The relationship between pharmaceutical companies and medical stakeholders will need to evolve thanks to the greater public scrutiny these relationships will now receive under various regulatory changes including the Sunshine Act. Under this intense public scrutiny and demands for greater transparency through financial disclosures, pharma’s engagement with thought leaders will need to significantly transform.
As a result of these changes, one of the primary goals of Medical Affairs in the near future will be enhancing patient access to and helping to determine the best use of optimal medical treatment. This will require the ability to demonstrate the medical benefit of products to practitioners and payers throughout the lifecycle for each product. To do this, Medical Affairs and Medical Science Liaison teams must continuously adjust their understanding of what value means from the perspectives of various healthcare stakeholders including patients, physicians and payer organizations.
Enhancing medical benefit will require not only a deep comprehension of product knowledge but also a robust, market-informed view of both unmet medical needs and risk tolerance. Medical Affairs needs to become more proactive about including insights from a broader range of external medical decision-makers and influencers into early clinical development. Furthermore, it must also take a lead in demonstrating improved comparative efficacy and cost effectiveness to payers by employing real-world evidence and data.
Engaging directly with the medical community helps pharma companies with new product development, generating data, refining strategy and creating relevant, credible and reliable medical and promotional content. Companies should consider broadening their network to include an expanded network of thought leaders as key representatives of the medical community. A well thought out strategy and objective-driven approach to thought leader engagement throughout the product’s lifecycle can be critical to the success of a product.
Pharmaceutical advisory boards are a crucial tool to gain the insights required to achieve a deep understanding and interpenetration of the various medical benefits for a product from the medical community. Advisory boards offer companies numerous advantages, including guidance on clinical development and trial protocols as well as future clinical strategies and product extensions that ultimately could improve the quality of life for patients.
Successful ad boards create actionable deliverables and provide incalculable value through strong relationships with medical professionals. Tighter budgets and increasing regulatory restrictions influence those organizing advisory boards to do more for less. Reducing costs without compromising meeting quality is essential, as poorly executed advisory boards will likely fail to provide companies with fully developed medical insights and valuable recommendations from medical experts in attendance. There are nine key elements to ensure that an advisory board—regardless of the therapeutic area—will deliver valuable insights.
1. Have a clear purpose based on the real needs of the medical community. The team needs to have clear objectives for holding an ad board which can be determined by continuously engaging the opinions of thought leaders and physicians in the specific therapeutic area of focus.
2. Invite the right experts. A representative group of advisors should capture the spectrum of opinions of the product. This doesn’t mean that the board will necessarily consist of product supporters only. In some cases, the best insights and opportunities come up when opinions differ. Understanding why physicians are non-supporters can be vital in determining future clinical strategies.
3. Focus on synergy. The optimal outcome will be from a combination of physicians who have little experience as well as those with extensive experience in using the company’s product or class of drugs.
4. Assign a great meeting moderator. Having a respected chairperson drives the dynamic of discussions and increases the chances of a successful meeting, including an end result that is effective and actionable.
5. Clarify mutual expectations. Teams should brief the moderator about their expectation for an end result. For the best outcome, prepare the agenda together with the moderator taking into consideration her/his input.
6. Incorporate adult learning principles. Reliance on didactic presentations often fails to work due to the diversity of learning and group discussion styles. Incorporate different communication methods that should include prepared handouts with relevant data, slides or videos.
7. Challenge participants to engage and prepare before the meeting. An effective approach is to meet all participants personally prior to the ad board to ask for their expert contribution at the meeting and to define goals. The Medical Affairs team will need to specify clear expectations for each participant and define the goals for the meeting as well as gain a commitment to prepare for the meeting.
8. Convert meeting results into action steps. It’s important for someone to manage the insights gained from the meeting. This should also include follow up with the advisors after the meeting to provide updates and future steps.
9. Clearly communicate the meeting objectives and outcomes cross-functionally. The Medical Affairs team needs to ensure that appropriate internal stakeholders (marketing, sales, etc.) are aware of the meeting agenda, the invited participants, the next steps and the follow-up responsibilities.
Company experts and medical thought leaders comprise the collective information exchange for a pharmaceutical product. A pharmaceutical company’s ability to share unbiased medical information with thought leaders is crucial to building trustworthy relationships within the medical community. Likewise, integrating data and knowledge gained from thought leaders within the medical community is equally important in building trustworthy relationships. These information exchanges have a direct impact on the success of a product and can be highly effective when part of an advisory board.
When effectively managed, ad boards can make an important contribution to a product’s lifecycle and play an important role in product management, including having an impact on the clinical strategy for a product. The ultimate goal of the insights gained from ad boards should be the improvement of the quality of life for patients.
The views expressed here by Dr. Alexander Tolmachev are his own and don’t represent the views of his company.