One of the most challenging projects a pharmaceutical or device company faces is preparing for an FDA Advisory Committee (ADCOM) meeting. This is a team effort that entails a lot of long days (and nights), constant practice, and never-ending critiques.
As a project lead, one of the biggest and frequently overlooked challenges is keeping your team motivated and moving forward. Here are tips to help avoid the pitfall of a shortsighted and apathetic team.
- This isn’t busy work – we have a purpose. While core presenters may get most of the attention, a succinct and clear ADCOM presentation relies on an entire team working together – often on parallel paths. Make sure your team is aware that they are valued and that their work is critical to the team’s success. Use email, phone calls, or personal conversations to reinforce the positive results of their work. Be specific in your praise.
- Take care of your team – we all work toward success. ADCOM preparation takes a fusion of finances and time, which are important to balance. Your team will sacrifice after-hours engagements, weekends, personal time, and family commitments during the project. While staying on budget may be critical to ensure the project continues to move forward, be careful about cutting too many corners when it comes to your team. When prepping off-site (or on-site), everyone is away from family and working hard for the team’s benefit. Make sure you don’t skimp on meals, snacks, and treats. When team members complain about the shortcomings of meals and the environment, it takes away from productivity. Keep everyone well fed, well rested, and energized!
- Foster collaborative efforts. Encourage input from everyone on your team and don’t be afraid to reach out to those within the industry to provide perspective. Preparing for an ADCOM is a process that cannot be successfully executed alone, and teams may be more productive if members feel their opinions and insights count. Moreover, seeking assistance from industry leaders can lead to a fresh set of eyes and can reenergize a team.
- Encourage positive thinking and happiness. ADCOM preparation requires a lot of planning, stress management, and flexibility. Many sponsors face tight timelines that exacerbate the burnout factor. Reminding the team of the real patients the drug or device will help can keep things in perspective.
- Create a realistic calendar that allows for flexibility. It’s important to construct a realistic timeline and track your milestones to complete the necessary steps to earn a “yes” recommendation. Working steadily to improve all along the way is of far greater value than overloading yourself and your team too early or too late in the process. Most teams are not solely devoted to an ADCOM, so it’s necessary to create realistic tasks for your team in a time frame that doesn’t overload or underutilize. It’s also important to remember that flexibility is essential in preparation. Since key dates can change based on FDA guidance and/or company position, it’s important to be ready to adapt.
- Say thank you. A team, and a team member, who feels their hard work is noticed and appreciated can be an invaluable asset in your pursuit of success. I’ve seen firsthand the positive impact a simple “thank you” can have. During an on-site prep week, a team member who worked behind the scenes for weeks developing necessary slides was identified in front of the whole team and publicly thanked at a stressful juncture during the project. That triage member’s diligent work ethic and commitment to the team inspired and perpetuated momentum going forward.
Remembering that your team is made up of individual human beings with very human needs – and addressing those needs – is a huge part of successful ADCOM meeting preparation.