Adventures in uncertainty: The challenges of developing new medicines

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Posted by APM on 2nd Apr 2013


At a time when we are looking to ‘All projects succeeding’, the latest event held by Wessex Branch demonstrated that measurement of this is through the perception of the stakeholders.

Local member Les Rose, who has spent most of his career in the Pharmaceutical industry, took the audience through ‘Adventures in uncertainty: the challenges of developing new medicines’.  If the project is to bring a new product to market, yet only 80% of products achieve this, with only a small percentage of those recovering their research and development costs, then why do these projects continue to be commissioned?

The research and development of drugs is a vast undertaking.  Project durations are long, usually well over 10 years and costs are high with a potential of no return on investment.  This indicates how risky the process is.  Companies should be able to predict which drugs are not going to be profitable, but often they can't, or are reluctant to face, and voice, the truth. Perhaps this uncertainty explains why project management has been so slow to penetrate the pharmaceutical industry as a formal and justifiable business case would stop most projects at inception.

As well as technical risks, there are huge operational risks.  Companies are obliged to rely on dispersed networks of workers, including scientists, doctors and patients, who may not see themselves as project team members at all. There are interesting lessons here for any project manager in team dynamics, risk management, cost control, quality assurance, and regulatory compliance.

The talk gave an overview of the drug development pathway, how it is organised into projects and programmes at various levels.  There are four stages within the pathway with stages 1 to 3 being the drug tests on selected subjects and stage 4 the roll-out of the marketed drug where return on investment is expected.  It is at the end of stage 3, prior to launch, that the majority of projects are stopped based on the lack of evidence of successful treatment.

With the high financial risk of not progressing past Stage 3, there has been a call in the industry for more funding to be put into Stage 2 to carry out longer or more detailed trials so that there is less risk in Stage 3.  However, as the probability is that if the drugs are not working in Stage 2 then they will not in Stage 3, there is an argument for the project to be closed earlier and save additional costs.  This takes the project into the stakeholder management of the investors and company shareholders whose perception is that a project stopping at stage 3, rather than 2, is more successful.

The talk finished with a breakout into small groups to discuss examples of projects issues experienced by Les during his career. Solutions were offered by the groups and compared to the way they were actually managed at the time.

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