From the President's Desk: Collaborative Competition!

Recommend

Miguel Forte, MD, PhD
ISCT President
Kiji Therapeutics
Belgium

Collaborative competition (often called coopetition) is the idea that different organizations cooperate in some areas while still competing in others, to create mutual benefit and value. Competition is the driver of innovation, progress and improving outcomes. If competition is done in a constructive and collaborative way it not only accelerates the deliverables but also expands the benefits so that all those involved get incremental benefits.

“The Wandering Earth”, a Chinese science fiction book and film, is a good illustration of collaborative competition. The players explicitly merge their technological and scientific capabilities into a single project, while individual identities, interests, and objectives still visibly persist in the background. Conceptually, the “Wandering Earth” project is like a massive pre competitive consortium: everyone must pool engineering, resources, and risk to move the planet, because no single country can do it alone. At the same time, the film highlights questions of who leads, whose values are foregrounded, and how choices are made and illustrates forms of symbolic or soft power competition playing out inside a formally unified project.

The gravitational center of innovation and product development in CGT is shifting towards Asia, China in particular, where the number of new companies and clinical trials, both academic as well as industrial are growing at a faster pace and already higher than in US or Europe. The number of CGT clinical trials in 2025 was 890, with a growth of 8%, versus 716, with a growth of 20%, in the US (1). Australia is also emerging as a rather competitive geography for early stage, proof-of-concept clinical trials. These early-stage clinical trials are often conducted as Investigator Initiated Trials (IITs) with fast approval, reassuringly always with regulatory and ethical approval, frequently via the local expedited (CTN) pathway. In this context it is meaningful and telling to note that investors a couple of years ago were questioning the value and relevance of IITs, while now, as the world has evolved, they are asking companies when do they do their IIT, maybe in China, to expedite clinical data generation and foster business development activities de-risking the project and progressing towards potential earlier exits.

European and US leadership, academic, industrial and political, have acknowledged the need to increase competitiveness versus other regions and actions are being taken in that context. The macroenvironment and the geopolitical competition, alongside scientific development, is fostering the development of CGT regulatory frameworks. FDA leadership has expressed commitment to ensuring that the US remains the center for CGT research around the globe and that this is in line with the Make America Healthy Again (MAHA)(1; 2).

In Europe, the European Commission has extensively and insistently communicated on the strategic imperative of increasing the competitiveness of the biotech sector, with ATMP at the front, in Europe. To translate this into legislative expedited action, the Commission published the first part of the EU Biotech Act (3) that is now under assessment and discussion at the European Parliament. The initiative is anchored on the understanding that success of the CGT sector depends on how regulation, investment and product delivery are chained together. The EU Biotech Act proposal (European Biotech Act) is seen as a horizontal framework to strengthen EU competitiveness in health biotechnology and biomanufacturing, structured around seven main groups of measures (3). In summary it aims at accelerating the approval and execution of clinical trials, incentivizing and extending product and Intellectual Property protection and providing funding. The funding approaches appear to aim at being nimbler in the decision and granting process while also focusing on early stage of translation, where the biotech projects represent higher risk (4). Understanding the need of collaboration and optimization of talent and resources – we do it better when we do it together - the Commission has expressed particular attention to the development and networking of centers of Excellence across Europe with specific funding programs.

These efforts to increase competitiveness, valuable per se, are very much driven as a reaction to the emerging competition from China, and other regions, in terms of increasing innovation, quality of science and product development together with cost-efficiency of operations. This is where the competitive collaboration concept is relevant as both the EU and the US, in their competitive intention, would benefit by retaining that competition intention but framing it in a collaborative and strategic context. The output would be stronger with benefits for the ecosystem, improvement of the biotech sector and the final intention, improved benefits for patients and unmet medical needs.

A couple of important points in this innovation process that deserve to be highlighted are the developments in Artificial Intelligence (AI) and Gene Engineering. They represent the forefront of innovation with huge opportunities but with the need of an Ethical approach within guardrails and with a clear risk/benefit approach where they represent benefit over alternatives. For AI the FDA and EMA jointly published guiding principles of good AI practice in drug development (5). In this context it is a matter of correct use of a tool, and in the broader context AI and risks of autonomy and super intelligence need to be properly monitored (6; 7). For gene editing, the somatic approach represents a clear opportunity to pursue and develop today what is already conveying transformative value in multiple conditions. Going from mono-genetic pathologies to multi gene and epigenetic represents is already a significant challenge while germinal gene editing – Human Heritable Gene Editing – should be an area where our technical capabilities and the current negative risk/benefit ratio call for a moratorium (8).

All these topics will be discussed in multiple sessions, some of them exclusively dedicated to the aspects mentioned above, in the International Society for Cell and Gene Therapy (ISCT) annual meeting in Dublin next May! It will be a great opportunity to learn and discuss these challenges and the opportunities that will define CGT and Medicine going forward!