Reflecting on Cell and Gene Meeting on the Mediterranean Conference, 202129 Apr 2021
With a vision to become the partner of choice to enable advanced therapies worldwide through our albumin-based products, solutions, and services; attending Meeting on the Med is a must in our yearly conference plan.
We virtually sent our European Business Development Director, Joanna Hay, as well as Business Development Associates, Edward Thornton and Maciej Trybull, to catch up with current and future partners in the Advanced Therapy Medicinal Product (ATMP) community and listen in on the exciting talks setting the direction of the industry.
We have collected some of our key takeaways to share with you in case you did not have a chance to participate and still want to catch the highlights; maybe even share with a colleague or fellow ATMP enthusiast!
The ATMP sector has been subject to intense growth and acceleration in recent years, with scientific knowledge and technical capabilities evolving at a rapid rate. This has created a paradigm where regulatory standards, guidance and requirements are evolving in parallel to ATMP products being developed, creating significant challenges for the regulators on how to appropriately regulate these novel, complex and often unique products. With such a rapid evolution and constant changes to understanding, it is more important than ever before to stay on top of regulatory updates and identify any trends for the regulation of ATMPs. At Meeting on the Med 2021, the key regulatory trend highlighted was the requirement for harmonization of regulatory standards across territories to enable more streamlined and consistent market access.
The MHRA (UK regulatory body) expressed a clear desire to remain aligned with the EU, despite Brexit with regards to the regulation of ATMPs and highlighted an accelerated pathway open to developers of all medicines (including ATMPs), aimed at accelerating the time to reach the UK market.
The importance of collaboration between industry, academia and the regulators was also identified in order to facilitate understanding and a more streamlined and effective route to market.
In addition to this, emphasis was put on increasing the harmonization in international regulatory cohesion regarding orphan disease drug development. It was pointed out that currently, it is not commercially viable to develop drugs for orphan diseases within the smaller population of a single nationality. Cohesion between regulatory bodies means there is a possibility to access the international patient population. The UK has recently joined the ACSS consortium to move towards achieving this.
Next-generation developments in iPSC therapies
iPSC therapies is a topic we often engage in with customers globally, and especially with our Japanese partners, it is an area where we are seeing great development.
Our in-house technical experts work continuously to explore the vast benefits of albumin in cell therapies, most recently in collaboration with Centre for Genomic Research in Barcelona, where we explored the benefits of Albumedix' albumin product for the cryopreservation of iPSC's.
At Meeting on the Med 2021, new developments in iPSC's were presented and included progress in immunotherapies with allogenic off the shelf T-cell therapies developed from iPSC's. Whilst the complexity of supply chains and logistical challenges were once again a topic of discussion in with autologous cell therapy developers.
The rise of allogenic therapies could however connect the globe and research centers, creating logistic connections and more collaboration. Here, optimal logistics and cryopreservation solutions become very important.
Concluding reflections from Meeting on the Med
Above are just a few of the topics of discussion at this years Meeting on the Med conference, but we hope it provided an interesting overview and food for thought on what is being discussed in the Advanced Therapy community. We will continue the discussions with our partners and look forward to Cell and Gene Meeting on the Mediterranean 2022 – Hope to see you there!