Delivering value through strategic leadership, insights and scientific exchange
By Caroline Horwood & Sophie Stiewe
With the needs of the healthcare environment continuing to evolve at speed, many pharma / biotech companies have been redefining how to deliver improved patient outcomes with acceptable economic value across a broad range of stakeholders. Our latest research, which included reviewing the current literature and interviewing multiple senior medics in leading global pharmaceutical companies, suggests that the Medical Affairs function is stepping forward to drive key strategic decisions and plays a key role in fostering strong external relationships as well as internal cross-functional collaboration.
The white paper covers the requirement for a more strategic approach in response to the unmet needs and challenges that health care professionals, healthcare systems and patients now have due to the information revolution. Not surprisingly a strong Medical Affairs team can link scientific and clinical results to patient outcomes, adding value at every stage of drug development.
These requirements will require a transition, with a need to lead and be strategic, working in a collaborative way across both internal teams and external stakeholders. Our interviewees were consistent regarding the implications for the Medical Affairs function and how they best add value for both industry and the patients / healthcare systems and health care professionals with whom they interact.
Lastly, the research showed there is a strong need to redefine the roles of Medical Affairs and the capabilities required, and for this to be underpinned with specific medical capability frameworks and development programmes to bring through the pharma strategy and ‘super-medics’ that the future industry needs.
PART 1: THE LITERATURE
Role & strategy shifts
Repositioning the Medical Affairs function as ‘a more strategic role… and “knowledge steward” that becomes the backbone of cross-functional activities among internal functions and a trusted partner for external stakeholders’1 is one of many examples found in the literature that summarises how pharmaceutical and biotech companies are evolving their Medical Affairs teams.
Historically the role of Medical Affairs was defined primarily by information support and the management of routine regulatory reporting requirements and compliance, but this definition has been shifting over several years. Today, there are differing structures and scopes across Medical Affairs teams. In some companies the scope has expanded to data generation and research, communication, intelligence and medical governance2. Others are more far-reaching, encompassing strategy, safety, stakeholder engagement, data interpretation and generation, field teams and medical education, publications, real world evidence and early pipeline involvement.
Additionally, the internal and external digital transformation required today must be considered. Digital, in its many guises, is of course at the forefront of multiple advances, especially via its ability to harness new insights through novel types of data and analytics – such as applying AI to clinical trials, real world evidence, customer interactions, and internal data – as well as by providing new ways for pharma to connect and engage with stakeholders.3 This shift is underpinned by the need for a more strategic approach and is in response to the unmet needs and challenges that healthcare professionals, healthcare systems and patients now have due to the information revolution. A strong Medical Affairs team can link scientific and clinical results to patient outcomes, adding value at every stage of drug development5.
What are the implications of these shifts? The literature demonstrates that the transformation required in the Medical Affairs function is both one of mindset as well as evolving towards customer-focused engagement. We see consistent trends in addressing both traditional and new stakeholder needs, creating a single source of truth with data, bringing in insights that inform strategic decisions, and finally, building and disseminating scientific information in the era of Big Data through the right channels. Medical Affairs professionals need to lead and be strategic in their work, working in a collaborative way across both internal teams and external stakeholders.
Healthcare professionals are becoming less reliant on sales representatives, particularly younger physicians, who are turning to more scientific sources of information. In parallel the total number of sales representatives is falling and the demand for real world evidence is increasing.5
In turn, Medical Affairs teams are stepping up to add value at every stage of a drug’s development. Two-way information exchange supports stronger prioritisation, clinical trial design and launches which can lead to competitive advantage and improved return on investment. Medical Affairs also leverage patient insights working with advocacy teams to further inform clinical, commercial, economic and real world evidence generation, accelerating timelines and ensuring the unmet needs of patients are met.
At Uptake Strategies, we were interested in investigating the reality of the Medical Affairs transformation to understand how different companies were evolving the Medical Affairs model, identifying areas of priority for Medical Affairs to engage externally and internally, and how any current capability gaps were being addressed. We conducted a series of independent interviews with ten senior industry-leading Medical Affairs professionals, to discuss the evolving role of Medical Affairs across a mid to large pharma and biotech companies. The interviews formed a fascinating picture of where Medical Affairs is going, how it is adding value and what areas may need upskilling for Medical Affairs to become the strategic partner both internally and externally.
PART 2: THE VIEWS OF SENIOR MEDICS LIVING AND DRIVING THESE CHANGES
The role of Medical Affairs has completely transformed in recent years and further transformation is anticipated in the future
Our interviews strongly validated the transformation of Medical Affairs described in the literature. Interviewees confirmed that the role of Medical Affairs has expanded into multiple areas, outlined in Table 1, including the provision of strategic direction for medicines across the complete life-cycle, as well as providing insights to ensure that medicines are evidenced, used and reimbursed in an optimal way. In particular, the impact of creating, interpretating and communicating real-world data was emphasised as critical.
This has created a need for having so-called ‘super medics’ with specialist medical skills as well as the ability to tell value stories, negotiate with governments, understand payer archetypes, understand and disseminate complex data to different audiences to meet their needs and expectations.
Table 1: The transformed role of Medical Affairs.
Medical Affairs – engaging stakeholders externally and informing strategic decisions internally
Medical Affairs teams are well placed to bring insights into all parts of an organisation and take information out to a broad range of stakeholders including clinical decision makers, payers and patients.
Consistently the interviewees discussed how the Medical Affairs teams act as a bridge between the company and a wide range of external stakeholders. These stakeholders stretch from professional and patient organisations, through to thought leaders, payers and patients. Each stakeholder has different needs, but at its heart, the Medical Affairs role is about communicating both a clinical and value story to address the unmet needs of patients. This also provides the opportunity to bring insights back into the organisation to inform strategic decisions. These actionable insights can be relevant to clinical and commercial colleagues thus we are seeing the Medical Affairs role as a bridge internally.
These observations are also supported in the literature: ‘Medical Affairs is increasingly seen to be playing a central role in coordinating internal company stakeholders (including commercial, market access, regulatory, clinical development and drug safety teams) with the needs of external stakeholders. Medical teams need to communicate data in a clear and consistent way and educate internal and external key stakeholders on the value of those data. ¹, ²
Industry Example: How different companies are organising themselves to bring insights into early phase clinical research The Medical Affairs team are now more involved than ever to bring insights early in the pipeline. In some companies this is a formal arrangement with clear prioritisation of Medical Affairs time in pre-launch whilst in others it is more ad hoc.
Medical Affairs – driving strategic decision making earlier in clinical development
Interviews revealed that current Medical Affairs professionals see Medical Affairs as having a stronger presence in early-stage clinical development in the future, acting as a bridge between science and the patient and impacting the prioritisation and decision making at Phase 2. The value of insights particularly around the unmet need of patients, as well as the potential evolution of the disease landscape over the next 5 – 10 years covering diagnosis, interventions and management, cannot be underestimated. Lastly the ability to communicate with R&D in a non-commercial voice was also raised. Most R&D teams do not see patients and healthcare professionals anymore – Medical Affairs can assist with bridging and translating the implications back in to inform what this means for future company direction.
Medical Affairs Focus: Medical Affairs in some companies get involved very early in clinical development – the greatest value is in sharing insights to help shape the clinical development of medicines to ensure that molecules gain a licence and are reimbursed. Without this early input from Medical, molecules may take longer to get to market, and may not be approved or reimbursed at all. Ensuring patient unmet needs are addressed is at the heart of this role.
‘Earlier involvement in pipeline and translating into one seamless end to end development and not hand over from one department to the next provides multiple benefits.’
Medical Affairs Focus: Some companies are looking to ensure the role of Medical Affairs is focused on pipeline and additional indications rather than in-market products. Asking the question’ where must Medical be and who else could do this?’ has led to this approach.
Medical Affairs – informing strategic decisions across the life cycle of a medicine
‘Medical is no longer a reactive function but has to become pro-active’.
In the past, Medical Affairs was often perceived as a supportive function to commercial, however, as the pipeline of pharmaceutical companies change to become more specialist, the Medical role is becoming increasingly important.
One interviewee had a vision for the medical team to become equal partners to the Marketing function in the development of strategic plans. This can be enabled through digital skills, leadership and business acumen and getting the whole Medical Affairs team working in the same direction with the right skills and capabilities. Some companies are approaching this through ad hoc training based on individual needs, others with an internal competency framework, but there is a clear need for expert partners to stretch and challenge the Medical Affairs team capabilities of the future. An additional theme was the need for Medical to use their insights to engage in and develop patient journeys. The message from the interviewees was clear – a robust approach to upskilling Medical teams in this rapidly evolving world is key to ensure teams are fit for the future. In addition, training to support the development of Medical Directors of the future also needs to start early given the breadth of role and expectation of organisations.
Medical Affairs Focus: Strategy is strategy whether led medically or commercially. We need our Medics to be the strategic leaders in an organisation and to earn this right through their strategic leadership and insight.
The role of Medical Affairs as leaders
As a result of such transformation, today’s Medical leaders need a broad understanding of many different areas, with the ability to have both a medical and business mindset. Translating the unmet need into a strategic approach and operating in a complex and diverse landscape both internally and externally are now key to being a successful Medical Affairs professional at any level. From day one, new Medical Affairs entrants to the pharmaceutical Industry will be expected to deliver across multiple teams in a collaborative and insightful way. Driving collaboration, leading others in a non-hierarchical way and having the ability to Medical Affairs Focus: Some companies are looking to ensure the role of Medical Affairs is focused on pipeline and additional indications rather than in-market products. Asking the question’ where must Medical be and who else could do this?’ has led to this approach. Medical Affairs Focus: Strategy is strategy whether led medically or commercially. We need our Medics to be the strategic leaders in an organisation and to earn this right through their strategic leadership and insight uptakestrategies.com 6 communicate the value of medicines to a wide range of stakeholders was seen as critical in our interviews.
Medical and Access will be the business leaders in the future with sales / marketing as support function. Medics need to be upskilled with business acumen and leadership’
Challenges of the Medical Affairs role transformation
One of the challenges of this transformation is the need for Medical Affairs to do more with much less time and to demonstrate the value created by Medical Affairs. This was a consistent feature within the interviews. Unlike commercial success, which can be measured through profit and loss, the success of Medical Affairs is largely measured qualitatively, making it more challenging for Medical to prove the value they add.
There are various suggestions both in the literature and from our research which inform potential ways of measuring and communicating the value that Medical Affairs can bring. One paper suggests ROI means ‘Return on Intelligence’ i.e., successes are measured by increases in knowledge6. The same paper also suggests ‘Share of Scientific Voice,’ a quantifiable measure of how a scientific message resonates across a scientific community over time, is another valuable metric for Medical Affairs6.
The Key Performance Indicator conversation was the most polarising in our interviews from those who felt that KPIs are less relevant when an organisation embraced the Medical role and what only it could deliver vs. those who routinely build comprehensive KPIs and dashboards to ensure they could clearly articulate the value that Medical Affairs could bring internally and externally. This is an area where there is clearly no consensus on a correct approach, and it may well need to be tailored to the organisational situation and role of Medical within each company.
In addition, Medical Affairs teams are now required to be innovators, bringing creativity and developing new ways to do both traditional and new activities with healthcare professionals. Companies are looking to support the team in a variety of ways such as deploying LEAN, 6 Sigma and AGILE capabilities to the Medical toolbox to further elevate the customer / patient to the forefront of thinking and to develop new ways of delivering value more quickly. This also supports moving from a reactive position to one of strategic leadership along with clearly articulating the value-add from their work.
What is the vision for a successful Medical Affairs function?
It is an exciting opportunity for anyone in a Medical Affairs team now or in the future to consider what ‘great’ Medical Affairs will mean. The list of potential roles in Table 1 demonstrates the breadth and depth that Medical Affairs professionals will need to build along with strong leadership all underpinned with a strategic approach. However, it appears that whilst there are similarities in approach across the 7 Medical Affairs – the future strategists of the pharma industry? companies involved in the interviews, there are also differences in scope, role and the potential evolution of Medical Affairs. Nevertheless, it was clear that it will not be enough to be ‘great’ at one element such as scientific knowledge and communication. In addition, business acumen to navigate an organisation and the decision making within that organisation is also key.
All of this work will require innovation as much will be ground-breaking. Channelling evidence generation in the world of Artificial Intelligence and Big Data through an understanding of science, data capabilities and stakeholder needs is a great example of this. Reimaging and personalising stakeholder engagement is another one. Patient centricity is another area which in some companies are being led by Medical. Curiosity, openness, and implementation of new techniques such as AGILE will ensure customer needs are at the forefront and encourage co-creation with those customers at all points on the journey.
One interviewee flagged the increasing gap between the head office and field Medical roles with the recommendation to clearly define what success looks like and build both competencies and training separately. Others were less vocal on the differences between field and head office roles with individuals moving successfully and seamlessly between the two roles if well supported and adaptable.
Key enablers of this change?
So, what did the senior medics we interviewed see as the enablers of this change?
It was clear that this will not necessarily be an easy journey, but it is critical. Such organisational change management requires a consistent and clear vision along with senior stakeholder endorsement and wide employee support and engagement.
Creating Medical 2.0
Collaboration with Medical Affairs, both internally and externally, is key for success. When it comes to Commercial and Medical teams, there is often an apparent lack of collaboration and a ‘them’ and ‘us’ approach is taken. Marketing’s perceived lack of compliance is often seen as the cause, however, if all parties can focus on the unmet need of the patient and customer and work within a compliance framework then there are many examples where the sum of the parts is magnified uptakestrategies.com 8 by a collaborative approach. Working together to build aligned customer and patient journeys across multi-disciplinary teams is a great way to start breaking down barriers. Being creative in bringing input and insights from other new entrants to healthcare, e.g. Google and IBM but also Medable, Teladoc and Livonogo7, to add to the internal knowledge is another area of value-add to consider. Additionally, partnerships can help to deeply understand the unmet needs of patients and customers. Pharmaceutical and biotech companies will not have all the answers and need to creatively consider who else has the insights and data to support understanding unmet needs. Again, Medical Affairs teams are well placed to consider and bridge these gaps.
Lastly another great example is co-creating customer engagement models. With the move to digitalisation and personalisation, customers want a single approach from a company that is tailored to their preferences. Despite these customer expectations, it will be challenging to get to a pull model, thus leadership and role modelling the behaviours that demonstrate this approach are crucial to help companies evolve and deliver.
Conclusion & recommendations
There is a strong consensus in the literature, validated by our interviews, about the evolved role of Medical Affairs in the pharmaceutical and biotech Industry. Through this research we learned there is a strong need to redefine the roles of Medical Affairs and the capabilities required, and for this to be underpinned with specific medical capability frameworks and development programmes to bring through the pharma strategy and ‘super-medics’ that the future industry needs. The value-add of ‘super-medics’ has the potential to be a game changer, with companies who invest in their medical team from recruitment onwards seeing significant reward in the leadership, strategy, innovation and outcomes delivered for patients and the stakeholders with whom they need to interact.
If you would like support with Medical Affairs capabilities training, please do get in touch with Uptake Strategies to discuss how we may help you. firstname.lastname@example.org
The authors Caroline Horwood, Senior Strategy Consultant and Medical Affairs Lead, and Sophie Stiewe, Project Manager, would like to thank the interviewed senior medics for sharing their insights, as well as Stephanie Hall, Maxine Smith, Kelly McDonald and Melissa Dagless for their involvement in conducting the interviews.
1. Sieffert, C. et al, (2018) Transforming the Medical Affairs Function. LEK Insights, Issue 54. Medical Affairs Function Transformed (lek.com)
2. Beelke, M. (2017) The Evolving Role of Medical Affairs: Opportunities for Discovery, Preclinical and Clinical Research. Journal for Clinical Studies, Vol 9(3) pp20-24
3. McKinsey & Company, (2019) A Vision for Medical Affairs in 2025. Mckinsey.com. https://www.mckinsey.com/industries/pharmaceuticals-andmedical-products/our-insights/a-vision-for-medical-affairs-in-2025
4. Groebel, R. The Evolution of Medical Affairs: A Changing Landscape | Veeva Video extracted 26/11/20. Veeva.com
5. Plantevin, L. et al, (2017) Reinventing the role of Medical Affairs. Bain and Company Brief. Reinventing the Role of Medical Affairs | Bain & Company
6. Laudano, J. Return on Intelligence – Medical Affairs ROI. Return on Intelligence – Medical Affairs’ ROI – Pharmaspectra
7. Cohen, D. et al, (2020) Healthtech in the fast lane: What is fueling investor excitement?. https://www.mckinsey.com/industries/pharmaceuticals-andmedical-products/our-insights/healthtech-in-the-fast-lane-what-is-fuelinginvestor-excitement