Marketing and sales personnel who leverage the expertise and insights of MedAffairs can often have better success.
Stephen Casey
Managing partner
Omni-HC
The role of Medical Affairs (MedAffairs) has become pivotal in the life sciences industry. By integrating real world considerations into development, clinical trials, regulatory strategies, and gathering, curating and disseminating scientific data, MedAffairs enhances the likelihood of market success. In our organization we have found marketing and sales personnel who leverage the expertise and insights of MedAffairs have better success.This cross functional collaboration means commercial gains a strategic partner who can help ensure product understanding and directly enhance the capabilities of healthcare professionals (HCPs) to utilize the product. Having the capability to use a product is fundamental to changing behavior and setting the stage for increased awareness, trial, and usage of the product.
MedAffairs seems to innocuously sit between the two anchors (clinical and commercial) of successful biotech and pharmaceutical (BioPharma) organizations. Years ago, a number of functions housed in MedAffairs were originally in the commercial division. Due to overzealous actors in the commercial side, the government started to place regulations which in turn forced BioPharma organizations to move specific functions such as medical communications into clinical. MedAffairs has grown since that point but due to today’s growing requirement to show product value, the importance of MedAffairs and its value in life sciences organizations is growing.
In many cases, MedAffairs is referred to as the bridge between clinical and commercial. However, if you are in commercial and you find yourself making this statement, you are not considering the potential that MedAffairs offers the company and you in optimizing the commercialization of your product. MedAffairs sits in a safe harbor outlined by FDA guidance. According to FDA, any commercial representative discussing a product prior to approval is doing so off label. Yes, a commercial representative can talk about a disease state but discussions on an unapproved product or use should never happen in commercial. Hence, without MedAffairs and its safe harbor to discuss unapproved products, most pre-launch market activity would not be allowable.
In the market today, we all know the requirement for financial evidence of the product value but the best way to gain access is clear scientific evidence of demonstrable value. When it comes to demonstrating scientific value, a MedAffairs team member is crucial. They can gather scientific evidence, curate it, and then communicate the evidence to activate it with market stakeholders. Proper coordination with MedAffairs can deliver significant returns that help build access relationships and advance market behavior change.
Sometimes it can be hard to understand why MedAffairs keeps itself distant from commercial. As we have discussed, there are legitimate reasons for that separation. But if we focus less on how MedAffairs can assist us with marketing and selling efforts and more on how they can help the overall behavior change effort, the collaboration path to a successful commercialization effort may come into focus.
Life science companies often talk about achieving behavior change, but it is unclear if they are using any behavior science to achieve those desired changes. One of the more popular behavior science models geared toward change is the ability, motivation, opportunity (AMO) model. According to this model, an individual's performance is likely to be limited if any of the three AMO qualities are missing, but performance is expected to be boosted if all three are present. A behavior model like AMO offers a management tool that we can use to better understand how to progress an HCP towards trial, adoption, and usage of a product. For this reason, I will use AMO to help outline how commercial can leverage MedAffairs to advance the commercialization of a product without crossing compliance firewalls.
Using the AMO approach as our behavior change model, it is easy to see a MedAffairs role whereby they create or improve the A (ability) of HCPs to use the product. Since one of MedAffairs core capabilities is medical education, they can use medical education and enhance the ability of HCPs to diagnose a disease state, better understand treatment choices or implement evidence-based care in their practices. Improving HCP capability can also be achieved through comprehensive scientific exchange whereby medical science liaisons have discussions on practice guidelines or the specifics of the clinical trial data or other scientific points. MedAffairs can also empower HCPs with training programs, providing access to relevant resources and databases, and facilitating professional development. When we look at the MedAffairs toolkit it is obvious they have the tools and know-how to engage healthcare professionals and empower them with the ability to make informed decisions. But what about the other two areas of the AMO model? How can MedAffairs participate in the M (motivation) and O (opportunity) to improve the brand for the market or the market for the brand?
Motivation plays an important role in driving behavior change but it is probably the behavioral change area that MedAffairs can affect the least. For those in commercial, increasing HCP motivation is a big part of what we try to accomplish from product launch forward. But how can we leverage MedAffairs to enhance our efforts in HCP motivation? One way is to encourage MedAffairs to share success stories, or ask them to provide HCP communications on how to utilize best practice to improve their patient outcomes. MedAffairs professionals are very good at encouraging healthcare professionals to embrace new knowledge and practices which can be extremely helpful for commercial and lay a solid foundation to generate further motivation. However, generating the motivation to use the product will still be a function that requires heavy marketing and sales focus.
Like ability, opportunity is an area where MedAffairs can have a positive behavioral change effect. Not only can they create opportunities for healthcare professionals by effectively applying and discussing medical knowledge and evidence-based practices, they can also assist in the creation of HCP opportunity by assisting with market access discussions. To help increase HCP opportunities to use products, commercial professionals can encourage their MedAffairs colleagues to facilitate access and disseminate clinical guidelines, protocols, decision support tools, and patient education materials. We can encourage market access to continue to collaborate with MedAffairs to advance the scientific understanding of product differences and benefits to payers. Also, commercial can encourage MedAffairs collaboration with internal departments, such as IT, to help in streamlining inbound physician information requests and removing barriers to scientific data access for the entire enterprise. All these examples allow MedAffairs to create opportunities for scientific evidence demonstration with both payers and providers which leads to better market understanding and improved HCP opportunity.
Collaboration with Medical Affairs on the commercialization process is not just beneficial but essential for the success of life sciences companies. By leveraging the capabilities of MedAffairs, Commercial teams can ensure that products are not only understood but also embraced by HCPs. The collaboration between MedAffairs and commercial creates a synergy that can drive behavior change, enhance product value, and ultimately lead to improved patient outcomes. As our industry continues to evolve, the role of MedAffairs will continue to become more critical in navigating the complex landscape of product development and market access. Embracing this partnership will pave the way for innovative solutions and sustained success in the competitive world of life sciences.
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