In this article, we shine the spotlight on Thomas Lönngren, Strategic Advisor and NDA Advisory Board Member, and learn how he is an inspirational leader with over thirty years of experience as a regulator.

Inspiring others through leadership

As the Executive Director of the European Medicine Agency (EMA) from 2001-2011, Thomas Lönngren, Strategic Advisor and NDA Advisory Board Member, transformed the agency from a small unknown agency to a world-renowned regulatory agency.

For most of his professional life, Thomas was a regulator with the Swedish Medical Product Agency. From 1997, he held various positions until he became the deputy Director General of the Medical Products Agency (MPA). In this role, he was responsible for the agency's pre and post authorisation procedures both nationally and in the EU regulatory system.

“While studying at Uppsala University, I worked as a junior lecturer at the Institution for Social Pharmacy. I lectured on drug regulation and organized a lot of projects and research in this area, so I have been involved in the regulatory aspects of drug development since my education. After I graduated from the university as a pharmacist, I was employed as a regulator at the Swedish Medical Product Agency. It is safe to say that regulatory affairs has been on the menu for me all my life.”

In October 2000, Thomas was appointed Executive Director of the European Medicine Agency (EMA), and for ten years (2001-2011), he led the agency and managed it's operations. These leadership roles helped him gain extensive experience and knowledge of drug/device regulation and approval, market access, management, strategy and leadership.

In 2011, Thomas left the EMA and decided to establish his own company as an independent consultant, and the first contract he had was with NDA.

Working towards a common goal

Thomas joined NDA as Strategic Advisor and Advisory Board member in January 2011. In this role, he uses his extensive experience in management to help NDA develop valuable strategies for clients at different levels of drug development. He also communicates with clients and represents NDA in conferences and events. According to Thomas, his role at NDA helps him to keep up with the trends in the industry, which promotes continuous learning.

“My role requires that I understand what is going on in various industries and learn how external factors affect the company and people at NDA. Besides using my experience to analyse the regulatory environment from an outside-in perspective, I enjoy interacting with clients to develop the best strategy for them to manoeuvre regulatory challenges, depending on where they are in their drug development process. I also advise on best practices according to FDA and EMA. For example, best strategies for a global regulatory submission or the best roadmap for interacting with regulators.”

When asked why he enjoys working with NDA, Thomas had this to say:

“I enjoy working with NDA because of the people. Although many of them are old colleagues from the Regulatory Agency, I have also met excellent regulators from industry and other sectors. NDA has a team of experts who excel at providing solutions to complex problems. Also, the mission of NDA—making sure that the best possible medicines reach the market without unnecessary delay and are beneficial to the patients—fits perfectly with my personal philosophy.”

For Thomas, one of the highlights of working with NDA is collaborating to build a successful Health Technology Assessment Board. “It was interesting to not only work with regulatory experts, but also with payers and Health Technology Assessment bodies, because developing a medicine does not only require control or a regulatory approval, but value and access to patients,” he recounted.

Reflecting on the past, present, and future

Although Thomas enjoys travelling around the world to speak at biotech conferences, family means a lot to him. He enjoys spending most of his time with his wife, children, and grandkids. He also keeps fit and healthy by engaging in sports, like golfing, boat sailing, running, and swimming.

Thomas is passionate about leadership and likes to look at things from the outside-in. This attribute helps him to put others first when undertaking any task, whether for the company or clients. Consequently, he is excited about how the regulatory system has evolved over the years and how these changes have improved the life and health of patients.

“It is fantastic to see how, over the years, regulators have turned from very rigid supervisors to becoming a part of the drug development cycle. It has become quite mandatory for companies to get help from regulators to map out their regulatory requirements for drug development and getting drugs to the market. It is also fascinating to see the international collaborations happening between regulators across the world. I hope to see more of these kinds of collaborations because they will be highly beneficial for companies and ultimately the patients.”


Thomas Lönngren

Strategic Advisor and NDA Advisory Board Member


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