This allows for information to flow freely between the medical community and the pharma organisation – and because its remit is positioned outside of commercial activities the team can help external bodies to … The basic functions of each group will be familiar to you from the previous sections of this module: Medical Services has a number of important responsibilities: The medical information center provides a venue for healthcare practitioners (and, to a lesser extent, consumers) to raise product concerns and seek information regarding product use. The breadth of variation will often depend on the role itself and the size of the company they are joining. The Medical Communications group briefs the Brand team on key clinical findings, handles internal medical writing related to later-stage trials, and performs publication planning. Church Road Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use. The Medical Research group is also responsible for health economics and outcomes analyses The third major “division” within Medical Affairs is its field-based team, known as Medical Liaisons. The FDA mandates that pharmaceutical companies have an adverse event tracking mechanism for their products. In just the last two years, MA teams have grownby 12 percent, and we should expect that number to go up drastically in the near future. 1,671 Medical Affairs Manager Pharmaceutical jobs available on Little Bookham You can change your ad preferences anytime. The time is now right to invest in a MA Mansard House The range of permissible clinical messages is circumscribed by FDA-approved language in the package insert, or label. One of the key ways the industry will be tracking a patient’s journey is to utilise real-world evidence (RWE), which is patient-outcome data gathered outside randomised controlled trials. On one hand, medical affairs now ensures that the drugs are being developed to address access and reimbursement challenges, and on the other hand, medical affairs pursues opportunities to feed the companies’ discovery, pre-clinical and clinical research. 2 Key Themes. Wolin MJ, Ayers PM, Chan EK. Within a number of companies, publication planning means determining simply “when” and “where.” When will the relevant data be available? Who are the customers? Medical Affairs can also help verify product messages related to claims and findings that do not require FDA approval, such such as a health-economics and outcomes analyses. There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. 2001;35(2):547-55. Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. Medical affairs professionals understand the complex research behind their pharmaceuticals, and play a critical role in scientific exchange between companies and healthcare professionals. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration. Most importantly, the medical information center gathers information regarding adverse events that may be associated with a particular product—and reports those adverse events to the FDA. Within individual markets, such as the US, Medical Affairs is sometimes organized by business unit, brand, or therapeutic area, so that the range of Medical Affairs services can be tailored to the complexity of the product and disease state. To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. Global Medical Affairs may also take the lead on activities that can truly span all markets, such as publication planning and cultivation of internationally recognized key opinion leaders. Medical Affairs is the majority of credible link with external stakeholders and also play a progressively more important role in communicating the product or service value message to physicians in an objective and ethical manner. The common objective of all pharmaceutical companies is to discover, develop and market safe, efficacious and cost-effective medicines that will bring benefits to patients, health care professionals and consumers and result in profitable returns to the company. See our Privacy Policy and User Agreement for details. As pharma companies search for ways to further unlock growth and better engage and support patients and stakeholders in the region, many executives see an increasingly important role for the medical affairs (MA) function. Title: The Role of Medical Affairs in Shaping Brand Development 1 The Role of Medical Affairs in Shaping Brand Development. Most remain focused on products instead of outcomes, and they regard medical affairs staff as technical product advisers. One thing seems certain: If the pharmaceutical industry is going to to defend itself against being 'Amazoned' it needs to go beyond simply proving the effectiveness of the drugs produced. Amazon recently announced that it is entering the healthcare business, looking to control costs but also to empower the consumer. Proposed medical affairs departmental structure for small organization. As the pharma industry grew, so did the perception that commercial exerted a disproportionate influence over the development process, scientific communications and other medical and clinical functions. Because Medical Affairs works closely with both scientific and commercial leaders within a pharma company, the function may be positioned under either Global Commercial or Global Development. All indications suggest a fundamental long-term shift in the drug development and commercialisation pathway. We have noticed this from time to time in our surveys that many Big Pharma Companies have considered Medical Affairs importance seriously and have now implemented a well-planned strategy to recruit, engage and manage their medical affairs team effectively. If you continue browsing the site, you agree to the use of cookies on this website. Because issues and regulations differ by market, Medical Affairs Global has a very limited role in country- or region-specific activities. This represents a gigantic opportunity for companies to step up and become leaders in the proliferation of RWE in their product lifecycles, and medical affairs teams will be the owners of how RWE is gathered and implemented. With increased access to information, skyrocketing expectations and recent regulatory changes, the urgency to embrace a new, more outcome-driven system has never been greater. Physicians working for smaller biotech companies, which often employ 50–100 people and focus on one or two disease areas, might have to fulfill multiple roles of R&D, medical affairs, and pharmacovigilance simultaneously. Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products. Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve with the emergence of new decision makers and with greater public scrutiny of these relationships. Medical Research handles the execution of non-registrational trials. Now customize the name of a clipboard to store your clips. This function responds to and tracks questions and concerns regarding company products. Product development was under clinical, while marketing and product lifecycle management was owned by commercial. Medical affairs services play critical role between a pharmaceutical company and external stakeholders. Increasingly, as regulatory scrutiny has highlighted the need for a clear separation of commercial and educational activities, Medical Affairs has been aligned with Development—or sometimes in a direct reporting relationship to the CEO. When should publications and press releases be scheduled? Their products have unique scientific aspects requiring explanation. PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve with the emergence of new decision makers and with greater public scrutiny of these relationships. To support messaging efforts by the Brand team, Medical Affairs can provide clinical and scientific insights into the product’s strengths and differentiating attributes, identifying Data required to support them Gaps in currently available data Means of filling those gaps—such as additional clinical trials or health economic analyses, The Medical Communications group also plays a role in medical writing for products in Phase IIIB and Phase IV trials. It’s simple: those who fail to invest aggressively in MA will be at  a significant disadvantage as the industry continues its dramatic shift to a patient-outcome and value-based system. The role of patients will also fundamentally change with the rise of consumerism in healthcare. By Deirdre Coleman on Nov 22, 2016. Drug Information Journal. Medical Writing is often in charge of drafting “Dear Doctor” letters, which we mentioned earlier are disseminated by the Medical Information group. Medical Affairs is a global function. Medical Affairs plays a vital role in launch and promotion of pharma products. Larger organizations operate a call center in which people with healthcare expertise receive these calls, respond to straightforward queries, and forward more complex calls to the appropriate experts in the Medical Information group. Even when Medical Affairs is, as shown, situated within the Global Development hierarchy, its activities often come out of the Marketing budget. E: Adverse events communicated to Medical Information are tracked and reported to the FDA. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. It is critical  that pharma finds ways to support the patient throughout their treatment. In some organizations, there are two categories of Medical Liaison: Although the names by which they are designated may differ, the basic principal distinction is between those dedicated to corporate accounts, such as managed care organizations, and those with special depth of therapeutic expertise whose focus is on interaction with key opinion leaders. Clipping is a handy way to collect important slides you want to go back to later. 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. Increased scientific, clinical, regulatory, and payer requirements to demonstrate clinical value and product differentiation in increasingly well-established therapeutic areas heightens the demand for an evidence package that clearly fulfills unmet medical need, and justifies cost. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. See our User Agreement and Privacy Policy. Thus Medical Affairs … The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company. By contrast, those working for a large pharmaceutical company often have extensive responsibilities within a clearly defined position. June 7, 2004. The Medical Liaisons cultivate relationships with key opinion leaders and serve as an expert resource for sales representatives and for Managed Markets account managers in the field. They produce highly innovative products addressing a previously unmet need. Many companies within the industry are already actively reorganizing their R&D groups to focus on core competencies and restructuring their commercial and sales forces in response to health reform and loss of exclusivity (LOE). What MA needs now is more comprehensive, strategic partners to complement its expanded roles and responsibilities. What is the role of Medical Affairs in today’s pharmaceutical industry? In the not-too-distant future, pharmaceutical companies without meaningful outcomes and clinical data could find themselves outside  the Amazon healthcare circle, which could be particularly risky if Jeff Bezos has wider ambitions in the field. The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries. Against this backdrop, McKinsey interviewed 20 medical leaders to gain insights into the evolving role of medical affairs within APAC (see sidebar “Who we interviewed”). Favorable findings from non-registrational trials may, however, convince a pharmaceutical company to conduct additional registrational trials, seeking FDA approval of changes to the product label. Medical affairs should play the leadership role in developing a complete map of the patient journey, beginning with desired outcomes – needs and expectations about the quality of care received and the outcome of that care. It has various roles in manufacturing of pharmaceutical products. APIdays Paris 2019 - Innovation @ scale, APIs as Digital Factories' New Machi... Mammalian Brain Chemistry Explains Everything, No public clipboards found for this slide, Senior PV Audit Manager at AMCo (Formerly Amdipharm Mercury Ltd), Cosulting Lead, Analytics-Healthcare, Cognizant Business Consulting-AIM, Global Commercial Lead Novel Therapeutic Nutrition-Pediatric Care - Allergy at Nestlé Health Science. As cost pressures continue to rise given ongoing healthcare reform, the decision-making … For information on how to enter visit:, PharmaTimes Media Ltd. The Brand team then leverages these findings as they develop product messages. It’s critical to note, however, that Medical Affairs has no control over the actual content of the program. At the heart of the pharma model has always been the clinical and commercial functions. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. While there is some variation in segmentation and structure, most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. Regulatory affairs in pharmaceuticals has crucial role from applying new products to research and development of new drugs. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. Medical Affairs professionals will continue to be a vital source of information for physicians looking to improve the health outcomes of their patients. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). The brand-specific model is common in larger organizations. pharmaceutical companies can make those relationships broader, deeper and much more meaningful. Evens R. Medical Affairs and Professional Services. All of these characteristics are likely to heighten the need—and demand—for clinical information. As cost pressures contni ue to rsi e gvi en ongoni g healthcare reform, the decision-makni … No longer focused solely on supporting marketing and sales activities from a medical perspective, medical affairs now plays a vital role in strategically communicating the nuances of sophisticated science with the larger medical community. What assistance can we provide to the paper’s authors? As a result, pharmaceutical companies were forced to separate the medical affairs, commercial and clinical functions into increasingly independent organisations with medical affairs taking a direct leadership role in communications with both internal and external stakeholders. Thus, the medical affairs role has evolved to become an integral part of the drug development process. To do so, Medical Affairs will need to re-imagine every aspect of their roles. Finally, Medical Affairs contributes valuable market intelligence. In some organizations, operating the Medical Information group is the Medical Affairs group’s sole responsibility, however, in others, Medical Affairs has more far-ranging responsibilities. Only medical affairs is able to put all of the pieces together. For a long time, experts have been talking about the increasing role of consumers in their own healthcare. Medical Communications may also be part of a promotional review committee, helping the Legal, Regulatory, and Compliance teams verify the accuracy of the clinical messages developed by the Brand team. In addition to obvious misstatements and exaggerations, the team will look at subtler issues, such as, Can we say our product has “fewer and less serious side effects,” implicitly comparing it to competing products, without a head-to-head study? In such organizations, each brand frequently has its own Medical Affairs Medical Director—an eminent physician—who is aligned with the Brand Director from Marketing. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. T: +44 (0)20 7240 6999 Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. This white paper is based on Best Practices, LLC’s benchmarking report that explores how Medical Affairs is involved in the launch process at leading pharmaceutical and biotechnology companies. In 2002, the Pharmaceutical Research and Manu- facturers of America (PhRMA), a pharmaceutical industry trade group, published its voluntarily enforced Code on Interactions with Healthcare Profes-sionals that was to be a guideline on ethical practices. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. Ankur Choudhary Print Question Forum No comments Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. The breadth and complexity of the role could be one reason why we are seeing more outsourcing of medical affairs by pharmaceutical companies. Medical affairs (MA) will be the single most powerful force in helping pharma do just that. The Education and Training group selects and funds speakers programs, conferences, and continuing medical education. Why have so few pharma companies started down this path? All of these characteristics are likely … Their products have unique scientific aspects requiring explanation. Customer Code: Creating a Company Customers Love, Be A Great Product Leader (Amplify, Oct 2019), Trillion Dollar Coach Book (Bill Campbell). Introduction 6. I appreciate that you brought this topic into light. Medical Affairs cultivates relationships with key opinion leaders in a number of ways. Today, patients are able to track their own health status and treatment outcomes, as well as engage with advocacy groups to increase understanding and set expectations about quality of care and outcomes on a broader scope. Medical affairs has the prominent role of helping healthcare practitioners (HCPs) navigate vast quantities of information and understand how to use new products for the best patient outcomes. These types of publication planning efforts are often outsourced to a Medical Communications vendor. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements.