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Business Transformation Consultants
Eliminating barriers to growth |
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From Stem Cells to Regenerative Medicine
Having the tools that provide clear direction and the ability to make effective decisions are essential to getting products to market faster. The lessons from regenerative medicine provide good insight for introduction of other innovative products and services.
World-renowned experts gathered last week for the final London Regenerative Medicine Network (www.lrmn.com ) meeting of the season to consider the complexities and barriers in getting regenerative medicine products to market.
Areas reviewed included:
Best practice in human embryonic cell derivation
Forming and implementing ethical protocols
Ethical Governance
Developing regenerative therapeutics in an emerging regulatory environment
Development of Regenerative Medicine as a Future Medicine
The rewards for successful introduction of effective regenerative medicine products, which are not about just fixing people but improving overall functionality and well-being, are huge:
large revenues available if successful in solving current health problems and associated costs
medicines that address disease, rather than symptoms
meeting the needs of the UKs aging population
However, there are some barriers to achieving a competitive UK market. These were identified as:
Science still at an early stage
Impact of the emerging regulatory framework
Control of the manufacturing process
Lack of monitoring tools
Scale-up to viable commercial production
Coping with the changing UK, European and international regulations and compliance mandates from a number of different regulatory bodies, identifying the standards and regulations and knowing what to do about them is difficult for established, well-resourced companies. It is even harder for newly-formed small innovative companies trying to get their products to market.
There is no set of rules available that companies can follow to enable them to ensure that their products can successfully navigate each stage of development to become acceptable for market introduction. Gaps exist in available standards and measurement techniques and test methods.
Companies in Berkshire will be working through these issues during the 5 July meeting of the Thames Valley Life Sciences Network meeting (See www.tvsln.org for details).
At the meeting Neil Harris, LGC (www.lgc.co.uk ) and Stephen Munden, Business Keys (www.businesskeys.co.uk ) will explain the process and tools used as part of the governments Technology Strategy to help create and shape a Regenerative Medicine market for the UK.
Stephen and Neil worked together to develop a standardization strategy for Regenerative Medicine in the UK, one product of which was the DTI sponsored 'Guidance on codes of practice, standardized methods and regulations for cell-based therapeutics'. The guide is now being successfully used by companies to navigate their way over the regulatory and compliance hurdles to market approval.
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