Nanomedicine is a term which can be used to define the application of nanotechnology in medicine. It deals with particles in the size range of 100 nanometres (nm) or less. Nanomedicines include liposomes, polymer congugates, protein/antibody conjugates, block polymer micelles, cross-linked (nano)gels, bioactive synthetic polymers/vesicles, nanoparticles and nano-sized drug crystals. These nanomedicines are mainly anticancer, anti-infective or immunomodulator drugs [1].

The Frederick National Lab is a federal national laboratory sponsored by the National Cancer Institute, which is part of the US National Institutes of Health.

The Lab’s Nanotechnology Characterization Laboratory (NCL) has already been working with companies for some time in order to help reformulate cancer drugs that have failed in human clinical trials because of toxicity or other issues. But now the lab is working with pharma giants Amgen, AstraZeneca and Pfizer on nanotechnology formulations to improve candidate cancer drugs early on, before they are used in first-in-human studies.

Applying smart drug formulations early in the pipeline it is hoped ‘will increase the chance of success for these drugs’, according to Dr Stephen Stern, Senior Principal Scientist at NCL.

‘The pharmaceutical industry has begun to recognize the benefits of nanotechnology in developing cancer drugs because nanoformulations can target drugs to tumour sites without harming the rest of the body, and thus reduce or eliminate side effects’, according to Dr Jennifer Grossman, another scientist at NCL.

Since it began in 2004, NCL has characterized more than 350 nanoparticles for medical applications, helped set industry standards for nanoparticle characterization and collaborated in advancing 10 nanomedicines into human clinical trials.

The collaborations with the three companies will focus on formulating pharmaceuticals for delivery to solid tumours and producing nano-formulations of a compound to enhance its ability to disperse throughout a tumour.

Nanomedicines are often mentioned in the context of non-biological complex drugs (NBCDs). The European Medicines Agency (EMA) has recognized the complications associated with approval of originator NBCDs and has in the past therefore requested extra information to support follow-on NBCDs on a case-by-case basis.

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Regulations for follow-on NBCDs

Reference
1. GaBI Online - Generics and Biosimilars Initiative. The future of nanomedicines - nanosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/Research/The-future-of-nanomedicines-nanosimilars

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