role of medical affairs in pharmaceutical companies ppt

For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. You can change your ad preferences anytime. pharmaceutical companies can make those relationships broader, deeper and much more meaningful. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. Medical Affairs teams are the medical face of the company. For a long time, experts have been talking about the increasing role of consumers in their own healthcare. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. 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. 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. Fast forward and medical affairs now encompasses strategy, safety, communications, post-launch trials, field teams and much more – a sort of command central of pharma. June 7, 2004. Who are the customers? The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. Their products have unique scientific aspects requiring explanation. 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. Pharma manufacturers must adjust to the new world order smartly, and medical affairs will play a critical role. 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 … External stakeholders include regulatory agencies, physicians, hospital administrators and patient groups. Recently, their role has expanded to include health economics and outcomes research (HEOR) and pharmacovigilance. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Their products have unique scientific aspects requiring explanation. All Rights Reserved. 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. Go to the App Store or Google Play and search for 'PharmaTimes' to download our free app. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. 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. 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. If you continue browsing the site, you agree to the use of cookies on this website. Does this promotional piece present a fair balance of benefits and risks? 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. 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. 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. See our Privacy Policy and User Agreement for details. Medical Affairs professionals will continue to be a vital source of information for physicians looking to improve the health outcomes of their patients. 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 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. PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. All of these characteristics are likely … 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. On the external side, the medical organization serves as the bridge between a company and numerous external stakeholders. Even when Medical Affairs is, as shown, situated within the Global Development hierarchy, its activities often come out of the Marketing budget. Transforming medical affairs to medical value. While there is some variation in segmentation and structure, most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. Why medical affairs is the most important role in the future of pharma. 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 sets general guidelines for selecting which studies to fund. In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. Evens R. Medical Affairs and Professional Services. 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. Drug Information Journal. With the proliferation of social media and patient-empowerment platforms, the voice of the patient is stronger than ever. Medical Affairs plays a vital role in launch and promotion of pharma products. Surrey KT23 3JG, E: editorial@pharmatimes.com Wolin MJ, Ayers PM, Chan EK. Medical communicates the safe and appropriate utilization of products to stakeholders and it also gathers insights … Within a number of companies, publication planning means determining simply “when” and “where.” When will the relevant data be available? The brand-specific model is common in larger organizations. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. 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. 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. 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. 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). This function responds to and tracks questions and concerns regarding company products. 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. 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. Welcome to the Understanding Pharma Series Course on Medical Affairs. 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. Apply to Information Manager, Medical Manager, Associate Director and more! Adverse events communicated to Medical Information are tracked and reported to the FDA. 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. 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. 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. It is critical  that pharma finds ways to support the patient throughout their treatment. 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. Medical Affairs is a global function. E: subscriptions@pharmatimes.com It needs to prove its value to the overall system and the ability to improve patient outcomes. 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. Mansard House Fast forward and medical affairs now … 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 . 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. Medical affairs professionals understand the complex research behind their pharmaceuticals, and play a critical role in scientific exchange between companies and healthcare professionals. There is a new navigator setting the course through an uncharted healthcare landscape. Clipping is a handy way to collect important slides you want to go back to later. 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. Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use. Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. MEDICAL AFFAIRSTHE UNDERSTANDING PHARMA SERIES Copyright © 2007. Medical Affairs can help ensure that the Brand team’s proposed messages are consistent with the insert. 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. Medical affairs services play critical role between a pharmaceutical company and external stakeholders. For information on how to enter visit: www.pharmatimes.com/medical_scientific_excellence_awards, PharmaTimes Media Ltd. Amazon recently announced that it is entering the healthcare business, looking to control costs but also to empower the consumer. Now customize the name of a clipboard to store your clips. 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. 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. Commercial can’t do that, clinical can’t do that. Customer Code: Creating a Company Customers Love, Be A Great Product Leader (Amplify, Oct 2019), Trillion Dollar Coach Book (Bill Campbell). Best Practices LLC's benchmarking study examines the role and impact of NPP groups on product commercialization efforts in pharmaceutical and biotech companies. I appreciate that you brought this topic into light. 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 Medical Communications group within Medical Affairs designs and executes the publication plan for a product. 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. The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function. 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. To do so, Medical Affairs will need to re-imagine every aspect of their roles. The range of permissible clinical messages is circumscribed by FDA-approved language in the package insert, or label. 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? Their value lies in their scientific and clinical expertise and they strive to build strong relationships with communities and academic physicians. Most remain focused on products instead of outcomes, and they regard medical affairs staff as technical product advisers. The role of patients will also fundamentally change with the rise of consumerism in healthcare. By Deirdre Coleman on Nov 22, 2016. The role of patients will also fundamentally change with the rise of consumerism in healthcare. the Medical Affairs role was, to a certain degree, compromised. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. 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. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. At the heart of the pharma model has always been the clinical and commercial functions. As cost pressures contni ue to rsi e gvi en ongoni g healthcare reform, the decision-makni … 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. The time is now right to invest in a MA In bridging the product from the R&D/Clinical Development Team to the Launch Tea… characteristics, Medical Affairs (MA) could be enabled to play this critical role. In: Evens R, editor. Little Bookham Amazon’s health insurance plans have put even more focus on patient outcomes because healthier employees are better for business. Proposed medical affairs departmental structure for small organization. Because issues and regulations differ by market, Medical Affairs Global has a very limited role in country- or region-specific activities. Why have so few pharma companies started down this path? 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. 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. These programs are typically in therapeutic areas and disease states relevant to the company’s product portfolio. Their products have complex or expensive treatment regimens. If you continue browsing the site, you agree to the use of cookies on this website. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration. 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 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. 1 the role and impact of NPP groups on product commercialization efforts pharmaceutical... Why medical Affairs teams are the medical Affairs – a responsibility long viewed as a support function as! 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