Reflecting on Bio Integrates 202024 Nov 2020
Last week, our CEO (Jonas Skjødt Møller) participated in a virtual panel discussion at the Bio Integrates 2020 conference. Topics of focus included urgent and pressing issues such strategies to overcome scalability and economic challenges associated with advanced therapies, in order to achieve the best possible patient outcomes. Joining Jonas in the panel discussion were other experts within the field, including;
- Keith Thompson, Chair, Pharma Advisory Board at Deep Science Ventures
- Tim Luker, Vice President Emerging Technology and Innovation at Eli Lilly and Company
- Jan Thirkettle, Chief Development Officer at Freeline
- Lucy Foley, Director of Biologics at CPI
- Michael Hunt, Chief Financial Officer at ReNeuron Group plc
The panel was moderated by Ian Campbell, Interim Executive Chair at Innovate UK.
We would like to share with you some personal reflections from Jonas -
“Firstly, thank you to the team at Life Science Integrates for the opportunity to engage with such a knowledgeable group of experts, discussing ways to tackle issues surrounding the advanced therapy field. The panel composition considered the views of pharma, biotech, venture capital and enabling tech innovators, such as Albumedix, I think that brought a good level of diversity in the perspectivations; though consensus was quickly established around some of the key challenges yet to overcome.
In efforts to establish further robustness and scale around cellular and gene therapy manufacturing, a theme of discussion emerged focusing on the need to simplify and standardize processes and materials employed. An example here was the range of different manufacturing systems currently being utilized. The group reflected that a consolidation of these systems will properly happen within a few years, enabling smoother development processes and approval.
On the same theme, discussions repeatedly circled back to two key words; scale and quality. In other words, the need to be able to scale without losing quality and potency of the drug product is of paramount importance. Here panelists were optimistic but also realistic about the pace of getting new products to market which address broader indications. From an Albumedix perspective, these are very familiar topics and questions that we work with our advanced therapy partners and clients to address on a daily basis.
The inherent heterogeneous nature of ATMP's pulls the scale and quality equation to the very center of the innovation battleground, as ensuring scalable consistency throughout production is imperative if these therapies are to become economically viable treatment options. Again, this debate relates to everything from the individual unit operations equipment, physical/chemical conditions, starting material, raw material, ancillary material, excipients, etc. From Albumedix' perspective, we have seen how important it can be for a therapy to include pure and consistent albumin sources. Often, (especially using serum derived albumin) unknown impurities and differences between batches can become detrimental, especially when scaling up production. Considering this topic from an economic as well as a patient outcomes perspective, further discussion took place in the panel around the need for the industry to secure sufficient margins on their drug products in order to secure investments for future products.
The next wave of therapies being developed will include higher dose therapies in markets with higher prevalence, with the efforts in Hemophilia A being highlighted as key example of this. A problem to reach this point however is the amount of virus possible to dose. The holy grail would be to have a more potent delivery system without triggering immunogenicity concerns, so that less product would be needed for same effect. Amazing progress is being made with AAV; advances that we here in Albumedix are following closely as well while engaging with customers and collaborators to try and facilitate this progress with our Recombumin® albumin-based products and technologies.
Finally, the panel considered the huge discussion topic of pricing advanced therapies. The big question here is; how do you value a curative treatment? Alternative pricing mechanisms and reimbursement structures will be needed in order to make these therapies truly economically feasible”.