Drug development is a global enterprise. One of the great things about working at Certara is the ability to learn from fantastic colleagues living around the world.
My Swedish colleague, Dr. Eva Berglund, is a clinical pharmacologist who is now a Senior Director of Regulatory Strategy at Certara after spending a long and distinguished career at the EMA. Eva has also been a member of the Pharmacokinetics Working Party at EMA as well as the former Paediatric Expert Group. She has worked with all types of regulatory applications from marketing applications of new chemical entities – which has been her major focus – to many applications for pediatric indications, new formulations, biosimilars, generics, etc. Her experience also involves the regulatory clinical pharmacology assessment of phase I to III clinical trials including first-in-man studies. Eva is a pharmacist by training and has a doctorate in clinical pharmacology, both from Uppsala University in Sweden.
I had the privilege of chatting recently with Eva about the latest trends in regulatory science, her advice for junior scientists, and what inspired her recent career change.
スザンヌ・ミントン: Let’s start with a fun question: If you could meet any historical figure, either living or dead, who would you choose and why?
Eva Berglund: I would choose Mahatma Gandhi because of his wisdom and endless compassion. I’ve always been impressed by him. I would probably also need a bit of his patience that he used when effecting change.
スザンヌ： You have over 20 years of experience in clinical pharmacology at the European Medicines Agency (EMA) and the Swedish Medical Products Agency. What are you most proud of from your career in the regulatory world?
EB: I’m most proud of the good we did for the patients. Both the guideline work (drug-drug interactions (DDIs), physiologically-based pharmacokinetics (PBPK), pharmacogenomics (PGx), Pediatrics, etc.) and in the day-to-day work with applications. The guideline work improved the regulatory assessments of new medications to be aligned with scientific progress and hopefully, resulted in the better use of medicines in the individual patient.
私はレギュラトリーサイエンスを次のレベルに前進させることに情熱を注いでいます。I hope that I will continue to do that at Certara.
スザンヌ： Can you elaborate on the landscape for pediatric drug development? That’s an area of huge unmet medical need as the majority of children’s medications are given off label.
EB: The work with the pediatric regulations within the EU was really rewarding because it led to more submissions of pediatric applications and, to some extent, better data being included in those submissions. We have learned a lot in years since the publication of the pediatric regulation. While there’s still a lot more work to be done, the approach to pediatric drug development has improved dramatically.
スザンヌ： Would you ascribe that improvement in pediatric drug development to the regulations requiring sponsors to conduct clinical studies in children?
EB: Yes, while the pediatric regulations in the EU differ somewhat from those in those in U.S., they both provide a “carrot and a stick” to ensure that pharma companies invest in pediatric drug development. The pediatric PK guideline also explains what kind of clinical pharmacology documentation should be included in a submission and how to extrapolate PK/PD data from adults to children. It always feels good to work in pediatrics where you really feel that you’re making a difference. We should be creative and do our very best.
スザンヌ： If you had a crystal ball, what regulatory trends would you predict are coming from the EMA?
EB: This spring, the EMA published a strategic reflection until 2025 that includes everything from drug therapies through precision medicine, medical devices, diagnostics, nanotechnology, and developing drugs that have a significant potential to address unmet medical needs. In the strategic plan, one goal was to optimize capabilities in modeling and simulation (M&S) and extrapolation. So, that included both enhancing modeling and simulation and its use across the product life cycle as well as international harmonization of methods via a multi-stakeholder platform. They are also thinking about redesigning how EMA partners work together to enhance knowledge exchange. I would assume that the exchange would be between the Modeling and Simulation Working Party (MSWP) and other groups outside the clinical pharmacology field for example, within Quality or Clinical efficacy and safety.
スザンヌ： That’s great to hear that the EMA is embracing modeling and simulation. What do American drug developers get wrong most frequently when seeking marketing authorization for drugs in Europe?
EB: From a clinical pharmacology perspective, the most common mistake is to align a submission to FDA guidelines and refer to them inside the EMA application. Scientifically, the agencies have very similar scientific understanding and concerns. We have frequent guideline discussions with the FDA, and we are usually on the same page.
But, there are small differences between the FDA and EMA which need to be accounted for when submitting an application. Some of these differences relate to choosing a somewhat different approach to solve a certain problem. In particular, how one should address the inevitable gaps in the available scientific knowledge.
Some of the other differences between agencies are consequences of how they are organized. In Europe, assessment of submissions is made by a network of national agencies, not by one large single agency as in the U.S. This difference has both advantages and disadvantages. From the European perspective, the EMA sometimes needs to unify internally and communicate our perspectives both internally and externally. A consequence of this can be seen in the EU PBPK guideline, which discusses qualification of PBPK software for a certain intended use as a way of establishing and communicating the regulatory confidence in a certain kind of simulation.
スザンヌ： Can you compare adoption of modeling and simulation in the U.S. versus the EU?
EB: Nowadays, there’s little difference between the two regions regarding adoption of modeling and simulation. But, the agencies work quite differently in practice. The FDA performs a lot of pharmacometric analysis. But, in Europe, that is rare due to time and resource constraints. So, EMA regulators may ask sponsors to perform different kinds of analysis or create different plots. The EMA MSWP has gathered pharmacometric assessors from the different member states and is working towards a harmonized viewpoint as well as with assessment of central scientific advice. There has been a big effort in the EU to gain momentum when it comes to pharmacometrics. In Sweden, we have had many excellent pharmacometricians over the years that have pushed modeling and simulation forward.
スザンヌ： What attracted you to work at Certara?
EB: Certara was my first choice for its focus on clinical pharmacology. I was also attracted to the ability to work with big and small pharmaceutical and biotech companies over the world while still being able to live in Sweden. In addition, people at Certara are progressive thinkers who have a very high level of scientific expertise. These are two qualities that I place great value on.
スザンヌ： We’re glad to have you! The next question relates to mentoring. If you were working with an early career clinical pharmacologist, what advice that you would give that person?
EB: My advice would be to have fun. [Laughs] For me, it’s never been about “having a career.”My focus has been on implementing innovative science and doing the best for the patients. An additional piece of advice would be to find work that really engages you.
スザンヌ： Is there anything else that you’d like us to know?
EB: In my personal life, I’m married and have two grown children. For fun, I love exercising, yoga, gardening, and nature.
スザンヌ： It sounds like you have a busy but balanced life in Sweden!
EB: Yes, I intend to do that. Being a regulator in Europe, I’ve worked a lot internationally. And, I really like that because I enjoy getting different scientific and cultural viewpoints. So, I am happy that I can continue to work in a global environment at Certara.
スザンヌ： There are always opportunities to learn from your colleagues at Certara. It is a great environment to work in.
EB: Yes, I’ve been very impressed with my colleagues. It’s good to be in an environment that is all about the science, and how we are going to help clients and patients.
To learn more about how Certara clinical pharmacologists are helping support the development of safer and more effective drugs, please read this article.