This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 721098
Matt Burton (Technical Manager) at JensonR+ Limited recently attended and presented at a very productive 3-day project meeting at Biberach University of Applied Sciences (Hochschule Biberach) in Germany. Matt attended as the regulatory work package leader in the 4 year EU-funded research project called the N2B-patch project. The consortium meeting was scheduled to bring all the partners together to focus on the current state of development.
The aim of the N2B-patch project is to develop an innovative N2B drug delivery technology for the treatment of MS based on the synthesis and delivery of a biomaterial-based innovative galenic formulation, a novel class of hydrogel matrix-patch and a medical applicator device system. The N2B route of administration aims to provide a minimally invasive method of bypassing the blood-brain-barrier (BBB). Moreover, the innovative multifunctional galenic formulation of N2B-patch aims to shield sensitive drugs and maintain the drug’s bioactivity. The goal is to avoid the need for injections and oral medicine and to improve treatment of MS patients. The project web page can be found at the following link: https://www.n2b-patch.eu/
The multidisciplinary consortium brings together Universities, Research institutes, SMEs, Industry and European Multiple Sclerosis Platform (EMSP) to represent the voice of MS patients in Europe. The partners come from eight European countries: Belgium, Czech Republic, France, Germany, Greece, Italy, Switzerland and the UK and all bring distinct expertise across chemical, biological, regulatory and business areas.
JensonR+ Limited’s role in the project encompasses scientific and regulatory advice covering the development, validation for manufacture of ancillary medical devices, medicine and construction of regulatory documentation. Other contributions cover scientific advice with EMA, market access and chairing the exploitation committee.
The next project meeting is planned for 18-Feb-2020 in Brussels where Matt, along with the other work package leaders, will present to the Commission’s External Reviewer.
- Matt Burton, Technical Manager at JensonR+ Limited and other scientists/experts discuss the N2B-Patch platform and the potential benefits for MS patients. - June 11, 2020
- Confirmed: Date of MDR application put back by one year - April 28, 2020
- EC Propose Postponement of Medical Devices Regulation due to COVID-19 - March 26, 2020