Medical Affairs: From Info Gatekeeper to Legitimate Value Driver

In its function of managing medical and scientific information for life sciences companies, accurate and trustworthy communication is a top priority of medical affairs departments. Traditionally, medical affairs is responsible for managing a company's external relationships with the medical and scientific communities, patients, and government regulators.

Today, the role of medical affairs is taking on greater importance, as relationships between life sciences companies and external stakeholders become more complicated. Medical affairs is required to communicate more often with medical practitioners, scientific researchers, patients, patient advocates, and government authorities, and to provide these groups with more complex and more comprehensive information.

Unfortunately, many life sciences companies still think the goal of medical affairs should be to limit and control the content that the company gives to external stakeholders. Enterprises often create "silos" within their organizations, where medical affairs, sales and marketing people, and clinical researchers don't share critical data. When this happens, medical affairs doesn't get the information it needs to develop productive external relationships.

In November 2013, Cegedim conducted a series of interactive workshops with medical affairs directors and consultants and life sciences industry executives to discuss solutions for the tasks and challenges facing medical affairs today. This panel of experts concluded that the ultimate goal of medical affairs should be to drive value for their company. Medical affairs should seek to:

» Strengthen the relationships between companies and their external stakeholders through more open and frequent communication.

» Foster better collaboration and exchange of information between internal departments in their own company, and between these departments and external stakeholders.

» Help to promote a positive image of the company as a reliable and trustworthy provider of drug products.

» Help companies to get products to market faster and increase sales.

To accomplish these goals, the life sciences industry must completely reset its approach to medical affairs. Companies must include medical affairs as a full partner in all stages of the drug life cycle, from R&D to commercialization, and must grant medical affairs full access to essential information from all parties involved in this cycle.

Trends dictating change

To understand how the medical affairs function has changed, one should look at the external and internal macro trends currently affecting the life sciences industry. The external trends include increasing healthcare costs, the changing dynamics in world population, environmental factors, and more informed patients.

The internal trends within the industry that companies must address include the increasing focus on specialty care products, and the acceleration of product development, as factors such as the R&D drought, faster launches of "me-too" products, patent expirations, and the emergence of competing generics are driving companies to minimize time-to-market and time-to-peak-sales for new product launches.

Medical affairs is the keystone

To address these trends, medical affairs must seek to develop partnerships between life sciences companies and their external stakeholders, based on the exchange of accurate, comprehensive, and trustworthy information about the product, the disease, care procurement, and patient management. To do this, medical affairs needs to have better and more complete access to information within their organization.

Developing successful relationships with external stakeholders relies on medical affairs being able to:

» Anticipate patient questions and government concerns to ensure compliant product delivery.

» Ensure the readiness of internal teams' expertise to handle external stakeholders' needs and concerns.

» Plan out the communication process and adapt content to serve the needs of stakeholders.

But to truly drive value, medical affairs must take the lead in fostering collaboration and open communication between teams in different departments in their own company, and between these internal teams and external stakeholders. This requires that medical affairs be included as a full collaborative partner in the product cycle.

Allowing medical affairs to get involved in the drug development process during the early stages of R&D provides the foundation for a successful product launch. Medical affairs can develop a technical expertise regarding the product, which enables it to:

» Better recognize the stakeholders, and deliver deeper understanding of product value to them throughout the drug life cycle.

» Identify quality insights about patient flows and scientific community networks.

» Improve compilation of comprehensive, reliable, and transparent medical information for the entire organization.

» Prepare market-facing evidence demonstrations to guide the product through the regulatory, market access, and launch steps.

» Anticipate and prepare effective education to address medical support demands.

» Create information flows that operate with agility and accuracy, support commercial teams while also managing risk, and ensure that communications remain compliant throughout the entire organization.

In terms of managing cross-collaboration of departments within their own organization, medical affairs should:

» Develop communication flows and information sharing across departments, allowing them to seize opportunities, mitigate risk, and better cater to customer needs.

» Plan effective training to ensure that commercial organizations master the required level of product understanding.

» Provide the right scientific input to access the market and develop the accounts.

Furthermore, medical affairs should be responsible for:

» Producing reports of clinical/observational and drug utilization studies, outcome research, and epidemiological data.

» Developing a risk management plan to identify risks associated with the product.

» Identifying and profiling scientific peers (i.e., physicians, scientists) who may wish to contribute information or collaborate in the drug development process.

» Managing inbound information (i.e., from scientific publications and medical conferences), and distributing it to the right people within their organization.

» Managing outbound information targeted to consumers (i.e., promotional materials) and to the medical and scientific communities (i.e., scientific publications, medical conference presentations, etc.).

» Keeping track of local implementation standards and regulatory principles in different countries to ensure that products are properly implemented in foreign markets.

Let them lead

While life sciences organizations may be reluctant to give their medical affairs departments this much access to and control of information, the cost of not doing so can be even worse. A few extreme cases have received considerable media attention, where patients experienced negative health outcomes after getting inaccurate information about a medication. This kind of patient outcome can damage a company's reputation, and may result in product recalls, cancellation of market authorization, and loss of profitability.

Allowing medical affairs to take the lead in developing collaborative relationships between internal and external stakeholders can only benefit the company. It helps to foster an open exchange of information that can provide valuable insights and calls-to-action to product developers, help speed product time-to-market and time-to-peak-sales, and help to ensure that all products and communications meet regulatory compliance.

Also, the ability of medical affairs to effectively enable these external/internal collaborative relationships is a key driver in promoting a company's positive public image. It helps to develop a lasting rapport and trust with external stakeholders, making them more likely to recommend the company and depend on it for quality drug solutions.

Pierre Morgon is Chief Marketing Officer, Cegedim Group. He can be reached at Pierre.morgon@cegedim.com.