Interview with Kurt Stoeckli, President NDA Advisory Services

Driven by the desire to understand the human nature, and eventually seeking to understand the physics that construct it all. Kurt Stoeckli’s road to becoming the new President of NDA’s Advisory Board may seem as long and winding as any rising mountain road in the alps in his native Switzerland, but just like them, it does follow a coherent logic and destination.

“It’s all about being curious, asking the right questions, staying passionate and being open to new inspiration”, says Kurt Stoeckli, the new President of NDA’s Advisory Board. “Because knowledge is changing rapidly, and the life cycle of innovation is shorter.”

Growing up in a rural area in Switzerland, between Basel and Lausanne, he dreamt to become a farmer and wanted to drive trucks as a schoolboy and then he became fascinated by climbing

high mountains in the alps; a seemingly unlikely background for someone who would move on to become a leader in the pharmaceutical industry. On his way there, the study of philosophy caught his attention.

“It was more of a hobby and an inspiration”, he says of his early academic career.

“In high school, I was engaged in literature and theater. I wanted to learn more about what drives humans.”

However, when the time came to aim for a professional career – “reading Kierkegaard, Wittgenstein or Heidegger can be fascinating, but epistemology is not a profession”, he points out – he was inspired by a teacher to turn his focus towards chemistry, and later on, biology..

“I loved experiments. You can set up a hypothesis and you can verify or falsify your hypothesis under defined conditions. I like it. Moving from chemistry to biology was a natural evolution in my scientific career. You start by understanding the structure of molecules which is incredibly useful to then understand their function.”

Becoming increasingly interested in physiology and pathophysiology, Kurt Stoeckli worked his way down towards the basics of immunology, fascinated by the immune system’s fundamental importance in keeping a multi-cellular organism, like the human body, in balanced and healthy state; unlike any other organ system of the body with a defined place, the immune system is more like a mobile organ system, doing its job effectively – regardless where it is needed.

When eventually entering the pharmaceutical industry, his leadership skills turned out to come in handy. He headed up the Biologics Division at the French pharma company Sanofi, later becoming the CEO of Glenmark Switzerland and the global CSO of the group.

“It’s all about being curious, asking the right questions, staying passionate and being open to new inspiration”

What are you most proud of during your career?

“Two major things. Having critically contributed to the development of at least two marketed drugs, dupilumab (Dupixent) and sarilumab (Kevzara); they are approved for multiple indications like severe asthma and RA; right now, sarilumab is also used in clinics to dampen excessive immune reactions associated with COVID-19. The other important achievement concerns the development of key talents. High potential people that could unfold their talents and grow into leadership positions, taking major decisions today, and developing next-generation talents for tomorrow. In that way, the cycle continues.”

What about your biggest challenges?

“The shutdown of entire research sites and separating from people that were completely committed to the company and gave their best. Yet I had to go through this twice during my 18 years at Sanofi, based on the company’s strategic direction. That was tough for me.”

Growing up on the border between the German- and French-speaking areas, Kurt Stoeckli speaks German, French, and a little Italian – as well as English, of course. Has the time come for a new challenge – Swedish?

“Hopefully, I will get more familiar with it. My son, who studied in Uppsala, told me it’s not so difficult.”

He calls himself an entrepreneurial scientist because entrepreneurial scientists make use of scientific innovations and must deliver results that make sense from a business perspective.

“While I was within big pharma, I learned how to work with start-ups, how to help them. I have been a co-founder of some companies as well as an investor. I built my own consultancy for start-ups, so my new role as an advisor at NDA isn’t completely new to me.”

What are your intentions for this job and for the Advisory Board?

“The NDA Advisory Board thrives on being proactive and understanding the big areas of growth and innovation. Let us take the Advanced Therapy Medicinal Products (ATMP) as an example. Gene therapies are emerging. Today’s approaches will further innovate, and fully targeted gene delivery along with controlled and precise repair mechanisms will offer new ways of treatment. It will require new regulation and development strategies. We need to know how to bridge emerging sciences and related regulatory challenges, so that new treatments can bring the benefit to patients and value to the healthcare system without delay. That is what we strive for, and that is why we have scientists, physicians and ex-regulators working together at NDA. This is what drives me.”

Where do you see yourself and NDA in the coming years?

“I see NDA offering unique value to clients by understanding the value chain for innovative medicines and providing differentiated premium services that are composed of expertise in translational sciences, integrated development, perhaps companion diagnostics, and definitely innovative regulatory sciences. My role is to set up a strategy and bring in my network to make sure we deliver on this promise.”

Are you looking for deep regulatory and strategic knowledge to support your drug development program?

Learn more about NDA Advisory Board and its members here.

What did we learn from the 2009 pandemic?

By: Thomas Lönngren Strategic Advisor, NDA Group

In this commentary, NDA’s Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.


In April 2009 we were in the middle of an ongoing influenza pandemic and as the Executive Director of the European Medicine Agency I was ultimately responsible for the Agency’s response.

EMA’s responsibility was to ensure that we could get a vaccine approved as soon as possible and evaluate potential antivirals for the prevention and treatment of the infection. We also set up a robust surveillance system monitoring the safety of vaccines and antivirals when they were put on the market. All of this had to be done while ensuring that staff and experts working at the agency could continue to operate and deliver advice to developers of vaccines and antivirals while maintaining their own well-being.

One of these proposals was the idea to create what became known as the Mock-up vaccines. Specific guidance was developed by the Agency for an assessment procedure for pandemic influenza vaccines

 

It was an intense period with many meetings, ensuring the operation of the agency as well as daily teleconferences with European Commission, WHO, other regulators such as the FDA, and the industry. Luckily there were preparations in place.

When the pandemic broke out in April 2009 we were not taken by surprise. Warning signals came from WHO as early as the beginning of 2000. The SARS outbreak in 2002 had also served as a wakeup call. The outbreak of bird flu caused by H5N1 virus was an additional indication that a pandemic was imminent.

Click here to read the full commentary
 

To learn more about our how our advisors can support your drug development program click here

 

Related article: What do we need to know before the next influenza pandemic: by Vaccines Expert Peiter Neels

Kurt Stoeckli joins NDA as President NDA Advisory Services

We are happy to announce and welcome Kurt Stoeckli to the team as President NDA Advisory Services.

Kurt brings significant experience from leadership positions in the pharmaceutical industry and has extensive expertise in the areas of immuno-oncology, autoimmune diseases and tolerogenic vaccination. His experience also spans medical devices and advanced digital e-health platforms.

As President of NDA Advisory Services Ltd, closely supported by Prof. Steffen Thirstrup, Director NDA Regulatory Advisory Board, Kurt will manage the operations, strategy and development of the NDA Advisory Board, including business development, sales, marketing and service development. His intimate understanding of the working conditions in large pharmaceutical, as well as small biotech companies, will enable him to ensure close interactions and a rapid response to the shifting conditions that these companies are facing.

The NDA Advisory Board comprises some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.

 

Johan Strömquist, CEO of NDA Group, commented on the appointment:

“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am delighted to welcome Kurt to our team. His experience, extensive network and industry reputation will break barriers and help us ensure that the best products get the attention they deserve. I very much look forward to working with him to help bring more good medicines to people all over the world.”

Kurt is joining NDA from Glenmark Switzerland where he was CEO and the groups global CSO. Prior to this he headed up the Biologics Division at Sanofi as Group VP & Global Head.

 

Steffen Thirstrup, Director NDA Advisory Board:

“Having Kurt on board is very exciting. He brings exactly the right blend of expertise and connectivity that is so important for us to have maximum impact on development of important therapies. His leadership experience and track record of launching new and bold initiatives will also be very welcome to our Advisory Board as we prepare to take the next step in our evolution.”

To learn more about the how the NDA Advisory board experts can support you and your drug development challenges click here

 

Celebrating the work of a patient advocate

Throughout his career Markku Toivonen has been a staunch patient advocate, focusing his life’s work on ensuring that suitable medicines accelerate and that only those products reach physicians and patients.

As a regulator he spent eight years providing scientific feedback and guidance to companies, as well as assess and recommend products for approvals as well as rejections through his work as Chair of the Scientific Advice Working Party and Finnish member of the CHMP. Following his stellar track record working for the regulatory agencies, he joined NDA and became our first Scientific Director, a role he proudly held for 15 years, up until his retirement end of 2019.

The legacy that Markku leaves behind, as he now travels the world together with his husband, is impressive. As a regulator he was involved in assessing hundreds of new products and advising a large number of companies. During his 15 years at NDA the track record is no less impressive; at final count Markku left his finger prints on more than 600 different projects. Most of these were in particularly challenging therapeutic areas, such as neurological conditions, psychiatry and oncology, but as an almost complete therapeutic area agnostic, there is almost no area that has gone untouched by his pen and intellect.

At the end of his tenure at NDA we took the opportunity to sit down with Markku to talk with him about his experiences coming from the European regulator and entering the consulting environment. In the below video are some of his parting thoughts for his regulator colleagues, who may be anxious to take the step and embark on the next part of their journey.

The whole NDA team wishes Markku and his husband Manu bon voyage – and we look forward to the post cards that we know we can expect from their travels. Thanks for all the fun and the wisdom you’ve imparted on all of us Markku. It’s been an honor and a great pleasure.