Major clinical stories and read-outs from key conferences for the cell and gene therapy space

Published: 25 November 2020
Commentary
Sven Kili
Sven Kili
Principal, Sven Kili Consulting Ltd, UK
Sven Kili provides specialist strategic consulting services to innovative Regenerative Medicine companies. His clients include small and medium sized companies from company 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 ex-vivo 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 commercialisation activities of the first combined ATMP approval in the EU for MACI®. 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 & 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 Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada; Xintela – a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA and the VP of the Standards Co-ordinating Body for Regenerative Medicine. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.

2020 has certainly been a testing year for all of us! One particular headache for the life sciences world has been the loss of live conferences. For so many of us, they represent a great opportunity to take the pulse of the field we work in: to make new contacts, catch up with friends, identify and track trends that might impact our work, and get updated on the latest scientific/technical breakthroughs.

Whilst many of the key conferences for the cell and gene therapy space have persevered online, it can be challenging to immerse oneself in these virtual events as much as one might wish, due to time zone differences and the pressures of the day-to-day workload being that much closer to hand. This final Clinical Insights edition of 2020 highlights some of the notable clinical development-related trends, stories, and data readouts from two important recent conferences for cell and gene therapy, which you might have missed.

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