Some of the most important are outlined in Figure 2. Medical Affairs teams face new challenges and great opportunities in delivering new products to patients in China efficiently. Challenges in the pharmaceutical industry and the pressures felt by medical affairs. Clearly define roles of Medical Affairs and communi-cate to other stakeholders Develop SOP for Medical Affairs activities on brand teams and a means to communicate progress Train Marketing and Medical Affairs to increase under-standing of roles and challenges of each Medical Affairs sees its main role as an internal and external information source Medical Affairs are therefore strengthening their leadership by developing innovative products & services driving business value and eventually become a key internal partner for portfolio development. As the interface between companies and KOLs, HCPs, payers and patients, medical affairs has grown rapidly in importance. Their unique positioning as a trustworthy function at the crossroad between all healthcare stakeholders (patients, healthcare professionals, regulators,…) also represents a unique opportunity to redefine their engagement strategy with enhanced scientific evidences and transparency and to deliver strong scientific value to patients and healthcare professionals. Medical Affairs has an opportunity to take an even greater role in creating regulatory awareness and being the trusted partner to maintain vigilance and compliance around quality medical information. They will generate and analyze vast volumes of real-world data and excel at communicating scientific evidence. Healthcare professionals (HCPs) face a number of challenges related to medical knowledge and information access. Figure 1. It is not the first time we say this: healthcare is rapidly changing and is driven by several different factors, chief among them our ability to create ever-increasing amounts of data ever faster – and also our increasing ability to make sense of them. Recognizing the challenges of HDHPs and deferred medical care, ... “The Challenges Of High-Deductible Plans For Chronically Ill People," Health Affairs … Such challenges have grown exponentially over the past few years due to an information revolution in the healthcare ecosystem. 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 … All Rights Reserved. (2012). > Success through cooperation. A successful Medical Affairs transformation requires the integration of new capabilities (digital, analytics,…) in a patient-centric organization supported by agile processes & collaborative tools to emancipate the full potential of this singular function. Découvrez les nouvelles tendances de demain. May 22, 2020. There is an obvious solution. Introducing patient-centric capabilities & culture within Medical Affairs in association with the development of relevant digital tools leads to a totally controlled healthcare ecosystem from which emanate winning partnerships driving an optimal positioning of the value proposition. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. Our strong strategic presence in the biopharmaceutical industry, high standards of corporate governance and Medicines Australia membership ensure we achieve our client’s goals to the highest quality and compliance. At the heart of the pharma model has always been the clinical and commercial functions. Medical affairs departments have an opportunity to become the voice of a company to the outside world, including speaking to payers, patients, physicians, regulators and government agencies. Meanwhile, medical education takes up 18% of allocations, according to the study. Ultimately, in such an increasingly challenging environment, the onus is on medical affairs to not only generate high level data but to translate this data into quality insights and programs that address the needs of all stakeholders, from patients and HCPs to payers and government bodies. 1 Otto, R., Santagostino, A. And demands are set to grow with a wider number of stakeholders needing ever more specific data, information and support. Medical Affairs, being the major scientific external facing team, has become a two-way conduit with healthcare professionals, key opinion … 5 Price, B. 1,2 As a result, drug approval and reimbursements require companies’ medical affairs to generate increasing amounts of complex, real-world patient outcomes data to demonstrate product value. 1. Your web browser needs to have JavaScript enabled to access features on this website and enjoy an optimal experience. In particular Medical Affairs has a key role to play in helping pharma in the following areas: Shift of healthcare patients to consumers changes the focus of information. It’s critical for medical affairs to understand the challenges that COVID-19 has created for physicians and the resulting shifts in their need for scientific information and how they get it. [1] Building an Insights Engine by Frank van den Driest and al, September 2016, Harvard Business Review, https://hbr.org/2016/09/building-an-insights-engine, Rapport des reconnaissances des analystes, Crisis management and business continuity, L’usine autonome : l’avenir de la fabrication, Le double enjeu des Plans de Continuité d’Activité, Agile transformation: a crucial, all-encompassing journey, Excellence Opérationnelle : c’est toujours le bon moment, Le Cloud : tout simplement incontournable, Retail Big Show Forum 2021 en podcast avec SAP, Blog Afrique & Développement International, Aymeric Colleville, Senior Consultant, Life Sciences, https://hbr.org/2016/09/building-an-insights-engine. Biopharma companies have a significant opportunity to meet this need by transforming the strategic relevance of their medical affairs … (Titusville, 2013). Science, safety and transparency are the key drivers of the Medical Affairs to establish and maintain the unbiased and trustworthy nature of the function and represent therefore a key stake area to consider. Notre différence réside dans nos collaborateurs et nos méthodes de travail. Medical affairs personnel must adapt to a host of external challenges, among them a sharper focus on risk management, the growing prevalence of chronic diseases alongside an increased industry focus on specialty and niche diseases, the emergence of new types of data, and finally a more difficult market access environment. Welcome to the Medical Affairs Professional Society’s Digital Focus Area Working Group’s podcast three part series entitled “typical challenges with moving digitalization initiatives forward for Medical Affairs.” My name is Rishi Ohri and I will be the moderator for this podcast. © Copyright 2021 Clinical Research Corporation. 4 Systems, V. Reimagining medical affairs: Creating value as stakeholders, commercial models and therapies evolve. These capabilities must then be integrated into a clearly defined evidence governance and planning owned by Medical Affairs. Rapid growth in biopharma: Challenges and opportunities. A strategic overhaul of medical affairs can help pharma companies win in an era of Big Data medicine. Respondents were recruited within North American and In this sense, facilitating collaboration can mean organizing access to the latest approved literature to quickly answer client inquiries. What are the future opportunities and challenges for medical affairs? I appreciate that you brought this topic into light. Healthcare professionals (HCPs), and specialist physicians in particular, are facing an increasing number of challenges related to medical knowledge and information access in their daily practice. However, this transformation has led to significant challenges and pressures faced by medical affairs to demonstrate product value and deliver on performance (Figure 1). Because of the increasing importance of data, information and other factors, Medical Affairs has become the key agent in helping pharma overcome today’s challenges. Le succès de nos clients est notre succès. As a trusted function, Medical Affairs are therefore well positioned to develop collaborative and open innovation (Thought Leaders, Patients Advocacy Groups, startup…) to co-create healthcare solutions with the entire ecosystem of the company and focus on value. Such required scientific evidence can today be generated through innovative ways enabled by the digital era requiring deep analytical capabilities to effectively manage and analyze health-related data emanating from various sources ranging from real-world studies to connected clinical trials. The pharmaceutical industry has traditionally been focused on supporting the delivery of R&D into commercially available treatment to improve patients quality of life. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond. 1 2 Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. An experienced medical affairs team can link scientific and clinical results to patient outcomes, adding value at every stage of a drug’s development. Medical Affairs, as a pillar function, must build a powerful insights engine to nurture the entire organisation and associated ecosystem. Medical affairs: past and future. 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. (UK, 2012). They know the history of the field, wrote the book chapter, performed the benchwork, or developed the study protocol. When discussing a potential new compound with physicians, payers and opinion leaders, for example, medical affairs teams 2 Coopers, P. W. From vision to decision Pharma 2020. Medical Affairs is one of the most important organizations within the pharmaceutical industry these days, and the future for the function is bright. Medical Affairs is uniquely placed to work closely with all stakeholders to truly understand the challenges they face and to work as a genuine partner with them to find solutions, leading to improved patient care and creating value for all stakeholders. 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 Medical Affairs is facing such challenges, Medical Affairs must build & leverage new capabilities to move from their traditional role to a pillar function which endorsing strong business value. The next generation of Medical Affairs will be challenged with the renewal of medical education and alongside with it, the role and positioning of MSLs, to strongly engage HCP, patients and demonstrate added scientific value. There is an overwhelming need to embrace the power of data and analytics, as … Medical Affairs – Bright Future Driven by Data. Pharma medical affairs 2020 and beyond. & Schrader, U. As Medical Affairs is facing such challenges, Medical Affairs must build & leverage new capabilities to move from their traditional role to a pillar function which endorsing strong business value. Medical affairs face significant challenges, The regulatory environment is becoming more rigorous with increased collaboration between global regulatory bodies.1,2 As a result, drug approval and reimbursements require companies’ medical affairs to generate increasing amounts of complex, real-world patient outcomes data to demonstrate product value.2,3, The expiration of patents for primary care blockbuster drugs has shifted focus towards specialty drugs.4 This has in turn, led to a reliance on medical affairs to provide an increased depth of knowledge in specialty therapy areas. 3 Evers, M. et al. Product development was under clinical, while marketing and product lifecycle management was owned by commercial. In bridging the product from the R&D/Clinical Developme… Medical Affairs are uniquely positioned at the crossroad of healthcare stakeholders, interacting with Thought Leaders, HCPs, Patients Advocacy Groups and healthcare authorities, and can therefore determining the best strategies to engage them and develop sustainable relationships based on trust. Moreover, compliance requirements mean medical affairs is responsible for providing HCPs with real-time, unbiased and transparent medical information.4. The most competitive pharma companies in the coming decade will be masters of data and digital technologies. Developing training that challenges and engages Medical Affairs associates can be a challenge. Notre métier : le conseil en management et en technologie. However, this is stifled somewhat by the decreasing percentage of specialists that are able to be accessed by pharmaceutical company representatives.4, The advent of readily accessible medical information has resulted in the evolution of the stakeholder landscape where new and diverse players such as patients and advocacy groups are now becoming key decision-makers.3 Furthermore, demands for transparency and intensifying public scrutiny adds significantly to the compliance pressures already felt by medical affairs to increase credibility and improve stakeholder engagement.3, Medical affairs play a pivotal role in overcoming barriers to accessing healthcare professionals (HCPs). The request for consulting services increases. The next generation of Medical Affairs considers powerful activities to endorse business acceleration and resilience. Advantages of outsourcing medical affairs. This enables our clients to re-deploy their resources to maximise commercial opportunities, thus expediting market access, increasing efficiencies and economies of scale. The next generation of Medical Affairs considers powerful activities to endorse business acceleration and resilience. “What increasingly separates the winners from the losers is the ability to transform data into insights […] and to turn those insights into strategy.” This quote of Frank van den Driest et al from the Harvard Business Review [1] highlights how important it is to efficiently generate and manage insights for any business, including the pharmaceutical industry. The transformation journey of Medical Affairs from Support Function to Pillar Function leverages the opportunities offered by the new technologies to adopt a more holistic approach of healthcare and improve patients quality of life as whole. This is the first of a three-part series looking at three key areas where external landscape changes are impacting the Medical Affairs function. Currently soaring regulatory requirements for medical devices often cause capacity bottlenecks. The goal of product lifecycle management—to maximize the value of an individual product—requires cross-functional collaboration. Medical Affairs Budget Challenges Future Predictions 4. The scientific communication platform (SCP) forms the core for all communications about a product and serves as the repository of available evidence and statements to support Medical Affairs strategy. Medical Affairs are therefore becoming a key partner within the organization to identify valuable scientific patient & HCP insights and leverage the most relevant of them into the brand strategy plan. Although change often creates challenges, there will also be important opportunities for Medical Affairs to take on an enhanced strategic role, shaping how Many Medical Affairs Directors or Vice Presidents offer extensive clinical expertise (such as a background in R&D, clinical practice, or medical school). A bolder vision for Medical Affairs A far larger and more ambitious vision for Medical Affairs is defined by four core areas of activity that combine to maximize patient experiences and outcomes (Exhibit 2). (Pleasanton, 2015). Nous sommes là pour mettre nos clients sur la voie du succès durable en les aidant à se transformer. Expert Challenges. Medical Affairs audiences are difficult to engage because they already possess knowledge and skill sets far above the average employee. This allows companies the opportunity to shift their headcounts to key initiatives, driven by the changing dynamics within the company and within the market.5 Companies can therefore increase their economies of scale, increase their strategic capabilities and broaden the value proposition (Figure 2), thereby maximising and sustaining strategic management and profitable growth.