial Phenotyping, Forschungszentrum Julich

Dr. Ing. Stephan Noack is head of the Quantitative Microbial Phenotyping department at the IBG-1: Biotechnology, which is one of the leading institutes in Germany in the field of microbial biotechnology. His research focuses on the optimization of microbial strains and production processes using lab automation, quantitative omics technologies, and bioprocess modeling. In addition, methods for automated molecular cloning and adaptive laboratory evolution are being developed and applied to prokaryotic chassis. Noack is co-author in more than 90 publications and 5 patents.

Johnson & Johnson Innovative Medicine

Morgan O'Brien, PhD, Associate Director, Gene Therapy R&D, Johnson & Johnson Innovative Medicine

Associate Director leading a team within the JJIM Gene Therapy R&D organization. Specializing in Drug Substance Tech Transfer/NPI, process validation, and manufacturing interface and CMC support for a portfolio of AAV gene therapy. PhD in Oncology Immunotherapy and a bachelor’s degree in Pharmaceutical Sciences. Alumni of the Johnson & Johnson Global Operations Leadership Development Program (GOLD).

Univ College Dublin

David O’Connell, PhD, Associate Professor, 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.

Ivy Farm Technologies Limited

Akin Odeleye, PhD, Head, Bioprocessing, Ivy Farm Technologies

Akin is Head of Bioprocessing at Ivy Farm, a company developing cell-based meat. His passion extends from biopharma to the novel food industry, and he has over a decade of experience translating life science discoveries into commercially viable products. Akin joined Ivy Farm in 2020 as their third employee, leading a team of engineers and scientists to develop Ivy Farm’s manufacturing process for cell-based meat. Akin's career path started as Bioprocess Consultant Engineer at Biopharm Services, followed by post-doctoral positions at Loughborough University and the University of Oxford. At Oxford, he developed innovative bioreactors for cell therapy applications with Prof. Cathy Ye. He also worked at Adaptimmune as a Senior Scientist, developing manufacturing processes for cancer T cell therapies. Akin earned his MEng in Chemical Engineering from the University of Nottingham, and an MSc and PhD in Biochemical Engineering from University College London.

Biopharm Services Ltd

Sa'ad Ojeili, Bioprocess Consultant, BioPharm Services Ltd

Sa'ad Ojeili has been a Bioprocess Consultant at Biopharm Services for 3+ years. His background is in biochemical engineering, having obtained a Master's Degree from UCL. Most of his work focuses on bioprocess simulation, process economics, and sustainability. Additionally, he has worked on projects involving supply chain, market size, and facility utilisation analysis.

RESPECTfarms

Nico Oosterhuis, Senior Bioprocess Consultant, RESPECTfarms

Nico Oosterhuis graduated in 1980 as food process engineer at the Wageningen University. In 1984 he achieved his PhD on Scale-up and Scale-down of bioreactors at the Department of Bioprocess Engineering at the Delft University of Technology. He worked for several companies in the food process industry, bioreactor manufacturing, and pharma industry as project manager and R&D manager. In 2006, Nico started the development of multi-purpose single-use bioreactors with unique properties and the company Celltainer Biotech BV. The CELL-tainer® is applied now at various industries, institutions and universities and been applied in microbial processes, as well as cell culture processes (mammalian cells, plant cells, cellular agriculture). In 2022, Celltainer Biotech was acquired by Bionet from Spain and in 2023, Nico stepped back as CTO. He still is involved as advisor and shareholder. He also did several consultancy jobs, including the projection and basic engineering of a large-scale wheat processing and lysine operation, and more recently consulting some cultured meat companies for bioreactor design. In 2023, Nico joined Respect Farms focused on the realization of cultured meat production at farm-scale.

eXmoor Pharma Concepts ltd

Angela Osborne, PhD, CEO & Founder, eXmoor Pharma Concepts Ltd.

Originally a biochemical engineer from UCL, Angela is the CEO and founder of eXmoor pharma, a “trusted one-stop cell and gene therapy partner, accelerating the manufacturing journey from research to patients”, which she founded in 2004. Prior to starting eXmoor, Angela was Senior Vice President of Pharmaceuticals at Aker Kvaerner, an engineering multinational, where she was responsible for the pharmaceutical business in Europe, growing the turnover to equal the previously dominant chemicals business. Angela started her career at British Biotech, where she built on her PhD, with practical experience of biopharmaceutical process development, scale-up, facility design, validation, and operation of facilities to US and EU GMPs. Angela is a keen supporter of the BIA, co-founder of the amc (ATMP Manufacturing Community) and active contributor to the UCL MSC in CGT Manufacturing. She enjoys teamwork, problem solving, new challenges and is passionate about developing the CGT industry and creating a CGT cluster in Bristol for the benefit of patients. Angela enjoys teamwork, problem solving and new challenges and am passionate about developing the biopharma and cell therapy industries for the benefit of patients and the economy.

Eppendorf SE

Benjamin Otto, PhD, Product Mgr, Life Cycle, Eppendorf SE

No bio available.

iBET Instituto de Biologia Experimental Tecnologica

Cristina C. Peixoto, PhD, Head Downstream Process, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica

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 Biologica (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.

Mario Pereira, PhD, Director of Technology & Business Development, ATUM

Mario is a Director of Technologies & Business Development at ATUM, with over 14 years of expertise in recombinant protein expression. He earned his PhD in Biotechnology from the University of Manchester, focusing on transcriptional mechanisms in CHO cells. Mario's career spans roles at FUJIFILM Diosynth Biotechnologies and Horizon Discovery, where he held scientific and commercial positions, including Senior Scientist and Strategic Account Manager for Horizon's CHO-GS platform.

Merck Biodevelopment SAS

Jeremy Peyrol, USP Innovation Expert, Innovation for Biologics, Merck Biodevelopment SAS

Jeremy Peyrol received his biotechnology engineering degree from ENSTBB. He started his career at the French Atomic Energy Commission as a research scientist and joined Merck in 2013 as an Upstream Development Engineer. Since then, he has worked on various projects including high-throughput process development on bacteria and yeast, and has served as Project leader on mAb and other complex protein expression systems. In his current role, Jeremy is an Upstream Innovation Expert within Life Science Services, Merck’s CTDMO business, and focuses on testing and developing next generation solutions for cell line development, upstream processes, and process analytical technologies.

Wen Clifford PhD, Scientific Account Manager, Genedata

With 15 years of experience in life science, Wen understands the critical role of digital innovation in accelerating bioprocessing development & process analytics. Wen joined Genedata UK 6 years ago, as a Scientific Account Manager & supports biopharmaceutical companies implementing global digital solutions for innovative biotherapeutics R&D. Wen worked a scientific consultant for IDBS delivering large scale deployments across Healthcare, Medicinal Chemistry, Molecular Biology, Bioprocess & Formulation domains.

Roslin Technologies Limited

Jef Pinxteren, Vice President, Development, Roslin Technologies Limited

Jef Pinxteren obtained his PhD in Biochemistry at the University of Antwerp in 1994. He then moved to University College London supported by a long-term EMBO fellowship. He studied the role of G-proteins in secretion from granulocytes, with further funding from the Medical Research Council and the Wellcome Trust he continued the research project. With UCL Bogue fellowships, he started US collaborations with UAB in Alabama, and UNC in North Carolina. Here he built experience with mouse ES cells, knock-out models, and cell differentiation assays. In 2000 he returned to Belgium and started on cord blood derived stem cells, then mesenchymal stem cells and collaborated with the Stem Cell Institute in Minneapolis. In 2004 he moved to the proteomics group of the Flemish Institute of Biotechnology. In 2006, he started for Athersys in Cleveland, as Head of R&D and set up the daughter company ReGenesys in Belgium. Late 2016 he started to work for Promethera Biosciences, until the end of 2019 as global VP Operations. In 2020 he joined Catalent Gene and Cell Therapy, functioning as Senior Director Process and Analytical Development. Late 2021 he moved into the cultivated meat sector (Meatable) and recently joined Roslin Technologies as VP Development.

Mathieu Porte, R&D Bioproduction Manager, Polyplus

Mathieu Porte is Manager of R&D Bioproduction at Polyplus. After obtaining his Biotechnology Engineering Degree from the European School ESBS (Strasbourg, France), he worked as Research Assistant at New England Biolabs and UCSF. He joined Polyplus in 2009. For the last 15 year, he contributed to the development of several innovative transfection solutions dedicated to biomanufacturing like PEIpro® and FectoVIR®-AAV, first in the lab as a scientist and now as manager of the R&D Bioproduction team.

Arnaud Poterszman, PhD, Research Director, Integrated Structural Biology, IGBMC

After studying at ENS Cachan (now Paris-Saclay), Arnaud Poterszman completed his PhD from Strasbourg University and joint the CNRS one year later. He holds a 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 nucleotide excision, particularly, the transcription/DNA repair factor TFIIH and its partners (Orchid 0000-0002-6702-5777)

Reza Ranjbar, PhD, Head of Technology Strategy-Biotechnology, CPI

Dr. Reza Ranjbar (Head of Technology Strategy at CPI Biotechnology) has over 25 years’ industrial experience in large corporations, SMEs, research institutes and academia as technical manager, consultant, scientist, biochemical engineer and assistant professor. He has led more than 30 commercial projects for multinationals such as Unilever, AAK, Friesland Campina and SMEs. Reza has coordinated/managed 18 European funded projects (e.g. FP7 and H2020) in the field of Industrial Biotechnology, and is an international professional, having worked in the Netherlands, Spain, Japan, Aruba, UK and Iran. Within CPI, Reza is Head of Technology Strategy for CPI’s Biotechnology business unit.

Devendra Ridhurkar, PhD, Director, R&D, Adalvo

Dr. Ridhurkar works as an R&D Director at Adalvo, Barcelona, Spain. He has over 16 years of scientific leadership and management experience in the development and manufacture of NCEs, proprietary and generic (505b2, hybrid, complex, specialty, and branded) for pharmaceutical companies worldwide in Europe at Neurax & Servier and in India, Dr. Reddy’s, IPCA, and Macleods. He is an expert in using platform technologies like modified release, pulmonary drug delivery systems, hot melt extrusion, 3D-printing, continuous manufacturing, nanotechnology, and cyclodextrin complexation. He obtained his M. Pharm and PhD in Pharmaceutics from IIT, Varanasi, India. He is a member of the editorial board of reputed pharmaceutical journals. He has earned over ten peer-reviewed papers in reputed international and national journals and nine patents. He is associated with various pharmaceutical bodies in Spain, Hungary, India, and the American Association of Pharmaceutical Scientists. He is a programme advisory committee member for Pharma Connect Congress, Hungary; Why Summit, Germany; and has attended and delivered seminars and presentations at various national and international conferences.

Paracelsus Medical University Salzburg

Eva Rohde, MD, Chair, Transfusion Medicine, Director GMP Unit, Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University Salzburg

Eva Rohde, MD, is Head of the Clinical Department of Transfusion Medicine at the University Hospital Salzburg, Austria, and Director of the first academic pharmaceutical manufacturing unit for stem cell- and extracellular vesicle-based therapeutics in Europe. Her research at the Paracelsus Medical University (PMU) in Salzburg focuses on the clinical application of stem cell-based therapies with a special emphasis on their extracellular vesicles (EVs). The overarching goal is to develop novel cell-free therapies in conjunction with scientifically solid application-oriented analytical technologies. Eva Rohde actively participates in a global network of academic and industrial partners with the goal of the clinical development of EV-based therapies in diseases with a high unmet need. Eva Rohde chairs the global “Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics” of the International Society for Extracellular Vesicles (ISEV) and is a member of the ISCT Exosome Committee.

School of Science and Technology, NOVA University of Lisbon

Cecilia Roque, PhD, Associate Professor in Bioengineering, NOVA University of Lisbon

Cecilia Roque is an Associate Professor in Bioengineering at the Chemistry Department, School of Science & Technology at NOVA University (Lisbon, Portugal). Cecilia is a principal researcher at UCIBIO-NOVA and leads the Biomolecular Engineering Lab. She holds a degree in Chemical Engineering (Major in Biotechnology) & a PhD in Biotechnology from Instituto Superior Tecnico, and has an Habilitation in Bioengineering from NOVA University of Lisbon. Cecilia has been a Visiting Scholar at the University of Cambridge and at the Catholic University of America, a Postdoctoral Researcher at the Institute of Biotechnology (University of Cambridge) and at INESC-MN (Lisbon, Portugal), and a visiting Professor at the University of Cambridge (2006, 2011), University of Sao Paulo (2015-2018), University of Nantes (2011) and City University of New York (2018). Her research focuses on bioengineering, namely on the development of advanced functional materials that combine novel affinity receptors with bio-based and sustainable materials for bioseparation, biosensing and biomedical applications. Check: https://sites.fct.unl.pt/biomolecular_eng/

Optimal Industrial Technologies Limited

Michael Sachpekidis, BEng MSc MIET, Business Development Manager - Europe, Optimal Industrial Technologies Limited

Michael Sachpekidis has a BEng in electronic engineering and an MSc in advanced control and automation, and extensive experience in software development, automation, and test & measurement systems. At Optimal, Michael helps customers improve product quality, manufacturing costs and time to market, with synTQ PAT knowledge management software.

Jolanda Scheenhart, Sales Manager Europe, CYTENA GmbH

Jolanda Scheenhart is Sales Manager Europe at CYTENA GmbH for more than 2 years, working together with her team to provide solutions for Cell Line Development. With her 20+ years of experience in the life science market and the latest innovative developments during her professional career in sales, academic institutes, and biopharma, she enjoys finding solutions for customers in a better, faster, and more affordable way.

Joachim Schulze, PhD, CTO, Planetary Group

Joachim has over 35 years of international experience in engineering, Process Development, Scale-Up and plant operation. He started his career with Uhde GmbH, an international operating engineering company, and worked from 1999 to 2007 as managing director at Canzler GmbH, then until 2016 as head of the biotechnology division for Thyssenkrupp Industrial Solutions (TKIS). The biotechnology division of TKIS has been taken over by the EW Group in 2017 and until June 2019, he worked as managing director of EW Biotech GmbH in Leuna. Joachim is managing partner at BioConsulting GmbH, CTO of Planetray AS and chairman of the board of the BioEconomy Clusters eV, Leuna. He holds a doctorate in chemistry.

Gyroscope Therapeutics

Tarik Senussi, PhD, Senior Director Process & Formulation Development, MSAT, Gyroscope Therapeutics, a Novartis Company

Tarik Senussi is the Senior Director of process, formulation development & MSAT at Gyroscope Therapeutics Ltd. Tarik joined Gyroscope in February 2017 and has been working on developed processes for rAAV manufacture from both suspension and adherent platforms. Prior to Joining Gyroscope Tarik was at GSK, as Lead Upstream Process Development Scientist, where he was responsible for establishing the upstream process development platform and team for the production of viral vectors. During this time, Tarik undertook support of Strimvellis the first ex-vivo cell and gene therapy to gain commercial approval and development of a suspension platform to progress pipeline assets. Prior to that Tarik worked at Medimmune Ltd as a scientist II and Lonza Biologics Ltd as a senior R&D scientist where he supported cell culture and fermentation sciences and new product development respectively. Tarik holds a BSc in Cell Biology and a PhD in Biochemical Engineering both from University College London.

Nayamylk Products

Aditya Shah, MSc, Co-Founder, Nayamylk Products

Aditya is the co-founder of Nayamylk Products; a company based out of India that uses novel ingredients to develop plant-based food products. He holds an MSc. in Biochemical Engineering degree from University College London. Aditya works in the alternative protein sector at an intersection of biochemistry and food technology. He is experienced in product development, process design, manufacturing and business management.

iBET Instituto de Biologia Experimental Tecnologica

Ricardo J.S. Silva, PhD, Senior Scientist, Downstream Process Development, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica

Ricardo Silva received his PhD degree in Chemical and Biochemical Engineering from New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of (bio)pharmaceutical products. Since 2014 he is a senior scientist at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell-based products.

Integration Consulting

Dominic Silvester, Senior Consultant, Integration Consulting

Dominic Silvester is a Senior Consultant at Integration’s UK Office. His experience includes projects in the Marketing & Sales and Supply Chain Practices, including market scans, entry strategies, go-to-market strategies, and process redesign. These projects have been conducted predominately with food & beverage companies from start-up to multinationals across Europe, North & South America and Asia.

Orchard Therapeutics

Chrysanthi Sitmalidou, Scientist II, Cell & Gene Therapy Technologies, Technical Operations & Global Technical Development, Orchard Therapeutics

Chrysanthi is a Scientist II in Vector Process Development team within Cell & Gene Therapy Technologies Department and joined Orchard Therapeutics in September 2020. She is working on the development and optimization of lentiviral vector (LVVs) USP platforms and involved in LVV analytical assay development. She was also responsible for the development of stable cell lines for LVVs and optimisation and establishment of a stable cell line platform. Chrysanthi’s background is in retro and lentiviral vectors. With wide experience in the process development field, she is skilled in Cell Line Development, Viral vector upstream Process Development and Molecular & Cellular Biology. Prior to Orchard Chrysanthi was a Senior Research Associate in Autolus, working on stable cell line development and optimization of CLD platform and vector analytical assays for CART cell therapies. Chrysanthi holds a MSc in Molecular Medicine and Cancer Research from Brunel University London and BSc in Molecular Biology and Genetics.

Arkeon Bio

Justin Smith, Chief Technology Officer, Arkeon Bio

Justin Smith, M.Sc, MBA is biochemist by education and a bioprocess developer by trade. Justin has over a decade worth of industry experience covering biopharmaceuticals and industrial biochemical manufacturing. In his current role as Chief Technology Officer at Arkeon, Justin oversees the growth of the company’s precision fermentation technology platform covering strain engineering to process development and scale up.

Legend Biotech

Sarah Snykers, PhD, Director of Operations, Legend Biotech

Sarah Snykers is Senior Director of Operations at Legend Biotech, Ghent Europe. She has 20 years of experience in cell and gene therapy (CGT). She has headed several departments in Biotech companies, including Manufacturing, QC, R&D and MS&T; all focused on clinical or commercial production of autologous & allogeneic cell- and gene therapeutic products. Over the last 15 years, she was involved in 3 greenfield production hubs, and in several global Tech Transfer projects for clinical/commercial production of CGT.

ExpreS2ion Biotechnologies

Max Sogaard, PhD, Senior Vice President, R&D and Technology, ExpreS2ion Biotechnologies

Max Sogaard boasts 23+ years in scientific research and process development, notably 10 at ExpreS2ion Biotechnologies, where he rose from Senior Scientist to Senior VP, driving innovation in vaccine manufacturing, collaborating with CMOS, refining processes, and aiding regulatory endeavors. With a 13-year academic research background in infectious diseases, structural biology and molecular biophysics, Max now spearheads ExpreS2's internal R&D, guiding platform and vaccine pipeline growth.

Michael Sokolov, PhD, Lecturer, ETH Zurich, COO, DataHow AG

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.

Wyatt Technology

Dan Some, Principal Scientist, Wyatt Technology

Dr. Daniel Some is Principal Scientist at Wyatt Technology Corp., where he contributes to product and application development as well as scientific and technical marketing. Currently he leads Wyatt’s program for commercializing PAT products based on real-time multi-angle light scattering.

AstraZeneca

Susie Sou, PhD, Associate Principal Scientist, Cell Line Development and Engineering, AstraZeneca

Susie obtained her BSc and MRes degrees at Imperial College London, in the area of biochemistry and biochemical research. She did her PhD study in the department of Chemical Engineering at Imperial College London, where she focused her research on bioprocess optimisation and modelling on biopharmaceutical production in Chinese hamster ovary cells. After the completion of her PhD degree, she worked as a post-doctoral research associate with Dr Cleo Kontoravdi on bioprocess modelling and she joined the Susan Rosser lab on CHO cell engineering. Since 2017, Susie has been working in Cell Line Development as an Associate Principal Scientist at MedImmune/Astrazeneca. Her research focuses on improving and optimising the cell line development platform, via CHO cell engineering and automation.

Oliver Spadiut, PhD, Associate Professor, Integrated Bioprocess Development, TU Wien, Vienna

Oliver Spadiut completed his PhD in Biotechnology at BOKU University, Vienna, Austria, in 2008 before doing a 2-year PostDoc at KTH, Stockholm, Sweden. Since 2010, he has been employed as University Assistant in Biochemical 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 150 papers in reputed journals and is serving as a peer-reviewer for 80 scientific journals.

Politecnico di Milano

Mattia Sponchioni, PhD, Assistant Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano

Mattia Sponchioni received his Master of Science in Chemical Engineering in 2015 with a grade of 110/110 cum laude and his PhD cum laude in Industrial Chemistry and Chemical Engineering in 2018, both at Politecnico di Milano. After his PhD, Mattia spent one year as a post-doc at ETH Zurich in 2019, working on the development of continuous countercurrent chromatographic processes for the purification of biopharmaceuticals, from therapeutic proteins to oligonucleotides. From 2020 to the present he is an assistant professor at the Department of Chemistry, Materials and Chemical Engineering “G. Natta” at Politecnico di Milano. Here, Mattia Sponchioni is leading the group of biomanufacturing, active in the development of continuous perfusion processes for the production of mRNA and bioplastics via fermentation and in the conversion of the traditional single-column batch chromatographic purifications into continuous countercurrent processes based on two twin columns. The vision of the group, inspired by the principles of Industry 4.0, is towards process intensification, to be achieved through both continuous processes and integrated manufacturing, as a way not only to increase productivity but also the sustainability of biomanufacturing, by reducing the wastes of buffers and feedstocks in the direction of a reduced environmental footprint.

BlueNalu Inc.

Keerthi Srinivas, PhD, Director, Bioprocess Development, Bluenalu

Keerthi Srinivas has over 15 years' experience developing upstream processes in the fields of food, nutraceutical, and bio-based products such as fuels and chemicals. In this current capacity, Keerthi is the Director of Bioprocess Development in BlueNalu, a cell-cultured seafood company, and is responsible for media and bioprocess development, optimization and scale-up to manufacturing. Keerthi Srinivas has a PhD in chemical engineering from University of Arkansas followed by over 8 years post-graduate stint in developing novel upstream and downstream biological as well as chemical processes for several industries within the Biotech sector, resulting in over 34 articles published in peer-reviewed journals, 4 book chapters and several presentations in national and international conferences. Over the years, he has actively collaborated/led projects on process optimization, omic and flux analyses, technology transfer, parametric, chemometric & mechanistic modeling of processes, QbD, PAT, data processing, analysis & integration and scale-up/scale-down models for process intensification. Keerthi Srinivas is currently based in San Diego, CA.

Boehringer Ingelheim Pharma

Anne Steinkamper, PhD, Scientist, Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG

Anne Steinkamper is a scientist in the Development Biologicals group of Boehringer Ingelheim Pharma GmbH & Co. KG. Her focus is on early stage bioprocess development for mammalian cell cultures and process scale-up. Before she gathered several years of experience at a contract manufacturer for biopharmaceuticals, she had worked at the University of Applied Sciences Esslingen in the field of bioprocess engineering and spectroscopical bioprocess analytic. She received her PhD in Biology from the University of Tubingen and holds a degree in technical biology from the University of Stuttgart.

Univ of Natural Resources & Life Sciences

Gerald Striedner, PhD, University Professor, Biotechnology, University of Natural Resources and Life Sciences Vienna (BOKU), Austria

University Professor at the Department of Biotechnology (BOKU), Head of the Institute of Bioprocess Science and Engineering, Head of working group fermentation technology 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.

Vladislav Strmiska, PhD, Senior Scientist, Mewery

Vladislav is Senior Scientist at Mewery responsible for science in a field of microalgae and mammalian cells. Over experiences as Postdoc at Harvard Medical School, University of Luxembourg or Medical University in Vienna. Vladislav studied cells cycle in cancer and development or in vivo oriented projects curing diseases. Vladislav also obtained university degree studying Food Quality and Safety at Mendel University in Brno, Czech Republic.

Univ College London

Michael Sulu, PhD, Lecturer, Biochemical Engineering; Senior Fellow, Higher Education Academy (SFHEA), University College London

Michael Sulu is an experienced lecturer and researcher. His expertise in both is focused on upstream bioprocessing, with a specific focus on fermentation and cell culture (and a subsidiary focus on harvest techniques). These interests lead to a passion in protein (alternative) production and FMCG production.

MaxCyte Inc

Cenk Sumen, PhD, Advisor, MaxCyte Inc.; PDM Committee Member, ISCT

At MIT, I trained with Prof. Daniel I. Wang at the Biotechnology Process Engineering Center, studying the effects of surface morphology on cell function. After graduating, I joined Biogen as a Cell Biochemist, working with Dr. Chris Benjamin on antibody engineering and cell culture scale-up, as part of the team that brought Avonex to multiple sclerosis patients. For my Ph.D at Stanford in Prof. Mark M. Davis' lab, I developed a novel system for deconstructing the molecular events in T cell antigen recognition. Under the leadership of Prof. Michael L. Dustin (then at Wash. U.), we outlined the immunological synapse paradigm and demonstrated that MHC clustering correlates directly with antigen strength, then showing that self-peptides can increase T cell sensitivity to antigen, and that antagonist peptides disrupt integrin engagement. After my Ph.D., I joined Prof. Ulrich von Andrian at Harvard to learn intravital multiphoton imaging. There, I developed a new molecular tool using quantum dots (2023 Nobel Prize) to track virus antigens in vivo. To apply my unique background to cancer research, I then joined Prof. James P. Allison's lab at MSKCC, where I built a two-photon imaging system to visualize the immune response to cancer in mice. Moving back to industry, I was a founding member of the Dynabead Technical Sales Team, driving adoption of Norwegian magnetic bead based separation. I then held roles of growing responsibility in technology, commercial, and strategy at STEMCELL Technologies, PerkinElmer, Hitachi Chemical, and ThermoFisher. In 2019 I took the entrepreneurial adventure of joining a cell therapy startup as CTO, helping guide them to a successful Series A. Since 2022, I have returned to innovating novel technologies to help therapeutic developers as CSO for MaxCyte, the premier non-viral cell engineering company in the world. Being a lifelong learner/teacher, I have lectured in university for over a decade as Adjunct Professor at NYU Tandon School of Engineering, where I taught Advanced Molecular Biology in Fall 2011 and Molecular Immunology in Spring 2013-2022. Will, knowledge, and action.

Cell & Gene Therapy Catapult

Nathan Sweeney, PhD, Lead Scientist, Technology & Process Innovations, Cell & Gene Therapy Catapult

Nathan Sweeney joined the CGT Catapult in 2022 as a Lead Scientist responsible for the design and leadership of viral vector process and analytical development projects. He has over 10 years’ experience in cell and gene therapy spanning vectorology, cell line development, upstream, downstream, and analytical development. His experience includes 5 years in GSK CGT where he was responsible for leading all viral vector process development activities from pre-CMC to FTIH for a lead asset. Nathan holds a PhD in Virology from Imperial College London, is the inventor on patents relating to viral vector manufacturing/analytics, and is the lead author on multiple peer-reviewed publications on viral vectors.

Tosoh Bioscience GmbH

Sebastian Thuermann, Product Manager MCC EMEA, Tosoh Bioscience GmbH

Sebastian holds a PhD in chemistry from the University of Leipzig. In his academic and industrial career, he designed chromatographic systems - from tiny analytical microfluidic chips to large-scale production and purification systems.

 

Today, he is a product manager responsible for multi-column chromatography at Tosoh. Author of numerous scientific papers, he regularly presents scientific results at international conferences or holds training courses for our customers.

 

Kiji Therapeutics

Anthony Ting, Chief Scientific Officer, Kiji Therapeutics, Chief Commercialization Officer and Board Member, ISCT

Tony Ting, PhD, has over 30 years of academic and industry experience in translational science and global regulatory filing, and 20 years specifically in stromal cell-based therapeutics. Most recently, he was a Program Leader in Oncology Cell Therapy Innovation at Takeda. He is also the former CSO of Bone Therapeutics and is the Chief Commercialization Officer on the board of directors for the International Society for Cell and Gene Therapy (ISCT). Additionally, he served and is serving on committees for the Alliance for Regenerative Medicine (ARM) and the Health and Environmental Sciences Institute (HESI). Prior to that, Tony served in the senior management team of Athersys, a clinical-stage cell therapy company. As Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs, he was responsible for all stages of development, from the bench to the bedside for the cardiovascular and pulmonary programs with Athersys’ most advanced cell therapy product MultiStem®, an allogeneic adult bone marrow-derived stem cell product.

Susumu Uchiyama, PhD, Professor, Biotechnology, Osaka University

Dr. Uchiyama, PhD, is Professor in the department of Biotechnology, Graduate School of Engineering, Osaka University, Japan, and is also currently Visiting Professor at Kyoto University and ExCELLS, Japan. His research topics are science-based engineering in the field of solution biophysics of protein and colloidal particles, especially by using various kinds of biophysical methods, such as analytical ultracentrifugation, mass spectrometry (especially native MS and HDX-MS), and calorimetry. His research interests include energetic understanding of immune-related proteins and virus vectors for gene therapy. Container closure system for biopharmaceuticals with better quality and more safety is also in his recent scope. He has published more than 200 peer-reviewed papers, including those in high impact journals, such as Nature and PNAS, and is on the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. In addition, Dr. Uchiyama has received Young Investigator Awards from the Protein Society of Japan, and is a member of the organizing committee of the Protein Society of Japan and the project committee of the Japan Association of Animal Cell Technology.

Takeda Pharmaceuticals

Alexandra Umprecht, PhD, Scientist, Digital CMC Sustainability and Technology, Pharmaceutical Sciences, R&D, Takeda Pharmaceuticals

Alexandra Umprecht is a Scientist in Sustainability & Technology, Pharmaceutical Sciences, R&D, Takeda. Following graduation from Uppsala University with a MSc in Applied Biotechnology and an initial exposure to bioprocessing at a large bio-pharmaceutical company, she joined Takeda to work on various Digital CMC initiatives, with special focus on process analytical technology, Raman spectroscopy & data-driven modelling approaches. Continuing her education at Technical University in Vienna, Alexandra is pursuing a PhD research on the topic of transferability of Raman calibration models.

Ram Uritski, PhD, Vice President, Bioprocess, Remilk

Ram Uritski has been Vice President Bioprocess at Remilk since 2021, with versatile experience in fermentation and purification process development and manufacturing. His career includes roles in biopharma industry such as Director of CMC Operations at 89bio and Director of Process Development & Production at Scinai Immunotherapeutics. He possesses strong capabilities in working with various types of cells and microorganisms, process scale-up, technology transfer, and industrial-scale manufacturing. Ram holds an MBA in BioMed and an M.Sc. in Biochemistry and Food Science from the Hebrew University of Jerusalem.

Cellulaire Agricultuur Nederland Stichting

Ira van Eelen, PhD, Co-Founder, RESPECTfarms

I am a founder, organizer, designer, and speaker. I am proud and happy to be able to work on more than one passion. My father, Willem van Eelen, was one of the pioneers of the creation and production of cultured meat. With my legacy as daughter of the godfather of cultured meat and a large network in this field, I support innovation in this field. More than 40 years of clean/cultured/cultivated/just/cell-based/in vitro meat history is written in me and converted into speaking, lobbying, organising, researching, and working on the potential-and the general understanding of the urgency of this innovation. By founding KindEarth.Tech I let people encounter and embrace the huge potential of the future foods industry that is here today. All roads-small, medium, and large-will play an important role in getting cultured meat to our plates. I find it important to take the role agriculture and farmers can play into account. I do so as a co-founder of RESPECTfarms.com and as a board member of Cellulaire Agricultuur Nederland. Next to cultivated meat, my passions for design, software system integration, preventive oral health care, and educating teenagers are important elements in my life’s journey. I work as a designer in events, healthcare ICT, marketing, and think tanks.

Alchemab Therapeutics

Paul Varley, PhD, Senior Vice President, Development, Alchemab Therapeutics

Dr. Varley is an expert in biopharmaceutical development with more than 30 years' experience developing antibodies, proteins, and other macromolecules into drugs from research into the clinic and through to commercialization. Paul is currently Senior Vice President, Development, at Alchemab Therapeutics. Previously Paul held similar roles in Cambridge Antibody Technology, Astra Zeneca, MedImmune, and Kymab. Previously Paul had also worked at British Biotech, the UK National Institute of Biological Standards and Control (NIBSC), and the U.S. National Institutes of Health. Dr. Varley holds a degree in Biomolecular Sciences (First Class) from Portsmouth Polytechnic and a PhD in Biochemistry from the University of Newcastle upon Tyne. Paul was until recently a member of the British Pharmacopeia (BP) Commission and Chair of BP Expert Advisory Group on Biological and Biotechnological Products (2013 - 2022). He also currently chairs a MHRA/BP working party on new standards for Biological Medicines (DPS) and is also a member of the European Pharmacopeia (EP) Expert Committee on Monoclonal Antibodies. Paul was also a founding member of the UK BIA COVID-19 Antibody Task Force which recently spun out as RQ Biotech and was a member of the BIA Manufacturing Advisory group supporting the UK Vaccines task force. Paul is also member the SAB of Spirea and Spliceor and has contributed to many Advisory Boards and related activities during his career including at University Cambridge Department of Chemical Engineering and Biotechnology, University College London Biochemical Engineering, the UK National Biologics Manufacturing Centre, and the White Rose Universities DTP in Mechanistic Biology. Paul has also been involved with many other activities in the Biopharmaceutical Development space including the European Biotech Enterprises (EBE) Biomanufacturing Committee, Bioprocess UK steering group, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Biotherapeutics group, and BioProNet.

Gyros Protein Technologies

Joris Venet, MSc, Field Application Scientist, Sales, Gyros Protein Technologies

Joining Gyros in 2023, Joris has experience in pharmaceutical development and has been fortunate to work with companies such as NovImmune, Molecular Partners and Quotient. As a valued member of the translational medicine departments, Joris has played a critical role as a scientist contributing to the development of cutting-edge bioanalytical immunoassays. These assays have been instrumental in supporting various drug development programs that have pushed the boundaries of medical research.

 

Biologics Consulting Grp Inc

Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, Biologics Consulting Group, Inc.

Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

Banc de Sang i Teixits

Joaquim Vives, PhD, Head of Production, Advanced Therapies, Banc de Sang i Teixits

Dr Joaquim Vives is a Biochemist, MSci in Biotechnology and PhD in Biochemistry (Universitat Autonoma de Barcelona, UAB, Spain) with extensive experience in the R&D biotech sector, both in private and academic environments, where he focused on the optimisation of cellular processes towards A) high yield production of diagnostic and therapeutic molecules, and B) the development of methods to manufacture cells for drug screening and therapy, in compliance with regulatory and pharmaceutical quality standards. Dr. Vives conducted post-doctoral research at the Institute for Stem Cell Research (University of Edinburgh, UK) in 2003, then moved to Stem Cell Sciences Ltd (Cambridge, UK) in 2006, and joined Banc de Sang i Teixits (Barcelona, Spain) in 2008, where he leads a Research Group focusing on the development of Advanced Therapy Medicinal Products from bioprocess design and validation to early phase I/II clinical trials. Dr. Vives collaborates with national and international institutions and is associated to the “Musculoskeletal Tissue Engineering Group” (Vall d'Hebron Institut de Recerca, VHIR, Barcelona, Spain), recognised as a Consolidated Research Group (2017SGR719). He is also an associated lecturer at the UAB Faculty of Medicine and coordinates the “Official master's degree in Transfusion Medicine and Cellular and Tissue Therapies”, a joint degree with Leiden University Medical Centre (LUMC, The Netherlands). He is engaged with scientific communication (e.g. TEDx on Innovative Therapies at https://youtu.be/qfV5IxdLpSg).

Boehringer Ingelheim Pharma GmbH & Co KG

Thomas Waerner, PhD, Senior Principal Scientist & Laboratory Director, Analytical Development & Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG

Thomas M. Waerner, PhD is Senior Principal Scientist and Laboratory director at the department of Analytical Development Biologicals at Boehringer Ingelheim Pharma GmbH & Co KG in Biberach, Germany. He takes responsibility for the control strategy of Host Cell Proteins (HCPs) and other biological process-related impurities for Biologicals from preclinic to marketing. Thus he is interacting closely with production units, customers, experts from other companies, and authorities. His lab focus is on the development, validation, and use of different immunological impurity tests including HCP assays. Since 1997, Thomas oversees how to develop and market biological products by accompanying responsible positions in research, development, production, analytical project management, and analytics at Boehringer Ingelheim in Austria and Germany. He received his Diploma Thesis and PhD in immunology, cell biology, and biotechnology from the University of Stuttgart Germany.

4basebio Discovery Limited

Amy Walker, Dr., VP of Research and Business Development, Research & Development, 4basebio Discovery Limited

Dr Amy Walker received her PhD from the Institute of Child Health, UCL, was awarded The Bogue Fellowship and spent time in Prof. Cullis’ lab University of British Colombia and Prof. Hanrahan’s lab McGill University. As VP of Research and BD at 4basebio, an innovative platform technology company focussed on production of synthetic DNA products, Dr Walker is responsible for synthetic DNA and targeted non-viral delivery platforms and their commercial development. 

 

Novartis Pharma

Paul Wassmann, PhD, Senior Principal Scientist, NIBR Biologics Center, Novartis

Paul Wassmann, Ph.D., Senior Principal Scientist, NIBR Biologics Center (NBC), Novartis Pharma AG, Switzerland Analytical technology and strategy lead for NBEs at the Characterization/ Formulation/ Bioinformatics unit (CFB). This role includes evaluation and coordination of implementation of appropriate innovative and strategic concepts in analytical space for challenging and completely new Biologics modalities with main focus on liabilities evaluation of Biologics molecules and their developability assessment. Prior industry experience includes Project management for Biosimilar projects at Solvias AG, Switzerland, and Scientific role in Antibody Engineering and Analytics departments at Glenmark SA, Switzerland. Holds a doctorate in Structural Biology from Biozentrum Basel, Switzerland.

Univ of Tuebingen

Rolf Werner, PhD, Professor, Industrial Biotechnology, University of Tuebingen

Prof. Dr. Dr. Rolf G. Werner is Honorary Senator of University of Tubingen and Professor for Industrial Biotechnology. After his promotion at University Tubingen he spent more than three years in academia at Max Planck Institute for Molecular Genetics, Berlin, Germany and Massachusetts Institute for Technology, Cambridge, USA and has more than 35 years experiences in industry at Boehringer Ingelheim in top leading positions. He was responsible for the development and registration of the first, genetically engineered, protein therapeutic from mammalian cell culture: tissue plasminogen activator for myocardial infarction and stroke. More than 20 therapeutic proteins and monoclonal antibodies have been developed, manufactured and regulatory approved under his responsibility. He designed an operated the first 6x15.000 L mammalian cell culture plant in Europe, constructed in 18 months. Under his supervision, also processes for viral therapeutics and vaccines have been developed. He is consulting biopharmaceutical, viral therapeutic and vaccine companies in Europe and Asia in all aspects of research and production technologies as well as conceptual design of GMP biotech plants. His achievements are recognized by the Prize of the City of Vienna, Austria, for outstanding scientific work as well as from the Zhejiang Government, China, as Hangzhou Qianjiang Distinguished Expert in Biotechnology. He is National Foreign Expert of People Republic of China.

ACIB GmbH & University of Natural Resources and Life Sciences, Vienna

Birgit Wiltschi, PhD, Head of Synthetic Biology Group, ACIB GmbH & University of Natural Resources and Life Sciences, Vienna

Birgit Wiltschi received a PhD in Biochemistry from Graz University of Technology in Austria. She continued her scientific work as a postdoc at the Max Planck Institute of Biochemistry in Martinsried, Germany and afterwards was a group leader at the Albert-Ludwigs University of Freiburg, Germany. After her return to Austria in 2011, she became the head of the Synthetic Biology Group at the Austrian Centre of Industrial Biotechnology. In 2020, she joined the Institute of Bioprocess Science and Engineering at the University of Natural Resources and Life Sciences, Vienna as a principal investigator and a faculty member of the BioProEng doctoral school. Her research focuses on the engineering of proteins and peptides using unnatural amino acids, for instance to introduce site-selective bio-orthogonal protein modifications.

Regeneron Pharmaceuticals Inc

Hui Xiao, PhD, Associate Director, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

No bio available.

Neurophth Therapeutics

Su Xiao, PhD, PhD, Co-Founder & Chief Tech Operations Officer, Neurophth Biotechnology

Dr. Su Xiao has more than 10 years of experience in gene therapy and biological product development and manufacturing. She is committed to innovating gene therapy manufacturing technology to make it accessible to rare disease patients. Prior to joining Neurophth, she served as the associate director of GMP production at Vigene biosciences, the senior scientist of gene therapy process development at Pfizer, and the research fellow at biotechnology pilot platform of National Institutes of Health. She has led or participated in several rare disease gene therapy projects for the process development, clinical material production and regulatory filing. Dr. Xiao holds a doctoral degree in chemical and molecular bioengineering from Johns Hopkins University and an undergraduate degree in chemical and industrial bioengineering from Tsinghua University. She is currently pursuing an MBA degree at Wharton Business School.

Merck Life Science KGaA

Michelle P. Zoeller, PhD, Senior Scientist, Liquid Formulation R&D, Merck Life Science KGaA

Dr. Michelle Pascale Zoeller is a Senior Scientist focusing on novel modality formulation at Merck Life Science KGaA in Darmstadt, Germany. She has 6 years of experience in the field of parenteral formulations of proteins and novel modalities. Michelle holds a M.Sc. in Biomolecular Engineering from TU Darmstadt. She then completed a joint PhD Program between Merck KGaA, Heidelberg University, and the Steinbeis Transfer Center of Biopharmacy and Analysis, during which she worked on the characterization of novel surfactants for the formulation of therapeutic proteins.

Ever After Foods

Barak Zohar, PhD, CTO, Ever After Foods

Dr. Barak Zohar joined Ever After Foods (EAF) in 2022 and currently serves as Chief Technology Officer. Dr. Zohar has 15 years of experience in bioprocessing and tissue engineering in both industry and academic settings. Prior to joining EAF, Dr. Zohar served as Head of Bioprocess Technologies at Teva Pharmaceutical Industries. Earlier in his career, Dr. Zohar held the positions of Production Manager at Biological Industries and Bioreactor Process Development Team Leader at Pluri. Dr. Zohar holds a PhD in Biomedical Engineering, MBA, and BSc in Biotechnology and Food Engineering from the Technion-Israel Institute of Technology.

Alexander Zollner, University of Natural Resources and Life Sciences, Vienna

Alexander Zollner is a PhD candidate who specializes in bioprocess engineering in his research after completing a Bachelor's and Master's degree in biotechnology. His focus is on purification methods for viruses and viral particles to accelerate the development of novel vaccines and therapies. His expertise spans a wide spectrum of downstream processing techniques, with a particular emphasis on chromatography. Alexander's overarching vision is to deepen our comprehension of viruses and harness their potential as valuable assets for enhancing our health and overall well-being.

Eppendorf Application Technologies S.A.

FranÇoise de Longueville, Dr., Managing Director / Head of Core Test Lab, Eppendorf Application Technologies S.A.

Francoise de Longueville is Managing Director of Eppendorf Applications Technologies, Belgium. She studied molecular and cell biology and received her PhD in toxicogenomics from the University of Namur. During her thesis, she analyzed the side effects of drugs using gene expression analysis with UCB. Since 2002, she is working in the field of applied research with a strong focus on expansion and differentiation of stem cells in 2D and 3D cell culture systems.

 

 

 

 

 

 

Hamilton Bonaduz AG

Yavuz Çelik, Product Manager, Process Analytics, Hamilton Bonaduz AG

Yavuz Celik is the Global Product Manager for Cell Density Sensors at Hamilton. He previously worked in Hamilton's Innovation Department as a Data Scientist, focusing on sensing technologies. Since 2022, he has an active role in supporting novel food producers by providing process insights based on in-line sensors.

Sartorius BIA Separations

Rok Žigon, Head of Product-Application Area (AAV and Adeno), Process development for viruses and vaccines, Sartorius BIA Separations

Rok is a Head of Product-Application Area (for AAV and Adeno) in Process development department for viral vectors and vaccines at Sartorius BIA Separations. He has 8 years’ experience in the field of downstream bioprocess development, leading gene therapy projects for clients, resulting in processes for clinical phase I, II, III and market supply. He acquired skills in AAV purification using monolithic technology through all production stages from Process Development, Technology Transfer and Manufacturing. He holds a Master’s degree in molecular biology from the University of Ljubljana.

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