takeholder management is an established cornerstone of project management and is a process clearly detailed in resources such as the Project Management Body of Knowledge (PMBOK). Additionally, pharmaceutical and biotech companies routinely describe expectations for stakeholder management in their operating procedures and business processes. Yet, stakeholder management too often fails to meet expectations and creates unnecessary risks.

The authors have both experienced working in environments where policies have been pedantically followed without application of critical thought, and they have observed that this strategy is minimally effective and tends to underutilize opportunities to identify synergies that can save time and lead to more successful outcomes. This article overviews the importance of stakeholder management, with a specific focus on the interactions between the project management and regulatory teams, and hopes to provide guidance on how to effectively and logically assess when collaboration between project management and regulatory is critical.

Because most deliverables generated during drug development will eventually be submitted to a regulatory authority, it is especially important to include the regulatory strategy in the development decision-making process. The authors have worked in environments where close interaction between these two groups has not always been fostered. Allowing the two groups to operate in their own silos, only interacting with each other irregularly or in specific meeting venues, is a potential problem because closer collaboration can save time and costs, substantially reduce potential risks, and provide other benefits to the drug development program.

Identifying Synergies

In the first step of this process, the project manager documents the core competencies of different stakeholders and considers how project management competencies can aid and assist each stakeholder. This can be accomplished through a review of job descriptions, SOPs that govern a role, and one-on-one meetings to understand priorities associated with each stakeholder. These, in turn, can be used to inform the creation of a “Responsible, Accountable, Consulted, and Informed” (RACI) grid that can then be leveraged to identify where PM support is critical. It is worth pointing out that RACI grids should not be used to assign tasks to specific team members, but rather as a tool to understand where communication is critical and where support can be effective in achieving program goals. The RACI grid is too often assembled in a perfunctory way and is not always used in the manner for which it is intended. Used properly, as a living document that is frequently referenced and refined, it can serve as a vital tool to help aid critical thinking about program communications.

We’ve also observed that regulatory strategists and project managers both have responsibilities to develop clear mitigation strategies and contingency plans to share with the development team, and to continuously revisit existing risks throughout the duration of a project. They share the goal of ensuring clarity through realistic planning that incorporates all stakeholder perspectives on the development team and helps inform necessary activities. Brainstorming with the team and examining lessons learned, timelines, and regulatory communications from other projects provides valuable insights. Working together to consider all nonregulatory tasks (such as initiation of clinical studies, production of clinical or commercial batches of drugs, generating stability data, etc.) provide essential feedback critical to informing a robust regulatory strategy.

Another core element of this synergy between regulatory affairs and project management is that both groups must prioritize clear, fact-based, proactive messaging that keeps management informed about ongoing regulatory strategy and upcoming regulatory interactions. Planning the timing and distribution of regulatory communications is key to optimal communication effectiveness. Although this may seem like a straightforward expectation, it requires a degree of forethought and dedicated attention that regulatory experts may “deprioritize” when they need to think deeply about strategy and the potential regulatory implications of different approaches. Project managers utilize a wide variety of tools to ensure that communications are completed on time and that any items requiring action are followed to completion. These tools are not necessarily complicated, but they do require time and focus to effectively utilize. It facilitates the development process for the regulatory strategists to collaborate with project management to delegate those tasks that are firmly in the project management operational realm. This allows the regulatory strategist to focus their attention on critical aspects of strategy—their field of expertise.

Case Study

Our company was developing a potential therapy that required reformulation to advance the asset. As a first-line activity, project management worked closely with the regulatory team to evaluate the benefit-risk profile before proceeding with reformulation activities. Our foremost consideration was to understand how the reformulation would impact patient safety and to carefully assess what toxicology work would potentially need to be revisited. Although the toxicologist was the clear subject matter expert (SME), the team felt strongly that strategy development should include a broader group of experts rather than being independently assessed by a single SME.

The team used the tools described in this article to consider how FDA feedback may impact these changes. This prompted them to immediately include the regulatory strategist in the conversation. This inclusion allowed the team to clearly understand how the potential reformulation strategies may affect a potential IND application and to appropriately analyze the risks of different options. The regulatory strategist felt it was prudent to submit a request for advice/information from the agency which provided background on the new formulation, plus pertinent CMC information as justification for not repeating the toxicology studies. The FDA response was instrumental in establishing the agency’s perspective on the reformulation and their clear guidance to the team on what additional activities would be warranted for an IND submission. These discussions led to the creation of decision-making aids that were used to inform a robust regulatory strategy which was critical in presentations made to company leadership and allowed them to determine the relative value of the asset compared to the potential risks involved with its development.

Utilizing project management to assist with identifying all potential risks, including delays and overlapping regulatory activities that might impact the current bandwidth of a regulatory strategist, is critical. Some of the activities that should be vetted through this collaborative approach include examining potentially difficult questions from, and the team’s responses to, the agency, ensuring that regulatory tasks/assignments are aligned with the proposed clinical trial activity (i.e., agency feedback that may impact study design, pediatric study plans, etc.).

Conclusion

The processes described in this article, validated by the experiences shared in our example, provide a useful framework for how to apply critical thinking to effectively leverage tools that many teams already use. The keys to this approach are to build strong relationships between team members so that collaboration is effortless, and to actually use these tools for their intended purpose and not simply for documentation or as a check-box exercise. These aids should be viewed as real tools that help the team think about how and when to more effectively collaborate.

Traditional risk management activities performed by project management tend to focus more strongly on later-phase activities such as risks to patient enrollment and data collection and cleaning timelines. Although these activities undoubtedly add value, neglecting to place an equal focus on regulatory strategy can leave organizations exposed to significant risks that can lead to far-ranging impacts on timelines. Mapping out and understanding the potential risk profiles of different strategies can allow organizations to save time up front and plan better to avoid late-phase costs.