Fast forward and medical affairs now … All of these characteristics are likely to heighten the need—and demand—for clinical information. Most remain focused on products instead of outcomes, and they regard medical affairs staff as technical product advisers. The materials are checked against the Association of British Pharmaceutical Industry (ABPI) code of practice as they have to be compliant to this code in the UK –“The detailed provisions in the Code aim to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner.“ (www.pmcpa.or… Church Road There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. Medical Affairs teams are the medical face of the company. 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. The Medical Communications group within Medical Affairs designs and executes the publication plan for a product. 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. Why have so few pharma companies started down this path? Medical affairs has transformed over the past decade, evolving from a supportive role into a strategic decision-maker and trusted scientific partner. Medical Affairs plays two key roles. These types of publication planning efforts are often outsourced to a Medical Communications vendor. 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. The FDA mandates that pharmaceutical companies have an adverse event tracking mechanism for their products. Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products. Medical communicates the safe and appropriate utilization of products to stakeholders and it also gathers insights … Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use. Although the precise way in which Medical Affairs defines its areas of specialization varies, for our purposes it is useful to arrange them in three broad groupings: Medical Services, Medical Research, and Medical Liaisons. Why medical affairs is the most important role in the future of pharma. 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. The role of patients will also fundamentally change with the rise of consumerism in healthcare. 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. Evens R. Medical Affairs and Professional Services. T: +44 (0)20 7240 6999 What assistance can we provide to the paper’s authors? Who are the customers? It provides reliable benchmarks, observations, and best practice insights to inform and shape executive thinking around the challenges of new product development in medical affairs. Here we focus on medical affairs, a critical part of the pharmaceutical industry. The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries. 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. In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. Their value lies in their scientific and clinical expertise and they strive to build strong relationships with communities and academic physicians. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. What publications are ideal? Title: The Role of Medical Affairs in Shaping Brand Development 1 The Role of Medical Affairs in Shaping Brand Development. 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. 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. All of these characteristics are likely … Medical Affairs plays a vital role in launch and promotion of pharma products. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. In: Evens R, editor. By Deirdre Coleman on Nov 22, 2016. Pharma manufacturers must adjust to the new world order smartly, and medical affairs will play a critical role. 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. 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. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration. Surrey KT23 3JG, E: editorial@pharmatimes.com These stakeholders include medical communities, medical societies, payers, regulatory authorities and patient advocacy groups, to name a few. 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. All indications suggest a fundamental long-term shift in the drug development and commercialisation pathway. 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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. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. Protections are usually in place, however, to ensure that Marketing does not impose its commercial perspective on the way those dollars are spent—particularly in regard to external educational programs. 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. Transforming medical affairs to medical value. The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. This function responds to and tracks questions and concerns regarding company products. 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. Drug and Biological Development: Springer US; 2007. p. 240-74. As cost pressures contni ue to rsi e gvi en ongoni g healthcare reform, the decision-makni … Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. It needs to prove its value to the overall system and the ability to improve patient outcomes. 1. The time is now right to invest in a MA But the fact is that pharma and the companies who support it will need to invest even more in MA to keep up with the rapidly evolving interactions among stakeholders in a notoriously complex industry. E: subscriptions@pharmatimes.com 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. 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. 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. If you continue browsing the site, you agree to the use of cookies on this website. Introduction 6. Ankur Choudhary Print Question Forum No comments Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. 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. External stakeholders include regulatory agencies, physicians, hospital administrators and patient groups. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. What is the role of Medical Affairs in today’s pharmaceutical industry? Medical affairs services play critical role between a pharmaceutical company and external stakeholders. To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. Adverse events communicated to Medical Information are tracked and reported to the FDA. The brand-specific model is common in larger organizations. Clipping is a handy way to collect important slides you want to go back to later. The breadth of variation will often depend on the role itself and the size of the company they are joining. 1,671 Medical Affairs Manager Pharmaceutical jobs available on Indeed.com. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. They produce highly innovative products addressing a previously unmet need. Amazon’s health insurance plans have put even more focus on patient outcomes because healthier employees are better for business. Their products have complex or expensive treatment regimens. 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. All Rights Reserved. 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 … Indeed, 68% of global medical affairs groups now elect to outsource at least one subfunction, with medical information and medical publications as the two most frequently outsourced subfunctions. A new and innovative way by which companies can use corporate partnerships to flexibly and efficiently maximize medical affairs support. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. Finally, Medical Affairs contributes valuable market intelligence. Only medical affairs is able to put all of the pieces together. 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. As cost pressures continue to rise given ongoing healthcare reform, the decision-making … If you continue browsing the site, you agree to the use of cookies on this website. While R & D defines the scientific direction and early stage development, medical affairs provides scientific support for late stage development and post market support for drugs and devices. 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. Does this promotional piece present a fair balance of benefits and risks? Medical affairs (MA) will be the single most powerful force in helping pharma do just that. By contrast, those working for a large pharmaceutical company often have extensive responsibilities within a clearly defined position. Now customize the name of a clipboard to store your clips. You can change your ad preferences anytime. Bob Muratore is principal at RPM ConsultingThis year PharmaTimes has launched the new Medical & Scientific Excellence Awards, desinged to challenge, recognise and reward professionals within medical science liaison, medical information and medical / scientific advisory roles.