Thought Leadership

At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.

We call it Thought Leadership.

Articles and White Papers



Sort by:


Addressing the challenges of GTMPs

Dr Paula Salmikangas and Dr Björn Carlsson address the challenges related to the development of novel gene therapies.

Integrated product development for ATMPs

In this article, published in the September issue of MedNous, Claes and Paula discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.

Design and optimisation of a quality target product profile for ATMPs

The QTPP is an inherent element of product development for an MAA, yet it is perhaps more familiar for those developing conventional pharmaceuticals

CAR T-Cells for Cancer Immunotherapy – Moving Target for Industry?

This article discusses the product-and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.

How to commercialise ATMPs in the EU

This article addresses recent findings from the EMA PRIME scheme and provides information about procedural updates and evolving guidance in the ATMP area.

Regulatory strategies for value maximisation of early clinical stage assets

This white paper written by Niamh Kinsella, Biologics Expert, Paul Chamberlain, Biopharmaceuticals Expert, Josi Holz, Clinical Strategy Expert and Eva Lilienberg, Service area lead Global Development, focus on how you can strengthen your partnering nego...