Tell us about your background.
For the last 15 years, I have held management positions in medtech and biotech companies, mainly in the field of cardiology.
Having trained as an ETH engineer, I’ve always been attracted by cutting-edge technology at the service of innovation, which led me to decide 8 years ago to take over the management of the biotech start-up CellProthera, a specialist in stem cells, which offers immense potential for therapeutic innovation.
Prior to that, I spent many years in charge of general management and business development for a Swiss Medtech company specialising in niche interventional devices. I have always loved working in an international context, previously managing large-scale projects or developing business for multinationals, including a three-year R&D period in Tokyo.
What was the impetus for you to enter entrepreneurship within the biotech and medtech space?
What drives me as an entrepreneur is the hope of finding and bringing a new solution to the patients who need it. This gives a lot of sense to what you do and more than compensates for the risk of failure inherent in this kind of business. It’s also a human adventure, where a limited number of employees, at the outset, are united, trust each other and work more than usual because they know that the challenge is enormous.
Why did you decide to lead the team at CellProthera?
I was attracted by the great and largely unexploited potential of stem cells, an area in which CellProthera specialises. There is still a great deal to be understood about how these cells work and how they can be used for new therapeutic indications, which will surely come thanks to continuous technological progress.
The team has developed a groundbreaking stem cell therapy to regenerate damaged heart tissue. What was the inspiration for this approach/technology?
While CD34+ stem cells had been first identified as hematopoietic stem cells, i.e. cells at the origin of all types of blood cells, it was observed later on that these cells, usually resident mainly in bone marrow, were unexpectedly present in greater than normal quantities in peripheral blood following a heart attack. Yet this natural phenomenon of an increase in the number of CD34+ cells seemed insufficient when considering the nearly 1 billion cells damaged during an infarction.
This gave rise to the idea of possible cardiac therapy using CD34+. To do this, we had to find a way of collecting, isolating and, above all, multiplying them in large enough quantities while maintaining their stem cell properties. The know-how we have acquired in the cell expansion process is the fruit of many years of research.
Could you elaborate on how StemXpand®, your automated bioproduction system for cell cultures, improves the scalability and accessibility of stem cell therapies?
From the outset, we developed equipment to automate certain stages of the manufacturing process, thereby reducing the risks of contamination and error associated with manual aseptic operations. The automated system also enables scale-out, i.e. the production of several batches in parallel to increase production capacity, which is essential to cover demand and give as many people as possible access to this autologous personalised therapy.
What has been the biggest challenge faced by the company? Is securing funding for a specialised field like regenerative medicine difficult?
To have Cellprothera operating like a small pharmaceutical laboratory, capable of independently managing international clinical trials and releasing clinical batches at different production centres, was a big challenge. A huge amount of work has gone into bringing the company up to standard so that all its activities are according to regulations and follow a pharmaceutical-grade quality management system.
I wouldn’t say that it’s more difficult to raise money in the field of regenerative medicine. Regenerative medicine holds out the promise of being able to heal and repair where traditional medicine cannot, which easily triggers enthusiasm among investors. Instead, there are financing trends that evolve over time and are influenced by commercial successes.
As an Advanced Therapy Medicinal Product (ATMP), how has this designation impacted the regulatory hurdles you’ve faced, and what steps has CellProthera taken to navigate these challenges?
ATMP’s designation was indeed a call for more demanding operating processes, but it was also an important step in providing a regulatory framework for our development. With a well-established regulatory pathway and clear rules, it was possible to set up a pharmaceutical organisation as described above and thus de-risk future investments.
Stem cell technology is a complex field with both medical and ethical considerations. How do you approach the ethical questions surrounding the use of stem cells in therapy, particularly with the potential for widespread application in cardiac care?
We are not working on embryonic stem cells, which are still a controversial subject and raise ethical issues, but on adult stem cells, derived directly from the patient himself after he has given his consent. The use of autologous adult stem cells does not give rise to any particular ethical problems.
How have your previous working experiences helped in your current role as CEO?
Before joining Cellprothera as CEO, I developed in-depth knowledge of the cardiology market, from product development, regulatory affairs to sales and marketing. I also had the chance to build an international network of experts, KOLs and industrial partners in the field, which I can always refer to now. Previously, as part of my activities in business development and international project management, I’ve had the opportunity to lead multicultural teams and deal with various public and private customers. Understanding cultural differences is important to successfully negotiate with partners, which is a day-to-day activity of a biotech CEO.
The team is currently working on Phase I/Iib trials. What are the upcoming milestones?
Following the publication of the Phase I/IIB results, expected by the end of the year, we will set up Phase 3 and aim for clinical authorisation in the USA and Europe in the second half of next year.
Outside of work, you are an avid mountaineer. How has your love for climbing expeditions contributed to your professional work life?
Originally from the Alps, I started mountaineering as a teenager with a group of friends. It’s a team activity that builds trust and friendship. You need to have a great deal of confidence in your mates when you’re attached by a rope and crossing a summit ridge together at an altitude of 4,000m. It also takes leadership to decide quickly on the best route to take when snow conditions are unstable or the weather deteriorates.