The Medical Affairs-Marketing Connection By Denise Myshko A changing regulatory environment is mandating that there is better collaboration between the medical affairs and marketing departments of pharmaceutical companies. These two groups are forging stronger relationshiPS for better product life-cycle management and the development of postmarketing studies. I f recent regulatory actions have taught pharmaceutical marketers anything, it’s that there has to be a balance between commercialism and education. Achieving this balance requires a harmonious partnership between two divisions within a pharmaceutical company: medical affairs and marketing. These two groups have to function effectively together to deliver a comprehensive marketing and educational message in a compliant manner. This focus on realigning roles and responsibilities arises from a heightened regulatory environment. The Office of the Inspector General (OIG) released Compliance Program Guidance for Pharmaceutical Manufacturers in April 2003. This builds on the voluntary Code on Interactions with Healthcare Professionals finalized by the Pharmaceutical Research and Manufacturers of America (PhRMA) in July 2002. The regulation aims to assist companies in ensuring ethical relationships with physicians and other healthcare professionals. The spirit of the OIG Guidance is to ensure that all interactions with healthcare professionals concern the delivery of scientific or educational product information. These regulations result from ongoing consumer concerns about the sales and marketing practices of pharmaceutical manufacturers. “The OIG guidance shut down a lot of previous sales and marketing tactics,” says Colin W. MacGillivray, Ph.D., principal and director of the life-sciences practice with Inforte Corp. “This raised the bar on marketing and pushes it to be more focused on patient care, scientific research, and medical issues. Strong collaboration with medical affairs is a competitive advantage in this environment.” Traditionally, medical affairs departments advise marketers about the technical and medical aspects of anything that would touch a marketed product. They provide medical information to physicians who request it. They do pharmacovigilance assessments. They review promotional material for scientific and medical accuracy. They are involved in publication planning and the training of sales representatives. An emerging role for medical affairs is involvement in postmarketing studies. “One of the responsibilities of medical affairs is shepherding the product once it actually has received its license to accurately reflect its adverse event profile in the real world,” says Michael J. Sumner, M.D., senior director of medical affairs, North America, at Aventis Behring. “There is more emphasis now on postmarketing surveillance studies to understand and get a more accurate picture of the product. My view is that medical affairs should work hand in hand with marketing on this to ensure the knowledge gained can, wherever possible, be turned into a market advantage.” There has been an evolution over the past few years regarding Phase IV studies, says Richard Gliklich, M.D., president and CEO of Outcome Sciences Inc. “Four or five years ago, many postmarketing or Phase IV studies were initiated by marketing departments. Over the past few years, that role has clearly been moving into the medical affairs department, and some sponsor companies have created medical affairs departments, though that’s not true of every company.” Medical affairs teams also are becoming more involved with investigator-initiated trials, says Gary J. Borchard, senior director of business development at MetaWorks Inc. “With individual physicians who are interested in conducting a trial on their own for a marketed drug, medical affairs would make sure these trials were being conducted properly, that the person doing them was capable, and that the trial was aligned with the strategic plan of the company.” Dr. Gliklich agrees. “Medical affairs is integral to identifying the scientific needs that must be addressed from a real-world perspective and translating those needs into the requirements of the study protocol.” “The medical affairs and marketing departments were once siloed but that is changing,” says Cyndi Verst-Brasch, Pharm.D., VP of medical affairs, marketing, and communications at Kendle International Inc. “Now, more than ever, there is a deep appreciation for life-cycle management. Medical affairs is getting involved with marketers to address patent-life extension and longevity. They are collaborating to assess whether a new formulation would be able to extend a product’s patent life or whether a new indication is warranted, as well as to appropriately manage that in a very prospective manner.” “Collaboration between marketing and medical affairs can help to align the marketing message with research data,” Dr. MacGillivray says. “Marketing should be monitoring all the data and literature that are available on a compound from the very beginning. This is a knowledge-management challenge. Through the product life cycle, the body of knowledge about a product grows and evolves and this information can be medical in nature. Marketing can collaborate with medical affairs to interpret this information and to refine the message accordingly.” Dr. MacGillivray says a common complaint among physicians is that the same information is recycled by pharmaceutical reps so the value of interactions is diminished over time. “The wider problem is that market positioning and publication programs often fail to evolve,” he says. “As the product life cycle proceeds, more studies become available and the questions being asked by physicians can also change. Medical affairs and marketing can work together to develop compelling messages and integrate these into a staged publication and marketing plan that evolves with the product life cycle.” Effective partnerships between marketing and medical affairs require an understanding of each department’s objectives, as well as the objectives of the company. “There needs to be an understanding of the expertise of each different functional area and how each can support the other to provide the various elements that are needed to meet those objectives,” Mr. Borchard says. “Medical affairs and marketing each bring a different talent to the table, and they need to combine those talents to have an effective program to market their drug.” Dr. Verst-Brasch says a top-down approach is needed to foster this integration. “In some cases, companies may need to structure the organization so that there is a middle layer to allow for optimal collaboration between medical affairs and marketing departments,” she says. “I came from an organizational structure within the industry that facilitated this interaction between medical affairs and marketing. We were ‘bilingual’ in the sense that we were able to communicate with both medical affairs and marketing to understand the real needs of each and foster an integrated, collaborative approach.” Medical affairs and marketing should establish shared goals in support of commercial growth of a product, says Kathleen Killmeyer, VP of business development at Dimensional HealthCare. “The two departments should not work as silos, but rather, have shared goals for defining strategy and tactics that consider the emerging competitive landscape of a product,” she says. “Advisory boards should be conducted, including members from both teams, to outline a foundation for a clinical plan to assess the outcomes in various patient populations, as well as determine any risk the product may pose when introduced into a usual-care environment.” Industry leaders, however, say there are some challenges to ensuring effective collaboration. “Medical affairs and marketing often have been quite separate organizationally,” Dr. MacGillivray says. “This meant there were separate missions, separate personnel, arguably different types of personalities, and fundamentally different ways of approaching the world. It takes a lot of hard work and persistence to work through those legacy issues and achieve the right kinds of collaboration.” These different perspectives often are a result of the way the members of each group are trained, Dr. Verst-Brasch says. “Medical affairs personnel, by and large, are scientifically driven,” she says. “They are trained to ensure regulatory and legal compliance. They usually are long-term oriented. Moreover, they are primarily focused on the regulatory approval of a product and gaining this approval in a timely and cost-effective manner. Marketing people, on the other hand, are trained very differently. They are short-term oriented and are primarily focused on gaining rapid market share and product success in the marketplace.” This difference in approach can occasionally strain relationships, Mr. Borchard says. “When I was in marketing, there were times when adversarial situations arose,” he says. “I would go to advertising promotion and review committee meetings where we would sit down with the medical affairs and regulatory folks to discuss our planned marketing activities. We told them why we wanted to do something, and they would describe what we could and couldn’t do. We would then fight for our promotion piece or program. The regulatory and the compliance requirements and guidelines have changed to such an extent that those kinds of adversarial relationships just are not going to work.” But Dr. Gliklich says marketing departments do seek guidance from medical affairs. “They are looking, in some ways, to medical affairs to help them understand where the envelope is and not allow them to push beyond that, because ultimately everyone is concerned not only with successful commercialization but limiting liability as well,” he says.F PharmaVoice welcomes comments about this article. E-mail us at [email protected]. Field-based medical science liaisons (MSLs) play a vital role within pharmaceutical and biotech organizations. Their various responsibilities impact the success of a therapeutic agent by engaging key opinion leaders in scientific exchange and research collaboration, developing educational programs, and communicating vital information to internal organizational functions, health practitioners, and clinical investigators. “Most companies place their MSLs under medical affairs,” says Jane Chin, Ph.D., president of Medical Science Liaison Institute. “In many companies, MSLs often are an extension of medical affairs and MSL activities are based on the medical affairs’ overall program objective. Some companies still organize their MSL teams under marketing or sales, but that is becoming rare because of the current regulatory environment.” Although the MSL position has been around since the late 1960s, it is now emerging as a profession with growing importance. Whereas companies that may be experiencing diminishing returns on field-based sales teams, their field-based science teams – MSLs – are delivering top-tier thought-leader capital and are transforming research collaborations into brand equity for companies. “The MSLs are the primary point of contact for top thought leaders who are at the cutting edge of research and who influence standards in healthcare,” Dr. Chin says. “MSLs have a wealth of information from the field that can help the pharmaceutical organization formulate better marketing strategies, branding strategies, service approaches, and messages from these collected insights.” She says there can be challenges for effective partnerships with marketing. “MSL roles are more long-term and strategic in nature,” Dr. Chin says. “But a lot of times the company’s marketing department interacts with them more on a tactical basis.” Additionally, marketing can experience a good amount of personnel turnover. “This means that MSL leadership must continually educate new marketing managers about the MSL role and about what MSLs can and cannot do and how they should work together,” she says. To solve these challenges, Dr. Chin suggests companies develop appropriate metrics for evaluating the performance of MSLs and, more critically, involve executive management in metrics development. “Conflict arises because current metrics are inadequate for evaluating a function that deals mostly with intangible deliverables,” she says. “The objectives of MSLs are geared toward building customer capital for the organization. MSLs also primarily interact with thought leaders who have a high ‘influence share’ but low market shares. This can be difficult for sales and marketing managers, who generally target thought leaders who have low influence share but high market shares, to understand how the MSL may support them or are contributing to the company’s bottom line.” Measures often used by marketing and sales, such as market share or sales dollars, cannot be used for MSL performance. “MSL teams always are smaller than sales teams so it is very difficult to demand that they have the same ‘reach’ that the salesforce would have,” she says. “The nature of many MSL activities requires a regulatory premise of nonsolicitation, which is antithetical to reach and frequency.” Experts on this topic Gary J. Borchard. Senior Director, Business Development, MetaWorks Inc., Medford, Mass.; MetaWorks provides systematic reviews, meta-analyses, literature monitoring, EMR cancer patient data, risk management and safety services, and custom databases for pharmaceutical, biotechnology, medical device, hospital, and healthcare provider industries. For more information, visit metaworksinc.com. Jane Chin, Ph.D. President, Medical Science Liaison Institute LLC, Redondo Beach, Calif.; Medical Science Liaison Institute offers consulting and training services that transform medical liaison programs into an organization’s competitive assets. For more information, visit mslinstitute.com. Richard Gliklich, M.D. President and CEO, Outcome Sciences Inc., Cambridge, Mass.; Outcome Sciences is a healthcare information services company that provides Web-based programs for clinical practice, research, and disease management. For more information, visit outcomesciences.com. Kathleen Killmeyer. VP of Business Development, Dimensional HealthCare, Cedar Knolls, N.J.; DHC designs and implements community-based research and focuses on the design and implementation of large, simple trials in the periapproval stages (Phases IIIb and IV) of drug development. For more information, visit dhcare.com. Colin W. MacGillivray, Ph.D. Principal and Director, Life-Sciences Practice, Inforte Corp., Chicago; Inforte is a consultancy focused on strategies and solutions for customer management, marketing, and business intelligence. For more information, visit inforte.com. Michael J. Sumner, M.D. Senior Director, Medical Affairs, North America, Aventis Behring, King of Prussia, Pa.; Aventis Behring, part of the Aventis family of companies, is a global leader in the plasma protein industry, providing a wide range of high-quality medicines. For more information, visit aventisbehring.com. Cyndi Verst-Brasch, Pharm.D. VP of Medical Affairs, Marketing & Communications, Kendle International Inc., Cincinnati; Kendle is among the world’s largest publicly held clinical research organizations, delivering innovative and robust clinical development solutions to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. For more information, visit kendle.com.