Sergio presently works 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 is currently 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 is 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.

Experienced Product Supply Manager with a strong history of working in the pharmaceutical & agrochemical business. Skilled in supply chain & project management, strong analytical & strategic mindset and passionate about leadership. He is holding a PhD from the International Max Planck Research School for Molecular Biology.

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.

Dr Houria Bachtarzi is the Principal Consultant of BIOCELLGENE Consulting Ltd., with strong expertise in the development and regulatory strategic aspects of advanced biological therapies covering virally vectored gene therapy, in vivo and ex vivo gene editing, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, cell-based immunotherapy, stem cell-based therapies; as well as other innovative therapeutic modalities.

She started her career by first training and registering as a pharmacist in the UK; and completed her PhD in cancer gene therapy at the University of Oxford, Department of Oncology (previously Department of Clinical Pharmacology). She subsequently followed up with additional Post-Doctoral work in AAV-based gene therapy and shRNA therapeutics for degenerative neuromuscular disorders at the Centre for Biomedical Sciences, Royal Holloway – University of London, in collaboration with Benitec Biopharma, Inc. and the Institute of Myology at the Pitié-Salpétrière Hospital in Paris, France. In 2013, she was appointed as a Lecturer in Biopharmaceutics at the School of Pharmacy and Biomolecular Sciences, University of Brighton.

Prior to founding BIOCELLGENE Consulting Ltd., Houria was a Director of CMC Regulatory Affairs (Consultancy) at Precision for Medicine, acting as an internal (for the Company) and external subject matter expert, to support organisations developing cell and gene therapy products and biologics for rare diseases and oncology indications. She also held senior positions at different product development and regulatory consultancies, notably Associate Director of Regulatory Sciences/ATMP Subject Matter Expert at ProPharma Group (formerly Diamond Pharma Services) and Senior Consultant positions at ERA Consulting (now Cencora PharmaLex), NDA Group and Dark Horse Consulting.

Houria is a registered Pharmacist with the General Pharmaceutical Council in the UK.  She is also a member of the British Society for Gene and Cell Therapy (BSGCT), the American Society of Gene and Cell Therapy (ASGCT) and the International Society for Cell and Gene Therapy (ISCT).

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).

Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was head of pharmaceutical services at Lonza Drug Product Services. In this role, he was responsible for pre-clinical drug product manufacturing for vials, pre-filled syringes, and ampoules. He also led the packaging and combination product development department as well as the lab automation group.

Roman joined Lonza from Roche. He is a pharmacist by training and holds a PhD in pharmaceutical technology from the University of Munich and an MBA. For 10 years he has been a lecturer at the University of Basel (Switzerland) teaching biopharmaceutical product development.

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.

Margarida Menezes Ferreira is a biologist by training, PhD in Medical Biochemistry (Université d’ Aix-Marseille II in France) and has a post-graduate fellowship at the National Institutes of Health, NIH, USA. Her research focused on molecular endocrinology. She has been invited lecturer on Regulatory framework for Biotechnology and Advanced Therapy Medicinal Products at the Faculty of Pharmacy from the University of Lisbon and in several post-graduate courses at University of Coimbra and University of Aveiro as well as at the Instituto Superior Técnico /University of Lisbon and at the PhD program MIT-Portugal and Harvard-Portugal. Margarida worked for 23 years as researcher at INFARMED - National Authority of Medicines and Health Products, Portugal, having developed, and coordinated the Biological Laboratory of the National Control Laboratory for Medicines and Heath Products (OMCL). She was also senior CMC assessor and Scientific advice coordinator. She acted on behalf of INFARMED as consultant expert for the building analytical capacity for laboratory control in the pharmaceutical sector in 2001 at Cape Verde for the World Bank and in 2005 at Angola with the European Commission. She represented Portugal and acted as expert in Biologicals at the European Medicines Agency (EMA). At EMA, she was member of the Biologics Working Party for 20 years. She was also member of the Cell Products Working Party until its closure. She was the Portuguese member at CAT, the Committee for Advanced Therapies, since its establishment in 2009 until retirement (1/2020). She was also founding Member of the EU Innovation Network (EU-IN). During her long experience as a Quality assessor of biological products, she has provided more than 150 scientific advice (national and European) and assessed and peer-reviewed several centralised European Marketing Authorisation including one Plasma Master File. She was actively involved in establishing the EU regulatory framework for ATMPs from the very start, involved in the drafting of the legislation and many of the EMA and European Commission guidelines applicable to ATMPs including Quality aspects for investigational ATMP, cell based and gene therapy products, comparability, GMP for ATMPs, GMO requirements etc. She is presently an independent consultant providing strategic orientation for ATMP quality development.

Dr. Sara Carillo completed her PhD in Chemical Sciences in 2013 at the University of Naples “Federico II” focusing on the structural characterization of polysaccharides and glycoconjugates from Gram-negative bacteria via NMR and mass spectrometry techniques. In 2015 she joined Dr. Jonathan Bones group in NIBRT working on the understanding of the effects of extractables and leachables from single-use bioreactors on CHO cells N-glycome and produced monoclonal antibodies. She is now working in NIBRT as Bioanalytical Research Lead and is mainly interested in the development on new mass spectrometry based analytical approaches to ensure deeper and easier understanding of biomanufacturing process and biopharmaceuticals structural complexity.

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.