A biomaterials approach to regenerative medicine

Added: 11th August 2015

The use of novel biomaterials to guide and stimulate tissue repair is a major approach in regenerative medicine, allowing the developer to engineer desirable characteristics into a material. In particular, electrospinning provides for the manufacture of products precisely optimised in terms of surface chemistry and topography. A major UK university approached us to design a regulatory roadmap for development of an electrospun scaffold for a tissue engineering solution to tendon repair. Working within the bounds of sequential grant funds we are now entering final design confirmation prior to preparation for a clinical investigation.

One of the main aspects of this project, and others involving university research, has been to help academic staff to understand the regulated environment for their product concepts. It is important to ensure team members have an understanding of the regulatory requirements to achieve the end goal - usually to deliver a product ready for use in the clinic - without overwhelming them with detail or hampering their creativity.  A team-based approach in which the different disciplines understand both their role and the interface with others is crucial for any regenerative medicine project: my job is to integrate the regulatory discipline into the team.

A spin-off from this particular project, based on the training we provided to the team, was an invitation to write a book chapter on the regulatory aspects of electrospinning for tissue regeneration.

"I have had the pleasure of working with Alison Wilson for the last few years and will continue to do so. Alison has been instrumental in providing valuable regulatory advice to our translational clinical project. Her significant expertise along with her proficient ability to rapidly comprehend the products we are delivering has led us to successes in our project. Alison is professional and able to concisely communicate with people from a wide range of disciplines and areas."

Sarah Cartmell PhD - Professor of Bioengineering - University of Manchester

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