Sergio recently worked as Global Director RegCMC – Cell and Gene Therapy.  He joined Novartis in 2016 and in the position he followed successful BLA and MAA filing of Kymriah in the US, EU, Switzerland, Japan Australia and Canada. After having successfully filed for FIH clinical trial a gene editing product for beta thalassemia, he was leading the development of a portfolio of next generation CAR-Ts presently close to approaching late stage development. 

Since 2001 he covered the position of QC head and Regulatory Affairs in Molmed (Milan), where he followed the manufacturing, non-clinical and clinical development of more than 15 cell and gene therapy investigational medicinal products through entire life cycle from the very early preclinical and clinical stage to the late clinical stages, and up to filing and MAA approval for Zalmoxis and Strimvelis. 

He started his professional life with 1 year post-doctoral research in biochemistry, followed by 15 years of experience at Merck/Serono where he worked in head of cell amd molecular lab focussed on cell bank characterization.

Formal education includes a MSc in Biology and a PhD in Biotechnology. 

Dr. Stephen Sullivan, PhD, MBA, FRSM, is a leading expert in the development and manufacture of Advanced Therapeutic Medicinal Products (ATMPs), particularly focusing on induced Pluripotent Stem Cell (iPSC) therapeutics. As the Chief Operating Officer and Board Member at iPSirius (www.iPSirius.com), a top immunotherapy company specializing in comprehensive cancer treatments using iPSCs, Dr. Sullivan was pivotal in advancing their patented technology and groundbreaking therapeutic cancer immunotherapy, IPVAC 1.0. This innovative treatment leverages the antigenic similarities between iPSCs and cancer stem cells (CSCs) to combat cancer relapse, metastasis, and resistance through immune response training. Preclinical studies of IPVAC 1.0 have shown promising results, including tumor size reduction, modulation of the tumor microenvironment, and induction of long-term memory immunity.

In addition to his current roles, Dr. Sullivan founded Lindville Bio (www.lindvillebio.com), a respected consultancy firm specializing in iPSC manufacture and ATMP development. Through Lindville Bio, guidance and expertise is offered to organizations and individuals navigating the complexities of stem cell therapies, with a particular emphasis on optimizing iPSC manufacturing processes.

Dr. Sullivan earned his PhD in Regenerative Medicine from the University of Edinburgh, focusing on nuclear reprogramming in mammalian ES cells. Dr. Sullivan has also held research fellowships at Harvard University, the University of Cambridge, and the University of California, San Diego (UCSD). He also holds an MBA from Trinity College Dublin, providing him with strategic management expertise. From 2017-2023, he served as a program manager of the Global Alliance for iPSC Therapies (GAiT). Presently, he is a iPSC Scientific Committee Member at the International Society for Cell & Gene Therapy.

Currently General Manager at Centre for Cell Manufacturing Ireland (CCMI) at University of Galway, Ireland. Manage all plant operations and personnel in conformance with GMP and in line with current industry norms for the product category - Investigational Medicinal Products.

At CCMI we manufacture stem cell therapeutic products where CCMI has received regulatory approval to manufacture and release cellular materials for administration to patients participating in clinical trials for the treatment of critical limb ischemia, osteoarthritis, and diabetic kidney disease.

CCMI also play an important role in providing GMP training and lectures to students on postgraduate masters program in cellular manufacturing at the University of Galway. This provides real hands-on coaching which prepares these students for research and industry roles in the Cell and Gene Therapy space.

Sofia Carvalho is a Senior Scientist at the Sanofi satellite laboratory within the Animal Cell Technology Unit of iBET’s Health & Pharma Division, where she has worked since 2018. Her research is focused on downstream processes and bioanalytics development, namely on bioprocess understanding and biologics characterisation. She is exploring how operating variables impact process performance and product quality, from mAbs to gene therapy products.

Sofia holds a Biochemistry degree and MSc (2009, 2011) from Faculdade de Ciências, Universidade de Lisboa and a PhD in Biotechnology (2018) from ITQB-NOVA, in collaboration with iBET. Her PhD was on Downstream processing strategies for Influenza VLPs as universal vaccine candidates, and on developing analytical tools for process optimization and product characterization. She did part of her PhD studies at the Max Planck Institute for the Dynamics of Complex Technical Systems, Downstream Processing Lab (Germany), and at PALL Life Sciences (UK).

In January 2018, she joined Genibet Biopharmaceuticals as a Project Manager, working on viral process development and cGMP manufacturing. Later that year, she returned to iBET, to integrate the Sanofi Satellite Lab team.

Sofia authors 18 manuscripts, 1 conference paper and 1 book chapter garnering 456 citations (h-index 12). She has more than 20 oral presentations and 30 poster communications at national and international conferences. Sofia is involved in the supervision of students and research fellows and is a team member in several publicly funded research projects (FCT and EC) and PI in 2 iBETXplore projects. She managed several R&D projects with the biopharma industry and is currently managing the Bioanalytics Scientific Committee at iBET, established in 2023.

Breech is currently a Process development scientist with Merck KGaA Darmstadt. She is also a focal point for Vaccine, Viral, Cell and Gene Therapies within EMEA and has over 10 years of industrial experience.

Andrew Steinsapir is the Acting Chief Technology Officer of Apertura Gene Therapy and a Director, Gene Therapy Program Lead of Deerfield Management’s Discovery and Development team. Prior to Deerfield, Mr. Steinsapir was a Consultant for over three years at Dark Horse Consulting Group, where he provided strategic and tactical support for more than 30 cell and gene therapy firms, pharma, and investment firms. Previous to Dark Horse, Mr. Steinsapir worked at 4D Molecular Therapeutics, in several research and process development roles. Mr. Steinsapir holds a B.S. in Chemical Engineering with an emphasis on Biotechnology and an MBA from the University of California, Berkeley

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

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

Dr. Marie-Christin Viehauser is Senior Scientist for Molecular Biology in the Manufacturing Science and Technology (MSAT) department at Biomay (Vienna, Austria). She specializes in AAV and lentiviral plasmid design, molecular biology techniques such as DNA sequencing, molecular cloning and the expression of plasmid DNA and recombinant proteins in E. coli. Dr. Viehauser joined Biomay in 2021, where led the GMP cell banking team. In this position she was responsible for the management and optimization of the GMP cell banking system, plasmid design and other molecular biology applications and gained extensive experience with cGMP quality systems.

Dr. Viehauser earned her PhD in Biotechnology from the University of Natural Resources and Life Sciences (BOKU) in Vienna in 2021, where her research centered on the expression of recombinant proteins in E. coli and P. pastoris as well as the biochemical and electrochemical characterization of oxidoreductases. She received her master’s degree in Biotechnology from BOKU in 2018 with a focus on molecular biology, biochemistry and bioprocess engineering.

David Dobnik, PhD in Biotechnology, has been developing new nucleic acid detection/quantification aproaches since 2007. From 2016, he has been closely working with companies in the field of gene therapy (such as AveXis (now Novartis Gene Therapies)) to develop and apply methods for precise quantification of viral vectors (e.g. dPCR), observation of viral particles (electron microscopy), and for identification and quantification of impurities (e.g. nucleic acids by high-throughput sequencing (HTS/NGS). David has been leading the development and tech-transfer projects for pharmaceutical companies focused on the field of gene therapy, helping their process development efforts with characterizations of viral vectors. Lately, most of his
work has been focused on new approaches for genome integrity evaluation.

Dr. Rahul Kaushik, is currently working as a Director at Cell and Gene therapy consultancy Ltd. and is passionate about advancing the field of genetic medicines to combat human diseases. His major expertise revolves around solving challenges related to AAV based gene therapy product development with a focus on vector design, lead selection and initial process and analytical development. Dr. Kaushik's has been extensively involved in the areas of AAV-based in vivo gene therapy product development across diverse disease areas, including CNS disorders, metabolic disorders, and ocular gene therapy. He has developed and helped advance the AAV and LV based platform technologies and programs at various organisations for gene silencing and gene supplementation strategies. With over 16 years of experience, he has authored various high impact publications and is dedicated to using advanced viral vectors and improving manufacturing processes in the pursuit of effective gene therapies for various human diseases.

Dr. Wenliang Dong is a seasoned executive with over 15 years of experience in pharmaceutical development, with a proven track record in leadership across operations, quality management, and business development. He currently serves as the CEO of ORCA Therapeutics, where he leads the company's strategic direction and growth initiatives. In addition to his executive role, Dr. Dong actively consults for biotech companies, advising on drug development strategies in antibody and cell therapies, helping clients navigate complex challenges in the rapidly evolving biopharma space.

Dr. Dong’s career includes significant leadership roles, including serving as a Head QA and Project Leader at Sanquin Plasma Products BV in the CMO division, where he has successfully managed diverse projects focussing on regaining compliance and improving the QMS.

He holds a Ph.D. from the University of Leiden, where he collaborated with the German Cancer Research Center (Heidelberg, Germany) and the International Agency for Research on Cancer (Lyon, France), focusing on cutting-edge research in cancer biology. Dr. Dong also earned an Executive MBA (cum laude) from RSM Erasmus University, which further strengthened his strategic, financial, and leadership skills in the biopharmaceutical industry.

In 2003 he gained his diploma of chemistry at the university of Marburg and finished his PhD in applied physical chemistry in 2006. He joined Merck in 2006 as lab manager for quality control. In 2009 he took over the group lead for process intensification. He led different worldwide projects for NPI and new technology implementations with focus on process intensification. Since 2018 he is the portfolio / innovation manager in the engineering department and the principal project lead for the smart manufacturing initiative in Merck. He describes himself as: a curious chemist in the process development engineering department, bringing forward smart manufacturing for Merck and being the ambassador for modular production ensuring the future for our children.

Dr. Françon, Ph.D., is the Chief Operating Officer of Coave Therapeutics, overseeing therapeutics product operations. She is an experienced biotech professional with over 20 years’ experience leading R&D, preclinical and clinical operations as well as global CMC and regulatory strategies for the accelerated development of innovative biologics, including advanced cell & gene therapies. Patricia joins Coave from Skinosive where she served as Chief Operating/Technology Officer, managing operational aspects of the business, proactively driving the company towards achieving its development goals. Patricia has also held various product development roles at Sartorius, Neuro-Sys, Enterome, Cellectis, Anaconda Pharma and Sanofi, managing all aspects of product development, coordinating multiple studies, selecting partners and managing regulatory processes. Patricia obtained her PhD in Molecular and Cellular Biology from Paris VI University and completed her postdoctoral research at McGill University.

John Kudolo, PhD received his Ph.D. in Neurobiology & Neuroscience from Otto-von-Guericke University, Germany with research focus on hippocampal protein synthesis in hippocampal learning and memory. John has over 8 years of academic research career experience and over 10 years of experience in industry supporting scientists with varied background in single-cell applications in antibody engineering, cell line development, and TCR discovery. John currently works with Quantum-Si as Senior Field Application Scientist supporting scientists both scientifically and technically on next-generation protein sequencing platform across Europe.

Dr. Riccardo Biavasco is an accomplished scientist and leader in analytical development for cell and gene therapy. He currently serves as the Head of Analytical Development at Vor Bio, where he oversees the advancement of analytical pipelines supporting both early- and late-stage development of HSPC gene therapy and CAR-T drug products. Prior to his role at Vor Bio, he held positions at Beam Therapeutics and bluebird bio, contributing to the development of pioneering gene therapies, including Zynteglo and Skysona. Dr. Biavasco earned his PhD in Molecular Medicine from San Raffaele University in Milan.

With over five years of experience in mentoring and leadership, Dr. Biavasco has played a pivotal role in regulatory interactions, authoring critical BLA sections, briefing books, and FDA responses. His expertise spans cell and gene therapy, lentiviral vectors, gene editing, and immunology, and has a strong background in analytical assay development and regulatory strategy.

Dr. Ben Hudjetz is a Principal Scientist in the Viral Vector R&D Organization at Cytiva. He holds a PhD in Cell Biology and Virology from the Heinrich-Pette-Institute (University of Hamburg) and has gained over 10 years of experience in the biotech industry with a focus on virological research and cell line development. Dr. Hudjetz’s expertise includes mammalian cell engineering, high-throughput cell cultivation and screening. He has made substantial contributions to the development of mammalian cell substrates for the manufacturing of rAAV-based gene therapies and has acquired a profound technological understanding of both transient and fully stable production systems. In his current position, Dr. Hudjetz focuses on the development of next-generation stable and transient ELEVECTATM cell lines with enhanced performance characteristics in terms of viral vector yield and quality.

Vasily has a background in biotechnology and business administration with a 13 years track record of process and product development in domains of monoclonal antibodies and viral vectors. Having worked in Europe, US and China, he currently leads the development department of Exothera, Belgium-based CDMO focusing on viral vectors and nucleic acids. In his role he oversees process, analytical and CMC development.

Dr. Jorge Santiago-Ortiz is the Senior Director of Chemistry, Manufacturing, and Controls (CMC) at Apertura Gene Therapy. Jorge completed his bachelor’s degree in Chemical Engineering at the University of Puerto Rico, Mayagüez, and his Ph.D. in Chemical and Biomolecular Engineering at the University of California, Berkeley. Working in Dr. David Schaffer’s laboratory, his Ph.D. dissertation work focused on the engineering of lentiviral and adeno-associated virus (AAV) vectors for gene therapy applications using in vitro and in vivo directed evolution. Following the completion of his Ph.D., Jorge transitioned to an industry role at BioConsortia Inc., where he led the fermentation and scale-up of beneficial plant-associated microbes for enhanced crop yields and improved plant health. Prior to his current role at Apertura, Jorge worked as the Sr. Director of Process Development at BioCentriq, where he oversaw process development for gene and cell therapy products and managed gene therapy projects.

Jens Keune leads the Data Science and Digital Products team at Viralgen, where he is responsible for providing decision support to clients and various departments by leveraging data captured from over 1,500 batches produced. His research interests focus on utilizing data to enhance both product quality and process efficiency in AAV manufacturing. Prior to joining Viralgen, Jens held several positions in the Data Science field at Bayer, collaborating across multiple functions and divisions. He holds a B.Sc. and M.Sc. in Mathematics.