Medical Affairs Advisory Board Equation: MSL + VAB = OEE
Medical advisory boards, which are comprised of a range of different stakeholders (e.g., external experts, healthcare professionals [HCPs], payers, patient advocate groups, patients, and pharmaceutical attendees), have been utilized by biotechnology and pharmaceutical companies for many years to challenge thinking or provide insight on a given topic or disease area. These advisory boards, bringing together a small number of advisors (6-12), are engaged in gaining medical insights about products either in development or already on the market. This direct consultation with the medical community in this way provides current, real-time information which may identify unmet medical needs and therefore may drive clinical strategies in the future. Assessments on early development programs may provide guidance on clinical trial design, risk management plans, and target patient populations. For a product in phase III/pivotal clinical trials, advisory boards can be vital in interpreting trial outcomes, such as clinical or physiological differences between patient subgroups and descriptive analyses. For a marketed product, advisory boards can assist in the design of post-marketing clinical trials, review and/or recommend medical or patient education programs and provide input for life-cycle management.
Having a clear objective, with actionable deliverables, is the key to the success of an advisory board. It is important to define exactly what the need is, which not only justifies the purpose of the meeting but also establishes the selection criteria for participants and drives the discussion. Typically, the need for advisory boards will be determined and established while developing the annual Medical Plan. Identifying the questions to be asked will aid in completing the Needs Assessment documentation and fulfilling compliance requirements. Effective advisory boards result in positive and impactful relationships with the scientific community. They can be considered a critical activity for Medical Affairs.
The pandemic has accelerated the use of virtual technology and made it a day-to-day necessity. Whether on Zoom, Microsoft Teams, WebEx, or any of a host of virtual platforms, this is the new normal for advisory boards and Medical Affairs, including the Medical Science Liaisons who need to adapt and contribute to the process.
The Medical Science Liaison can have a pivotal role in the virtual advisory setup and execution.
The MSL can maximize efficiency for recruitment. With no spatial barriers to overcome, MSLs can organize a mutually acceptable time for the advisory board, allowing flexibility for attendance without the travel fatigue using the virtual setting. Medical Affairs get the best of the advisor’s attention, and the advisor has the convenience of their own setting. Hence, it becomes a win-win situation for both parties.
Because of the virtual nature, accelerated recruiting is possible. Many times, a vendor is utilized for the administrative aspects of the meeting. The MSL can work with the vendor for optimal communication with invitations, tracking, attendance, and other logistical issues. For a productive, successful agency-client relationship, there must be transparency, authenticity, and understanding between all parties involved. We recommend the invitations begin 4 to 6 weeks ahead of the meeting. This allows for the Key Opinion Leader (KOL) to block their schedule, and complete the administrative collection of documents, including the CV. This allows time for the KOL to complete any pre-reads/related materials.
Depending on the type of advisory board, the MSL may be the moderator or co-moderator with a KOL for the meeting. The MSL may need to learn effective moderating skills before taking on that role in an advisory board. Specific training may be needed for this unique skill. Successful moderators have their audiences’ needs in mind and are focused on listening. It is their advisor’s point of view, experiences, and practices that are interested in discovering and discussing. As the moderator, the MSL must stay focused and concentrate on what’s being said while also thinking of the next question to direct the discussion. Identifying key points and pulling out threads from the Q&A is paramount but often difficult especially when the group gets bogged down in too much extraneous detail that is mostly irrelevant.
It is a skill to politely redirect an important KOL who seems to be going off the discussion track. It is also a skill to change the direction of a conversation while being respectful. Learning to “read the room” is more difficult in a virtual environment. It is important to focus on real-time audience feedback that will help to make subtle or overt changes in style to generate better discussion. No matter what may happen, the most important goal is to gather the information that is useful and timely. Insights from experienced experts can prevent mistakes and lengthy delays in the use and development of treatments. Importantly, a successful VAB has the KOLs talking, discussing, and engaging; this is not the time for a company to data dump. Overall, the MSL has many tasks to manage—presentation of data and addressing questions while asking key questions, listening to answers, and summarizing the discussion.
While there are many advantages to a virtual advisory board, challenges arise too. During virtual advisory boards, it is more difficult to keep the audience engaged. People lose attention after 45 minutes to an hour and distractions like email, texts, and other activities can interfere. With an exponentially increasing reliance on digital communication tools to connect people together today, the need to listen has never been stronger. The demand for the “better story” is apparent with the competition for attention and increasing therapeutic options. Another challenge can be the technology platform that is chosen. The meeting can become derailed if the connectivity issues arise and are not resolved in a timely fashion.
The MSL can aid in these key elements of success for the advisory board:
- Convenient- by offering the HCP a selection of available times/dates for the advisory board
- Data-Driven- by making sure the ad board participant has materials ahead of time for review and understanding (often called pre-reads)
- Personalized- by selecting HCPs with specific therapeutic area expertise and those treating the right patient population
- Focus on value- by communicating the clinical and/or economic unique aspects, as that will help elevate the information as compelling and relevant
Advisory Boards are not going away with the pandemic and post-pandemic era. The dynamic technology, increasing availability, and more efficient time management with resultant enhanced value will continue to be part of the Medical Affairs landscape. While there are many aspects to this critical activity, the incorporation of the Medical Science Liaison into the Virtual Advisory Board process leads to Optimal Expertise Exchange.
Susan Malecha, PharmD, MBA
Susan Malecha is a results-driven versatile medical professional with a proven track record for achievement in the pharmaceutical/biotechnology industry. An accomplished author, she has lectured extensively and is called upon to present the latest developments in the areas of medical affairs for the pharmaceutical industry. Dr. Malecha is an active member of the Healthcare Businesswomen’s Association (HBA), and the current President of the San Diego Chapter. She is also Vice-President, Board of Directors, Health Care Communicators of Southern California, and Board Director for California Special Projects Fund for the American Association University of Women. Earning her BS in Pharmacy from Butler University, she completed her Doctor of Pharmacy at the University of Illinois at Chicago and earned her Masters of Business Administration from Keller Graduate School of Management. Dr. Malecha is a certified Etiquette Consultant and is currently the Senior Director, of Medical Affairs at Puma Biotechnology.
Kristie Traverso, BA
Kristie Traverso is an experienced, versatile, and customer-centric industry professional with clinical and commercial acumen focused on the field of oncology. With her 25+ years of pharma/biotech experience, she has held a variety of roles in both the commercial organization and Medical Affairs. In her current role as Associate Director of Med Affairs/ MSL, she works closely with key opinion leaders, manages all aspects of advisory boards, and supports patient advocacy groups related to Medical Affairs.