Biomedical Engineering Reference
In-Depth Information
it would take to produce an off-the-shelf human embryonic stem
cell-derived product for diabetes, say, would be a minimum of 15 years
(Martin et al., 2006). Now that half that time has elapsed, it is not clear
how much closer such a product actually is. What was made clear in
2006, though, is that 15 years is clearly too long to wait for venture
capitalists who typically expect to make a return within 3-5 years of
their original investment (Martin et al., 2006).
One of the other difficulties with stem cell products is that
standardization in accordance with good manufacturing practice
(GMP) poses a barrier to successful translation into clinical products
(Belardelli et al., 2011). Research conducted on advanced therapies
in the EU identifies the lack of access to GMP facilities as a significant
issue for small start-up companies that cannot afford to build the
amenities required to conduct their own clinical research (Belardelli
et al., 2011). The expense of hiring outside facilities is also
prohibitive. Coupled with the technical complexity of advanced
therapies, the lack of sufficient animal models and unknowable
requirements such as dosages and efficacy, translating advanced
therapies into clinical products is already challenging before the
difficulties of scale-up and manufacturing are even factored in.
1.3
Some prospective possibilities for the stem cell
industries
When government funding for basic research runs out and the
product is still a long way off prospective commercial investment,
there are other opportunities available for companies to try and
remain liquid across the 'valley of death'. A diversity of
commercialization opportunities is generally seen to be the main
way forward for a small company. Instead of having only one goal,
such as the long awaited blockbuster product for a disease that
affects a large number of people, a diverse range of products
attacking different outcomes with variable time frames is considered
more desirable. That might include developing some products to
license out to other companies in addition to some products that
might be sold for different purposes while continuing to work
