James Man

A company might come up with the best drug in the world, but if patients don’t use it, that investment will be wasted. This is the kind of strategic consideration R&D organizations need to include more prominently in their R&D productivity improvement agendas. Yet too often the governance of these programs is too fragmented to allow for the bigger questions. James Man, director of advisory services at Kinapse, considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.

	Every life sciences company has ‘increasing productivity’ high on its strategic agenda. But without a clear line of sight across everything the R&D organization is doing and a broader sense of why, it can be a challenge to address some of the bigger and more business-critical questions-such as ‘how do we ensure we’re producing products that customers actually want?’. It is vital that companies do find a way to address them, however, because when it comes down to it enhanced productivity is not just about doing more of something and getting there faster-but about doing more of the things that count in the market. With finite resources and budgets to draw on, being in tune with patients has never mattered more.

	Certainly, life sciences companies, in common with most other businesses in 2018, have made clear pledges to be more customer-centric. Yet, over-zealous and overly complex governance frameworks around R&D decision-making can prevent those involved from understanding the fuller considerations about the potential market value of products. To address this, organizations need to find a more definitive way of bringing patient considerations to an earlier stage in the decision process.

	Patient value-a drug’s value to the patient-can be thought of in terms of an improved patient experience, improved outcomes, and better access to medicines. New innovative medicines or solutions must address a patient’s condition more effectively than currently available treatment regimens. If they don’t, there is a risk that a new medicine will be developed that patients either do not want or will not use, or where the benefits cannot be realized due to patient non-compliance. These factors need to feature prominently in early-stage programs, as net present value (NPV) and return on investment (ROI) are based on sales forecasts which can be skewed, consciously or subconsciously, to what teams would like the outcome to be, rather than the actual situation post launch.

	Understanding patient value also helps with ongoing medicine lifecycle management, i.e. how the medicine will continue to be differentiated after launch. This too must be considered early in development. This requires continuous learning about the medicine so that further value can be delivered to existing or new patient populations, based on unmet needs in terms of patient outcomes, as well as patients’ and healthcare professionals’ experience post launch.

	Including the patient perspective more prominently in decision-making

	So where does this fit in strategic thought processes? Decision-making in R&D is an organizational capability. It requires alignment and a maturity of processes and governance, to ensure that decisions are informed by data and insigh-including insight about patient priorities. To make certain of this, companies need to have a clear and transparent framework in place so that decisions are consistently made in the context of ‘is this of real value to customers, and how do we know?’.

	Simplified governance is recommended, so that different teams don’t retreat into siloed thinking. It is not uncommon for companies to have one forum for strategic endorsement of a new product, another for funding approval, and a third for operational plan review and endorsement. Yet this is a time-and resource-consuming way of working which leads to a fragmented review and can in turn reduce effectiveness, engagement, and value creation in decision-making. A single approval process per therapeutic area-and one overarching governing body across all therapeutic areas-is a better bet. This will ensure benefits are clearer and decisions more timely-especially as leaders can more easily see the competing priorities across the company’s R&D programs, and make informed trade-offs. It could even present an opportunity to move away from annual portfolio and budget reviews towards something more responsive and ‘in stream’.

	The strategic importance of including the patient perspective more prominently has already been outlined. Defining patient value creation as a key decision-making criterion, alongside scientific and net present value (NPV) criteria, offers a useful indicator of a product’s value to the broader healthcare ecosystem. It also keeps a focus on the longer-term value throughout the lifetime of the medicine. Including the patient perspective more prominently in decision-making will inform the value proposition for all external stakeholders too, and reinforce the insight and inputs required.

	Specific strategies to support longer-term, patient-centric value creation for a medicine include:

	• Segmenting patients using real-world evidence. The use of actual patient experiences and information help to (1) identify specific unmet patient needs; (2) create specific solutions that address multiple patient needs; and (3) enhance advocacy strategies and interventions that empower patient self-management.

	• Embedding patient centricity into R&D processes. Although much progress has been made (e.g. through Kinapse-, PFMD- and TransCelerate-led initiatives), actual implementation in individual biopharmaceutical companies has been variable. In most companies there is still scope to greatly improve the way in which medicines are co-created with adequate patient input. One concrete approach is through a well-defined patient engagement strategy-a collaboration between the patient community and R&D teams spanning discovery, research, development, distribution, and access to medicines. This leads to better value creation for patients and better outcomes for the healthcare system. Though models for patient engagement vary by company, an approach that has been gaining traction across the industry is a three-part framework which includes patient insights, patient collaboration (the way patient input is integrated into medicine development), and patient enablement (how the patient community is supported to lower barriers to enable participation). 

	• Innovating service packages around the medicine as well as new medicine combinations and medicine device pairings. Ultimately, the goal is to enhance the patient experience with the target medicine. This supports disease self-management and treatment compliance. Examples include medication technology (e.g. ingestible sensor pills, patch and iPad apps to track treatment adherence as well as other emerging technologies) and partnerships with digital health coaching programs (e.g. Omada Heath for pre-diabetic populations).

	While these types of initiatives are simple in theory, they are not yet being adopted systematically across the industry, perhaps because companies have found it hard to know there to begin and have not prioritized this enough to seek help. Change is never easy, but it is becoming pressing now if companies want to succeed and stay profitable in a challenging market when they are increasingly being called to account by patients with rising expectations, as well as regulators advocating for their best interests.

Articles

James Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.

James Man

Articles

Patient Value Creation & Pharmaceutical R&D Prioritization