| |DECEMBER 202419With 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 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
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