Regulatory plan Celluminova
|Funding from Vinnova||SEK 88 200|
|Project duration||February 2017 - September 2017|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The company’s goal is to develop tools to improve survival rates and life quality for patients with glioblastoma. The purpose of the project was to assure correct classification of the product, as required before development of a regulatory strategy and plan. The goal was reached; it is beyond doubt that the product is classified as a drug. The regulatory plan has been initiated. Furthermore, several products based on the same compound have been identified to strengthen the company business case. Clinical experts and business competences have been approached.
Expected results and effects
In discussion with clinicians and researchers, current directives and regulatory barriers / opportunities were identified. Possible preclinical and in vitro diagnostic products were identified, with relatively good market potential and of major strategic significance. Development plan and regulatory strategy were developed with these included. We have received very strong positive feedback from experts in clinical and preclinical research, as well as business development, and now form a highly competent board.
Planned approach and implementation
The project plan was that the CEO would work very closly with the experts from SICS East, through physical meetings and telephone / e-mail. The cooperation has proceeded as planned and worked very well. As well the CEO as the experts have individually and together met a large number of external experts. Communication has worked well within the group.