Dr Paula Salmikangas

Paula is the Director of Biopharmaceuticals and ATMPs and has been at NDA since 2017. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and the CMC aspects of biopharmaceuticals.  As a former EU regulator, Paula was actively involved in establishing the regulatory guidelines for ATMPs and applies her unique experience to provide companies with technical & strategic advice for their drug development programs.

Key Areas Of Expertise

• In-depth scientific and regulatory knowledge of biopharmaceuticals
  • scientific and regulatory aspects of ATMPs (cell and gene therapies and tissue engineering)
  • CMC aspects of biomolecules, including clinical bioassays and immunogenicity
  • Detailed knowledge of the European approval system including the European Medicines Agency (EMA)
• Clinical documentation requirements supporting European regulatory applications
  • EU (Co)Rapporteur for several ATMPs
  • CMC documentation requirements to support European Clinical Trial Applications (CTA) and Marketing Authorisation Applications (MAA)
• Clinical development plan scientific strategy and design
  • Legal, regulatory, and scientific knowledge on ATMPs
  • Design of CMC development plans: Scientific and strategic aspects, comparability
  • Biosimilars
• Medical Devices and combined ATMPs
• Professional presentation skills and extensive teaching experience
  • Adjunct Professor of Biochemistry for the University of Helsinki

Before Joining The NDA Advisory Board

Paula was a Research Professor at the Finnish Medicines Agency and the Chair of the EMA Committee for Advanced Therapies (CAT). 

She was also the Chair of EMA CPWP, Vice-Chair of the Committee for Advanced Therapies and a member of both, the BWP and EMA Scientific Coordination Board (Scicobo). Paula also acted as the Finnish representative in the European Commission STAMP group.

Paula has a PhD in muscle cell biology. Her main research has focused on cell and molecular biology of various inherited diseases.

Recent Publications

Tourdot S, Abdolzade-Bavil A, Bessa J, Broët P, Fogdell-Hahn A, Giorgi M, Jawa V, Kuranda K, Legrand N, Pattijn S, Pedras-Vasconcelos JA, Rudy A, Salmikangas P, Scott DW, Snoeck V, Smith N, Spindeldreher S, Kramer D. 10th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals. MAbs. 2020;12(1):1725369.

Salmikangas P, Chamberlain P, Silva Lima B and Toivonen M. Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures. Cell & Gene Therapy Insights 2019; 5(7), 829–857

Salmikangas P, Kinsella N, Chamberlain P. Chimeric Antigen Receptor T-Cells (CAR T-Cells) for Cancer Immunotherapy - Moving Target for Industry? Pharm Res. 2018;35(8):152.

Boran T, Menezes-Ferreira M, Reischl I, Celis P, Ferry N, Gänsbacher B, Krafft H , Lipucci di Paola M, Śladowski D, and Salmikangas P. Clinical Development and Commercialization of Advanced Therapy Medicinal Products (ATMPs) in the EU: how are the product pipeline and regulatory framework evolving? (2017) Human Gene Therapy Clinical Development, 28 (3) :126-135

Narayanan G, Cossu, G, Galli, MC, Flory, E, Ovelgonne, H, Salmikangas, P, Schneider, CK., Trouvin, JH. (2014) Clinical development of Gene Therapy needs a tailored approach: A regulatory perspective from the EU. Hum Gene Ther Clin Dev. 2014 Mar;25(1):1-6.

Related Reading

• Get to know Dr Paula Salmikangas
• Integrated product development for ATMPs
• Design and optimisation of a quality target product profile for ATMPs
• CAR T-Cells for Cancer Immunotherapy – Moving Target for Industry?

• Controlled Human Infection Studies

• Why is a potency assay important for cell and gene therapy products?

• The outlook for gene editing in treating disease

• Addressing the challenges of GTMPs

• Strengths and shortcomings of new EU rules for ATMPs