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Novel nanometrically structured therapeutic hydrogel as injectable for fascial tissues surrounding the nerves intended for preventive treatment of chronic pain

Periodic Reporting for period 1 - TherGelFas (Novel nanometrically structured therapeutic hydrogel as injectable for fascial tissues surrounding the nerves intended for preventive treatment of chronic pain)

Reporting period: 2018-11-01 to 2020-10-31

Worldwide chronic pain conditions are one of the major reasons why people exit the labour market prematurely and it contributes significantly to disability retirement. When acute pain is not properly treated in the first few days, it can become chronic, and the current treatments for chronic pain are costly and not effective. Successful postoperative acute pain treatment is key to avoid pain chronification and associated complications. Thus, it is important to receive adequate pain management from early stages post-surgery.
“Fast track” recovery methodologies are multi-disciplinary pain management techniques that combine commonly used medicines against pain in different ways intra-operatively and post-operatively. Nevertheless, current prescription medicines used by this method relieve pain symptoms temporarily but do not prevent chronic pain from the start and have side effects because the drug is not correctly located by the nerves and randomly spreads locally.

The main objectives of the project were:
to develop, validate and scale-up a novel nanostructured hydrogel-based injectable pharmaceutical product to be applied during and post-surgery in the fascial tissue that protects the nerves where the pain originates and chronifies.
To create the proof of concept of a new easy-to-use technology by combining innovation in advanced biomaterials (porous nanostructured hydrogel based on hyaluronic acid) with the ability to load and release drugs to reduce pain in a controlled manner.
To address the above, new formulations of hydrogels have been developed, loaded with the active substance, controlled release studies have been performed, and all the procedures have been verificated, validated and scaled-up. Nanometric hydrogels have been included to provide a better control of the drug from the hydrogel matrix, developing a combined system of nanocarriers and macroscopic matrix.
The product is a sterile viscoelastic solution of cross-linked sodium hyaluronate (NaHA) indicated for the vehiculization of an anaesthetic substance.
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.
The major factors restraining the global market for controlled-release drug delivery technology are prices and technological factors. The beneficiary has identified unmet needs in the pain disease area, developed deep customer insight as a basis for a truly differentiated positioning, and aims to land the TherGelFas product safely in the market while maximizing launch uptake. It is expected that the product will be ready for commercialization by end 2022, and is expected that the projected future cash inflows cover the future costs of starting and running the project, so it adds value to the company. The plan for the product is to achieve a reduction in the overall costs of pain management, rather than direct costs on medication. Involvement of clinicians will become an opportunity to insert TherGelFas in newly created clinical “fast track” and “rapid recovery” protocols.
The Fellow has already assessed the process at lab scale, and pilot batches have been manufactured, but it needs readiness for a massive production. The roadmap to TRL9 is set up. In general, controlled-release drug delivery technology has a higher price compared with traditional pharmaceutical formulations. However, patents are expiring, and product pipelines are shrinking. Pressure over big pharmaceutical companies to launch new drugs is only likely to increase. Moreover, changes in Healthcare Industry are taking place. Even though pharmaceutical and biotechnology companies will continue to play a leading role, many players will change the current industry landscape with many disciplines and technologies. Physicians will also increase their involvement in the use of new emerging tools that combine professional experience with novel trends and optimal treatment based on disruptive technologies.