Like most life sciences veterans, I hate it when others in the community say we are just concerned with selling products. If you look at the entirety of life sciences organization efforts, in the process of selling their products, they are also ensuring the scientific advancement of disease understanding and treatments throughout the medical community. The result is an improvement in patient outcomes. Much like the relationship pollinators have to plants and the whole ecosystem, the continued new product efforts from life sciences companies (medical education, publishing, etc.) keep driving the understanding and treatment of patients forward.

For optimal utilization of a new product, a life sciences company must first empower healthcare providers with comprehensive knowledge on who, how, when, where, and why they might use the product. Without an empowered audience, no company can gain usage of any type of new product. Take for example, new software offerings. Many are now offering a free trial version which helps users to educate themselves on how to use it. As humans, education and understanding is how we gain empowerment. And, as Medical Affairs, one of the key areas where value can be added is the empowerment of stakeholders (e.g., provider, payers & patients) prior to the commercial entry of the product.

The ability to empower stakeholders is a key result of what I like to call the Enterprise Commercialization Process (ECP). The ECP is a fundamental process of each life science company and how we achieve improved patient outcomes. As members of a life sciences enterprise, all employees are striving to maintain the health of that organization, which, in this industry, means the commercialization of healthcare products that improve patient outcomes.

Understanding your company’s ECP and how it works is more important than ever. It helps to ensure your organization’s raison d’etre is continually optimized and an integrated effort is conducted effectively throughout the development process. Active participation in the ECP helps ensure the needs of the community are integrated into our decision-making processes, from product concept through retirement of the commercial effort. Keeping the ECP as a front and center consideration helps us focus on the community and the required steps to align and address the clinical treatment needs, be they improved capabilities, opportunity creation, or motivation. Successful life sciences commercialization requires a coordinated divisional orchestration of effort and asset value creation all along the ECP.

Medical Affairs is uniquely positioned within the organization, standing out as the only department capable of impacting the ECP at every stage. This unique role offers Medical Affairs the ability to significantly improve an organization’s chances of success by maximizing the value they bring to the ECP. From the initial product concept through the entire commercialization effort, Medical Affairs plays a pivotal role. They achieve this by:

• Encouraging decisions in product development that are driven by healthcare delivery needs.
• Educating and informing stakeholders (healthcare providers, payers, and patients) to empower them with the latest scientific knowledge.
• Facilitating a smooth exchange of knowledge between development and commercial teams, ensuring alignment throughout the entire process.

By performing these critical functions, Medical Affairs bridges the gap between different departments and guarantees that all efforts are strategically aligned with the stakeholder needs in the community.

Encouraging Community-Oriented Product Development Decisions

By engaging in and educating the development process, Medical Affairs can foster community-oriented decision-making during the critical product development phase. From assisting clinical development in the creation of a target product profile to conveying healthcare delivery dynamics, Medical’s influence can help shape the product data and claims that commercial relies on to generate awareness, trial and usage of a healthcare product.

Through its continuous insight generation, Medical can help the product development team identify unmet needs and better understand healthcare delivery dynamics and trends; thus, improving the likelihood of future patient/provider adoption of a proposed product development initiative. Such information guides critical decisions through improved understanding of the target patient population, necessary product data, and competitive differentiation. By understanding the community landscape and situation, development groups make more informed choices. For a company’s early-stage assets, informing these choices also enhances the value of the product in the community and to investors.

We all know that clinical trials are pivotal in demonstrating the safety and efficacy of a product, but they are also critical in generating evidence and information which can be used to further the product value in the community. Strategically focusing on the ECP encourages Medical to influence trial design, site selection, patient recruitment, and endpoint selection, in ways that positively impact the product’s value proposition. By aligning clinical trial objectives with the value proposition goal, the organization can gather robust evidence from the data which, in turn, supports eventual commercial efforts, including market access, reimbursement strategies, and rapid market adoption.

Educating and informing to empower stakeholders.

Within the life sciences industry, Medical Affairs play the primary role in educating, informing, and empowering a wide range of community stakeholders. Through a process of strategic planning and tactical execution, the Medical Affairs group creates a:

• Scientific Foundation: They build and ensure a product’s scientific evidence and data are aligned with the ECP and remains intact throughout the product’s life. This foundation validates a product’s value for commercial and sustains it in a competitive environment.
• Educational Initiatives: The Medical department spearheads educational efforts, equipping healthcare providers with nuanced scientific understanding. This empowers stakeholders, engenders trust and helps bolster a product’s credibility for commercial.
• Key Opinion Leaders (KOL) Engagement: Collaborating with KOLs, Medical Affairs enriches scientific discourse, fostering a network of influencers that advocate with their peers to improve product understanding and awareness.
• Evidence Generation: By continuing to generate scientific evidence, such as real-world evidence and post-marketing data, Medical Affairs bolsters a product’s profile and supports its long-term value proposition to community stakeholders and the healthcare system.

Medical Affairs teams empower healthcare providers through ongoing information exchange. Often using:

• Medical conferences and workshops
• Educational symposia
• Clinical data publications
• Development of educational materials

They provide the latest scientific information to inform physicians, nurses, or other healthcare providers. Whether pre or post launch, Medical’s dissemination of scientific advancements, clinical trial results, treatment options, and best practices related to the organizations products and therapeutic areas helps to empower providers with the current information to improve their patients’ outcomes.

Creating a smooth transition of corporate knowledge

• Medical Affairs professionals are essential in driving value creation and ensuring seamless knowledge transfer between development and commercial teams within pharmaceutical companies. Here are some strategies to facilitate a smooth transition of corporate knowledge along the ECP:Take the lead on fostering a culture of open communication and collaboration within the organization. By encouraging collaboration, knowledge sharing is increased and silos between functions begin to break down.
• Begin early collaboration in the development process. It allows a better understanding of the scientific rationale, target indications, potential risks and benefits, and future “go-to-market” strategies.
• Ask clinical teams to actively share the clinical trial data, research findings, and safety profiles to allow for early identification of potential key scientific points, value propositions, and gaps requiring further data.
• Organize joint training sessions/workshops where development and commercial teams exchange knowledge and discuss potential challenges and opportunities. This enhances understanding and collaboration all along the ECP.
• Collaborate with development teams to create educational materials and consistent messaging across development functions to accurately reflect the scientific data and clinical trial results.
• Solicit community insights, physician perspectives, real-world data, and feedback from commercial teams. This information can give a different perspective and inform future development work.
• Ensure post-marketing surveillance data and analysis is readily accessible to development teams. It can help identify potential safety concerns, track long-term outcomes, and inform future research efforts.
• Develop clear metrics and key performance indicators (KPIs) to track the effectiveness of knowledge transfer cross-functionally. This allows for continuous improvement and ensures that corporate memory is sustained and effectively utilized.

By implementing just a few of these strategies, the medical team can strengthen their role and ensure they are viewed as a key element in the ECP.

Conclusion

The ECP is pivotal in the life sciences industry, aligning focused decision-making throughout the product lifecycle. By integrating commercial considerations into development, clinical trials, regulatory strategies, and their own work, Medical Affairs helps their company increase the likelihood of product success. Embracing the ECP as the core framework of the organization, Medical Affairs departments will consistently add value to the organization and facilitate optimal commercialization of innovative products that address community needs and improve patient outcomes.

The ECP is an essential process in the life sciences industry, where commercial-oriented decision-making shapes product development, clinical trials, regulatory submissions, and market launch. Medical Affairs’ understanding and strategic engagement in the ECP throughout the product lifecycle fosters a community-driven approach, ensuring that innovation and healthcare needs go hand in hand. By facilitating the alignment of community needs with product development, Medical will continue to optimize commercial success, enhance patient access, and drive positive healthcare outcomes.