It has been said knowledge is power. Throughout the ages, healthcare professionals have been revered as powerful not only for their medical acumen but for the ability to heal the sick. Today as therapeutic options become more complex, physicians need to continually update and expand their knowledge base to stay current and provide the best patient care possible. Medical affairs professionals within the pharmaceutical industry, given their scientific background and training, have the ability and distinct opportunity to help fill this information gap and establish themselves with their “physician base" as a trusted source for scientifically sound medical communications. The Evolving Role Over the last decade, the medical affairs function has continued to evolve as a core competency within the biopharmaceutical industry. Now more than ever before, medical affairs is increasingly involved in strategic medical communications planning and implementation across the product lifecycle, including lifecycle management post initial indication approval. With this expanding role comes the responsibility to prepare the medical community for new treatment concepts and advances from the clinical research stage through preparation for an indication. Opportunities include disease state awareness, publication planning, product launch communications, and post-launch phase IV planning. These activities often require the assistance of medical communications agencies that specialize in various disease states and have proven success with strategic planning and tactical implementation. Historically, for example, the responsibility for strategic planning solely resided within commercial teams. Now we are beginning to see this task shift in the prelaunch phase to a function initiated by the medical affairs team with strict adherence to sound scientific interpretation of data and its implications, whether product-specific or disease state or both. In this role, the medical affairs professionals provide great value to their corporate colleagues by helping to bridge the science with commercial aspirations. In a similar manner, the medical affairs teams may assist external thought leaders and clinicians by providing a solid understanding of specific disease states and the corresponding role of pharmaceuticals; in other words, helping all medical professionals stay current and translate cutting-edge science to address clinical needs and potentially provide better patient care. The figure to the left provides an overview of the breadth and length of engagement medical affairs teams must now contend with as novel compounds move from “the bench" to the marketplace as viable therapeutic options. Responsibilities Shift as ­Compounds Move Toward ­Approval To succeed in this paradigm shift with a myriad of new responsibilities and multiple key stakeholders, medical affairs may “take a page" from their commercial counterparts’ playbook. Creation of and adherence to a broadly focused, systematic strategic plan that ultimately supports the product vision and is aligned with its scientific foundation and clinical development plan will help mobilize medical affairs efforts and demonstrate unique value to their colleagues and customers. This is a prime example of how the medical affairs role has expanded in the path-to-approval process. In the recent past, the medical affairs function was often more narrowly defined within many companies and the majority of strategic responsibility resided with the commercial teams. Here again, collaboration with a medical communications agency experienced in how the industry brings new therapeutic options to market can provide medical affairs teams with the framework and support to meet the needs of various key stakeholders. Additionally, skilled agencies should be familiar and up to date with best practice industry regulations and guidelines, which can help medical affairs teams to ensure compliance and high-quality scientific activities. Another case in point is the communication strategy element, a key plan driver, which requires a critical assessment of the disease state/therapeutic category to identify areas to improve disease awareness and focus the scientific foundation. Yet again, we see the value of scientific teams taking the lead on planning, developing and validating the scientific foundation and corresponding communication points. At this point, the team also has the opportunity to inform the appropriate language and terminology that most completely and uniquely describes a compound’s attributes and its place in therapy. With an informed and rational communication strategy, communication point matrix, and data dissemination plan in place, medical affairs, as one of their core competencies, can gain support and input from the primary audiences (e.g., thought leaders, investigators, clinicians, payers, and patients) on the overall strategy. These insights are critical to understanding and verifying the educational needs and translating the science to address the clinical imperatives. Armed with a roadmap for how to communicate the science of a disease state and new therapeutic entity, medical affairs staff can assume the leadership position for supporting and educating their internal and external colleagues. Medical affairs personnel by virtue of their role and training are perfectly positioned to achieve this goal. Educating the Clinician Community As new therapeutics make their way through clinical development, NDA submission, FDA approval and ultimately into the market, research scientists, clinical investigators, thought leaders, and clinicians all play a part in advancing scientific discovery and bringing solutions to patients in need. Medical affairs teams build relationships with medical professionals in each of these segments and tap into their areas of expertise for various purposes. Medical liaisons, in particular, have the opportunity to foster scientific exchanges with their medical colleagues, whether with thought leaders as expert educators or practicing clinicians looking to learn about new treatment options or how to improve patient care. As the graphic above depicts, experts from influential physician groups can foster collaboration globally and form communities of educators within key therapeutic areas. For medical affairs, these communities may provide valuable insights and a forum for various educational exchanges, which can be implemented as live events and/or in virtual formats. Engage Experts in Activities That Provide Clinical Value These interactions, whether one-on-one or in group settings like advisory boards, can incorporate best practices to ensure professional dialogue, authentic feedback, and unbiased data sharing. For example, any planned physician group discussions can be guided by a needs assessment and corresponding discussion guide, which can help identify key issues needing clarity or exploration and set a framework for constructive feedback. Any formal interaction between healthcare providers and a medical representative of a pharmaceutical company can have specific objectives that ensure an educational discussion and promote sound scientific exchange. A Driving Force for Innovation To that end, educating clinicians on advancements in our knowledge of disease states and novel compounds is a critical component of building advocacy at a grassroots level. With current technological platform advances (e.g., iPad applications, tablets, and web-based technologies), medical affairs leaders can build content with experts and disseminate the information through multiple channels and media. Through innovative techniques, education based on instructional design principles with interactive capabilities can be delivered to large numbers of healthcare providers within a variety of settings and even at the point of care. This approach affords cost-effective delivery and proven comprehension and retention of information and key concepts. The Road Ahead Medical affairs, as a distinct function, has existed within the pharmaceutical industry for several decades. The primary role has always been to engage in scientific and educational exchange with experts, practicing clinicians, and allied health professionals. With fairly recent industry changes including more conservative regulations and governmental scrutiny, this function has had to stretch and grow beyond its originally conceived charter to include not only physician education but also taking on a more pivotal role in managing the strategic scientific components involved in bringing a therapeutic advance to market. This functional balance can be difficult and cumbersome to navigate, and medical affairs teams will need to continue to be vigilant and compliant with their own and the industry’s rigorous standards. This has become a highly visible and critical role within individual companies and throughout the industry, especially with the advent of healthcare reform. The need to provide the world population with quality, affordable healthcare has never been greater and the wealth of information for healthcare professionals to sort through has never been more daunting. Therapeutic category experts and practicing clinicians alike can benefit from a trusted source that provides timely scientific information combined with quality clinical debate and practical knowledge that ultimately may lead to improved patient care. Knowledge is power…in this case, the power to affect the quality and delivery of our healthcare. Medical Affairs: The Catalyst for Effective Medical Communications Contributed by Debra Joyce Senior VP, Managing Director SCI Scientific Communications & Information, part of Ogilvy CommonHealth Worldwide Responsibilities Shift as Compounds Move Towards Approval Engage Experts in Activities That Provide Clinical Value SCI (Scientific Communications & Information (www.scicominfo.org), a wholly owned separate legal entity within the Ogilvy CommonHealth Worldwide network (www.ogilvychww.com), is focused solely on the specific needs of medical affairs and R&D teams in pharma, biotech, and device manufacturing.

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