Katherine Baria, BSc (ARCS), PhD, AstraZeneca, Gaithersburg, MD, USA; Richard Baker, ISMPP CMPP™, BSc (Hons), Novartis, Basel, Switzerland; Claire Bartlett, ISMPP CMPP™, BA (Hons), CMC Connect, McCann Health Medical Communications, Macclesfield, UK; Belinda Dean, ISMPP CMPP™, BSc (Hons), CMC Connect, McCann Health Medical Communications, Macclesfield, UK; Johanna Dixon, ISMPP CMPP™, BSc (Hons), CMC Connect, McCann Health Medical Communications, Macclesfield, UK
Are you considering running an advisory board meeting? Do you want to improve on an advisory board you managed recently – or are you about to start planning your first?
Do you have questions such as:
- How do I plan the meeting?
- How can I ensure compliance with regulations?
- Whom should I invite?
- How can I ensure the meeting meets my objectives?
This article provides advice on how to address these key questions, plus a helpful 10-point checklist at the end (see Figure 5).
Advisory Boards 101
An advisory board is a meeting in which a small number of advisors (8–15) are engaged to challenge thinking or provide insight on a given topic or disease area. The meeting format can vary and involve a range of different stakeholders (e.g. external experts, healthcare professionals [HCPs], payers, patient advocate groups, patients, and pharmaceutical attendees).
Direct engagement with the medical community in this way provides pharmaceutical companies with a valuable tool to gain expert input throughout the entire drug development program, in addition to identifying unmet medical needs that might drive clinical strategies in the future. Early in development, guidance might focus on clinical trial design, risk management plans, and target patient populations. When a product progresses onto phase III/pivotal clinical trials, advisory boards can play a key role in interpreting trial outcomes, such as clinical or physiological differences between patient subgroups. Once a product is licensed, advisory boards can help to identify and design post-marketing clinical trials, review and/or instigate medical or patient education programs, and provide input for life-cycle management.
Effective advisory boards result in actionable deliverables and promote positive relationships with the scientific community; as such, they can be considered a critical activity for the success of a pharmaceutical company and its products.
Planning for Success
The key to the success of any advisory board is to have a clear objective – this should be a focused goal, outlining exactly what you want to achieve, that not only justifies the need for the meeting, but also determines the choice of participants and drives the discussion.
You should also consider whether an advisory board is the most appropriate way to achieve this objective, or would other options such as surveys or medical/market research be more suitable? Advisory boards are an opportunity to gather feedback in open discussion with a small group and gain in-depth insights from a wide range of external experts, influencers, and decision-makers. Formats such as market research or real-world evidence can provide a broader view but are less flexible.
Finally, think about whether you need assistance? Some companies may have in-house support; however, if this is not available, strategic-partner agencies can be employed to support planning and delivery. An overview of the process for delivering an advisory board is outlined in Figure 1 below.
Figure 1. Overview of the Advisory Board Delivery Process
What are the Compliance Considerations?
The pharmaceutical industry operates within very strict compliance requirements, and you must always follow the relevant company, industry, and local rules and laws when organizing an advisory board meeting.
- Advisor contracting. Always check if you are allowed to engage the advisor before you contact them. Some countries impose limits on the number of interactions with an HCP you can have or specific checks you must make, e.g. US debarment checks for US physicians. Fair market value (FMV) compensation for advisors’ preparation time and meeting attendance must be followed. (Note: advisors should not be paid for any work on publication development if they serve as authors on any follow-up publications associated with the meeting.)
- Travel, accommodation, food, and beverages. Remember to check the regulations in the country where your meeting will be held, and those in the home countries of your advisors – sometimes travel visas are required, which take time to be processed.
- Content approval. The invitation, materials for pre-reading, and presentations will likely require compliance approvals. A general rule is that 60% to 75% of the meeting should focus on discussion, but local/company regulations may vary.
- Attendee ratios. It is advisable to stick to a ratio of three advisors to every internal participant. At a minimum, the company attendees should not outnumber the advisors.
Whom Should You Invite?
Assuming you have already undertaken a robust expert identification program, deciding whom to invite can be a complex decision with several variables to consider:
- Identify advisors with the right experience. Advisors should be selected based on their ability to answer your planned questions, whether they are clinicians who regularly see patients, physicians who have hands-on experience with a treatment in development, researchers with highly specialist knowledge, or patients/caregivers. A specific geographical representation may also be required.
- Multi-disciplinary representation may be useful. Inviting a varied group of advisors will provide a more balanced expert opinion. If you were planning on discussing clinical study design, ensuring that a statistician is present may be helpful; if you’re talking about biomarker data, a pathologist or biomedical scientist may be valuable.
- The role of the meeting Chair is critical. The choice of Chair can be based on therapy-area knowledge or ability to contribute to setting the meeting agenda; however, they may not have the facilitation skills needed. In such cases, it may be wise to engage a meeting facilitator to support the Chair in ensuring that objectives are met and time is used effectively. If you are covering more than one topic, consider having Co-Chairs. If you know that one or two of your panel members have strong personalities, make sure you are confident that the Chair and/or meeting facilitator can handle this appropriately, to avoid dominating viewpoints.
- Consider the seniority and experience of your panel members. While the proper mix of experience is important, this may affect how your panel interacts, e.g. individuals from some cultures may be reluctant to participate in group discussions if their interactions might be considered disrespectful towards senior members of the profession; one-to-one meetings with these individuals may be more suitable in such situations.
Here, There, or Everywhere?
Determining when and where to hold your advisory board is a key decision that needs to be made early. When organizing face-to-face meetings, deciding whether your meeting will be a standalone event at a central, convenient location, or linked to a congress can be a conundrum. As technology advances and global connectivity improves, pharmaceutical companies are increasingly opting for virtual advisory boards as an alternative to the traditional face-to-face meeting (see Figure 2 below).
Figure 2. Face-to-Face versus Virtual Advisory Boards: Practical Considerations
How Do You Engage Your Advisors?
Ensuring advisors are prepared to contribute effectively to the advisory board meeting is crucial, and some simple considerations, early in the planning process, can optimize the meeting format (see Figure 3 below).
Figure 3. Puzzling Over Meeting Format?
Have You Thought About the Logistics?
Poor logistical planning can leave advisors frustrated and less likely to participate in future events. A logistics supplier is typically contracted to assist with the arrangements unless in-house company support is available (see Figure 4 below).
Figure 4. Logistics: The Small Details Matter
What Are Your Outputs and Next Steps?
Following the advisory board, it is important to make a critical evaluation. Consider:
- Holding a team debrief within 24 hours.
- Capturing whether your advisors reached a consensus in their conclusions? If they didn’t agree, make sure that this is recorded to ensure you take a balanced view from the meeting and consider whether any follow-up activities will be necessary.
- Reviewing the recording of the meeting to assist with the preparation of post-meeting outputs. Outputs should be fit for purpose, and range from key actions and discussion points to verbatim transcripts of the proceedings.
- Asking the attendees to assess the meeting content, format, technical provision, and venue.
- Sharing pre-agreed meeting outputs with the appropriate internal stakeholders, such as your brand or project team, and archiving these in an accessible place to support others in planning future events or in support of an audit.
- Recording any learnings to support the planning of subsequent meetings. This is particularly important if your advisory board will be part of a series of meetings or if any of the key external experts involved are contracted for further activities.
Finally, it’s essential to confirm that the meeting objectives were met and define how the learnings and actions from the advisory board can be applied to the relevant strategic plans.
Figure 5. Advisory Board Checklist – Top Ten Tips
If done well, advisory boards can be an extremely valuable strategic activity for the pharmaceutical industry. We hope these words of advice will help to ensure your advisory boards are a resounding success!