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New Business Models and Value Systems in Regenerative Medicine

Mittra, J   Tait, J

MHRA Joint Workshop on the Regulation of UK Regenerative Medicine

London

Invited Keynote Lecture

October 30 2012

• Making goods measureable and comparable is a driver of new market creation, but in the regenerative medicine field there is considerable uncertainty regarding data and product classifications, both in the UK and internationally. This means there is a very strong need for soft interactions between the regulators and stakeholders, especially with MHRA on the one hand, and NICE and Health Technology Assessment agencies on the other, because their approaches to the central issue of product classification and scientific evaluation are very different.

• Similarly, a key intermediary agency for the NHS, the NIHR Horizon Scanning Centre, which provides notice of significant new and emerging health technologies up to three years prior to their launch in the NHS, does not have experience of how long it will take for various types of regenerative medicine therapies to diffuse since the product and development models are very different from drugs and devices. In response they have undertaken horizon scanning reviews to identify developments in cardiovascular disease, ophthalmology, neurological conditions, musculoskeletal disorders and skin conditions/wounds. They have also prepared detailed briefing reports on two current products that are closer to market.

• Overall, from a corporate perspective, research by the panel members shows that the most important factors are future regulatory and reimbursement systems, future market position/competitive landscape, future costs of inputs to manufacture process, requirement for developments in cryopreservation and GMP solutions. Companies producing starting materials have a better understanding of regulatory pathways/risk than therapy companies entering the field, as they already understand much of the regulatory framework.

Further details on the workshop available here.