While stem cells are now in the clinic and offer the hope of new therapies for intractable diseases such as Alzheimer's and diabetes, the ability to generate sufficient profit to justify commercial involvement seems some way off and investors are still wary of this technology. Barriers to developing a commercial "off the shelf" therapy include the issues on IP, the use of allogeneic cells, expansion and manufacture to GMP quality, and issues on demonstrating clinical efficacy.



Objectives:

Discuss how the barriers are being resolved for the final benefit to patients.

Examine the impact on the investment landscape of time scales, costs and risks in taking potential therapies through the regulatory process and through to market.

Highlight the importance of early collaboration between scientists, clinicians, engineers, regulators and reimbursement agencies to accelerate the delivery of patient benefit.