Medical Affairs in Building a Value-Based Healthcare System

In an interaction with India Pharma Outlook, Dr. Dyotona Sen, Head of Medical Affairs and Clinical Research at Galderma, emphasizes Medical Affairs and Clinical Research as strategic pillars in the pharmaceutical sector, highlighting data-driven innovation, patient-centric approaches, and collaboration. Key trends include rapid evidence generation, AI-enhanced engagement, and leveraging digital tools for optimized clinical outcomes. An accomplished leader with over 13 years of experience, Dr. Sen specializes in strategic medical affairs, personalized medicine, and compliance. Renowned for her patient-centric mindset, ethical practice, and mentorship, she is recognized as both a thought leader and an effective mentor.

How do you currently see the role of Medical Affairs and Clinical Research evolving within pharmaceutical enterprises, and what key trends are shaping this transformation today?

The Healthcare Ecosystem comprises 4 major pillars: patients, physicians, providers and policymakers. The pharmaceutical Industry is the face of “Providers” in this evolving healthcare ecosystem, with an emphasis on personalized medicine, targeted remedies & patient centricity. As innovation transforms the healthcare landscape, science and data are becoming the foundation for pharma to meet its obligations to patients and customers—and realize commercial opportunities. This imperative has accelerated the evolution of Medical Affairs and Clinical Research as key strategic pillars of an Organisation, along with Commercial. Medical Affairs and Clinical Research play a critical role in building the voice of the patient into Pharmaceutical Innovation and are thus imperative to the creation of a value-based healthcare market.

There are 4 critical trends that are shaping this transformation today:

Innovate evidence generation: Need for rapid and integrated evidence generation across Phase IIIb/IV studies, RWE, and HEOR, embedded in data-informed prioritization to address evidence needs and reduce quantifiable patient unmet needs.

Accelerate access: Generate high-quality evidence and content to enable access and drive changes in access and healthcare delivery across the healthcare ecosystem for the benefit of all patients.

Transform medical engagement: Orchestrate data-backed and AI-driven tailored medical affairs omnichannel engagement to upgrade medical decision-making across physicians and patients.

External collaboration and partnerships: Establish long-term and strategic partnerships with the clinical community and drive impact through co-creation.

With real-world data becoming crucial for regulatory submissions, ensuring data quality and consistency is increasingly challenging for Medical Affairs teams. How are businesses addressing these issues?

Digitalization has brought new transparency to the medical landscape by democratizing healthcare. It can harness new insights through novel types of data and analytics, such as applying AI to clinical trials, RWE, customer interactions, and internal data—as well as by providing new ways for pharma to connect and engage with stakeholders. Medical Affairs is at the center of action for data generation since data quality and consistency ensure that it can also be repurposed when the need arises —for instance, RWE data is being accepted for label changes; in many cases, it will also be available in real-time, including big data. Patient-reported outcomes (PRO) will soon become the norm across all trials, with some outcomes also monitored in real time.

Best-in-class RWE requires:

A deep understanding of stakeholder evidence needs

An evidence-generation process that is continuously refreshed and agnostic to data type as long as it gets to the right insights

Deep expertise in all forms of evidence generation(including novel data-generating technologies) such that the Medical, Clinical, & Regulatory teams know when and how to utilize and apply it.

The need for collaborative RWE developed in partnership with industry, academic physicians, medical societies, and others.

In what ways have collaborations between Medical Affairs, R&D, and Commercial teams strengthened pharmaceutical strategies, and how can these relationships be further optimized?

The Indian Pharmaceutical Industry (IPM) has been recognized as the “pharmacy of the world” for several decades. It commands over 20% of global generics supply by volume and addresses approximately 60% of the worldwide demand for vaccines. The IPM aspires to reach the milestones of US$ 130 billion by 2030 and US$ 450 billion by 2047. In this context, it is important to note that a McKinsey report, “A Vision for Medical Affairs 2025”, outlined that Research & Development, Medical Affairs, and Commercial & Market Access are the 3 strategic pillars of a Pharmaceutical enterprise. It is important to note here that the attributes used to explain the role of Medical Affairs as the bridge between R&D and Commercial are “Highly strategic,” “In-market data generation,” and “In-market monitoring.”

Strategic Medical Affairs is seen as a Business Partner by infusing science into Business growth through:

Customization: New product ideation and development is a critical lever in the life cycle of every product. This comprises formulation improvements, delivery system changes to address specific unmet needs, and designed to improve patient compliance.

Closed-loop process: MA teams can benefit by evolving from a linear process to a more closed-loop approach. Avenues for this approach include ongoing data curation of existing evidence, creating more personalized questionnaires for HCP feedback, and analyzing it for adapting or improving existing medico-marketing strategies.

Empowerment through Tech collaboration: MA is a pivotal function to reflect customer needs and allow real-time adaptation to changes, in those needs. This will help accelerate access to treatments and transform and personalize medical engagement. Hence, MA can integrate its divergent tasks to form unified pathways, to best optimize the critical relationship between R&D, Medical Affairs & Commercial teams.

How has the growing focus on patient-centricity influenced the direction of clinical research, and how is Medical Affairs helping to ensure this remains a strategic priority?

Patient centricity is central to best-in-class Medical engagement. Enhanced understanding of customer journeys—whether this be the physician, patient, or consumer journey—provides multiple benefits, including the acquisition of valuable knowledge and insights. Prescriber and patient journey maps are designed to represent people’s needs, mindsets, and emotional ups and downs during the full course of therapy: they highlight challenges and opportunities from the prescriber or patient’s perspective and reveal the pain points and major reasons for understanding and choosing therapy, as well as its rejection or discontinuation. Moreover, the personalization of healthcare for the consumer is critical due to a distinct shift from Disease Management to the Wellness experience. Thus, patient-centric insight generation is the need of the hour for Medical Affairs to lead a revolution in improving outcomes for patients with innovative approaches to the use of real-world data.

Medical Affairs can engage patients more directly and in ways that meet them where they are already getting their information to support them in their treatment journey e.g. patient advocacy groups. Inclusion of patients and consumers early on, in their journey, will enhance patient autonomy, resulting in improved adherence rates, reduced disease severity, and improve overall patient engagement in their healthcare journey.

In summary, Medical Affairs must embrace enterprise leadership, devoted entirely to improving patient outcomes. MA can thus act as the voice of the consumer, patient, and physician internally and the medical voice of the company externally.

With the increasing integration of digital health technologies, how is Medical Affairs leveraging these tools to enhance clinical trial efficiency and medical insights?

The amount of healthcare data available is estimated to have reached 2 zettabytes, or 2 trillion gigabytes, in 2022. This explosion in data provides a unique opportunity for better medical affairs decision-making.

Medical Affairs has begun to focus on 3 key priorities to deliver the promise of integrated data and analytics:

Establishing medical data and analytics capabilities: A clearly articulated digital and analytics strategy, including critical use cases, requires resources, and the road map forward is necessary. To generate immediate impact, the initial focus can be existing data sources and tools to help build the case for additional investment in more advanced analytics, automation, richer data sets, and performance-tracking systems.

Integrating digital and analytics into day-to-day decision-making: The fast-evolving landscape of data, analytics, and AI is already revolutionizing the way medical affairs operate. Thus, analytics can be integrated into everyone's daily decisions in medical affairs to generate and test hypotheses, inform prioritization, and rapidly measure impact. For example, data that quantifies the education needs of individual HCPs can be used to focus medical engagement on those who most need it and monitor its impact on care delivery.

Automating repetitive non-core activities: With expanded expectations for medical affairs, teams will need to operate at the top of their potential. They will need to prioritize the high-impact activities while deprioritizing but still delivering traditional activities, such as medical reviews and medical-information standard responses. Automation, including recent breakthroughs in gen AI, could significantly increase efficiency across all medical affairs. For example, gen AI can scan a broad range of sources, including external interactions, social media, surveys, trial data, and real-world data, to instantaneously produce insights and recommendations for evidence-generation plans, medical strategies, and other applications. Moreover, an emerging gen AI capability could also observe and generate actions in the digital or physical world to optimize medical processes such as medical review.

As the pharmaceutical landscape continues to evolve, how do you anticipate Medical Affairs and Clinical Research will drive future innovations and address emerging challenges in healthcare?

Evidence generation forms the foundation of all transformative science-led organizations, and Medical Affairs and Clinical Research are the 2 critical pillars of the same. These two functions must utilize advances in data capture and analytics capabilities to integrate information and derive insights on how to improve health outcomes. It will be critical to make available any data that supports the medical and economic impact of treatment throughout the entire product lifecycle to impact development and commercialization activities as well as to help shape treatment paradigms.

Moreover, Medical Affairs can lead from the front in enhancing compliant cross-functional collaboration to sharpen strategy. A collaboration model across Medical, R&D, and Commercial can commit to developing an integrated strategy for each therapy and collecting and sharing insights about external stakeholders across the organization to elevate cross-functional strategy.

The third and most important lever for the medical affairs and clinical research functions is the Scientific Exchange. Scientific exchange requires a strategic shift in focus from marketing and selling treatments to understanding and solving the ‘patient problem.’ From an internal perspective, enabling scientific and medical discussions can help incorporate the patient-centric viewpoint into strategic R&D and commercial decisions. When directed externally, the exchange can act as a conduit to help integrate the efforts of industry, academia, and government agencies around meeting patient needs.