Sven Kili Consulting Ltd.
Dr. Sven Kili is Principal at Sven Kili Consulting Ltd. where he provides specialist strategic consulting services to innovative cell and gene therapy companies. His clients include small and medium sized companies from formation through to clinical development and commercialisation. He was previously the Head of Development for the Cell and Gene Therapy division of GSK Rare Diseases where he led teams developing and commercialising exvivo gene therapies for a variety of rare genetic disorders including Strimvelis®, the first ex-vivo gene therapy to be approved for children with ADA-SCID; Wiskott – Aldrich syndrome (WAS); Metachromatic Leukodystrophy (MLD) and Beta-Thalassemia. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development, approval and commercialization activities of the first combined ATMP approval in the EU for MACI®. He and his team also prepared and submitted advanced therapy regulatory filings for Australia and the US, including health technology assessments, and he was responsible for late stage developments for Carticel® and Epicel® in the US.
Before joining Genzyme, Sven led the cell therapy activities and oversaw all UK and Irish regulatory functions and was the QPPV for pharmacovigilance for the Geistlich Pharma. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise in cell and gene therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He is on the board of CCRM in Canada; Xintela, a Swedish Stem Cell company, the SAB for LGC Corporation and is the chair of the CGTAC as part of the UK BIA and a Board member of the Standards Co-ordinating Body for Regenerative Medicine. Most recently, Sven was appointed as Chair of the UCL course “Masters in Manufacture and Commercialisation of Stem Cell and Gene Therapies” steering committee. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.