Medical Affairs: centre-stage in scientific engagement strategies

The Medical Affairs function within pharmaceutical, biotechnology and medical device companies has been on an accelerated evolutionary trajectory in recent years. Shifting from its previous supportive and reactive role, Medical Affairs has become central to developing proactive strategies for evidence generation, data communication and personalised engagement, and on a larger scale, optimising the life cycle of an asset. In that regard, we are seeing the foundation of the Medical Affairs function occur earlier and earlier in the asset life cycle, even ahead of clinical trial initiation. There are myriad drivers of Medical Affairs’ strategic renaissance – increased complexity of technologies and therapeutics being developed to address disease pathophysiology, the rise of precision medicine as a standard of care, and a focus on value demonstration from clinical, humanistic and economic perspectives, to name but a few. At its core, Medical Affairs remains central to data stewardship and effective scientific engagement, both internally within the commercial organisation, as well as with a growing variety of external stakeholders.

A deep knowledge of science and medicine is the hallmark of Medical Affairs and drives the function’s criticality to two-way interactions with various internal and external stakeholders who are relevant to the continuum of patient care and medication access. Within the commercial organisation, one fundamental responsibility of Medical Affairs is to translate important details of an asset’s profile, such as its mechanism of action and resultant clinical value, into a less technical language that can be better understood by those without scientific or clinical expertise. Beyond the academic and professional knowledge that Medical Affairs team members bring to their roles, they are also uniquely positioned to gather and mine insights from external stakeholder interactions, particularly those of healthcare professionals (HCPs), as they can engage at a peer-to-peer level. These insights are then brought forward to a cross-functional strategic table along with insights from R&D, clinical, commercial, patient advocacy and/or market access in order to curate actionable next steps.

One workstream that is particularly dependent on cross-functional insight mining is evidence generation planning. Companies have increasingly been appointing Medical Affairs teams as the driver of this workstream, wherein they work collaboratively with other functions to determine the mechanisms for and the feasibility of addressing data gaps, as well as the risks of not generating evidence of importance to external stakeholders. In addition, Medical Affairs is championing the identification of non-registrational evidence needs, which can be communicated in peer-reviewed scientific forums and in response to unsolicited requests in order to optimise product utilisation and patient benefit. Medical Affairs also brings to this role the ability to engage with external stakeholders to validate the evidence generation plan and identify proposals for investigator-initiated research that are strategically aligned with the overall plan.

Medical Affairs’ future in scientific engagement for gathering and mining insights entails further elucidating a role for artificial intelligence as well as leveraging social media and exploring the role of digital opinion leaders in this virtual world that will likely continue to exist, at least in part, post-pandemic. In addition, Medical Affairs’ engagements with stakeholders will continue to expand beyond HCPs. A renewed focus on patient-centricity has elevated strategic thinking around leveraging patients’ insights and voices through co-creation workstreams.

Its legacy as a trusted scientific partner places Medical Affairs at the forefront of data communication with external stakeholders. It is the Medical Affairs team that most commonly spearheads the development of scientific communication platforms, a foundational element for communications around a disease state, an asset’s clinical profile and, at emerging biotechnology companies, a platform technology. In this role, Medical Affairs ensures that communications are strategically aligned with the organisation’s medical objectives, that available and relevant evidence is integrated into communications to ensure scientific rigor and accurate interpretation of data, and that communications are placed in the appropriate context, with value being translated in a manner that resonates with the intended audiences.

In this era of data overload, a rapidly evolving digital communication landscape and the emergence of hybrid forums for stakeholder engagement, including meetings with Medical Science Liaisons and participation in medical congresses, Medical Affairs is being tasked with implementing new models of engagement to optimise its communication formats and channels. Data visualisation is increasingly being used to place data into context and allow stakeholders to evaluate data subsets and analyses in a more personalised, on-demand manner. With regard to digital and virtual engagement, Medical Affairs must develop communication strategies that go beyond data dissemination, allowing for scientific exchange in these forums while continuing to conform with compliance policies. Medical Affairs is well positioned to excel here, leveraging feedback from its interactions with external stakeholders to inform new omnichannel approaches to communication.

Jill Condello is Senior Vice President, Global Strategic Services at OPEN Health

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