Open Innovation Test Bed projects: Bringing Together Service Providers along the Value Chain to Accelerate Development

An Open Innovation Test Bed (OITB) is developed during an EC-funded project, as a coordinated group of entities, providing from a single entry-point common access to physical facilities, capabilities and services required for the development, testing and upscaling of nanotechnology and advanced materials in industrial environments. 
BNN has been initiating, co-developing and then working as a beneficiary in two EC-funded OITB-projects. In NextGenMicrofluidics (NGM), services were provided for the development of nano-enabled surfaces and membranes, and the association Microfluidics Innovation Hub (MIH) was launched as the single entry point (SEP) to the microfluidic technologies offered by NGM project partners. In the project PHOENIX, services were developed, provided and tested in demo cases for the development of different types of nanopharmaceuticals, and the PHOENIX OITB gGmbH was launched as the SEP to access these services.
Before NGM, BNN had been collaborating with partners in the EC-funded project R2R Biofluidics, many of whom conceived the NGM idea together. Within NGM, BNN provided project management, quality management, Safe-by-Design and communication & dissemination. In the PHOENIX project, BNN brought together the consortium to provide added value in nanopharmaceutical development and is responsible for communication & dissemination, business development and sustainability, as well as regulatory support for pharmaceutical development.
As both projects come to a close this year and their SEPs transition to full-time service provision, Caitlin Ahern from BNN sat down with their teams to talk about the process of bringing together diverse service providers into a one-stop-shop, the challenges and benefits, and the impact on their customers. From Phoenix-OITB-project we have Tommaso Serchi of Luxembourg Institute for Science and Technology as project coordinator and Nazende Günday-Türeli from MyBiotech GmbH, Germany, as project scientific coordinator and CEO of the SEP Phoenix OITB gGmbH. From NextGenMicrofluidics we have coordinator Martin Smolka of JOANNEUM RESEARCH – Materials and Ronald Tingl, General Manager of the SEP Microfluidics Innovation Hub (MIH) association, both based in Austria. BNN as the starting- and connecting-point in both projects, contributed one of its key competences: facilitating the collaboration of academia and industry, paving the way from fundamental research to the market.

Caitlin Ahern (BNN): Thank you all for joining us! Starting at the beginning of the PHOENIX project, Nazende, can you tell us what need you saw in the nanopharmaceutical community that you wanted to address with your proposal? 

Nazende Günday-Türeli: When it comes to bringing nanopharmaceuticals towards GMP – whether this is from characterization, from preclinical studies or most importantly, GMP manufacturing – what we see as the biggest challenge for the really successful, innovative products is the scalability or the challenges to make them regulatory compliant to enter clinics. Sometimes the developing parties don`t even know how to deal with different parts of the supply chain. They don’t know where to go to find the right partner or they don’t have access to these facilities with state-of-the-art characterization or manufacturing possibilities. And this was our motivation when we started creating the idea of the PHOENIX-OITB for GMP manufacturing of nanopharmaceuticals. We want to create the ecosystem to boost innovation all around nanopharmaceuticals. The OITB should be an enabler, actually, to access a Single Entry Point that can unite fragmented services across Europe, even globally. An environment where the developers and innovators can find the right services and the right roadmap for them to bring their products towards the GMP – and, of course, from this point on, to the clinics and market.

CA:  What did you think would be achieved by bringing together multiple service providers?

NGT: From my side, the most important thing is saving time and money, but also saving many successful products that are still unable to make it to the market just because developers don’t know how to access the infrastructures and services and what possibilities are out there. We wanted to create a seamless pipeline for everyone, independent of the nanopharmaceutical that you are developing, whether you’re an academic or coming from a spin-off or maybe even large pharma. We want to offer the consolidated set of expertise, facilities, equipment, knowledge, etc. delivered from a central contact in a cost- and time-effective manner, so that we not only help move these products towards the higher maturity but also make it simpler and less risky from their side in terms of both cost and moving towards higher developmental phase.

CA: Turning to NextGenMicrofluidics, Martin, did you have similar motivations in the proposal phase? Was there a need in the microfluidics community that you really wanted to address?

Martin Smolka: The main need which we saw in the microfluidics community was very much technology-related, very microfluidic-specific. It all started with a previous EU-funded research project, and in this project, the core concepts did already work together as we developed technology for a new approach for manufacturing microfluidic chips.
The main story was about how we produce microfluidic chips. We wanted to move away from processing single chips, for example with plastic pieces which can fall out of injection-molding machines. Typically you have such single plastic pieces and you run several processes required for a functional microfluidic device on them. We wanted to move away from processing of these single chips towards large-area processing.
We worked on implementation of processes on large-area polymer film substrates – that was our core technology which we had developed before.
One of the main goals of this development is always reduction of prices per chip, i.e. reduction of process cost per chip, because we move away from processing a few chips in parallel to hundreds of chips in meter-long substrates.

CA: Ronald, from the business side, what did you think could be achieved by bringing together these multiple service providers along the value chain? 

Ronald Tingl: Essentially it’s very similar to what Nazende said. As a single entry point, we received a lot of inquiries especially from smaller companies, startups and SMEs. These people are not exactly super familiar with the supplier universe, which is very large and fragmented. So they came to us and had very straightforward ideas like, “We have first prototypes out of the lab. Basically what we have works, but now we want to scale up.” Scaling up means that they don’t know which technology to choose. They don’t know what to do when it comes to design for manufacturability, so they came to us, clearly stating, “We don’t have sufficient know-how, we don’t have the resources, we don’t have time. We don’t have enough money to talk to all the potential suppliers in this market. That’s why we’re coming to you. And we expect that whoever you pick for us can work together smoothly to serve us.” As a matter of fact, in most of our client projects we have at least 2-3 companies which have to cooperate in order to come up with a final product.

CA: Tommaso, in both projects we had academic partners working alongside companies both large and small. From your perspective as project coordinator of PHOENIX-OITB, what could the academic partners learn from the companies?

Tommaso Serchi: That’s a very good question. From a scientific point of view, we are always ready to support and to help, and we were already doing research which we considered to be at an excellent level, so we didn’t need to learn much about the technical part. But in the management of the projects – how to deal with the customer, how to do services – I can’t speak for all academic partners, but at least for some who are in in PHOENIX, we definitely learned a lot. We offer services every now and then, but not so much with pharma.
We had to adapt our processes, our reporting, supply chain, level of precision, quality that these required, especially for pharma, and this is something that academia is not typically ready for.
So working in PHOENIX helped us a lot to refine what we do scientifically.

CA: Martin, did the academic partners in NextGen have a similar experience? 

MS: Yes, it was definitely similar. As a technology and research partner, we can offer new insights and new technology trends, new processes. But on the other hand, with the Open Innovation Test Bed funding, we needed to develop a customer-oriented and service-oriented mentality, and that was definitely a learning experience. We moved away from pure publicly funded research towards customer projects where we needed to deliver with more concrete timelines and also more concrete specifications.

CA: Nazende, did companies in the PHOENIX-OITB also benefit from working with academic partners? 

NGT: That’s the idea of Open Innovation Test Beds between academia and industry. We have the industry-backed best practice. We do understand how and what to bring to the customer, how to communicate with them, how to attract people so that they stay with you.
But what we learned as industry from academia is, first of all, novel methodologies, because industry is often interested in the result – I have a very concrete question and I want to know what the result is. In the pharma industry this is driven by the regulatory guidelines and what we have to deliver.
However, we don’t always know exactly what novel methodologies might be necessary, because in the nanopharmaceutical world every product is different and one methodology does not necessarily apply to all.
Advanced and customized methodological approaches that can be used for different products are coming more from academia. While the industry brings the need from the market and the regulatory requirements for the quality, efficacy and safety characterization, academia brings cutting-edge research, very specialized equipment and identifying the right tools to characterize certain products. We have pharma-regulated characterisation, equipment and approaches while in academia they are more novel, not validated, not verified. However, at early stages of the developments, these kinds of approaches that can give us not regulatory conform, but quick results to proceed with the development. This is a risk that we can take instead of failing the product under regulated environment.
Let’s be honest, this is also one of the things that helps de-risking the development of nanopharmaceuticals: it’s a synergistic learning experience from both sides.
From my point of view, this synergy drives innovation.

RT: Those are some interesting insights which we would a 100% agree with on our side.

CA: Were there any challenges that you faced, Ronald? Was it helpful to have partners from different backgrounds to meet these challenges? 

RT: I think that the biggest challenge we had was, first of all, having to set up this single entry point very quickly.
Sometimes we had the impression that the European Commission thinks that all of this can be done within two years, being successful in the third year.
We operated like a startup, which means it takes time. It simply takes time, going from scratch with a brand-new company, hiring a completely new team – where everybody says that a team is the most important factor for success.
The second was managing all the stakeholders. We set up this association on one hand, which is the single entry point, and in parallel, we had to manage 21 stakeholders. This was another pretty big challenge.
We would have wished for a little bit more flexibility from the side of the European Commission, especially when it comes to, for example, amendments, financial topics.
When it comes  to the benefits for us or for companies, one of the biggest benefits we saw  was the outstanding improvement in the consortium partners. Along the value chain, we now understand each other much better having worked together on industrial projects, and we see the benefit that small companies and startups have when they work with MIH.

CA: Tommaso, were there also aspects in PHOENIX you wished the Commission had been aware of or been more supportive to help the success of these projects?

TS: From my point of view, we always got what we needed from the Commission. We extended the project because we needed some more time and they supported us. So from my point of view, that was fine.
We did have some trouble, like Ronald said, in the timing and aligning with the stakeholders. Then, like everybody else, we had the COVID pandemic, which extended some bureaucratic issues. In Germany, for example, we were supposed to be done establishing the SEP with the notary in  two weeks, but because of COVID, they changed the procedure, which extended the time that we needed to establish the association from a few months to two-and-a-half years.
So we wasted a lot of time in bureaucracy, which was not related to the Commission but more to the national stakeholders. We also had public institutes like LIST, like CSIC, in different countries and everybody had a different chain of approval. So for me at LIST it was up to the directors to join the SEP, but for CSIC it was up to their board of Directors and the ministry. That made the process take a lot longer than expected.
We did manage in the end, but I would have wished for the bureaucracy to have been a bit lighter.

NGT: If I may add here to what Tommaso said, during the project runtime, we did come across minor difficulties that could have been handled differently. But what is important is the idea for the OITB is really coming from the call that has been written, from the building sector to the pharma sector, from microfluidics to biomaterials – and the Commission wanted a consolidated network. I realized, though, PHOENIX is one of the youngest OITBs, and still, I’m not sure if it was consolidated at the Commission level when our project was funded. Issues of how to deal with certain bureaucratic aspects of OITBs had still not been tackled.
How could the Commission offer, for example, more structured funding schemes and mechanisms?
How this new infrastructure as a new entity, which was also an obligatory part of the calls that the Commission made for different OITBs, could be well integrated in the existing frameworks, existing rules and regulations?
Though I must say direct contact was always offered, and the Commission made a great effort to bring OITBs together for brainstorming, and they offered a lot of support. This was much appreciated.
I think the sustainability of the well-established OITBs with the support of the Commission could have been better handled and we could eventually have more time to engage stakeholders instead of dealing with the bureaucratic difficulties, etc. Regarding visibility in the calls, it would have been nice if the OITBs were mentioned more frequently in other calls – so that we are visible to someone just entering the community.
From the other side, as you already said, you are aligning expectations of academics and also industry. That’s not an easy task!

CA: Ronald and Martin, do you have any success stories to share?  

MS: We had 18 open calls acquired by the MIH and spent at least 95% of the money we were provided, which we consider to be quite successful. We also received €380,000 in cash contributions from the customers, which was very encouraging.

RT: So that’s one-fourth of the total €1.5 million we received from the European Commission. Quite a lot of companies were moved from TRL 4 or 5 on to TRL 6, so at least one TRL level higher. And out of these 18 companies, we see at least six companies are continuing to do business with us or with the members of the MIH, which we believe to be quite a success.

CA: Nazende, in PHOENIX, were you able to achieve the goals you set out at the beginning of the project to bring nanopharmaceuticals to GMP level and also to increase the maturity of the projects, increasing their TRL? 

NGT: Definitely. Our goal was to bring all of our five demo cases to a maturity level that they are ready to enter the clinics at any time. And indeed, even though some of them are at the latest stage of finalization of this development, we are convinced with the additional six months’ project prolongation that we received, we will bring all products to a level that they are ready for GMP manufacturing and can be further used in clinics. In one of the demo cases, for example, I can already tell you that they are not far from getting to the clinics – they are already planning within two to three years from the end of the project lifetime they will be entering the clinics. We also have other demo cases where we could completely adapt the manufacturing process to be regulatory compliant, to be greener and more cost effective, but also to reduce the risk towards the GMP  thanks to the services that OITB service providers provided during the project runtime.

CA: That’s great news. Looking into the future, what are the next steps for the PHOENIX Single Entry Point (SEP) after the project ends? 

NGT: Since the beginning of this year, the Single Entry Point is actively offering services in the market and doing business. Now we want to increase our network with new clients so that they can profit from the services that we are offering, and we want to increase our visibility in this ecosystem and also create our OITB network so that we have long-term strategic partnerships with the main players in the innovation of the nanopharmaceuticals.

CA: And what about for Microfluidics Innovation Hub? Ronald, what are the next steps? 

RT: We started to promote the MIH years ago and our awareness campaigns have paid off. We meet potential customers at fairs who are telling us, “I’ve been seeing you now here for the second or third time, we started believing in you. Let’s talk business.” From our perspective, we see more and more leads coming either from events or from our online campaigns. We also see an increasing number of people finding our website via web search and contacting us. And we will continue to go down this path and further work on our awareness, go to events and invite people to work with us and extend our ecosystem.

CA: For any potential new customers watching this now, how can they get in touch if they are interested in what MIH and PHOENIX have to offer?

RT: First, go to our website, where we have call to action buttons. You can immediately schedule a 30min call with us to see how we can help. Or go to well-known industry events like COMPAMED, Medica, Lab-on-a-Chip, etc. We’ll be there, let’s have a chat.

NGT: The best is to go to our website so that they can have direct contact with our project and innovation managers under non-binding and confidential conditions. In the first consultancy we discuss what we could offer to bring their products forward and identify what they really need.
Our service portfolio is already available in our website in a PDF form, but we are offering a more user-friendly online service search tool very soon.

CA: Thanks so much. Martin, maybe you plug the final event for the NextGenMicrofluidics dissemination outcomes. 

MS: For all parties interested in the Microfluidics Innovation Hub and the results of our project, we are organizing a final dissemination event. It’s dedicated to microfluidics technology, all about chips in which you can measure chemical or biochemical parameters or cultivate cells. You can  see a lot of results through presentations and hands-on demonstrations in our final event The Next Generation of Microfluidics: linking expertise across Europe coordinated in Austria on March 26^th in Graz.

CA: Thanks to all of you for your insights, and we look forward to staying in touch and seeing the further outcomes!

 

These projects have received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 862092 (NextGenMicrofluidics) and 953110 (PHOENIX-OITB).