An experienced cell and gene therapy development executive with extensive surgical and medical clinical experience, Dr. Sven Kili is focused on delivering positive ethical outcomes for patients and customers. Sven is currently the VP and Head of Cell & Gene Therapy Development for GSK Rare Diseases where he led the teams developing a suite of life-saving gene modified cell therapies, including Strimvelis®, the first ex-vivo gene therapy ever approved, MLD, WAS and Beta-thalassemia indications in clinical stage as well as four pre-clinical programs. Prior to GSK he led the development and approval of MACI in the EU and other global territories. Sven brings a positive track record of leadership and teamwork, both internally and externally and is driven to deliver results in a variety of settings.
photo credit: Wiki Commons
I am sitting next to a clear sparkling pool on my summer holiday, watching my daughters playing in the water and it makes me think of the parallels between how my children have developed and the growth of the regenerative medicine industry over the last few years.
Following its well-documented birth with the “discovery” of elements such as genetic material and the stem cell, regenerative medicine grew somewhat slowly to start with as we tried to learn how to care for and nurture this powerful new technology.
We are now all very excited parents and family as we observe with fascination the changes and developments in the industry we see before us. Just as with growing children, the regenerative medicine industry has had growth spurts of innovation interspersed with setbacks, just as children do due to various childhood illnesses.
These setbacks were manifest in our initial failed attempts at certain therapeutic gene therapies including for OTC deficiency, X-linked SCID and WAS, with the result our growing child struggled to reach the next milestone of acceptance and investment at the pace we, as new parents, hoped for. But, despite these early delays and false starts, this regenerative medicine child is growing rapidly at the moment and is in rude health, but it is still a child who will require support and education to see it mature into an independent and self-sustaining member of the medicine family.
Now we have finally turned the corner and begun to tick off developmental milestones including the approval of the first handful of advanced therapies in Europe, the U.S. and further afield. Just as it is at times frustrating watching a baby transition from sitting to standing to walking, it has been at times frustrating watching the stop-start, “will it – won’t it” successes of early approvals such as Carticel, ChondroCelect, MACI and Glybera move into mainstream therapy and toward commercial success.
More recently, we are now beginning to see the regenerative medicine landscape “walking unaided” with further approvals of Zalmoxis, Strimvelis, Kymriah, Yescarta and Luxturna, all with a solid scientific base of strong translational science and commercial preparedness.
The early ‘steadying furniture’ including improved regulatory mechanisms, improved CMC techniques and reimbursement discussions, focused more on value than cost, has fueled this recent advance in regenerative medicine development and commercialization. The various leading regulatory agencies are now becoming much more familiar with the unique challenges of developing a living, cell-based regenerative medicine, facilitating meaningful engagements focused on accelerating development while keeping patient safety at the forefront.
We now find ourselves in the present “sweet spot” as a toddler lurching between furniture, legs and other solid supports, trying to find its place in the adult world of pharma. We are mobile enough to generate limited profits for defined patient groups with astonishing outcomes, but not yet able to take on large and complex indications.
Our child is still cute enough to melt the hearts of adult Venture Capitalists and big pharma who are willing to invest in our child’s future college fund, but still too young to prove definitively that their investments are well placed.
As I continue to gaze out over the pool watching my children play in the sunshine, I have faith that, just as with my daughters, the regenerative medicine community will continue to flourish and grow from strength to strength with the right support and guidance and, at times, a firm hand.
My blog is just one of many exploring whether regenerative medicine has “come of age” as part of Signals’ third annual blog carnival. Please click here to read what other bloggers think about this.
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