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Forge Biologics

Frank K. Agbogbo, PhD, Vice President, Process Development, Forge Biologics

Dr. Frank Agbogbo has over 18 years of experience in process development, biotechnology, gene, and cell therapy industries. He is currently the Vice President of Process Development at Forge Biologics, responsible for rAAV process development and plasmid DNA production. Previously, Dr. Agbogbo was the Senior Director of Process Development at Cytovance Biologics for over 7 years where he took increasing responsibilities as Director of Process Development with oversight responsibilities over the Upstream and Downstream teams. Frank’s experience includes process development, Design of Experiments (DoE), process optimization, process characterization, and scale-up from R&D to manufacturing (cGMP and non-cGMP). He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. He holds a Bachelor of Science in Chemical Engineering, PhD in Chemical Engineering from Texas A&M University, College Station, TX, and an MBA with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University, OK.

Neeraj Agrawal, PhD, Director, Attribute Science Data Engineering, Amgen

Neeraj is a Director in the Process Development organization of Amgen and leads a data science team. This group is accountable for end-to-end digital strategy for the Attribute Sciences department. Since joining Amgen 10 years back, Neeraj has worked in both Discovery & Development organizations and has expertise in applying in silico and data science tools to a variety of drug discovery and development problems from biologics design & optimization and molecule assessment, to process, product, and method monitoring. Neeraj received his M.S. in Chemical & Process Engineering from the University of Twente, The Netherlands, and PhD in Chemical & Biomolecular Engineering from the University of Pennsylvania. Neeraj then attended Massachusetts Institute of Technology for this postdoctoral research on computational antibody engineering and assessment. The in silico predictive models developed by Neeraj during his postdoc have been licensed by a number of biotech & life science companies. He has also co-authored 26 peer-reviewed manuscripts and 4 book chapters and is listed as an inventor on 27 patent applications.

Genentech Inc

Hamza Ahsan, Principal Engineer, Pharma Tech Development, Genentech Inc.

Hamza is a principal engineer at Roche/Genentech with the Pharma Technical Development organization. In his current role, Hamza is focused on new process platform development and leading the integration of these platforms into the Roche manufacturing network's capabilities as well as defining the overall network's scale out strategy. Hamza has previously held various roles within Genentech's Vacaville and South San Francisco Production facilities in site Manufacturing Sciences groups supporting both upstream and downstream processes as well as technology implementations including leading area design for one of the areas of the the new Clinical Supply Center at Genentech's South San Francisco Campus. Prior to Genentech, Hamza has held MSAT & Process Development roles at Bayer Pharmaceuticals and holds a BS in Chemical Engineering from the University of California at Davis.

Christian Airiau, PhD, Global Head, Data Sciences, CMC, R&D, Sanofi

Christian Airiau is the Global Head of Data Science in Sanofi R&D, Biologics Development, based in the Boston area. He has over 18 years of experience in the pharmaceutical industry, working on Data Science, Process Modeling, and Process Analytical Technologies (PAT). His remit is to drive alignment across the global Sanofi network to develop data science, process modeling and control in Biologics development. Christian is also the Advanced Analytics lead in the iCMC-Digital Transformation program in Sanofi. In this role, he is developing and implementing the program strategy to maximize the use of data across the CMC perimeter, as Sanofi implements its digital transformation. Trained as a chemist, he holds a Masters and a Ph.D. in Data Science/Chemometrics from the University of Bristol in the UK.

Autolus Therapeutics plc

Caraugh Albany, PhD, Research Scientist, Analytical Development, Autolus Therapeutics plc

Dr. Caraugh Albany is an accomplished cellular immunologist and flow cytometry SME in the Analytical Development team at Autolus Therapeutics, a late-stage CAR T cell biotech company based in London, UK. Caraugh has an unwavering passion to deliver high-quality flow cytometry data and teaching the technique has gained her an Associate Fellowship in Higher Education (AFHEA). Caraugh has worked to transform flow practices within Autolus Product Delivery and Quality Control, ensuring the implementation of QbD and alignment with current and emerging regulatory guidelines. As the AD flow cytometry SME, Caraugh draws on her extensive background in both immunology and flow cytometry. Having completed a British Heart Foundation PhD studentship at Kings College London supervised by Professor Giovanna Lombardi, focusing on the role of Regulatory T cells in Atherosclerosis, Caraugh became well versed in developing both functional and phenotypic assays. Through this work she was exposed to multi-parameter (20+) flow cytometry , developing numerous panels for use with primary human T cells, B cells and monocytes. With a special focus on identifying and sorting rare T cell populations, she gained expertise in best practice QC strategies. This work contributed to the technical publication ‘OMIP-090: A 20-parameter flow cytometry panel for rapid analysis of cell diversity and homing capacity in human conventional and regulatory T cells’. Passionate about ‘bedside to bench side’ innovation, following a post-doc placement Caraugh elected to move into industry where she continues to use her flow cytometry experience in a GMP setting, supporting Obe-Cel commercialisation.

Nadia Amharref, PhD, Staff Scientist, Vaccine Production Program Lab, NIH NIAID

Dr. Nadia Amharref is a senior scientist at the Vaccine Production Program in the Vaccine Research Center, NIAID/NIH. She is a member of the Upstream cell line development group where she focuses on production efficiency and platform optimization. In her current role, she is leading a team in charge of engineering cell lines supporting the development of novel vaccines and biologics targeting infectious diseases of global public health importance. Prior to this role, Dr. Amharref was a Research Fellow at the FDA/CBER campus in the Washington DC area and completed her postdoctoral studies on the characterization of Ebola entry into host cells and the evaluation of the antibody response elicited by experimental vaccines against filoviruses. She obtained her PhD in molecular biology from the University of Reims, France where she worked at the interface between pharmacology and biophysics laboratories. She defended her thesis on “Discriminating healthy from tumoral tissue on a glioma model by spectroscopy imaging and characterization of spectroscopic modifications induced by antitumoral treatment in vitro and in vivo.”

Rosalind Ang, PhD, Associate Principal Scientist, Merck

Rosalind grew up in Singapore. She went to college in Liverpool, U.K., and then completed Master of Science in National University of Singapore. Rosalind received her PhD from Mount Sinai School of Medicine - New York University, U.S.A.. Her graduate research focused on delineating the mechanism of actions of hallucinogens with the goal to understand cognition (Neuron 2007 and Nature 2008). She completed her post-doctoral training in Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, NYC, U.S.A.. In her post-doctoral training, her research focused on understanding the impact of cellular deaths on immune system and development of diseases (e.g. Cell Death & Disease 2020, JCI Insights 2021 and PNAS 2021). In 2018, she joined Cell Therapy Development Operation, Celgene, as a Scientist. She supported the development of early CAR-T drug candidates and commercialization of drug products. Rosalind then continued her career in MERCK, as an Associate Principal Scientist in Biologics-ARD. Working with a multi-functional team, her primary focus is on analytical strategy and method development (with heavy emphasis on residuals, purity and adventitious virus) and authoring specific BLA/IND sections. She enjoys hiking and traveling.

National Institute of Standards and Technology

Anthony Asmar, PhD, Biologist, National Institute of Standards and Technology

Anthony graduated from Old Dominion University with a Master’s and PhD where he worked in the Center for Bioelectrics focusing on how the cell microenvironment affects cell differentiation and tissue development through electrophysiological responses. He then joined the NIH as a postdoc fellow investigating ubiquitin signaling pathways involved in stem cell fate decisions. Anthony then joined NIST as a Biologist working to develop faster and streamlined imaging pipelines to advance live cell imaging capabilities of stem cells combined with AI-based approaches for single cell tracking of cell dynamics.

Vertex Pharmaceuticals Inc

E. Morrey Atkinson, PhD, Executive Vice President, Chief Technical Operations Officer, Head, Biopharmaceutical Sciences and Manufacturing Operations, Vertex Pharmaceuticals Inc.

Throughout his decades-long career in the biopharmaceutical industry, Morrey has contributed his expertise in the development and commercialization of multiple modality therapeutics across all aspects of preclinical, clinical and commercial manufacturing including small molecules, biologics and cell therapies. He joined Vertex in 2020 and serves on the Executive Committee as Chief Technical Operations Officer and Head of Biopharmaceutical Sciences and Manufacturing Operations. In his role he oversees all aspects of our preclinical, clinical and commercial biopharmaceutical sciences, manufacturing operations and global supply chain functions. He earned his bachelor’s degree in biology from Indiana University and his doctoral degree in biological sciences from Stanford University. Prior to Vertex, Morrey was the Senior Vice President of Global Manufacturing Operations at Bristol Myers Squibb (BMS) and was responsible for the global network of internal and external manufacturing for BMS commercial products. He joined BMS in 2012 as the Vice President of Biologics Development and progressed through various roles, including Vice President of Biologics Manufacturing and the Integration Leader for Manufacturing, Product Development and Cell Therapy during the Celgene-BMS Integration. Prior to BMS, Morrey’s career included various scientific and management roles of increasing responsibility at Eli Lilly and Company, Cook Pharmica (now Catalent) and Targeted Genetics Corporation. Morrey serves on the board of directors for 89bio and is active in advocating for LGBTQ+ equality, including serving on the National Leadership Council for the Lambda Legal Defense and Education Fund. He is the executive sponsor for Vertex PRIDE, our employee resource network that supports, provides visibility of, and celebrates our LGBTQ+ employees and allies.

Obsidian Therapeutics

Meisam Bakhshayeshi, PhD, Senior Director, Process Development, Obsidian Therapeutics

Meisam

Sowmya Balasubramanian, PhD, Group Leader, Cell Culture, Genentech Inc.

I am currently leading the Research Materials Group at Genentech which uses high throughput automation to produce research grade proteins to support Discovery and Early Development. I did my PhD in Biotechnology at the Swiss Federal Institute (EPFL) with Professor Florian Wurm, on application of transposon systems for Cell Line Development. I then did my post-doc at Eli Lilly and worked at ATUM as a Scientist/Team Lead in Cell Line Development.

Patrick Banzon, Associate Scientist, Biogen

Patrick D. Banzon, MS, is a purification scientist, specializing in aqueous purification methods for oligonucleotides. He received his BS in Chemistry in 2017 at East Carolina University and his MS in Chemistry in 2020. His previous work includes the physiochemical understanding of collagen unfolding through fluorescent probes, analytical development of proteins and antisense nucleotides, and manufacturing of GMP-scale oligonucleotide drug substances. While a scientist by trade, he is an avid photographer and hopes his trade can further fund his hobby.

Daniel Barry, Senior Conference Director, Cambridge Healthtech Institute

No bio available.

Wake Forest Institute for Regenerative Medicine (WFIRM)

Steven R. Bauer, PhD, Chief Regulatory Science Affairs Program Officer, Wake Forest Institute for Regenerative Medicine (WFIRM)

Dr. Bauer joined the Wake Forest Institute for Regenerative Medicine in 2022 as Chief Regulatory Science Affairs Program Officer after 31 years at FDA as Chief of the Cellular and Tissue Therapy Branch (CTTB). CTTB staff review cell therapy products and conduct research to improve characterization of products. At WFIRM, Dr. Bauer supports regulatory science and participates in the Regenerative Medicine Development Organization (ReMDO) and the Piedmont Triad Regenerative Medicine Engine.

Eli Lilly and Company

Sean Bedingfield, PhD, Senior Advisor, Lilly Genetic Medicine, Eli Lilly and Company

Sean is a specialist in nonviral RNA delivery with work spanning multiple platforms. He is currently in Lilly’s Genetic Medicine division working in early discovery efforts for delivery platform technologies. He leads a small team in a blend of internal platform development, external collaborations and vetting external technologies. Lilly’s interests are broad and ambitious in genetic medicine, as highlighted by their public partnerships including Dicerna, Verve Therapeutics, Scribe Therapeutics, Entos Pharmaceuticals, Evox Therapeutics and acquisitions such as Prevail and Akouos. Receiving his PhD in Biomedical Engineering from Vanderbilt University, his publications include high impact papers in relating to intracellular assay development, RNA delivery leveraging targeted nanoparticles, protein engineering applications (now licensed by Anchor Biologics), and nanomedicine-related material science investigations. Prior to this role, he worked as a technical lead in business development for Pendant Biosciences. Sean lives nearby in Cambridge, MA. He enjoys audiobooks (all genres) and meeting the many local enthusiastic scientists.

Ahmet Bekdemir, PhD, Senior Scientist II, Formulation & Analytics, Novartis Institutes for BioMedical Research Inc.

Ahmet Bekdemir is a formulation scientist at Novartis since 2023. Before joining Novartis, he gained experience in the field of immuno-oncology while working at Xilio Therapeutics. Ahmet completed his PhD in Material Science and Nanotechnology at EPFL in Switzerland and subsequently pursued postdoctoral research at the Massachusetts Institute of Technology (MIT). His research expertise lies in the interdisciplinary fields of nanomedicine and oncology, with a specific focus on drug delivery and formulation.

Asklepios Biopharmaceutical Inc.

Rashmi Bhangale, PhD, Senior Scientist, Downstream Process Development, Asklepios BioPharmaceutical Inc.

No bio available.

Johnson & Johnson Pharmaceutical R&D

Ravi Bhatia, Scientific Director, Cell Technology, Johnson & Johnson Pharmaceutical R&D

Ravi is a Scientific Director with a focus on the Cell Technology department at Jansen R&D. Leading a dynamic process development team, he spearheads autologous CARt cell therapy, lentiviral vector process development, and cGMP manufacturing of autologous cell therapy products. At Jannsen R&D, Ravi played a pivotal role in successfully leading the team for CAR-t cell therapy process development and lentiviral vector, contributing significantly to the commercial approval of Carvykti (autologous cell therapy product for multiple myeloma). Prior to this, he demonstrated innovation and leadership by implementing the industry's first large-scale single-use bioreactor (1000L) and single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing. Ravi's expertise extends to cell culture process development and scale-up, managing up to 10,000L bioreactors. He has also been instrumental in the development and implementation of single-use technologies for clinical material production. He has delivered numerous presentations on single-use technologies for biopharmaceutical manufacturing and authored publications on cell physiology and single-use technologies.

Anthony Blaszczyk, PhD, Senior Scientist, Global Biologics, US Pharmacopeia

Dr. Anthony Blaszczyk is in the Pipeline Development group within USP’s Global Biologics department. At USP, he works with scientific experts and stakeholders to develop new standards to support biopharmaceutical quality assessment and development. Prior to USP, Anthony worked at Catalent Cell and Gene Therapy, where he managed an analytical development team responsible for the development, qualification and transfer of methods. He obtained his Ph.D. in Biochemistry from Penn State University in 2018.

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.

Rajeev Boregowda, PhD, Associate Director, Bioassay and Molecular Analytical Development, Genomic Medicine CMC, Sanofi

Rajeev has PhD in Biochemistry. He worked as bioassay and analytical lead for various gene therapy programs supporting method development and tech transfer to internal and external QC labs. In addition, he worked closely with the CMC and manufacturing team to support all their activities.

Michael Boyd, Senior Scientist II, Novartis

Michael Boyd has been working on gene therapy at Novartis for the past four years, with a focus on rAAV molecular biology. Before working at Novartis, he gained experience in viral vector development through roles at Homology Medicines in the rAAV process development group and at Beth Israel Deaconess Medical Center focusing on vectorized adenovirus vaccine development. He completed his BS in Biochemistry from Worcester Polytechnic Institute and a MS from Northeastern University.

Massachusetts Institute of Technology

Richard D. Braatz, PhD, Edwin R. Gilliland Professor, Chemical Engineering, Massachusetts Institute of Technology

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

Lisa Bradbury, PhD, Senior Director, Analytical Development, Be Bio

No bio available.

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.

Ultragenyx Pharmaceutical

Dorota A. Bulik, PhD, Senior Director, Pharmaceutical Development, Ultragenyx Pharmaceutical

I have received my PhD in Biochemistry and Molecular Genetics from Northeastern University, Boston, MA, and did the post-doc at Boston University Medical Center. I worked for 14 years at Momenta Pharmaceuticals, Cambridge, MA in research and development focusing on the development of protein, peptide and heparin-based therapies for the broad spectrum of the inflammatory and autoimmune indications. Some of the activities I was involved in were: translational research, analytical methods development of the complex biologics, bioprocess development and bioassays for preclinical and clinical development including d potency. For the last two years I have worked at Ultragenyx Gene Therapy supporting several programs for the rare and ultrarare diseases for the AAV-based therapies. My major focus is on the potency matrix development during clinical development and registration.

Advanced Cell & Gene Therapy LLC

Scott R. Burger, Principal, Advanced Cell & Gene Therapy LLC

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 30 years of experience developing cell and gene therapy products and has consulted for over 180 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products for immunotherapy and regenerative medicine. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous regulatory submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies. Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board, and multiple ISCT committees. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis, and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.

Amgen Inc

Shawn Cao, PhD, Scientific Director, Amgen

Dr. Cao is the Scientific Director at Amgen, a leading biotechnology company. He has a PhD in chemistry and has over 20 years of experience in protein product development. His expertise covers various aspects of protein structure, aggregation and particulation, formulation development, process-related impurities, formulation excipients, and subvisible and visible particles. He has published multiple papers and book chapters on these topics. He is also an active member of several professional societies and editorial boards related to biopharmaceutics. Dr. Cao is passionate about advancing the field of protein therapeutics and improving the quality and safety of biologic products.

Qinjingwen Cao, PhD, Principal Scientist, Technical Development, Genentech

Qinjingwen Cao is a Technical Development Principal Scientist in the Protein Analytical Chemistry department at Genentech. Her primary focus is on advancing mass spectrometry techniques and software infrastructure to fulfill unmet needs in the development of therapeutic antibodies and emerging drug modalities. Previously, she worked at Regeneron Pharmaceuticals, where she developed quantitative proteomics methods and digital solutions to accelerate drug discovery and development. Qinjingwen has a PhD in analytical chemistry from University of Wisconsin-Madison.

Univ of Virginia

Giorgio Carta, PhD, Lawrence R. Quarles Professor Emeritus of Engineering and Applied Science, Chemical Engineering, University of Virginia

Giorgio Carta is the Lawrence R. Quarles Professor Emeritus at the University of Virginia. He has published over 180 archival journal articles, and co-authored the book “Protein Chromatography - Process Development and Scale-Up”, Wiley -VCH (2010, 2020), and Section 16 “Adsorption and Ion Exchange” of Perry's Chemical Engineers' Handbook. He has served as a member of the Organizing Committee of the International Symposium on Preparative and Process Chromatography (PREP) since 1997 and as the PREP Symposium Chair annually from 2009 to 2022. His research is focused on understanding biochromatography focusing on resin structure and function, mechanistic modeling, and bio-process design and scale-up.

Ultragenyx

Dennis P. Chen, Senior Scientist, Downstream Process Development, Ultragenyx Pharmaceutical

I am a scientist in downstream process development at Ultragenyx. My work focuses on CMC activities that support the development of rAAV-based assets. Active areas include early-stage process development and late-stage process characterization. Interests include integrating high-throughput platforms, process analytical tools, and user-friendly software applications and modeling approaches to enable efficient and effective bioprocess development.

Twinkle Christian, MS, Senior Scientist, Amgen, Inc.

Twinkle Christian is a Process Development Senior Scientist at Amgen. She has 20 years of experience in drug product development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation development and drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an inventor on multiple patents related to formulation and drug delivery. Twinkle is an adjunct lecturer at California State University, Channel Islands. She holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.

Dana Farber Cancer Institute

Felicia Ciuculescu, MD, Director, Technology Transfer, Cell Manipulation Core Facility, Dana Farber Cancer Institute

Dr. Felicia Ciuculescu is serving as the Tech Transfer Director of the Cell Manipulation Core Facility (CMCF) at Dana Farber Cancer Institute (DFCI), Harvard Medical School (HMS). Felicia joined CMCF in April 2023 and is overseeing technology transfer for the Novel Cell Therapy Program at CMCF/DFCI. Prior to joining CMCF, Felicia spent 4 years in the translational clinical research program at Boston Children's Hospital (BCH), where she co-directed the program and contributed to the development/advancement of multiple pre-clinical studies, on-going clinical studies and biorepository studies. Felicia earned her MD from UMFT, Romania, followed by a Doctor of Medicine degree at Goethe University in Frankfurt am Main, Germany. In 2012, Felicia joined Dr. David Williams's program at BCH, HMS where she completed post-doctoral trainings in fundamental stem cell biology research, followed by clinical research in the gene therapy program at BCH/DFCI. Felicia is a very dedicated and heart-passionate physician-scientist, who hopes to bring many preventive/curative treatments to those in suffering.

US Pharmacopeia

Ben Clarke, PhD, Senior Scientist, USP

Ben Clarke supports USP’s portfolio of documentary and physical reference standards for the Global Biologics group. He specializes in cell and gene therapy, vaccines, and monoclonal antibodies. Before joining USP, Ben developed analytical bioassays at GSK Vaccines for RSV and self-amplifying mRNA vaccines. Before GSK Vaccines, he pioneered the development of mouse models of sphingolipid biology using CRISPR/Cas9 genome editing technology at the National Institute for Health. Before NIH, he optimized upstream PER.C6 cell culture for the production of adenovirus at Janssen. He received his PhD from Cornell University for his work on mammalian membrane biology and lipid remodeling enzymes. He received his BS from Pennsylvania State University for Biochemistry, Molecular, and Cell Biology.

Unicorn Consultations

Nathalie Clement, PhD, Vice President, Vector Development, Translational Gene Therapies, Siren Biotechnology

Dr. Clement has 25+ years of experience in the field of Gene Therapy, with industry leading expertise in viral vectors, specifically adeno-associated virus (AAV). She led AAV production and process development at research, preclinical and clinical grades during her time at the Powell Gene Therapy Center, University of Florida, Gainesville. SHe oversaw manufacturing, release and stability campaigns of more than eight AAV INDs, including CMC preparation. Her research focused on optimizing large-scale suspension platforms using HSV or transfection systems in suspension to produce clinical rAAV. Dr. Clement then joined Resilience as the head of the Process Development group for Viral Vaccines and Gene Therapy, where she oversaw production at scale up to 200L in suspension format, and in large scale adherent platforms. Currently, Dr. Clement acts as the Vice-President of Vector Development at a new startup company and continue to consult in the field of gene therapy and AAV.

Eli Lilly & Co

Alex Cohen, Senior Principal Engineer, Bioproduct R&D, Eli Lilly & Co.

Alex has a BSE in Chemical Engineering and a MSE in Pharmaceutical Engineering from the University of Michigan. He has worked at Eli Lilly and Company since 2012 in Manufacturing Technical Services and transitioned to Bioproduct Research and Development in 2015. Alex has supported upstream and Primary Recovery processing in the development pilot plant and leads the Engineering Technology Group.

Biologics Consulting Grp

Diana Colleluori, PhD, MBA, Consultant, CMC Analytical, Biologics Consulting Group

Diana M. Colleluori, PhD, MBA is an Accomplished Executive Leader with 20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, and raw materials. Previous head of Quality Control for several innovator companies including Iovance Biotherapeutics, bluebird bio, and Merck. PhD in Biochemistry from Temple University School of Medicine and MBA in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

Regeneron Pharmaceuticals Inc

Louis Coplan, Process Development Engineer II, Regeneron Pharmaceuticals Inc.

Louis Coplan is a bioprocess engineer with five years of experience in gene therapy manufacturing. He received his Bachelor of Science degrees in Biochemistry and Biological Sciences, and a Master of Engineering in Chemical and Biomolecular Engineering from the University of Maryland, College Park. As a bioprocess engineer at Regeneron, Louis focuses on upstream preclinical process development for adeno-associated virus vectors.

Genentech Inc

Madalene Crow, Senior ISA Product Manager, Genentech Inc.

Madalene is a Senior Product Manager at Genentech, where she leads cross-functional agile teams and scientific stakeholder engagement to design and deliver a range of innovative technology solutions. Her passion lies in fostering collaboration and driving operational excellence within dynamic environments, making meaningful contributions to the biotechnology and pharmaceutical industries to enhance patient outcomes and quality of life.

Susan D'Costa, PhD, CTO, Genezen

Susan D’Costa, PhD, is the CTO at Genezen. She is a molecular virologist with extensive expertise in viral vector analytics, process development, and manufacturing. She has built a considerable amount of this experience in the contract manufacturing industry (Thermo Fisher/Brammer Bio) working with different viral vectors, liaising with diverse biotech clients, and building teams with scientific and operational excellence. Prior to Genezen, Susan was the CTO at Alcyone Therapeutics, where she oversaw both internal and external CMC (chemistry, manufacturing, and controls), device development operations, and building out new technologies for both gene therapy and precision delivery. In her current role, Susan is working on building out the AAV business unit at Genezen, a reputed CDMO for lentivirus and retrovirus development and manufacturing. Dr. D’Costa holds a PhD in Biology (specializing in molecular virology) from Texas Tech University, an MS in Biochemistry from Mumbai University (Grant Medical College), and a BS in Microbiology/Biochemistry also from Mumbai University (St. Xavier’s College).

Hussain Nuruddin Dahodwala, PhD, Director, Upstream Process Development, NIIMBL

Hussain Dahodwala earned his PhD from RPI in 2007 and has an extensive research background. He has worked at SUNY Polytech, NIH VRC labs, and the University of Delaware. His focus lies in understanding how culture conditions and cell physiology impact living systems used in industrial processes. Specifically, he explores mammalian cell systems for therapeutic protein production. His numerous publications delve into the use of modern cell and molecular biology, as well as “omics” approaches, to optimize production systems from both engineering and biological perspectives.

Lumilytics

Avinash Dalal Ph.D. is director of data science at Lumilytics. His team works to build fit for purpose solutions for pharmaceutical drug development by applying generative AI and computational modeling. Prior to Lumilytics, Avi worked as a principal data scientist leading development and deployment of AI and modeling solutions in biotherapeutics at Pfizer. Prior to joining Pfizer, he worked in forecasting for the retail market and was also a tenure-track professor in mathematics & statistics. He has his Ph.D. in mathematics from Drexel University where his work was in algebraic combinatorics and geometry.

Lumilytics

Varsha Daswani, PhD, PMP, Senior Director, Data Strategy, Lumilytics

Varsha Daswani Ph.D. PMP is the senior director of data strategy at Lumilytics. Her team works to adapt and advance generative AI, natural language processing, and machine learning tools to create fit for purpose solutions for pharmaceutical drug development. Prior to joining Lumilytics, Varsha worked at both Pfizer and Janssen. Most recently at Pfizer, she led the large molecule Analytics and Data Science group. She has her Ph.D. in Biochemistry from Temple University where she developed a novel liposome encapsulation method for small molecule chemotherapeutic agents.

Francesco Destro, PhD, Postdoctoral Associate, Chemical Engineering, Center for Biomedical Innovation, MIT

Dr. Francesco Destro is a Postdoctoral Associate at the Department of Chemical Engineering and at the Center for Biomedical Innovation at MIT, where he conducts research into process systems engineering and advanced biopharmaceutical manufacturing. He obtained a Ph.D. in Chemical Engineering from University of Padova in 2022, with a dissertation on the use of mechanistic modeling and machine learning for optimizing pharmaceutical systems. He is the first author of 11 peer-reviewed publications, and complemented his research training in systems engineering and (bio)pharmaceutical manufacturing as a Visiting Scholar at Siemens Process Systems Engineering (London, UK) in 2019 and at Purdue University in 2020 and 2022.

Pfizer Inc

Gayatri Dhara, PhD, Senior Scientist, Upstream Process Development, Pfizer Inc.

No bio available.

Alexion Genomic Medicines

Nick DiGioia, CMC Process Development, Alexion Genomic Medicines

Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst. and has over 7 years of experience in the biotech industry developing biologics manufacturing processes. He got his start supporting commercial manufacturing at Sanofi and has since held roles of increasing responsibility in the process development groups at Bristol Myers Squibb and LogicBio therapeutics. He is currently serving as a manager of genomic medicines process development at Alexion pharmaceuticals.

BOKU Vienna

Felix Dieringer, PhD Student, BOKU Vienna

Felix is a PhD student at Takeda and member of the Bioprocess Engineering Doctoral School at BOKU (University of Natural Resources and Life Sciences), Vienna. His PhD thesis focuses on environmental sustainability of biologics and the improvement of Green Metrics. Felix has several years of industry experience in downstream process development for recombinant complex proteins. Felix holds a master's degree in Medical Biotechnology from BOKU.

Abbott Labs

Yongxue Ding, PhD, Principal Scientist, Biologics Process Design R&D, Abbott Diagnostics Division, Abbott Laboratories

Principal scientist with over ten years’ industry experience for biologics, and with extensive hands-on expertise in the full cycle of upstream process development from R&D phase of small scales DoE experiment, to scale up at pilot scale up to 2000 liters, and technical transfer and support for full scale commercial production at up to 40,000 liters.

Terrence Dobrowsky, PhD, Head, Gene Therapy Drug Substance, Biogen

Terrence has led the Upstream Process Development group for Gene Therapy programs at Biogen since 2016. His group has supported the development of multiple programs, enabled by multiple industry and academic collaborations as well as internal development. Before joining the Gene Therapy Department, he contributed to program and technical initiatives for Biogen Biologics programs including early phase development, mid-phase optimization and late-phase process characterization. Terrence earned B.S. in Chemical Engineering from the University of Notre Dame in 2005 and a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2010 where he focused on characterizing lentiviral adhesion kinetics.

Snaha Dogiparthi, Scientist Bioassay Development, Early Bioprocess, Pfizer Inc.

A talented and motivated Scientist with 6+ years of laboratory experience. Proficient in molecular biology techniques (ddPCR, RT-qPCR, NGS), assay design, troubleshooting, leadership, mentoring, and project management. Experienced professional in drug discovery research & development. Progressing my career in the biotechnology/pharmaceutical industry by continuously being curious and creative.

Takeda Pharmaceuticals

Michael Dolan, Staff Engineer, Process Development US, Takeda Pharmaceuticals

Mike currently works as a Staff Engineer at Takeda, where he specializes in the downstream process development of protein therapeutics. His efforts largely focus on harvest, chromatography, filtration, and UF/DF development of monoclonal antibodies and engineered proteins, spanning from early manufacturability through process performance qualification and commercialization. In addition to his day-to-day responsibilities, Mike is pursuing his PhD in Chemistry & Chemical Biology under the direction of Prof. Sunny Zhou at Northeastern University. Through their industry-academia collaboration, Mike and Sunny are investigating and characterizing host cell protein impurities to better understand their interactions with therapeutic proteins and to develop practical solutions that can aid the industry at large.

Alexion, AstraZeneca Rare Disease

Victoria Drake Carnein, Associate Scientist IV, Upstream Process Development, Alexion, AstraZeneca Rare Disease

Victoria Drake Carnein is a senior associate scientist in upstream process development at Alexion, AstraZeneca Rare Disease. She has expertise in cell culture, cell clarification, bioreactor automation, and data analytics. Victoria has experience leading the development of upstream cell culture processes during early and late stages of process development. She has a BSE in Chemical Engineering from the University of Connecticut and an MSE in Chemical and Biological Engineering from Princeton University.

Caring Cross

Boro Dropulic, PhD, Co-Founder & Executive Director, Caring Cross

Boro received his PhD from the University of Western Australia and his MBA from the Johns Hopkins University (JHU). He has been in the gene therapy field since the late 1980s. As CEO, Boro brings 30+ years of leadership and experience in the design, development, manufacturing, clinical translation, regulatory, clinical implementation, and commercialization of Lentiviral vector technology. After a Fogarty Fellowship at the NIH, he joined the faculty at JHU where he worked on developing Lentiviral vectors as delivery systems for gene therapy. After 4 years in academia, he founded his first company, ViRxSys, and led the team that first demonstrated the safety of Lentiviral vectors in humans with his UPenn colleagues. Later he founded Lentigen, which first developed the Lentiviral vector used to produce Kymriah, the first FDA-approved gene therapy product. He implemented and directed the company’s CDMO business model and therapeutic pipeline of gene therapy products. He led Lentigen until 2021, and then left to co-found and launch Caring Cross, a 501 (c)(3) non-profit, and serves as the Executive Director. Lentiviral vectors are critical to produce many gene therapy products such as CAR T cells and gene-modified Hematopoietic Stem Cells (HSCs) for the treatment of an increasing number of important diseases. Presently there are huge bottlenecks in obtaining high quality Lentiviral vectors in a reasonable time that motivates investigators and investors alike. This delays and puts at risk the development and commercialization of innovative and potentially curative gene therapies that are desperately needed. Seeing a need to help investigators improve and accelerate their medicinal concepts needing Lentiviral vectors into the clinic, Vector BioMed was launched and Boro serves as the CEO.

BlueSphere Bio

Zhimei Du, PhD, CSO, BlueSphere Bio

Dr. Zhimei Du is a leader in the fields of Cell/Gene Therapy and Biologics with significant experience in both early and late-stage development. Currently serving as Vice President at Landmark Bio, she leads the Translational Research and Early Development of next-generation cell/gene therapies for various diseases. Prior to joining Landmark Bio, Dr. Du served as Vice President at Atara Biotherapeutics, where she focused on accelerating both early and late-stage cell therapy pipelines. She also worked at Merck & Co. as Executive Director and Global Head of Process Cell Sciences, where she established various new core functions in cell therapy and biologics during early development. Dr. Du has also been actively involved in successful business development activities, including evaluating and building partnerships for CAR-T and CAR-NK programs. Her research contributions include numerous patents and publications in cell and gene therapy, process development, protein engineering, cell engineering, vector engineering, and genetic/epigenetic biomarker development. Dr. Du received her Ph.D. in Immunology from Cornell University Medical College. She then worked as a Postdoctoral Fellow in Robert G. Roeder's laboratory at Rockefeller University, a world-renowned lab known for its groundbreaking work in transcription, in vitro transcription, and epigenetics.

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.

Regeneron Pharmaceuticals Inc

Huu Thuy Trang Duong, Senior Scientist, Formulation Development Group, Regeneron Pharmaceuticals Inc.

I’m currently a Senior Scientist in the Formulation Development Group at Regeneron Pharmaceuticals. I completed my PhD in Chemical Engineering and have over 10 years of experience working in drug delivery systems, specializing in nanomedicine and nanovaccine development. My expertise includes biomaterials applications and nanoparticle formulation, in vitro assays, as well as vast experience working with animal models that are relevant and transferrable for the field of drug delivery systems. During industry jobs, my work has been focused on the development of RNA and DNA delivery platforms based on peptide nanoparticles and lipid nanoparticles by optimizing, lyophilization, and stability studies.

National Research Council Canada

Yves Durocher, PhD, Research Officer & Head, Mammalian Cell Expression, National Research Council Canada

Dr. Durocher obtained his Ph.D. in Biochemistry at the Universite de Montreal. He joined the NRC in 1995 to work on the production of membrane receptors and recombinant proteins for various industrial partners involved in drug discovery projects. He manages a section of 30 scientists and 4 Ph.D. students involved in protein expression and stable CHO cell line development for internal projects and external clients. His research activities focus on improving large-scale transient gene expression (LSTGE) platforms using HEK293 and CHO cells for r-protein production, and on developing and engineering stable CHO pool and clonal cell line platforms for r-protein manufacturing. Dr. Durocher is also an Assistant Professor at the Departement de biochimie et medecine moleculaire at the Universite de Montreal.

Prime Medicine Inc

Joseph Elich, Senior Engineer, Prime Medicine

Joseph Elich is a Senior Engineer and mRNA Group Leader in the "mRNA and Non-Viral Delivery" group at Prime Medicine. Joseph received Bachelor's and Master's degrees in Biological and Chemical Engineering from Cornell University. He has over 10 years of experience in process, analytical, and automation development in various CMC and Technical Development organizations. Prior to Prime Medicine, Joseph worked in mRNA Process Development at Moderna and supported the early-stage development, scale-up, and eventual regulatory approval of SpikeVax COVID-19 mRNA Vaccine, among other programs. Joseph also previously worked on the early-stage development of antibody conjugates at Genentech.

REGENXBIO Inc

Metewo S. Enuameh, PhD, Senior Scientist, Vector Core Cell Line Development, REGENXBIO, Inc.

I am a Cell Line Development Scientist with over 11 years of experience in mammalian cell engineering using various platforms including, the CRISPR/Cas9 technology, Zinc finger nucleases (ZFNs) and Transcription Activator-like effector nucleases (TALENs) as well as proficient in cell line cloning. Presently at REGENXBIO, I am utilizing this expertise for the creation of stable cell lines, disease model cell lines and novel engineered cell lines for enhanced production of rAAV vectors and reduction in cost of goods.

HebeCell Corp

Allen Qiang Feng, PhD, Founder and CSO, HebeCell Corp.

Allen is the Founder and Chief Scientific Officer of HebeCell Corp. Prior to HebeCell, Allen was the Director of Cell Biology of Semma Therapeutics (Acquired by Vertex), R&D Head of Stem Cell Bioprocessing Group at EMD Millipore (Merck, KGaA), Director and Senior Scientist at Advanced Cell Technology (Acquired by Astellas), and Senior Scientist at Stemgent, Inc (Now ReproCell). Allen is an inventor of several key patents of hematopoietic lineage-specific differentiation from human pluripotent stem cells (hPSCs), such as the generation of HLA-negative platelets, and a scalable 3D manufacture platform of NK from hPSCs.

Samuel Fredericksen, Oligonucleotide Purification Development Engineer, Biogen

No bio available.

Paul Ehrlich Institut

Erika M. Friedl, PhD, Quality Expert, Haematology & Transfusion Medicine, Paul Ehrlich Institute, Germany

Erika Friedl is currently working as quality assessor (pharmaceutical quality/CMC) at the Paul-Ehrlich-Institute (PEI) in Langen, Germany. As a senior quality expert in the European authorization process, she is responsible for the evaluation of blood products covering plasma-derived and recombinant proteins. In addition, she is involved as an expert in national and international GMP inspections. Erika is a member of the Host Cell Protein Working Party at the EDQM (European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France). Erika received her PhD in biochemistry from the Albert-Ludwig University of Freiburg, Germany. During her career she worked in the fields of virology and transcription factors. As research associate, Erika joined the Department of Biochemistry at the Howard Hughes Medical Institute (UMDNJ, USA).

Data Science Institute, University of Technology Sydney

Bogdan Gabrys, PhD, Professor of Data Science, Data Science Institute, School of Computer Science, University of Technology Sydney

Bogdan Gabrys received a Ph.D. degree in computer science from the Nottingham Trent University, Nottingham, U.K., in 1998. He is currently a Professor of Data Science and a co-Director of the Complex Adaptive Systems Lab within the Data Science Institute at the University of Technology Sydney, Sydney, Australia. His research activities have concentrated on the areas of data science, complex adaptive systems, computational intelligence, machine learning, predictive analytics, and their diverse applications. He is particularly interested in the foundational aspects and challenging applications of fully automated and autonomous machine learning approaches including those in biopharma. He has published over 220 research papers, chaired conferences, workshops, and special sessions, and been on program committees of a large number of international conferences. More details can be found at his personal webpage: http://bogdan-gabrys.com

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.

Alayna George Thompson, PhD, Senior Research Scientist, AbbVie

Alayna received her PhD at the University of Arizona studying structural biology of metalloproteins, with post-doctoral training at Rosalind Franklin University. In 2016, she joined AbbVie where she has been performing mass spectrometry of biologics ever since. Her current focus is applying mass spectrometry to the late Discovery timeline to guide candidate decision making.

Ronit Ghosh, PhD, Purification Process Development Scientist, Genomic Medicine Unit, Sanofi

Ronit Ghosh, a Purification Process Development Scientist at Sanofi’s Genomic Medicine Unit, holds a Ph.D. in Chemical and Biological Engineering from Rensselaer Polytechnic Institute. Specializing in downstream bioprocessing, Ronit has led innovative research in developing biomanufacturing processes for non-viral and viral gene therapy vectors like AAV and lentiviral vectors. With expertise in gene therapy process development, he has been involved in developing purification strategies for diverse modalities, contributing to the advancement of gene and cell therapy applications.

Davide Gianni, PhD, Principal Scientist, Biogen

Davide has a Masters in Biotechnology form University of Milan and a PhD in Biochemistry from Imperial College, London. After earning his PhD, he focused on the development of AAV-based gene therapy approaches for brain tumors and neurological disorders in Dr. Miguel Sena-Esteves’s Lab (Massachusetts General Hospital, Neurology Department, and UMass Medical School, Horae Gene Therapy Center). Davide joined Biogen’s Neurology department in 2013 as an in-vivo pharmacologist primarily supporting the multiple sclerosis and neuroinflammation preclinical and exploratory pipelines. In 2019 he joined the Gene Therapy Accelerator Unit, where he’s currently leading the production and purification team to generate AAV material supporting the entire internal preclinical Gene Therapy pipeline as well as ongoing Gene Therapy-related tech development projects.

Joanne Gilchrist, Scientist I, Process Biochemistry, Biogen

Joanne is Scientist in the Biologics Development organization at Biogen. Since graduating from Glasgow University, her career has focused on the development of downstream purification processes, first at a CDMO in the UK, and then at Biogen for the past 12 years. Joanne works within a team of scientists to develop and optimize chromatography steps for monoclonal antibody processes, both for early and late-stage projects.

Eli Lilly & Co

Brian Good, PhD, Senior Research Advisor, Eli Lilly and Company

Brian Good is a senior research advisor in the disruptive and transformation technologies team at Eli Lilly and Company. Mr. Good has over 20 years of experience in the application of information and scientific solutions within the pharmaceutical industry. Brian is currently leading projects in the space of data transformation, ontology, and machine learning. He is a member of the International Consortium for Quality & Innovation in Pharmaceuticals (IQ Consortium) and the Emerging Technologies Committee (ETC). He leads working groups within both of those forums. Mr. Good is a past recipient of the Lilly Research Laboratories President Award and the Lilly Innovation Award for his work in the area of scientific search and analytics. His research interests have included National Science Foundation grants in quality-by-design and the national Engineering Research Centers (ERC) program.

Bharathi Govindarajan, PhD, Principal Scientist, Bioanalytical Sciences, Sanofi, United States

Bharathi Govindarajan PhD is an Associate Director working at Sanofi in Framingham, MA. Bharathi received her doctoral degree from Case Western University in Cleveland, OH, and completed her postdoctoral studies at the Schepens Eye Research Institute, Harvard Medical School, Boston, MA. Through her time in the pharmaceutical industry, she has worked on developing Bioassays and residual impurity methods in the development functional to support product development for biologics.

Eli Lilly and Company

Claudia Gributs, PhD, Senior Director, Research and Development, Eli Lilly and Company

Claudia Gributs, PhD, is a Senior Director in Bioproduct Analytical Development at Eli Lilly and Company. Claudia has 19 years of experience in the biopharmaceutical industry, having held positions in both development and commercial manufacturing at Lilly. Currently, Claudia’s focus is on the development and commercialization of monoclonal antibodies, in particular the design of integrated control strategies and implementation of appropriate analytical and bioanalytical testing. Claudia earned her BSc and PhD in Chemistry at McGill University (Canada).

Robert S. Gronke, Senior Principal Scientist, Technical Development, Biogen

Robert Gronke is a Senior Principal Scientist in the Technical Department at Biogen. For the past 34 years, he’s been involved in the purification development, CMC team leadership, regulatory liaison, and new technology assessment for recombinant biopharmaceuticals including Biogen’s commercial and clinical antisense oligonucleotide and biologic products. Rob currently manages a group of 6 associates/scientists. Prior to joining Biogen, Rob was a post-doc at Merck, West Point, PA. He received his PhD degree in Biochemistry from the University of Kansas, Lawrence, Kansas in 1987, and a BS degree in Biochemistry from Northern Illinois University, DeKalb, Illinois in 1982.

Genentech

Axel Guilbaud, PhD, Principal Scientist, Genetech

Axel Guilbaud is a Principal Scientist at Genentech with 5 years of experience working on analytical method development of proteins and small molecules (i.e., DNA and mRNA). Having contributed significantly to the field, Axel Guilbaud has pioneered innovative approaches including reverse phase liquid chromatography, capillary electrophoresis, mass photometry, and mass spectrometry, ensuring the safety and efficacy of biotechnological applications.

Elben Guimaraes, Senior Manufacturing Manager, Upstream Manufacturing, Ultragenyx Pharmaceutical Inc.

Elben Guimaraes is a Senior Manager of Upstream Manufacturing at Ultragenyx. Elben has worked in the biotech industry for more than 15 years in clinical and commercial manufacturing of bioproducts for companies such as Vertex, Sanofi, and Agenus. Elben was fortunate to participate in the buildout and start-up activities of multiple manufacturing facilities and labs. As one of the highlights of his career, he was part of a small team responsible for manufacturing a first-in-human insulin-making cell therapy for Type 1 Diabetes patients.

Janssen Pharmaceutical Companies of Johnson & Johnson

Harsha Gunawardena, PhD, Principal Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & Johnson

Harsha Gunawardena obtained his Ph.D. from Purdue University where his thesis research was carried out in advanced multi-source ion traps to facilitate the manipulation, reactivity (ion parking) of gaseous ions. He was a post-doctoral fellow at the Lineberger comprehensive cancer center, at The University of North Carolina at Chapel Hill, where his research focused on developing and refining quantitative platforms to support investigators in large-scale proteomics studies in the basic sciences to clinical research. He was a co-investigator for the National Cancer Institute’s Clinical Proteomics Tumor Analysis Consortium (CPTAC) and was a member of UNC ENCODE consortium. He has over 100+ research publication and proceedings and 3 patents. His industry career as scientist started at Bayer Health Care providing mass spectrometry and bioanalytical support of plasma-based therapeutics. He later worked at Amgen applying proteomics methods to support biomarker programs in discovery. His current role at Janssen R&D uses mass spectrometry to support discovery and early development programs.

Brian E. Hall, PhD, Distinguished Scientist, Large Molecule Research, Sanofi

9 years at Amgen in Biologics protein production, 5 years at Merck, and 2 Years at Sanofi where I currently lead the characterization, Expression and Purification group for US research. I can provide more detail if needed.

Roche/Genentech

Ken Hamilton, Distinguished Engineer, Genentech

Ken Hamilton is a chemical engineer with over 30 years' experience. He has a Master's and Ph.D. from University of Wales and undergraduate at University of Manchester Science & Technology, in the UK. His background includes process and facility design and engineering and leading projects to enable drug substance manufacturing sites to receive new products and platforms. He also undertakes process economic analyses for new processes. He is a Distinguished Engineer at Roche/Genentech, in their global technology organization, and has been at Roche/Genentech for the past 18 years. Responsibilities include leading evaluations of new process platforms and new equipment technologies for manufacturability and cost, working closely with R&D, Finance, business strategy groups and the drug substance manufacturing sites. Previously, he led the process-engineering group at one of the drug substance sites, supporting ongoing manufacturing operations and the engineering aspects of product transfers to the site. He was chapter president of the ISPE San Diego chapter, and is a co-lead for the NIIMBL Sustainability team. Several years ago, he was an affiliate professor at Colorado State University. Ken has made roughly 20 presentations and publications to the biopharm industry.

Children's National Hospital

Patrick J. Hanley, PhD, Associate Professor, Pediatrics; Chief & Director, Cellular Therapy Program, Children's National Hospital

Dr. Hanley is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 16 years he has helped to translate more than 300 products on over 25 cell therapy protocols - ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells - into the clinic. Dr. Hanley was elected Vice President, North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors, on the Immuno-Gene Therapy Committee (and former co-chair),and co-founded and served as the inaugural co-chair of the Early Stage Professionals committee which focuses on workforce development and training. He also serves on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and is an active cellular therapy and cord blood inspector. Dr. Hanley has actively participated in the Cell Therapy Liaison Meeting with the Food and Drug Administration since 2018 and he is the commissioning editor of the journal Cytotherapy. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys tweeting with fellow scientists and Bills fans, playing soccer, cycling, cooking, and traveling.

Amgen Inc

Jia He, Senior Scientist, Amgen

Jia He is a Process Development Senior Scientist at Amgen, where she works on drug product formulation and process development for biologics. She has over 10 years of research experience in formulation and process development in diverse modalities. Jia obtained an MS degree in Biomedical Engineering from Carnegie Mellon University and a PhD degree in Pharmaceutical Sciences from University of Connecticut, where she conducted research on combination products and long-acting injectables. She has co-authored 17 publications and 2 book chapters and is listed as an inventor on 5 patents.

Abbvie Biotherapeutics Inc.

Guannan He, PhD, Principal Research Scientist I, CMC Bioprocess, Development Sciences, Abbvie Biotherapeutics Inc.

Guannan He is a Principal Research Scientist in the downstream process development, CMC Biologics group at AbbVie in South San Francisco, CA. Guannan received her PhD in Biochemistry at Washington University in St. louis in 2015. She joined the Genentech Protein Science department the same year to focus on antibody/antibody fragment purification and conjugation. Guannan joined AbbVie in 2018 and, as a group leader, currently works on CMC purification process development of biologics to enable first-in-human clinical studies.

GC Therapeutics

Mo Heidaran, PhD, Head, Translational and Regulatory Strategy, GC Therapeutics; Former FDA Reviewer

Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. He has close to 9 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ). During his tenure at OTAT, in addition to his review responsibilities, he also served as Acting Team Lead and Branch Chief briefly and as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP. He has also been involved in various standard development activities, cell-based product manufacturing initiatives and various compliance activities. Mo is currently member of USP Bio3 Complex Biologic Expert Committee, ISCT Legal and Regulatory Affairs Committee and contributor to the A-Gene Project sponsored by the Alliance for Regenerative Medicine (ARM). Dr. Heidaran has a multidisciplinary academic and industrial background in basic and applied cell biology and innovative cell therapy and tissue engineering product development. He also has hands-on industrial experience in manufacturing of cell therapy and tissue engineering products for about 15 years in small and large size Biotech companies. His long lasting scientific interest is to understand the molecular control mechanisms that regulate growth and differentiation of stem cells in the three-dimensional microenvironments. He is also founder and first chair of prestigious Gordon Research Conference in “Signal Transduction by Engineered ECMs.” Mo received his formal training at the National Cancer Institute where he served as a Senior Staff Scientist for about 6 years and 3 years as an IRTA fellow studying signal transduction by receptor tyrosine kinases. Dr. Heidaran holds a Ph.D. in biochemistry from the University of South Carolina, and received his formal training at the National Cancer Institute. Prior to FDA, he served as R&D Director at both Celgene and Becton Dickinson. He has been an ad hoc reviewer and member of editorial boards of several peer reviewed publications. He also holds 25 issued patents and 54 pending patents and his work has appeared in more than 50 scientific publications.

Michigan Technological Univ

Caryn L. Heldt, PhD, Professor, Chemical Engineering, Michigan Technological University

Dr. Caryn L. Heldt is the Director of the Health Research Institute, the James and Lorna Mack Chair in Continuous Processing, and a Professor in the Department of Chemical Engineering at Michigan Technological University. She received her PhD in Chemical Engineering from North Carolina State University in 2008 and completed a two-year postdoc at Rensselaer Polytechnic Institute. In 2015, Dr. Heldt was awarded an NSF CAREER award to study virus surface chemistry. She was awarded the Bhakta Rath Research award at Michigan Tech in 2021 and the Faculty Distinguished Service award in 2022. Her lab is focused on the purification, inactivation, and stability of viral vectors.

Christoph Herwig, PhD, former Professor, Bioprocess Engineering, Vienna University of Technology; CPO, Fermify GmbH; Senior Scientific Advisor, KÖrber 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 KÖrber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for KÖrber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

Spark Therapeutics Inc

Van M. Hoang, PhD, Senior Vice President, Head, Analytical & Quality Control, Spark Therapeutics Inc.

Van Hoang, PhD, has over 20 years of experience leading analytical organizations and developing medicines for patients globally. Her area of expertise is in bioprocess development of gene therapies, vaccines, and therapeutic proteins. Van joined Spark Therapeutics in March 2020. She currently serves as Head of Analytical and Quality Control at Spark Therapeutics, where she leads an organization focused on analytical development, quality control testing, and operations for assets spanning preclinical development through marketed products including asset lifecycle maintenance. Before joining Spark Therapeutics in March 2020, Van was at Merck for 17 years. Van holds a Doctor of Philosophy degree in Pharmaceutical Chemistry from UCSF and a Bachelor of Science degree in Biochemistry from the UCLA graduating with Magna Cum Laude honors.

Regeneron Pharmaceuticals Inc

Yunli Hu, PhD, Senior Principal Scientist, Regeneron Pharmaceuticals Inc.

Yunli Hu is a Senior Principal Scientist in Analytical Chemistry at Regeneron Pharmaceuticals in Tarrytown, New York. Her current role focuses on the host cell protein characterization and quantitation by mass spectrometry. Prior to joining Regeneron, Yunli worked at Mylan, where she was involved in complex product characterization by mass spectrometry from 2017 to 2021. Yunli Hu has also worked at Biogen Analytical Development group for therapeutic protein characterization from 2015 to 2017. Yunli Hu received her PhD from Texas Tech University, where she focused on glycan characterization and quantitation by LC-MS/MS.

Dana Farber Cancer Institute

Ruud Hulspas, PhD, Technical Director, Process Development, Dana-Farber Cancer Institute

Dr. Ruud Hulspas works at the Dana Farber Cancer Institute as Technical Director of Process Development in the Cell Manipulation Core Facility. He is the Founder of Cellular Technologies Bioconsulting, a company dedicated to increase reproducibility and quality of (pre-)clinical research, with a focus on incorporating reliable analytics into cell therapy manufacturing processes. Previously, Dr. Hulspas was Vice President of Scientific Affairs at Cytonome, a company originally created to develop technologies for cell sorting in manufacturing of cell-based products for cell therapies. Prior to joining Cytonome, Dr. Hulspas led the R&D and lean operations of cytometry assays and cell-sorting methods in the stem cell expansion and cord blood storage divisions of ViaCell, Inc. He received his B.S. and M.S. from Leiden University, his Ph.D. in Cell Biology from University of Amsterdam, and his technical training at the TNO Radiobiological Institute in Rijswijk, the Netherlands. As a postdoc at the newly founded Cancer Center at the University of Massachusetts, Dr. Hulspas headed the Cytometry core facility, while his research projects focused on the identification and purification of a wide range of hematopoietic and neural progenitor cell types.

BioPharma Technical Consulting (BPTC)

Martin Hurley, Managing Director, BioPharma Technical Consulting (BPTC)

Martin Hurley is the director and co-founder of Bio Pharma Technical Consulting, a consultancy that partners with clients to deliver expertise in CMC, Cell & Gene Therapy, Tech Transfer, GAMP5 in the Biopharma and Pharma space. He brings 30+ years of international Automation, System development (SCADA), and PM experience in electronics, pharma industries. Prior to establishing BPTC, Martin was Applications Systems Manager EMEA with Elanco Animal Health (a division of Eli Lilly until 2019) where he liaised with scientists and equipment vendors to develop and deliver high-end enzyme application systems and solutions. Martin also worked with Eli Lilly in the Caribbean Island of Puerto Rico where, as a member of the Capacity Expansion Team, he managed business critical projects involving application of lean strategies to optimize CSV processes to meet or exceed regulatory expectations. Previous roles include software engineering in the electronics industry (Apple Computer) and SCADA development/deployment (Gilroy Automation) for clients in the Pharma industry. In Summary: Martin is analytical and strategy-oriented, with experience in large-scale multiphase and high-profile projects in a variety of areas including automation, equipment deployment and capacity expansions in a GMP environment.

Jonathan Janke, PhD, Scientist, Biologic Drug Product Development and Manufacturing, Sanofi

PhD from Rensselaer Polytechnic Institute (advisors Robert Linhardt and Angel Garcia). PhD work was on MD simulations of the conformational ensembles of heparin sequences Postdoc was at Sanofi (Sanofi department is Biologic Drug Product Development & Manufacturing). Postdoctoral work on coarse-grained simulations of mAbs Current position is a Scientist, Drug Product Development at Sanofi (Sanofi department is Biologic Drug Product Development & Manufacturing)

WEJ Cell & Gene Therapy Consulting

William E. Janssen, PhD, Principal, WEJ Cell & Gene Therapy Consulting Services LLC

William E. Janssen, Ph.D. has worked for more than 30 years at translating lab bench models into cell and gene therapy products for administration to patients. In the course of these efforts he has developed and refined methodologies for all aspects of cell based therapy from cell collection, through manufacturing and administration. Dr. Janssen has also been responsible for facility design, drug master file creation, development of staff training programs, process engineering, technology transfer, SOP development, process validation, comparison studies and integration of processes, equipment and raw materials. He is particularly interested in and has been both a proponent and implementer of informatics solutions for management of cell and gene therapy development and manufacturing data.

Koerber Pharma Software

Sherwin Jayashinghe, Technical Sales Engineer, Koerber Pharma Software

Sherwin Jayasinghe is a Technical Sales Engineer for Koerber Pharma Software. In this role, Sherwin has presented technical demonstrations of PAS-X Savvy to potential clients that are interested in the capabilities of the software. He is a graduate of Rutgers University-New Brunswick with a Master's in Information Science with a concentration in Data Science.

Sanofi

Xin Jin, PhD, Scientist, Biological Drug Product Development, Sanofi

Xin Jin is a Scientist within CMC Drug Product Development Department at Sanofi. She joined Sanofi in 2019 to support protein formulation platform establishment. Later, she joined the gene therapy group and lead one of the AAV drug product development, including formulation study, fill finish process study, enclosure system and administration device selection, and in-use study. Prior to Sanofi, she worked at Armstrong Pharmaceuticals for 7 years and lead Metered Dose Inhaler drug product development. She obtained her PhD in Chemical Engineering from Ohio University.

Spark Therapeutics Inc

Mi Jin, PhD, Head, Downstream and Drug Product Development, Spark Therapeutics Inc.

Mi Jin (Jinmi) is Head of Downstream and Drug Product Development at Spark Therapeutics. She has over 20 years' experience in large molecule characterization, manufacturing process development, scale up, tech transfer, process characterization/PPQ, and regulatory filings. She has worked in Bristol Myers Squibb and Teva Pharmaceuticals prior to joining Spark.

University of Pennsylvania

Pranav Joshi, PhD, Associate Director, Upstream Process Development, University of Pennsylvania

Pranav Joshi currently serves as an Associate Director, Upstream Process Development, for Gene Therapy Program at the University of Pennsylvania. In this position, Pranav oversees upstream process development and platform improvement activities for rAAV-based gene therapy vector production. Pranav graduated from McGill University, Montreal, Canada, in 2021, with a PhD in Bioengineering. In his doctoral work, Pranav developed upstream and downstream processes and process analytics for rAAV manufacturing employing insect cell- and mammalian cell-culture platforms in collaboration with National Research Council of Canada in Montreal. Pranav started his career in industry with Intas Pharmaceuticals Ltd., in India, as an upstream process development engineer for manufacturing of monoclonal antibody-based therapeutics. Collectively, Pranav has more than 8 years of process development experience for biotherapeutics manufacturing and has authored several research publications on rAAV manufacturing technologies.

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.

Merck & Co.

Jon Jurica, PhD, Principal Scientist, Analytical Research and Development, Merck & Co.

I received my undergraduate degree in Chemistry from James Madison University before starting my career at Merck, in 2000. I worked for three years in the Technical Operations group at our Elkton, VA, chemical manufacturing plant. In 2003, I enrolled in the University of Pennsylvania as part of the Merck PhD program where I earned my PhD in organic chemistry under the supervision of Amos B. Smith, III. In 2008, I returned to Merck, this time to Chemical Engineering Technical Laboratories focused on reaction engineering and general optimization and troubleshooting of small molecule API’s. In 2014, I was appointed to the Process Development Intensification Lab, whose focus is to develop and implement tools and methodologies to foster efficient, data rich experimentation within the process engineering groups. In 2016, I was appointed to lead an initiative to further expand our data rich experimentation efforts across all of Process Research and Development. In 2018, I took a position as the Automation group lead within Small Molecule Process Research and Development. I then moved to Biologics Analytical Research and Development in 2020 where I lead a similar Automation group, focusing on developing and deploying automated solutions across the department.

Cambridge Innovation Institute

Nandini Kashyap, M.Pharm., Senior Director, Conferences and Social Media Strategy, Cambridge Innovation Institute

Nandini is a seasoned professional who seamlessly transitioned from a successful career as a pharmaceutical scientist to becoming a conference and business networking expert with over 16 years of experience within the biopharmaceutical industry and the partnering ecosystem. As the Senior Director of Conferences and Social Media Strategy at Cambridge Healthtech Institute, she and her team play a pivotal role in fostering connections among key stakeholders in the biotech, MedTech, and digital health sectors. She holds a bachelor's in pharmacy and a master's in pharmacy in Pharmaceutics and is a published author and speaker in diabetes and insulin delivery space. Beyond her professional endeavors, she is a fitness enthusiast who passionately advocates for fitness and postpartum weight loss. She is an Indian American Pageant winner, and enjoys dancing, modeling, and being the human spinner in response to endless requests of "Mommy, spin me!".

Spark Therapeutics

Ohnmar Khanal, PhD, Downstream Technology Lead, Downstream Purification and Drug Product Development, Spark Therapeutics

Ohnmar Khanal leads the Downstream Technology team at Spark Therapeutics, developing platform chromatographic processes and innovating Spark's Downstream purification process. She has 10 years of experience in purification research and development. Her interest and expertise lie in designing novel separation strategies for various drug modalities, employing experimental and model-based approaches. Her previous work addresses the retention, adsorption, competitive binding, and transport of biomacromolecules in the realm of depth filtration and chromatography. She has developed novel methodologies and techniques using her fundamental understanding of protein transport and protein biophysics. Ohnmar received a BS in Chemical Engineering from MIT and a PhD in Chemical Engineering from the University of Delaware.

Sangamo Therapeutics

Santoshkumar L. Khatwani, PhD, Director, Analytical Development, Sangamo Therapeutics

I received my Masters degree in Organic chemistry in India. In addition, I obtained PhD degree in chemistry from University of Kentucky in 2010. Then I joined University of Minnesota for Postdoctoral training in the Department of Chemistry until 2012. I joined BioVision Inc where I built a team focused on designing, manufacturing and analytics for metabolic enzymes for commercial use. Then I pivoted to Gene Therapy when I joined Brammer Bio (now a part of Thermofisher Viral Vector Services) as principal scientist and led the team for developing analytical assays for viral vectors. Furthermore, in 2018, I joined Sangamo Therapeutics as a Senior Scientist for helping build analytical team on developing assays for viral vectors. I left Sangamo to join Asklepios Biopharmaceuticals (North Carolina) as the Director of Analytical Development but after a short duration, I rejoined Sangamo Therapeutics as an Associate Director where I am overseeing analytical development for early and late phase viral vectors.

Madiha Khurshid, Senior Associate, Pivotal Drug Substance Process Development, Amgen Inc.

I am a Senior Scientist at Amgen with over 8 years of experience in developing, characterizing, and transferring biopharmaceutical processes. I have worked on several late-stage drug substance programs with diverse process formats and business cases. I also manage the process development activities for an asset externalized at a CMO. I am passionate about exploring new tools to solve bioprocessing challenges. My areas of interest include PAT, CM, process intensification and modeling. I have championed the use of these technologies to optimize several processes. I have submitted multiple patent applications and given many presentations on these topics. I am eager to expand my knowledge and network and look forward to connecting with professionals at this conference.

Genentech

Michael Kim, PhD, Technical Development Senior Principal Scientist, Protein Analytical Chemistry, Genentech

Mike is currently a technical development senior principal scientist at Genentech/Roche and helps to define internal strategy for critical quality attribute identification and risk assessment. Mike has 14+ years of protein characterization and biotherapeutic development experience, including contributions to successful BLA and IND filings, nine manuscripts, and three issued patents. Mike received his BS in Biotechnology and Biochemistry from UC San Diego and his PhD in Analytical Chemistry from the University of Kansas.

Chava Kimchi-Sarfaty, PhD, Deputy Associate Director, Research, Office of Tissues and Advanced Therapies, CBER, FDA

Chava Kimchi-Sarfaty currently leads a group at the FDA within the Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies (OTAT) that investigates various blood coagulation factors with a specific focus on the genetic determinants of coagulation factor biosynthesis and structure. She is also the Acting Deputy Associate Director for Research of the Office. She reviews and chairs pre-INDs, INDs and BLAs for recombinant proteins and plasma derivatives products such as von Willebrand factor, ADAMTS13, factor VIII, FIX, thrombin and fibrinogen.

Pfizer Inc.

Michael King, PhD, Senior Scientist, Pfizer Inc.

My name is Michael King. I am a Process and Protein Scientist with over 10 years of experience developing downstream processes for the manufacture of monoclonal antibodies, antibody-drug conjugates, chimeric and multispecific proteins for phase I-III clinical trials as well as commercial processes. Recently my research and technical development initiatives have been focused on generation of mutlispecific antibodies.

Jianmei D. Kochling, PhD, Senior Director, Head of Analytical Development and QC, mRNA Center of Excellence, Sanofi

Jianmei Kochling is a Senior Director of Analytical Sciences, mRNA Center of Excellence. She leads the analytical development CMC and QC team supporting vaccine product and process development from early to late clinical phase. Prior to this position, Jianmei was a director of analytical science and technology and global project leader within Sanofi Specialty Care, Industrial Affairs supporting numerous biological products. She also held the director position in quality control technical service for 3 years and scientific associate director of analytical R&D for small molecule drug development for 4 years at Sanofi Genzyme. Jianmei also worked at Vertex, GSK, and Waters prior to joining Sanofi Genzyme. Jianmei received her PhD degree in Bioanalytical Chemistry from Northeastern University, and an MBA degree from Babson College.

Alphalyse

Thomas Kofoed, PhD, Co-Founder & CEO, Alphalyse, Denmark

Dr. Kofoed is co-founder and CEO of Alphalyse and has been responsible for general management of Alphalyse since its inception in 2002. He has more than 25 years of experience in the Biotech industry, and previous posts include Head of Proteomics at ACE BioSciences, Associated Professor at Copenhagen University, and Senior Scientist at PNA Diagnostics. He holds a PhD in Chemistry from the University of Southern Denmark and a degree in Business Administration.

Daniel P. LaCasse, Senior Principal Scientist, Early Stage Biologics Process Development, Pfizer Inc.

Daniel has over 20 years of experience in biologics process development and scale-up of manufacturing processes. He is a Senior Principal Scientist in Pfizer’s Bioprocess Research and Development organization located in Andover, Massachusetts. His areas of expertise include viral safety, process intensification, high concentration formulation, harvest technologies, microbial control, CMC regulatory strategies and cGMP manufacture of biologics for clinical development through commercialization. His experience spans a wide range of biological constructs and modalities, including recombinant proteins, viral vectors, plasmid DNA, linearized RNA and lipid nano-particles.

Stevens Institute of Technology

Pin-Kuang Lai, PhD, Assistant Professor, Department of Chemical Engineering and Materials Science, Stevens Institute of Technology

I am an Assistant Professor in the Department of Chemical Engineering and Materials Science at Stevens Institute of Technology.

Nicholas Larson, PhD, Scientist, Biogen

Nicholas Larson is a scientist at Biogen in the analytical development department. He received his bachelor’s degree in chemical engineering from the University of Colorado and his PhD in pharmaceutical chemistry from the University of Kansas. His research centers on biophysical and analytical characterization of proteins, oligonucleotides, and viruses for use as medicines.

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.

Prime Medicine Inc

Ann Lee, PhD, CTO, Prime Medicine, Inc.

Ann Lee is Chief Technical Officer at Prime Medicine, a next generation gene editing company aiming to deliver a new class of one-time curative genetic therapies to patients. For over 30 years, she has built and led industry-leading global technical and operational organizations across multiple biopharma companies including BMS, Celgene, Juno, Genentech, Roche and Merck. Her teams have developed new processes and technologies, designed new facilities, manufactured high quality vaccines, small molecules, biologics, and cell therapies, and built global supply chains and digital systems to deliver these medicines. Ann is an elected member of the National Academy of Engineering, the American Institute of Medical and Biological Engineering, and the American Academy of Arts and Sciences. She serves on the board of directors of Alliance of Regenerative Medicine, American Institute of Chemical Engineering, and two public companies. Over the course of her career, she has contributed to the commercialization of 25 new vaccines and medicines, the most recent being two CAR-T cell therapies.

Alexion-AstraZeneca Rare Disease

William Lee, Research Associate, AAV Analytical Method Development, Alexion-AstraZeneca Rare Disease

William Lee is a chemical engineer who focuses on developing analytical methods to support process development. In the past, he has worked in several research areas including photovoltaics, medical devices, and small molecule manufacturing. He has worked on analytical development teams at Takeda Pharmaceuticals, Voyager Therapeutics, and LogicBio Therapeutics. Currently, he works at Alexion-Astrazeneca Rare Disease focusing on characterization of AAV vectors.

Univ of Delaware

Abraham M. Lenhoff, PhD, AP Colburn Professor, Chemical & Biomolecular Engineering, University of Delaware

Abraham Lenhoff is the Allan P. Colburn Professor of the Department of Chemical and Biomolecular Engineering at the University of Delaware, where he has been on the faculty since 1984 and was Chair from 2012-7. He earned a Bachelor's degree from the University of Cape Town and Master's and Ph.D. degrees from the University of Wisconsin, all in chemical engineering. His research is primarily on application of principles of thermodynamics, transport phenomena, biophysics and colloid science to protein separations and phase behavior, with an emphasis on chromatography.

Modalis Therapeutics

Seth Levy, PhD, Director, Bioprocess Development, Modalis Therapeutics

Seth Levy, PhD, joined Modalis Therapeutics in 2021 as Director of Bioprocess Development to build and oversee internal process development and analytics efforts, as well as manage external manufacturing. Prior to Modalis, Seth lead teams in Manufacturing Science and Technology and Small-Scale Development for AAV and LV manufacturing at Viral Vectors Services. Seth worked in gene therapy R&D before his time at a CDMO and drove numerous AAV projects including basic biology research, capsid engineering, and translational gene therapy approaches at Sanofi Genzyme and academia.

Prime Medicine Inc

Weiyi Li, PhD, Scientist II, Prime Medicine Inc.

Dr. Weiyi Li is currently a Senior Scientist I at Prime Medicine with a PhD in Materials Science and Chemical Engineering at Stony Brook University (2019). At Prime Medicine, she has been working on advancing the Lipid Nanoparticle (LNP) delivery platform for Prime Editing by delving into LNP formulation, process development, scale-up, and characterization. Prior to Prime Medicine, Dr. Li was a scientist at Phosphorex where she focused on the development of micro/nano materials for diverse drug delivery applications.

Lijuan Li, Senior Staff Engineer (in silico CMC), Technology Development & Implementation, Takeda

Dr. Lijuan Li, a Senior Staff Engineer in Biologics Process Development at Takeda, pioneered the implementation of a comprehensive suite of modeling capabilities, spanning molecular, mechanistic, AI/ML, and economic & ecological modeling to optimize biotherapeutics process development over the past 5 years. Leveraging her PhD in Chemical Engineering (focusing on protein surface design for Alzheimer's treatments) and strong process systems engineering skills, Dr. Li previously implemented the first real-time modeling system at Bristol Myers Squibb, optimizing resource allocation across their Biologics facilities. Her combined expertise drives cutting-edge Biologics process development at Takeda.

Sanofi Pasteur

Angela Li, PhD, Senior Scientist, Sanofi Pasteur

Angela is a Senior Scientist at Sanofi, Vaccine CMC Development & Supply, where she gained vast experience in bioprocess development, driving new vaccine targets from early-phase to late-stage following QbD principles. With an aptitude in process analytics, she has led various initiatives on the application of advanced analytics and process systems modeling for bioprocess development. Angela holds a PhD in Biochemistry from the University of Toronto, where her research focused on protein dynamics using a combination of structural biology and computational methods.

Rutgers Univ

Dongfang Liu, PhD, Associate Professor, Director Immunoassay Development, Pathology & Immunology & Lab Medicine, Rutgers University

Dongfang Liu, PhD, Associate Professor, Director of Immunoassay Development Program in the Department of Pathology and Laboratory Medicine and the Center for Immunity and Inflammation in Rutgers University. In 2012, Dr. Liu was recruited to Baylor College of Medicine as a tenure-track Assistant Professor in the Department of Pediatrics and Department of Pathology & Immunology, before joining Houston Methodist Research Institute as an assistant professor in 2015. In 2018, Dr. Liu was promoted to an Associate Professor in Houston Methodist Research Institute. Dr. Liu did his postdoctoral training on natural killer (NK) cells at the National Institute of Allergy and Infectious Diseases (NIAID) in National Institutes of Health (NIH) from 2005 to 2011. After completing the postdoctoral training, he joined Ragon Institute of MGH, MIT and Harvard in 2011 as a senior research scientist, where he worked on HIV-specific CTL dysfunction with a focus on PD-1 in HIV-specific CTL immunological synapse. Dr. Liu’s current research is primarily focused on the immunobiology of chimeric antigen receptor (CAR) T and NK cells, immunoreceptors, CAR immunotherapy, and HIV-specific CTLs in chronic HIV and its related malignancies, with a focus on immunological synapse biology and its clinical applications.

Childrens Hospital of Philadelphia

Xueyuan Liu, Director Research Vector Core, Pathology, Childrens Hospital of Philadelphia

Xueyuan Liu serves as the Director of the Research Vector Core at the Children's Hospital of Philadelphia. Recognized as a subject matter expert in Cell and Gene Therapy, she has successfully established the Lentivirus (LV) manufacturing process for multiple pseudotypes and transformed the traditional recombinant Adeno-Associated Virus (rAAV) manufacturing and characterization processes, making them more flexible and scalable. As an innovative scientist with two decades of leadership experience, she has led advances in vector engineering and capsid modifications to improve the efficiency and specifications of gene delivery. Her work has contributed to publications, patents, and related intellectual properties. She and her group continue to support investigators across academia and industry around the globe seamlessly.

Regeneron Pharmaceuticals Inc

DingJiang Dean Liu, PhD, Senior Director, Formulation Development, Regeneron Pharmaceuticals Inc.

Dingjiang (Dean) Liu, PhD, is currently Senior Director in Formulation Development Group at Regeneron Pharmaceuticals, Inc. (Tarrytown, NY). Dean’s current work is focused on formulation and drug product development of protein therapeutics and genetic medicines, as monoclonal antibody, bispecific antibody, antibody drug conjugates (ADC), AAV, LNP, and siRNA from research to commercialization. He has successfully led the product development, commercialization, and life cycle management for 6 FDA approved products. In the past 20 years, Dean has accumulated extensive experience in developability assessment, drug product development and manufacturing strategy, shelf-life stability and compatibility, and in-use stability of biological drug products and application of QbD in development of biologics. He has authored/co-authored more than 60 scientific papers and patents. Dean graduated from Fudan University (Shanghai, China) with a BS degree in Chemistry; then from University of Wisconsin-Milwaukee with a PhD in Chemistry and Biochemistry. Dean worked at Schering Plough (now Merck Co.) and Amgen prior to join Regeneron.

National Research Council Canada

Martin Loignon, PhD, Team Leader, Cell Engineering, National Research Council Canada

Martin Loignon holds a Ph.D. in molecular biology from Universite de Montreal and a postdoctorate in oncology from McGill University. He joined the Human Health Therapeutics Research Centre of the National Research Council Canada in 2015 and lead of the Cell Engineering team. In this role, he has led projects related to the production of difficult-to-express recombinant proteins and contributed to the development of a CHO expression platform. Since 2020, he is leading the Cell Culture Scale-Up team, overseeing experts in bioprocess development and scale-up, and engineering viral-based and non-viral tools for gene editing and cell engineering.

Ultragenyx Pharmaceutical

Matthew J. Lotti, Senior Research Associate II, Ultragenyx Pharmaceutical, Inc.

Matthew Lotti is a Senior Research Associate II in the the Analytical Development department of Ultragenyx's Gene Therapy Pharmaceutical Development facility, located in Woburn, MA. His background involves assay development for multiple impurity and titer immunoassays.

Takeda

Wei Lu, PhD, Staff Engineer, Bioprocess Development, Takeda

Dr. Wei Lu is a Senior Staff Engineer in the Biologics Process Development group at Takeda Pharmaceuticals. He has more than 15 years of mixed experience in academia and industry, with the main focus on process development for large molecules. Wei’s previous research also covered protein engineering, conjugation technology, structural-functional study and analytical assay development. Currently Wei is leading downstream process development, conjugation process development and technology innovations for multiple programs in Takeda.

Ultragenyx Pharmaceutical

Xiaohui Lu, PhD, Director, Analytical Development, Ultragenyx Pharmaceutical

Dr. Xiaohui Lu is the Sr. Director of Analytical Development in Ultragenyx Gene Therapy, overseeing analytical activities for the development of Ultragenyx’s gene therapy products. Before join Ultragenyx, Dr. Lu was a Director of Analytical Development in CRISPR Therapeutics. Dr. Lu spent 8 and a half years in Analytical Development at Biogen from 2009 to 2018, leading bioassay development and process-related impurity assay development for biologics and gene therapy programs. Prior to joining Biogen Idec, he was Senior Research Scientist at Ariad Pharmaceuticals in Cambridge, MA from 2007 to 2009. Dr. Lu received his Ph.D. in Biochemistry from Dartmouth Medical School, and had post-doctoral training at the Whitehead Institute.

NIAID, NIH

Paolo Lusso, MD, PhD, Chief, Senior Investigator, Viral Pathogenesis Section, NIAID, NIH

Dr. Lusso received his MD, summa cum laude, from the University of Turin and his PhD from the Ministry of Scientific and Technologic Research, Rome, Italy. He is board-certified in Internal Medicine and in Infectious Diseases. After a post-doctoral period at the National Cancer Institute in Bethesda, in 1995 he became the Chief of the Laboratory of Human Virology at the San Raffaele Institute in Milan, Italy, and Professor of Infectious Diseases. In 2006, he returned to the NIH in Bethesda, where he became the Chief of the Viral Pathogenesis Section in the Laboratory of Immunoregulation. He is an elected member or the European Molecular Biology Organization (EMBO) and a Fellow of the American Academy of Microbiology (AAM). His major scientific accomplishments include the discovery of the chemokine trio that naturally block HIV-1 (ie, RANTES, MIP-1? and MIP-1?), the identification of the cellular receptor for the herpesvirus HHV-6, and the discovery of a second CD4-binding site in the HIV-1 envelope. His current research interests include the structure-function relations in the HIV-1 envelope and the development of innovative mRNA-based vaccines against HIV-1 and COVID-19.

Teva Pharmaceuticals

Slobodanka (Dina) Manceva, Associate Director Drug Product and Technology Development, Teva Branded Pharmaceuticals

No bio available.

Cellino Biotech

Kentaro Marchionni, Automation Engineer, Cellino Biotech

Kentaro Marchionni graduated from Cornell University with a BS in mechanical engineering and first started in the biotech space as a lab operator performing and developing analytical chemistry methods. Kentaro’s responsibilities over the years have evolved into a more automation-focused frontier and he now designs and develops automated workflows to support lab operations, leveraging both lab robotics and cloud computing. One of his many passions in this space has been breaking down barriers between automation developers and analytical scientists by creating flexible and dynamic automated solutions to fit scientists’ needs and requirements. He currently works at Cellino as an automation engineer where he supports development and operation of automated integrated systems consisting of proprietary technology, liquid handers, robotic arms, and other lab equipment for the purpose of supplementing cutting-edge AI-driven cell therapy bioprocesses.

Resolution Therapeutics

Damian Marshall, PhD, Vice President, Analytical Development, Resolution Therapeutics

Damian Marshall is the Vice President of Analytical Development at Resolution Therapeutics, a UK biopharmaceutical company developing engineered macrophage therapies for end-stage liver disease. Prior to joining Resolution, Damian spent 2 years as Vice President of Bioprocess Development at Achilles Therapeutics and 8 years as Director of New Technologies at the Cell and Gene Therapy Catapult. In these roles he led multi-national programs working on bioprocess automation, PAT integration, and advanced product characterisation.

University of Massachusetts Amherst

Craig Martin, PhD, Professor, Chemistry, University of Massachusetts, Amherst

35+ years researching the enzymology of T7 RNA polymerase. Postdoc, Yale Univ; Ph.D., California Institute of Technology

Amit Mathur, PhD, Senior Scientist, Genomic Medicine Unit, Sanofi

Amit Mathur, Senior Scientist in Cell Line Development in Genomic Medicine Unit at Sanofi, has published numerous articles on characterizing mammalian cells using OMICS technologies. Amit is one of the early pioneers in characterizing CHO cells using transcriptomics and proteomics and currently applies his extensive knowledge in the field for leading a subteam to characterize Sanofi’s HeLa cell lines for improving the productivity and efficiency of the host cells. Prior to Sanofi, he worked at Amgen and Merck after completing PhD in Chemical and Biomolecular Engineering in Dr. Michael Betenbaugh’s lab at Johns Hopkins University.

National Resilience, Inc.

Mukesh Mayani, PhD, Head of Process Development, Gene Therapy, National Resilience, Inc.

Dr. Mukesh Mayani is a Head of Process Development, Gene Therapy Technical Development, at National Resilience, Waltham, USA. In his current role, Mukesh is responsible for AAV and LVV viral vector platform development, and supporting development of Resilience's early- through late-phase client programs. Previously, Mukesh worked at Genomic Medicine CMC organization at Sanofi, USA, where he supported development of Lentiviral, AAV, and non-viral GT modality platforms. Prior to Sanofi, Mukesh worked at Cytiva, Bristol-Myers Squibb (BMS), and Therapure Biopharma for the development of viral vector, mAbs, RNA-based vaccines, and other modalities. Dr. Mayani trained in Chemical Engineering and acquired a PhD degree in Chemical Engineering.

Diane McCarthy, PhD, Senior Scientific Director, Global Biologics, US Pharmacopeia

Dr. McCarthy is Senior Director, Science and Standards in USP’s Global Biologics Department, where she leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports standards and tools across a diverse range of therapies, including vaccines, peptides, cell and gene therapy, monoclonal antibodies, and other protein therapeutics. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

MassBiologics

David McNally, Director, Process Development, MassBiologics

No bio available.

Tufts University Center for Cellular Agriculture

Matt McNulty, PhD, Associate Director, Tufts University Center for Cellular Agriculture

Matt is the Associate Director for the Tufts University Center for Cellular Agriculture (TUCCA), a top-in-class institute in the emerging field of cellular agriculture, in which agricultural goods typically procured by means of animal husbandry are instead produced via cell culture - with TUCCA specializing in cultivated meat and precision fermentation approaches to alternative proteins. Matt is committed to advancing innovative and sustainable biotechnical solutions to food insecurity, public health risks, and climate change challenges. He leverages a foundation in industrial bioprocessing to approach alternative protein education and research from a systems-oriented focus on commercialization bottlenecks. His professional experiences include upstream biologics process engineering at Sanofi, biopharma operations analysis and change management consulting at N-SIDE, and a Research Fellowship investigating cultivated meat research whitespaces at the Good Food Institute. Matt has authored +15 publications and holds a PhD in chemical engineering from UC Davis, where he focused on plant-based protein production for biopharmaceutical and food applications.

Dublin City Univ

Paula Meleady, PhD, Associate Professor, School of Biotechnology, Dublin City University

Graduated in 1997 with a PhD in Cell Biology from Dublin City University (DCU), Dublin, Ireland. In 2007 was appointed Programme Leader of the Proteomics and Mass Spectrometry Core Facility at the National Institute for Cellular Biotechnology (NICB), DCU. Appointed Associate Director of the NICB in October 2015. Research interests are focused on the application of advanced proteomic and mass spectrometry methods to understand biological systems, in particular characterisation of recombinant mammalian cell lines (Chinese hamster ovary) in order to gain insights to improving efficiency of production of biopharmaceuticals. Also have research interests in clinical proteomics, specifically uveal melanoma and pancreatic cancer. Co-author of over 90 peer-reviewed publications and 12 book chapters to date in research areas related to proteomics, bioprocessing and cancer.

University College London

Beatrice Melinek, PhD, Bioprocess Engineer, University College London

Beatrice is a bioprocess engineer currently working at University College London within the Future Targeted Healthcare Manufacturing Hub, in a postdoctoral role. Her focus is on the use of cell-free synthesis as a platform for distributed production of stratified biotherapeutics, both proteins and nucleic acids. She previously specialised in the purification of viral vectors and vaccines, with an Engineering Doctorate (EngD) in biochemical engineering, postdoctoral experience with UCL haematology, developing a new chromatography based analytic for empty-full Adeno Associated Virus capsids and worked for Univercells on modifications to a polio production process. Prior to her doctorate she worked for a number of years in an engineering consultancy, on dynamic simulations of processes for use in design validation and control studies.

North Carolina State Univ

Stefano Menegatti, PhD, Associate Professor, Chemical & Biomolecular Engineering, North Carolina State University

Prof. Menegatti has earned his Ph.D. in Chemical Engineering at NC State University in 2013, with a project on affinity purification of protein therapeutics using peptide affinity ligands (advisor: Dr. Ruben Carbonell). After 2 years as a postdoctoral fellow working on drug delivery technology in the group directed by Dr. Samir Mitragotri at UCSB (now Harvard University), Dr. Menegatti rejoined the Department Chemical Engineering at NC State University as an assistant professor in 2015. Dr. Menegatti has made key contributions in bioseparations: he has introduced the new paradigm of “affinity flow-through chromatography” for continuous purification of therapeutic antibodies; he has invented and patented single-use adsorbents for plasma fractionation, and purification of CRISPR-Cas nucleases and other therapeutic proteins; he has developed novel, rapid at-line assays to support continuous bioprocessing; and designed novel biomaterials for drug delivery and tissue engineering. This intense research activity has translated into numerous impactful publications, patents, and invited lectures in universities and industries. Prof. Menegatti is highly recognized by the academic and the industrial communities alike, and has established a broad network of collaborations with distinguished scholars across three continents (US, Europe, and Australia). He also leads joint research projects with and consults for global companies including Merck & co., Genentech, Merck KGaa, CSL Behring, Millipore Sigma, KBI Biopharma, Johnson and Johnson, and Eastman Chemical Company. He was the key contributor to the $27M AIM-Bio research instituted funded in 2019 by the Novo Foundation (https://news.ncsu.edu/2019/08/future-of-biomanufacturing/). Dr. Menegatti has also established himself as a successful entrepreneur, pursuing the translation of his technology to broaden the access of patients of advanced biological therapies. His IP portfolio has been licensed to private companies - such as LigaTrap, for which he serves as main scientific advisor - and is now being converted into commercial products. Prof. Menegatti is actively engaged in a number of outreach activities in North Carolina: he co-chairs the Triangle Soft Matter Symposium, and collaborates with the NC Biotech Center, the NC Center of Innovation Network, and the UNC Institute for Convergent Science.

Univ of Maryland Baltimore County

Antonio R. Moreira, PhD, Vice Provost, Academic Affairs & Advanced Technology Center, University of Maryland, Baltimore County

Dr. Antonio Moreira is Vice Provost for Academic Affairs at the University of Maryland, Baltimore County (UMBC). He has previously been Chair of the Department of Chemical, Biochemical, and Environmental Engineering; Associate Dean of the College of Engineering and Information Technology; and Associate Provost for Academic Affairs. He joined UMBC after 10 years in industry where he held senior positions with International Flavors and Fragrances, Inc., and Merck & Co. (then Schering-Plough Corp.). He led the biotechnology development group at Merck that brought alpha interferon to the market. Dr. Moreira obtained a BS degree in chemical engineering from the University of Porto, Portugal, and MS and PhD in chemical and biochemical engineering from the University of Pennsylvania. He was honored by the President of Portugal with the National Order of Public Education and awarded the title of Comendador. He is an Honorary International Member of the Brazilian Academy of Pharmaceutical Sciences and is currently Chair of the Board of the International Society of Pharmaceutical Engineering Foundation.

Paria Moxley, PhD, Scientist, Biologics Drug Product Development & Manufacturing, Sanofi

My name is Paria Moxley and I am currently a scientist at Sanofi in Drug Product Development and Manufacturing department. I obtained a Ph.D. in Chemical Engineering from Northeastern University in 2020 and have been with Sanofi since. In the beginning of my professional career, I started my work with focus on protein therapeutics formulation development and later followed my interest in gene therapy modalities.

Amgen Inc

Jerry A. Murry, PhD, Senior Vice President, Process Development, Amgen

Jerry Murry is senior vice president, Process Development. Murry has held several roles at Amgen, including vice president of Small Molecule Process & Product Development, vice president of Chemistry, Manufacturing & Controls Lifecycle Management, and, most recently, vice president of Drug Product Technologies. Prior to Amgen, Murry spent six years at Merck Research and the preceding six years at Pfizer Central Research. Earlier, he was a National Institutes of Health (NIH) fellow at Harvard University. Murry received his bachelor’s degree in biochemistry from Texas Lutheran University and earned his PhD in chemistry from the University of Utah.

Yogapriya Murugesan, Scientist I, Gene Therapy & Drug Product Development, Biogen

Yogapriya works as a Scientist I at Biogen, Inc. in the Drug product group of Biologics and Advanced therapy medicinal products department. She has over 10 years of experience in Research and Product Development of Biologics comprising of monoclonal antibodies and AAV drug products. She has managed multiple biologics programs at different stages of development. Her current role focuses more on the developability assessment of biologics (mAbs and AAV) to help in candidate selection process for R2D transitions and end-to-end drug product development of biologics drug product candidates from R2D to FIH with respect to formulation lockdown, process development, and container closure selection. In the past, she has worked as a biochemist in discovery programs focused on purification, biochemical, and biophysical characterization of monoclonal antibody therapeutics.

Sarah Muse, PhD, Senior Scientist, Sanofi

Dr. Sarah Muse graduated from the Pennsylvania State University Biochemistry, Microbiology, and Molecular Biology program studying host immune interactions for respiratory pathogens. Following her passion for public health, Dr. Muse accepted a position at CDC in the Center for Preparedness and Response. Recently, Dr. Muse joined the mRNA Center of Excellence at Sanofi in the Bioassay group where she performs analytical method development for nucleic acid and cell-based assays.

Janssen R&D LLC

Hirsh Nanda, PhD, Director, Analytical Sciences, Janssen

Hirsh Nanda is the Director of Analytical Sciences at The Janssen Pharmaceutical Companies of Johnson & Johnson. Hirsh joined Janssen in 2015 and currently he is leading an analytical sciences group supporting research and development of biologic therapeutics, including cell line engineering and development. His team performs in-depth mass-spec and biophysical characterization across modalities and next-generation therapies. State-of-the-art robotics, along with high-throughput mass-spec data acquisition and analysis, is used to automate and streamline our processes. Prior to joining Janssen, Hirsh was Senior Scientist at NIST, working on the adsorption and aggregation of mAbs at surfaces relevant to pharmaceutical processing.

Anastasia Nikolakopoulou, Investigator-Modeling and Simulation, Pharmaceutical Development, R&D Medicinal Science and Technology, GSK

Anastasia Nikolakopoulou was a graduate student at the group of Professor Richard D. Braatz at the Massachusetts Institute of Technology (MIT). She received a Diploma in Chemical Engineering from the National Technical University of Athens, Greece, and an MS in Chemical Engineering Practice and a PhD from MIT. Her research is in the optimization and control of modular manufacturing systems, state estimation and control of nonlinear dynamical systems, and model predictive control of distributed parameter systems. In 2021 Anastasia moved to an industrial position in the pharmaceutical industry. Currently she is an Investigator at GSK focusing on model predictive control for bioreactors.

eGenesis, Inc.

Knut Niss, PhD, CTO, eGenesis, Inc.

Dr. Niss is Chief Technology Officer at eGenesis, overseeing the organization’s use of cutting-edge technology to redefine the future of organ transplantation. Dr. Niss is a seasoned biotechnology executive and scientist with more than 20 years of experience in molecular biology and the biotechnology industry. Most recently, he served as Chief Technology Officer at Mustang Bio Inc., where he led a team developing and manufacturing cell therapy products, including the build-out of the company’s autologous CAR-T manufacturing platform. Dr. Niss also served as Mustang’s Vice President of Operations, with a focus on the establishment of facilities to support commercial manufacturing. Prior to his tenure at Mustang, Dr. Niss held various scientific and technical leadership roles at the vanguard of innovation in cell and gene therapy. At Biogen, Dr. Niss led the Cell Therapies group, overseeing operations and supporting regulatory filings. Dr. Niss played a pivotal role in the advancement of Kymriah® (tisagenlecleucel), the first chimeric antigen receptor therapy to be approved in the US, establishing critical CMC and manufacturing capabilities and supporting cross-functional development activities. At Pfizer, Dr. Niss led global research teams supporting target identification and validation as well as preclinical, clinical development. Dr. Niss earned a Ph.D. in Molecular Biology from Humboldt University in Berlin, Germany, an M.S. in Biology at Georg-August University in Goettingen, Germany. He completed post-doctoral work at the Children’s Hospital and Dana-Farber Cancer Institute.

Theresa O'Brien, Scientist, Sanofi

Theresa O’Brien is a Scientist working at Sanofi in Framingham, MA. Theresa received her Bachelor’s of Science degree from The University of Massachusetts, MA. She joined Sanofi (previously Genzyme) in 1997, with focus on development of residual Host Cell Protein Impurity assays to support a number of drug development programs.

Daniel C. Odenwelder, PhD, Senior Engineer III, Gene Therapy and Upstream Process Development, Biogen

Dan Odenwelder is a Senior Engineer in the Gene Therapy Cell Culture Development Team at Biogen. He is responsible for cell culture media development, upstream process development, and process characterization. Prior to Biogen, Dan obtained his PhD in Bioengineering at Clemson University.

Shape Therapeutics Inc

Sandhya Pande, PhD, Associate Director, Cell Sciences, Shape Therapeutics Inc.

Dr. Sandhya Pande is an Associate Director in the Process and Product Development department at Shape Therapeutics. She is currently leading cell line and upstream process development activities to support stable producer cell engineering for AAV vector production. Prior to Shape, she worked as a Development Scientist leading the cell line development group at AGC biologics in Bothell, WA. She did her post-doctoral fellowship at Amgen Inc, Seattle, and has a PhD in Cell Biology from the University of Massachusetts.

Ultragenyx

Jin Park, PhD, Associate Director, Ultragenyx

Jin is an Associate Director of Analytical Development at Ultragenyx. Her work focuses on assay development, troubleshooting, and providing support for internal and external projects related to the biophysical characteristics of AAV, biologics, and small molecules. Her team handles various techniques including AUC, MALS, HPLCs, DLS, CE-SDS, iCIEF, LC-MS, etc. Prior to Ultragenyx, Jin worked for many years at Takeda Global Gene Therapy, Takeda Vaccine, Charles River Laboratories, and Sanofi. She has extensive experience in building biophysical profiles for viral and non-viral gene therapy products, Vaccines, biologics, and small molecules.

Janssen Pharmaceuticals Inc

Keshav Patil, PhD, Scientist, Advanced Therapies, Janssen Pharmaceuticals Inc.

I am Scientist with a strong focus on Drug Discovery and Development. My doctoral research centered around utilizing computational techniques to investigate the activity of mutations in protein kinases, contributing to the field of drug discovery. Currently, as a dedicated professional, I apply my expertise in data science to support and optimize cell therapy operations at Janssen, playing a vital role in the field of drug development.

Jessica Pedroso, PhD, Process Development Principal Scientist, Pivotal Drug Substance Technologies, Amgen Inc.

Jessica is a Principal Scientist at Amgen, where she is a group lead in late-stage cell culture and purification development. She is a highly motivated, results driven biotechnology professional with 20 years of experience and has strong expertise in attribute-focused, multi-modality process development from preclinical through Phase 3 development and commercialization. Jessica earned her B.S. in Biology from the Bridgewater State College.

Laura Pierce, Biomedical Engineer, Biosystems & Biomaterials, NIST

Laura Pierce is a Biomedical Engineer in the Biomaterials Group at the National Institute of Standards and Technology. She is responsible for technical planning and conducting studies to support development of the ISO standards for Cell Counting. In that capacity, she routinely performs cell counting measurements on a variety of lab instrumentation typically used in the Regenerative Medicine field, and she supports analysis and dissection of data with collaborators to define the points in their experimental workflow which introduce measurement error and uncertainty, and offers recommendations to improve precision and robustness of measurements. Laura has over 12 years of experience in the biotechnology industry in the areas of drug discovery for oncology and infectious disease, as well as experience in high-throughput automation and robotics and assay development. She received her B.S.E. degree in chemical engineering from Princeton University and she holds an M.S. degree from Northeastern University.

Carme Pons Royo, PhD, Postdoctoral Associate, Massachusetts Institute of Technology

Maria del Carme Pons Royo is a bioprocess engineer with experience in development and optimization of biotechnological products. She completed her bachelor's degree in biotechnology from Universitat Autonoma de Barcelona, followed by a master's degree in Life Science and Technology from TU Delft. Recently, she successfully defended her PhD thesis at BOKU, titled "Millifluidic devices to accelerate process development with a primary focus on protein precipitation and filtration." Currently, she is employed as a postdoctoral researcher at MIT, where she continues her research on the development and optimization of innovative bioprocesses utilizing cutting-edge prototyping tools.

Sail Biomedicines

Francis Poulin, PhD, Vice President, Analytical Sciences, Sail Biomedicines

Francis Poulin is Vice President of Analytical Sciences at Sail Biomedicines, a Flagship Pioneering Company based in Cambridge, MA. Francis leads the development of analytical procedures intended to release and characterize Endless RNA (eRNA), a uniquely engineered closed-loop RNA that was invented at Flagship Labs. Prior to Sail Biomedicines, he led Analytical Development teams at Lyell Immunopharma, Sanofi, and Genzyme, and contributed to several successful regulatory filings. Francis received his PhD in Biochemistry from McGill University, where he worked with Professor Nahum Sonenberg on the regulation of mRNA translation initiation.

Merck & Co Inc

Pavlo Pristatsky, Associate Principal Scientist, Merck & Co. Inc.

Pavlo Pristatsky is an Associate Principal Scientist in the Mass Spectrometry group within Analytical Research and Development department at Merck in West Point, PA. Pavlo joined Merck in 2007 where he develops and utilizes various mass spectrometric techniques (such as intact mass, peptide mapping, HDX-MS, LIP-MS, etc.) for characterization and development of vaccines and biologics. Outside of work Pavlo enjoys spending time with his family, running, and making music.

Philip Probert, PhD, Technology Lead, CPI, United Kingdom

Philip is an experienced research scientist familiar with high-throughput process development, design of experiment approaches to process optimisation and process scale up and validation. At CPI Biologics, Philip manages the technical team, working across mammalian, microbial, viral and cell-free projects.

Rensselaer Polytechnic Institute

Todd M. Przybycien, PhD, Professor, Chemical and Biological Engineering, Rensselaer Polytechnic Institute

Professor Todd Przybycien received a BS in Chemical Engineering and a AB in Chemistry from Washington University in St. Louis in 1984. He attended California Institute of Technology for graduate education, receiving MS and PhD degrees in Chemical Engineering in 1987 and 1989. Prof. Przybycien worked for two years at Monsanto Agricultural Company as a Senior Research Engineer before joining Rensselaer Polytechnic Institute as an Assistant Professor in 1991. He came to Chemical Engineering at Carnegie Mellon in 1996 and served as the (founding) Head of BioMedical Engineering from 2002-2008. Professor Przybycien currently holds a joint appointment in Biomedical Engineering and in Chemical Engineering.

Pavan Puligujja, PhD, Director, Analytical Development, Adicet Bio

Pavan works as Associate Director of the Analytical Development Team at Adicet. He has over 9 years of experience supporting preclinical and CMC activities of cell therapy drug products and peptides. Currently, he is leading assay development and tech transfer activities to support the release of gamma retroviral vector and CAR-gamma delta T cell product. Prior to Adicet, he worked on Rubius's analytical development team and designed, developed multiple cell-based potency assays, flow assays for release of novel red-cell therapy products for early-phase immuno-oncology trials. Prior to Rubius, he spent 3 years at a start-up developing formulations for novel oral peptides that are indicated in Diabetes and neurodegenerative diseases. Pavan has a PhD in pharmacology from University of Nebraska Medical Center and a Bachelor’s in pharmacy from Kakatiya University.

Eli Lilly and Company

Ken K. Qian, PhD, Scientific Director, Eli Lilly & Co.

Dr. Ken Qian received his PhD from the University of Connecticut, followed by a National Research Council post-doctoral fellowship at the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland. At NIST, he studied protein mobility in condensed phase using neutron scattering and laser spectroscopy. Ken joined Eli Lilly in the BR&D-Formulation group in November 2015 and has been leading multiple peptide projects. Additionally, he leads several Lilly-sponsored academic collaborations in the colloidal physics field, using X-ray and neutron scattering techniques.

Eli Lilly & Co

Shannon A. Raab, PhD, Research Scientist, Bioproduct R&D, Eli Lilly & Co.

Shannon completed her undergraduate degree in biochemistry at Purdue University where she worked on small molecule mass spectrometry research in Graham Cooks's lab. She then completed her PhD in analytical chemistry in 2021 at Indiana University where she studied protein conformations with ion mobility spectrometry under the supervision of David Clemmer. She joined Eli Lilly in Indianapolis in 2021 and is currently a member of the Protein Characterization Team in the Bioproduct Research and Development organization where she provides LC-MS and structural characterization support for several Lilly molecules.

Bristol Myers Squibb

Sarah Rajani, Scientist, Cell Therapy Drug Product Process Development, Bristol Myers Squibb

Sarah is a Scientist that has been leading Process Analytical Technology Development efforts for cell therapies at Bristol Myers Squibb for the last 4 years. During this time, she has led a team of enthusiastic scientists towards evaluation, development and integration of several novel monitoring technologies into process that enable the production of more affordable and robust cell therapies. Sarah is a strong advocate for PAT integration, speaking previously on the promise Quality-By-Design and adaptive manufacturing approaches provide for improved drug product quality.

Srivatsan Ramesh, PhD, Scientist, Downstream Process Development, BridgeBio

At BridgeBio, Srivatsan Ramesh is dedicated to advancing the development of scalable, cost-effective therapeutics through gene therapy for a range of genetic disorders and rare diseases. His responsibilities include refining the downstream purification processes for AAV-based gene therapies and investigating innovative technologies to streamline and strengthen the transition of therapies from development to clinical or commercial manufacturing. During his doctoral studies in chemical engineering at North Carolina State University, his research primarily concentrated on two areas: the synthesis of stimuli-responsive polymers for applications in membrane purification and drug delivery, as well as the development of biosensors for protein quantification.

Phillip Ramsey, Senior Vice President, Head, Technical Development, Sangamo Therapeutics

Phillip Ramsey is the Senior Vice President of Technical Operations at Sangamo Therapeutics where he oversees manufacturing, technical development, supply chain and quality. He has over 35 years of experience in biotech and pharmaceutical operations, development, and quality and has been active in multiple therapeutic areas including autoimmune, cardiovascular, central nervous system, emerging infectious diseases, oncology, rare genetic diseases, and vaccines. Prior to joining Sangamo, Phillip was Senior Director at Emergent BioSolutions where he played a key role in the design and construction of a 85,000 square foot award winning commercial facility, as well as Leidos where he was a part of the development of a 130,000 square foot vaccine pilot plant for the NIH. Additionally, Phillip has contributed to multiple regulatory submissions for product approval and more than 50 investigational new drug submissions. Phillip received his B.S. in Chemistry and Physics from the University of Nebraska, an MBA with a specialty in regulatory sciences from San Diego State University, and his M.S. in Biochemistry from John Hopkins University.

Regeneron Pharmaceuticals Inc.

Pinaki Ranadive, PhD, Senior Scientist, Formulation Development Group, Regeneron Pharmaceuticals

Pinaki Ranadive is a Senior Scientist in the Formulation Development Group within Regeneron Pharmaceuticals (Tarrytown, NY). She has 2+ years of experience in leading drug product (DP) process development activities to support technology transfers for early-stage and late-stage monoclonal antibody-based biologics. She also supports process development activities for mRNA-lipid nanoparticles (mRNA-LNPs) and has expertise in developing mRNA-LNP buffer exchange processes using tangential flow filtration (TFF). She enjoys cross-functional collaboration with teams including chemistry, manufacturing, and controls (CMC), process sciences, and manufacturing sciences and technology within Regeneron to ensure seamless tech transfer. Prior to joining Regeneron, Pinaki completed her Ph.D. in Chemical Engineering from the Ohio State University (Columbus, OH) where she developed continuous scalable microfluidic processes for synthesizing inorganic metal and metal-oxide based nanoparticles with the goal of controlling particle properties.

Univ of Colorado Boulder

Theodore Randolph, PhD, Professor, Chemical and Biological Engineering, University of Colorado

Ted Randolph received his Ph.D. in Chemical Engineering at the University of California, Berkeley. He worked as a post-doctoral fellow at the Ecole Polytechnique Federale de Lausanne, and then joined the Department of Chemical Engineering at Yale University as an Assistant Professor. After promotion to Associate Professor, he was named to Yale’s first John J. Lee Junior Professorship Chair in Chemical Engineering. In 1993, Dr. Randolph accepted the Patton Associate Professorship Chair in the Department of Chemical Engineering at the University of Colorado. He currently serves as the Gillespie Professor of Bioengineering, co-Director of the University of Colorado’s Center for Pharmaceutical Biotechnology. Dr. Randolph is a National Science Foundation Presidential Young Investigator, and received the AIChE Professional Progress Award and has twice received the American Pharmacists’ Association Ebert Prize. He is an author of more than 230 peer-reviewed journal articles in the areas of biopharmaceutical formulation, lyophilization of proteins, protein-solvent interactions in non-aqueous environments, and protein refolding. Dr. Randolph is an inventor on 27 US patents, and has cofounded three companies, RxKinetix Inc., Barofold, Inc. and VitriVax Inc.

Rau Consulting & Biopharma Technical Consulting

Tiffany D. Rau, PhD, Owner, Rau Consulting LLC

Tiffany D Rau, Ph.D., Owner and Principal Consultant of Rau Consulting and is an expert in bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing. Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems. Previously, Dr. Rau has held leadership positions at Evonik-Degussa, Eli Lilly, Pall and GlaxoSmithKline all focused in process development, tech transfer, commercial manufacturing, and CMC strategy. Dr. Rau has over 75 invited speaking engagements focused on delivering current and next-generation products from R and D to commercialization/post-commercialization. Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.

Sanofi Pasteur

Jennifer Reid, PhD, Senior Scientist, Vaccine Drug Substance Development, Sanofi

Jennifer Reid is a Senior Scientist in Global Bioprocess Development at Sanofi Vaccines in Toronto Canada. At Sanofi, she incorporates new-process analytical technologies and automation solutions to improve drug substance yield and operational efficiency in upstream processes. Jennifer has a PhD in biochemistry, with experience in bioinformatics.

AbbVie

Jian Ren, PhD, Principal Scientist, AbbVie

Jian Ren is a principal scientist in the Purification Development, Biologics Development & Launch organization at AbbVie Bioresearch Center in Worcester, MA. She leads process development and tech transfer activities for the downstream manufacturing process for early-to-late-phase biologics programs, including monoclonal and bispecific antibodies. Prior to AbbVie, her research focused on the development and optimization of polymeric membranes and modules for various separation applications. Jian holds a PhD in Chemical Engineering from the University of Connecticut.

Nvelop Therapeutics

Xiaozhi Ren, PhD, Director, Plasmid and Cell Line Development, Nvelop Therapeutics

Xiaozhi Ren, PhD, is Director of Plasmid and Cell Line Development at Nvelop Therapeutics. Prior to Nvelop, he was Director of Cell Line and Process Development at Vedere Bio, where he designed and developed a high-quality clonal suspension HEK293 cell line called X-RAP for AAV production. Prior to Vedere, he was Senior Scientist in Upstream Process Development at Casebia Therapeutics. Prior to Casebia, he was Scientist in Cell Line Development at Sanofi, where he led the New CHO host cell line development. Before Sanofi, he worked as Visiting Scientist at Mike Betenbaugh's lab for CHO cell engineering.

Alkermes Inc

Wilhad H. Reuter, Lead Engineer, Upstream Process Development, Mural Oncology, Inc.

Wilhad “Hans” Reuter is currently a Lead Engineer on the Upstream Process Development team for Mural Oncology Inc., supporting CMC strategies for both early stage development programs as well as late stage clinical candidates, and has experience with a variety of therapeutic modalities including lentiviral vectors, AAV gene therapies, and cytokine-based immunotherapies.

Interius BioTherapeutics, Inc.

James Richardson, PhD, Senior Director, Analytical Development, Interus BioTherapeutics

Jim leads analytical development at Interius, cutting across all scientific efforts at the company. Trained as a virologist, Jim has over 25 years of experience developing viral products for the prevention and treatment of disease. Jim comes to Interius from Altimmune, where he was Director of Scientific Affairs. Previously, Jim led the cell and gene therapy standards development efforts at US Pharmacopeia. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Jim has also held positions responsible for performing viral clearance and adventitious agent testing at Viromed Biosafety as well as AAV vector development and characterization at Genovo/Targeted Genetics.

Natl Research Council Canada

Julien Robitaille, Research Council Officer, Cell Culture Scale Up, National Research Council Canada

Julien Robitaille is currently a Research Council Officer at the Human Health Therapeutics Research Center of the National Research Council Canada (NRC) in Montreal. His research is focused on the scale-up and optimization of upstream process. He has worked on the process development, scale-up, and technology transfer of the manufacturing process for many different therapeutic products, including recombinant proteins and viral vector for cell & gene therapy applications. He received his Bachelor’s degree in Chemical Engineering from Polytechnique Montreal and completed his Master’s degree at Polytechnique Montreal in Chemical Engineering as well, focusing his research on the metabolomics of biologic production in bioreactors.

BioCurie Inc.

Irene Rombel, PhD, CEO & Co-Founder, BioCurie Inc.

Dr. Irene Rombel is the CEO, President, and Co-Founder of BioCurie, a TechBio startup company that is harnessing AI to transform the process development and manufacturing of cell and gene therapies. She is deeply committed to transforming great science and technology into disruptive products that will help patients and society, while creating shareholder value. Dr. Rombel is an industry veteran and entrepreneur with 25+ years of leadership experience in science and business, spanning biotechnology, big pharma, consulting, investing, and academia. Prior to founding BioCurie, she was Chief of Staff, Research, at Spark Therapeutics, a leading gene therapy company, and Senior Director of Strategy and External Innovation at Janssen, J&J. Irene was previously the Founder and President of Biomedical Intelligence LLC, a life science consulting company, and a biotech hedge fund analyst. Dr. Rombel started her career in academia as an Assistant Professor at UT Southwestern Medical Center in the Center for Biomedical Inventions, where she conducted research on DNA vaccines, synthetic biology, and cell-specific targeting. Prior to her faculty position, she was a postdoctoral fellow at UC Berkeley and UC Davis, where her research on transcriptional regulation made fundamental scientific contributions to the understanding of promoter-enhancer control of gene expression. Dr. Rombel has advised and mentored many start-up companies over the past 20+ years, serving as a JPAL for the J&J JLABS Incubator companies, and as a Scientific Advisory Board member of the North Texas Enterprise Center (a life science incubator). She is on Columbia University’s Translational Therapeutics Accelerator Steering Committee and the Columbia University Irving Cancer Drug Discovery Advisory Board. Dr. Rombel received her PhD in Biochemistry and B.Sc. (First Class Honors) in Biochemistry with a double major in Microbiology from the University of Otago, New Zealand, and her MBA from Southern Methodist University, Dallas, Texas. Irene is also a registered U.S. Patent Agent with the USPTO.

Sergio Rossell, PhD, Expert Scientist, Upstream Development, GSK

Sergio was born and raised in Venezuela, where he studied biology. In 2002, he moved to The Netherlands to pursue his PhD. Thereafter, he held several academic positions, in all of which his research revolved around metabolic systems, always at the interface between experiments and modeling. In 2016, he transitioned to the food-ingredients and biofuels industry, and since 2012, he worked in the development of vaccine production processes. His professional life has been driven by the conviction that, to understand and engineer biological systems, we need to combine experiments, mechanism-based models, and data analysis.

Roush Biophama Panacea

David J. Roush, PhD, CEO & Distinguished Scientist, Roush Biophama Panacea

Experienced, distinguished scientist with a demonstrated history of innovation in pharmaceutical and biotechnology industry in diverse areas including Vaccines, Biotechnology, Life Sciences, Technology Transfer, Viral Clearance, and Commercialization of Biologics. For example, Dr. Roush pioneered the development and use of computational biophysics models to support rational development of downstream processes and formulation development via collaborations with key research institutes (e.g., RPI). He also contributed to the development of five life-saving therapeutics including the natural product/semi-synthetic anti-fungal drug Candidas and the immuno-oncology antibody Keytruda. Dr. Roush has a demonstrated track record of publication and presentations-authoring more than 120 publications and presentations on the topics of primary recovery, adventitious agent control strategy and associated mechanisms, modeling, and new technologies for HCP/lipase control. Awards and recognitions including ACS Fellow (2019), ACS BIOT Industrial Biotechnology Award (2016), and ACS Heroes of Chemistry Award in (2021) for development and commercialization of Keytruda. He serves on the Scientific Committee for the PREP International Symposium on Preparative and Process Chromatography. Dr. Roush is also an Adjunct Professor at University of Delaware and a member of the Recovery of Biological Products Conference Series Board of Directors.

Harvard Medical School

Silvi Rouskin, PhD, Assistant Professor, Harvard Medical School

Silvi completed her PhD at UCSF in Dr. Jonathan Weissman's lab, where she pioneered a method to measure RNA structure in high throughput in cells. After graduating in 2014, she started her own lab at the Whitehead Institute/MIT as a Whitehead Fellow. Her lab developed experimental and computational approaches to measure alternative RNA structures formed from the same sequence. Since 2021, Silvi has been an Assistant Professor at Harvard Medical School, studying RNA structure and RNA viruses.

Joe Saelens, PhD, Senior Principal Scientist, Computational Biology, Molecular Informatics, Pfizer

I am a computational biologist in the Molecular Informatics group at Pfizer based in Kendall Square. My work focuses on developing computational tools for sequencing-based methods for characterizing nucleic acid therapeutics. I received my PhD in Molecular Genetics and Microbiology from Duke University in 2017.

Kanika Sarpal, PhD, Senior Scientist, Biologics Drug Product Development, Sanofi

Kanika Sarpal is a Senior Scientist in Biologics Drug Product Development at Sanofi, US. She obtained her PhD in Pharmaceutical Sciences from College of Pharmacy, University of Kentucky with the focus on solid-state characterization of spray dried formulations. In her current role, she is working on formulation and process development of protein therapeutics for clinical programs. Prior to Sanofi, she worked at Vertex Pharmaceuticals in formulation development of small molecules for early and late stage projects.

Stefan R. Schmidt, PhD, MBA, CEO, evitria AG

Dr. Stefan R. Schmidt, MBA, is currently CEO at evitria AG, a company dedicated to antibody discovery services in Zurich, after leading operations at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland, as COO. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma, Germany, with overall responsibilities for biologics development and manufacturing. Before that, he was CSO at ERA Biotech in Barcelona, Spain, directing the company’s R&D efforts based on fusion proteins. Prior to that, he worked at AstraZeneca in Sweden where he led the unit of Protein Sciences within Global Protein Science & Supply as Associate Director. He started his leadership career 25 years ago at Biotech companies in Munich, Germany, where he built up protein biochemistry teams for Connex and GPC-Biotech. He holds a PhD in Biochemistry from the Julius Maximilians University in Wuerzburg, Germany and an MBA from the University in Gavle, Sweden.

Saurabh Sen, PhD, Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi

Saurabh Sen, PhD is a research scientist with a domain expertise in Gene Therapy, Antibody Therapeutics, Proteomics, GPCRs and CNS disorder (Parkinson’s disease). In his current position at Sanofi, he is actively engaged in Cell Line Development (CLD) delivering top class Producer Cell Lines (PCL) for Gene Therapy and stable cell lines for Biologics. Previously, at Boehringer Ingelheim (BI), he was leading antibody discovery projects (from early discovery to final leads for pre-clinical development) towards developing new drugs for unmet medical needs; as well as being the SME for antibody expression (transient and pools).

Kyverna Therapeutics

Ranjita Sengupta, PhD, Senior Director, Process Development, CMC Lead, KYV-101C, Kyverna Therapeutics Inc.

Ranjita is Senior Director, at Kyverna Therapeutics, a clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. In her current role, she is the CMC lead for Kyverna’s lead product candidate, KYV-101 which is advancing through clinical development across two broad areas of autoimmune disease: rheumatology and neurology with two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with Lupus nephritis. Ranjita has been working in the Cell & Gene Therapy space for the last 6 years. She has 17 years of Viral Vector experience, working with Lentiviral and Gammaretroviral Vector Platform Development, Process Development, Product Development, and CMO Management. Before joining Kyverna Therapeutics, she was at Adicet Bio, an allogenic off the shelf gammadelta T-cell therapy company focusing on cancer and other diseases. At Adicet Bio and Kyverna Therapeutics, she formed and led the Vector Process Development group. Her Vector PD group was responsible for the development and manufacture of gammaretroviral vector and lentiviral vector for research, development and preclinical studies. Before Adicet Bio, Ranjita worked at System Biosciences (SBI), a Biotech company specializing in lentiviral, exosome and gene editing technology. where she led the Lentiviral Vector Product and Custom Services portfolio. Ranjita obtained her PhD from North Carolina State University, Raleigh, NC in Biochemistry and then attended UC Berkeley for post-doctoral research.

Medical College of Wisconsin

Nirav N. Shah, MD, Associate Professor, Hematology, Medical College of Wisconsin

Nirav Shah, MD, MSHP, is currently an Associate Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology, specializing in lymphoma, stem cell transplant, and CAR-T therapy at Froedtert Hospital. He graduated with honors and Alpha Omega Alpha Honor Society membership from the University of Illinois at Chicago College of Medicine in 2008. He then completed his Internal Medicine residency at Massachusetts General Hospital in 2011. Post-residency, he took a position at Northwestern Memorial Hospital in Hospitalist medicine before proceeding to the University of Pennsylvania where he completed both hematology/oncology fellowship and a Master’s degree in Health Policy research in 2015.

Amgen Inc

Pranali Shah, Senior Associate Scientist, Process Development, Amgen Inc

I have a Master's degree in Biotechnology from Northeastern University. I work as a Process Development Senior Scientist at Amgen and lead the downstream process development for biologics. I have ~9 years of experience in process development, with strong expertise in process design, technology development, technology transfer, viral clearance and IND/BLA CMC authoring.

University at Albany

Susan Sharfstein, PhD, Professor, Nanobioscience, Nanoscale Science and Engineering, University of Albany

Susan Sharfstein is a Professor of Nanobioscience at SUNY Polytechnic Institute in Albany, New York. Professor Sharfstein received her B.S. in chemical engineering with honors from Caltech in 1987 and her Ph.D. in chemical engineering from UC Berkeley in 1993. Her interests include mammalian and microbial cell bioprocessing, control of protein glycosylation, metabolic engineering, biosensing, and development of systems for high-throughput screening of nucleic acids and small molecules. She is the author of over 65 papers and book chapters in the fields of biotechnology and bioprocessing.

Asian Cellular Therapy Organization (ACTO)

Akihiro Shimosaka, PhD, Chairman, Asian Cellular Therapy Organization (ACTO)

Dr. Akihiro Shimosaka is a chairman of Asian Cellular Therapy Organization(ACTO) having served from 2010 and is a director of Research Foundation for Community Medicine in Japan. He is one of pioneer developing biotech business creating and operating Kirin-Amgen, a JV company between Kirin and Amgen for commercializing EPO, G-CSF and TPO in 1984. He had various positions and worked as business consultant in different companies including Genentech, Immunex, Dendreon, Anosys, Cerus, Miltenyi, Medarex etc. Furthermore, he has served as a chairman of International Society of Cell Therapy (ISCT) Regulatory Affairs.

Adebowale Shoroye, Scientist, Biogen

Adebowale is a skilled professional with a background in Biochemistry and Mathematics, boasting 7 years of experience in the industry. Experienced in Quality Control (QC) and Analytical Development (AD) environments, Adebowale has developed methods for the analysis of Proteins, AAVs, and Oligonucleotides. Adebowale possesses extensive knowledge in chemical separation and biophysical characterization techniques. He is skilled in analytical instrumentation, method development in GMP settings, and is proficient with various computer programs and instruments. He possesses practical experience in introducing new instrumentation and methods to teams.

BioPharm Services Ltd

Andrew Sinclair, MSc, CEng, FIChemE, FREng, President & Founder, BioPharm Services Ltd.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

Beam Therapeutics

Manmohan Singh, PhD, CTO, Beam Therapeutics

Dr. Manmohan Singh is the Chief Technology Officer at Beam Therapeutics. Dr. Singh has more than 24 years of drug discovery and development experience at Takeda Pharmaceuticals, Novartis and Chiron Corporation. Prior to joining Beam Therapeutics, Dr. Singh was the Global Head of Drug Product Development at Takeda Vaccines, where he oversaw the drug product development of all vaccine programs, including Takeda’s dengue vaccine that was in Phase III efficacy study. At Novartis, he served as the Head of Formulation Development for more than 10 years and was instrumental in the licensure of several key vaccines (Bexsero , Fluad, Flucelvax) that were subsequently divested to GSK and CSL. He also led the development of the LNP platform of Novartis’s RNA vaccine. Prior to Novartis, Dr. Singh also spent more than 10 years at Chiron Corporation, where he led the development of Novel adjuvants and delivery systems for vaccines. Based on his contributions at Chiron and Novartis, Dr. Singh is considered as one of the leading experts in the field of adjuvants and vaccine delivery systems. He has authored six books in this field and has more than 120 publications. He was elected as a Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2011. Dr. Singh holds a Ph.D. in Pharmaceutics and Drug Delivery from the National Institute of Immunology in New Delhi, India.

Bristol Myers Squibb Co.

Peter Soler, PhD, Senior Research Investigator, Bristol Myers Squibb Co.

Peter Soler earned a Ph.D. from the University of California at Berkeley, and holds a B.S. in Chemical Engineering from Florida State University, Tallahassee, FL, with a double major in Biomedical Engineering and Biomedical Mathematics. Currently, Peter is the Automation Lead for Drug Product Development at Bristol-Myers Squibb. Peter was instrumental in designing the automated buffer exchange workflow for BMS and has been responsible for bringing the system into production. Peter oversees all automated drug product screening workflows for both small and large molecule and seeks to better digitize the information collected during the development of an asset. Peter is a champion of new technology and working with teams to usher in digital transformation.

Lasse Stach, PhD, Principal Investigator & Leader, Developability Profiling Team, GSK

Lasse is a Scientific Leader in the Developability team within Large Molecule Discovery at GSK. His expertise is in drug discovery, structural biology, protein characterisation, and post-translational modifications. In 2017 Lasse joined GSK, and since 2020 he has been leading the Developability team. At the interface between discovery and CMC, the team’s focus is the physical and chemical characterisation of protein-based therapeutics to identify developable leads for progression.

Bristol Myers Squibb

Claire State, Scientist, Drug Product Process Development, Bristol Myers Squibb

Claire is a Scientist that works on novel technology development within the Cell Therapy Drug Product Process Development team at Bristol Myers Squibb. She is currently leading development of several novel Cell Therapy technologies and supports transfer of these technologies to manufacturing. Claire has experience with technologies that range from islands of automation to all-in-one cell processing systems. The evolution of end-to-end automation in the Cell Therapy space is a topic she is well-versed in and eager to discuss.

Madhuresh Sumit, PhD, Principal Scientist, Pfizer Inc.

Dr. Madhuresh Sumit works at the interface of systems biology, mathematical modeling and cell culture experimentation to understand and optimize upstream bioprocesses. At Pfizer, Madhuresh has worked in collaboration with MIT on precision control of N-glycosylation in CHO cell culture using systems and synthetic biology approaches for accurate prediction and pro-active control of temporal variations in N-glycans in the recombinant proteins produced in CHO cells during a fed-batch process. Madhuresh is also a recipient of 2021 Martin Sinacore Outstanding Young Investigator Award.

Merck Manufacturing Division

Robert Taylor, PhD, Associate Scientist, Bioseparation Sciences, Merck Manufacturing Division

Graduate Degree in Physics at UC Irvine, 2016-2022; thesis on rare events in diffusion on surface of T cells. Postdoctoral Position for Merck 2022-present; researching digital twins for continuous biomanufacturing.

Lawrence C. Thompson, PhD, Senior Principal Scientist, Analytical R&D, Pfizer Inc.

Lawrence (Larry) C. Thompson, PhD. is a Principal Scientist in Analytical Research and Development within BioTherapeutic Pharmaceutical Sciences at Pfizer. He has been with Pfizer for 5+ years and is currently analytical lead on viral & plasmid based immunotherapeutics and gene therapies. He received his PhD in Biochemistry from Vanderbilt University in 2006 for his work with enzymes and their structure/function determination, spent 4 years as a post-doc at the University of Tennessee investigating the binding interactions of serum proteins and then 3 years in small biotech at two different companies as a lead scientist in the development of serum-based cancer diagnostics. His work has generated a number of peer reviewed publications and presentations at scientific conferences as well as internally within Pfizer.

Ronald T. Toth, PhD, Senior Scientist, Characterization, Sanofi

Biophysicist, data scientist, and roboticist with 8 years of experience in protein analytics, gene therapies, and cell therapies.

Eliquent Life Sciences (DataRevive)

Ageliki Tzovolos, Principal Consultant, CMC Biologics, Eliquent Life Sciences; Individual Consultant

Joined Eliquent Life Sciences (DataRevive) in 2023, following a distinguished career of 16+ years of industry experience working on biological products, including 8+ years in Regulatory Affairs. Current role at Eliquent Life Sciences (DataRevive) is as a Principal Consultant for CMC biologics with main focus in Cell and Gene Therapies. Prior to joining DataRevive worked at Genentech Inc. for sixteen years holding a variety of roles of increasing responsibility. During tenure at Genentech, worked on over 20 products spanning Phase I-III, and Marketed/Approved/Commercial products. Developed and executed regulatory strategies to support global filings, represented Regulatory on multi-functional product teams (including representatives from. technical development analytical development, quality control, quality assurance, upstream, downstream, purification, cell culture, nonclinical, safety, clinical, bioinformatics), and represented function in governance committee meetings for assigned programs. As a Regulatory Lead, was responsible for leading discussions on planning and coordination of technology transfer submission and comparability plan at cross-functional levels and external partners using appropriate risk management approaches. Holds a M.S. degree in Bioscience Regulatory Affairs and is currently pursuing a second M.S. degree in Individualized Genomics and Health from Johns Hopkins University. Received B.S. in Cell and Molecular Biology from San Francisco State University.

Janssen Pharmaceuticals

Bharathi Vellalore, PhD, Senior Scientist, Therapeutics Development and Supply, Janssen Pharmaceuticals

Bharathi Vellalore, PhD is a scientist with 14 years of experience in the discovery and development of biotherapeutics for therapeutic and diagnostic applications.

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).

Michail Vlysidis, PhD, Senior Engineer, AbbVie

Dr. Vlysidis obtained his PhD in Chemical Engineering at the University of Minnesota, Twin Cities, studying and modeling the stochasticity of biochemical reaction networks. With over 6 years of experience in the industry, he has made significant contributions to the fields of scientific software development and engineering. Currently serving as a team leader at AbbVie, Dr. Vlysidis' primary focus is on supporting the biologics organization in capturing and analyzing experimental data. He possesses a deep understanding of protein properties and leverages innovative protein language models to further enhance research in this area. Prior to joining AbbVie, he worked at Intel, where his expertise was instrumental in supporting R&D research on semiconductors and cutting-edge technology. With a strong academic background and industry experience, Dr. Vlysidis is dedicated to driving advancements at the intersection of chemical engineering, software development, and AI/ML models.

Novartis

Miha Vodnik, PhD, Senior Expert Science & Technology, Novartis

My name is Miha Vodnik and I am a Senior expert in science and technology at Novartis. I have a diploma in Pharmacy from Faculty of Pharmacy and a PhD in Biochemistry and molecular biology from Faculty of Medicine, both Ljubljana, Slovenia. I was always interested in nature and fascinated with the ability to extend and improve people’s lives. For the last nine years I worked at Novartis in the development of biologics, where I was responsible for development of analytical methods, automation and analytical project development. As analytical expert I was involved in the development of several biosimilars and new biologics, including a recently approved biosimilar. In my free time I like outdoor activities, especially with my wife and two children.

TreeFrog Therapeutics

Bryan Wang, PhD, Senior Scientist, TreeFrog Therapeutics

Bryan Wang is a Senior Scientist at TreeFrog Therapeutics. Bryan is a chemical engineer by training. He started his career in biotech at Sanofi, working on their protein therapeutics small scale manufacturing platform. Bryan joined the cell and gene therapy space when he started working at Rubius Therapeutics, where he was part of the upstream process development team. Bryan completed his PhD in Bioengineering at Georgia Institute of Technology in December of 2023, with a thesis focused on process development, PAT integration, and automation of cell therapy manufacturing. During this talk, he will be presenting part of his thesis work.

Bristol Myers Squibb Co

Chaojie Wang, Scientist, Biologics, Bristol Myers Squibb Co.

Chaojie Wang is currently a Principal Scientist at Bristol Myers Squibb based in New Jersey, USA. His major responsibility is raw materials and molecular analytics support for cell line development, and novel molecular assay development to support biologics development and gene therapy development. He is also leading the efforts using multi-omics approach for biologics process optimization. Chaojie obtained his PhD in Molecular Biology and Cancer Genomics from the Ohio State University and had worked at Oregon Health and Science University before joining BMS.

Merck & Co Inc

Yi Wang, PhD, Senior Scientist, Vaccine Analytical R&D Merck

Yi Wang is a senior scientist in the Vaccine Analytical Research and Development group at Merck, located at West Point in Pennsylvania. Yi received a BE degree in Polymer Science and Engineering from Beijing University of Chemical Technology, China, in 2016. She completed her PhD study in Materials Science and Engineering at Lehigh University in Bethlehem, PA, in 2021 with a thesis focusing on characterization of protein conformational change via microfluidics and fluorescence microscopies. During Yi’s post-graduation journey, she has developed an expertise in analytical assay development with a focus on lab automation and high-throughput techniques, supporting various studies for vaccine development.

Passage Bio

Shaoying Wang, PhD, Senior Scientist, Upstream Process Development, Passage Bio

Shaoying Wang is a senior scientist in process development department at Passage Bio. He received his Ph.D. in pharmaceutical Science from the University of Kentucky, and has extensive experience in virus packaging, process development and protein engineering. His work has resulted in over 20 peer-reviewed journal articles and more than 10 patents.

Lili Wang, PhD, Research Chemist, Biomarker & Genomic Sciences Group, NIST

Dr. Lili Wang is a NIST fellow and a leading expert in quantitative flow cytometry critical for diagnostics and advanced therapeutic development. She serves as the principal manager for the NIST Flow Cytometry Standards Consortium, a major Public-Private Partnership with key stakeholders from other agencies, industries, and academia, where she and her team work with consortium members to address pressing measurement and standards needed for bioassays, including SARS-CoV-2 antibody testing for diagnostics, vaccine testing, and surveillance. In collaboration with WHO, her team has established multiple standards, including critical reference materials for HIV/AIDS monitoring, stem cell counting for blood transplantation, and most recently, the first and second international serology/antibody standards. She serves on multiple professional committees and published over 100 peer-reviewed articles. She is a recipient of the 2020 and 2021 US Department of Commerce Gold Medal. Dr. Wang obtained her PhD in Chemistry from University of Notre Dame in 1996 and joined NIST in 1998.

Ultragenyx Pharmaceutical

James Warren, PhD, Senior Vice President, Pharmaceutical Development, Ultragenyx Pharmaceutical

Dr. Warren has 28 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads a team of 86 scientists and engineers, responsible for all early- and late-stage Process and Analytical Development of AAV portfolio products as well as Pilot Scale Manufacturing in Woburn, MA. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co., leading process development and manufacturing teams responsible for development of several clinical candidates as well as the licensure of RotaTeq®, Varivax®, ProQuad®, and Zostavax®. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.

Neurona Therapeutics

Michael W. Watson, PhD, Associate Director, Assay Development & Quality Control, Neurona Therapeutics

Michael Watson is the Associate Director of Assay Development and Quality Control at Neurona Therapeutics, working to create, qualify and validate novel cell-based and molecular assays to elucidate the identity, stability, and potency of the clinical NRTX-1001 product. Following a Ph.D. in Bioanalytical Chemistry at the University of Toronto, Dr Watson has been focused on developing novel instrumentation and methods for biologics and cell analysis for over 12 years in industrial positions. Having previously worked at Abbott: Point of Care and Fluidigm (Standard Biotools), Michael joined Neurona Therapeutics in 2018 and was part of the teams for assay development, CMC, QC Release and IND submission for the NRTX-1001 drug product now in Phase 1/2 clinical trials.

Alexander Way, Scientist, AbbVie

Alex graduated from the University of Massachusetts Amherst in 2013 with a Bachelor of Science in chemical engineering. He worked in a manufacturing sciences and technology laboratory for four years at Sanofi Genzyme providing small scale purification lab support to the manufacturing groups, and has worked in the downstream purification process development laboratory at Abbvie since 2017. In his time at Abbvie, Alex has performed the process downstream development and GMP tech transfer of multiple pre-IND products, and has performed validation-enabling process characterization experiments for multiple pre-BLA products.

Merck & Co., Inc.

Benqian Wei, PhD, Senior Scientist, Merck

Benqian Wei is a Senior Scientist from the Analytical R&D department at Merck & Co., Inc. His work mainly involves preforming various assays including intact/reduced-mass, reduced/non-reduced peptide mapping, multiple reaction monitoring, and top-/middle-down mass spectrometry to characterize therapeutic proteins to support biologics programs. Prior to joining Merck, Benqian earned his PhD from Professor Joseph Loo's lab at UCLA. His thesis research focused on using top-down and middle-down mass spectrometry from both fundamental and application perspectives to explore the utility of internal fragments for more efficient protein sequence, structure, PTM, and ligand binding characterization, particularly for proteins of therapeutic significance.

Rivanna Bioprocess Solutions LLC

John Welsh is the Principal Consultant at Rivanna Bioprocess Solutions LLC, an independent consultancy that provides CMC and process development services for biotherapeutic companies. He previously worked at Merck & Co., Inc. for over 11 years in bioprocess purification development where he supported preclinical and clinical candidates in process development and characterization activities. He also led a high-throughput chromatography screening lab and has expertise in chromatographic separations, process modeling, and continuous manufacturing. John holds a Ph.D. in Chemical Engineering from Stanford University where he worked under James Swartz's tutelage to better understand and apply cell-free protein synthesis technologies. He is a co-author on a number of peer-reviewed papers from both academic and industrial studies.

AbbVie Operations Singapore Pte Ltd

Niki Wong, PhD, Director Global Tech Operations CMC, Global Tech Operations CMC, AbbVie Operations Singapore Pte Ltd.

Niki Wong is currently the Director of the Global Technical Operations group in AbbVie Biologics Singapore, which oversees process development and tech transfer activities for biologics processes. She also leads a CMC drug substance commercial program. She has spent 12 years in AbbVie/Abbott, with prior roles as process and tech transfer leads. Her previous experience as a Research Scientist at the Bioprocessing Technology Institute involved various aspects of bioprocessing research that resulted in co-authorship of 18 publications. Given her exposure to both academia and industry, she is passionate about realizing bioprocessing innovation in industry.

The Ohio State University

David W. Wood, PhD, Professor, Chemical & Biomolecular Engineering, The Ohio State University

David Wood is currently a professor of Chemical and Biomolecular Engineering at The Ohio State University, where he continues to work on self-cleaving tag technologies for research and biopharmaceutical applications. He holds an undergraduate degree from Caltech with a double major in biology and chemical engineering, as well as a PhD from Rensselaer Polytechnic Institute in Chemical Engineering, and has experience in downstream processing and proess development at Amgen and Bristol Myers Squibb. He has published over 50 papers, book chapters and reviews in protein engineering, and holds several patents on technologies developed in his lab. Most recently, he is a co-founder of Protein Capture Science; a company formed to commercialize his split-intein technology for protein purification.

Northeastern Univ

Wei Xie, PhD, Assistant Professor, Mechanical & Industrial Engineering, Northeastern University

Dr. Wei Xie's research interests focus on process analytical technologies (PATs), machine learning (ML), interpretable Artificial Intelligence (AI), digital twin, data analytics, risk/sensitivity/predictive analyses, optimal design of experiments, data-driven stochastic optimization, systems and synthetic biology, and bioinformatics for biomanufacturing process risk management, optimal learning, and robust control.

MacroGenics Inc

Weichen Xu, PhD, Director, Analytical Sciences, Macrogenics

Dr. Weichen Xu currently holds the position of head of Analytical Development Group at MacroGenics, where she leads a diverse and skilled team dedicated to advancing the boundaries of analytical methodologies and bringing life-saving medicines to patients. Her team supports a variety of modalities, including monoclonal antibodies, bispecific molecules, and antibody-drug conjugates. Their work spans from early to late stage development, as well as post-approval activities. Prior to MacroGenics, Weichen worked at AstraZeneca, where she served as analytical lead for multiple biologics projects, including the rapid development and approval of Evusheld, the long-acting antibody combination to combat Covid-19. Weichen is passionate about enhancing the efficiency of her team. Focusing on leveraging prior knowledge and streamlining processes, she aims to achieve acceleration and success while reducing the workload on her dedicated team.

TriLink BioTechnologies

Khaled Yamout, Analytical Sciences, Quality and Manufacturing, Consultant Y-Chem Consulting, LLC

Khaled Yamout is a thought leader in Analytical Sciences, Quality and Manufacturing. Previously held a position as a Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported several Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.

Univ of Pennsylvania

Kenneth Yancey, Senior Director, Downstream Process Development, University of Pennsylvania

Kenneth Yancey is the Senior Director of Downstream Purification for University of Pennsylvania’s Gene Therapy Program. Kenneth oversees downstream process development, tech transfer and manufacturing and has several patents and publications in areas related to gene therapy and protein production. His interests include development of platform approaches for AAV-based gene therapy, implementation of emerging technologies, scale-up of AAV production and understanding impact of product quality on clinical safety and efficacy.

Merck & Co. Inc.

Ross Yang, Scientist, Merck Research Labs

Rong-Sheng (Ross) Yang is an analytical scientist with devotion in analytical enabling technology. He is specialized in chromatography and mass spectrometry. He earned an MS degree from Rutgers University/UMDNJ and has 30 years of experience in biopharmaceutical industry. Worked at Enzon, Roche, Schering-Plough, and currently at Merck. His works are published in journals including AC, JASMS, JOC, JPBA, JPS, OPRD, etc.

Palleon Pharma

Mark Yang, PhD, Vice President, CMC, Palleon Pharmaceuticals

Dr. Yang is Vice President of CMC at Palleon Pharmaceuticals Inc., where he oversees all CMC-related activities, including cell line development, cell culture/purification/formulation/assay development, tech transfer, GMP manufacturing, IND submission, and CDMO management. Prior to Palleon, Dr. Yang was the Director of Global Pharmaceutic Development Biologics at Sanofi for about 10 years, where he led a team responsible for drug product process development, process scale-up, CTM manufacturing, IND/IMPD/BLA submission, and product commercial launch. Dr. Yang also worked for many years in protein formulation, drug delivery, and GMP manufacture support at Acceleron, Baxter, and Altus. He is the recipient of VP Award from Sanofi Genzyme, Outstanding Technology Achievement Award from Baxter, and Fellows Award for Research Excellence from NIH. Besides numerous patents, he published over two dozen peer-reviewed research papers in many prestigious journals.

Interius Biotherapeutics

Elaine M. Youngman, PhD, Principal Scientist, Analytical Development, Interius Bio

Elaine Youngman is a Principal Scientist in Analytical Development at Interius Biotherapeutics. Since joining in 2022, Elaine’s work has focused on nucleic acid characterization related to lentiviral vector production, including characterization of the vector genome, residual DNA, and proviral integration. Prior to Interius, Elaine was an Assistant Professor of Biology at Villanova University, where she directed a laboratory investigating RNA-centered gene expression as well as the COVID-19 Surveillance Testing Laboratory. She earned her PhD in Molecular Biology and Genetics at the Johns Hopkins University and completed a postdoctoral fellowship at UMass Medical School and is an expert in molecular biology, RNA biochemistry, and cellular RNA quality control.

Eugenia Zah, Process Development Principal Scientist, Amgen Inc.

Eugenia Zah is currently a Process Development Principal Scientist at Amgen. Prior to joining Amgen, she completed her PhD at University of California, Los Angeles in Chemical and Biomolecular engineering under the supervision of Yvonne Chen where she worked on engineering next-generation chimeric antigen receptors to improve the efficacy of adoptive T cell therapy. At Amgen, she worked on developing manufacturing strategies for autologous cell therapies before transitioning to her current role in advancing automation capabilities in cell line development.

IGM BIO

Kevin Zen, PhD, Senior Director, IGM Biosciences

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining IGM Biosciences, he held various positions in biologics CMC disciplines at Allergan, AnaptysBio, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.

Janssen R&D LLC

Bo Zhai, PhD, Principal Scientist, Analytical Method Development, Janssen

Bo Zhai holds the position of principal scientist at Johnson & Johnson, where he is part of the Cell Engineering and Analytical Science group within the Department of Protein Therapeutics API Development-Biologics. With a PhD in Biochemistry and Cell Biology, Bo Zhai possesses extensive experience in biologics characterization, with a specialized focus on mass spectrometry data analysis and the streamlining of data analysis processes. Furthermore, he leads the data analytics endeavors within the group.

Tune Therapeutics

Heidi Zhang, PhD, Executive Vice President, Head, Technical Operations, Tune Therapeutics

Heidi Zhang is the Executive Vice President and Head of Technical Operations at Tune Therapeutics. Her responsibility includes technical development, manufacturing, supply chain, quality, and regulatory. Heidi is a seasoned Techops executive with leadership experiences from Tune, Juno/BMS, Genentech, Novartis, and Amgen. She has been involved in the development and commercialization of a wide range of biological and genetic medicines.

Merck & Co.

Yixiao Zhang, PhD, Senior Scientist, Merck

Senior Scientist at Merck & Co. with dynamic experience in bioprocess: CLD, upstream, downstream, and conjugation.

Regeneron Pharmaceuticals Inc

Sisi Zhang, Principal Scientist, Regeneron Pharmaceuticals, Inc.

Sisi Zhang is a principal scientist in the Analytical Chemistry group at Regeneron Pharmaceuticals. Her work in Regeneron is focused on host cell protein analysis, particularly in identifying problematic proteases and lipases that may impact drug product quality. Prior to Regeneron, she worked on metabolism at Princeton University. Sisi Zhang holds a BS in Pharmaceutical Sciences from Peking University and MS in Chemistry from Rutgers University.

Hao Zhang, PhD, Senior Principal Scientist and Team Lead, Pivotal Attribute Sciences, Amgen

Experienced technical development leader in analytical development of biologics. Leading analytical team in collaborating with cross functional product delivery team (PDT) to support biological product development and advancement. Manager/lead author for multiple successful biological marketing applications. Team leader in supporting Multi-Attribute Method (MAM) development, implementation/collaboration.

Merck & Co.

Shengyuan Zhao, PhD, Senior Scientist, Process Cell Sciences, BPR&D, Merck & Co.

Shengyuan Zhao received his PhD in Pharmacology and Toxicology from the University of Texas at Austin. He is currently a Senior Scientist in the department of Process Cell Sciences at Merck, where he leads several platform optimization efforts to facilitate pipeline development and streamline workflow between early discovery and preclinical development. His areas of expertise include DNA repair, gene editing, and cell biology, with extensive experiences in CHO engineering and fed-batch process optimization.

Alexion

Kate Zhao, PhD, Scientist I, Alexion

Kate Zhao is a Chemistry PhD graduate from the University of Wisconsin-Madison. She joined Alexion in August 2023 and has been working on harvest development using polymer flocculation. Kate has led the execution of the first polymer pilot-scale flocculation and small-scale studies, improving the process filter throughput. She is also involved in risk assessment and process characterization for biologics at Alexion. During her time in graduate school, Kate studied the mechanism of quorum sensing in notorious bacteria Staphylococcus aureus by performing kinase assays using purified membrane protein.

Northeastern University

Sunny Zhou, PhD, Professor, Chemistry & Chemical Biology, Northeastern University

Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”-a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable, such as photomedicine. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals. Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.

Bayer Healthcare Pharmaceuticals

Yuechen Zhu, PhD, Process Development Scientist, Gene & Cell Therapy Process Development, Bayer Healthcare Pharmaceuticals

Yuechen Zhu, Ph.D., is a cryopreservation and cell therapy expert. With a robust career spanning over a decade in the biomedical field, Zhu has carved a niche as a leading expert renowned for his in-depth understanding of both current methodologies and the exploration of next-generation cell therapy processing. His work, demonstrated by a prolific output of publications and patents, has advanced the understanding and capabilities of cryopreservation. Currently, he is also enrolling at the University of California-Berkeley MBA program.

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.

Siemens Industry Software

No bio available.

Delft University of Technology

Ramon van Valderen, PhD Candidate, Delft University of Technology

My name is Ramon van Valderen and I am an analytical and motivated person with a Master's degree in biochemical engineering from Delft University of Technology, the Netherlands. My strengths include knowledge on numerical simulations, data science and machine learning, and I am motivated to use such computational tools to further advance biotechnological processes. I am currently a 2nd year PhD candidate at the Delft University of Technology in the Netherlands in the group of Cees Haringa working on designing a bioreactor for the cultivation of stem cells using computational fluid dynamic simulations.

Childrens Hospital of Philadelphia

Johannes C.M. Van Der Loo, PhD, Director Clinical Vector Core, Perelman Center for Cellular & Molecular Therapeutics, Children's Hospital of Philadelphia

Dr. van der Loo has been involved in early phase GMP viral vector manufacturing since 2002. He is the Director of the the Clinical Vector Core at the Children’s Hospital of Philadelphia (CHOP). The Clinical Vector Core has manufactured AAV and lentiviral vectors for 18 years in support of phase 1, 2 and 3 clinical trials in 10 countries. His expertise includes upstream and downstream process development and manufacturing of pre-clinical and clinical grade vectors on several viral vector platforms, including gamma-retrovirus, lentivirus and AAV. Dr. van der Loo is a member of the Editorial Board of Molecular Therapy - Methods & Clinical Development. He is also a member of the 4Bio Ventures Management Advisory Board and serves as consultant in several capacities.

AstraZeneca

Eivor Örnskov, PhD, Principal Scientist, AstraZeneca

Dr. Eivor Örnskov, Principal Scientist at AstraZeneca Gothenburg, Sweden, leads the development of analytical characterization tools for the company's mRNA LNP Drug Products. Dr. Örnskov has been instrumental at AstraZeneca in establishing numerous release and stability methods pivotal for both pre-clinical and clinical phases. Dr. Örnskov's expertise extends to authoring regulatory submissions and contributing to the scientific community through published research in the field of mRNA and LNP characterization.

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