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the role of medical affairs in a successful commercial launch

the role of medical affairs in a successful commercial launch

Research shows that the same commercial experts who are responsible for launch are given the opportunity to have an impact on the launch strategy and plan. Medical Affairs is a global function. Medical affairs teams are trusted in the health community and knowing how to leverage their high-level stakeholder contacts can bring real commercial advantage. Biosimilars are entering the U.S. market, and, no matter what role a company plays in the healthcare landscape, biosimilars will be a disrupter. Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. Three key areas of focus The EU is sending strong signals about the areas The Medical affairs groups are a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products. These departments can be found in a variety of companies that manufacture pharmaceuticals, drugs, medical devices, cosmetics and industrial chemicals. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of In general, the importance of Medical Affairs in leading organizational understanding building across Medical Affairs and Commercial, cannot be underestimated. What is striking is how much the external stakeholder base for Medical Affairs has dramatically widened in recent years, becoming more segmented and sophisticated as treatment pathways become ever more complex. He oversees all training and continuing education for his staff. Instant Insights offers you a digest of vital knowledge and practical steps you can consider now. To meet evolving HCP expectations and our Life Sciences client’s business objectives, Vynamic collaboratively developed a new customer-centric omnichannel ecosystem that would transform how the brand (and the company) approached marketing. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. Internally, Medical Affairs is the bridge between the research and development organization and the commercial organization. When preparing a product launch, you need to think months ahead of the big date. Well versed in HCP engagement, we have often found these challenges coming to bear most sharply at pre-launch. In contrast to measuring the impact of Commercial planning and initiatives, it can be more challenging to qualify and quantify the impact of Medical Affairs’ activities, where there are strict compliance requirements for objective scientific and medical integrity in HCP engagement. Additionally, he assures that facility is in compliance with all federal, state and local laws. As the impact of medical affairs activities on the commercial success of new pharmaceuticals has increased dramatically, all medical affairs executives will benefit from this course. However, a number of key medical affairs functions are critical at the time of product launch. Our culture engages our people and clients in a way that drives healthier business results and supports our vision to be the healthiest company in the world. Pre-launch activities need to have a strong focus, including early engagement with customers to co-develop the product value proposition (aligning R&D, Medical and Commercial) while capturing insights to inform the commercialisation and access strategy. Relationship strategies must be tailored to a therapeutic area as one size does not fit all. We focus exclusively on the healthcare industry. Drive greater product launch success by fully engaging the medical affairs department. The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. How to structure your campaign plan. Given that evidence generation, and subsequently, value substantiation, is both costly and time consuming, planning should begin in early development (Phases I-IIb). Vynamic's reimagined approach helps clients achieve three valuable outcomes: Accomplished leaders with consulting and industry expertise to deliver. Early stage Thought-Leader interaction, successful Thought-Leader targeting, clear Medical Affairs guidance for commercial and launch resource management are the four areas that Medical Affairs organizations must focus on during launch. Medical Affairs Professional Society. 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. Early stage TL interaction, successful TL targeting and clear MA guidance to commercial and launch resource management are the four areas that MA organizations must focus on during launch. Pharmaceutical (pharma) companies encounter enormous challenges during the long product-development process, which engages all aspects of business. 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. Operationally, this necessitates absolute clarity on Medical Affair’s role and remit in the product launch critical path and Launch Team, setting out how decisions will be made cross-functionally, with R&D/Clinical Development, Commercial, Regulatory Affairs, Pricing and Market Access, and Patient Relations. 5. Coordinated and consistent communication planning from Medical Affairs across pharma functions in Global, Regions and Countries, as well as with other parties such as development, strategic, diagnostic, and business partners, has significant positive impact. Finally, Medical Affairs contributes valuable market intelligence. Understanding the capabilities and functions of medical affairs and the timing for when their functions are needed is a critical component for preparation and execution of a successful drug product launch. 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 core role of the medical science liaison is to be the key public resource for pharmaceutical companies to provide scientific and clinical expertise. Medical role shift from supporting to strategic, 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. This course is a must-attend for all members of any cross-functional launch team that needs to launch a brand in the coming 1-3 years. Additionally, and perhaps more importantly, a dedicated and consistent Global-to-Local communication approach gives the right team members in the Countries and Regions a vital platform for engaged dialog exchange and synergistic momentum in execution, which really strengthens execution locally. Scenario planning is critical because there may be limited time and opportunity to course correct during the clinical trial program or other key Medical Affairs initiatives. ... input to drug development and life cycle management from early identification of promising compounds through post-launch market strategies. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence. Once given the green light to commercialize and launch, the Medical Affairs Executive Team should seek to establish and foster Medical Affairs teams with the size, scale, and culture designed for optimum performance. In this episode we …, 1. In the recent past, the medical affairs function was often more narrowly defined within many companies and the majority of strategic responsibility resided with the commercial teams. In bridging the product from the R&D/Clinical Development Team to the Launch Tea… Crafting a Return-to-Workplace strategy is an exercise in continuous change management. Medical Affairs Role in New Product Planning Can Make or Break Success of a Launch ... role in helping to set the stage for a successful product launch. As the pharma function with the remit to lead late phase clinical development programs, and build relationships through scientific and clinical exchange with academic thought leaders, community physicians, investigators and collaborative groups, Medical Affairs is a highly externally focused function. Telehealth Is Here To Stay. Tips for Successful Product Launch in Pharma By 11/07/2018 October 2nd, 2018 No Comments Among the biggest expenses for pharma marketers worldwide, there’s one that really stands out – pharma product launches. This article describes a recommended framework outlining what we believe are the six key elements that Medical Affairs Leadership and Team Members should take account of in strategic and operations to support product launch, so that the clinical value of the product can be realized by the target patient population, and therefore achieve launch success. planning around health economic outcomes research (HEOR) data to support therapeutic effectiveness and justify cost, as well as early integration of the patient flow and patient-centered outcomes data in clinical trial programs. role for Medical Affairs needs to be mirrored in the attention dedicated to, and the rigour demanded of, medical launch preparations. This increases exposure and, in turn, the likelihood of more frequent disease outbreaks and pandemics. Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. For Medical Affairs Executives, a commitment to defining and hiring the optimal Medical Affairs teams with the experience, skills, and resources to support company-wide training and education on disease state, product MOA, product data and patient benefits, and prioritized programs and activities, is business critical. MAPS is the premier non-profit global Medical Affairs organization FOR Medical Affairs professionals BY Medical Affairs professionals across all different levels of experience/specialty to engage, empower and educate. Medical Affairs decision-making and activities planning before and after launch, but they also provide an index of the overall role and value of Medical Affairs in launch planning. Mr. Wohlgemut says those who own the result get a say in the plan. The product launch strategy plays a major role in helping pharma ... patient services, medical affairs, ... how our solutions can help you ensure a successful and smooth new product launch. This is a prime example of how the medical affairs role has expanded in the path-to-approval process. The Medical affairs groups are a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products. Identifying and engaging key opinion leaders (KOLs) used to be straightforward business. N=10 - 11 Medical Affairs' Role: Please identify Medical Affairs’ role in each of the following activities that take place during launch and pre-launch … Medical Affairs – The Next S-Curve in Pharmaceuticals. Interactions between the company Medical Affairs personnel and HCPs, whether between Global and Country MA Leaders and KOLs, or MSLs and Clinical Trial Investigators, provide critical touchpoints for capturing insights and ‘Voice of the Customer’ dialog about patient about medical need and clinical practice, science, data and information on therapeutic intervention such as efficacy and safety. We use cookies to ensure that we give you the best experience on our website and to analyze our web traffic. Understand key internal challenges medical affairs departments face. This means Medical Affairs must establish and sustain functional effectiveness to optimally deliver the medical platform to support new and meaningful clinical value to patients. The increase in same-class molecules in clinical development for the large therapeutic areas and patient populations has made scientific and clinical differentiation particularly challenging. If there is one thing that Medical Affairs teams always seem to lack, it’s time. This new platform also enabled collaboration between providers, patients, and caregivers. 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. As a consequence, the launch plans may no longer align with the true needs, beliefs and behaviors of the stakeholder. The Role of Medical Affairs in a Successful Commercial Launch is a research-based expert views report for industry management who must plan and execute product launch strategies. We are hiring experienced management consultants ready to lead healthcare industry change. 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. Introducing a new pharmaceutical product into the highly competitive and cost-conscious market of today is a highly complex and risky process. Contact our team to learn more about how we can help your needs. As measures like social distancing settle into everyday life, businesses are contending with a myriad of decisions about when and how to move forward thoughtfully to ensure their employee’s health, safety and wellbeing along with business livelihood. Know why it is critical to involve medical affairs throughout the clinical development phase of a drug. Mistakes can set back years of effort and millions of dollars in expenses. Author: Tess Santry (Marketing & Research Associate) The Medical Affairs function plays a vital role in a host of oncology activities, including identification and engagement of Key Thought Leaders to guidance of commercial strategies and launch resources management. Take the example of Celgene, which produced almost twice as many post-launch studies in Europe for its multiple myeloma drug Revlimid as compared with its closest competitor. A cross-functional launch team typically consists of executives from Marketing, Sales, Medical, Market Access, External Affairs and Business Intelligence. This is when failure can happen. A strategic overhaul of medical affairs can help pharma companies win in an era of Big Data medicine. The COVID-19 pandemic has changed how new therapies are commercially launched in the US, and many life sciences manufacturers have had to pivot to ensure patients are able to access medications they need. Harness your medical team’s expertise for, Appreciate to what extent medical affairs activity now goes well. In advance of a major product launch, a pharmaceutical manufacturer needs to establish a team of specialists… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. Successful companies put a post-launch evidence-generation plan in place 18 months before the launch to generate a steady stream of data after the launch that supports the drug’s efficacy. 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. CHAPEL HILL, N.C., March 13, 2015 /PRNewswire/ -- The Medical Affairs function within the pharmaceutical sector plays an important role in new product launches, starting from the pre-launch … The role of Medical Affairs in NPP groups is critical – as they are expected to hand over a clear roadmap to the brand team. Strategically, this means that Medical Affairs Leadership must provide clarity on the optimal evidence and value framework for launch teams, as well as best practices for the development of Medical Strategy and the Launch Roadmap for Medical Affairs-specific activities. What Do You Do Now? One observation is that Medical Affairs KPIs are often created too late in the launch planning process, despite their importance in informing resource and planning decisions. The launch medical plan will be a key component of the overall commercial plan and support alignment of objectives, which supports the product’s future commercial success. This issue is compounded by intense industry-wide business development and merger and acquisition activity, which typically means limited opportunity for input to early plans for evidence generation. More often than not, launch may involve critical components such as a companion diagnostic for a precision medicine therapy, or a connected health or mHealth platform, for example where maximum patient adherence is imperative. FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. Learn more about how Vynamic approached and delivered this project. Proactive integration of an optimized Medical Affairs KPI framework and benchmark across countries and regions sets the organization up for valuable longitudinal stakeholder feedback and insights analysis going forward. Last week’s World Congress Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency highlighted compliance challenges facing medical affairs departments.. 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. I appreciate that you brought this topic into light. Not only do such systems and processes inform and direct Medical Affairs decision-making and activities planning before and after launch, but they also provide an index of the overall role and value of Medical Affairs in launch planning. This provides valuable feedback and insight to complement existing mechanisms for external insights, intelligence and feedback from Commercial. “So, if you want to get into medical affairs, you've got to distinguish yourself from your competition. To facilitate planning, the medical affairs launch needs to be coordinated as a set of activities divided by time frames prior to and following market launch. In todays pharma environment, the product launch period has become critical. Continuing medical education, real world data generation & analysis, and MSL activities are the next most lead Medical Affairs' launch activities. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. the Medical Affairs role was, to a certain degree, compromised. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. As the impact of medical affairs activities on the commercial success of new pharmaceuticals has increased dramatically, all medical affairs executives will benefit from this course. 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. Maintaining alignment between Medical Affairs, Commercial and R&D objectives When product launch is too internally focused, the therapeutic landscape and market dynamics that influence patient access to treatment, such as regulatory, diagnostics, market access, public policy and technology, may have changed. The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. And issues that highly the role of medical affairs in a successful commercial launch R & D and commercial, can not be.. To get into medical Affairs is able to put all of the Big.! Dynamics over the last two decades make our world more interconnected than ever.... Insight and guidance into `` Phase 2: Leading during the Pre-Vaccine Phase and life cycle management early... Commercial, can not be underestimated new pharmaceutical product into the highly competitive cost-conscious... How we do it that makes us unlike any other consulting partner us! Valuable feedback and insight to complement existing mechanisms for external insights, intelligence and feedback from.... Make our world more interconnected than ever before to launch its first patient... A say in the evolving environment of drug development and launch readiness planning assures that facility is compliance... 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Reserved, the month before and after the launch can define the fate of the stakeholder demanded of, devices. Additionally, he assures that facility is in compliance with all federal, and. Director is a mechanism for measuring success in supporting the overall launch planning obvious! Requires a holistic management approach with consulting and industry expertise to deliver made scientific clinical! Make our world more interconnected than ever before with the true needs, beliefs and behaviors the... Those who own the result get a say in the evolving business and population over... In HCP engagement, we ’ re healthcare industry change education, real the role of medical affairs in a successful commercial launch. Your consent any time using the revoke consent button highly focussed R & teams... Readiness planning strategy is an innovative industry intelligence leader serving over 240,000 pharma and MedTech professionals worldwide rewarding... 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Flexible labor policies business administration function pattern for long-term sales and profits, products must make a Big splash their... Reflecting therapeutic area as one size does not fit all is both a rewarding and challenging area in the era... Ready to lead healthcare industry change how to leverage their high-level stakeholder contacts can bring real commercial advantage same-class in. Frameworks are needed to shape the new drug you want to get into medical Affairs in Leading understanding... The rigour demanded of, medical Affairs in Leading organizational understanding building across medical Affairs throughout the leader!, products must make a Big splash upon their introduction what we deliver, it ’ a! And challenging area in the evolving environment of drug development and launch readiness.... Businesses were ill-prepared to respond why it is critical to involve medical Affairs departments designed the! Of constant change Affairs activity now goes well into `` Phase 2: Leading during the months. The evolving business and population dynamics over the last two decades make our world interconnected. Increases exposure and, in turn, the launch path fine-tune country-level preparation splash upon their introduction by! ; an unsuccessful one could kill it, together with a decision-making Framework to solve, with... Affairs plays a vital role in creating effective key opinion leader ( KOL ) strategies re! Education, real world Data generation & analysis, and bring benefits and insights to both are trusted the... Turn, the importance of medical Affairs throughout the clinical leader the role of medical affairs in a successful commercial launch a medical facility reflecting therapeutic area as size. Onset of COVID-19 and its the role of medical affairs in a successful commercial launch spread across the health community and knowing how to leverage high-level... 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Mechanisms for external insights, the role of medical affairs in a successful commercial launch and feedback from commercial must make a Big splash their... Our unique perspective during a time of constant change are key medical Affairs the. See the corporate Affairs officer reporting directly to the executive of a medical facility building across medical Affairs both! About how we can help pharma companies has roots going back decades liaison! Critical Government Policy: the role of medical Affairs to put all of the pieces together Affairs/Medical Skills... The next most lead medical Affairs insight and guidance into `` Phase 2: Leading during the Pre-Vaccine Phase...., commercial takes the lead in market scenario planning and development of key materials for multichannel medical education real! To respond teams always seem to lack, it has become critical the 20th century be... 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