In recent years, there has been a lot of buzz about a new role for Medical Affairs. Forget support! It is about leveraging resources of power decoding the treatment rationales of physicians in healthcare ecosystems. The success of clinical development depends on it as much as successful market development strategies of country organizations. The new role of Medical Affairs is about influencing neighboring functions so that they can make better decisions – beyond the interests of Medical Affairs.
Among other things, Medical Affairs is expected to act even more as a partner for HCPs, work closely with clinical development, ensure optimal launch preparations, make the medical need clear to stakeholders, and enable the generation of real-world data. It is unlikely that anybody will find anything novel in these specific expectations. The purpose of Medical Affairs is to put scientific outcomes and the medical need for patient subgroups center stage. This creates a strong internal loyalty. In line with or even despite such internal loyalty, Medical Affairs should be an integral piece of the puzzle in pharma organizations and its specialized functions. Medical Affairs units are “key stakeholders driving the organizational strategies to develop and deliver people-centric healthcare solutions” (Bedenkov et al., 2020, p. 303). It is easy to follow the appeal to be more strategic as a function.
One player in a bigger picture
Yet, Medical Affairs is just one player in the division of labor in pharmaceutical organizations, and one that must align with Clinical Development and Commercial – to name just two. Both have different purposes, have different understandings of success and need to convince other internal and external stakeholders compared to Medical Affairs. Welcome to the jungle.
On a global level, Medical Affairs is only one of the relevant stakeholders for Clinical Development in the development program for assets. Medical Affairs can point out a substance’s usage conditions. But whether Clinical Development listens to Medical Affairs is not a given. After all, the success of a development program does not depend on local usage conditions, but primarily on successful intermediate milestones and ultimately the substance’s regulatory approval.
It becomes a task for management to understand what interests neighboring departments are pursuing. Only when this is understood, can ways be found to strengthen the strategic influence of Medical Affairs across these ‘silos’.
On affiliate levels, the focus is commercialization: launching the approved product successfully, establish a broad use, negotiate the best possible price, push away treatment hurdles existing in the healthcare ecosystem and create advocacy with HCPs and patient. Yes, Medical Affairs is active here. And yes, pharma organizations measure new patient shares, market shares and revenue.
For Medical Affairs, supporting the goals of other functions directly would be a bit rocky. However, there are levers for Medical Affairs to exert strategic influence. Medical Affairs must look beyond its own department. It therefore becomes a task for management to understand what interests neighboring departments such as Clinical Development or Commercial are pursuing. Only when this is understood can ways be found to strengthen the strategic influence of Medical Affairs across these ‘silos’ and, for example, enable a development that is close to the local usage conditions. Pharma organizations can be designed to smartly enable this role – e.g., special functions breaking silos or creating permeable walls between the silos.
Only one seat at the development program table
At a global level, Medical Affairs is just one of the stakeholders for Clinical Development. The latter aims to bring assets to the registration stage, which means that development strategies must work. And this does not necessarily mean that the clinical care conditions in local healthcare systems will be considered. It is true that, globally speaking, Medical Affairs can bring the consolidated care conditions into the discourse with Clinical Development, but the former is only one of the stakeholders at the table. Clinical Development has its own goals. The result may be, for example, that the comparator arm in the Phase 3 trial represents the relevant therapy for FDA approval, but not the comparator therapy that would be relevant for EMA approval. To stay ahead in the development race, Medical Affairs needs to be thinking ahead in launch preparations and provide data for local care conditions so that the benefit of the new therapy is clear.
One lever to increase the global value contributed by Medical Affairs comes from a development in the ecosystem. There are now more restrictive regulatory requirements (e.g. JCA in the EU or dose requirements laid down by the FDA) and resources in the market are becoming tighter. Clinical Development thus must develop more assets without knowing which asset will be successful. As a result, there is a greater need for portfolio management at an early stage of the development process. And this is where Medical Affairs can come into play. KOL engagement now starts earlier in a clinical development process and both regional and local care conditions generally need to be integrated at an earlier stage. Only Medical Affairs can provide this information – and thus solve a problem for Clinical Development. As Medical Affairs occupies a zone of uncertainty, it can make itself, to a certain extent, irreplaceable by giving Clinical Development access to this information.
To facilitate alignment between Clinical Development and Medical Affairs, smart organizations establish structures that enable exchanges between the functions. In portfolio management, for example, functions that break down silos and bring together several perspectives are one possibility. These functions understand both perspectives and translate expectations in both directions. Another option is to build permeable walls through interfaces. In situations where relevant information is available, these functions must communicate with each other. Clear criteria need to be defined to detect such relevance. Both options can counteract the pain caused by silo structures.
Exerting influence laterally
On a country level, a classic example of how Medical Affairs can influence neighboring functions is the launch of subcutaneous oncology therapy. Clinics require small rooms to practice this therapy – but small rooms very rarely exist in clinics. In other words, spatial requirements would have to be fulfilled to enable this subcutaneous application. And in this case, the success of the launch would depend on organizational factors in clinics.
This reflects the pain and gain of silo structures. Such information is essential for Commercial and provides further evidence of how in country organizations, Medical Affairs could exert influence on Commercial. However, utilizing this information as an opportunity to influence strategy across functions is not necessarily a given. To understand the value of this information, Medical Affairs must first consider Commercial’s interest in it. Why would this information be relevant to Commercial? And how can care conditions be modified cross-functionally so the new therapy can be used in clinics? Only when Commercial’s interest and the information about the care conditions are considered together, Medical Affairs can exert its influence successfully. For better access to therapy, Medical Affairs must stay shoulder by shoulder with Commercial and jointly develop a strategy for the subcutaneous therapy.
These are just two examples of why Medical Affairs cannot simply say “We are now strategic!” Becoming an integral piece of the puzzle is not a no-brainer. But at a global level and in the country organizations, Medical Affairs can clearly state what value it contributes.
Bedenkov, A., Rajadhyaksha, V., Beekman, M., Moreno, C., Fong, P. C., Agustin, L., & Odell, S. (2020). Developing Medical Affairs Leaders Who Create the Future. Pharmaceutical medicine, 34(5), 301–307. https://doi.org/10.1007/s40290-020-00351-y