Cell & Gene Therapy Specialist and Board Member (October 2023)

Dr Sven Kili, is Principal at Sven Kili Consulting Ltd. where he provides specialist strategic consulting services to innovative Cell & Gene Therapy companies. His clients include small and medium sized companies from creation through to clinical development and commercialisation, as well as investors. He has deep experience in all stages of Cell & Gene Therapy development, including previous roles as CEO of Antion Biosciences, where he built an academic team into a financed, development company focussed on engineered CAR-T therapies; he was also Head of Development for the CGT division of GSK Rare Diseases where he led teams developing and commercialising 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 and others.

Prior to this, he led the Cell Therapy and Regenerative Medicine group for Sanofi (Genzyme) Biosurgery which included the clinical development, approval, and commercialisation activities of the first combined ATMP product in the EU for MACI®. He and his team also prepared and submitted various 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 EU 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 strategic company formation, clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities.

He chairs a number of boards, including UK BIA CGTAC, UK Innovation Hubs, ARM Gene Therapy committee, CCRM Investment Committee and co-chairs ISCT Business Development and Finance committee. He further sits on the CCRM Board, LGC Corporation SAB, ISCT Strategic Advisory Council and Saisei Ventures Investment Board.

Sven received an academic appointment as Chair at UCL for the course “MSc in Manufacture and Commercialisation of Stem Cell and Gene Therapies” where he leads the course steering committee. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor and SCUBA diving instructor trainer in his spare time.

Key milestones in your career journey to date?

  • When I reflect back on my rewarding and exciting career, it has evolved as a result of being in the right place at the right time; and grasping those opportunities.
  • Most recently I was CEO of a Swiss based start-up, Antion Biosciences, focussed on cell engineering. My mission was to grow the company from a 3-person academic group to a fast-growing Series A stage company of 17 people. It was an amazing opportunity to learn from really smart scientists and set the strategy for rapid growth and financing.
  • Prior to settling on a medical career as a surgeon in Trauma & Orthopaedics in the NHS, I spent some time in the military and also travelling the world. As a ‘mature student’ I was able to grasp the bigger picture of where my career might be going and what was important to me.
  • As a surgeon, developing a special interest in biological cell and gene therapies piqued my curiosity in the power they have to cure, as opposed to just repair with metalwork, particularly for my patients with hip, knee and ankle injuries.
  • Inevitably, this led me to be introduced to the development of these innovative therapies and to my first role in industry with a Swiss biomaterials company where I oversaw the safe use of cells and developed a few new surgical techniques. As a small company, my responsibilities were broad based, including becoming the QPPV for Europe for the company’s pharma business.
  • The opportunity to join Genzyme arose in 2009, to assist setting up and running the first ATMP GCP study for a cell therapy product. My role evolved to leadership of medical and clinical teams, including for three global cell therapies; and leading the approval of MACI®, the first ever combined ATMP.
  • Following Sanofi’s acquisition of Genzyme in 2015, and divestment of all cell therapy assets, I joined GSK to head up the Cell & Gene Therapy development group. The portfolio of eight gene therapies, included Strimvelis® which was approved as the first ex vivo GT ever and later followed by Libmeldy®.
  • The catalyst to launching my consulting career in 2018 was GSK’s decision to divest the rare gene therapy assets. This enabled me to really start to live my experience, by helping CGT companies form, develop, and grow; and develop my portfolio career – more of which later.
  • Joining Antion in 2020 capitalised on my CGT expertise, working with a super talented young team pushing science and technology forwards. I also quickly learnt about fund raising, and the challenges of the investment space in these uncertain macroeconomic times. Raising the Seed Series and establishing a strategic collaboration were proud moments.
  • My portfolio career provides intellectual stretch and access to a network of outstanding colleagues. My involvement includes the BIA, CCRM Board, Saisei Ventures, LGC Corporation SAB, ISCT and ARM committees to mention a few. UCL – chair for CGT MSc Degree and Chair of the UK Gene Therapy Innovation Hubs.

Who has had the greatest influence over your career?

  • My personal SAB has been nurtured and proved invaluable over the years. Besides them, I would particularly like to highlight three:
    • My grandmother, who was the first woman in our family to go to university. She taught me to always be curious and never stop asking questions!
    • My mother engendered my values; she taught me the importance of respect and consideration to others no matter how successful you are.
    • Prof James Richardson encouraged me to think beyond where everyone else is going and figure out where they wish they were going.

What top three attributes make an outstanding and relevant leader in today’s world?

  • Honesty and authenticity in all you do, especially in communication.
  • Empathy in all interactions on a personal and work level; our lives are so complex and multi-faceted that we need to be alert to things happening in other’s lives which may not be obvious but may have a huge impact on them and those around them.
  • The ability to be flexible; moving between the strategic and the day-to-day operational activities.

Describe your approach to identifying and developing high performing teams

  • One of the key aspects is self-awareness and willingness to grow.
  • Focus on individual growth and group team development; both aspects are intertwined.
  • Once the team is performing well, regular reviews and resets are required to maintain top performance.

How does your company meet the challenges of leading a multi-generational workforce?

  • Recognising that whilst age brings experience, it does not require age to have insight and empathy.
  • Be open to suggestions and ideas from across the organisation to enable colleagues to identify the solutions.

Tell me something about your company that you would like to share with the PIR community

  • My consulting company is built on the foundation of ensuring we create better, safer cell and gene therapies for our patients – and value for our companies.
  • I work closely with organisations to develop strategies and use my experience to empower their growth and development.

How has your company created a more diverse culture in recent years; and what do future challenges look like?

  • Encouraging diversity in thought processes and problem solving has proven particularly powerful.
  • This leads us to make a conscious decision to assess not only expertise, experience, capabilities, but also things such as approaches to problem solving; willingness to support a perspective and willingness to integrate.

The provision of flexible working and employee wellness support are increasingly important in the retention and attraction of key talent. How are these being managed by your company whilst ensuring that productivity targets are met?

  • This approach requires a large degree of trust in each other; and trust in the person that they know what is needed and where the best place is to achieve that.
  • For this to succeed It is critical that there are certain times and activities that require face to face interaction; to be agreed between the team members involved and to meet the business needs.
  • Global team leadership has always required the ability to communicate and influence across different time zones. This has simply been highlighted and finessed in recent years, supported by technology and greater awareness by all.

What will be the biggest technological transformation in your sector over the next 5 years?

  • I believe it will be AI and ML. We are generating so much data, and seeking ever more insights from that data, that the only way will be with the thoughtful use of improved insights.
  • Additionally, it will be very basic science – helping us to better understand normal development, function and pathology at a deeper scale to provide us better insight into designing therapies for the future.

What is your hidden talent or something that might surprise others about you?

  • I am still active as a SCUBA instructor and often moonlight as an instructor trainer.
  • I can often be found running in the mountains over the weekend.

What advice would you give your 23-year old self?

  • Don’t be intimidated – just go and speak to that person over there…

Words of Wisdom?

  • Best Advice I was given:
    • If it was easy – everyone would do it.
    • During my first company acquisition – Genzyme by Sanofi. “Control your space. Don’t try to change factors outside your direct control.”
  • Advice I’d give:
    • Success is a team sport, but growth is an individual sport.
    • Treat others as you would like to be treated.
    • The patient is your North Star.
  • What I wish I’d known:
    • Just because some people speak more and louder, does not mean they know more than you.