OR WAIT null SECS
With an organization's future commercial success under its remit, the NPP function has rapidly progressed to a prominent role in the biopharma industry—but evidence-generation strategies must evolve with an eye toward emerging trends and technologies.
At its core, the new product planning (NPP) function exists in biopharmaceutical organizations to bring the commercial voice to R&D pipeline programs. In today’s complex healthcare ecosystem containing multiple stakeholders, NPP is seen as critical to improving a product’s probability of success from a commercial standpoint—notably with the potential to be beyond what is required from the regulatory perspective. With the demise of the “me-too drug” blockbuster days, the importance of product planning has earned greater prominence among drug manufacturers. Thus, helping improve commercial viability early in the product value chain improves the future success and sustainability of an organization.
To assess the evolving role of NPP functions and evaluate the current organizational scope of work, structures, capabilities, and challenges, the Biopharma New Product Planning Network conducted primary research to learn how organizations have implemented this function to adapt to the rapidly evolving landscape. Included was a survey, where quantitative questionnaires from NPP professionals (n=33) and qualitative interviews with senior leaders (n=12) across a range of company sizes provided an insightful look into how NPP has progressed and highlighted divergence and ongoing challenges.
Once upon a time in our industry, marketing organizations welcomed almost any drug that came out of R&D. With significant unmet needs among the most prevalent disorders, there was plenty of market real estate. The discovery of new mechanisms of action led to multiple companies chasing a piece of the market with their own me-too drug molecules, and this model was highly successful in creating blockbusters in areas where there was room for multiple entrants. R&D organizations were largely free to develop molecules that they could pitch over the fence to the commercial side of the company. The sales and marketing group welcomed new drugs with open arms, spending its budget to gain a share of voice and capture market share.
Alas, this model did not last. Ecosystem changes forced the system to adapt and raised the alarm for organizations taking late-entrant me-too drugs into therapeutic classes without strong differentiation. With the extremely long development cycles in pharma, the need for early and effective product planning to demonstrate value proposition and differentiation became paramount. Drugmakers recognized the need to build pipelines with a target product profile (TPP) that had the “end in mind,” delivering evidence for strong value propositions and product positioning—not just to regulators but across stakeholders. With this, the NPP function had its beginnings.
What’s in a name? NPP as a function goes by many as evidenced in the NPP function survey. Alternate names include new product commercialization, early commercialization, new product strategy, commercial planning, and portfolio strategy. Alternate naming of the function likely comes from a desire to be more descriptive than just calling the work “planning,” but the alternate names were highly fragmented in small percentages in comparison to the NPP moniker that was reported in 43% of the responses.
Diversity in reporting lines is also of interest. The survey found a mixture in where organizations are positioning the function, but the clear favorite with 59% of the vote was under the chief commercial/marketing officer. Other options with minority votes included the chief business officer, chief strategy officer, therapeutic area head, or even the CEO. Additional examples included the function reporting up to the head of R&D and the head of medical affairs.
The assortment of responses highlights the evolution of the NPP function across different biopharma companies, with organizations searching for the optimal way for the group to impact the portfolio.
The key collaborating stakeholders of the NPP function are well-aligned. More than 75% of respondents highlighted that those collaborators include clinical development, pricing and market access, medical affairs, regulatory, business development (BD), and research (ranging from 78%–93%). Approximately half of the respondents further collaborate with real-world evidence (RWE) and health economics and outcomes research (HEOR) units, brand teams, patient advocacy, government affairs, key affiliates, and regional peers (ranging from 30%–63%). The overarching results highlight the cross-functional and holistic nature of the NPP work, demonstrating the need for team members to be able to have the agility and comfort of working with scientists and drug developers while also understanding and connecting with leaders of commercial operations.
NPP teams recruit talent from a number of biopharma disciplines or consulting firms, and function leaders tend to bring in complementary experiences to build competencies across a broad range of activities. Desired capabilities include scientific and clinical understanding, comprehension of commercial operations, leadership skills, and an attitude and desire to learn. New members of NPP tend to come from marketing, medical affairs, research, market access, or BD.
During the qualitative discussions, NPP group heads were asked for three keywords that characterize the NPP department. Responses were varied but highlighted that, at its core, the function is strategic, collaborative, and focused on value maximization. Group heads stated that the optimal NPP function brings together professionals with multiple different backgrounds and experiences to form rich and diverse teams. Participants indicated that functional competencies, leadership skills, and attitudes were central to an ideal NPP profile (See Figure 1). Collective team competencies and attitudes enable the ability to learn from each other to lead through the broad range of activities included in the role. In short, the ideal NPP team is a “jack of all trades.”
NPP teams shape the asset evidence-generation strategy through stage-appropriate insight gathering along the development path. Data and deliverables generated by the NPP commercial teams help inform key decisions along the value chain—at indication prioritization; at proof-of-concept; and advancement to registrational Phase III trials. Key information for NPP research and analysis can be summarized across six domains: corporate strategy, disease landscape, TPP development, value and access, indication and lifecycle management (LCM) strategy, and market sizing. The depth and breadth of the activities evolve as the asset progresses, requiring progressive NPP budgets to gather additional information needed to address the knowledge gaps and uncertainties as the development investment is increased.
Insights generated by the NPP team help define what is needed to be successful, making sure that the new asset will bring value to critical stakeholders beyond the standard of care and that the data needed to demonstrate this differentiation is generated as part of the clinical program. The TPP is the key deliverable that helps define the data thresholds needed to advance the asset to the next stage, and the cross-functional generation of this document is typically led by the NPP professional. Beyond capturing data differences in key endpoints to get past regulatory hurdles, the TPP also takes into consideration the meaningful differences required for patients, physicians, and payers to enhance the probability of success from a commercial perspective.
In essence, the NPP function serves as a connection between R&D and commercial. As summarized by a VP head of NPP for a mid-sized company: “We are bridging between R&D and launch commercial teams to shape the asset strategy, portfolio strategy, and disease strategy. We partner with many colleagues to make sure new assets deliver differentiated value beyond [the] current standard of care and generate the evidence required by all stakeholders to bring them to the market and patients in need.”
With the view toward increasing the commercial viability of the pipeline, we can summarize that NPP is a critical strategic discipline that shapes the long-term commercial success of the organization. In doing so, NPP holds a key role in the sustainability of an organization.
Although the value provided by NPP seems clear, the function is not above its own challenges that may hinder optimal impact on an organization. One clear challenge described in the survey was the inconsistent recognition of the value of the NPP function across the organization. Stakeholders who work most closely with NPP, including asset team members from R&D and senior executives with an eye on the pipeline understand the value that the function provides. However, in some companies, it was reported that later-stage commercial functions focusing on a short-term view toward peri-launch and LCM activities were less likely to understand and value the contributions of the NPP professionals. Resourcing (budget and full-time equivalents) for NPP can be a challenge since the activities don’t directly contribute to the company’s top-line revenue growth in the near term.
In addition, the survey respondents cited challenges that were categorized as asset-, organization-, or tool-related.
With challenges come opportunities, and NPP has the potential to provide guidance related to processes, organization, and tools. Related to process, NPP can enhance cross-functional collaboration related to its activities, including indication prioritization, setting data thresholds for internal and external assets, and insight gathering that affects brand strategies. As described by a VP and head of an NPP team, “[W]e have an opportunity to build cross-functional planning so that we are all heading in the same direction, thus breaking down silos. We also need to be clear on our priorities—what we focus on while not attempting to solve a million things.”
With its dynamic nature, the biopharma industry is never dull. New market forces emerge over time and shape the way that organizations must adapt. As NPP focuses on pipeline assets that will not hit the market for many years, the function plays a critical role as a futurist in understanding important trends that can impact asset development and commercialization. NPP teams need to be forward-thinking and able to adapt to arising pressures. The survey uncovered a number of emerging trends that NPP teams believe will be drivers of adaptations to the function over the next several years.
The first key market force is patient centricity. Although all biopharma companies claim to be patient-centric, some walk the talk more than others. NPP functions should seek the patient’s voice in their analysis of unmet needs and the burden of disease and factor these insights into the TPP if there is reason to believe that the product can deliver on them. NPP organizations may need to enhance their understanding of patient-reported outcome (PRO) measures and RWE—when they should be used, how they can deliver value, and the process needed to create and validate measures if none exist that capture the patient experience.
Another prominent market force emerging is the use of digital tools. In our current era of “the internet of things,” there is a wide range of devices emerging on the scene in the biopharma industry, including digital therapeutics, diagnostics, clinical trial enablers, and “beyond-the-pill” solutions that improve the patient experience of taking medicine. NPP professionals must monitor these technologies and understand where they could bring value to pipeline assets and their clinical programs. NPP teams need to lead the conversation of what digital tools will be required at launch (or even before) and help incorporate those into clinical program management.
A critical emerging force with a wide-ranging impact on biopharma is the overall strain on healthcare systems. NPP professionals need to understand the holistic healthcare burden and budget impact of a targeted disorder and help plan to demonstrate the value of treating with the asset. NPP professionals will need to incorporate the possibility of new pricing models and may even need to trigger an assessment on whether a new product fits into the healthcare system of some countries. NPP will need to enhance its understanding of the payer value proposition and collaborate further with pricing and market access colleagues in efforts to find ways to translate its analytical tools to the early development space.
Given the shrinking white space for new drugs in addition to the healthcare system pressures, increasing pricing pressure, and the rise of biosimilars, organizations may need to prepare for smaller product launches as another trend. NPP professionals must incorporate these factors into their valuations and may need to spark conversations with a corporate strategy on what revenue threshold is needed to move an asset forward.
Fortunately, scientific discovery and the innovation engine continue to bring new promising technologies that have the potential to bring disruptive change to the industry. Following many years of trial and error, cell and gene therapies (CGTs) are starting to emerge onto the market, bringing significant value to patients in need. The field is evolving rapidly, requiring NPP professionals to collaborate closely with competitive intelligence colleagues to monitor where disruptive therapies may enter patient populations of interest. NPP professionals working on CGTs must also closely monitor the nuances of the fields, including differences in manufacturing and distribution channels (and associated costs). Close alignment and planning are needed with pricing and market access, as the acute budget impact arising from a very high price drug with short-term treatment will not be universally accepted, and may, therefore, require novel pricing and access strategies.
The NPP function is still relatively young in the biopharma industry, gaining prominence as the me-too drug bubble was bursting and raising alarms. The function has already brought significant impact to strategic commercial planning despite its modest size, yet organizations are still experimenting with where to optimally position the group and may not fully give the function the visibility and credit it deserves. With the long-time horizon of its planning activities, NPP groups need to keep a keen eye on market forces shaping the future and incorporate them into strategic planning.
Despite already being the holistic “jack of all trades,” NPP professionals will need to advance their understanding of IP, digital tools, pricing and access, HEOR, PROs, and disruptive technologies to keep on top of their game. With the future success of the organization as its mandate, the NPP function has staying power of its own and is poised to play a prominent role for the foreseeable future.
The authors contributed this article as representatives of the Biopharma New Product Planning Network Steering Committee.