FormalPara Key Points

Current trends that focus on complex targeted treatments, higher evidence burden of medications and focus on corporate reputation continue to demand strategic leadership from Medical Affairs.

There is an opportunity to elevate Medical Affairs to the next level; increased business acumen, strategic approach, innovation and project management are competencies that have been identified to drive the overall impact of the function.

General managers should foster the evolving role of Medical Affairs, encouraging lateral moves for a broader enterprise mindset, imparting a culture of shared governance responsibilities to encourage innovative thinking and investing in upcoming Medical Affairs leaders.

1 Introduction

The Medical Affairs function has evolved significantly over the past 50 years. Originally a support function, Medical Affairs activities were mainly limited to the provision of medical information, the review and approval of promotional messages and general compliance activities. Over time, the increasing complexities of drug development and mechanisms of action, discovery of new targets, emergence of subgroup population data and regulatory changes regarding the relationship between industry and healthcare professionals (HCPs) has propelled Medical Affairs to become a strategic partner in the company, and in some companies, the strategic leader, leading the launch of innovative therapies [1, 2]. The aforementioned trends have seen the expansion of the field medical or medical science liaison (MSL) role, fostering stronger partnerships with medical societies and diverse medical projects that have resulted in autonomy over budgets. Furthermore, the function has grown to incorporate specialty roles including evidence generation, medical data analytics and, in some companies, leading patient support programs.

If it has not done so already, then it is time for Medical Affairs to challenge itself with an aspirational goal to transform the role from a reactive function partner to an assertive strategic leader across the industry. The current trends impacting the industry (Fig. 1) highlight that the Medical Affairs function is in a prime position to harness these changes and lead the organization through this evolution [2].

Fig. 1
figure 1

The evolution of the Medical Affairs function supported by trends in the life sciences industry. MSL medical science liaison; RWE real-world evidence

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1.1 Higher Evidence Burden

There is an increasingly higher evidence burden to demonstrate the value of a medication, with health technology assessors demanding true differentiation of novel therapies over the standard of care, including increasing emphasis on meaningful, patient-relevant benefits [1, 2].

1.2 Digitalized and Integrated Healthcare

Technology is fueling rapid advancements and integration of screening, diagnosis and disease management. Healthcare is becoming digitalized and decentralized, with improvements in wearables connecting the patient to the prescriber and providing personalized information to enable better outcomes [1]. Although technology companies are poised to disrupt the industry with advanced data, analytical capabilities and deep expertise in consumer engagement, there is also a strong opportunity for partnerships that leverage the pharmaceutical industry’s healthcare regulatory experience and sensitivity [2].

1.3 Complex Therapeutics

Biotechnological innovation has given rise to complex therapeutic modalities, such as cell and gene therapies. With the emergence of new biomarkers, there have also been advancements in the full treatment paradigm with wider screening and complex diagnostic methods to accompany treatments for niche populations. As a result, there is a greater need to educate stakeholders on the complex modes of action, applications and suitability across varying patient types of these new therapeutics [3].

1.4 Innovative Data Generation

The abundance of data (through claims data, electronic medical records, patient-reported technology) coupled with artificial intelligence (AI) processing has started to shape healthcare policy, providing drug utilization information to improve treatment pathways and provide stakeholders with integrated, cross-functional insights to support decision making [1, 3]. Internally, these data points have provided greater access to real-world information, helping to bridge the higher evidence burden to support the value of medication.

1.5 Advent of Artificial Intelligence

Natural language processing tools are significantly changing healthcare, particularly influencing how patients and HCPs retrieve medical information and the creation of medical education content, from patient aids to publications [4]. In addition, AI algorithms, particularly deep learning, have demonstrated remarkable progress in imaging, namely in radiology, improving detection, characterization and monitoring of many diseases [5].

1.6 Changing Stakeholder Engagement

Healthcare professionals are being overwhelmed with mass digital communication. There is a need for an HCP-centric approach in engagement to contextualize and personalize the deluge of data. In addition, HCPs are seeking deeper medical insights coupled with access to on-demand, accurate, broader scientific information (clinical trial, pipeline and healthcare developments) from pharmaceutical and biotechnology companies [2].

1.7 Focus on Corporate Reputation

The COVID-19 pandemic saw a surge in corporate reputation for pharmaceutical companies and although this has returned to pre-pandemic levels, there remains a heightened exposure of major pharmaceutical companies [6, 7]. There is now greater responsibility and focus for companies to be accountable beyond shareholder interests, including a greater need for governance to uphold strong corporate reputation. With the rapid advancements in data and AI, there is further scrutiny around transparency of clinical information, data security and governance around use of data.

Although the aforementioned trends are favorable for the function to evolve into an internal strategic leader, a key challenge that surfaces is that the direct impact of Medical Affairs and its value internally has always been difficult to measure. Unlike commercial functions, where key performance indicators (KPIs) such as increased sales or market share serve to measure success, the medical function has tended to rely on more qualitative assessments, including key opinion leader (KOL) feedback or patient stories to highlight impact. Although there is now greater focus on tracking activity and quantitative reporting, the translation into a recognizable outcome for the enterprise can still be ambiguous. For these reasons as well as differences in educational background (scientific versus business trained), Medical Affairs often struggle to define their value within their respective organizations [8]. This challenge can be exacerbated at the country level with typically lean resources and where difficult investment decisions can sometimes be favored toward functions with quantifiable and clearly associated impact on the organizational goals. At the country level, success can be assessed by feedback from external stakeholders (patients and HCPs), and also by enterprise leaders, such as business unit directors (BUDs) and general managers (GMs). This review, written by country general managers and medical directors from various companies, examines the value proposition of Medical Affairs for the country-level GMs and BUD and how this function can be leveraged to its full potential now and into the future.

2 Value Proposition of Medical Affairs from the Lens of the Country General Manager

To evaluate the full impact of Medical Affairs, there needs to be a complete appraisal of the value provided to all its stakeholders, both externally and internally. In most organizations, Medical Affairs represents the voice of the patient, providing a thorough understanding of the patient experience based on clinical insights, and through work conducted with patient advocacy groups (PAGs) [8]. This close relationship manifests into supporting pathways for early access of medicines and impactful patient support programs. Medical Affairs may not be the only function tasked with these insights, as some larger pharmaceutical companies may also employ a dedicated Patient Support function to gain a robust understanding of this key stakeholder.

Healthcare professionals are another critical stakeholder, and their perspectives are typically conveyed by the Medical Affairs group to other functions within the organization. The Medical Affairs function is often responsible for engaging with clinicians through the establishment of collaborative relationships during early KOL discussions and advisory boards, prior to the launch of new medications. The function builds constructive collaborative partnerships with clinicians providing value through the sharing of current data, establishment of advisory boards and medical education opportunities, clinical trial involvement and pipeline discussions that contribute to the ongoing development and optimal use of new therapies [8]. Although it is important to distinguish field Medical Affairs roles (i.e., MSLs) from commercial field roles (Sales), there is a distinct place for each function to provide the HCP a full offering of both scientific education (MSLs) and product promotion (Sales). With HCPs now opting for fewer promotional discussions, there is a transformation of the original sales position to become more of a product agnostic role in the form of a ‘disease management partner’ [9]. The scope of these new roles must be carefully considered to ensure they are compliant, and complementary to the MSL function so as to not create further confusion for HCPs. In some companies, these ‘hybrid’ roles are led by Medical Affairs, replacing both the sales representative and MSL roles.

Paradoxically, in a function that is a voice for the patient and HCP, Medical Affairs at times struggles to voice its value to internal stakeholders [8]. Although Medical Affairs can be succinctly perceived as ‘pre-launch champions and scientific experts’, the function has much more to offer, as highlighted in Fig. 2. With the patient as the central focus for the organization at large, Medical Affairs can serve to link patient experience and HCP insights into the quality use of medicines, driving overall stronger decision making for the organization on the optimal place of a particular intervention. The greater recognition of real-world evidence (RWE) for patients, HCPs and health technology assessment (HTA) bodies has dramatically prioritized the need for evidence generation. Real-world data generation coupled with medical information dissemination helps to shape practice by ensuring that high-quality scientific data is provided to HCPs to advance the full therapeutic area paradigm from screening to diagnosis, acute treatment and finally on-going management.

Fig. 2
figure 2

Multifaceted value of Medical Affairs to the local affiliate. H healthcare professional interactions; I institutions; P patient organizations

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Upholding compliance and governance expectations are the responsibility of all functions within the organization. Medical Affairs, due to its unique position of engaging with HCPs and patients across the full product life cycle, assumes a broader scope of responsibility to ensure that quality practices are maintained, continuing the license to operate and supporting the corporate reputation of the affiliate [10].

Successful partnerships with external stakeholders are vital in policy shaping and the creation of a robust healthcare system. The position of Medical Affairs as the scientific external face of the organization provides opportunities for the establishment of innovative partnerships that contribute to the shaping of policy and therapeutic area environment. Medical Affairs is positioned at the center of the interactions between the patient, medicine, health technology and the healthcare ecosystem, bridging the gap between all of these stakeholders to foster improvement in patient outcomes [8]. Due to the need for broad collaboration across diverse stakeholders, the Medical Affairs function is a source of internal talent that can be developed to fulfill senior leadership roles within the medical function or broader enterprise leadership.

2.1 Medical Affairs Internal Value Over the Lifespan of the Medication

The value of Medical Affairs can also be examined through a stronger focus on key activities throughout the lifespan of an innovative molecule from bench to bedside (Fig. 3). Medical Affairs typically provide input on the basic science of the molecule, outline the patient journey with insights into screening, diagnosis and challenges associated with clinical management, provide epidemiology figures and predict the future competitive landscape when the intervention is launched, thus contributing to the business case. The increased level of collaboration between affiliate and regional teams early in the medication lifecycle (phase I/II) can lead to better identification of local high-quality clinical trial sites, broader input through KOL engagement in international advisory boards and pathways of access to provide patients with earlier access to medicine. Furthermore, the collaboration with regional or global functions supports RWE gap analysis to ensure that necessary local data is generated in a timely way to positively impact reimbursement discussions, or later in the growth phase of the medication for population subgroup analysis.

Fig. 3
figure 3

Key Medical Affairs activities across the lifespan of the medication. HCP healthcare professional; IIR investigator-initiated research; KOL key opinion leader; MSL medical science liaison; PSP patient support program; RWE real-world evidence

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The engagement of Local KOL stakeholders is led by the MSLs, who seek to gain an in-depth understanding of the therapeutic landscape and respond to reactive requests for information on the introduction of a new medication. The primary function of the MSL is scientific exchange, fostering RWE generation, gathering insights and supporting clinical trials; hence, the deployment of this role is ideally at the pre-launch and launch phase of the medication [11]. Local advisory boards, particularly focusing on the local landscape, patient journey and required patient support, yield a significant advantage when developing specific tactics to support the launch of new medications.

There are many different functions that generate different types of evidence—clinical development, market research, business analytics. RWE generated by Medical Affairs focuses on data about the health of patients and the routine delivery of healthcare, collected using a variety of methods other than traditional clinical trials. This has been and will continue to be an opportunity to unlock further potential for the reimbursement, growth and mature phase of a medication. More data points, greater accessibility and real-time data in the context of constrained health spend may see a greater requirement of real-time data from HTAs [12]. Therefore, it is imperative to adequately invest in RWE to fund both the studies and supporting resources to manage these trials. The impact of RWE really harnesses the power of Medical Affairs, from initial HCP discussions conducted by MSLs, through to multi-stakeholder engagements, and more importantly via the delivery of data that can support reimbursement through epidemiology, disease burden and cost-effectiveness data. During the growth phase, these RWE studies can provide subpopulation information, real-world efficacy and safety across local sites and drug utilization information, including persistence and adherence data. As the medication enters the mature phase, these studies help to strengthen both the relevance of the medication and the value of Medical Affairs via long-term safety information, comparative real-world efficacy between treatments, treatment sequencing, effects of switching medication and the potential for new indications.

2.2 Highlighting Activity and Impact

Understanding the value of Medical Affairs as a GM can sometimes be challenging, given the heterogenous nature of different roles (medical information, promotional review teams, MSL field teams and medical advisors) within Medical Affairs, and noting there has never been a universally recognized singular metric to showcase performance for this function. Typically, the Marketing and Sales functions highlight market share and sales, Market Access measures the reimbursement success rate, and likewise Regulatory Affairs can highlight the duration and approval status of a regulatory submission to demonstrate their value, however, there is no single quantifiable KPI that highlights the value of Medical Affairs [8]. Substantial progress has been made to track the output and impact of Medical Affairs through capturing the volume of MSL interactions coupled with KOL net promoter scores, scientific share of voice measurements, promotional pieces reviewed, number of internal strategic meetings held, number and impact of MSL insights.

The impact of Medical Affairs can also be highlighted by anchoring the function’s activity to the improvement in the patient journey. Beginning with the end in mind and linking the impact to improvement in the treatment paradigm (screening, diagnosis, acute and long-term treatment), coupled with improvement in the emotional experience for the patient can make the impact of activities much more evident and aligned with the enterprise objective of patient centricity. Highlighting Medical Affairs activity in this way makes the contribution of the function much more relevant for the GM or BUD and provides clear rationale for the funding of projects.

2.3 Prioritization of the Importance of Medical Affairs Activities for the GM/BUD

We conducted a short online survey involving nine GMs and nine BUDs across 13 different innovative pharmaceutical companies in Australia (August 2022–October 2022). The short anonymous survey examined the perceptions of local Medical Affairs teams in Australia, specifically focusing on the prioritization of Medical Affairs activities most valuable to the GM/BUD, current value and future desired competencies, which were quantitatively assessed. Other domains that were examined (through qualitative means) included attributes and behaviors expected from medical directors, background qualifications of Medical Affairs leaders and an overview of any challenges/frustrations. Interestingly, the Medical Affairs activities rated of greatest value were focused on HCP field interactions, educational events led by Medical Affairs, pipeline assessments and strategic discussions (Fig. 4). These areas highlight the more strategic and external facing role that Medical Affairs offer to the local affiliate. Compliance guidance and promotional review, although well regarded by BUDs, was not a priority for GMs (Fig. 4). Although these tasks are still essential activities for local affiliates performed by Medical Affairs that support corporate reputation, in some companies this focus is a shared responsibility with legal and compliance functions. Whilst these custodianship tasks remain a vital responsibility of the medical function, more mature companies have imparted a truly shared compliance responsibility throughout all functions that has allowed the Medical Affairs department to direct their thinking toward more strategic and innovative opportunities.

Fig. 4
figure 4

Medical Affairs activities GMs (9) and BUDs (9) value most. BUDs, GMs general managers, HCP healthcare professionals, HCO healthcare organizations

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Insight generation is another core responsibility of the Medical Affairs function, yet from the 13 companies surveyed, this was not deemed to be impactful by the GMs (Fig. 4). This is perhaps due to the high scientific focus of Medical Affairs engagements that can sometimes detract from what is relevant to the commercial objectives of the organization. Furthermore, the presentation of insights may be done on an infrequent basis, thus highlighting information that may not be of great relevance. Although most MSLs are confident to understand and uncover insights, they may lack the confidence to proactively share these during internal meetings and to manifest this insight into something more tangible and actionable. The advent of big data and digital processing of information through AI yields a lot of promise for insights, with the opportunity for pattern recognition from local data superimposed with international company data and current trends, that can be succinctly composed to answer business-critical questions in real time [12]. The Medical Affairs function should not wait for technology to improve this competency, rather it should focus on cultivating internal insights validation, strategic awareness and presentation skills to deliver actionable outcomes based on insights. Enterprise leaders play a role in fostering this competency, setting expectations regarding the collection and presentation of insights through dialogue with Medical leadership, supporting training and system infrastructure and highlighting the impact of insights.

3 The Value of the Enterprise Medical Leader

Bedenkov et al. [10] outlined the evolving role and multifaceted responsibility of the Medical Director being the scientific expert, the conscience keeper, the people leader and external face of the company. Additionally, there is a call for quality medical directors to be enterprise leaders, to think strategically for the benefit of the organization. Interestingly, in the results of the aforementioned survey, there was recognition that people leadership, strong collaboration and communication skills are vitally important to effectively lead the medical function. In addition, there was strong commentary on hiring the Medical Leader based on competence and experience rather than academic qualifications. Commercial experience was also recognized as a valuable skill to help broaden the enterprise perspective of Medical Affairs, to think strategically and be able to provide pragmatic sustainable solutions that will address patient needs and progress the enterprise.

In the past there was a strong vertical focus on career development in Medical Affairs centered around scientific acumen, yet interestingly, future capabilities that will allow Medical Affairs to grow are focused on strategic business acumen and innovation. Supporting cross-functional moves of aspiring Medical Affairs leaders into other functions (Market Access, Marketing, Business Development and Regulatory Affairs) can foster a broader understanding of those functions and improve the enterprise mindset. It is important, however, to ensure that there is an opportunity to return to Medical Affairs and not just provide a one-way career platform as this will help to impart a broader perspective to the rest of the team.

The value of Medical Affairs can be challenging to articulate. Although the entire medical team has a responsibility to highlight its value, it can be weighted differently, particularly to the quality of opportunities the medical leadership team may have via the increased exposure at the affiliate senior leadership level. An enterprise-minded Medical Director should consistently and quantifiably showcase the value of Medical Affairs across the organization, highlighting the function’s periodic achievements and impact to the patient journey but also the cross-functional successes that have unified and advanced the enterprise. It is important to note that this level of exposure should occur not only at the local senior leadership level, but also to regional teams and throughout the local affiliate to encourage future involvement with the function.

4 Launch Leadership in Medical Affairs

Traditionally, the role of Medical Affairs in the launch of a new medication was characterized as the reviewer and approver of promotional materials and medical information updates and providing feedback on protocols for investigational or new indications of medications (Fig. 5). Notable changes have impacted the healthcare system, resulting in a need for more sophisticated approaches that emphasize the role of evidence-based medicine, particularly with the scientific intricacy surrounding precision medicine, targeting of rarer disease segments, complexity of the patient journey with the advent of biomarkers and evolving diagnosis tools [1, 13]. These changes have resulted in Medical Affairs taking a more active role in the launch of new medications, advising and even co-designing the launch strategy with various tactics to augment the launch activities (Fig. 5). There are also multiple examples where in highly scientific and complex therapeutic areas (e.g., oncology and rare diseases), the launch has been led by Medical Affairs due to its early involvement with clinical trials and early engagement with scientific thought leaders, underpinned by the creation of medical education platforms that allow for open discussion that stimulate unbiased, high-quality scientific information.

Fig. 5
figure 5

Evolution of launch responsibilities for Medical Affairs. FAQ frequently asked questions; KOL key opinion leader; MA Medical Affairs; MSL medical science liaison

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Although Medical Affairs is often viewed as a strategic partner, there can at times be a retraction of leadership at the launch and postlaunch phase with Medical Affairs tactics often falling behind those of the commercial functions, highlighting an opportunity for co-leadership. This may stem from the fact that the contribution of the medical function toward the financial objectives of the company are less clear than those of commercial functions, particularly during the critical launch phase. Part of this conundrum can be alleviated by highlighting the short- and medium-term (1–3 years) Medical Affairs plan post-launch, and the impact for key stakeholders, these being patients, PAGs, HCPs and policy makers. The broader plan needs to include medical tactics aligned to overall strategy that can be tracked to assess the impact. Such activities should include HCP engagement planning, patient-focused activities and integrated evidence generation. Lastly, it is imperative that the Medical Affairs team frequently presents the progress on this medium-term plan, working closely with and aligned to the broader cross-functional team to drive the enterprise goals forward.

As healthcare continues to undergo more disruptions, driven primarily by the transition to digital health, MSLs will be key to providing strategic insights beyond the launch phase. MSLs will need to be familiar with how each health network incorporates digital updates and how this impacts the patient journey, for example enhanced AI screening will improve disease detection resulting in a stronger recruitment on patient support programs. The MSL role is already key in driving launch success, excelling in scientific information dissemination through early discussions with KOLs, providing access to global clinical data, emerging trends of practice in other geographies from KOLs and off-label information that can be provided reactively [11]. Further complexity of medications coupled with the higher evidence threshold will continue to demand stronger scientific discussions from all stakeholders, leading to the true integration of MSLs in the omnichannel plan beyond launch. Lastly, MSLs will continue to shape the value and evidence agenda, understanding the clinical gaps for the medication and orchestrating timely evidence to guide the optimal use of therapies, shifting the focus beyond the current launch to future launches [14].

5 Medical Affairs—Proponents of Corporate Reputation

The COVID-19 pandemic catapulted the pharmaceutical industry into the spotlight with the advent of vaccines for COVID-19. Public perception and patient trust are more important than ever with the new biopharmaceutical operating model built on higher expectations of integrity and transparency. Medical Affairs is a critical facilitator of this new model, fostering a reputation built on high levels of trust by providing current, accurate, unbiased and complete medical evidence to reaffirm the focus on delivering improved patient outcomes over the long term. Positive perceptions of the company can be translated to its brands and can potentially become just as influential as the attributes of the medication itself [6, 15].

A survey of over 1000 HCPs in six different geographies (Australia, China, Germany, India, the United Kingdom and the United States) examining the value of company and brand/medication perception, highlighted that HCPs scored corporate reputation as 7.66 out of 10 regarding importance. HCPs commented that outside a medicine’s functional factors (safety, efficacy, price, etc.), company reputation is the most influential factor in their decision to prescribe or recommend a drug [16]. A close second is a company’s reputation as a leader in the relevant health condition. These results are further supported by research from Ion et al. [6], which demonstrated that a pharmaceutical company’s corporate reputation has a significantly positive effect on general practitioner prescriber intents. Authors noted that corporate reputation is a multi-dimensional construct composed of communication (including disease awareness), ethical behavior, socially responsible behavior and image of its field employees [6]. These results are particularly important when the clinical difference and price of medications are not so easily distinguishable, and highlights that socially and ethically moral decisions, generally occurring over the long-term history of the enterprise, can have an economic impact.

The Medical Affairs function is well placed to support the enterprise to articulate the local and global impact on the patients it supports, highlighting how it improves the patient experience and overall reduction in barriers in the treatment journey. It is important to continue highlighting the company’s focus on patients; Medical Affairs could facilitate this by contributing to the overall local annual report, alongside other functions, which would have an overall positive effect on corporate reputation. Although the function has an important role to play given its earlier involvement and closer interaction with patients and HCPs, compliance is a shared responsibility across all functions and having a stronger focus on this throughout the enterprise will be more effective in upholding the integrity of the business. Furthermore, charging Medical Affairs with a solo task of monitoring compliance may adversely affect the ability to innovate; rather, a separate compliance function may yield more objectivity and independence, particularly to any function engaging externally, with Medical Affairs acting to support governance activities.

6 Future Fit of Medical Affairs

In the previously mentioned survey, business leaders were asked to highlight the importance of competencies in Medical Affairs. Scientific acumen, engagement excellence (discussion with key HCPs), HCP/KOL centricity (understanding the current issues impacting HCPs), patient centricity (understanding the patient journey) and collaboration with other functions were amongst the highest scoring competencies (Fig. 6). This strengthens the current perception of Medical Affairs as therapeutic experts and organizational partners for key projects.

Fig. 6
figure 6

Value of Medical Affairs competencies, scored by GMs (9) and BUDs (9). BUDs business unit directors, GMs general managers, HCPs healthcare practitioners, KOLs key opinion leaders

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When assessed on what future competencies Medical Affairs could further improve on, that would add value to business leaders, the results pointed towards four key areas, namely strategic approach, innovation, KOL/HCP centricity and business acumen (Fig. 7). Having strong scientific acumen did not rate highly on the survey, suggesting that although these are very important competencies, they are now considered standard for Medical Affairs professionals. Business acumen was broadly defined as understanding the financials and the language of business, which will help a medical leader provide pragmatic input to improve the standing of the patient, trust and reputation of the organization appropriately. Strategic approach was broadly defined as understanding the regional commercial and medical plan, being able to identify trends in other countries that may impact the local affiliate, utilization of regional resources, showcasing alignment and performance above country, horizon scanning for new data, competitor activity and impact on screening and diagnosis. Although, at the country level, hierarchy may decrease the proximity to the overall enterprise strategy for Medical Affairs professionals, a great resource to close this gap in awareness is the company annual report as it provides a sense of direction and priorities for the wider organization. A missing competency that was not canvassed in the survey centered around project management, defined as being able to appropriately allocate budget, predict activity timelines and scale investment. This is a crucial skill that is often neglected when aspiring leaders are promoted and stronger training in this area will support better strategic decisions and improve the organization’s agility. Overall, there is an opportunity to provide stronger foundational training in enterprise skills focusing on HCP engagement, building mutual value, presentation skills and executive presence to complement the key competencies highlighted here, namely strategy, innovation, KOL/HCP centricity and business acumen.

Fig. 7
figure 7

Medical Affairs competencies that could be improved, scored by GMs (9) and BUDs (9). BUDs business unit directors; GMs general managers; HCPs healthcare practitioners; KOLs key opinion leaders

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7 Medical Affairs as a Source of Innovation

The empowerment of deeper and earlier institutional relationships coupled with the advent of health technologies has empowered Medical Affairs to be a source of innovation within the organization. As the Medical Affairs function is positioned early in the lifecycle of the medication, opportunities arise for the discovery of, and collaboration with, local emerging companies that can improve the standard of care within the therapeutic area. The early insights driven by KOL discussions also have the potential to better support the launch of a new medication and could lead to more diverse business relationships at the local affiliate.

Furthermore, Medical Affairs is the custodian of many sources of data, including medical information systems, pharmacovigilance (PV) data sets, early access programs, patient support program information and HCP relationship management systems (Fig. 8). The industry is continuously evolving its data mindset in an effort to take advantage of key trends such as the growing number of data points (data lakes), genomics data, real-time access to data which could shorten the duration of clinical trials, early access to real-world outcomes for HTA and overall better analysis of data through AI. Medical Affairs is uniquely placed to harness the power of these diverse and complimentary data sets to demonstrate their value and contribution to shape the evolving healthcare landscape. For example, the processing of insights through AI yields tremendous value for screening, diagnosis and management insights, as does the PV system as an additional source of post-marketing data driving a better understanding of safety and additional uses of the medication [17, 18]. These innovative opportunities should be explored with the highest level of integrity and responsibility as the legal and ethical landscape of privacy and data security evolve with technology.

Fig. 8
figure 8

Examining the trends of data and digital on Medical Affairs. CRM customer relationship management; HTA health technology assessment; PV pharmacovigilance

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8 Balancing Commercial Imperatives with Medical Goals

Most Medical Affairs leaders have the desire to elevate the function to a position of strategic leadership, influencing decisions, impacting company performance and delivering better patient outcomes. To achieve this, they need to understand the “big picture” of the enterprise and grasp how their decisions and actions contribute to both short-term and long-term success and growth [19].

Given the early and deep relationships Medical Affairs has with key external stakeholders, the function has adopted a long-term lens to its impact, which is why focusing solely on short-term financial goals can be a frustrating mindset for Medical Affairs to grapple with. However, shorter goals are imperative to keep accountability and highlight a path to longer-term impact for patients. Developing a stronger business acumen can help Medical Affairs leaders identify if any short-term focus is jeopardizing longer-term strategic decisions or partnerships, and more importantly suggest an alternative course of action that will ensure better long-term sustainability and hence better long-term performance for the company.

It is also important for aspiring Medical Affairs leaders to understand that they are part of a profit-generating company and that this is necessary to advance the science and health of the patient and society. Companies need growth and profit to develop or acquire innovative medications; these medications have a place of therapy in the treatment regimen, improving the quality of life of patients and then ultimately they are genericized, opening up broader access and less societal expenditure. The company has a responsibility to act in a sustainable way to benefit patients, public, payors and shareholders. Coming to terms with this philosophy helps functions which do not have a direct link to the profitability of the organization understand the importance of sustainable growth. Adopting this broader, holistic mindset, mature Medical Affairs leaders understand and are comfortable with the broader social responsibility of pharmaceutical companies to generate profit that can be reinvested into research and development activities. However, whilst adopting this mindset Medical Affairs leaders need be mindful to still maintain the integrity of the function as an unbiased source in the generation and delivery of data to do what is best for the patient and to maintain the trust of the public and the reputation of the industry, which ultimately leads to improved outcomes for the enterprise.

General managers also play an important role in imparting this sustainable mindset with other functions across the affiliate. By collectively aligning and focusing on improving patient outcomes and enhancing trust and reputation—central tenants in most pharmaceutical organizations, there is a greater likelihood of achieving sustainable growth with a focus on long-term objectives rather than quick wins. In addition, imparting shared responsibility for business decisions amongst major functions can alleviate some of the concerns Medical Affairs leaders face when they are often the final signatory on a particular decision.

9 Conclusion

The role of the Medical Affairs function has evolved significantly over the years, from a support function to a strategic partner within pharmaceutical companies, driven by innovative therapies, an evolving healthcare landscape and increased patient centricity. Future trends, including the need for timely and increased levels of evidence for new medicines, the rapid evolution of data and technology, cost-effective and sustainable patient solutions, and the increased expectation of corporate reputation, place the Medical Affairs function in a prime position to help pharmaceutical organizations navigate this evolving landscape.

While the direct impact of Medical Affairs has always been difficult to measure and assess, the function plays a crucial role in voicing the needs and perspectives of patients and HCPs. At the local level, the function delivers early lifecycle insights and is the custodian of evidence generation and dissemination which strengthens internal decision making and shapes external clinical practice. Focus on governance and compliance enhances corporate reputation which is paramount in the post-COVID era. The early engagement of Medical Affairs and its proximity to KOLs provides good exposure to innovative advancements in the therapeutic landscape. Lastly, the function is a source of internal talent that can be developed to fulfill senior leadership within the medical function or broader enterprise leadership. Although this intrinsic value to the organization and activities over the lifecycle of a medication can be easily described, the true impact of Medical Affairs can be lost within the noise of the organization. Therefore, Medical Affairs leaders need to consistently and quantitatively highlight the independent and collaborative achievements of the function within the local affiliate and broader organization.

New medication launches that are led by Medical Affairs provide a great opportunity for the function to shift from strategic partners to strategic leaders. In highly scientific and complex therapeutic areas, the value proposition of Medical Affairs is in higher demand due to information on clinical trials, early access programs, discussion on appropriate patient identification and activities that allow for open discussion that stimulate unbiased, high quality scientific exchange. Additionally, Medical Affairs will need to better define and measure the success of such launches, ideally through the lens of quality use of medicine, whilst incorporating the strategic goals of the business through a cross-functional, collaborative approach.

Looking ahead, the future of Medical Affairs lies in its ability to adapt to emerging trends, build enterprise competencies and embrace technology. The function needs to not lose sight of key competencies such as scientific acumen, scientific engagement excellence and collaboration, but also look to improve on strategic thinking skills, business acumen and innovation. Deep stakeholder engagements that can flow through to institutional partnering, along with the advent of big data coupled with AI processing, offers tremendous opportunity for the function. General managers can advance the function, cultivating an enterprise mindset through investing in fundamental training and promoting cross-functional role secondments. Furthermore, empowering Medical Affairs to identify enterprise partnerships, share governance responsibilities with other functions and nurture its launch leadership capabilities will improve innovative solutions to better address patient and HCP needs.

In summary, the robust value proposition of the country Medical Affairs function lies in its ability to understand and represent the needs of patients and HCPs, contribute to the success of product launches, uphold corporate reputation and adapt to the changing landscape of the pharmaceutical industry. By leveraging its multifaceted role, embracing innovation, strategic and business acumen, Medical Affairs functions can evolve to be a more assertive and strategic leader within the organization.