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. 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. 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 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. These days, it’s a more complicated game. Additionally, he assures that facility is in compliance with all federal, state and local laws. Identifying and engaging key opinion leaders (KOLs) used to be straightforward business. 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. 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. A Global Medical Affairs infectious disease team wanted to understand and leverage key learnings from Disease Awareness pre-launch/launch activities of relevant analog vaccines to inform a global strategy for a vaccine in clinical development. 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. 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. 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. Biosimilars are entering the U.S. market, and, no matter what role a company plays in the healthcare landscape, biosimilars will be a disrupter. Instant Insights offers you a digest of vital knowledge and practical steps you can consider now. 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 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. 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. Medical role shift from supporting to strategic, Medical Affairs – The Next S-Curve in Pharmaceuticals. 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. 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. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of This not only highlights the importance of launch success in core areas, but also the need for launch teams to set their horizons beyond the projected launch indication and timeline, supported by frameworks and tools to facilitate lifecycle management planning. The 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. 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. 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. COORDINATED & NEEDS-BASED EXTERNAL STAKEHOLDER MULTICHANNEL ENGAGEMENT, 4. MSL Utilization It was between these separating tectonic plates Medical Affairs is both strategically and operationally critical in planning, creating, and delivering differentiated scientific and clinical value in product launch readiness planning. 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. 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. SCENARIO PLANNING & LIFECYCLE MANAGEMENT, Slomiany, Mark, PhD, MBA, MPA; Madhaven, Priya; Kuehn, Michael; Richardson, Sasha, MBA. This is when failure can happen. And so, selecting the right problems to solve, together with a decision-making framework to solve them, are indispensable to maximize effectiveness. 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. 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. Telehealth Is Here To Stay. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. With pharma companies increasingly reorganizing their structure around disease areas, Global and Country Medical Affairs personnel often have commitments to portfolio products or disease area on top of their pre-launch product commitments. 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. Relationship strategies must be tailored to a therapeutic area as one size does not fit all. 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. Contact our team to learn more about how we can help your needs. (PV) Finally, Medical Affairs contributes valuable market intelligence. 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. • Post-launch: Answering prescriber questions will become an increasingly large part of the MSL role, along with continued medical education and implementation of 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. 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. The Medical Affairs function plays a vital role in product launch beginning right from the pre-launch phase and extending well beyond market entry. Medical Affairs’ external liaising informs and supports launch planning to ensure that pharma addresses true clinical and patient needs along the launch path. However, a number of key medical affairs functions are critical at the time of product launch. Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. 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. He develops and implements policies, procedures and best practices. You can revoke your consent any time using the Revoke consent button. “. 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. We are hiring experienced management consultants ready to lead healthcare industry change. View Vynamic's full insight and guidance into "Phase 2: Leading During The Pre-Vaccine Phase". 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. A medical director is a physician who serves as the clinical leader of a medical facility. 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. ORGANIZATIONAL KNOWLEDGE BUILDING & PERFORMANCE OPTIMIZATION, 3. At the launch date gets closer, initiate discussion on the disease that needs to be targeted. 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. Know why it is critical to involve medical affairs throughout the clinical development phase of a drug. 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. Regulatory affairs is a comparatively new business administration function. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs. One observation is that Medical Affairs KPIs are often created too late in the launch planning process, despite their importance in … Reinventing the Role of Medical Affairs Reinventing the Role of Medical Affairs. 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. COVID-19 Business Response – Phase 2: Leading During The Pre-Vaccine Phase. Please contact us at info@fwreports.com. 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. He oversees all training and continuing education for his staff. Leadership teams eager to rethink the role of medical affairs can begin by adding the following key questions to their next strategy meeting agenda: 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. 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. 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. It was between these separating tectonic plates 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. The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. 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. 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. The role of Medical Affairs in NPP groups is critical – as they are expected to hand over a clear roadmap to the brand team. What Do You Do Now? 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. 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. A rapidly changing medical device marketplace coupled with a highly regulated promotional environment has pushed the medical affairs function into a more prominent launch role for the device sector. role for Medical Affairs needs to be mirrored in the attention dedicated to, and the rigour demanded of, medical launch preparations. Ensuring there is a mechanism for measuring success in launch planning is obvious. In this episode we …, 1. Early and well-orchestrated collaboration and co-ordination with the regions and countries provides vital insight to inform the optimal development and implementation of multichannel education and communication programs. 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. Identifying the strengths and weaknesses of the organization’s launch teams at Global, Regional and Country levels, as well as existing programs, is a logical starting point here, and benefits from an objective review. 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. IntroDUctIon Biosimilars in Europe 3 b 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. 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. 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. As a consequence, the launch plans may no longer align with the true needs, beliefs and behaviors of the stakeholder. 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. 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. 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. 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. Only medical affairs is able to put all of the pieces together. Understand key internal challenges medical affairs departments face. Successful launches also stem from companies investing earlier in customer-facing activities, roles, and capabilities. This process also provides an excellent vehicle for constructive pre-launch collaboration and planning with Country and Regional Medical Leaders to fine-tune country-level preparation. Three key areas of focus The EU is sending strong signals about the areas Also, Medical Affairs should play a pivotal role in creating effective key opinion leader (KOL) strategies. How to structure your campaign plan. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. We focus exclusively on the healthcare industry. For some Medical Affairs teams, being too short-term focused and not exploring possible events, their probability and impact on their launch plans, can be detrimental. Medical affairs teams often struggle to secure sufficient funding and value recognition for their ever widening workload – is this a lesson for senior management? 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. Interactions with Thought Leaders must start at the early stage of product development for a successful launch. Drive greater product launch success by fully engaging the medical affairs department. I appreciate that you brought this topic into light. Adding to the complexity, is the interest among providers and payers in applying frameworks to critically assess and compare the value of therapeutic options. As evidenced during the initial months of the COVID-19 pandemic outbreak, businesses were ill-prepared to respond. In general, the importance of Medical Affairs in leading organizational understanding building across Medical Affairs and Commercial, cannot be underestimated. In the European Union, the focus will be on financial and environmental regulation and probably more flexible labor policies. But making this happen is a process that can be filled with uncertainty, confusion and frustration. Critical aspects of launch support that Medical Affairs leaders need to focus on are early stage thought leader (TL) interaction, successful TL targeting, […] 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. 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. This increases exposure and, in turn, the likelihood of more frequent disease outbreaks and pandemics. Mitigating the effect of a pandemic on an organization requires a holistic management approach. In fact, it has become quite common to see the corporate affairs officer reporting directly to the executive of a company. 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. Medical Affairs Professional Society. 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. 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​. Maintaining alignment between Medical Affairs, Commercial and R&D objectives 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. The evolving business and population dynamics over the last two decades make our world more interconnected than ever before. 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 key challenge companies need to face now is how they will adapt their commercial strategies to be successful. Today we see an even clearer case for medical affairs taking on a more strategic leadership role in the face of current technology, economic, and regulatory trends. 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. the Medical Affairs role was, to a certain degree, compromised. The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. Instant Insights offers you a digest of vital knowledge and practical steps you can consider now. How medical affairs can play a greater role in market access and payer engagement. Mistakes can set back years of effort and millions of dollars in expenses. A cross-functional launch team typically consists of executives from Marketing, Sales, Medical, Market Access, External Affairs and Business Intelligence.