Only medical affairs is able to put all of the pieces together. The model needs to be revised because: 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. 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. In this episode we …, 1. 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. 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. 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. In the medical devices industry, the success of a new product launch can often determine the positioning of the company over the coming years and, although all the components of the strategy contribute to this success, anyone individual can also have the power to cause its failure. In instances where the plan is to launch a product in a therapeutic area or patient population with no or little prior institutional therapeutic area or product knowledge, there is great need to educate and re-educate company personnel. Given that evidence generation, and subsequently, value substantiation, is both costly and time consuming, planning should begin in early development (Phases I-IIb). This process invariably uncovers pivotal opportunities and barriers to enabling Medical Affairs’ success in supporting the overall launch planning process. Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. Medical Affairs plays a vital role in launch and promotion of pharma products. Instant Insights offers you a digest of vital knowledge and practical steps you can consider now. As an example, Medical Affairs launch planning in Infectious Disease (ID) may need to consider: academic and community ID Specialists, General Practitioners, Investigators and Collaborative Groups, Pathologists, Providers, Payers, Pharmacists and Public Policy Makers, patient advocacy groups, among others, depending on the disease and its multi-disciplinary management. As part of building the foundation for launch, significant Medical Affairs time and effort is invested in strategies to identify, profile and engage with HCPs, in particular academic and expert Key Opinion Leaders (KOLs), as these experts inform strategy and planning, and support community education on disease, unmet need, and product rationale, and play a role in shaping the treatment algorithm. 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. EARLY SCIENTIFIC & EVIDENCE LEADERSHIP, 2. 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 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. One observation is that Medical Affairs KPIs are often created too late in the launch planning process, despite their importance in … Many companies also chose to focus R&D resources on developing new products and moved post-launch activities, such as … How medical affairs can play a greater role in market access and payer engagement. MSL Utilization 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. The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. 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.. 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. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. 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. The 3-year roadmap included contracting design and implementation vendors to deliver both healthcare provider and patient visibility into the therapy onboarding process, patient status, and key resources. Successful launches also stem from companies investing earlier in customer-facing activities, roles, and capabilities. 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. Biosimilars are entering the U.S. market, and, no matter what role a company plays in the healthcare landscape, biosimilars will be a disrupter. 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. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. We focus exclusively on the healthcare industry. 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. A successful launch requires deep involvement of Medical Affairs. A strategic overhaul of medical affairs can help pharma companies win in an era of Big Data medicine. Maintaining alignment between Medical Affairs, Commercial and R&D objectives It was between these separating tectonic plates ORGANIZATIONAL KNOWLEDGE BUILDING & PERFORMANCE OPTIMIZATION, 3. Yet, in our experience, medical launch readiness efforts all too often fall short of those expectations, with bleak consequences for the prospects of launch success. We expect successful future drugs to benefit from substantial investments between phase 2b and launch backed up by a risk mitigation strategy, and paired with a more integrated, cross-functional approach (R&D and Commercial) and efficient digitally-enabled go-to-market activities. 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. 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 … 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. A growing area of investment by Pharma companies is in optimizing processes and governance for more structured and strategically valuable KPI collection using CRM platforms across Medical Affairs. “Medical affairs has grown dramatically, so there are many more career opportunities for pharmacists than ever, but it’s also a very competitive space; for each MSL opening there are about 200 applicants on average,” he explained. Don’t forget to subscribe, we’ll keep on explaining. Telehealth Is Here To Stay. Internally, Medical Affairs is the bridge between the research and development organization and the commercial organization. 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. 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. 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. You can revoke your consent any time using the Revoke consent button. Similarly, problematic for Medical Affairs Teams is supporting commercialization where there has been a regulatory thin development program, giving a sub-optimal clinical evidence package for regulatory authority submission. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of Continued regulatory pressure has shifted many “commercial” responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap … 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. Crafting a Return-to-Workplace strategy is an exercise in continuous change management. This is when failure can happen. 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. We approach healthcare as five interwoven sectors, giving you access to our unique perspective during a time of constant change. Contact our team to learn more about how we can help your needs. Relationship strategies must be tailored to a therapeutic area as one size does not fit all. 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. Government Policy: The Role of Government is Critical Government policy frameworks are needed to shape the new economy. 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. The key challenge companies need to face now is how they will adapt their commercial strategies to be successful. 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. 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. 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. 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. In our experience, there is greater scope for Medical Affairs functions to utilize third-party support to help drive critical projects, track Medical Affairs planning progress, and proactively identify risks and issues, especially across the Global to Local axis. 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 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. the Medical Affairs role was, to a certain degree, compromised. It is all too easy to wrongly assume that new stakeholder groups will need and value the same type of engagement with pharma as traditional stakeholder groups. 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. These professionals work throughout a product’s lifecycle, help to ensure that products are used effectively, serve as scientific peers and resources within the medical community, and are scientific experts to internal colleagues. 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 … This white paper is based on Best Practices, LLC’s benchmarking report that explores how Medical Affairs is involved in the launch process at leading pharmaceutical and biotechnology companies. The onset of COVID-19 and its rapid spread across the globe presents uncertainty today. New Delhi, 14 Mar, 2015: The Medical Affairs function within the pharmaceutical sector plays an important role in new product launches, starting from the pre-launch phase and extending well beyond the launch date. We are hiring experienced management consultants ready to lead healthcare industry change. 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. Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. Reinventing the Role of Medical Affairs Reinventing the Role of Medical Affairs. Without doubt, the most successful product launches occur when all functions, especially Medical Affairs, have a firm handle on what may change, why and when, and how this impacts key launch decision-making on strategy and tactics. Typically, Commercial takes the lead in market scenario planning and future-scoping activities within the launch team. 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. 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. Brand Performance Assessment During Critical Launch Window, Engaging HCPs Through True Omnichannel Marketing, Health Plan Call Center CRM Business Migration Strategy, Six Key Elements for Medical Affairs in Product Launch Planning, Value Frameworks in Oncology: Comparative Analysis and Implications to the Pharmaceutical Industry, COVID-19: An Approach for Business Re-Opening, COVID-19 Business Response – Phase 1: Initial Re-Opening, Empowering Specialty Organizations with Specialized Tools, Pivoting Oncology Launch Plans Amid COVID-19, Global Vaccines Strategy: COVID-19 Impact Assessment, Digital Patient Journey Platform For HCPs. Medical affairs is the bridge between R&D and commercial, and bring benefits and insights to both. This is a prime example of how the medical affairs role has expanded in the path-to-approval process. 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. Critical aspects of launch support that Medical Affairs leaders need to focus on are early stage thought leader (TL) interaction, successful TL targeting, […] 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. SCENARIO PLANNING & LIFECYCLE MANAGEMENT, Slomiany, Mark, PhD, MBA, MPA; Madhaven, Priya; Kuehn, Michael; Richardson, Sasha, MBA. A multi-therapeutic area biotech company aimed to launch its first digital patient journey platform for HCPs. As a consequence, the launch plans may no longer align with the true needs, beliefs and behaviors of the stakeholder. 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. Adding to the complexity, is the interest among providers and payers in applying frameworks to critically assess and compare the value of therapeutic options. I appreciate that you brought this topic into light. 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. 5. 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 fact, it has become quite common to see the corporate affairs officer reporting directly to the executive of a company. He oversees all training and continuing education for his staff. Brand members would identify the eight to twelve heavyweights in a disease class and seek to curry their favor, or at least minimize their opposition if outright support wasn’t possible. Medical affairs departments designed for the 20th century will be eclipsed by the coming era of Big Data medicine. “So, if you want to get into medical affairs, you've got to distinguish yourself from your competition. Leadership teams eager to rethink the role of medical affairs can begin by adding the following key questions to their next strategy meeting agenda: 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. 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. We’re healthcare industry management consultants driven by our purpose: We believe there is a better way. Medical affairs teams often struggle to secure sufficient funding and value recognition for their ever widening workload – is this a lesson for senior management? Improve the quality and efficiency of interactions to create a better experience for all stakeholders (Exhibit 3): The evolving role of medical: Three imperatives. 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. Product management is led by a… product manager.Don’t confuse the role with a project manager. Learn from the experience of 8 medical affairs professionals working for major pharma/biotech companies in the US and Europe - see who they are now. Long-term agility in anticipating and managing potential disease area disruptions should be a cultural mindset backed up by strategic intent and process across the organization. As evidenced during the initial months of the COVID-19 pandemic outbreak, businesses were ill-prepared to respond. The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. 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. 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. Relationship strategies must be tailored to a therapeutic area as one size does not fit all. FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. 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. Regulatory affairs is a comparatively new business administration function. COORDINATED & NEEDS-BASED EXTERNAL STAKEHOLDER MULTICHANNEL ENGAGEMENT, 4. Medical affairs Driving influence across the health care ecosystem Instant Insights Solving your most pressing business challenges starts with knowing the landscape. 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. 1. Instant Insights offers you a digest of vital knowledge and practical steps you can consider now. These days, it’s a more complicated game. Medical affairs Driving influence across the health care ecosystem Instant Insights Solving your most pressing business challenges starts with knowing the landscape. 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 … Ensuring there is a mechanism for measuring success in launch planning is obvious. 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. To set up a pattern for long-term sales and profits, products must make a big splash upon their introduction. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of 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. While we take pride in what we deliver, it’s how we do it that makes us unlike any other consulting partner. We use cookies to ensure that we give you the best experience on our website and to analyze our web traffic. Finally, Medical Affairs contributes valuable market intelligence. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. One of the study findings was that for a successful launch, medical affairs groups must build strong communication between key external decision-makers and the internal commercial group. In Pharma Product Launches: Strategies for Success, FirstWord looks at how successful launch strategies can place pharmaceutical companies in a strong position, despite the weak market. 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. This course is particularly suitable for medical affairs executives involved in preparing the market for a new pharmaceutical during the pre-launch phase, as well as new executives in medical affairs departments. The role of Medical Affairs in NPP groups is critical – as they are expected to hand over a clear roadmap to the brand team. 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. The Medical Affairs function within the pharmaceutical sector plays an important role in new product launches, starting from the pre-launch phase and extending well beyond the launch date. 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. Identifying and engaging key opinion leaders (KOLs) used to be straightforward business. 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. Vynamic's reimagined approach helps clients achieve three valuable outcomes: Accomplished leaders with consulting and industry expertise to deliver. You may know the Smart Insights RACE Planning framework which covers five parts which are essential outcomes of a marketing or digital marketing plan, they’re Plan – Reach – InterAct – Convert and Engage an audience. Harness your medical team’s expertise for, Appreciate to what extent medical affairs activity now goes well. Continuing medical education, real world data generation & analysis, and MSL activities are the next most lead Medical Affairs' launch activities. 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. Medical Affairs is both strategically and operationally critical in planning, creating, and delivering differentiated scientific and clinical value in product launch readiness planning. It was between these separating tectonic plates Understand key internal challenges medical affairs departments face. At the launch date gets closer, initiate discussion on the disease that needs to be targeted. Well versed in HCP engagement, we have often found these challenges coming to bear most sharply at pre-launch. Medical Affairs’ external liaising informs and supports launch planning to ensure that pharma addresses true clinical and patient needs along the launch path. As a key healthcare professional (HCP)-facing pillar of the company, operating models to ensure field teams receive training on, and real-time access to, the latest therapeutic area and product knowledge, with optimized skills, processes and systems to feedback valuable customer insights through Knowledge Management Systems and Tools and CRM platforms, will build and sustain a valuable customer-company dialogue aligned to the launch vision and medical objectives. 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. 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. Know why it is critical to involve medical affairs throughout the clinical development phase of a drug. In todays pharma environment, the product launch period has become critical.
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