The agility fallacy: Why is R&D failing to make headway?

Achieving greater operational agility remains high on the agenda for life sciences. Yet too often the results don’t measure up. Kinapse’s James Man believes this is because companies need to transform R&D decision-making, to make this leaner and more impactful too.

Driving cost and delay out of R&D has been a focus of much effort and investment for life sciences organisations in recent years. Yet in many cases this is not producing the intended benefits, which is probably due to the protracted and disjointed way that companies reach portfolio decisions.

True agility and improved market responsiveness requires that the pharmaceutical industry becomes smarter about the programs it delivers, through the ability to prioritise according to the criteria that matter most – such as what patients and healthcare providers actually want. This in turn relies on having access to the right range of supporting evidence from the outset. Yet few R&D organisations have the line of sight and decision-making structures to achieve this. Too often effective decision-making is thwarted by restrictive governance structures, functional silos and a lack of 360-degree insight at key investment points.

Agility starts with alignment

A more synchronised decision process offers R&D groups a better chance of backing long-term winners. Fragmented decision-making, divided across different teams and governance processes, leads to protracted rounds of approvals and a loss of perspective. The first step, then, should be to bring down such barriers and bring decision-makers across R&D into closer alignment.

Having a clear framework and criteria for decision-making will help to keep everyone and everything moving in the same direction towards known goals. Simplicity is key, for example having a single approvals and review processes per therapeutic area, then an overarching governing body. This will create a clearer line of sight, so leaders will be better able to see the competing priorities of the R&D programs and agree on trade-offs. In time, it may be possible to perform project portfolio reviews as a continuous, in-stream activity.

Evidence gathering

Strategies for making the patient perspective central to decision-making at every stage include increased observational research, and capturing real-world evidence from the growing range of external sources including online patient communities and scientific literature.

There may be some challenges in keeping the right data flowing into the decision process – such as access to external data for certain populations. Even harnessing internal data can present its own challenges, needing to be drawn and collated from different sources, and combined and compared in reliable and meaningful ways to support confident decision-making. Appropriate technology and process automation can help with this.

Agility in decision-making should continue right across the product lifecycle, too, to ensure that medicines continue to be of value and remain differentiated in the market, and that R&D is able to react with speed to changes in market conditions and requirements.

Operational efficiency & an adapted role for quality

Agility in strategic decision-making must be matched by operational agility if companies are to get products to market quickly, efficiently and reliably.

Robotic process automation, machine learning and AI technologies offer a means to complete many routine tasks more swiftly, accurately and intelligently, accelerating routine processes – as long as plans for using these tools and techniques are focused and well-coordinated. It follows that partnerships should be aligned with any plans too. It’s all very well having a strong agenda for change internally, but if this isn’t supported by agile partner processes and innovative solutions, the potential for transformation will be compromised.

Finally, it is worth reviewing approaches to risk management to ensure these aren’t an unnecessary barrier to agility. One option is to adapt processes and systems so they provide more of a positive support to the business – geared more toward what could be done, rather than what shouldn’t. This may involve giving quality teams more direct input into strategic decision-making, rather than restricting their role to compliance and fine avoidance.

Certainly, a willingness to think differently is an important pre-cursor to sustainable agility.

Image credit: tableatny/Flickr