Micro and Nanotechnology Adoption by the Pharmaceutical Industry Essay
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Micro and nanotechnology is starting to show promise in the pharmaceutical industry. The two key questions in this field are ‘what is nanotech’ and ‘aren’t all drugs nanotech – after all, they are in the nano size range’. These can be answered fairly simply; Nanotechnology is where the nano-size of a substance affects its activity – the size placing the substance at the interface between quantum and material effects. The classic example to demonstrate these effects is that of gold nanoparticles. Bulk gold is insoluble and metallic-yellow in colour.
However, once the gold is formulated as a nanoparticle it is soluble and the size of the particle determines its colour – from bright blue to vivid red.
Two key areas where nanotechnology is showing promise in the pharmaceuticals industry are tools for drug discovery, and secondly in formulation and delivery systems.
In the development of tools to support drug discovery, nanotechnology is developing a trend to move away from high throughput to high content screening, where greater information on fewer compounds is achieved.
As our knowledge about drug-target interactions increases, it is becoming apparent that high-volume/low-content screening can miss extremely interesting interactions and effects. For example, SPR biosensors can detect a ligand binding step and measure the binding constants. But it cannot measure surface stresses caused by binding, which are an important factor for example in antibiotic efficacy against MRSA and VRE. Here nanomechanical cantilevers have been shown to be effective in providing extremely elegant information that can explain the difference between various drugs that appear to have the same binding kinetics.[i]
The move to high content screening has been slow due to the large investments in high throughput screening laboratories and so new systems need to be compatible. However, where systems are compatible with these techniques – for example using 96 well plate platforms, adoption is possible. As a result, improvements and adoption is currently iterative, rather than revolutionary, but it is happening.
With regards to nanotechnology in formulation and delivery science, there are a number of early adopters of nanotechnology in the pharmaceutical industry. Table 1 shows a number of types of nanoparticle formulations that are already approved for marketing.
The full list of approved ‘nano-enabled’ products is very small and those that have made it to the market are generally reformulations of existing generic drugs. We are still awaiting the second-generation nanodrug, where the nano-effect is integral to the product activity.
Nanotechnology appears to be following the classic technology adoption curve as shown in Figure 1. This shows the bell-shaped adoption curve for any technology, overlaid by the technology acceptance line. Nanotechnology appears to have passed through the hype and trough and is now starting to be slowly adopted.
It appears that the problem for nanotechnology in formulation is one of risk. Companies need to get their products to market quickly to allow as much market exclusivity time as possible – not to recoup their investment, as this is a sunk cost, but to recoup the cost of developing future drugs, the cost of which is becoming ever more expensive. The Tufts Center for Drug Development estimated that the cost of bringing a single drug to market was in the order of $1.2 billion in 2008, compared to $802 million in 2000.[ii],[iii] Given these issues, companies won’t adopt new technology unless they know that the technology has a clear and fast route to approval.
This is particularly poignant in drug formulation and other rate-limiting activities that occur post-patent filing. Once a patent is filed, the clock is ticking on the product’s life. If a product is going to be a $1billion a year blockbuster, lost revenues will be at least $2.7 million for every day a product is held from the market. This produces a catch 22 scenario; no-one will take the risk to demonstrate a new technology, especially if it is competing with existing and proven methods, so no-one will see a clear adoption path and use it.
This is reminiscent of the fledgling biotech industry 15-20 years ago. Pharma was focussed on small molecules and didn’t want to risk bringing into their portfolio relatively unstable products, with complex manufacturing methods and which were without a clear regulatory pathway. Now however, many traditional large-pharma refer to themselves as biopharma companies and Amgen and Genentech (prior to the Roche purchase) are in the top twenty pharma by revenue.
Early adopters, such as Abraxis and Elan, have started to clear a pathway to approval, but as yet no company has developed a true nanodrug – ie one which was conceived as a nano-enabled product from first principles as opposed to using nano-formulation on existing products.
Nanotech has a lot to offer the pharmaceuticals industry and if it follows previous technology examples such as biotech, the successful early adopters will reap the rewards. It still has a number of hurdles to leap, such as a clear regulatory pathway and a demonstration of value above and beyond current technologies, before it can become mainstream. However, there are significant efforts by industry and governments to help it to jump the technology adoption gap quickly and ensure it can assist in developing the next generation of products that are needed to solve some of the significant unmet medical needs faced by patients and healthcare professionals.
[i] Ndieyira, J. W. et al. Nanomechanical detection of antibiotic–mucopeptide binding in a model for superbug drug resistance. Nature Nanotech. 3, 691-696 (2008). [ii] Outlook 2008, Tufts Center for Drug Discovery (Available at http://csdd.tufts.edu/InfoServices/ OutlookReportsRequest.asp) [iii] Outlook 2000, Tufts Center for Drug Discovery (Available at http://csdd.tufts.edu/InfoServices/ OutlookReportsRequest.asp)