Névine Zariffa, Founder NMD Group LLC co-wrote this article with Sarah Jarvis.
The coronavirus pandemic has tested us all. It’s been humbling to have so little direct power to respond to it. For colleagues in drug development, their mission has never been so critical. Some are focused on the treatment or prevention of COVID-19, while others assess and manage the impact of the pandemic on their plans to help patients with diseases other than COVID-19. How should study teams handle the disruptions to ongoing non-COVID-19 clinical trials? How should sponsors ensure that the dissemination of scientific information is both appropriate and timely through their medical affairs organizations? When and how should companies reinitiate evidence generation activities? Such decisions benefit from scenario planning. None of us can predict with any certainty when our world will emerge fully from the lockdown into a new normal, what the mid- to long-term consequences will be, or whether there will be additional waves of lockdowns. Scenario planning is a powerful tool to help us assess various possibilities, so we’re prepared to act on whichever possibility reveals itself. It creates flexibility in our thinking. It reveals actions we can take immediately. Best of all, it ensures that we don’t fall prey to magical thinking about how clear the future will be, and we remain prepared to adapt to what it presents us.
Launch teams often use scenario planning or “war-gaming” to map out potential competitive actions. Clinical and medical affairs teams are less likely to use these approaches. However, in today’s environment, we believe scenario planning deserves a new, elevated role to ensure that sponsors are prepared to navigate the journey to a new normal. While COVID-19 is certainly providing the current focal point, there are many events that are worth mapping out in full to ensure the company is prepared for uncertainty such as IT attacks or manufacturing meltdowns. To prepare, several steps should be taken:
- Form a cross-functional team with a high degree of diversity. Augment your project team if it’s often stuck in groupthink. Lateral thinking is essential and has proven to be effective time and again.
- Have an expert in scenario planning from outside the team facilitate the work. This will ensure all the team members can participate equally. An independent facilitator can also draw out ideas and not be influenced by politics or hierarchy within the team.
- Lead team members through a comprehensive overview of what to expect. While the exercise can scale, this is not an hour’s effort. Teams should define the scenarios for what is most likely, somewhat likely and the least likely (in other words, the most extreme). Each scenario should be fully defined with timelines and specifics.
- Depending on the area of focus and the size of your team, map out a "straw man" of responses and options per scenario. Use these responses as building blocks to ensure diverse, expert input and cross fertilization of ideas across all team members.
- For each scenario, use a template. In your scenario templates, include key aspects that affect you, what actions need addressing today, an assessment of the probability of the scenario happening, and an estimate of the impact.
- Identify actions which are common across scenarios. If you see actions that are common across multiple scenarios, it may be worth initiating them preemptively. Likewise, some of the extreme scenarios may be so catastrophic in terms of their impact that you opt to initiate risk mitigation now.
- Make this an ongoing process. Potential actions are regularly reevaluated. In each evaluation, ask what makes sense to act on now. This is important to do as the business context may evolve. Since you’ve done the work, don’t leave it on the proverbial shelf.
Medical and clinical teams’ lack of familiarity with scenario planning is a gap that should be closed to deal with both the near-term response and the yet-to-be-determined new normal beyond COVID-19. To be successful in this upskilling, medical leadership will need teams to be more open and agile, embrace the improbable within the context of the exercise and have a bias for action that’s balanced with hypotheticals. At the team level, colleagues will need to trust in the process, value diverse views and lateral thinking, and be able to switch from idea creation to concrete action planning. From there, leadership and decision makers must trust their teams to do this hard work and be willing to make investments when the process reveals there is value in doing so. The key is developing the discipline to set and follow decision criteria when events trigger actions based on scenario planning.
For medical teams, it’s better to have worked through several awkward scenarios in a virtual meeting room than be caught off guard in the future. It’s also helpful to have flexed and stretched the team’s mental muscles in a carefully orchestrated venue rather than under pressure and with little to no preparation. Lastly, it gives teams a constructive means to channel both anxieties and overly confident stances productively. At its best, scenario planning supports teams to be prepared for any eventual scenario.