The primary function of medical advisory boards is to provide consultation to the company on core topics of high interest related to the product. The strategic output sought at an advisory board will likely vary based on the phase of the product in its life cycle, which could include:
- a pre-launch advisory board to assess the clinical development program (what the data means and how to best present it)
- an at-launch advisory board to maximize medical education and impact
- a post-launch advisory board to assess clinical experience with the product
- an evidence-generation planning advisory board at any life-cycle phase
Planning for an optimal advisory board experience is critical to assure business objectives are met as outlined in the needs assessment for the advisory board, as there will undoubtedly be a need to package and debrief after the advisory board with internal stakeholders. The needs assessment should clearly state the objectives of the planned advisory board and align with the medical objectives.
In the past six months, I’ve participated in four medical advisory boards for two separate products; for that fourth advisory board, I was tasked with being the primary organizer. This is what I’ve learned about organizing an advisory board:
First and foremost, understand company objectives for holding the advisory board before deciding who should be invited. If the company seeks high-level advice on medical strategy for their product(s), then nationally recognized Key Opinion Leaders (KOLs), with in-depth research experience in the desired disease and treatment landscapes, would be the most appropriate invitees. Alternatively, the company may wish to better understand the “on the ground/ in the trenches” use of their product(s); in this case, it would be more appropriate to invite clinicians (aka regional or local KOLs) who spend most of their practice time in direct patient care. The choice of whether to include advisors based on education level or therapeutic specialty will be based on company preference and/or clinician availability.
Following this understanding of the strategy and the types of KOLs that should be invited, select and add attendees to this advisory board, with the intent of maximizing the board seats, with at most fifteen advisors. Beyond fifteen advisors, it can be difficult for individuals to sufficiently and thoughtfully express their opinions in an allotted time. For advisors who are particularly valuable to the company, prioritize aligning their availability with the timing of the advisory board; this often requires sending out invitations at least three months in advance. KOLs should have a reputation for being able to comfortably and respectably speak within a group of peers. Holding the advisory board near the time of a largely attended national meeting may be convenient for many key advisors. Also in advance of the meeting, consider sending pre-reading material to prime the discussion of key topics. Of note, the inclusion of pre-work will be company-dependent, as this factors into the needs assessment and FMV (fair market value) calculation for KOL time and payment allowance for the advisory board program.
Amongst the particularly valuable advisors, the company may wish to invite one advisor to act as the chair of the meeting. The chair is likely a KOL who has worked with the company in the past, on research, consulting, or speaking engagements, and has a strong familiarity with the product. In terms of tasks, the chair (or moderator) would be expected to open and close the meeting, present data on the product, and steer the conversation towards answering the company objectives; in terms of personality, the chair should be someone who has fluency in the primary language of the meeting, holds the respect of most other advisors in the room, and has the wherewithal to ensure that all attendees have a chance to speak. The company may also wish to have an in-house representative co-chair the meeting.
After deciding upon the desired attendees and chair, next decide upon where to host this advisory board. While the overarching destination should be accessible, by car or by a major airport, it also should be both a reputably safe and desirable location. The program cannot be held in a hotel or venue that could be considered a luxury or entertainment-oriented, such as a casino. KOLs may seek to tack on a few hours of sightseeing at their own expense if they have taken the time to travel to an advisory board. The location of the advisory board is often within a private hotel conference room; ideally, this conference room should have closed walls/doors to ensure confidentiality of the discussion. Having a conference room with windows is preferable for advisor mood and energy, especially if the advisory board is an all-day event. If catered meals will not be provided during the event, ensure that there are multiple proximal options for obtaining food so that time away from the meeting is minimized.
Consider whether the advisory board will be recorded and if so, assure audio-visual equipment support and set up. Regardless of whether the program is recorded, someone should be tasked with taking notes at the advisory board session, as this is a requirement for all advisory boards. Some advisory boards may opt to publish the proceedings of meetings.
One or two days before the advisory board commences, email the advisors the key logistical details so it is easy to locate within their inboxes. In this email, provide advisors with multiple ways to easily connect with on-site contact for any last-minute questions.
Keeping these advance planning tips in mind will help you to orchestrate vital discussions at your next advisory board.
For details on executing the advisory board on meeting day as well as debrief strategies, please see Part II of this article in the next MSL Society Journal.
Author:
Elise Fields, PharmD
Elise is a Seattle-based Medical Science Liaison (MSL) working for Syneos Health on the Acerus project. Prior to becoming an MSL in 2020, Elise worked directly with underserved patient populations, overseeing a diabetes team and clinical pharmacy programs. She graduated from the PharmD program at the University of Washington and was the first pharmacy student to concurrently complete a certificate in Global Health. She completed a hospital residency and holds board certifications in pharmacotherapy and diabetes education.
In her spare time, Elise hosts a podcast that raises awareness of fertility research.
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