By Fran DeGrazio, executive editor
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Expectations within a company are to have a clear vision, mission, values, and strategy that provide direction for an organization. Those expectations are as true of a biopharmaceutical organization as of any organization type. Executive management bears responsibility for these activities across the entire organization. My focus here is on strategy and its execution, as both are essential elements of any business. Together, they establish a roadmap that defines the organization's direction as it outlines how to achieve its objectives. Successful outcomes cannot be achieved if either component is missing.
Consider that, most often, strategy is built at the overall market level to guide an organization. So, in that sense, strategy is very top-down.
In some cases, however, strategies emerge from the middle of the organization, at the level of individual activities and functional area needs, such as a specialized need for a particular drug product development program or project.
The locus of the genesis of these strategies — from the top or in the middle — will have a direct impact on the effectiveness of an organization to adopt the new direction. This is especially significant when the strategy, regardless of origin, requires that the organization take on or refine drug product delivery capabilities.
When Product Delivery Strategies Emerge At The Organization’s ‘Middle’
Take, for example, a pharma or biopharma company that has traditionally been focused on the research and development processes for a new drug therapy in a specific therapeutic drug class. The organization has already been built around achieving this goal, meaning the company is heavily focused on the research and technology of drug development. Its goal is to get regulatory approval globally. But its execution plan is to start in the US market, then move to the European region and then the rest of the world.
The development and manufacturing processes, whether internal or external, are built to meet FDA drug regulations such as CFR 210 & 211. The organization has also adopted global expectations through ICH Q8, Q9 and Q10, forming the basis for Quality by Design and Risk Management relating to drug products. All talent and processes that have been built are focused on achieving this goal. In all characteristics and operations, this is a pharmaceutical /biopharmaceutical company.
What happens when, in the middle of the organization, the project team, tasked with guiding a new drug product through development, clinical trials, and CMC regulatory submission in a competitive therapeutic area, determines that incorporating a delivery system into the project is necessary? While safety and efficacy remain top priorities, the product will be offered in a prefilled syringe for self-administration with an autoinjector. This is an example of a decision that comes from within the organization and is not a top-down directive.
The primary challenge is that the organization must now adapt to developing and launching a combination product, likely a new execution muscle to build. Implementing this initiative from the middle of the organization presents challenges due to its cross-functional nature, requiring support through budget allocation, additional personnel, and updated compliance objectives across the organization. Responding to this kind of challenge and reorienting execution to achieve the market goal can be significantly more difficult when this kind of strategy transition was not originally defined by and sanctioned within an official company directive issued “from the top.”
When Product Delivery Strategies Come From The ‘Top’
By contrast, consider a strategic decision initiated by executive leadership based on its comprehensive understanding of the market landscape. For instance, if executive leaders decide that the future of drug development and delivery lies in combination products, it would be prudent to shift organizational focus from solely pharmaceuticals to an integrated approach encompassing both the drug and its delivery system.
This transition does not signify a transformation into a device company; rather, it highlights continued expertise in pharmaceuticals while also developing capabilities in delivery systems. Such a strategic direction should be clearly communicated, recognized, and reinforced across all levels of the organization, beginning with senior leadership.
Regardless of the original locus or impetus for a strategy’s emergence or shift — coming from the executive top or emerging from the functional middle — I offer five key considerations for effectively yoking strategy to execution:
Consideration #1: Strategy Creation And Execution Should Be Shared
Strategy should be co-created, shaped, and adjusted, if necessary, with others in the organization. It is important to include multiple viewpoints to ensure buy-in along the development pathway to the final product. It’s a given that executives must be committed to the strategy. But functional leaders also want to have a sense of ownership around the organization’s strategy and execution. Collecting input from these functional area sources is vital, even if their perspectives appear narrowly focused or limited in market exposure.
This process of fostering a culture of co-created strategy serves two primary functions: 1) It enables the evaluation of a wide range of viewpoints prior to making final decisions. 2) It encourages greater ownership among the broader team involved in implementation.
In our example of a transition to a combination product company, gathering feedback from functional area leaders and stakeholders promotes greater participation and trust among those tasked with execution. For example, when transitioning to a combination product company, senior executives can obtain relevant input from functional heads to gain insight into the potential outcomes of such changes. This conveys to the functional leads that executive management understands the challenges of this kind of transition.
Moreover, the feedback loops created by involving functional perspectives in company strategy can help executive management better understand the resource needs across the organization. For instance, new processes and procedures may need to be implemented across the organization to ensure compliance with relevant standards for a new and different kind of offering. Another common need in a strategy expansion or transition is comprehensive training, critical to facilitating a successful addition to or change in strategic direction. Securing proper resources and budget allocations will be more attainable when the strategy is not only clearly defined but also clearly endorsed and supported by executive leadership.
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Expectations within a company are to have a clear vision, mission, values, and strategy that provide direction for an organization. Those expectations are as true of a biopharmaceutical organization as of any organization type. Executive management bears responsibility for these activities across the entire organization. My focus here is on strategy and its execution, as both are essential elements of any business. Together, they establish a roadmap that defines the organization's direction as it outlines how to achieve its objectives. Successful outcomes cannot be achieved if either component is missing.