Björn Carlsson joins the NDA team!

We are excited to welcome Björn Carlsson. Björn comes from a comprehensive scientific and regulatory background and has extensive experience in ATMPs. We have no doubt that he will be a valuable asset to our team.

In this interview we take the opportunity to get to know him a little better.


Welcome Björn Carlsson, tell us a bit about your background.

Thank you very much. I started out as a research scientist at Uppsala University in Sweden where I focused on bench-to-bedside adoptive T-cell therapy.  Later, I became an associate professor in industrial experimental clinical immunology.

In 2008 I started working for the Swedish Medical Products Agency as a non-clinical assessor, evaluating everything in terms of the development of new drugs. It covered the whole process from first-in-human trials to market authorizations and included every kind of pharmaceutical; chemicals, biologics, biosimilars, and ATMPs.

Thanks to my in-depth scientific knowledge of ATMPs, I was appointed the Swedish substitute delegate in the committee for advanced therapies at the European Medicines Agency. This helped me gain international scientific and regulatory knowledge of advanced therapies. For the last four years, I have used my experiences within the field of ATMPs as a Horizon 2020 evaluator for the EU commission.

That is quite an interesting background. How do you see your experience helping NDA’s clients?

I believe that I can contribute in many different areas of the drug development process. I have a lot of experience in non-clinical development as we as extensive experience in how the regulatory system works.

In addition, my long experience with ATMPs would be of great interest, especially when it comes to the non-clinical packages, which are tremendously specialized and different from traditional drugs, including biotech drugs. There is a great need to have expertise in this area, from progress, via CMC, into clinical development.

The most challenging part of the ATMP non-clinical development is to generate relevant data in order to make a comprehensive risk assessment. Without such evaluation, it is very difficult to get approval by the regulatory agencies, especially within non-life-threatening indications. I do believe this is another area I can contribute to.

What do you see happening in the Nordic Life Science landscape, anything that gets you excited?

There are a lot more initiatives these days compared to how it used to be, people are much more organized now. There has also been a widespread recognition that there is legislation around ATMP products to which we need to adhere to.

In the early days of the legislation for advanced therapies, the community did not really like to be regulated. Many of the developers were under the impression that the products they were developing were for transplantation or standard of care, rather than an experimental drug. However, due to local regulatory agencies and financial contributors, this has changed a lot. I would say that one of NDA’s strengths is that we are well equipped to deal with these regulations

What in your personality adds an extra asset to your professional persona?

I would say that I am a very diplomatic person. I adapt easily to new people and new ways to work. I prefer working with other people and want to be a contributing factor to the collective intelligence. I am a social kind of guy who takes pride in being available and takes time to talk to people.

What are your expectations of working at NDA?

What made me transfer from the regulatory agency to the consulting business is the fact that now I will be working with a team that helps develops drugs. This is a sharp contrast to assessing it from the agency’s point of view, where you were just looking at what has been done. Now I can influence the process as it unfolds, helping to make it right from the start, and perhaps saving the developers some headaches.

Are you looking for deep regulatory and strategic knowledge to support your drug development program? Email us at info@ndareg.com to get in touch.