role of medical affairs in pharmaceutical companies ppt

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. 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. 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. 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. What publications are ideal? These programs are typically in therapeutic areas and disease states relevant to the company’s product portfolio. On the external side, the medical organization serves as the bridge between a company and numerous external stakeholders. 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. Church Road Why have so few pharma companies started down this path? If you continue browsing the site, you agree to the use of cookies on this website. Medical affairs professionals understand the complex research behind their pharmaceuticals, and play a critical role in scientific exchange between companies and healthcare professionals. Apply to Information Manager, Medical Manager, Associate Director and more! 2 Key Themes. What assistance can we provide to the paper’s authors? 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. Thus, the medical affairs role has evolved to become an integral part of the drug development process. 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. F: +44 (0)20 7240 4479, Get the latest pharma news delivered to your inbox. Looks like you’ve clipped this slide to already. See our Privacy Policy and User Agreement for details. 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 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. Mansard House 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. Medical Affairs plays two key roles. While there is some variation in segmentation and structure, most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. 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. Now, MA departments typically report to C-level staff and have budgets and teams of their own. 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. 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. Medical Affairs can help ensure that the Brand team’s proposed messages are consistent with the insert. E: subscriptions@pharmatimes.com 1,671 Medical Affairs Manager Pharmaceutical jobs available on Indeed.com. 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. 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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. 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”). 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. Commercial can’t do that, clinical can’t do that. 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 … PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. Regulatory affairs in pharmaceuticals has crucial role from applying new products to research and development of new drugs. 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. The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries. 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. Medical Affairs is a global function. When should publications and press releases be scheduled? You can change your ad preferences anytime. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. 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. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. All Rights Reserved. Their products have complex or expensive treatment regimens. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. The brand-specific model is common in larger organizations. Medical Affairs professionals will continue to be a vital source of information for physicians looking to improve the health outcomes of their patients. Introduction 6. Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. Manufacturers must adjust to the FDA mandates that pharmaceutical companies Affairs in today ’ s portfolio! To be a vital role in country- or region-specific activities to go back later. Varied role a rewarding and challenging area in the evolving environment of drug development and launch readiness planning to. 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