Future-Proofing the Medical Affairs Function 🚀

Carlos Eid (views are strictly personal)

Introduction

In an era where medical innovation is advancing at an unprecedented pace, the need to future-proof the medical affairs function is very critical. Acting as the bridge between development and commercialization, medical affairs plays a pivotal role in ensuring that the healthcare solutions are not only scientifically sound but also meet the evolving needs of patients, regulators, HCPs, payers and healthcare systems.

With the advent of personalized medicine, digital health technologies, and complex regulatory landscapes, medical affairs professionals must be equipped with the right skills and tools to navigate these changes proactively. Moreover, medical affairs should continue to play the role of the strategic partner providing strategic insights that drive the development of therapies that are safe, effective, and aligned with the unmet needs.

In order to future-proof the function, I have identified 8 key areas where we have the opportunity to improve and evolve.

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Shifting Gears: From Reactive to Proactive

• Being proactive does not mean engaging in inappropriate or unethical activities, such as discussing off-label data. Rather, it means being strategic and innovative in finding ways to deliver value to the stakeholders and the patients.

• Being proactive also comes with its own challenges and barriers, such as compliance, alignment, resources, or culture. We need to overcome these obstacles by being collaborative, flexible, and resilient.

For example, proactively conducting a comprehensive stakeholder mapping and analysis, in addition to seeking external insights while mapping the patient journey, helped us to identify the key opinion leaders, the unmet needs, and the gaps in the patient journey. This enabled us to design and implement a tailored engagement plan that addressed the specific needs and preferences of each stakeholder group.

Another one is how proactively getting involved in access discussions and understanding the unmet needs of the healthcare systems led us to propose RWE generation projects to better support decision making and improve patient access.

Finally, proactively seeking partnership opportunities with societies and patient groups led to impactful educational programs, registries and awareness campaigns, all aiming to improve health outcomes at large scale.

Key questions:

1. Are we in the driver’s seat, or waiting to be asked for support?

2. Do we feel our role is only being a data generator/disseminator, material approver and adverse event reporter, or these essential tasks and other ones as well?

3. Does our current structure offer us the freedom of taking initiative, co-creating and co-owning the strategy?

Equipping for Success: Building the Right Skillset

When thinking of the right skillset, we can list tons of competencies and skills that medical affairs professionals need in order to be successful. Things like insights, evidence generation, implementation science, market access, ... (the list goes on) However, If I want to highlight a few that I personally feel are crucial for the future, they are as follows.

• Scientific Knowledge and Expertise: This remains fundamental for interpreting complex data, understanding healthcare trends, new treatment modalities, and patient journeys. It should be continuously updated to keep pace with the rapidly evolving medical landscape.

• Digital Proficiency: As healthcare becomes increasingly digitized, proficiency in digital tools and platforms, including AI/machine learning for data analysis, evidence generation, stakeholder engagement, and insights management, is essential. This involves not only using these tools but also understanding their limitations and ethical implications.

• Business Acumen and Strategic Mindset: This involves understanding the broader business context, breaking silos, collaborating cross-functionally, anticipating future trends, and making strategic decisions that align with the organization’s goals and values.

• Effective Communication: This is the ability to articulate complex scientific data or collaboration/partnership proposals in a clear and understandable manner to various stakeholders. It also involves storytelling skills, negotiation skills and active listening to understand the needs and perspectives of others.

• Partnership Building and Management: The role of medical affairs professionals has evolved beyond being only the evidence generator, data communicator, and material approver. The ability to build and manage partnerships with external stakeholders to achieve a common goal is key. This involves understanding the needs and interests of different partners, finding common ground, and fostering collaboration and trust.

Key questions:

1. Are you actively building those skills (+others) and investing in your teams to be more impactful as the landscape evolves?

2. Are you able to balance the business operational needs with the individuals' development needs, offering them the opportunity to grow and remain relevant?

3. When hiring or promoting, what comes first? Titles, years of experience, degrees, or skills to get the job done?

Aligning the Stars: Balancing Short-Term and Long-Term

In the dynamic landscape of pharma, the tug-of-war between short-term focus and long-term goals is a constant challenge. How do we navigate this delicate balance?

Short-Term Focus: It’s crucial to celebrate quick wins and maintain momentum. These are the milestones that keep teams motivated and stakeholders engaged. Whether it’s a successful advisory board meeting, the launch of a new educational program or achieving a clinical trial milestone, these achievements provide immediate value and set the stage for continuous success.

Long-Term Goals: However, we must not lose sight of our ultimate mission – advancing patient care and impacting patient outcomes. This requires a long-term commitment with the right strategies such as continuous medical education, robust data generation plans, impactful partnerships, and successful thought-leader relationships.

Integration is Key: The secret lies in integration. By aligning our immediate tasks with our overarching objectives, we can ensure that each step we take is a step towards a larger goal. It’s about making strategic choices that serve both today’s needs and tomorrow’s aspirations.

Always be Adaptable: change is the only constant. We must remain agile, ready to pivot our strategies in response to new scientific discoveries, regulatory shifts, and healthcare trends.

Key questions:

1. Do you often feel that your organization focuses more on the short-term wins vs long-term commitments and outcomes?

2. What can you/are you doing to counter that as a Medical Affairs professional?

3. How do you balance the need for impactful partnerships, successful thought-leader relationships and evidence generation (all which require sufficient time to develop) with the pressure to deliver results and demonstrate value?

Navigating the Maze: Compliance & Transparency

When we mention medical affairs and compliance, unfortunately some people might say that we put complex processes in place like MLR, aiming to block or delay commercial teams from doing their activities. I also often hear that medical do not understand the business needs.

Compliance & Transparency may differ from one regulator or country to the other, but the essence is the same - conducting our business with the highest ethical and moral standards, ensuring we do our best for patients.

Before doing any activity ask yourself: Will I feel proud if my action/activity is mentioned as a headline in the newspapers tomorrow?

For me the core in whatever we do should be INTEGRITY.

I - Incorruptible: Upholding honesty and moral principles without compromise

N - Noble: Demonstrating honor, dignity, and ethical behavior.

T - Trustworthy: Reliable and deserving of confidence.

E - Ethical: Adhering to a code of conduct and moral standards.

G - Genuine: Sincere and authentic.

R - Responsible: Accountable for actions and decisions.

I - Impartial: Treating all fairly and without bias.

T - Transparent: Open and honest in communication and actions.

Y - YOU: you are responsible of your own integrity.

Key Questions

1. Are you acting as a role model by prioritizing patient safety and well-being in all decisions?

2. How can we optimize compliance and integrity processes to ensure both patient safety and efficient workflow?

Keeping the Patient at Heart

Patient-centricity isn’t just a buzzword; it’s a commitment to improving patient outcomes, enhancing their experiences, and ensuring that every decision aligns with their well-being. While many claim patient centricity we still see a lot of product centricity.... It is important that we keep the patient in our hearts and not only in our minds. How can we do that?

Understanding Patient Perspectives

Listening to Patients: actively seeking out patient perspectives. Engaging patients, caregivers, and patient advocacy groups to understand experiences, needs, and preferences.

Patient Journey Mapping: gaining insights into pain points, challenges, and opportunities, which help inform decision-making across medical affairs activities

Leveraging Patient Insights in research

Clinical Trials: Patient insights should guide study design, endpoints, and recruitment strategies.

Real World Evidence (RWE): RWE studies capture real world patient experiences, providing valuable data beyond controlled clinical trials. This helps inform treatment decisions.

Regulatory and Market Access Considerations

Health Technology Assessment (HTA):  Patient preferences, PROs and quality of life are important when preparing HTA submissions.

Patient Access and Reimbursement: Advocating for patient access to innovative therapies. Considering affordability and patient burden.

Patient Advocacy, Education and Support

Collaborating with Advocacy Groups: Partnering with patient advocacy organizations to amplify patient voices.

Educational (Awareness) Initiatives: Developing/Supporting patient education programs and webinars. Empowering patients with knowledge about their condition.

Patient Support Programs: Implementing programs to support patients during treatment, addressing their emotional and practical needs

Patient-Centric Communication

Clear and Accessible Information: Medical information, educational materials, and websites (where applicable) should be accessible, patient-friendly, and avoiding jargon/complex language.

Shared Decision-Making: Encouraging patient engagement and involvement in treatment decisions, allowing them to discuss risks, benefits, and alternatives while considering their values and preferences.

Key Questions:

1. How can we go beyond simply understanding patient perspectives and actively involve patients/patient groups as partners?

2. How can we measure or ensure that our patient-centric efforts translate into impact in patient outcomes and access to care?

Thinking Globally, Acting Locally

This topic is very specific to medical affairs at a global, regional or international level. However, some of the tips might even work locally (or you can influence change in your teams globally)!

Have you ever said or heard someone saying?

"The global team lives in their own bubble!"

"This does not help us locally!"

"These trial endpoints will not help us secure access."

"Are you listening to what our HCPs are saying?"

"We don’t think you understand our local landscape!"

The Potential Problem

There is a misconception (or truth in some cases) that individuals based in the global offices lack a comprehensive understanding of the unique nuances, requirements, and challenges that are specific to local regions.

There are often individuals in global teams that have limited experience working in-country, in the field, or engaging extensively with external stakeholders.

Furthermore, we often hear that a considerable amount of time and/or resources are often allocated to large-scale projects and initiatives... However, the value these projects bring to individual countries may not always be substantial, and their localization may be either unfeasible or extremely challenging.

Should we LISTEN more?

Learn & understand

Incorporate the right insights

Share best practices & learnings

Tailor our deliverables

Engage externally continuously

Never lose focus on impact

Learn & Understand

Learn about the dynamics and patient needs in your key markets. Don’t assume you know. Spending time with countries & seeking to understand the local landscape, challenges and nuances are important to ensure success.

Incorporate the Right Insights

Ensure that you gather the right insights from country interactions, advisory boards & other external engagements and incorporate them in your strategy and integrated evidence plans to help generate the right impact at the right time with the right stakeholders.

Share Best Practices & Learnings

Global teams play a pivotal role in spotlighting country-specific learnings and experiences. This helps create a global community and strong bonds/networks between colleagues worldwide. Additionally, they serve as a bridge, connecting countries that encounter similar challenges or share common needs.

Tailor Deliverables

As much as possible, ensure that your deliverables, whether they are medical education programs, evidence generation projects, congress activities, or even “slide decks” are useful/impactful locally (at least in your key markets). Recognize that a universal approach won’t work! Instead, co-create and allow room for personalization to meet specific local needs

Engage Externally

Leave your “Ivory tower” (as some refer to it) and try to consistently engage with local healthcare professionals (HCPs), patient advocacy groups, society members, and other external stakeholders. I truly believe that the most impactful leaders are those who started their careers in the field and still actively go there!

Never Lose Focus on Impact

Always keep your purpose and the ‘why’ behind your work in mind. It’s not a mere ‘tick-the-box’ exercise. As a global leader, your role involves co-creating impactful strategies, developing meaningful tactics, and actively contributing to improving patient lives on a daily basis.

Key Questions

1. How can we move from simply ticking the boxes to creating a culture of continuous, in-depth understanding of local needs? What specific metrics or success measures can we use to track progress?

2. How can we ensure that learnings and best practices from local markets are not just shared but actively implemented and influence global strategies

3. How can we empower local teams to have a stronger voice in shaping global direction?

Speaking the Right Language: Evidence Generation & Communication

Depending on the role (whether it’s local or global), the portfolio, and the size of the organization, the activities related to evidence generation and the role of Medical Affairs can vary significantly. However, I would like to share three key areas that I find crucial when it comes to evidence generation and communication.

The IEP (Integrated Evidence Plan)

Medical affairs leads the co-creation of an IEP, a cross-functional strategic approach to evidence generation that aligns the needs of the functions, in addition to the key geographies, across the life cycle of an asset. This strategic approach leads to focused evidence generation activities that meet the needs of regulators, payors, HCPs and patients.

(ultimately improving patient outcomes by generating the right data at the right time for the right stakeholder)

Beyond Ph I-II-III

Real-World Evidence (RWE) studies: They bridge the gap between research and clinical practice by designing and analyzing studies that leverage real-world healthcare data.

Implementation Science: They help develop strategies to ensure effective integration of new treatments into real-world clinical practice.

Phase IIIb/IV trials: They play a key role in informing long-term safety and efficacy data to support product positioning.

Investigator-Initiated Trials (IITs): They play a key role in reviewing and approving IITs, ensuring they align with the scientific priorities of the company and comply with ethical guidelines.

Tailored Communication

Medical Affairs acts as a bridge, ensuring the right evidence reaches the right stakeholder at the critical moment through the most effective channel.

This involves tailoring clear, concise, and targeted messages to specific audiences, such as HCPs, payers, and patients.

By delivering information strategically, we avoid data overload and support informed decision-making.

Key Questions:

1. How are we making strategic decisions on what data to generate?

2. Are we involving the right internal/external stakeholders and mapping their needs?

3. Are we communicating the right data to the right stakeholder at the right time using the right channels? Or are we taking a one-size-fits-all approach, potentially overloading stakeholders with unnecessary information?

Embracing the Digital Wave

Digital tools, tech and AI are critical for the future, but they need to be used at the right time and in the right setting- to empower and enable Medical Affairs. The future lies in creating a symphony of tech, science and HUMANITY! None of these elements is indispensable or can replace the other.

FIRST LET’S AGREE THAT IT IS MORE THAN A HYPE!

Tech is advancing at a phenomenal rate, AI is here to stay, and those who embrace the wave will have the competitive advantage.

How can we leverage tech and AI to enable us in the present and future?

Data Analytics and Insights

Leveraging digital tools and AI will help improve operational efficiency. Beyond evidence generation, data analytics and AI can help measure performance & impact, identify trends & opportunities, do literature reviews and most importantly manage all the different sources of intelligence we gather in order to generate actionable insights.

Medical Information and Inquiry Management

AI can help manage and respond to medical inquiries. It can provide timely, relevant, accurate, compliant, and up-to-date medical information to healthcare professionals, patients, and caregivers through different digital channels.

Medical Education & Scientific Communication

Traditional in-person interactions with HCPs are becoming less frequent due to time constraints, so HCPs are sometimes seeking on-demand learning like Interactive webinars, virtual simulations, and online educational modules. AI enhances this by tailoring learning to their research, activities, and interests, ensuring they stay current with medical advancements and guidelines

Stakeholder Identification and Engagement

AI-powered mapping platforms equip teams with the ability to identify key stakeholders, gaining insights into their expertise, influence networks, and digital footprint. This helps crafting targeted engagement strategies & activities such as advisory boards, clinical trials, and publications. Moreover, digital tools facilitate the execution of virtual engagements, significantly broadening both reach and influence.

Clinical Trials & RWE

Digital platforms can help in designing clinical trials and recruiting suitable patients. AI can also help in the collection and analysis of real-world data, which can aid in understanding the effectiveness, safety, and value of treatments in real-world settings.

Patient Engagement and Education

Mobile apps and online communities can provide patients with educational resources, connect them with others facing similar conditions, and facilitate communication with healthcare providers. Certain digital platforms can also provide personalized patient support programs, improving medication adherence and patient outcomes.

Some of the Potential Challenges

External

1. There are too many tools/platforms

2. No perfect holistic solution yet

3. Not all tools can be integrated together

Internal

1. Cost

2. Capabilities (Infrastructure & Talent)

3. Compatibility/Integration

4. Change Management

5. Data Privacy, Security & Ethical use of AI

Key Questions:

1. How long will it take us to properly embrace the technological advances and adopt them in our industry?

2. How can we keep a god balance of ethics, science, tech and humanity?

Conclusion: The Future of Medical Affairs - A Symphony of Expertise

The future of medical affairs is bright, but it requires a proactive approach. By embracing these key challenges turned opportunities, we can ensure medical affairs remains a strategic partner, driving innovation and improving patient outcomes.

This journey is based on a symphony of expertise. Scientific knowledge remains the foundation, but it must be coupled with digital savviness, business acumen, effective communication, and partnership-building skills. We must find the right balance between short-term wins and long-term goals, ensuring every step serves a larger purpose. Integrity is the key note in everything we do. Keeping the patient at the heart of everything is the crescendo. Thinking globally, acting locally ensures our efforts resonate on a regional and individual level. Speaking the right language involves generating the right evidence at the right time and communicating it effectively to diverse stakeholders. Embracing the digital wave doesn't just mean adopting the latest tech. It's about finding the right blend of technology, science, and humanity.

This is our call to action. Are you ready to join the symphony?