Medison Pharma Trading AG

Gerd Möller

All patients, wherever they are in the world, have the right to get access to the best available novel treatments. Physicians and scientists working in medical affairs (MA) function in the life science industry want to make this happen. Their medical knowledge and their work help biotech companies to accelerate product launches in countries around the world and reach more patients. MA contributes as a key player in achieving such common strategic goals.

The MA function is as a service provider, medical expert and strategic partner following medical, ethical, regulatory and legal standards for all matters where internal and external clients need medical expertise and scientific understanding of specific diseases, company´s drugs or product groups.

MA is uniquely positioned as a partner at the interface of the various stakeholders in the healthcare sector. It steers scientific conversations around critical issues and potential gaps that may impact commercialization down the road. MA acts as a bridge between research and development (R&D) and commercial. Medical teams engage early with commercial, market access and clinical teams to contextualize the healthcare ecosystem for successful product launches. This allows MA to drive a scientific scenario that defines clinical endpoints and improves patient recruitment efforts.

MA has always played a crucial role throughout a product’s lifecycle. Traditionally a support role, during the last years, the MA role has evolved very much. The role moved at pace from one of support to one of leadership. The function has never previously been so well positioned to lead enterprise strategy and generate internal and external change. The transformation of MA from a communicator to a key strategic player makes this function so important for the success of innovative biotech companies. In addition, the rapid development of new communication channels and ways of working has brought a number of adaptations to how MA works and communicates with HCPs and other key stakeholders.

Today, the main contributions of MA are:

Strategy Development: MA operation provides market insights and strategic thinking. MA is using its extensive scientific expertise to inform short- and long-term planning strategies across the product development lifecycle, from understanding product attributes and current standards of care to competitive landscape and customer insights. Based on this, medical is delivering a strategic medical direction to the organization. Medical operation develops and communicates the strategy. MA is the voice of the patient, working at the highest levels of the company to shape strategy to provide patient value. This is a unique differentiator for the MA function.

Insight Generation and Leadership Role: Medical understands the difference between data/information and insights. It develops insights that matter and shares them with impact both externally and within the organization, e.g., to shape the brand or R&D strategy to improve outcomes for patients. Rapid insight generation enables MA to steer the company in the right direction. Medical identifies what are the priority areas to explore using a patient journey map and aligned to brand strategy.

Shaping the Brand Plan: The medical function reviews the annual brand planning cycle that exists across the global and local levels. The medical team adds value at multiple points along the brand planning journey, including strengthening the competitive situation through evidence generation and pulling in HCP, payer and patient insights. 

The medical plan is developed as part of the brand plan. Medical understands the importance and the requirement to internally network to engage multiple functions for further brand development and life cycle management. MA's responsibilities for late product development include developing a medical narrative for a product to address the key needs of the medical community.

Multichannel Medical Communication: MA continues to adapt and gain competencies in the evolving digital world. A tactical multichannel MA plan as part of a holistic brand communication strategy is created. Medical has a range of tactics available across digital, hybrid and face-to-face channels. In addition, multichannel medical communication influences the quantity and quality of medical insights positively.

Market and Stakeholder Engagement: People working in MA engage in scientific exchange activities with key opinion leaders (KOLs) independent of sales departments. Through these activities, MA ensures that patients receive optimal medical care. Medical is engaging with stakeholders and understands the power of networks. Medical function plays a critical role in engaging externally to share scientific information. It covers practical topics from a medical perspective to understand what a KOL is and how to develop/execute an engagement plan with a KOL of relevance linking to the brand plan. HCPs and patient-centric medical engagement tactics are created and aligned to clear objectives and brand priorities. Key steps are defined to implement medically led projects working with key external and internal stakeholders.

Evidence Generation: Medical can identify gaps in the evidence requirements to augment randomized controlled trials (RCTs). The next step involves planning to address the gaps. Medical can establish an integrated evidence plan (IEP) for MA and beyond. MA departments aim to fulfill unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. The use of real-world evidence (RWE) for regulatory and commercial purposes can be optimized.

In summary, the future of MA function in the biopharmaceutical industry is bright. MA has taken advantage of its existing and evolving capabilities to broaden its scope. It is uniquely placed and can share valuable insights. MA teams have excellent therapeutic area and product knowledge. Tremendous emphasis is placed on internal and external stakeholders. Agile, high-performance MA teams match the company´s strategic and brand strategy goals. MA is on the front lines of engaging with the medical community, understanding the successes and challenges as they unfold and helping the broader organization evolve as needed. The function is further involved across the biopharma value chain, from early scientific leadership pre-launch to external stakeholder engagement post-launch. MA has taken on a leadership role, and MA professionals have the opportunity to lead strategic decision-making. Moreover, crucial medical affairs capabilities, such as medical insights and real-world evidence generation, create unique opportunities to shape enterprise strategy. Together, MA has become a powerhouse for added value and brand success to accelerate the access of innovative therapies to patients in countries around the world.