Drug Delivery Product Strategy: Aligning The Organization For Execution

By Fran DeGrazio, executive editor, Drug Delivery Leader

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 mportant 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.

Consideration #2: Strategy And Execution Should Be Intentional

Being intentional, in the context of strategy and execution, means having a plan. And a business planning process ties directly to execution. The business planning process that occurs (or should occur, at least) annually should revalidate the strategy and enable the execution of the plans to achieve the business objectives and goals.

It is imperative that the priorities of all functions be aligned and funded during planning. A strategy built in a vacuum is never going to be delivered for the organization. This connectivity between the business planning process and the functions must be made explicit. Doing so enables clear program/project prioritization. Do not expect a pharma organization to easily adopt the changes needed to make a transition to a combination product without clear plans for each function and with defined resources and budgets to execute.

Not strengthening key ties between strategy and execution during business planning can be, in effect, a plan for failure. For example, I have seen smaller organizations just assume that their regulatory organizations will do what is needed for submission. They may outsource hands-on testing and documentation support with limited internal knowledge or support. Even if leadership decides to use third parties to support these efforts, there must still be knowledgeable, internal people engaging with them. Supplier quality organizations, for instance, must be built to meet the purchasing control needs of combination products.

All these potential components and responsibilities of execution should be considered upfront during business planning and defined and aligned at that time. Then, throughout product development, they should be diligently monitored for success, including at formal, intentional milestone or checkpoint reviews of strategy and execution.

Consideration #3: Strategy Into Execution Should Be Seamlessly Multi-Level

Once strategic planning has established a clear link between the overall enterprise strategy and functional strategies, both levels of strategy must be explicitly articulated and communicated throughout the relevant functional area roles and responsibilities. Alignment with individual personnel’s objectives ensures cohesive progress towards shared organizational goals.

In the example of a transition to a combination product strategy, from a functional perspective, the organization would transition from drug cGMPs [current good manufacturing practices] to an integrated approach, implementing both drug and device cGMPs. This transition involves adopting the Quality Management System Regulation, which aligns the existing device Quality System Regulation (CFR 820) with the international standard ISO 13485:2016. The implications of this change are significant: Most departments interacting with the product, including Regulatory, Quality, Development, Supply Chain, and Manufacturing, will be required to update their processes and procedures accordingly.

Consideration #4: Transitions In Strategy May Require Reorganization

Reorganization is often used as a solution to company challenges. For larger organizations, investing in bringing specialists together through organizational changes can support a combination product development model. Most important to successful reorganization for strategy execution is to have the right people in the first place. A top consideration is ensuring that talented individuals are assigned to roles that align with their skills and strengths. The concept of having people in suitable positions is described in the book Good to Great by Jim Collins as getting the “right seat on the bus.” When this alignment is achieved, organizations tend to be more adaptable and motivated to succeed.

For example, I have observed situations where individuals with strong technical expertise join a team but exhibit limited emotional intelligence. This often leads to dissatisfaction within the team and can ultimately be more detrimental than beneficial.

Middle managers are especially pivotal in ensuring successful execution; therefore, it is essential that they possess not only specialized knowledge but also the interpersonal skills necessary to effectively address personnel matters and resolve issues that could negatively impact the long-term success of the organization. Promoting accountability and maintaining transparency throughout the organization are essential to achieving effective execution. These principles should be consistently applied at every organizational level.

Consideration #5: Some New Strategies Require Some New People

Finally, a move to a new strategy — in our example, expanding from developing drug products to offering combination products — often means bringing in the right new talent to complement those already in the organization. These are people who understand the new regulatory requirements, have experience with devices and components, and understand the characteristics and direction of new drug and biopharma drug development. The organization is asking for problems if no new talent is added to supplement current team members. From a leadership perspective, these expertise-alignment factors represent some of the most vital elements for ensuring successful outcomes.

When individuals are appropriately placed within their roles, they are more likely to take responsibility for their actions and hold one another accountable. In my experience, employees strive to make meaningful contributions and accomplish strategic objectives. Having them committed to and capable of disciplined execution is the best way to ensure functional alignment with higher level strategic transitions and expansions.