The pharmaceutical industry has focused considerable effort on increasing organizational agility, particularly in terms of reducing cycle times and getting products to market faster. But too often this has failed to produce meaningful improvements - because agility alone is not the answer. Rather, R&D organizations need to hone their R&D decision-making to focus on programs that drive maximum value for stakeholders – and in a practical timeframe.
Improving operational agility is a high priority for most businesses in the modern age, and in life sciences it has been a source of considerable focus – particularly in relation to reducing R&D cycle times and improving speed to market. Yet in many cases this has not led to meaningful improvements. The reason is that agility is only half the story. If they are to deliver benefits from sharper practices, pharmaceutical companies must be smarter about the programs they deliver – able to determine and accelerate those that offer maximum value to external stakeholders. This means improving the way R&D groups make and review strategic decisions on drug development programs.
In our experience, agile decision-making is at least as important as agile development and delivery. Yet, as things stand, few biopharmaceutical R&D organizations have this capability. Their strategic decision making is held back by restrictive governance structures and functional silos, and a lack of supporting market, patient and regulatory evidence and insight at key investment points.
Turning this situation around so that the portfolio of drug development programs being taken forward delivers maximum value to external stakeholders, both on market entry and into the future, relies on improving the integration, quality and speed of decision-making across the R&D organization.
The R&D Decision Process
In an ideal world a drug company would generate as many successful programs as possible from the available options, and design these in a way that maximizes the value of the medicine to external stakeholders - not only at the point of launch, but right through to patent expiry. A more holistic and agile decision process, geared to external stakeholder value from the outset (not just how likely a product is to be approved by regulators), offers R&D groups a better chance of backing long-term winners as they choose which programs to take forward. Agility here should mean delivering more of what the market wants, and doing this more promptly and economically with minimal risk.
So what does an agile decision-making process look like?
It should be conducive to making more good decisions quickly. That means being able to consider more of the critical determinants of success (or failure) much earlier and more consistently across the decision-making process and indeed across a medicine’s entire lifecycle. Too often, however, decisions are split across different teams and governance processes, leading to protracted rounds of approvals, and meaning that no one team has a clear line of sight across all of the considerations. So the first move toward greater agility must be to bring down some of those barriers, yet without removing any of the rigor and risk management those individual teams and processes were established for.
A key priority should be to introduce and keep patient value in focus throughout the decision-making process, and to keep collating and feeding in evidence to support this, along with supporting data in respect of other critical considerations such as regulatory and competitive insight. Including internal and external input and analysis, this evolving ‘big picture’ will underpin the program as it approaches its investment decision points.
Supported by this holistic perspective, R&D groups will be able to develop an optimal evidence generation strategy and specific plans for the medicine under development, including the design and placement of pivotal clinical studies as well as the populations and markets to target. Once data has been evaluated and endorsed by internal governance bodies at an initial investment decision point, the team would go on to execute the approved plans and generate further evidence. This too is then shared with internal and external stakeholders, so that through a cumulative and iterative process evidence is built up to support the value proposition, hypotheses and proposed strategy at a later investment point. Anticipating the future needs of external stakeholders is crucial, so that these are driving and guiding decision-making from as early as possible in the process.
This isn’t as easy as it sounds, however. Setting up a series of advisory boards is not sufficient to achieve the consensus needed, with patient value central to the decisions being made. Rather, it will be crucial to include real-world data and compelling evidence and insight that will bring everyone - commercial, R&D and medical decision-makers
– into alignment. Scientific advice from health authorities should be proactively requested and included in the process, too, to ensure that evolving decisions do not fall down from a regulatory or safety perspective later down the line.
Rigor as an Enabler of Agile Decision-Making
Although it may sound counter-intuitive to suggest that rigor is critical to decision-making agility, this is exactly the case. In the IT software development industry, ‘agile’ approaches and techniques are well established, resulting in the more rapid design and delivery of products that are wanted and enthusiastically adopted by the target market. This is achieved through a continuous process of incremental design adjustments achieved through ongoing collaboration with stakeholders. Without rigor to manage this process, projects would become unwieldy and unmanageable, undermining fast and successful delivery. The same is true of agile decision-making in pharmaceutical R&D.
Having a clear framework and criteria for decision-making helps to keep everything and everyone moving in the same direction towards known goals, while ensuring that no important considerations are left out at any point. The aim is more efficient and predictable decision-making, in that decision-makers are routinely presented with the information they require, and teams become more attuned to what is expected
- and what is likely to be supported. Discussions can then focus predominantly on future value opportunities and scenario planning which is vital in a dynamic landscape influenced by evolving stakeholder needs, competitor activities, emerging evidence as well as precedents and government policies.
Rigor should not be confused with complexity, however. As noted, the danger of establishing multiple governance teams is that it breaks up the big picture, and can lead to a protracted decision process which is less, rather than more effective.
It is far more supportive of agility to simplify approvals and review processes so that there is one per therapeutic area, plus an overarching governing body across all therapeutic areas. This enables clearer and more timely decisions, especially as leaders can more easily spot the competing priorities of the R&D programs and make trade-offs as appropriate. Over time, organizations could even move away from an annual portfolio and budget review exercise altogether, making this more of a continuous, ‘in stream’ activity.
Patient Input
Considering a drug’s value to patients and other external stakeholders, such as healthcare providers, should happen continuously across the decision-making process too. This will ensure that the right evidence is gathered from day one, and that program leaders and strategic decision- makers never lose sight of the patient’s perspective as their plans evolve. Unless the drug that eventually enters the market is embraced by the target patients, and is seen to be of value to them for a considerable time to come, everything else will have been for nothing. Patient value can be considered in terms of an improved patient experience, improved outcomes and better access to medicines.
Taking patient value into consideration at every point will help with ongoing medicine lifecycle management too, i.e. how a medicine will continue to be differentiated after launch. 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 in decision- making include capturing real-world evidence from the growing range of sources, such as online patient communities (while respecting people’s data privacy); devising plans for including patient input as part of early decision-making (e.g. through observational research); and reviewing clinical trial planning and recruitment.
Maximizing Data Availability
Data has a critical role to play in enabling evidence-based, value- creating decision making. Whether this is through real world evidence and advanced analytics, independent internal reviews or artificial intelligence (AI) tools and data lakes, the aim should be to use credible data to reduce the influence of individual bias, assumptions and organizational politics.
Yet there are some practical challenges to overcome with all of this. These include access to external data for specific populations (e.g. in many 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, 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.
Maintaining Focus across a Medicine’s Lifecycle
Agilityindecision-makingisn’tanylessimportantonceadrughasentered the market. In many ways it is even more important that companies can react quickly to changing circumstances – so that patients aren’t put at risk; the business isn’t left exposed if regulatory conditions change; and that emerging threats and spin-off opportunities are spotted early.
Ownership is an important aspect of maintaining a fuller strategic focus, so that products aren’t only being considering in terms of budgetary management, license maintenance, and soon. Team leader accountability through budget control could drive performance and allow decisions on innovation and appropriate risk tolerance to be made by those closest to the medicine under development and the population in question, rather than layering these decisions under functional leadership. At the R&D governance level, there is merit in aligning R&D investment decisions across the full length of the value chain under one committee. This would help ensure a more holistic strategy based on unmet needs of the population recognizing co-morbidities, the importance of integration with the development of devices, lifecycle management opportunities and the ultimate evidence needs of external stakeholders.
Operational Agility: Speed, Cost and Quality Management
Agility in strategic decision-making must be matched by operational agility if companies are to get products to market quickly, efficiently and reliably. Considerations here include how to reduce cycle times, optimize sourcing, and adapt quality management so that it fits the evolving needs of the business – and patients.
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 can complete many routine tasks more swiftly, accurately and intelligently. But this relies on plans being focused and well-coordinated, so that the benefits feed into each other. This comes back to the need for continuity and clear and joined-up goals, to maximize the impact and prevent costs from spiraling.
For the same reason, partnerships will need to be aligned with any ambitions and plans too. It is all very well having a strong innovation and digital agenda internally, but if this isn’t supported and fueled by innovative partners and solutions, the potential for transformation will be compromised. The ability to outsource effectively is a capability in its own right and, as agility and innovation become central priorities for pharmaceutical companies and stakeholders, pharmaceutical R&D organizations will need to look hard at those companies’ own value propositions, innovation agendas and agility credentials, to ensure everyone stays in step. Additional considerations should include developing and sustaining genuine collaboration through alignment of incentives, and appropriate governance and management of providers to avoid duplication and overlap.
Last but by no means least, companies need to find a more optimum balance between innovation and risk management, so that they are not automatically defaulting to the most conservative ways of doing things - and so that quality processes and systems are not continuously swamped with time-consuming audits, but have space to support the business in its need to differentiate itself in new ways.
This is another dimension through which external business process partners could add value. While no life sciences business can afford to leave itself exposed to excessive risk, there are ways of adapting quality management to allow for small, previously unproven steps to be tested out – especially if these are in the interests of ‘doing the right thing’ by patients. This shift is about seeing the quality profession as having a role beyond ‘avoiding fines’, and reflecting this by giving those involved greater representation in strategic decision-making.
Big changes may not be possible overnight, but by chipping away at the status quo and being prepared to look at things differently and challenge established thinking, life sciences firms have an opportunity to steadily align themselves with a brave new future.
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. Kinapse provides advisory, capability building and operational delivery services across the life sciences lifecycle, working with 19 of the top 25 as well as some of the fastest growing life sciences companies in the world.