Regulatory guidance covering the development of regenerative medicine therapies exists; however, there is room for considerable subjectivity in the interpretation of these guidelines by sector stakeholders across different territories. The value of developing and introducing formal standards across common research, development, and production processes is that it provides a basis for best practice, and thus aligns and potentially expedites commercialization of therapies.
As a guiding principle, the formalization of best practice into recognized standards should be a constructive process for the benefit of the industry as a whole. That is to say, it is not so much about restrictive rules; it is about the development of common, validated methods and solutions that contribute to quality, safety, and performance.
By working within a common standards framework, companies operating in the regenerative medicine space can share best practices and use this as a platform upon which to accelerate innovation. There is also opportunity to position these standards as a benchmark upon which regenerative medicine therapies, and the underlying processes by which they are derived, must meet to gain regulatory approval.
The field of regenerative medicine is a complex regulatory environment, heavily segmented with many different variants and definitions of what constitutes regenerative medicine. It is also a multidisciplinary field covering, for example, tissue sampling, manipulation of cell lines, encapsulation, information handling, and delivery devices.
As with many other sectors before it, validated methodologies are being created internationally, and so standards need to be harmonized globally. A wider challenge that emerges once a standard or best practice has been agreed upon by stakeholders is how to achieve widespread adoption.
Developers of regenerative medicine need to be able to demonstrate cost-effective, expedient development programs combined with feasible commercialization strategies in order to attract significant investor funding. Equally, robust exit strategies for investors also need to be defined in order to attract funding in the long term. The introduction of harmonized standards as a means to de-risk generic R&D and production processes can support these commercial considerations.