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. Although project management has been known to drive industrial success in other industries, its principles have only been applied to business practices in pharma recently. 5. A medical director is a physician who serves as the clinical leader of a medical facility. For some Medical Affairs teams, being too short-term focused and not exploring possible events, their probability and impact on their launch plans, can be detrimental. Medical affairs Driving influence across the health care ecosystem Instant Insights Solving your most pressing business challenges starts with knowing the landscape. As stated by Docplexus, the month before and after the launch can define the fate of the product in the following years. Maintaining alignment between Medical Affairs, Commercial and R&D objectives In the European Union, the focus will be on financial and environmental regulation and probably more flexible labor policies. Let us know if you accept and we will save a cookie to remember your choice. 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. Continued regulatory pressure has shifted many “commercial” responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap … Typically, Commercial takes the lead in market scenario planning and future-scoping activities within the launch team. Medical affairs teams often struggle to secure sufficient funding and value recognition for their ever widening workload – is this a lesson for senior management? In a healthcare environment that is increasingly complex, unpredictable, and regulated, Medical Affairs should devote early focus to building strategic and operational launch success by adopting our Six Key Elements Framework. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. Medical affairs see the bigger picture and can often identify opportunities and issues that highly focussed R&D/commercial teams miss. In such a scenario, the Medical Affairs function plays an important role beginning right from the pre-launch phase and extending well beyond the launch date. Additionally, he assures that facility is in compliance with all federal, state and local laws. In summary, leaders articulated three distinct imperatives on the evolving role of medical affairs in APAC in terms of what it will take to deliver in the next three to five years. ... input to drug development and life cycle management from early identification of promising compounds through post-launch market strategies. Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. 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. FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. Learn how Vynamic recently advised two large pharmaceutical companies working within in an alliance on how to pivot their launch planning efforts (both internally and externally) for two oncology indication launches. In this way, Medical Affairs teams can proactively invest in Phase IV/RWE/HEOR evidence generation and clinical development for future lifecycle label expansions, confident in their plans to sustain clinical value beyond launch and maximize lifecycle potential. Government Policy: The Role of Government is Critical Government policy frameworks are needed to shape the new economy. Medical Affairs organizations have emerged over the past half century in response to federal regulations around the separation of medical and commercial activities within drug companies. Global Medical Affairs Director – Top 10 Pharma Company, Vice-President of Medical Affairs, US – Medium-sized Pharma Company, Former Vice President, Head of Medical Affairs Europe and Canada – Top 10 Pharma Company, Global Medical Affairs Lead – Top 10 Pharma Company, Franchise Head, Medical Communications – Top 10 Pharma Company, Executive Medical Director, Medical Affairs – Top 10 Pharma Company, Global Head of R&D and Medical Affairs – Biotech Company. SCENARIO PLANNING & LIFECYCLE MANAGEMENT, Slomiany, Mark, PhD, MBA, MPA; Madhaven, Priya; Kuehn, Michael; Richardson, Sasha, MBA. The map can be extremely useful in helping to fully understand the steps needed to successfully launch & manage the new drug. (PV) The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. The evolving business and population dynamics over the last two decades make our world more interconnected than ever before. At the enterprise level, Medical Affairs should strongly consider all possible multichannel capabilities in order to select, design and execute the optimal multichannel educational strategies. Consequently, as part of early phase of launch preparations, Medical Affairs, in association with other functions, must assess and decide where to invest in real-world evidence generation to support value, through quality of life studies, Investigator-led studies, and patient reported outcomes studies, to back up clinical value at launch and beyond. Mistakes can set back years of effort and millions of dollars in expenses. When preparing a product launch, you need to think months ahead of the big date. Today we see an even clearer case for medical affairs taking on a more strategic leadership role in the face of current technology, economic, and regulatory trends. Therefore, successful new product development and commercialization require that the right evidence to substantiate value is available at the right time to the right stakeholders. Know why it is critical to involve medical affairs throughout the clinical development phase of a drug. The two roles have a number of areas in which there is a definite overlap; however, there are differences and in recent years the role of the Corporate Affairs leader has gained more traction than that of marketing. This not only highlights the importance of launch success in core areas, but also the need for launch teams to set their horizons beyond the projected launch indication and timeline, supported by frameworks and tools to facilitate lifecycle management planning.
the role of medical affairs in a successful commercial launch