Dr Paula Salmikangas former chair of EMA Committee for Advanced Therapies (CAT) has joined the NDA Advisory Board as Director of Biopharmaceuticals and ATMPs.
Dr Salmikangas has a Ph.D. in muscle cell biology and extensive knowledge in biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals. Her main research has focused on cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki.
Dr Salmikangas is joining NDA from her position as a Research Professor at the Finnish Medicines Agency (2003-2017) and as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. Dr Salmikangas has also been the Chair of EMA Cell Products Working Party and a member of the Biologicals Working party.
Dr Salmikangas is joining the NDA Advisory Board, a unique team of experts comprising some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.
Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:
“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr Paula Salmikangas on board. With her experience in and in-depth knowledge of biopharmaceuticals and advanced therapies she will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”
Dr Markku Toivonen, Scientific Director NDA Group, commented on the appointment:
“Dr Salmikangas brings a tremendous amount of multi-disciplinary scientific and regulatory expertise and experience to the NDA Advisory Board, particularly in the rapidly evolving field of biopharmaceuticals and advanced therapies.”
Dr Salmikangas is the second appointment in a short time frame to the NDA Advisory Board as the NDA Group expands its world class capabilities to bring novel treatments to patients. This follows on the back of the company’s significant expansions in the US, with the establishment of offices in both Boston, MA, and Princeton, NJ. Providing leading edge expertise in emerging technology, as well as in focus therapeutic areas has been a key concern in the company’s expansion efforts.
NDA Group CEO, Johan Strömquist, comments:
“It is becoming increasingly important for pharmaceutical companies to work with partners that truly understand the science of the technology, the therapeutic area and the regulatory and payer environment, to ensure that their products reach the intended patients with minimum delay. At NDA we expand both to get closer to our clients, many who are based in the United States, and to ensure we continue to be at the forefront of technical and medical development.”
