The gene and cell therapies clinical impact, production, and processes efficiency depend on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.
Key therapies experts, advisers, and practitioners will focus primarily on:
The #VLGeneCell brochure 2023 contains additional key insights as well as information about the concurrent #VLasepticRead more
Gene and cell therapies breakthroughs are advancing rapidly.
Autologous and allogenic cell-based therapies, including CAR-T, TCR, NK-cells, TIL, viral and non-viral vector mediated therapies, and other ATMPs demonstrate tremendous progress.
The full extent of their clinical impact, production, processes performance, and efficiency hardly depend on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.
At the #VLGeneCell Summit, key experts, advisers, and practitioners will focus primarily on:
The leading gene and cell therapies practitioners and consultants will share insights, technical and regulatory requirements, and expectations on successfully achieving and scaling-up robust, cost- and quality-efficient products, process developments, and manufacturing, as well as explore recent developments, emerging technologies, methods, and tools, including the updates on the aseptic processing at the concurrent event.
Join the #VLGeneCell to explore the industry challenges, standards, and advancements on June 20-21, 2023, and take an advantage of the concurrent #VLaseptic.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:
The demand of aseptic manufacturing is rising, and, therefore, the challenges of aseptic processing will continue to grow in complexity.
Ensuring product quality at faster speed and with better flexibility is becoming the key priority.
The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered to be the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The changes to Annex 1 are bringing new obstacles to pharma company operations that should be overcome from both technical and organisational perspectives.
The 6th Aseptic Processing Summit on June 21-22, 2023, will bring together pharmaceutical developers, manufacturers, CDMOs, suppliers, engineering companies, and experts from the field to highlight:
Join the #VLaseptic to explore the industry challenges, standards, and advancements, as well as develop new partnerships and showcase innovative technologies at the premium conference and exhibition on June 21-22, 2023.
Chief Executives, Directors, Vice Presidents, Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers, and Fellows specialising in:
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
NOVADIP Biosciences S.A.
Amandine Breton is associate director of cell process MSAT at Orchard Therapeutics. In 2019 she joined Orchard Therapeutics, where she oversees and manages cell and gene therapy drug product manufacture from pivotal clinical trials to commercial, including authoring of regulatory filings (IND, IMPD, MAA, BLA). In addition to her MSAT responsibility, she has been leading the Strimvelis® CMC team since 2020. Amandine has a BSc and MSc from the University of Versailles St-Quentin (UVSQ) and a PhD in cellular biology from UVSQ. She did three post-docs at the Roslin Institute, Queen’s Mary University, and King’s College London, working in induced pluripotent stem cells biology, hematopoietic cells, and globin gene activation in the context of beta-thalassaemia and sickle-cell disease. She then chose to join the CGT field and held two consecutive positions in GMP manufacture at Guy’s and St Thomas GMP unit and CRUK GMP manufacture, where she worked on autologous and allogenic cell therapies in phase I/II clinical trial, building her expertise in technology transfer, process development, and GMP manufacturing processes.
Dr. Behnam Ahmadian Baghbaderani is the global head of process development and cell and gene technologies at Lonza. He has over 18 years of experience in development of cell and gene therapies for clinical and commercial applications.
Behnam holds a PhD degree in biomedical engineering from the University of Calgary (Canada), where he developed bioreactor protocols for large-scale expansion of human neural stem cells for clinical applications. He completed nearly three years of a postdoctoral program, including a two-year postdoctoral fellowship at the NIH focussing on generation of human-induced pluripotent stem cells (iPSCs), bioprocessing of human embryonic stem cells and human iPSCs, and controlled differentiation into neuronal lineage.
After joining Lonza in 2011, he started to lead a group of scientists in process development, establishing pluripotent stem cell platform technologies and a cGMP compliant manufacturing process for iPSCs. Behnam then led the cell therapy development department, focussing on the development of cGMP compliant processes and analytical methods for different autologous and allogeneic cell therapy applications. In his current role, Behnam has been leading a global organisation offering development services for a wide range of early- and late-stage viral vector gene therapies as well as autologous and allogeneic cell therapy applications at Lonza.
Branden Salinas is a passionate, strategic problem solver in the CMC and technical operations biotechnology space. His data-driven roots were founded during his PhD studies in the chemical and biological engineering department at the University of Colorado in Boulder. He followed this with several roles in both large and small organisations, varying in functions from process and product development, to manufacturing support, to multiple capital projects. Over the years he has collected technical transfer experience from multiple angles, at multiple scales, and at multiple phases of development. He enjoys building teams and relationships and is fully motivated to deliver Umoja’s game changing in vivo CAR-T technology to first in human clinical trials. Branden is now leveraging these experiences to support Umoja’s technical operations buildout in the Boulder, Colorado, area where he lives with his beautiful wife and three daughters. Outside of work he loves watching and coaching his daughters fútbol activities, listening to music, trying new recipes, cooking outdoors, and enjoying the company of family and friends.
Angeliki Grammenos is a physicist by training and has a PhD in biophysics specialized in cell biology. In 2012, she left her teaching position at the University of Liège to join the international office of Doctors Without Borders, where she assisted the ethical review board as well as the quality assurance department of the organization. In 2015, she left to lead the regulatory department at Bone Therapeutics S.A, a biopharmaceutical company dedicated to the development of cell therapy products based on autologous and allogeneic adult stem cell technology. From 2018-22, Angeliki led the regulatory department of Celyad Oncology, a biopharmaceutical company developing allogeneic and autologous CAR-T cell therapy candidates for cancer patients. Additionally, she was acting as a program management team chair for the company. Since 2022, she has been working at Debiopharm, an independent biopharmaceutical company based in Switzerland aiming to develop innovative therapies that target high unmet medical needs.
Christiane Niederlaender has spent nine years at the UK medicines regulator MHRA, most recently as the unit manager of the biologicals unit. At the same time, Christiane was a biologicals senior quality assessor and the UK delegate at the EMA committee for advanced therapies (CAT). As UK CAT rapporteur, she was responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the rapporteur for the EMA CAT gene therapy guideline, and a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector.
Christiane joined Parexel in January 2021 as vice president technical for CMC and now works with developers to get cell and gene therapies into the clinic and to market. Since joining Parexel, Christiane has done a significant amount of work within the US regulatory system and can advise on EU, UK, and US CMC considerations.
Dr. Houria Bachtarzi is an Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies, with 15 years of experience in the scientific and regulatory CMC aspects of advanced biological therapies including virally vectored gene therapy, in vivo and ex vivo gene editing, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based therapies. Houria started her career by first training and registering as a pharmacist in the UK, before embarking into a unique journey in gene therapy and regenerative medicine. She 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 neuro-muscular 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, Houria was appointed as a lecturer in biopharmaceutics and biotechnology at the School of Pharmacy and Biomolecular Sciences, University of Brighton.
Prior to joining Diamond BioPharm Ltd., a ProPharma Group Company, Houria was a senior consultant in gene and cell therapies at other product development and regulatory consultancies: ERA Consulting (UK) Ltd., NDA Group and Dark Horse Consulting, where she provided technical scientific, CMC, and regulatory/development strategic advice in relation to different complex gene and cell therapy technologies. She also provided expert advice on matters related to genetically modified organisms (GMOs).
Dr. Kuldip Sra has over 25 years of work experience in biotech and pharmaceutical industries. Currently, Kuldip is executive director in tech ops at Crisper Therapeutics. Previously, he worked at Kite Pharma/Gilead, where he was director of QC. Kuldip is involved in developing and validating analytical assays for lot release and characterisation of autologous and allogenic cell therapy drug products.
In the past, he worked at MedImmune/AstraZeneca for 15 years. Kuldip led the vaccine analytical development and characterisation group at MedImmune at its Mountain View site.
Chaminda Salgado is a highly experienced CMC Leader, with experience in CMC biological assets and cell and gene therapies, ensuring the smooth flow of programs from lead candidate through to commercialisation. Before joining T-Cypher Bio, Chaminda was leading the analytical innovation capability projects for CGT at GSK to address testing issues to releasing autologous therapies for indications with high patient numbers.
NOVADIP Biosciences S.A.
Carmen Brenner is currently director of manufacturing, science, and technology (MSaT) at Novadip, a Belgium-based pharmaceutical company developing a unique platform for tissue regeneration in the field of bone and skin.
Carmen has been working in the field of cell therapy for more than 10 years. Prior to joining Novadip, Carmen was head of quality in another cell therapy company, where she was leading QA and QC activities and was participating in the launching of Phase IIb and Phase III clinical trials in several European and non-European countries.
Carmen holds a PhD in biomedical sciences (cancer epigenetics) from the University of Brussels (ULB).
Eugenio Montini started his scientific career in 1995 in the field of human molecular and medical genetics at the Telethon Institute of Genetics and Medicine (TIGEM, Milan, Italy). Later, in 1999, he worked in the field of liver gene therapy and liver regeneration and characterised the therapeutic potential and the genomic integration events of Sleeping Beauty transposons and showed for the first time that adeno associated vectors (AAVs) integrate in the genome of hepatocytes in vivo.
Since 2009, he has been leading the safety of gene therapy and insertional mutagenesis research unit at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget, Milan, Italy), a research group aimed at unravelling the basic mechanisms governing the genotoxicity in gene therapy applications and understanding the impact of cellular senescence upon oncogene activation and identification of markers and targets for their elimination. In 2012, he established and has since directed the vector integration core in SR-Tiget, a team whose mission is to monitor clonal composition of genetically modified cells in gene therapy patients and to devise and validate novel molecular readouts for safety assessment.
His main scientific contributions include the demonstration that self-inactivating lentiviral vectors (SIN-LVs) have a superior safety profile over gamma-retroviral vectors, which has resulted in the adoption of SIN-LVs as the preferred platform for therapeutic gene delivery internationally. He has also successfully used integration site analysis to perform clonal tracking and cell lineage specification and differentiation in preclinical models and clinical trials. He has also utilised novel ad-hoc designed LV vectors to uncover novel cellular oncogenes and novel pathways involved in drug resistance in human cancers, developed a liquid biopsy integration site sequencing (LiBIS-seq), a polymerase chain reaction technique optimised to quantitatively retrieve vector (including AAV) integration sites from cell-free DNA released into the bloodstream by dying cells residing in diverse tissues, and discovered that oncogene-induced senescence in hematopoietic progenitors features myeloid restricted hematopoiesis, chronic inflammation, and histiocytosis in a humanised model.
Francesco Cicirello is currently director of quality assurance at Evelo Biosciences in Cambridge, MA (USA), and he enjoys helping the company bring to the market an entirely new therapeutic modality.
Prior to Evelo, he was site quality head at Adaptimmune, an ATMP company headquartered both in the UK and USA, with a gene therapy drug products with PRIME and RMAT designation.
Before joining Adaptimmune, Francesco worked in a regulatory agency, where he was an expert inspector at the Therapeutic Good Administration (TGA) in Australia. He also was elected to several roles in PIC/S (Pharmaceutical Inspection and Cooperation Scheme) including chairperson of the working group that revised the PIC/S Annex 2 and deputy chair of the subcommittee on harmonisation. He also represented PIC/S at the EMA IWG and was a member of the PIC/S coordinating committee on human blood, tissues, cells, and ATMPs. Francesco is the author of the recently published PIC/S Annex 2A and 2B, and he contributed to the revision of the latest published draft of the EU Annex 1 and the PIC/S transposition of Annex 16.
Francesco has a degree in chemistry and pharmaceutical technology from the University of Florence, an MSc in oncology pharmacology from the University of Milan, and an MSc in cosmetic production from the University of Siena (he may still remember how to make sunscreens!). He is a member of the PDA ATMP board, and of the ISPE SIG Biotech and CoP in ATMP.
Dr. Ana Sofia Coroadinha has a degree in biochemistry (University of Lisbon) and a PhD in gene therapy performed at Généthon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009, she has been the head of cell line development and molecular virology lab at iBET and ITQB-NOVA.
She has over 20 years of experience in viral vectors and animal cell culture, areas where she has published over 65 peer-reviewed papers.
Ana’s group research ties virology and technology in order to find treatment solutions through the use of recombinant virus in the areas of gene therapy and vaccine development.
Dr. Gregory Fiore is a co-founder and is the President and CEO of Exacis Biotherapeutics. He is a pharmaceutical/biotechnology executive and entrepreneur and is a co-founder and former CEO of Sollis Therapeutics, a clinical-stage pharmaceutical company. As CEO of Sollis, he led fundraising efforts and raised up to $50M to perform a pivotal trial for the company’s lead asset.
Before this, Gregory provided senior medical support as consultant and acting CMO for several early-stage biotechnology companies through two successful consultancies he founded, SSI Strategy and Fiore Healthcare Advisors. He was the first CMO of The Medicines Company and held leadership roles at Merck and Abbott Laboratories, and previously he had been a management consultant at McKinsey and Company.
Gregory completed an internal medicine residency and received clinical pulmonary/critical care training at Harvard Medical School following graduation as class valedictorian with an MD degree from New York Medical College. He serves on several medical and business advisory committees/boards. He is on the executive board of the Institute of Neuromodulation, the scientific advisory board for Advera Health Analytics, the business advisory board for the Advanced Group of Companies, and the editorial advisory board of the industry publication Clinical Leader. He serves as an advisor to several biotechnology companies.
Amnon Eylath is a seasoned quality leader who's experienced in the complete life cycle of biological and small molecule drug development, from discovery through nonclinical and tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions, and US/EU/MHRA commercial product approvals. Amnon has direct experience with cell and gene therapy and with developing and troubleshooting aseptic processes, including design and fabrication of isolators and the implementation and validation of highly effective decontamination and sterilisation technology.
Amnon has worked at various capacities in international companies, such as Amgen, Ely Lilly, and Genzyme-Sanofi, as well as at cell therapy companies such as Cellcore Therapies, Histogenics, and Minovia Therapeutics. Currently, Amnon is the global vice president of quality at Minovia Therapeutics, working out of the Massachusetts site and developing quality systems and implementation of continuous improvement methods to the development of clinical cell therapy processes.
Active volunteer with the Parenteral Drug Association (PDA), chair for the drafting of Technical Report T-56 (Application of Phase-Appropriate Quality System and cGMP), co-author for TR-65 (Technology Transfer), and former president of the New England Chapter of the PDA.
Amnon is an active volunteer with the Parenteral Drug Association (PDA), chair for the drafting of Technical Report T-56 (Application of Phase-Appropriate Quality System and cGMP), co-author for TR-65 (Technology Transfer), and prior president of the New England chapter of the PDA.
Christopher P. Locher, PhD, is CEO and co-founder of Versatope Therapeutics, a preclinical-stage Massachusetts-based company currently focussed on the development of technology platform using nano-vesicles. He previously led drug discovery projects for infectious diseases at Vertex Pharmaceuticals in Boston, inflammatory diseases at Opsona Therapeutics in Ireland, and malaria and alphaviruses vaccine development programs at Maxygen in California. He completed postdoctoral training at the University of California, San Francisco, was a Fulbright Hayes Research Fellow at the Institute of Tropical Medicine in Antwerp, Belgium, and received his PhD in tropical medicine and bachelor's in biological sciences from the University of Hawai`i.
Shi-Jiang (John) Lu, PhD, MPH, is currently the president and CEO of HebeCell Corporation, focussing on the development and clinical translation of regenerative medicine and cell therapy technologies, especially iPS-CAR-NK cells for the treatment of cancer, autoimmune and viral infectious diseases. Before establishing HebeCell, he was the senior director of research at Advanced Cell Technology/Ocata Therapeutics, which was acquired by Astellas Pharma in 2016. John is an expert in stem cell biology and regenerative medicine with 20 years of experience.
He has been conducting translational research and discovery of novel therapeutic strategies utilising human pluripotent stem cells (PSC) and their derivatives. The goal of his research is to generate human PSC-derived products for the treatment of human diseases. He also has extensive experience in process development and large-scale production of human PSC derivatives under defined conditions for clinical trials. John is the inventor of more than 20 patents in the stem cell field: in an analysis of global stem cell patent landscape by Nature Biotechnology in 2014, John’s patent application and citation ranked No. 7 and No. 5, respectively. In addition to stem cell research, John also has more than 10 years of experiences in cancer research.
John received his BS degree in biochemistry from Wuhan University, MSc degree in oncology/pathophysiology from Peking Union Medical College, MPH degree in molecular toxicology/environmental sciences from Columbia University and PhD degree in molecular cancer biology from University of Toronto.
Dr. Li Ou is currently the vice president at Genemagic Bio, a startup focussed on AAV gene therapy for neurological and ocular diseases. Previously, Li was associate director of gene therapy at Capsida Biotherapeutics and assistant professor at the University of Minnesota, USA. Li obtained his PhD in genetics (minor in biostatistics) at the University of Minnesota. He has over 10 years of experience in leading IND-enabling studies of gene therapy (AAV, lentivirus, ZFN, CRISPR, gene regulation), resulting in two IND approvals, six pending patents, 23 manuscripts, 62 abstracts, and 23 oral presentations.
Patricia Françon is the chief operating officer at Coave Therapeutics, responsible for managing operational aspects of product development. She has over 20 years’ experience in the biotech industry leading R&D, preclinical, and clinical operations as well as manufacturing for the accelerated development of innovative biologics, including advanced cell and gene therapies. Patricia obtained her PhD in molecular and cellular biology from Paris VI University and completed her postdoctoral research at McGill University.
NOVADIP Biosciences S.A.
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It was a well-prepared, practical review of the major issues affecting the cell and gene therapy area, with recommendations from the experts in the field of CGTPs.
This conference brought many opportunities to exchange the contacts and the recent cases in the field. Must attend for those looking to overcome the numerous challenges in the process of gene and cell therapies development and manufacturing.
The success of this summit & exhibition is in the excellent speakers board, emerging and critical topics, and networking opportunities. I will be glad to attend it again.
Thank you for your interest!