Once an emerging biopharma company has committed to launching its first product and building the required commercial organization to support doing so, its leaders must begin to understand the magnitude of change associated with this decision. A biopharma company building its commercialization capabilities is quite different from a smaller R&D-focused organization, and adding new functions and team members will require a company to evolve existing ways of working (or establish new ones). There can even be new organizational dynamics when determining which initiatives to fund across discovery and development vs. launch and commercialization, though for the rest of this article we will focus on decisions related to commercialization.
At the most basic level, new or enhanced ways of working related to three key areas:
- Decision-making: Who has the authority to make which decisions?
- Collaboration: How should key functions or team members work together? Who should be consulted to help inform which decisions?
- Communication: Who should be informed of what? When and how should they be informed?
On the surface, these seem like relatively simple questions. Beneath the surface, there are numerous complexities, including operational challenges and even “political” landmines related to individual biases and personalities.
In this brief article, we will aim to:
- Describe why it’s important to develop new ways of working
- Provide some recommendations to help leaders determine how to establish new ways of working
Why Clearly Defining New Ways of Working Is Important
The main reason new ways of working will become especially important is pretty basic: The organization itself is going to change with new strategic priorities, new functions and team members, and new corporate guidance (such as compliance). Therefore, the “old” ways of working that helped a company advance a product through the clinic often aren’t fit-for-purpose for launching that product.
Once ways of working start to evolve, the changes may feel significant and rapid. If a leadership team does not explicitly define new ways of working, team members may feel directionless and may default to prior ways of working based on their experience from prior companies. As a result, a diverse team with different backgrounds—which is usually a strength—can quickly experience miscommunications and inefficiencies since people have different expectations of how they should work with each other. On one end of the spectrum, this can cause a form of organizational paralysis, as decisions end up being made “by committee” and progress slows to a crawl. On the other end, it can result in excessive “freelancing,” when people make unilateral decisions without gathering the proper input, potentially resulting in rework, delays, or worse. Both situations are frustrating and cause a lot of organizational swirl, aggravated by politics and confusion.
To help a company anticipate and prepare for changes in ways of working, it can help to look at key milestones where we typically see the biggest changes.
Milestone #1: Bringing on Commercial Expertise
One of those first milestones occurs when the company begins bringing commercial expertise on board. Up until this point, the CEO or incumbent leadership team, which may be somewhat more scientifically- or financially-oriented, likely made all the decisions for advancing the product through the clinic.
Upon this milestone, however, a company will need to make new types of decisions that have commercial impact – including preparing for launch – which require different expertise. As new leaders with commercialization expertise join, it may be the first time that only a subset of the leadership team has the right expertise to inform decisions (example: a Chief Commercial Officer or Head of Market Access providing recommendations on a pricing and contracting strategy or distribution model). Another important consideration for this milestone is that while leaders with commercial expertise may be on board, their teams generally are not, which we will address further below.
Establishing new ways of working at this milestone, particularly around decision-making and collaboration, will be critical to setting a foundation into which future team members can easily integrate.
Milestone #2: Ramping Up Tactic Development / Execution
Another milestone is when the launch team shifts from focusing on strategy to developing tactics that will be deployed at launch, which typically happens ~9-12 months before the anticipated launch. At this point, many strategic decisions have already been made and the work shifts to be more focused on tactic development and execution. As a result, the total number of decisions rises dramatically, while the potential impact of each individual decision typically decreases. Even though the team may have effectively navigated earlier decisions on market shaping tactic development and execution, the sheer magnitude and interconnectedness of tactics to be deployed after approval creates greater complexity that needs to be navigated.
New ways of working are critical at this point, and they relate to our previous article on “right-sizing” the launch. Companies that over-resource their launch may end up creating overly-complicated approaches to governance, collaboration, and communication, creating significant inefficiencies. Companies that under-resource the launch may go too far in the other direction, with team members operating without the right guidance and input from leadership or critical collaborating functions as they focus on “doing” as much work as they can with their limited time.
Key Recommendations for Establishing or Evolving Ways of Working
Decision-Making: Create the Right Level of Accountability for Commercial Leaders
Commercial leaders must be given the right amount of latitude and accountability for driving work forward and for making decisions. This becomes important at the first milestone listed above and it remains important for the life of the company.
We bring up the idea of “driving work forward” in this context because new leaders who join an emerging company will typically need to drive initiatives forward before the rest of their teams are hired. They must have a “roll up their sleeves” attitude and be willing to do the work, especially to lay the foundation for their team members to build from as they join.
For example, the head of market access might be deep “in the weeds” assessing the access landscape and building a pricing and contracting strategy well before they hire any other team members. Likewise, the commercial/marketing head might be leading the overall launch strategy and roadmap in coordination with other functional leaders before any other team members are in place. They’ll need to be accountable for keeping these initiatives on track while simultaneously building out the rest of their teams.
When it comes to making decisions, the executive leadership team will need to either delegate decisions to commercial leaders or have them as heavy contributors to decisions that are ultimately endorsed or finalized by the CEO. The right amount of accountability for decisions depends on the capabilities and personalities of the people involved. No one size fits all and for commercial issues, it often boils down to the dynamics that exist between the CEO, Chief Commercial Officer (CCO), and board of directors.
Consider two simplified example situations:
- Example 1 – The CEO is a clinical expert with no commercial background who has hired a highly competent CCO. The CEO has delegated all commercial decision-making to the CCO and only wants to be kept informed. This is a great approach if the CCO is really good at his or her job and keeps the CEO appropriately updated. That way, the CEO is always prepared for strategic meetings, discussions with investors and potential investors, and so on, while the CCO can focus more of their effort on building the organization to lead the launch.
- Example 2 – The CEO is also a clinical expert with no commercial background who hires a highly competent CCO. However, the CEO wants to continue making all key decisions for the company – even down to the layout of the office. While this may risk burning out the CEO with too many decisions – especially decisions that may be outside the core areas of his or her expertise – this is still an understandable position since the CEO is ultimately accountable for the company’s success or failure. This is often the case in emerging companies, where the launch of a first product is one of the most significant events that will impact the company’s value. In this type of dynamic, the CCO and broader commercial leadership team should develop robust recommendations with clear rationale that leverage their expertise, then provide that robust thinking so the CEO can make—or endorse—well-informed decisions.
Neither of these approaches is right or wrong. It is just important to clearly establish who makes which decisions, when/how those decisions are made, and—most importantly—why this model is right for the people and teams involved. Otherwise, new hires who transition from a larger pharma company and bring a wealth of launch experience may feel some culture shock at how involved their new CEO is in making decisions that they used to drive much more independently.
Collaboration: Form a Launch Core Team
As a company’s key product(s) move toward launch, it’s important to form a launch core team that is made up of all the key functions involved in the launch. The launch core team’s primary functions are to:
- Facilitate effective coordination across functions: This is needed to help drive decision-making, get feedback, etc. A good example would include the Marketing team getting feedback on proposed peer-to-peer programs from field teams and Commercial Operations to incorporate robust perspectives on how those programs would be executed.
- Make cross-functional decisions (or recommendations) for launch: These can include decisions regarding positioning and differentiation, customer segmentation, etc.
Based on this remit, it is critical for the Launch Core Team to have representation across all core functions working on the launch. This will typically include Marketing, Insights and Analytics, Market Access, Sales, and Medical Affairs, but we recommend also including “non-Commercial / non-Medical” teams such as Finance, IT, HR, Legal & Compliance, Supply Chain, and Regulatory as appropriate. This can help connect the right dots across activities and can also help many of these “internal functions” better understand the “why” behind their activities related to supporting launch.
A few considerations to help maintain the Launch Core Team’s agility include:
- Earlier on – especially when the work is more strategic – the Launch Core Team may be composed of the leaders of the functions mentioned above. As a result, this cross-functional leadership team may overlap with existing forums, in which case the optimal team structure and cadence would need to be determined.
- Leaner teams are more agile. Keeping the membership tight will help the group work more quickly. Since many people often want to sit on a Launch Core Team, it will be critical to have the right communication forums to keep everyone updated at the right frequency (see below).
- Launch Core Team structure is often supported by organizing the work into distinct sub-teams. Sometimes these sub-teams are organized by function to match the organizational structure, which is efficient and straightforward. Other times, there may be cross-functional sub-teams focused on the biggest strategic issues for the launch, in which case the Launch Core Team might be composed of sub-team leads plus ad hoc subject matter experts
Collaboration: Define Major Planning Milestones
In part 4 of this series, Knowing What It Takes to Commercialize, we talked about developing a roadmap to outline key activities, milestones, and timelines related to developing a commercial organization and launching a product. Implementing this roadmap requires teams to work in an integrated cross-functional way. The Launch Core Team gives a great forum for that.
This roadmap should include major planning milestones where big sections of the launch plan need to come together to ensure alignment across functions. At the highest level, these sections of the plan are:
- Situation Analysis
- Strategy (overall and function-specific)
- Tactical Plan
To illustrate the value of these milestones, let’s consider how the Market Access team will be working on pricing, contracting, and distribution strategy while the Marketing team works on the promotional strategy and the Sales team works on the field force model and deployment strategy. At the Strategy milestone listed above, these teams should come together and share the choices they are each making to ensure that they are appropriately aligned. This does not mean that functions shouldn’t stay in coordination during the development of their individual strategies (they should). Rather, the major milestone provides a designated point at which they should come together and align. It’s also a natural point to share with leadership (and potentially the broader organization) an integrated plan that provides a complete view of the launch across all functions.
Communication: Keep the Right People Informed
As a company builds out its commercial organization and advances toward launch, it’s critical to keep the right people informed. People need to know what is happening, why it’s happening, how it affects them, and what they need to do about it. Key stakeholders include the executive leadership team, the launch team, and the broader organization.
The key is to keep people informed at the right intervals with relevant information. Over-communication can waste people’s time with too many meetings and /or irrelevant information, resulting in people “tuning out” and ignoring important communications.
The key planning milestones listed above offer excellent opportunities to level-set everyone and align on the current status, goals, and next steps. Between those milestones, ongoing forums (such as Launch Core Team meetings, full Launch Team update forums, or broader town halls) can help keep the right people up-to-date.
What’s Next?
We hope this series on 7 “make or break” factors has been helpful and informative. For convenience, here are links to all the other articles in the series:
- Series Introduction
- Factor 1 – Educating & Aligning Internal Decision Makers
- Factor 2 – Generating the Most Important Customer Insights Early
- Factor 3 – Integrating the Commercial Perspective into Clinical & Commercial Decision
- Factor 4 – Knowing What It Will Take to Commercialize
- Factor 5 – Choosing the Best Commercial Path Forward
- Factor 6 – Right-Sizing the Launch
Within a few weeks, we’ll also consolidate all those articles into a single e-book for easier reference. However, we’re not stopping there. We are planning a completely new follow-up series of articles and supporting videos to run throughout 2024.
This new series will focus on emerging companies that have made the strategic decision to evolve their organizations to launch their first asset. After making such a decision, the first question that usually arises is, “How?” Most leaders understand the need to build Commercial and Medical Affairs functions in addition to evolving many existing functions like IT, HR, Finance, and Legal / Compliance.
What’s less obvious is that these functions cannot be developed independently in siloes. Rather, their design, roles, resourcing levels, and timing must be defined in an integrated way in which implications of choices in one function’s design are pulled through to other functions. To make this even more complex, these functions must grow and evolve while simultaneously preparing for launch.
Throughout the series, we will provide insights and guidance to help emerging companies:
- Understand why an integrated approach to launch planning and organizational scale-up is so important
- Outline a framework for integrated planning and decision-making
- Share best practices—and pitfalls—regarding the early priorities and design of key functional areas
Thank you for reading and stay tuned!
