Public-private collaboration in the health and research environment and some of its successes in which GENESIS Biomed has collaborated

This post is also available in: ES (Spanish)

Public-private collaboration in the health and research environment and some of its successes in which GENESIS Biomed has collaborated

Article by Jaume Ruiz – Business Development Director and Senior Consultant at GENESIS Biomed

 

The main objective of any innovation generated by a health research centre or public hospital is to reach the market as soon as possible, i.e., to ensure that potential users, be they doctors, patients or society in general, can benefit from the technology. This is the main goal of any researcher or healthcare professional who has participated in the development of an innovation project.

Currently, in practically all the tertiary hospitals that make up the public network, as well as in some of the secondary hospitals attached to the former, we can find the so-called “Innovation Support Units” (UAI), true key elements of the healthcare innovation system. The UAI burst onto the national scene in 2010 within the framework of the ITEMAS Platform, financed by the Carlos III Health Institute and coordinated by Dr. Manuel Desco.

The IAUs are responsible for acting as antennae for ideas generated within their own environment, be it their own health research centre or hospital, as well as for transferring the results of their own research, either by creating a spin-off from the hospital or research centre itself, or by licensing results to the private sector, mainly to national or international companies in the pharmaceutical or biotech sector. In other cases, the technological solutions developed are implemented in the hospitals themselves. In either case, value and knowledge are generated in the hospital environment itself, as well as wealth in the region.

The IAUs are responsible for attending to, studying, advising, and accompanying the research staff throughout the entire process described above, from the moment they knock on the door of these units until the innovation project reaches its final goal: the patient.

It should be noted that this long road from idea to market depends, in the vast majority of cases, on obtaining financial support, since the costs of scaling up, prototyping, patent application fees, in vitro or in vivo validation, market studies, freedom-to-operate (FTO) studies, software development, etc. are incurred, which need to be financed and carried out in order to achieve the appropriate valuation of the project, so as to progress gradually through the corresponding stages of development.

It is highly advisable for each institution to have a portfolio of potential strategic partners, identified by their interests in certain fields of science and towards the business area they develop. For this reason, it is essential to have a network of companies, scientific societies, hospitals, health foundations and private investors, among others, with which to establish alliances that can foster, in the future, assessment processes and, therefore, transfer to the market. These joint collaboration activities may include different types of agreements, co-developments, collaborations, etc., that allow working together to successfully achieve the aforementioned objective. In other cases, and mainly with companies in the sector, these agreements and collaborations can become so-called “strategic alliances”, which will play a key role in the valorisation stages of each institution’s project portfolio.

There are different types of agreements, alliances and public-private collaborations between public centres and companies and agents in the biotechnology, pharmaceutical and health ecosystem, including the following:

  • Framework collaboration agreements, where research centres or hospitals establish a first contact with companies to assess future more specific collaborations in the generation of new products and technologies. These agreements, although they may seem irrelevant, are the gateway to more extensive relationships over time in the form of collaboration agreements for specific projects.
  • Collaboration agreements with companies in the sector (pharmaceuticals, medical devices, etc.) to jointly develop proofs of concept, pre-clinical or clinical trials, etc., necessary for rapid transfer to the market. These agreements are much more specific than framework agreements in terms of the description of the activities to be carried out. Companies sometimes need external research centres to carry out certain types of projects and, more specifically, in certain preliminary phases of their development. It should be remembered that many pre-clinical studies, as well as clinical validations of their projects, require the participation of hospitals in order to carry out the necessary studies on volunteers and patients. Therefore, these agreements are often of high strategic value for all parties involved. In most cases, these collaborative agreements can, over time, develop into strategic alliances with high added value.
  • In some cases, co-development agreements are reached, which regulate R&D&I activities between two or more entities, where generally one of the parties is a private company, and where each of them contributes its experience and resources, whether human, technological or economic, typically providing complementary capabilities, to bring a project of common interest to a successful conclusion. This type of agreement is essential in most cases in order to get out of the well-known “valley of death” in which a project may find itself, since the public centre may not have the necessary resources to make progress in valorisation. Mainly, the contribution of external capital by a company to a public research centre allows the development of the project to continue or, in other cases, the company or private technology centre offers its collaboration in developing formulations, medical devices, in vitro diagnostics, etc., under a win-win It is common in this type of agreement to agree on the sharing of the intellectual or industrial property derived from the results of the project.
  • Service provision contracts: this type of contract, which do not generate an employment relationship or social benefits, is becoming more and more frequent. In these contracts, a researcher, doctor, research group or institution undertakes to provide a scientific service to a company (be it an experiment, specific training, consultancy, know-how, clinical trial, etc.) in exchange for an economic consideration. The execution of these contracts provides a much-needed source of income for both the research group and the institution (overheads) and, in most cases, is used to continue advancing in their own lines of research, acquiring material or hiring new support staff. For this reason, this type of agreement should be promoted by the institution itself as another strategic axis to achieve a high degree of economic sufficiency, both for the research group and for the management of the institute. Moreover, in the case of clinical trials, part of the benefits also accrues to the associated hospital, since it is the place where the service is performed. This means more income for the hospital, its researchers and the associated research centre.
  • Technology transfer agreements, which are also known as “licensing agreements or contracts”. In these agreements, technology developed by a research centre or hospital is transferred to a private company in exchange for financial compensation, either in the form of an upfront payment or a milestone payment, and often linked to the volume of sales over the duration of the contract (royalties). The latter arrangement allows the risk to be shared between the research centre and the company and is less of a burden on the latter in the early stages of the project. These agreements symbolise the ultimate success that a technology can achieve: its transfer to the private sector for subsequent economic exploitation and an even more rapid delivery to patients and society.

 

In short, all types of agreements are always beneficial for the institutions since, with the collaboration of the private sector, they allow each project to progress towards the objective of reaching the market as soon as possible and, therefore, benefiting patients or end users. It is the responsibility of all the actors involved (managers, researchers, research managers, etc.) to be oriented towards these objectives, and to actively seek material or financial resources from the private sector so that each of the projects that make up the portfolio of each institution can have these resources or be licensed as soon as possible.

In the last 4 years GENESIS Biomed has been an important player in promoting public-private collaboration through specialised support in the creation of numerous start-ups in Spain from academia and hospitals, among which we can highlight: Corify Care and Telara Pharma. In these cases, the IiSGM (Institute for Health Research) has had the close collaboration of the consulting firm GENESIS Biomed.

Corify Care was founded in 2019, among others, by Andreu Climent (CEO, UPV), María Guillem (UPV), Francisco Fernández-Avilés (HUGM) and Felipe Atienza (HUGM), thanks to the multidisciplinary work of clinicians, engineers and biomedical scientists from the Hospital General Universitario Gregorio Marañón and the Universitat Politècnica de València, based on the development of an innovative, completely non-invasive cardiac mapping system that in less than two minutes can map any cardiac rhythm, both in the consulting room and in the operating theatre, ACORYS®. This first Corify Care device will make it possible to personalise the treatment of cardiac arrhythmias, as doctors will now be able to see the origin of the arrhythmia and identify the most appropriate treatment for each patient.

In this specific case, Corify Care has relied on private participation, in the form of raising investment to carry out the final version of the design and technological validation in more than 300 patients.  This private fundraising has been carried out through two crowdfunding campaigns and other successful financing rounds (CDTI, Clave Mayor, Corporación Mondragón, etc.), totalling EUR 2.35 M, which will allow the clinical validation of ACORYS® to be completed, as well as obtaining regulatory approval in Europe and the United States in 2023 and starting its launch on the national and international market. This private participation includes the Caixa Impulse Validate call, in addition to a first round of seed funding (EUR 0.3M) from a family office, as well as funding from the EIT Health Programme (EUR 0.75M), the CDTI Cervera (EUR 1M) and European public funding.

It is also worth highlighting the active role of GENESIS Biomed from the constant support of Josep Lluís Falcó and his team since 2017, when Climent, together with the Instituto de Investigación Sanitaria Gregorio Marañón and other partners, was maturing the possibility of creating the company. This constant support was essential to jointly travel the path that has led them to the current moment, when GENESIS Biomed becomes a partner of Corify Care and Josep Lluís Falcó becomes a member of the Board of Directors of the company.

This case is an excellent example of public-private collaboration in which the private sector, made up of shareholders, investors and consultants, believed from the outset in the success of the project, aware of its importance, both for the benefit of patients with arrhythmias and for doctors and specialists who will be able to optimise the effectiveness and efficiency of the treatment to treat heart rhythm disorders, as well as for the benefit of the health system itself, in the form of savings in public resources.

Another case of public-private collaboration is the spin-off Telara Pharma, where, with the support of GENESIS Biomed, an exclusive worldwide licence agreement was signed with a private company for the use of cilastatin in the treatment and prevention of acute kidney injury and in sepsis processes.

The Cilastatin project arose thanks to the research carried out by the late Dr. Alberto Tejedor, who was head of the Nephrology Department at the Gregorio Marañón General University Hospital and professor at the Complutense University. His team patented the ability of the compound cilastatin to prevent and treat acute renal failure. They demonstrated that cilastatin protects the kidney by more than 80 percent against the toxicity of widely used drugs such as cisplatin, cyclosporine or gentamicin, essential drugs in the treatment of certain cancers, transplants or infections, without interfering with the therapeutic effect of the drugs used to treat these pathologies. The new drug has opened up the possibility of improving and extending the most effective treatments, currently known, for diseases such as cancer, HIV and immunosuppressants to prevent rejection in transplants, and the use of antibiotics for the treatment of infections that could not be used due to their high renal toxicity.

The Gregorio Marañón Hospital, through its Health Research Institute (IiSGM), carried out all the relevant pre-clinical trials, as well as publishing them in international scientific journals that endorse the excellent results.  All of this while taking the precaution of protecting the results at the appropriate time, in order to make possible a possible transfer.

Telara Pharma has signed an exclusive worldwide licence agreement with the Canadian company Arch Biopartners in 2021 to use cilastatin in the treatment and prevention of acute kidney injury and sepsis.  This agreement was reached in record time, in just 6 months, with the contribution of the consulting firm GENESIS Biomed. Arch Biopartners develops new drug candidates to treat organ damage caused by inflammation and has a portfolio of products in the clinical phase. Of particular note is its molecule, Metablok, with the same mechanism of action. This licence paves the way for better selection of therapies for DPEP-1 inhibitors and faster time to market for these molecules, opening the door for a new Phase II trial for Metablok and cilastatin targeting acute kidney injury. In addition, Telara Pharma and Hospital Gregorio Marañón will participate in the clinical development of cilastatin, led by Arch Biopartners.

As part of the licensing agreement and collaboration, the Telara team will provide Arch Biopartners with safety and pharmaceutical development data originating from Phase I to support a future Phase II clinical study.

GENESIS Biomed also contributed to and led the closing of a €100,000 seed round for Telara Pharma, providing the necessary support for the strategic management of the company and the promotion of the Cilastatin project.

Another example of public-private collaboration has been the recent creation of the spin-off THYTECH, which, with the support of GENESIS Biomed acting as Interim CEO, has accompanied its founders throughout the process of creating the company, as well as its future financing. The THYTECH project arises from researchers at the Laboratory of Immuno-regulation (LIR) of the IiSGM, led by Dr. Rafael Correa Rocha, who have developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in paediatric cardiac surgeries. After completing preclinical studies, the researchers initiated a phase I/II clinical trial to test the safety and efficacy of autologous thyTreg adoptive transfer to prevent graft rejection in paediatric heart transplant recipients. THYTECH’s main innovation is the use of thymic tissue as a new source of Tregs to obtain massive amounts of thyTreg cells with very high purity and improved survival and suppression capabilities. These cells are a promising therapy for allogeneic use as undifferentiated cells that confer low immunogenicity when transplanted. These cells can be applied to a wide range of immune-related conditions, the main areas of focus being autoimmune diseases, acute respiratory distress syndrome (COVID-19) and organ transplantation (GvHD). THYTECH is thus considered a new advanced cell therapy based on the use of thymus-derived Treg cells to induce immune tolerance for the treatment of diseases related to unwanted immune responses.

The creation of three spin-offs is a clear win-win example of public-private agreements, to the benefit of the end user, the patient. In the case of Corify Care, the private collaboration has materialised in the form of economic investment by several mainly private actors, and in the case of Telara Pharma, the public-private agreement has resulted in the licensing of the technology to a Canadian biotech company.