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Feature Articles : Nov 1, 2011 ( )
Regen Med Success Hinges on Engineering
The Right Strategies Can Lower Cost of Goods and Make Field More Attractive
As highlighted in the article “Engineering Regenerative Medicine’s Future” in the September 1, 2011 issue of GEN, there is international recognition among stakeholders in the regenerative medicine sector that the commercialization of novel therapeutic interventions must be expedited in order for them to be provided by healthcare systems and providers, within the existing infrastructure.
In the last article, I wrote about standards and enabling technologies, but this time I turn my attention to approaches for reducing the total cost of goods.
Why worry about the cost of goods? Although the health economics of the different regen med therapeutic approaches are yet to be fully understood, it is generally recognized that reducing the prohibitively high costs associated with the delivery of regenerative medicine interventions is paramount to successful market access.
Of course, within the regenerative medicine space it is recognized that the diversity of therapeutic approaches (cells, devices, biomaterials, and biologics) means that there is no single economic model, and not all therapies are equal.
Nevertheless, until the costs of regen med therapies can compete with conventional biopharmaceutical therapies, where margins are typically 65–90%, the regen med industry will principally remain a niche therapy option divorced from mainstream healthcare reimbursement systems. As a result, there will be a detrimental impact on inward investment and funding into the regenerative medicine industry.
Sometimes this is because the immediate focus is on achieving a licensing deal, but potential licensors are conscious of such issues, and during due diligence will conduct thorough risk assessments and consider the balance between progressing with a constrained manufacturing approach, or the cost, time, and effort required to develop a scalable process.
How Can Engineering Help?
It is worth remembering that the majority of challenges that regen med face are no more challenging than those that are faced by the biopharmaceutical industry, and that advice can be taken from others as to how to approach some of these challenges.
Here are a few areas where product developers can focus to reduce the overall cost of goods, and produce capable and cost-effective enabling technologies and products:
It is unlikely that all of the above will be appropriate for any single therapy, but they do demonstrate the value that engineers bring to any given development program and can help to ensure that the science can translate into robust, capable, and cost-effective product.
A further tangible benefit that will likely come as a result of such engineering work is the development and commercialisation of intellectual property (IP) relating to innovations that go beyond direct cell therapy based approaches, and which add further breadth to a developer’s overall portfolio. The European Union’s Grand Court judgement in 'Brüstle v Greenpeace' (October 2011), which ruled that stem cells from human embryos cannot be patented, means that the commercial value of IP in such interventions will migrate, for example, to enabling technologies such as processing equipment and devices.
Over the last decade, there have been a number of casualties in the regenerative medicine industry due to economics—sometimes due to treatment costs, and sometimes due to cash flow during extended regulatory approval time—and this has been exacerbated by the international austerity that is tightening the purse strings.
However, there are those companies and collaborations that have considered that addressing the cost of goods from the outset is critical to success, and across the realm of regen med they are typically the ones that are still surviving in these difficult times.
Addressing the complete product design, manufacture, and manner of use at an early stage means that many of the non-value-added parts and stages can be minimized or eliminated. An efficient and lean product that delivers a novel therapy, coupled with scalable manufacturing, provides an attractive investment target whether you are looking for external funding or an increased slice of internal R&D budget.
Many of the examples that I reference in this article are common problems affecting many developing regen med systems and products. By addressing the non-value-added costs, the regen med sector will be free to focus on the ground-breaking therapies being developed, which will enhance its potential to go mainstream.
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