4 Cornerstones of Pharma Medical Affairs
Medical Affairs (MA) is an integral function within pharmaceutical and biotechnology companies and serves as a key connection to the wider medical community. In the late 20th century, the need to separate medical from commercial activities was widely recognized; as a result, MA departments were formed. Today, MA encompasses four “cornerstones”: insights generation, evidence generation, the scientific platform, and medical education. The first two involve understanding and addressing medical needs, while the third and fourth facilitate consistent, accurate, and relevant stakeholder education. Together, the MA cornerstones have become fundamental to the pharmaceutical industry, serving to support the medical community in alignment with the highest standards of medical integrity.
Insights Generation
Uncovering actionable ideas to inform medical strategy
In order to support the medical community in a meaningful way, we must have a clear understanding of its needs – this is the goal of insights generation. To achieve this, MA proactively gathers information from key stakeholders (including patients, healthcare practitioners [HCPs], and payers) about the patient journey, the treatment landscape, the product, and the regulatory and reimbursement environment. These insights are collected via a variety of sources – including, for example, medical science liaison (MSL) interactions, advisory boards, systematic literature review, social media – and are used as the basis for a comprehensive medical and brand strategy. This strategy is in turn translated into actionable drivers of value throughout each product’s lifecycle. The information collected can also be used to provide market-based strategic input to drug development and portfolio management. Overall, this process ensures that MA activities are based on the most pressing needs of the medical community.
Evidence Generation
Generate data to address medical needs or gaps in the scientific or clinical knowledge
Once a need has been identified, the next step is to address it with supportive evidence. MA achieves this by conducting a wide variety of studies, ranging from small interventional phase 2 to large observational phase 4 trials. In addition, real-world studies represent an area of growing importance, in which existing datasets can be leveraged to generate evidence more rapidly and less expensively than with randomized clinical trials. Digital advancements may enhance this further by using, for example, artificial intelligence to assess complex datasets that can include information from telemedicine and wearable devices. Other research activities MA supports include health economics and outcomes research (HEOR) activities (in collaboration with market access) and investigator-initiated studies (in partnership with academia and cooperative groups). Together, these activities can support local regulatory or reimbursement decisions, explore new potential indications outside of the Research & Development (R&D) plan, or demonstrate the value of a drug post-launch and throughout its life cycle.
Scientific Platform
Develop the core “story” of a product based on the scientific evidence
The scientific data that addresses a previously unmet need represents a scientific story that, to have a strong impact, must be communicated in a clear, accurate, and globally consistent manner. This is the purpose of a scientific platform – it harmonizes scientific communications across an organization to ensure that product and disease state information are reliably and optimally delivered to all stakeholders across all channels. Although led by MA, creation of the scientific platform is a cross-functional process (including R&D, HEOR, and marketing, among other functions) that is based on evaluation of the patient journey, the scientific literature, and feedback from the medical community. As a living document, the scientific platform should be periodically revisited to reflect any changes in the landscape or when new data become available so that it remains relevant. The core story outlined in the platform forms the basis of the medical education strategy and is the foundation of all subsequent medical communications.
Medical Education
Disseminate scientific data to the healthcare community
Once the cross-functional team has aligned on the central scientific story for a disease state or product, MA helps communicate this information to the broader medical community. MSLs, a pivotal role within MA, are the main point of contact for peer-to-peer medical education, as they have the responsibility of providing HCPs with timely and accurate information on the company’s medicines and research areas. MSLs work in synergy with two other important departments within MA: (1) Medical Information, which responds to drug-information inquiries, and (2) Scientific Communications, which disseminates data at medical congresses and in peer-reviewed publications. MA may also support independent medical education, for instance in the form of Continuing Medical Education (CME), and is also involved in training the sales force and other internal stakeholders within the company.
Although these four cornerstones reach into almost all aspects of the pharmaceutical industry, the role of MA is likely to grow and adapt even further, with greater emphasis on the patient (eg, outcomes that are clinically meaningful to patients and personalized medicine) and on innovative, digital approaches (eg, to reach target audiences). By building upon these four cornerstones, MA is poised to further strengthen the patient’s voice, thereby becoming true partners to patients, their families, healthcare providers, and the global community of which we are all a part.
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All the views, analysis, and perspectives are fully independent and belongs to the author only. They do not represent the views or opinions of any company or organization.