In this article we shine the spotlight on Dr Steffen Thirstrup. Steffen has been with NDA since 2013 and excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world.
When experience is knowing how to manage expectations
To be able to give constructive advice as a consultant in this branch, it is essential that you know the development and regulatory history of the product, regulatory precedence in the therapeutic field and have an in-depth knowledge of the regulatory system and an understanding of how regulators think. These are the key differentiating factors if you are to give the optimal advice to clients to help them get their product on the market in a timely manner. Most of the time it means answering questions by asking more questions.
Steffen Thirstrup knows the importance of asking the right questions.
Steffen is a medical doctor with a PhD in pharmacology. Before joining NDA, he spent nine years as the Chief Medical Officer and Head of Division at the Danish Medicines Agency. During five of those he also acted as the Danish representative in the Committee for Human Medicinal Products (CHMP) and Committee for Advanced Therapy (CAT) in the European Medicines Agency (EMA).
So, if there is a question to be asked, Steffen knows which one will make the difference.
The road to regulatory
Steffen thrives on a challenge. Looking back, he admits that his career evolved from an inherent restlessness. Entering medical school was challenging enough and allowed him to keep many doors open. His education resulted in a broad clinical background in general internal medicine with special interest in respiratory, clinical pharmacology and therapeutics.
Clinical pharmacology is the medical field which encompasses all aspects of the relationship between drugs and humans, bridging the gap between science and the practice of medicine. This resonates well with Steffen’s mission, as he always has had an interest in how to implement the outcomes from a clinical trial to common clinical practice of a new drug.
While he was considering making respiratory medicine his speciality, Steffen was offered a part time position as an external assessor at the Danish Medicines Agency. The role provided such a variety of challenges, that when Steffen was offered a full-time contract, he responded with nothing but enthusiasm.
“I can’t see myself working with just one type of drug”, Steffens says. “I think I would feel limited. Our clients challenge me every day and I find it very exciting to see what the next innovation is going to be. Solving problems in a complex matrix also helps to keep me alert and up to date”.
Let me get this right
“Clients often want to know; What do we need to do at this point? Do we have enough data? What does the agencies need to know?” Steffen says. “Before I can answer, I need to ask them a battery of questions in return as I cannot give proper strategic advice unless I know the preconditions”.
It takes someone who is familiar with drug development and the regulatory system to identify the potential gaps and scope out the project which can bring the client one step further towards approval. It is about finding solutions, about getting it right. This means understanding the essential need of each client, not just meeting their expectations.
“As a consultant, it is my responsibility to provide support in the best interest of the client”, Steffen explains. “When you have been developing a product for ten to fifteen years, it has become your baby. It falls upon me to align the expectations with reality, bringing impartial advice to the process and guiding the next steps”.
When push comes to shove
Depending on whether the drug is intended to be lunched in the US or the EU, the approval processes are fundamentally different, putting unique demands on the developer. In the US, if the company approaches the Food & Drug Administration (FDA) early on, they can have an ongoing dialogue with them throughout the development and approval process. In Europe, the European Medicines Agency (EMA) expects the company to initiate any encounters or ask for advice.
“In the ideal world, all agencies would join hands with the developers right from the start, Steffen says. “Early engagement would align expectations as well as the path to approval, which, in the end benefit the patients”.
Even if all regulatory authorities across jurisdictions would harmonise, there are plenty of new medical innovations to keep Steffen occupied. Questions to ask and problems to solve. His impatience might not serve him well privately, but in his profession, it is the driving force of progress.
“If the process turns to a standstill, or a dead end, I would be the first one to say that we need to move on, Steffen explains. “But I trust that every problem I’ve previously encountered, every challenging project - each different from the others – has given me the knowledge to make accurate decisions under pressure”.
Dr Steffen Thirstrup
Advisory Board Director