We are excited to be hosting the 2nd edition of our Gene and Cell Therapy: Quality Developments to Commercialization Summit and look forward to meeting you in the fast-growing center for knowledge, research, and innovation, Munich.
This is the perfect place to take part in exciting presentations while networking with attending speakers and delegates. Together you can address the key burning issues and innovative approaches. Learn more about the delivery of cost and quality efficient process development, manufacturing and commercialization of cell and gene therapies, and much more.Read more
This premier B2B event provides the appropriate platform to engage and discuss ideas with your fellow peers, while facilitating a professional atmosphere and environment for good company representation and development. The Summit will shed light on the delivery of cost and quality efficient process development, manufacturing and commercialisation of cell and gene therapies. It is an honour and privilege to invite you to participate in this Summit.
Chief Executives, Vice Presidents, Directors, Heads, Leaders and Managers specialising in:
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The Early Bird Offer expires in 12 days!
Dr. Rajesh Thangapazham is a regulatory affair professional with over 10 years of experience and specialisation in regenerative medicine and cell and gene therapies. He is currently the head of regulatory strategy and innovation at the cell and gene technologies unit of Lonza Pharma Biotech & Nutrition.
Raj has a bachelor’s in pharmacy, a Master of Engineering, and a PhD in biotechnology. His training includes postdoctoral fellowship, staff scientist tenure, and research assistant professorship at the US Department of Defence, where he advanced regenerative medicine and was actively involved in the preclinical development of cell and gene therapies.
With a background in biotechnology commercialisation, intellectual property creation and considerable experience in orphan drug development, Raj joined and has supported sponsor’s CMC sections of regulatory filing, regulatory briefing documents, registration/licenses for Lonza’s establishments as well as lifecycle management of drug master files for facilities, cell banks, and donor programs.
Raj has also provided regulatory support to Lonza’s innovative technologies, such as induced pluripotent stem cell technology, automated and closed-cell processing systems, and single-use disposables.
Since 2018, Dr. James Wang has been the global quality auditor in cell and gene therapy at Novartis. From 2011-18, he worked in QA and operation management, cell therapy and MSKCC. James received his PhD from the Hebrew University of Jerusalem.
Alex Klarer is a senior engineer in Hitachi Chemical Advanced Therapeutic Solutions’ (HCATS) innovation and engineering group. The mission of the I&E group is to investigate new technologies and capabilities across the bioscience landscape with the goal of increasing patient access to cell and gene therapies. Since joining HCATS in 2017, Alex has worked on a wide array of projects including T-Cell culture platforms with a focus on dynamic 3D methods, novel transfection methods, label-free selection methods, supply chain security, and GMP assay qualification. Prior to joining the team at HCATS, Alex worked at Genentech on their tocilizumab and rituximab products.
Peter has a biology background and has been active in R&D for thirty years. His academic career started as a Virologist at the Wageningen University in The Netherlands, where he obtained his PhD in 1991. In 1991 he joined Novartis Seeds where he held several research management positions in the field of plant biotechnology. He is a co-founder of Phytovation B.V., formerly active in biopharmaceuticals and vaccine production, and of its subsidiary Viruvation B.V., which was active in developing a therapeutic AIDS vaccine. Peter is founder and CSO of Amarna Therapeutics a gene and immunotherapy company based in Leiden, the Netherlands. He developed Amarna’s SVac viral gene delivery vector platform derived from the macaque polyomavirus SV40. Because of its non-immunogenicity in humans the SVac platform is unique in its capacity to develop effective treatment for genetic disorders and degenerative/inflammatory/autoimmune diseases. Throughout his career Peter has worked on applications of virus-associated technologies. He has a long-standing expertise in virology, molecular biology, immunology, cell biology and is highly experienced in molecular cloning activities, tissue culture of mammalian cells and production of (recombinant) virus particles in mammalian cell systems. Peter has an H-index of 35, wrote more than fifty peer reviewed scientific articles and is (co-) inventor of more than fourteen different awarded patents and patent applications.
Sarah Thomas is the VP of quality at REGENXBIO, responsible for the quality assurance and analytical development/quality control organisations. She has over 30 years’ experience in pharmaceutical and biotech quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led quality teams through the transition from clinical to commercial operations, and multiple product approvals. Sarah received an MBA from George Washington University and a BSc in chemistry from Butler University.
Wenliang Dong has over 15 years of life science experience. He has worked 10-plus years in the pharmaceutical industry in R&D, manufacturing, preclinical development and management. As COO at ORCA Therapeutics BV, he manages internal and external operational activities related to the development of ORCA’s technology from R&D to clinical development. Wen holds a PhD from the University of Leiden, and he previously worked at the German Cancer Research Centre (DKFZ, Heidelberg) as well as the International Agency for Research on Cancer (IARC, WHO, Lyon). He worked at Sanquin Plasma Products BV as project leader at the CMO division and was a member of the management team of pharmaceutical services.
Christiane Niederlaender has spent more than 12 years in medicines tissue, cell and gene therapy regulation. She spent eight years with the MHRA, where she worked until August 2019, assessing all groups of biological medicines and managing the biologicals unit.
Christiane was the UK representative at the EMA committee for advanced therapies (CAT) and the rapporteur/co-rapporteur/CMC assessor for several ATMPs. She acted as the rapporteur for the EMA gene therapy guideline and was drafting group member for many other CAT guidelines.
Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European tissues and cells directive as an assessor and inspector. She has a PhD and research background in cell-signalling, cancer, and stem cells and obtained a law degree in 2005.
As principal of Keane Consulting LLC with over 25 years’ experience in the biopharma industry, Bernadette Keane provides professional consultation services globally to small and mid-sized gene and cell therapy companies as they transition programs from research into development, through the development pipeline into clinical trials and commercialization. Consultation services and support includes CMC development strategies, GxP regulatory compliance strategy development and operational support, analytical development, CMO selection and management, quality management systems development and implementation, quality operations and GxP auditing. For over four years prior to starting Keane Consulting LLC, Bernadette held the position of VP of quality at bluebird bio, a company specialising in ex-vivo gene modified cellular therapies for rare diseases and CAR-T immune-oncology indications. Throughout her career, Bernadette previously held positions of increasing responsibility in quality, regulatory, process and analytical development.
Dr. Simon Briggs is the senior technical product steward for Kymriah, at Novartis, supporting the successful launch of Kymriah for PedALL and DLBCL patients in Europe, as well as global manufacturing data and process analytics initiatives. Simon entered the world of cell and gene therapy nearly 20 years ago through PhD and postdoctoral research on polymeric materials for viral and non-viral gene therapy vectors at the University of Oxford. However, after 6 years as an academic researcher, it was clear that these technologies were not mature enough to penetrate into the commercial space so Simon made the switch from academic research to industry. He started his industrial journey at UCB Pharma in the process analytics team supporting high throughput biologics process development and novel analytics to support late and early phase projects. Simon continued to extend his experience in the commercial drug product manufacturing of biologics and small molecule-based products at Biogen, where he was responsible for setting up in the process analytics data platform supporting OPV for external manufacturing.
Dr. Jef Pinxteren obtained his PhD in biochemistry at the University of Antwerp in 1994. With a long-term EMBO fellowship he moved to the UK to study the role of G-proteins in secretion from granulocytes. This was in the group of Bastien Gomperts and Peter Tatham at University College London. After his fellowship he obtained further funding from the Medical Research Council (MRC) and the Wellcome Trust. In both 1999 and 2000, he received a UCL Bogue fellowship to work in the US with Vytas Bankaitis, first at UAB in Alabama, later at Chapel Hill in North Carolina. In this project a mouse ES cell model was used to establish a role for phosphoinositol transfer protein (PITP) in secretion from granulocytes. In 2000, he returned to Belgium and he joined the group of Jean Plum and Bart Vandekerckhove at the University of Gent for a project on cord-blood derived stem cells. He started work on human MAPC and collaborated with Catherine Verfaillie in Minneapolis. In 2004, he started to perform proteomics on human MAPC and moved to the VIB (Flemish Institute of Biotechnology), where he joined the group of Joel Vandekerckhove and Kris Gevaert. In 2006, he moved to the newly formed Stem Cell Institute Leuven under Catherine Verfaillie and worked with Athersys (Cleveland, Ohio) to set up the daughter company ReGenesys. In May 2007, he started to work as head of R&D at ReGenesys. With support from the EU Framework Program and IWT, the R&D support agency of the Flemish government, he built out ReGenesys to a 17-person research team. The focus of the team is developing a xeno-free version of the MultiStem® product and alternative, compact and more economical ways of expanding the product for clinical production. In November 2016, he moved to Promethera Biosciences, where cell therapies for liver diseases are being developed. He started as director of preclinical and product development in the R&D department and then became director of process development in the operations department and later took the whole operations responsibility worldwide.
Alfred Luitjens has a profound background in development and production of vaccines, with more than 30 years of experience. He worked for research & development at Solvay, DSM Biologics and Crucell. He had a management position at the Animal Science Group and was senior manager process architecture at GSK.
“I like the format and the idea of speed networking. I especially like the mix of compliance / regulatory / CMC / academia / company presentations. I think there is a need in Europe for such a meeting which will focus on GT from a perspective of developers / manufacturers to exchange views and opinions.”
“Meeting was really great - content but also networking opportunities especially your initiation to bring people together was really fantastic. The organisation was really super top!! And the onsite team so perfect!!”
BONE THERAPEUTICS S.A.
“It was my pleasure to meet peers and having the opportunity for this high quality networking.”
“We have enjoyed your summit a lot. It was a nice network opportunity.”
Beckman Coulter GmbH
“I think the event was a great success to connect on the ongoings in this young field, and I would love to join again next year. “
ProJect Pharmaceutics GmbH
“It has been a pleasure for me to participate to this meeting. It had been well organized and full of interesting contents. “
Thank you for your interest!
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