"The achievements of an organization are the results of the combined efforts of each individual" - Vince Lombardi
“I know you are in a hurry, but I just need a minute for you to approve this exhibit booth panel. May I walk you to your car?”
ASCO (American Society of Clinical Oncology) is rapidly approaching. Everything is ‘on deadline’. The ad/promo review committee is meeting 10 hours a week and still can’t keep their heads above the proverbial water. Some members can’t attend the scheduled meetings and therefore send a substitute. No one can even remember what was approved last week, much less last month. Ongoing reviews include everything from exhibit panels to hotel key card space, billboards on circling trucks, advisory meeting slide decks, MOA endless loop tapes, disease state materials, satellite speaker program slide decks, pipeline panels, sales representative materials, poster sessions, reprints, etc.
Everything is a rush job. What could possibly go wrong?
- Inability to maximize commercial impact secondary to inadequate materials, programs, etc.
- Review without adequate time and multi-disciplinary discussion: potential for missing risks, therefore increasing regulatory/compliance concerns
- Review out of context with other materials and activities: no “big picture” coordination
- Last minute submissions often result in poor quality materials: require greater scrutiny and increased editing, increasing review and production times
- Minimized opportunity to effectively coordinate with other important departments within the organization, such as with the compliance department
Which may result in:
- Increased potential for FDA or other government agency enforcement
- If unapproved drug or indication, increased risk for impact on final PI wording
Why Improve the Process? What is in it for you?
- Improved corporate risk management
- Maximized commercial opportunity with more effective and compliant materials
- Increased review efficiency
- Improved resource planning – internally and with agencies
- Created early agreement for meeting strategy and concepts
Process Improvement suggestions
This takes committed preparation and a well-coordinated, fully functioning team. We know large meeting dates years in advance, and can use this information in our favor.
- Convene a complete team summit at least 3-6 months in advance of the meeting
- Ensure EVERYONE is there – commercial, compliance, legal, regulatory, medical, perhaps clinical (if unapproved product, recruiting investigators, etc.), communications, and perhaps lead agencies
- Plan a full day with a detailed agenda
- Completely present the overall strategy and everything the company plans to do at this upcoming medical meeting - EVERYTHING (for instance: door drops, hospitality gatherings, key cards, advisory meetings, etc.)
- Gain buy-in for the strategy, programmatic tactics, and specific claims as possible. Prepare for the changes that may occur over time, while remaining consistent with the core agreements.
- Select an overall champion/medical meeting lead to ensure smooth process flow, accountabilities, mitigate challenges, etc. This champion should also ensure Commercial has fully reviewed and approved all draft materials before routing for committee review.
- Select a project manager and create a project plan with responsibilities, accountabilities, and specific milestones
- Consider, and plan for, complete ad/promo meeting review coverage for all disciplines throughout the process and set expectations for substitutions – anticipate vacations, parental leave, etc, as possible
- Ensure there is an agency contact lead (company lead and agency contact) to share project milestones/ expectations, convey importance of meeting all deadlines with compliant materials, etc. and hold them accountable
- Prepare a strategy for post-congress assessment to enable improved future process
Clearly, these are just a few of the many considerations necessary to create a strong and compliant commercial presence at a medical congress. But the bottom line:
Disciplined preparation and strong teamwork are the imperatives.