Finally, Medical Affairs contributes valuable market intelligence. Medical affairs Driving influence across the health care ecosystem Instant Insights Solving your most pressing business challenges starts with knowing the landscape. 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. When preparing a product launch, you need to think months ahead of the big date. 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. Successful launches can "make" a small pharma company; an unsuccessful one could kill it. 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. 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 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. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of 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. The proliferation of media channels combined with the rise of 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. 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. Questions? 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. Leadership teams eager to rethink the role of medical affairs can begin by adding the following key questions to their next strategy meeting agenda: 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. 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. A cross-functional launch team typically consists of executives from Marketing, Sales, Medical, Market Access, External Affairs and Business Intelligence. MSL Utilization 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. The evolving role of medical: Three imperatives. In fact, it has become quite common to see the corporate affairs officer reporting directly to the executive of a company. Medical Affairs plays a vital role in launch and promotion of pharma products. (PV) 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. 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. Understand key internal challenges medical affairs departments face. 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. 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. As evidenced during the initial months of the COVID-19 pandemic outbreak, businesses were ill-prepared to respond. 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. 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. 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. 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. 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. 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. Contact our team to learn more about how we can help your needs. IntroDUctIon Biosimilars in Europe 3 b The core role of the medical science liaison is to be the key public resource for pharmaceutical companies to provide scientific and clinical expertise. 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. That’s a serious concern for the pharma industry, which is expected to derive 25% to 80% of its revenue from new launches by 2021. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. 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. 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. But making this happen is a process that can be filled with uncertainty, confusion and frustration. One observation is that Medical Affairs KPIs are often created too late in the launch planning process, despite their importance in … The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. A strategic overhaul of medical affairs can help pharma companies win in an era of Big Data medicine. 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. The evolving business and population dynamics over the last two decades make our world more interconnected than ever before. 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. Medical Affairs is both strategically and operationally critical in planning, creating, and delivering differentiated scientific and clinical value in product launch readiness planning. 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 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. Critical aspects of launch support that Medical Affairs leaders need to focus on are early stage thought leader (TL) interaction, successful TL targeting, […] Pharmaceutical (pharma) companies encounter enormous challenges during the long product-development process, which engages all aspects of business. In bridging the product from the R&D/Clinical Development Team to the Launch Tea… 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. 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. 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. 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. He develops and implements policies, procedures and best practices. 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. Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. 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. Please contact us at info@fwreports.com. Knowing how to prioritize and optimally cadence stakeholder-specific value creation in communication platforms and channels specific to the needs and roles in the treatment value chain, is essential. These departments can be found in a variety of companies that manufacture pharmaceuticals, drugs, medical devices, cosmetics and industrial chemicals. EARLY SCIENTIFIC & EVIDENCE LEADERSHIP, 2. 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. This new platform also enabled collaboration between providers, patients, and caregivers. Introducing a new pharmaceutical product into the highly competitive and cost-conscious market of today is a highly complex and risky process. Identifying and engaging key opinion leaders (KOLs) used to be straightforward business. Medical affairs teams are trusted in the health community and knowing how to leverage their high-level stakeholder contacts can bring real commercial advantage. Medical Affairs – The Next S-Curve in Pharmaceuticals. 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. 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. 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. 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. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. 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. SCENARIO PLANNING & LIFECYCLE MANAGEMENT, Slomiany, Mark, PhD, MBA, MPA; Madhaven, Priya; Kuehn, Michael; Richardson, Sasha, MBA. As a consequence, the launch plans may no longer align with the true needs, beliefs and behaviors of the stakeholder. 1. 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. 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. 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 this episode we …, 1. Continuing medical education, real world data generation & analysis, and MSL activities are the next most lead Medical Affairs' launch activities. 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. Improve the quality and efficiency of interactions to create a better experience for all stakeholders (Exhibit 3): This is when failure can happen. 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. Crafting a Return-to-Workplace strategy is an exercise in continuous change management. Commercial can’t do that, clinical can’t do that. 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. 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. 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. 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. 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. 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 … 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 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. 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. ... input to drug development and life cycle management from early identification of promising compounds through post-launch market strategies. Taking oncology, for example, there are already many professional organization- and institution- endorsed value frameworks in play, each with varying levels of current awareness and utility among physicians and payers.1 A key consequence for Medical Affairs of the desire for robust value evidence is the need for earlier 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. Mr. Wohlgemut says those who own the result get a say in the plan. 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. 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. The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. Ensuring there is a mechanism for measuring success in launch planning is obvious. 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. 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. Many companies also chose to focus R&D resources on developing new products and moved post-launch activities, such as … It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. Continued regulatory pressure has shifted many “commercial” responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap … Relationship strategies must be tailored to a therapeutic area as one size does not fit all. As stated by Docplexus, the month before and after the launch can define the fate of the product in the following years. Regulatory affairs is a comparatively new business administration function. 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. Biosimilars are entering the U.S. market, and, no matter what role a company plays in the healthcare landscape, biosimilars will be a disrupter. The role of Medical Affairs in NPP groups is critical – as they are expected to hand over a clear roadmap to the brand team. Adding to the complexity, is the interest among providers and payers in applying frameworks to critically assess and compare the value of therapeutic options. COORDINATED & NEEDS-BASED EXTERNAL STAKEHOLDER MULTICHANNEL ENGAGEMENT, 4. An integral part of this review should consider the implementation of Global Medical Affairs/Medical Affairs/MSL Skills and Capabilities Framework and operating models. 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. We’re healthcare industry management consultants driven by our purpose: We believe there is a better way. 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. 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. This increases exposure and, in turn, the likelihood of more frequent disease outbreaks and pandemics. You can revoke your consent any time using the Revoke consent button. Vynamic's reimagined approach helps clients achieve three valuable outcomes: Accomplished leaders with consulting and industry expertise to deliver. How to structure your campaign plan. I appreciate that you brought this topic into light. Successful launches also stem from companies investing earlier in customer-facing activities, roles, and capabilities. The key challenge companies need to face now is how they will adapt their commercial strategies to be successful. 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. 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. 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. 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. 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. Reinventing the Role of Medical Affairs Reinventing the Role of Medical Affairs. the Medical Affairs role was, to a certain degree, compromised. 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. Telehealth Is Here To Stay. 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. 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. 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. And so, selecting the right problems to solve, together with a decision-making framework to solve them, are indispensable to maximize effectiveness. 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 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.