Commercialisation of Regenerative Medicine

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Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damages tissues and organs in the body by stimulating previously irreparable organs to heal themselves.

By 2015, the global market for regenerative medicine is expected to be worth $1.4 billion (£0.9 billion), according to a recent report by Global Industry Analysts, driven by factors including advancement in stem cell research and an aging population plagued by osteoporosis and arthritis.

But for all its possibilities, the fact is that the sector remains in the early stages thanks to the void which exists between promising research and commercialisation.

So far, many of the developments which have made it to market are in the field of orthopaedics, but with the advances being seen in stem cell research in particular, the potential regenerative medicine holds is so much greater.

Researchers at the Colorectal Cancer Lab at the Institute for Research in Biomedicine, in Barcelona, recently succeed in growing human cancer cells on a lab plate for the first time, marking a significant leap in the area.
"For years, scientists all over the world have been trying to grow intestinal tissue in lab-plates; testing different conditions; using different nutritive media. But because the vast majority of cells in this tissue are in a differentiated state in which they do not proliferate, they survived only for a few days," Toshiro Sato, from the University Medical Center Utrecht in The Netherlands, explained.

But unless steps are made to boost commercialisation opportunities for regenerative medicines, it is unclear when patients will be able to see the benefits of these scientific advancements

Understanding the problems this presents, Canada created the Centre for Commercialization of Regenerative Medicine(CCRM), supported by a cash injection of $15 million by the Government of Canada's Centres of Excellence for Commercialization and Research program.

The centre has a partnership with MaRS Innovation, providing an integrated commercialization platform with discoveries from 16 research institutions, and an industry consortium with more than 15 partners.

Chief executive officer of CCRM Dr Michael May said: "If we are to maximize returns on the investment made in basic Research & Development (R&D) and drive paradigm-shifting new regenerative medicine products to market, we need to find ways to translate early-stage discoveries with even more capital efficiency.

"Our plan is to coordinate academic infrastructure into platforms, resourced with CCRM personnel, which target bottlenecks in product development and thus enable commercialisation."

Elsewhere, however, not all are as enthusiastic about the future prospects for stem cells in regenerative medicine.

The advocate-general of the European Court of Justice, Yves Bot, earlier this year recommended that patents involving human embryonic stem cells should be prohibited on ethical grounds. If the court were to follow these recommendations, it would have serious consequences on the development of stem cell therapies in the European Union, and possibly pave the way for other regulatory agencies to follow suit.

regenerative medicine A group of 13 scientists submitted an open letter to the journal Nature which said the effect a ban could have on the Europe-wide stem cell research community could be disastrous. Negative public perception of the field could lead to government funding being cut.

Companies are unlikely to invest in R&D if they will not see a patent at the end of it, restricting medical treatments. At the same time, the industry outside of Europe may continue to develop, leading to revolutionary treatments being made available elsewhere, but being prohibitively expensive for European patients.

For now, signs would suggest companies are willing to invest in regenerative medicine.

Shire, for example, recently acquired Advance Biohealing with the aim of establishing a new regenerative medicine business unit, based on tissue regeneration using cell-based therapies. The deal brings with it DERMAGRAFT, a US marketed product which acts as "a regenerative bio-engineered skin substitute".

The company said it also sees this as a potential base from which to further extend its capabilities in this area.

Mike Cola, president of Shire's Specialty Pharmaceuticals business unit, said: "We believe there's an opportunity to create more value from DERMAGRAFT and Advanced BioHealing's proprietary technology and that with Advanced BioHealing's team joining Shire, we can build Advanced BioHealing into an exciting new business providing regenerative medicine for patients' unmet needs."

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