Launching a series of fi rst-hand accounts of practical risk management, Mike Florence, who led AstraZeneca’s programme, explains how the team’s strategy has breathed new life into its respiratory and infl ammatory efforts

Like most companies, AstraZeneca is under increasing pressure to produce more for less and to do so faster. While facing challenges particular to the pharmaceuticals industry – increased generic competition, more regulation, demanding healthcare reforms – we are also subject to common industry pressures and those resulting from the global fi nancial downturn. But although there are more challenges, this evolving environment also offers opportunities: new technologies, new abilities to target medicines and, through acquisitions – such as AstraZeneca’s takeover of MedImmune – the potential to benefi t from increased expertise and resources.

We have implemented a business-wide programme to help us develop medicines for respiratory and infl ammatory (R&I) diseases, which places risk management at the heart of our strategy.

As a large, international organisation, our aim was to deliver a programme that would allow the broader teams – not just risk-management professionals – identify and manage the risks associated with our projects. We wanted to implement a consistent approach across functions (research and development), continents (Asia, Sweden, UK and USA) and companies (AstraZeneca and MedImmune). As a result, we could effi ciently deploy and align our resources to manage the risks and meet the needs of patients and physicians, while delivering value to the business.

We undertook an interactive, collaborative process to build on AstraZeneca’s risk management track record and an existing integrated riskmanagement tool, using an organisation-wide business improvement approach (LeanSigma).

Team effort

Having scoped our leadership’s view on risk, we delivered a framework and integrated tool at the level of individual drug projects. This drove a structured and standardised approach across the business. We added a common, structured vocabulary and risk categories across our AstraZeneca research anddevelopment functions and MedImmune.

This gave us a way to collate and calibrate our interpretation of events, allowing us to benchmark the likelihood of an event happening and its impact.

At this stage, our project teams assessed the risks associated with their parts of the business and began to use them to make rapid, robust decisions at a project level. This not only gave us some quick wins but strengthened our team-working and increased understanding about risk across the project teams.

“The main benefit of this work was the dialogue stimulated within and between project teams and with the portfolio management. It got people thinking and talking about risk (threats and opportunities) in a structured way and encouraged honesty about the state of projects. The riskmanagement tool also helped governance bodies with their decision-making at project transition points, presenting clearly visible and scored risks, with associated impact and likelihood values,” says AstraZeneca (UK) R&I team leader David Nicholls.

MedImmune (USA)’s senior director for product development, Micki Hultquist, adds: “Our team discussions were invaluable, as people challenged the impact and likelihood scores established by the individual technical experts, explored mitigation and contingency plans, and identifi ed and assessed new potential risks. Team members emerged with a clear understanding of the risks from other areas, as well as others’ perspectives on those risks. The discussion made us ultimately better prepared to face those risks and, perhaps more importantly, more aligned as a team on our overall strategy.”

Common risk areas

Our next step was to look at the risks at a portfolio level. R&I project managers and directors identified common risks – in particular, the fast-moving risks and ‘big hitters’ – across the portfolio and assessed the impact versus our strategic objectives. This made our portfolio objectives, needs and risk level much more visible and allowed us to prioritise and develop plans to address the common risk areas across theportfolio and more effectively align our resource.

Finally, we took what turned out to be a relatively simple step in aligning with the company’s objectives and timelines (the outputs and deadlines that AstraZeneca expected from the R&I business) to ensure they were delivered through the R&I portfolio.

AstraZeneca (UK/Sweden)’s strategy and portfolio director, R&I therapy area, Holger Adelmann, says: “Proper risk management allows transparent mitigation planning across all supporting functions, thereby maximising effi ciency in terms of both resource (by minimising duplication of effort) and time (by effi cient scheduling of work).”

Chris Kell, senior director, product development, MedImmune (USA), adds: “The risk programme provides a common and consistent framework and tool that allows teams to improve performance by taking a more rigorous and integrated approach to risk management. This is particularly important in relation to drug development, which is an inherently complex, risky and costly undertaking.”


This risk management project has given us a clearer picture of the risks associated with our R&I portfolio and a plan of action to address the threats and opportunities. It promises to support AstraZeneca in moving projects forward at the right level of risk, facilitating faster and more robust decision-making and aligning resource more appropriately.

Because our approach has involved colleagues from across the business, the programme has helped us embed risk management within the organisation.

The process has generated a surprisingly simple, yet powerful, business cycle that can be naturally integrated into the day jobs of our R&I teams, as well as the AstraZeneca corporate risk and compliance framework. In linking company, portfolio and riskmanagement objectives, we have created something that adds value. This is the secret ingredient that will add value not only to the business, but also to the patients and physicians who are awaiting our new generation of medicines.

Rodger McMillan, global vice-president, R&I, at AstraZeneca says: “You know you are on to something when, in hindsight, it looks obvious. When you play it back, this solution seems clear; but it didn’t seem so at the time. The result is a programme that is ‘value-added’ rather than an ‘add-on’, which can so often be the case with risk management.”

Mike Florence is a global product manager, respiratory and infl ammation therapy, for AstraZeneca