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The medical affairs function continues to evolve and to adopt a more collaborative role with companies’ research and commercial functions. At the same time, it must remain vigilant in its compliance with regulatory guidelines.
Providing healthcare professionals, key opinion leaders and payer groups with critical medical and scientific information and education, the function not only enhances a company’s scientific reputation, it also complements the work of Research & Development – all the while communicating the value of a company’s products and services.
While the expansion of responsibilities has made Medical Affairs a pivotal function globally, it still faces the daunting challenge of quantifying its value internally, while still meeting the growing demands brought on by the multiple facets of its role. Medical Affairs leaders wrestle with how best to serve thought leaders, coordinate Medical Science Liaisons, prepare compelling scientific publications, communicate Health Outcomes and cutting-edge science conducted by the company, and at the same time demonstrate value to internal stakeholders.
Thus, medical affairs groups across both mature and emerging markets are seeking ways to optimize their activities and develop reporting formats and metrics that can demonstrate value to senior management.
Best Practices, LLC’s Research & Consulting services provide medical affairs leaders with the expertise and intelligence needed to address many of the aforementioned challenges, while also helping to develop and to cultivate processes to create a best-in-class Medical Affairs organization at the global and local level. Our experienced consultants provide insight and access to key benchmarks and best practices that:
Our research and consulting service has worked with industry leaders and benchmarked organizations across global markets to address key medical affairs topics, including:
The Best Practices, LLC research reveals that Medical Affairs teams lead two key launch activities -- Scientific Publications and MSL activities at 93% of participating companies. Other activities include leading advisory boards and investigator & site identification.
The study identifies the best practices and lessons learned in how Medical Affairs successfully supports launches. Leaders can use the insights from this study as a reference point for creating value-based and science-driven launch strategies.
Recent research by Best Practices, LLC identifies operational issues and varying regulations and compliance guidelines as the top obstacles to global implementation of standards for Medical Science Liaison/Field-Based Medical Specialist teams.
The research can help Medical Affairs leaders with this task. It benchmarks the organizational models, resources, internal communication processes and global standards that drive success in globalizing MSLs worldwide.
An understanding of the important drivers of KOL management can help companies to build stronger thought leader relationships.
Recent research conducted by Best Practices, LLC reveals that degree of Thought Leader support required to change current treatment approach is the most important driver of KOL management for 70% of benchmark class. The study benchmarks the organizational structures, management strategies, activities, tools and tactics associated with excellence in KOL management.
In order to build robust outcomes capabilities, many organizations have begun improving their field-based capabilities around outcomes, as well as customizing outcomes data for different stakeholders.
According to Best Practices, LLC’s benchmarking research; Health Outcomes groups have multi-dimensional field-based responsibilities. The field-based team provides scientific, medical, and pharmaco-economic support to customers and brings back feedback that can improve products.
The study provides best practices and insights around developing effective Health Outcomes groups for organizations.
Critical elements for optimizing medical education capabilities include: structure and activities of the medical education function, effective medical education staffing levels, role of medical education group in important activities (including involvement with thought leaders and professional societies) and allocation of resources by region and program type.
According to Best Practices, LLC’s benchmarking study, education grants and programs make up most of the Medical Education budgets in pharma. With fewer FTEs allocated to medical education, the percentage of budget dedicated to staff is less.
The related study evaluates a broad range of medical education factors, and provides benchmarks around staffing, budget, services, structures and investments for medical education. Additionally, the report presents current and future trends and direction of medical education for field-based medical educators.
The accompanying slide from Best Practices, LLC’s case study highlights the importance of different Medical Affairs functions in an organization’s success. 74% of participating Indian companies consider Medical Science liaisons to be important for an organization’s success, while 67% spotlight Outcomes Research to be gaining significance.
This Best Practices, LLC report analyzes how leading global and Indian biopharmaceutical and medical device companies structure and organize their Medical Affairs groups. The study provides benchmarks around leadership, spend allocation, staffing, budget, regulatory requirements and functional responsibility.
Executive Director, Research and Business Operations
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For this reason, successful product launches require a growing level of involvement from this function from pre-launch phase to well beyond market entry.
As such, Medical Affairs has ramped up its role in health outcomes (HO) information exchanges.
However, growing regulatory scrutiny and increasingly crowded therapeutic areas have made it necessary for biopharmaceutical companies to reassess their approach to conducting medical education.
Research and Business Operations