During the first months the Fellow was trained by the beneficiary company by the Quality and the Engineering & Production Depts., on scale-up planification and resources management, and by the Quality Management Dept. on implemented procedures and protocols and on Regulatory issues that affect the company as a medical device manufacturer.
She selected and registered the suppliers, learned how to perform a suitable registry of bills and orders, implemented the raw materials manipulation procedures, the characterization methods and equipment, and all the task that would later on allow a correct development of the project.
It was also very important for the project to get her trained in business development: competitive vigilance, IP protection, business model innovation, negotiation, clients management, market surveillance strategies and entrepreneurship, among others.
Dissemination and outreach activities were key elements of this project from the beginning. Preliminary data was presented in several conferences, symposia and workshops:
She took part representing the beneficiary as exhibitor at CPhI Worlwide 2019, also in the International Congress on Sports Medicine and Thraumatology, and DayOne Innovation Summit¨19, hosting meetings with potential clients, suppliers, partners, manufacturers and distributors. Watching and experiencing the new trends and approaches in the medical devices and pharmaceuticals market.
The Fellow also attended the Research and Innovation Sessions yearly organized by BioAraba, the Institute for R&D of the Public Clinical Service, where she actively took part in the Workshops and as speaker.
She also took part in Nanobiomed Barcelona¨18, Regenerative Medicine and Advanced Therapies Sessions of the Technological Park, and as invited speaker at the conference on “Polymers and Medical Applications” at the Lea-Artibai Innovation Pole, among others.
Regarding the impact of this grant on the Research career of the Fellow ER, we would like to highlight that this grant helped to improve her CV substantially. As a result, she secured a permanent position at the company.
In the technical WPs, she focused in the development of a hyaluronic acid (HA) based product to be able to be injected and be used as carrier of drugs. There is a deep previous knowledge of HA at the beneficiary company. However, the load of the HA hydrogels with active molecules had not been performed in house before, and formulations required modifications to be adapted to TherGelFas objectives. Thus, these were the main tasks of the fellow researcher: to synthesize and characterize new formulations of the hydrogels, load them with the active, perform controlled release studies, and verificate and validate all the procedures. The Fellow was in charge of the development and scale-up of these systems. Those formulations that showed the best results and robustness for scalability were selected for the final prototypes. After the manufacture of the prototypes, the pre-industrial batches in aseptic conditions were formulated and specifications validated in the same way as for the prototypes. The Fellow applied the manufacturing flowchart for the product processing that she previously developed. The batches were also manufactured at the beneficiary´s premises. All the test were performed following regulation.
A technical and economic feasibility study was also performed. It contained a detailed business plan with the envisaged exploitation means for the further commercialisation of the product, marketing and communication strategies, and analysis of the regulatory standards.
