Managing Expectations

Workpackage 6 of the Osteocord project is a detailed look at MSCs including an analysis of expectations, prospects and potential.

 

Aims

 

To assess the different expectations of MSCs held across the research community

 

To assist the research community in better understanding broader technical, regulatory, commercial and clinical factors in the future shaping of MSCs

 

To articulate robust and empirically informed scenarios for the European exploitation of MSCs

 

Like all radically novel areas of research, MSCs present a broad set of difficulties to the research community. Whilst being a source of great promise, uncertainties remain in respect to questions of safety and standards, commercial viability, potential investment, consensus amongst scientists, clinical diffusion, and so on. This Workpackage is an opportunity to link the scientific questions (of MSC isolation and expansion) to the wider environment, surveying the different expectations of key stakeholders and defining plausible scenarios, potential barriers and areas of weakness.

 

Expectations in the Commercial development of MSCs

We will assess the level of existing commercial activity in MSCs, identifying key business and commercial strategies. Initial scoping analysis for this proposal identifies 131 patent applications (since 2001 US PTO) from companies with R&D investment in MSCs. Expectations of the future innovation in this area are often clearly stated in company financial reports to shareholders and financial authorities, in addition to patent applications, and often include detailed information on key uncertainties (where required by financial regulators).

 

Expectations in the public research and clinical development of MSCs

Initial scoping for this application identifies a number of clinical trials on MSCs presently progressing. However, clinical priorities and expectations are likely to differ somewhat from those of commercial innovators. This deliverable will be an important opportunity to bring public, clinical and commercial expectations in MSCs together, through a comparative analysis.

 

Networks and expectations in the regulation of MSCs

We will review a range of regulatory issues relevant to the future development of MSCs, particularly in relation to questions of standards and quality. Whilst European and EU domestic measures are important in this respect, regulatory developments elsewhere (US FDA, etc) are likely to have an important impact on worldwide MSC research and exploitation.

Analysis and presentation of scenarios at a stakeholder workshop
Empirical findings will be drawn together into a written report from which a suite of stakeholder driver scenarios will be derived and interrogated at a concluding workshop. The scenarios will vary according to known uncertainties about the present and future direction of the field. This has become a now established means of both checking the plausibility of expectations and exposing them to detailed stakeholder scrutiny. The research team is highly experienced in this field of methodology.