Reducing R&D cycle times and accelerating market delivery have been a focus of much effort and investment for life sciences organizations in recent years. Yet success rates for improved agility are generally low, and much of this can be put down to the cumbersome ways companies still make decisions. True agility requires that companies are also smarter about the programs they deliver through the ability to prioritize. This in turn relies on rounded insight from the start about which products or treatments will offer maximum value to patients and healthcare providers—at launch and long into the future.
Yet few R&D organizations have the line of sight and decision-making structures to achieve this. Too often, effective decision making about project portfolios is thwarted by restrictive governance structures, functional silos, and a lack of 360-degree insight at key investment points.
An agile decision cycle
A more holistic, agile decision process that is well supported by the big picture from day one offers R&D groups a better chance of backing long-term winners as they choose which programs to take forward. This means being able to consider more of the critical determinants of success (or failure) much earlier and in a sustained way across a medicine’s entire lifecycle—not just from a regulatory or safety perspective, but also in terms of what the market is demanding, lacking, and is most likely to embrace.
Fragmented decision-making, divided across different teams and governance processes, is not conducive to agility. It results in protracted rounds of approvals and poor overall vision. The first step, then, should be to bring down such barriers without removing any of the rigor they were designed to ensure.
More complete insight throughout, including strong patient input from the outset, will help steer better decisions about clinical studies and the populations and markets to target. The idea should be to work toward a cumulative and iterative process, during which evidence is built up to support the value proposition, hypotheses, and proposed strategy on an ongoing basis. Anticipating the future needs of external stakeholders is crucial. The considerations must not be an afterthought if companies are to ensure lasting patient value and commercial longevity.
Simplified decision structures & richer insights throughout
Having a clear framework and criteria for decision-making will help to keep everyone and everything moving in the same direction towards known goals. This shouldn’t create undue complexity though. Agility will be greatest if approvals and review processes are kept simple—so that there is one per therapeutic area, plus an overarching governing body, for instance. Having a clearer line of sight will mean leaders are more easily able to identify the competing priorities of the R&D programs and make suitable trade-offs.
In time, organizations may get to a position where they are able to perform project portfolio reviews as a continuous, ‘in stream’ activity. Continued learning about the medicine is also important, so that further value can be delivered to existing or new patient populations based on ongoing or new unmet needs.
Strategies for keeping the patient perspective central to decision-making include capturing real-world evidence from the growing range of sources: online patient communities (while respecting people’s data privacy); devising plans for including patient input as part of early decision-making (eg through observational research); and reviewing clinical trial planning and recruitment.
However, there may be challenges in keeping the right data flowing into the decision process, such as access to external data for specific populations (eg in emerging markets), and how data sets should be organized to allow easy curation and analysis to support decision-making. Even harnessing internal data can present its own challenges: the need 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.
Once a drug has entered the market, companies will need to be able to react quickly to changing circumstances so that patients aren’t put at risk, the business isn’t left exposed if regulatory conditions change, and emerging threats and spin-off opportunities are picked up early. So improvements to processes, governance, and capture and use of data in support of greater agility in decision-making should continue right across the product lifecycle.
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.
Process improvement and adoption of new technologies can help reduce R&D cycle times quite significantly. For instance, robotic process automation, machine learning, and AI offer a means to complete many routine tasks more swiftly, accurately, and intelligently—as long as plans are focused and well-coordinated, so that the benefits feed into each other.
It follows that partnerships will need to be aligned with any ambitions and 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, companies should review approaches to risk management so that this does not become a barrier to agility. One approach 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 might involve giving quality teams more 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.
About the Author:
James Man is Director of Advisory services at Kinapse, where he has been part of or led more than 50 advisory engagements for over 15 different clients over more than a decade. Regulatory productivity and putting patient centricity into practice are among James’s areas of special interest.