Welcome to the second three-part blog series from Ian Siragher, Commercial Director of Agenda1 Analytical Services.
In this new series of blogs, Ian provides his thoughts and analysis on the obstacles facing business working in new medicine research and development, and the tools that can be employed to change Research into Development.
In the current marketplace, there are many obstacles facing businesses working in dose form development. But if the right approach is taken, businesses can maximise their chances of success.
Researching and developing new drug products is not an easy process. Here it is in simple steps: identify a molecule that might have a therapeutic benefit, learn how to synthesise it, take that ingredient and turn it into a dose form, administer it, find out if it does have any benefits, convince the regulators that it works and is safe, make it consistently and safely, then convince someone to buy it. Do all that, and within 12 years or so you will have a blockbuster drug making you an overnight fortune. This is as long as the market does not move against you, you don’t have any adverse reactions, and any number of potential chickens don’t come home to an uncomfortable roost!
The model for achieving these tasks has been evolving over the last few years. For instance, the decision by GlaxoSmithKline to make data available on over 13,000 molecules that might treat malaria is part of the changing model. Their decision should encourage greater external research and development. Part of that change has been the growing trend for Big Pharma to in-license more products, often during Phase II. This trend has been commented on by pharmalicensing.com, who said these Big Pharma companies are expected on average: “to [be] deriving 26.1 per cent of their ethical sales from licensed products,” in 2010.
This pace is only likely to accelerate in the future, driven partly by the well-recognised ‘patent (expiry) cliff’ faced by the Big Pharma companies in 2011/2012. A recent Reuters report commented that “… industry analysts [have] long warned of a looming sales drop, say[ing] it will reach a crescendo around 2011/2012, when many lose patent protection on their largest or second-largest products.”
The ‘outsource development’ strategy would work well if drug discovery start-up companies were able to fund the work, from discovery to out-licensing, with the sort of cashflow that large pharma companies have access to. However, the venture capital funders of such start-ups are now being much more careful about how funds are released – setting tightly controlled milestones. Lipitor co-discoverer Roger Newton, CEO of Esperion Therapeutics commented: “investors are no longer willing to provide one major round of funding all at once.” He says that instead: “they are choosing to require that start-up companies achieve specific milestones that trigger access to additional dollars.”
One milestone is often a successful first-in-man study. As a result, where historically a ‘near miss’ first study was simply a step along a development pathway, the cost of a sub-optimal first-in-man study can be much more significant in the current climate, where time and cash are limited by the ever watchful VCs.
The scientific challenge thus remains the same, but the resources to achieve the technical goals are becoming more limited. Time, cash, expertise and experience are all in short supply. The onus is on companies to optimise the likelihood of a successful first-in-man study.
Over the next couple of blogs, I’ll be looking at a few of the tactics, both traditional and new, that can be adopted to achieve this goal.
The second part of this blog series will be available on this Agenda 1 Analytical Services Blog in August. You can follow @Agenda1Blog on twitter for the latest updates from Agenda1 Analytical Services.