We are thrilled to introduce Björn Carlsson, the esteemed Director of the NDA Advisory Board. Björn brings a wealth of knowledge and experience in non-clinical development for various pharmaceuticals and has carved a niche in advanced therapies, including cell and gene therapies, as well as tissue engineering. With over a decade of expertise, he possesses a solid understanding of the EU regulatory systems.

Björn embarked on his journey with NDA as a Principal Consultant in October 2020. Recently, he was promoted to his current role as Director of the NDA Advisory Board. In this capacity, Björn collaborates closely with fellow NDA Advisory Board members and clients, bringing forth his invaluable insights and expertise.

When reflecting on his role, Björn shared,

"Our Advisory Board members are seasoned professionals with independent roles. Being part of the NDA Advisory Board allows me to contribute to NDA projects and the field of science itself. I also have the opportunity to work directly with clients, leveraging my expertise in nonclinical development. I'm constantly engaged in intriguing projects that involve strategic planning and addressing agency inquiries. Additionally, I enjoy connecting with new potential clients through scoping calls, as I find great pleasure in meeting new people."

Björn's academic accomplishments include holding a Ph.D. in Clinical Immunology and serving as an associate professor in industrial experimental clinical immunology. Prior to joining NDA, he conducted research as a scientist at Uppsala University, focusing on T-cell-based therapies. Subsequently, he embarked on a twelve-year journey at the Swedish Medical Products Agency, serving as a nonclinical assessor. During this time, he was appointed as the Swedish alternate member in the Committee for Advanced Therapies at the European Medicines Agency, where he played a role in authorizing medicinal products, classifying ATMPs, and certifying ATMPs. Björn also represented the committee in external meetings with regulatory bodies worldwide, including the Japanese agency and FDA. In his final years at the MPA, Björn assumed responsibility for managing clinical assessors in the fields of oncology, haematology, dermatology, and gynaecology.

With his current position as Director of the NDA Advisory Board, Björn combines his inquisitiveness with strong managerial skills and extensive experience. A firm believer in the power of teamwork, he takes pleasure in collaborating with colleagues to deliver optimal solutions for clients. "I joined NDA because I wanted to be more closely involved in drug development and help clients make the right decisions from the start," Björn affirms. "Through my varied experiences, I have learned that teamwork always surpasses individual efforts. At NDA, our success in developing new drugs hinges on our collective collaboration. We cannot push the boundaries or tackle complex challenges without being effective team players. It's essential to involve and listen to one another, accepting that we may not always have the right answers."

When asked about the highlights of working with NDA colleagues and clients, Björn enthusiastically shares,

"Our experts at NDA are unparalleled in their prowess in handling regulatory affairs for our clients. As a company, we excel at facilitating effective communication between drug developers and regulatory agencies. It's comforting to know that we have a team of experts who provide prompt and reliable support. At NDA, we foster a familial environment, where everyone is friendly and open-minded. We genuinely care about each team member's well-being, both professionally and personally, and strive to strike a harmonious work-life balance. This is one of our greatest strengths."

Drawing from his vast experience, Björn sheds light on the essence of regulatory affairs and how it operates. "Many developers view regulatory affairs as a hindrance to treating diseases, often expressing frustration when assessors raise questions or when delays occur due to data requirements. However, when we look at the bigger picture, regulatory agencies diligently work with all products to ensure their safety and efficacy. When a drug reaches the market, we can be assured that it has undergone a rigorous system to ensure its effectiveness," Björn explains.

In addition, Björn emphasizes that success as a regulatory consultant or agency professional requires qualities such as flexibility, open-mindedness, curiosity, and a willingness to explore new avenues. "Being comfortable stepping outside your comfort zone is crucial. Always consider the worst-case scenario and realize that it often isn't as dreadful as it seems," Björn advises.

Björn Carlsson's journey exemplifies the remarkable contributions and expertise found within our organization. His dedication to regulatory affairs, commitment to teamwork, and passion for delivering excellence have made him an invaluable asset to the NDA family.