ATMPs, Advanced Therapy Medicinal Products, cell and gene therapy and tissue engineering products are an increasing group of innovative products, often targeting diseases and conditions with high unmet medical need. Within the last decade the industry developing ATMPs has grown tremendously for example there are over 900 ATMP companies with more than 1000 ongoing clinical trials worldwide last year1.

Dr. Salmikangas, Director of Biopharmaceuticals and ATMPs, NDA Group, explains that ATMPs are very complex medicinal products with unique risks and limitations. At NDA we are witnessing an increasing need for scientific and regulatory support for ATMP development from clients. 

Recently the outstanding efficacy of the first chimeric antigen receptor T cell (CAR-T) products Kymriah and Yescarta raised the interest of the wider public, patients and investors in ATMPs.

Dr. Salmikangas states “These products offer a new path from symptomatic treatments towards medications which can treat the cause of the disease on a molecular level and even be curative.  Within a few years the focus in clinical studies has moved from Phase I exploratory trials towards Phase II/III confirmative studies targeting commercialization.  This has been identified also by regulatory authorities, as can be seen from the targeted support of the FDA2 and EMA3.”

Dr. Salmikangas explains that the most rewarding aspect for her is having the opportunity to work closely with companies, helping to solve their problems including identifying data gaps and providing strategic support for the development of their medicinal products.  

“Our mutual motivation is to get new, efficacious and safe treatment options for severely ill patients.”

To learn more about how Paula and NDA can support your company contact us at info@ndareg.com or see out website www.ndareg.com.

 

1 Alliance for Regenerative Medicine: Q3/2019 Regenerative Medicine Sector Report

2 FDA Continues Strong Support of Innovation in Development of Gene Therapy Products, https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products     

3 CAT/EMA Support for advanced-therapy developers https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/support-advanced-therapy-developers

The Author

Dr Paula Salmikangas

Advisory Board Director

Read more

Stay up to date

Contact us