ISSUES IN TRANSLATING NEW MATERIALS AND TECHNOLOGIES TO CLINICAL APPLICATIONS

Cowan RSC (1, 2).  

(1) The HEARing CRC, Melbourne, Australia; (2)  The Department of Otolaryngology, University of Melbourne, Australia.

Abstract: The intersection of such diverse fields as polymer chemistry, micro and nanotechnology, microsurgery, bioengineering and biomaterials heralds the potential for significant advances in cell-based therapies and re-engineering of damaged neural systems for locomotion, hearing and sight.

Enthusiasm for the application of new knowledge from such diverse fields must be tempered with recognition of the difficult path for drug or device development from the basic underpinning research to full application in humans.

In particular, the issue of the biosafety of chronic use or presence of new materials and therapies in biomedical applications, and the potential for unexpected side effects is one that has to date received insufficient attention and research. 

A second concern is the manufacturability of new applications, which may demonstrate efficacy in the laboratory or small-scale trial, but encounter problems in scale-up to large volume manufacturing, or scale-down to microminiature applications.  Such problems may be restricted to effects on efficacy, but may also render applications too costly for large scale use in health therapies.

A third potential problem is that of intellectual property and commercialisation, in particular for developments arising from consortiums, where aligning the interests of partners from different sectors with varying strategic aims and objectives is a major challenge to successful translation.

These issues will be discussed in more detail with examples.

E-mail: r.cowan@unimelb.edu.au