Theme 5: Tissue Engineering for Regenerative Medicine

Moderating the ‘race’ to market

It is understandable that developers of new cell-based products want to commercialise them as quickly as possible, to get the jump on competitors and to reap the rewards from their investment. But unnecessary haste brings risk. Any action, including a ‘pause-and-think’, that might help moderate what otherwise might be a headlong and mistake-prone rush to get from lab to clinic/market needs to be considered.
In addition to the point in the trek at which a pause-and-think5 might be instigated is the question of who would have the power to do it. In the early part of the trek [to left of blue zone in fig 7] academia and associated non-commercial entities would be able to do this unless, of course, industry sponsors, if there are any at this early stage, insist otherwise. As one moves to the right, however, academia’s ability to pause progress would be more limited.
So, the first planned pause would be somewhere within or slightly to the left of the blue zone. This pause would be occupied by actions necessary to complete the science, do the prototyping work including [critical but oft-underemphasised] finalisation of product design and specification and prepare for translation: in effect for all-round tightening up and confidence-building before handing to those with stronger commercial imperatives.
The red zone represents the sink hole [Death Valley, chasm, by other authors], the point in the trek where the go-ahead clinicians are satisfied by the design, utility, efficacy and economics, of a new innovative product and quickly adopt. It’s also where other clinicians whose representative colleagues have not been involved with product development from an early stage in the trek can and do drag sales down, possibly to oblivion, because they are not ready [even if it’s just attitude] for that product.
Chart showing the trek for cell-based product from laboratory bench to market/clinic. It shows a \
Fig 7 Cell-based product trek from laboratory bench to market/clinic
Industry always faces difficult challenges in managing its way past or through such a crash. Often there is little or no planning for the event, rather a stubborn belief that ‘this is the product that everyone will want, so we’ve nothing to worry about’. Or the ‘planning’ comes down to last-minute, desperate, emergency action. This is seldom a recipe for success.
There will never be a ‘perfect’ point in the product development trek for serious pause-and-think. But it could be possible to narrow it down a bit by looking for a ‘zone of confluence’, where product development progress is ranged up alongside (1) the succession in the means of building ‘hard’ value [re. licences, partners, shares, etc] and (2) waypoints in the evolution of the key commercial organisations’ SME status to something bigger. There should be a ‘soft point’ somewhere, a locus of least resistance to a planned pause-and-think. The location and timing will differ from one cell-based product to another.

5 Represented by the P in the circle in fig 7