Richard Watts and Chris Hart highlight some of the issues companies need to tackle to speed up their drug development process.
At the forefront of every pharmaceutical company’s concerns is the challenge of getting their new drugs to market. This issue is especially relevant at the moment, with the patent expiry cycle set to peak over the next few years. Recent research by Cowen revealed that, by the end of 2012, more than $55 billion of branded drug sales will be lost to cheaper generic drugs. With drugs taking on average 12–15 years to go from laboratory to pharmacy, at an approximate cost of £500m each, and worldwide patent protection limited to 20–25 years from the time of application, getting your drugs to market as quickly as possible can make a huge difference to the bottom line. So what do you do if your drugs are taking too long to get to market?
Most pharma companies will have evolved a structure and set of operational procedures that have stood the test of time in supporting complex multi-disciplinary research. However, internal communication is often a problem. In our experience there can be an inherent mistrust between departments, for example. Marketing departments may veto a drug approved by technical staff, often causing unfortunate tensions between departments. Have you considered how well the various groups within large multi-disciplinary research teams are communicating? Do the pharmaceutical scientists meet regularly with the regulatory and manufacturing teams? And have you considered breaking the teams into smaller groups to enable easier regular communication and to help to reduce an ‘us’ and ‘them’ mentality between departments?
The sheer size of a pharma business can naturally make it challenging to be fleet-of-foot in your drug development programme. With large numbers of staff working on numerous projects, clarity in what needs to be achieved can easily be lost. For example, there’s no point in setting a tight deadline for a research project to have reached a certain point in the clinical or regulatory process if the initial task is to analyse whether the market wants the drug in the first place. So how clear are the goals of your research teams? Do the clinical research staff draw up clearly articulated statements of what they need to do on a job? Does the planning process break down key stages in the decision-making for a new job? In the long term, lack of clarity and problems with communication can lead to a real drop in productivity amongst employees, further slowing down the race to market.
In an industry with such a long development timeline and an inevitably high number of abandoned research projects, it can be very easy for employees to lose their initial enthusiasm and creative spark. So how are you motivating employees, particularly when a research project they have devoted substantial time to has to be abandoned? Even if internal communications are working well and everyone is working towards consistent goals, there are often blockages in the drugs development pipeline which cannot be avoided but need to be anticipated. For example, finding enough people to participate in studies during the human trial stages is a common problem. Do your planning systems incorporate problems that should be anticipated and are development teams encouraged to tackle these problems early enough in the process to avoid delays?
Finally, does your company have proper systems for deciding which drugs should be prioritized to market? Often, the reluctance with which unsuccessful drugs are dropped from the process causes unnecessary delays. Do your planning systems include a number of key breakpoints in the research and development programme with their own set of goals to help with the prioritization process? When clear objectives are communicated and understood by clinical research teams the results can be empowering. By looking closely at its communications and clarity of objectives, Pfizer was able to complete its clinical research into the use of one of its key drugs, Revatio, more popularly known as Viagra, as a treatment for pulmonary arterial hypertension six months ahead of schedule. By successfully registering the drug’s use for this purpose ahead of time, Pfizer was able to benefit from a longer period of patent protection for the drug and hence millions of dollars in additional revenue.
Asking a few searching questions now about your research and development process and addressing the issues uncovered, can really enable you to get your drugs to market more quickly.
Richard Watts and Chris Hart are partners of global business performance consultancy McKinney Rogers.