Moving in Harmony: Aligning a Multidisciplinary Team on a Communication Strategy

BOLDAPPROVED Newsletter: Issue 1

Moving in Harmony: Aligning a Multidisciplinary Team on a Communication Strategy

Eli Lilly recently received an unexpected notice that it must bring its Alzheimer’s disease treatment, donanemab, before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (AdComm). This means that the donanemab team is suddenly facing a huge amount of work in a compressed time frame. The extended drug development team will need to work in harmony to prepare multiple deliverables and be ready to answer any of a thousand possible questions at a public meeting that is broadcast live around the world.

What would you do if your team received notice of a surprise, high-pressure, public meeting involving discussion of serious review issues for your product approval? What’s the first step?

Whether you’re facing a surprise AdComm or any other critical meeting, aligning the team on a compelling communication strategy is essential. This first step is foundational for all subsequent deliverables, such as a persuasive multidisciplinary presentation, an in-depth briefing book, responses to questions for an AdComm, or the communication deliverables for any other important step in drug development and commercialization. If a team member is not pulling in the same direction, it’s easy to go off course, especially when the team is under pressure.

If a team member is not pulling in the same direction, it’s easy to go off course, especially when the team is under pressure.

Welcome to the inaugural issue of BOLDAPPROVED, the monthly BOLDAPPROVALS newsletter for people involved in drug development and approval. In this first issue, we will provide our five best practices for aligning a multidisciplinary team on a persuasive communication strategy when getting it right the first time is imperative.

Five best practices for aligning a multidisciplinary team on a communication strategy

1. ENGINEER A PROCESS CONDUCIVE TO ALIGNMENT

Bringing together the key stakeholders and incorporating their cross-functional expertise gives your project a unified and compelling voice.

The first step is to commit to a collaborative approach in developing the communication strategy, usually in a virtual or in-person workshop. Choose workshop leaders who can bridge the various areas of expertise and elicit each participant’s best contributions.

All team members must be engaged to ensure everyone’s voice is heard. Too often, the loudest voices or most senior leaders can unknowingly silence crucial input from valued colleagues. The workshop leader needs to prevent this by using multiple approaches to promote engagement, including innovative use of meeting technologies, IT systems that allow multiple people to contribute to a live document in real time, and facilitation techniques to engage the team.

The goal is to get everyone’s contributions and address divergent viewpoints to gain alignment on the communication strategy.

2. ESTABLISH THE DESIRED OUTCOMES

Establishing the desired outcomes of your communication deliverables means specifying the actions you need the intended audience to take. With a shared goal in mind, the team should then work to define what emotions and reasons will propel the audience to those actions.

From a distance, the goals of a communication deliverable may seem obvious, but up close, there is nuance and complexity. This is especially true when your goal is to address a difficult topic, such as a troubling safety finding, a disagreement with FDA, a complex statistical issue, or an anomalous result.

Team members can have differing perspectives on the same data or circumstances, so constructively working through these differences is essential for building alignment and ownership. In coming together, the team will align on a stronger set of outcomes, reflecting a broader set of views and expertise.

3. DEFINE AND ANALYZE THE AUDIENCE

The next step is to check the desired outcomes against a thorough audience analysis to confirm that the goals are achievable. To do this, the team should systematically evaluate audience motivations, biases, education, cultural backgrounds, and any other factors that may influence how they respond.

Once your team has a shared understanding of the audience, they can assess their desired outcomes for achievability and adjust if needed.

4. DEVELOP THE ARGUMENT

With the outcomes defined and the audience understood, the team can then develop a bespoke argument tuned to propel the audience toward the desired actions. Construct the argument with three main claims that are inherently persuasive to the audience—claims so strong that each will need proof and support.

It is a common pitfall to skip the development of the argument and believe that “the data will speak for themselves.” This leads to deliverables with tons of information but no persuasion. Instead, succinct communication based on a compelling argument is far more likely to persuade the audience.

5. DRIVE ALL DELIVERABLES FROM THE ARGUMENT

Following the agreed argument, the team can move forward in parallel workstreams to produce their communication deliverables. The argument will keep each deliverable focused on the needs and interests of the audience and drive toward the team’s goals.

CONCLUSION

Aligning a multidisciplinary team on a communication strategy maximizes the team’s efficiency and effectiveness. The result is a compelling argument that will persuade the audience to enact your goals, raising the value and impact of the downstream deliverables.

About the Authors

Angela W. Corona, PhD, is a Senior Scientific Director with BOLDAPPROVALS where she supports teams approaching new drug or biologics approvals. With 10 years of broad medical and regulatory communications experience across a range of therapeutic areas including neurology/neurodegenerative disease, oncology, and immunology, she has played a key role in preparing teams for FDA advisory committee meetings, strategic submission messaging, and other complex regulatory communication challenges. Her PhD training was in neuroscience at the Ohio State University and she performed post-doctoral research in Alzheimer's disease at Case Western Reserve University.

Steven C. Cohen is the Managing Director of BOLDAPPROVALS, the division of BOLDSCIENCE that prepares clients for FDA advisory committee meetings, regulatory submissions for the approval of new therapeutics (NDAs/BLAs), FDA meetings, and label development. Steven has 33 years of leadership in communication consulting, strategy, and delivery coaching, including 117 AdComm preparations. He has supported numerous health authority interactions at key milestones and led submission messaging workshops. He has trained and coached over 1000 scientists, clinicians, and other leaders across disciplines. Steven earned a bachelor’s degree in French Literature from Wesleyan University. He studied medical science at NY Medical College and marketing, communication, and the internet at Columbia University.

About BOLDAPPROVALS

BOLDAPPROVALS blends science, communication, and technology to support product approvals. We deliver comprehensive support for FDA Advisory Committee meetings (AdComms), submission messaging, labeling strategy, and health authority interactions.

Our proven methodology integrates in-house scientific expertise with communication consulting to develop compelling, data-driven arguments for persuasive presentations, responses to questions, and briefing materials.

Our highly experienced team has supported over 250 AdComm preparations and aligned teams on messages for regulatory submissions and interactions with health authorities. Our team can address the unique needs of your people, products, and circumstances.

To learn more about how BOLDAPPROVALS can help your team, please visit boldapprovals.com, email [email protected], or call Steven Cohen at +1(646)930-0453.