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Medical Affairs is responsible for developing and executing medical marketing strategies and tactics for a brand or therapeutic area. Medical Affairs is a function in pharmaceuticals, medical device and healthcare organizations. Medical Affairs actually oversees many responsibilities in the areas of medical communication, MSL etc. A medical affair is a critical part of the pharmaceutical industry. There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. After describing the role of medical affairs and its key functions, we present a case that highlights its importance both in prelaunch and during launch. The case demonstrates a new and innovative way companies can use corporate partnerships too flexibly and efficiently maximize medical affairs support. The traditional bio manufacturing model includes two main pillars: an R&D organization in charge of developing new products and a commercial organization in charge of marketing and selling those products. Pharmaceutical manufacturing has a similar split: a development group (responsible for getting FDA approval for drug products) and a commercial team (that markets and sells those products). One big difference, however, is that the biopharmaceutical industry lacks an additional group to act as a bridge between development and commercialization. This is the role of medical affairs.
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Scope and Importance
Medical affairs originally emerged as a reaction to increasing pressures from regulators to separate medical and commercial functions. Companies were experiencing increasing internal demands to focus the role of development on generating and developing new products rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure shifted a number of commercial activities to people with medical expertise, most often to medical affairs groups. Thus medical affairs has evolved into a separate medical organization that often sits within development organizations but primarily works on post approval activities and has both the scientific and clinical expertise to support commercial products. Examples of medical affairs functions include
• Managing key thought-leader relationships
• Publishing data from corporate-sponsored trials
• Presenting educational information about a product or therapeutic landscape
• Answering questions from healthcare providers regarding product safety or efficacy that is not addressed in a product’s label
• Supporting research initiatives outside labelled indications for marketed products.
For a company whose product is years away from commercialization, the information above may be interesting, yet may seem irrelevant. It may be thought-provoking, but otherwise meaningless in day-to-day operations of a typical biotechnology company that is involved more with drug discovery than with drug development and commercialization. Although gaining a deep understanding of medical affairs may not seem immediately relevant, understanding the overall purpose of it and the functions it performs becomes crucial as a product moves closer to commercialization. Medical affairs can sometimes be overlooked due to competing priorities such as establishing a commercial organization, ensuring a smooth path toward regulatory approval, and creating and validating a stable and reliable manufacturing supply chain. However, a number of key medical affairs functions are critical at the time of product launch. The foundation for such functions must be laid 12–24 months before launch for this important department to deliver maximum value to a company. Medical communications/publications is a medical affairs group that directs and plans for all drug-related publications such as abstracts, posters, and manuscripts. Such communications are essential for product commercialization. The group is also responsible for developing a strategic plan that integrates and aligns the timing of clinical trial data locks with the release of key data points at scientific meetings. That plan outlines the timing of abstract submissions and defines when key manuscripts can and should be published in the years leading up to and following a launch. This includes publication of interim data (if available) for either early stage or pivotal trials, which can occur months to years before drug approval. To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. That period will allow a medical affairs team to become familiar with the product, understand related issues, and become experts in the group’s wide variety of roles and responsibilities. Understanding the capabilities and functions of medical affairs and the timing for when their functions are needed is a critical component of preparing for and executing a successful drug product launch.
The market was valued at US$1.56 billion in 2013 and is estimated to reach a value of US$4.49 billion by the end of 2020.With the help of regulatory affairs outsourcing, life science, pharmaceutical, and medical device manufacturing companies are able to get their drugs or devices approved or launched in the global market. Regulatory affairs outsourcing by biopharmaceutical companies has minimized losses due to recalls and product approval delays. Regulatory affairs service providers also provide effective services such as clinical trial services, medical writing, and pharmacovigilance to biotech, pharma, and medical device companies.
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