role of medical affairs in pharmaceutical companies ppt

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. Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. Thus, the medical affairs role has evolved to become an integral part of the drug development process. As would be expected, the medical information center fields the greatest call volume in the time around the time of the market launch of a new product. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. 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. Does this promotional piece present a fair balance of benefits and risks? Church Road What publications are ideal? 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. The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. Drug Information Journal. 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. These stakeholders include medical communities, medical societies, payers, regulatory authorities and patient advocacy groups, to name a few. As cost pressures contni ue to rsi e gvi en ongoni g healthcare reform, the decision-makni … Now customize the name of a clipboard to store your clips. For information on how to enter visit: www.pharmatimes.com/medical_scientific_excellence_awards, PharmaTimes Media Ltd. 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? 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. Recent legislation, such as the 21st Century Cures Act,  will likely increase the demand for RWE, yet just 47 percent of respondents in a recent survey say they have a plan in place to support real-world evidence, and among those there is no clear consensus on a specific role to lead that support, according to ZS. What is the role of Medical Affairs in today’s pharmaceutical industry? Medical Affairs stands to be one of the most strategically important and valued functions in a pharmaceutical company, as the nexus of cutting-edge medical, scientific and patient-centred insights that drive strategy and innovation throughout the entire product life cycle. Amazon’s health insurance plans have put even more focus on patient outcomes because healthier employees are better for business. 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. 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. The range of permissible clinical messages is circumscribed by FDA-approved language in the package insert, or label. 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. Only medical affairs is able to put all of the pieces together. 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”). Ankur Choudhary Print Question Forum No comments Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. See our User Agreement and Privacy Policy. By Deirdre Coleman on Nov 22, 2016. There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. It is critical  that pharma finds ways to support the patient throughout their treatment. In: Evens R, editor. Medical Affairs professionals will continue to be a vital source of information for physicians looking to improve the health outcomes of their patients. 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. Their products have complex or expensive treatment regimens. 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. It has various roles in manufacturing of pharmaceutical products. On the external side, the medical organization serves as the bridge between a company and numerous 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. Product development was under clinical, while marketing and product lifecycle management was owned by commercial. The time is now right to invest in a MA 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. All of these characteristics are likely to heighten the need—and demand—for clinical information. Evens R. Medical Affairs and Professional Services. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. Medical Affairs can help ensure that the Brand team’s proposed messages are consistent with the insert. Wolin MJ, Ayers PM, Chan EK. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. 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. Its function is similar to that of Global Marketing—that is to say, Global Medical Affairs defines a broad overall medical affairs strategy and ensures that the activities across markets are aligned and that redundant efforts are avoided. Welcome to the Understanding Pharma Series Course on Medical Affairs. At the heart of the pharma model has always been the clinical and commercial functions. Little Bookham The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. 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). All indications suggest a fundamental long-term shift in the drug development and commercialisation pathway. Their value lies in their scientific and clinical expertise and they strive to build strong relationships with communities and academic physicians. Medical affairs has transformed over the past decade, evolving from a supportive role into a strategic decision-maker and trusted scientific partner. 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. 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. What assistance can we provide to the paper’s authors? The role of patients will also fundamentally change with the rise of consumerism in healthcare. Medical affairs professionals understand the complex research behind their pharmaceuticals, and play a critical role in scientific exchange between companies and healthcare professionals. I appreciate that you brought this topic into light. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration. Medical affairs (MA) will be the single most powerful force in helping pharma do just that. As cost pressures continue to rise given ongoing healthcare reform, the decision-making … 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. MEDICAL AFFAIRSTHE UNDERSTANDING PHARMA SERIES Copyright © 2007. Their products have unique scientific aspects requiring explanation. Their products have complex or expensive treatment regimens. pharmaceutical companies can make those relationships broader, deeper and much more meaningful. Proposed medical affairs departmental structure for small organization. Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Medical Affairs cultivates relationships with key opinion leaders in a number of ways. 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. 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. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. What MA needs now is more comprehensive, strategic partners to complement its expanded roles and responsibilities. It’s critical to note, however, that Medical Affairs has no control over the actual content of the program. 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. Leatherhead 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. Their Medical Writing team may also assist with the development of Meeting presentation materials, such as slide sets Posters—that is, oversized summaries of preliminary trial results, which key opinion leaders may present at medical conferences and in other settings, in what are known as “poster sessions.” Abstracts—summaries of published journal articles. Why have so few pharma companies started down this path? Because issues and regulations differ by market, Medical Affairs Global has a very limited role in country- or region-specific activities. Over many years, pressure from regulatory agencies, payers and healthcare professionals, as well as public sentiment, has led to a clearer separation between the Medical and Commercial functions. 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. Medical Affairs is a global function. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Looks like you’ve clipped this slide to already. Fast forward and medical affairs now … 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. 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. 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. Regulatory affairs in pharmaceuticals has crucial role from applying new products to research and development of new drugs. 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. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. 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. If you continue browsing the site, you agree to the use of cookies on this website. characteristics, Medical Affairs (MA) could be enabled to play this critical role. F: +44 (0)20 7240 4479, Get the latest pharma news delivered to your inbox. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). 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. 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. Because the call center mechanism is often used, people sometimes use the term “call center” as shorthand for the medical information function. 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. In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. Big Pharma must make cost-effectiveness analyses and treatment support initiatives predicated on a patient’s entire treatment  journey and outcome, not just whether they continue to purchase  the product or the impact of the medicine provided. All of these characteristics are likely … Customer Code: Creating a Company Customers Love, Be A Great Product Leader (Amplify, Oct 2019), Trillion Dollar Coach Book (Bill Campbell). PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. Drug and Biological Development: Springer US; 2007. p. 240-74. 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. By contrast, those working for a large pharmaceutical company often have extensive responsibilities within a clearly defined position. The Education and Training group selects and funds speakers programs, conferences, and continuing medical education. Amazon recently announced that it is entering the healthcare business, looking to control costs but also to empower the consumer. Medical communicates the safe and appropriate utilization of products to stakeholders and it also gathers insights … They produce highly innovative products addressing a previously unmet need. 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. Some more Senior Medical Information roles involve copy approval which is the review process for promotional and non-promotional materials that are produced by the company. Within a number of companies, publication planning means determining simply “when” and “where.” When will the relevant data be available? Here we focus on medical affairs, a critical part of the pharmaceutical industry. 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. T: +44 (0)20 7240 6999 For a long time, experts have been talking about the increasing role of consumers in their own healthcare. All Rights Reserved. It sets general guidelines for selecting which studies to fund. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Medical Affairs plays two key roles. 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 services play critical role between a pharmaceutical company and external stakeholders. the Medical Affairs role was, to a certain degree, compromised. The Medical Communications group within Medical Affairs designs and executes the publication plan for a product. 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. 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. It needs to prove its value to the overall system and the ability to improve patient outcomes. Even when Medical Affairs is, as shown, situated within the Global Development hierarchy, its activities often come out of the Marketing budget. 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. Clipping is a handy way to collect important slides you want to go back to later. Their products have unique scientific aspects requiring explanation. Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use. Medical Affairs teams are the medical face of the company. Adverse events communicated to Medical Information are tracked and reported to the FDA. 2001;35(2):547-55. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. 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 FDA mandates that pharmaceutical companies have an adverse event tracking mechanism for their products. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. Recently, their role has expanded to include health economics and outcomes research (HEOR) and pharmacovigilance. Title: The Role of Medical Affairs in Shaping Brand Development 1 The Role of Medical Affairs in Shaping Brand Development. Medical Affairs The Role of a Medical Advisor... A Pharmaceutical Physician working in medical affairs will have a hugely varied role. These types of publication planning efforts are often outsourced to a Medical Communications vendor. With the proliferation of social media and patient-empowerment platforms, the voice of the patient is stronger than ever. While there is some variation in segmentation and structure, most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. 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. 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 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. Medical Research handles the execution of non-registrational trials. There are integrated strategic and implementation service companies that support both the clinical and commercial sides of pharma with comprehensive offerings, but no such full-service offerings dedicated to medical affairs. Medical Writing is often in charge of drafting “Dear Doctor” letters, which we mentioned earlier are disseminated by the Medical Information group. 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. When should publications and press releases be scheduled? A new and innovative way by which companies can use corporate partnerships to flexibly and efficiently maximize medical affairs support. To do so, Medical Affairs will need to re-imagine every aspect of their roles. Now, MA departments typically report to C-level staff and have budgets and teams of their own. Mansard House 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. 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. Commercial can’t do that, clinical can’t do that. Why medical affairs is the most important role in the future of pharma. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. Transforming medical affairs to medical value. You can change your ad preferences anytime. Most remain focused on products instead of outcomes, and they regard medical affairs staff as technical product advisers. 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. Thus Medical Affairs … Surrey KT23 3JG, E: editorial@pharmatimes.com Pharma manufacturers must adjust to the new world order smartly, and medical affairs will play a critical role. 2 Key Themes. 1. Medical Liaisons Shares product information with KOLs Seeks their participation in clinical trials Encourages them to educate potential prescribers about the disease and appropriate therapies And sponsors studies of interest to them . External stakeholders include regulatory agencies, physicians, hospital administrators and patient groups. Medical Affairs plays a vital role in launch and promotion of pharma products. Introduction 6. Go to the App Store or Google Play and search for 'PharmaTimes' to download our free app.

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