Is research the easy part? Key Takeaways from the Regenerative Medicine workshop
The event was kicked off the evening before with a networking dinner at which international guests had a chance to get to know each other and enjoy traditional Czech cuisine.
3 EU-funded projects (Tumor-LN-oC, MARVEL and Organtrans) were represented at the event and shared with the audience their ambitions and achievements to date but also the difficulties encountered.
- Tumor-LN-oC proposes the development and validation of tumor-lymph node-on-chip microfluidic platform that will connect primary surgically removed human tumors and lymph node tissue from the same cancer patient for metastasis research and drug test.
- ORGANTRANS (Controlled Organoids transplantation as enabler for regenerative medicine translation) aims to develop a disruptive solution that enables the 3D printing of tissue-engineered constructs and thereby provide an alternative to donor organs for patients with chronic end-stage liver diseases.
- MARVEL (Evolving reversible immunocapture by membrane sensing peptides: towards scalable extracellular vesicles isolation) aims to develop an out-of-the-box solution for scalable small Extracellular Vesicles (EVs) isolation that is based on a paradigm shift from antibodies to peptides as an alternative class of affinity ligands, characterized by high efficiency of EVs capturing.
One of the shared challenges noted by the project representatives was the strategic decision between publishing and protecting the outcomes of the project given the different and sometimes conflicting interests in the consortium. A second obstacle identified was the coordination of the project exploitation activities to ensure that project outcomes are commercialised and transferred to the market, which usually requires close collaboration beyond the project duration.
In the next block of the event, representatives from 3 companies (RESCOLL, Biomedical Engineering, Volumina Medical) shared their best practices and reflected on the challenges in transforming promising innovations in the RegMed field into a sustainable business model. The speakers and audience agreed that the biggest challenge in Regenerative Medicine is the successful transfer of innovations to the market and clinical practice, rather than the Research & Development itself, with the largest obstacle posed by the complex regulatory and legal landscape pertaining to medical devices: While in the pharmaceutical sector, manufacturers, as well as regulatory authorities, can operate under long-established processes, there are more gaps and uncertainties in biotechnology (such as cell and biomaterials production, bioprinting, organ-on chip devices), where regulation is barely keeping up with technological developments and possibilities. This goes hand in hand with the second key challenge identified: the fact that standardisation is (still) often absent and difficult to achieve, particularly when it comes to personalised medicine. This leads to the fact that quality management and regulatory procedures are considered only after successful prototyping, which is risky and expensive.
A potential solution is offered by Czech company Betthera, which specialises in Health Technology Assessment (HTA) looking into medical, economic, social and ethical implications of innovative technologies including a comprehensive cost-benefit analysis. Conducting this type of analysis in the early days of development is key to advance from the prototype to product. Not only is it crucial to determine the potential market and value of the technology, it also serves as evidence for public and private funding organisations.
Lastly, experts agreed that it is essential to keep a patient-centred perspective and engage with clinicians and patients both during the development stages and clinical validation phase, making sure that the innovation addresses a real clinical need that benefits patients and is implementable in the clinic. This goes hand in hand with the necessity to approach R&D “as simple as possible, as complex as necessary” and not over-innovate, which might lead to increased scepticism and hesitancy to adopt the novel solutions.
The fact that speakers came from different backgrounds ensured a diversity of perspectives and inspired a fruitful exchange, especially during the roundtable towards the end of the workshop. Thanks to our amazing speakers for coming to Prague and sharing your thought-provoking presentations, which facilitated insightful discussions! We were glad to see so much interaction during the coffee breaks and hope that the event will inspire new collaborations and partnerships.
A huge thank you also to our amazing audience both in the room as well as online, for your engagement with the speakers on this difficult topic!