the role of medical affairs in a successful commercial launch

As the medical affairs launch is meant to prepare the market prior to entry, many critical activities must take place well in advance of actual launch. Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. being successful in medical affairs As the importance of medical affairs has grown greater in recent years, we have seen the specific challenges for our clients change. 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. 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. Three key areas of focus The EU is sending strong signals about the areas 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. 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. We are hiring experienced management consultants ready to lead healthcare industry change. 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. Relationship strategies must be tailored to a therapeutic area as one size does not fit all. 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. And so, selecting the right problems to solve, together with a decision-making framework to solve them, are indispensable to maximize effectiveness. Medical Affairs Professional Society. It was between these separating tectonic plates What Do You Do Now? Government Policy: The Role of Government is Critical Government policy frameworks are needed to shape the new economy. 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. FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. Typically, Commercial takes the lead in market scenario planning and future-scoping activities within the launch team. 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. IntroDUctIon Biosimilars in Europe 3 b 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. 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. 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 this episode we …, 1. Identifying and engaging key opinion leaders (KOLs) used to be straightforward business. Ensure maximum exposure and positive uptake of new therapies by harnessing their talents in scientific interpretation, evidence gathering, trial planning and KOL/payer engagement. 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. 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. In the European Union, the focus will be on financial and environmental regulation and probably more flexible labor policies. 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. Don’t forget to subscribe, we’ll keep on explaining. 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. Evaluate Pharma predicts that, for the top 20 pharma companies’ recently launched and pipeline portfolios, value creation for products in existing core areas will deliver the greatest value gain between 2018 and 2024, with cumulative sales of $579bn.2 The corresponding forecast for non-core areas is $334bn. 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. The evolving role of medical: Three imperatives. We use cookies to ensure that we give you the best experience on our website and to analyze our web traffic. 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. Medical role shift from supporting to strategic, How to structure your campaign plan. 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. 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. 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. 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. Careful and balanced evaluation of external, internal, and personal readiness criteria make for robust, flexible plans. In such instances, proactive and focused company-wide co-ordination will greatly maximize the value of Medical Affairs interactions with HCPs about the therapeutic area and launch product across all launch program elements. 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. Support from a third party brings best practice in providing focused and clear communication to help busy Medical Affairs teams achieve awareness and understanding of product launch vision, objectives, and key initiatives. 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. Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. A common scenario is that pharma companies are launching a new product where competitor same-class products have more indications and/or are already established in terms of safety. However, a number of key medical affairs functions are critical at the time of product launch. In addition, it is Medical Affairs that commonly leads the charge in organizational education and training about disease or product mechanism of action and data across Global, Regions and Countries, so that Medical Science Liaisons (MSLs) and Sales Representatives can attain the required standard of knowledge for informed and value-add external stakeholder interactions. 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. Telehealth Is Here To Stay. Program management and oversight to drive the Medical Launch activities enables Medical Affairs Leaders and Managers to focus on key decision-making for core processes, innovation and value-add initiatives that create clinical and patient value, and devote valuable time to liaison with internal and external stakeholders. In bridging the product from the R&D/Clinical Development Team to the Launch Team for phase IIIb/IV clinical development, Medical Affairs takes on the broad responsibility of Scientific and Clinical Expert to support the commercialization process. 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. A second-in-portfolio pharmaceutical product faced underperformance during their critical launch window and asked Vynamic to conduct a 360° assessment of brand strategy and tactical execution. Medical affairs see the bigger picture and can often identify opportunities and issues that highly focussed R&D/commercial teams miss. ... input to drug development and life cycle management from early identification of promising compounds through post-launch market strategies. 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. 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. 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. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. 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. Mistakes can set back years of effort and millions of dollars in expenses. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. 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. 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. 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. A multi-therapeutic area biotech company aimed to launch its first digital patient journey platform for HCPs. In fact, it has become quite common to see the corporate affairs officer reporting directly to the executive of a company. The Global Vaccines team of a large pharmaceutical company engaged Vynamic to provide a strategic assessment of the potential impact of COVID-19 on the future landscape of diagnostics and surveillance of respiratory viruses​. 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. This provides valuable feedback and insight to complement existing mechanisms for external insights, intelligence and feedback from Commercial. Dossier reports present unbiased and concise analysis based on interviews with leading industry experts on important trends and challenging issues affecting the pharma industry today. He oversees all training and continuing education for his staff. One observation is that Medical Affairs KPIs are often created too late in the launch planning process, despite their importance in … At the launch date gets closer, initiate discussion on the disease that needs to be targeted. If there is one thing that Medical Affairs teams always seem to lack, it’s time. With so much to achieve prior to launch, a key challenge can be not paying enough attention to risk mitigation and expecting the unexpected, both in the product’s clinical development program and in the therapeutic area in general. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of ORGANIZATIONAL KNOWLEDGE BUILDING & PERFORMANCE OPTIMIZATION, 3. The Role of Medical Affairs in a Successful Commercial Launch Introduction The medical affairs role is an increasingly valuable asset to the pharmaceutical industry as relationships between companies and external stakeholders become more complicated.1 The medical affairs team is … In 2002, the Pharmaceutical Research and Manu- ... ment of Medical Affairs in new product launch, ... was reluctant, if not averse, to letting commercial needs of the business drive its administration of these programs. “So, if you want to get into medical affairs, you've got to distinguish yourself from your competition. Best-in-class Medical Affairs groups can become a kind of conduit between key external decision makers and the organization, particularly in the areas of early-stage thought leader interaction, successful thought leader segmentation, alignment of commercial training to demands of key stakeholders, and effective launch resource management. Medical Affairs plays a vital role in launch and promotion of pharma products. Know why it is critical to involve medical affairs throughout the clinical development phase of a drug. Commercial can’t do that, clinical can’t do that. Pharmaceutical (pharma) companies encounter enormous challenges during the long product-development process, which engages all aspects of business. While the level of clinical differentiation plays an important role in a drug’s success, there are many examples of successful drugs that were not considered a major clinical breakthrough at launch, such as Bayer’s and Johnson & Johnson’s Xarelto.

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