The “First Hire Puzzle” of Commercialization

by Susan Nemetz, April 2021

As an early-stage company continues to progress its science, raise funds for its future growth, and define its corporate strategy, there comes a point when the team begins wrestling with two crucial decisions: who to hire to commercialize its precious asset and when to do so.

Embracing commercialization early as the bridge from target to patient with the same translational concept as bridging from bench to clinic requires challenging the execution-only oriented sales and marketing definition of twenty years ago.

In working with such companies, The NemetzGroup team often has a front-row seat for this process. As you might expect, we also have a particular point of view regarding these essential questions.

For starters, company leadership must first conduct an objective situation assessment to identify its highest priorities. It must also determine how best to flex its leadership skills while at the same time leveraging alternative resources to fill known gaps. Sometimes, there are gaps that even the leaders do not at first fully appreciate. In essence, this is a puzzle that can only be solved by reflection and conversation.

For the sake of this e-conversation, we will address the “first hire puzzle” by focusing on commercial, market access, and medical affairs – all functions that drive the early commercialization strategy. Along the way, we will offer a perspective regarding outsourcing vs. hiring for those roles and suggest considerations around timing of the organizational build.

Solving the Puzzle

As a framework, it might be helpful to drill down on three points of time in the lifecycle of a privately held, soon-to-be-public company (with the IPO process imminent) and discuss the broad commercialization priorities at each.

It’s worth noting that as a company moves through the various phases, the requirements of the individual hires — their competency, experience, and personality characteristics — will necessarily change. In the early stages, the “best” people are those who can wear multiple hats, flexing where their talents are most needed (sometimes day-to-day). As more layers and more people join, specialization naturally increases. It’s all part of the hiring puzzle and growth of the company.

Preclinical through Phase 1

For a company at this stage, the highest priorities are understanding the asset, gaining insights into the market (specifically, the competitive situation, patient journey, and unmet need), and determining the path the asset might take. This could take the form of an indication selection/prioritization exercise or deep market assessment.

Here, commercial planning work can be done internally by a new product planning (NPP) professional or respected consultant who knows how to right-size the work to answer critical questions. This resource should sit on the program team to inform clinical and regulatory development discussions with market insights from the earliest stage of planning.

Medical affairs planning (or hiring) is less of a priority at this early stage beyond alignment on scientific messaging and potentially conducting advisory boards to guide prioritization. However, this effort can be outsourced or led by the clinical team.

Market access insights are an important component of a market assessment, but would most often be outsourced at this stage to leverage the broad expertise of dedicated firms that operate in this space.

Phase 2

As the asset moves into Phase 2, the needs across the commercialization spectrum increase. That said, there is often, still, a mix of outsourced support and internal team leadership.

A key driver in the decision of how to build the organization at this stage is the ultimate commercialization strategy. This can be a challenging decision point — company leadership needs to align on whether to commercialize alone, partner, out-license, or seek acquisition. No matter the chosen strategy, making early commercialization investment decisions consistent with the proposed path will be of paramount importance.

If a company plans on commercializing the asset on its own, its hiring priorities are best viewed through the lens of balancing risk and preserving resources while tackling the huge amount of work required to be positioned for success.

Commercial resources and efforts should be aligned with both the company and asset strategy. In addition to the NPP resource, a brand lead may be an appropriate hire at this point, together with a marketing analytics resource to ensure ongoing market insights are gathered and interpreted to guide decision-making.

At this stage, around Phase 2, a company may consider bringing on board a Chief Commercial Officer (CCO). This can be a challenging position to hire, as the profile of a CCO in an emerging biotech should include experience in building a full team, understanding the various aspects of commercialization, communicating the strategy for the asset, collaborating cross-functionally, and delivering results. Ideally, the CCO is selected once the company is relatively confident the product will achieve clinical endpoints, make it through the regulatory process, and get cleared for the market.

The medical affairs function becomes increasingly important in Phase 2, particularly in certain therapeutic areas, such as oncology and rare diseases. Medical affairs forms a bridge between the company’s clinical team and the external medical community regarding how patients are managed in a given disease and how the company’s product can address needs. Medical affairs also builds relationships that are important for clinical trial recruitment while building capabilities for an ultimate market introduction, including mapping plans for the sub-functions.

At this stage, hiring a head of medical affairs is recommended, as the medical affairs team will often develop a scientific platform that forms the basis for scientific communications. The recruiting goal is an individual who has both medical knowledge and leadership skills. Deep scientific expertise needs to be balanced with a strong ability to engage with customers, guide the team, and map out a strategy for the ongoing sustainability and value of the asset(s).

Market access focus becomes more pronounced in Phase 2, and the hiring decisions follow the same guidance. To the degree the company is confident in the trajectory of its asset, the decision to hire a market access leader follows naturally. Typically, this role is hired by the CCO; however, the market access leader may come on board sooner if there are particularly challenging or complex access considerations for a given product or market.

The market access leader’s role is partly focused on strategy, but there is a large execution element to ensure optimal access to the product by all stakeholders in the market. Although some of it is formulaic (literally and figuratively), this role requires depth in the plans that need to be developed and how to implement them. Experience is critical and strong leaders in this space can be difficult to find.

Phase 3 through Registration

Once the asset reaches Phase 3, and the data inspires confidence for the internal team, the Board, investigators, and investors — a full commercialization team should be built. We are strong proponents of “right-sizing” the organization, and this is a time when we often see extremes occurring in either direction. Ideally, the size of the team is dictated by and tailored to the effort needed for the asset and shaped by the sequence of additional assets to follow in the pipeline.

At this point, the company should have strong commercialization leaders in place, including the Chief Commercial Officer, Chief Medical Officer/Head of Medical Affairs, and Market Access leader. Together, they must attract a diverse team of professionals who share the vision of bringing a valuable therapy to the patients who can benefit most.

As is the case for all hiring in an early- to mid-stage company, ensuring that commercialization people that join the company are aligned with its vision and culture is critical. Even outsourced resources need to operate in a style consistent with the company’s ethos, providing their expertise in a focused manner that is supportive of the strategy. The commercialization team is a company’s connection to its customers and, through them, the patients it is striving to help. This is the human side of building a team that makes a difference for patients. Solving the commercialization hiring puzzle requires understanding the company’s needs at each point in time throughout the lifecycle and bringing on the right resources at the right time to balance forward planning with resource conservation.

Conclusion

At various points in its evolution, every early-stage company needs to bring on additional talent and resources. These decisions are not simple, nor are they static across the different phases of an asset’s development and a company’s growth. As the organization’s make-up predictably shifts from a primarily science-based staff to include those with more of a customer-facing commercial background, the company’s culture will evolve as well.

Like most puzzles, fortunately, there are solutions, provided those involved invest the time, thought, and perspective required to reach their commercialization goals and hold true to the overall company vision.


Posted in All Categories, Decision-Making and Process, Organizational Development and Culture, Strategy and Planning