IMI Programme Office: Why was the project like yours needed and what challenges you had to address?
Courtney: Although there were a number of substantial cell repositories, particularly in the US, a facility that actively assembled a new catalogue of iPSC lines from different locations across Europe, did not exist at all. This was very much a visionary project.
Ebneth: Another important aspect was for the commercial entities that the iPSC lines that are supposed to be deposited in EBiSC are free to operate, consented, and quality controlled. In our experience, if we ordered an iPSC line from somewhere, the quality control was typically not appropriate, and there was quite an effort to get the legal requirement in place in order to start working with them. Long lasting negotiations, for instance, with tech transfer offices from the universities were prohibitive to really embark on using the iPSC lines for research and development purposes in pharma companies. All that was addressed by EBiSC.
IMI Programme Office: What are the achievements that you are most proud of as project coordinators?
Ebneth: The existing infrastructure is operational after the end of the project. The request for iPSC lines is steadily increasing, so it looks like EBiSC is on the right track to achieve its vision.
Courtney: The lines are sold on a not for profit basis to cover the costs of maintaining the bank. The distribution is being coordinated by one of the consortium partners with a global sales reach, and we now have over 800 cell lines available in the catalogue. Looking back at 2012, when the call was established, a significant concern was whether it would be possible to acquire and centralise stem cells from many research centres. This was achieved. Stem cell lines created in one research centre, can now be used for research in other centres, and deliver consistent data and results. We provided innovation in the science of stem cells and were also able to accommodate changes such as the development of CRISPR/cas9 gene entity, which was unforeseen in 2012. EBiSC has been able to bring these technologies into its workflow.
Ebneth: Another important aspect that I would like to add is that all ethical requirements were harmonised, and the patient consent forms were used already for other IMI projects to derive iPSC lines. This is not visible if you order from the catalogue online, but it was a huge amount of work to start harmonising this across Europe.
IMI Programme Office: How did the pharmaceutical industry benefit from this project?
Ebneth: Speaking specifically for Janssen, we didn’t have easy access to human disease derived cells before, including isogenic controls attached to it, with required QC [quality control], consent, and freedom to operate. Such cell lines are now, thanks to EBiSC, available, and we use them now in our research and run comparative studies across industry. The use of these iPSC lines might help researchers to deliver robust results which are, most importantly, reproducible across laboratories.
IMI Programme Office: What about SMEs and the academic community, how did they benefit?
Courtney: For SMEs, the project provided a mechanism to engage with large pharmaceutical companies and get a better understanding of what they require in research. Speaking for my own company, we are now engaged in commercial research with pharmaceutical companies who were not involved in the project because we have an ability to access some of the catalogued cell lines. This commercial research would not take place if the EBiSC catalogue did not exist. Speaking for the academics, EBiSC has allowed the research groups to accelerate or expand the iPSC production element of their research. It has allowed other academic researchers to develop and validate new technologies, such as for cryopreservation and cell expansion.
IMI Programme Office: In the longer term, will patients benefit from EBiSC through faster medicines development for example?
Ebneth: In terms of direct treatments, this technology is currently not yet benefiting the patients, but EBiSC ensures that we now have access to disease-relevant iPSC lines for research purposes.
IMI Programme Office: Would this project be possible without IMI?
Ebneth: No, it would probably not. It was quite an effort to set up the legal framework and prepare a Europe-wide harmonisation. Different expertise areas had to be assembled: legal, ethical, along with basic research. That would be an effort far too complex to be taken up by anyone alone.
Courtney: I think the importance of bringing together the academic researchers, SMEs, and EFPIA partners into a group should not be underestimated. It allows EFPIA to clearly articulate what they want, so that the research and infrastructure is much better aligned to user needs. There is a clear market pull as opposed to a simple technology push. Without the facilitation provided by IMI to bring together both users and suppliers of the stem cell lines, the whole concept would be misaligned.
IMI Programme Office: What happens next?
Ebneth: A new project, EBiSC2, will build on the assets of EBiSC and aims to bring in new lines, expand existing lines so that they can be easily distributed, and work on additional technologies that would support iPSC technologies across commercial and non-commercial entities.
IMI Programme Office: What was it like to be the coordinators of the project and what advice you want to give to the other coordinators?
Ebneth: My advice is to have a very strong coordination and administration office to act as sort of a co-coordinator. You need this strong support to secure smooth and seamless operations.
Courtney: I agree. Assembling and coordinating a very large project is a significant challenge, but also a worthwhile activity. A very strong administration needs to be in place along with all other mechanisms. It is important to ensure that the goals of the project are clearly articulated and in long-term research, one has to have the flexibility to accommodate unforeseen changes.