Lygature Scientific Advisory Board: “Regulatory innovation needed to adapt to new developments”

Firstly, according to the SAB of Lygature, there is a clear need to adapt and create new approaches and regulatory pathways to prove, in a more sophisticated way, the effectiveness of regenerative medicine solutions, including ATMPs such as cell therapy, gene therapy and tissue engineering. While this area is growing, the (small) registration data packages, as well as regulations around manufacturing and quality control, are not well enough advanced. An innovating regulatory environment, including adaptive pathways concepts, will be crucial in judging and regulating these innovations in the future.

The second area put forward is the use of artificial intelligence in developing therapeutic interventions and solutions for patients. New techniques and algorithms used to analyze data, especially the large data sets generated by apps and gadgets, should not become ‘black boxes’ in registration procedures. The regulatory system needs an active strategy to keep pace with developments and ensure the ethical application of these technologies.

The Lygature SAB noted that The Netherlands has historically held a strong position in regulatory science, bundled in the Regulatory Science Network Netherlands (RSNN). This position is further strengthened by the presence of the European Medicines Agency in Amsterdam. Combined, this provides an ideal breeding ground for collaboration on regulatory innovation by building a platform where all stakeholders next to sharing their experiences actively join forces in scientific research on which new regulatory concepts can be build and implemented.

In this context it is great to see that at the end of 2020 a novel proposal for a regulatory innovation platform was listed as the number one action in the ‘Action program new chances for the Topsector Life Sciences & Health’, developed by sector ambassador Clémence Ross – van Dorp. The FAST (Future Affordable Sustainable Therapies) report also stressed the need for regulatory innovation. Both reports were sent to parliament by the ministries of Health, Welfare & Sport and Economic Affairs & Climate. 

The Scientific Advisory Board of Lygature consists of:

• Daan Crommelin (chair), Emeritus-Professor Biopharmaceutics at Utrecht University. As of December 2020 Ton Rijnders (Former Managing Director Oncode Insitute and former Senior Vice-President Research Organon) has taken over the chair.
• Rob Williams, PhD, Chief Drug Development Scientist at the Centre for Drug Development, Cancer Research UK
• Laurent Degos, MD PhD, Professor Emerite of Hematology at University of Paris, Diderot Hopital Saint Louis, Paris, and past Vice President of the Pasteur Institute and Curie Institute
• Sjaak Deckers, PhD, Venture Partner at NLC Health and CEO of Microsure
• Tomas Salmonson PhD, partner at Consilium Salmonson & Hemmings, former chair of the Committee for Human Medicinal Products at the European Medicines Agency

To read the full report of the recent annual meeting of the SAB, click here. For more information about the SAB.