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This white paper is inspired by an inquiry to the Medical Affairs Professional Society (MAPS) Digital Focus Area Working Group (FAWG) requesting guidance on best practices to establish a digital framework within Medical Affairs at a small pharmaceutical company. While this paper seeks to provide this specific guidance, the digital framework described herein is not only applicable to small organizations but can be seen as a basic digital framework for Medical Affairs teams in biopharmaceutical and MedTech organizations of any size.
Digital tools power the ability of Medical Affairs teams to generate, analyze and disseminate data to external stakeholders across the product lifecycle, while at the same time bringing essential learnings from these stakeholders back to the organization in the form of insights. That said, no single digital structure or set of digital tools will be appropriate for all organizations. Thus, rather than considering the recommendations of this paper a one-size-fits-all system, it is important to evaluate how digital transformation may empower and support a company’s core beliefs and key messages.
Importantly, no matter the specifics of implementation, we recommend a vision-first approach to digital – only once an organization’s vision has been established is it appropriate or even possible to successfully define the digital pillars needed to implement and execute this vision.
Once a company’s vision is clear, Medical Affairs teams may consider the core components of developing a Medical Affairs digital strategy and plan shown in Figure 1, each of which will be discussed in turn.
Pharmaceutical companies continue to evolve the way they operate, both internally and within the external environment. A variety of factors drive this evolution including societal expectations, continued changes in healthcare systems across geographies, advances in digital technology and its application (as highlighted during COVID 19), and complex legal, regulatory, compliance, and privacy obligations. As a result of these factors, the Medical Affairs (MA) function will become increasingly critical due to its unique positioning, as follows:
This paper explores the MA-based medical insights function and insights-related activities from an MA operational perspective, and identifies basic operational elements required to establish medical insights as a core strategic MA function.
Medical Affairs is a function within the biopharmaceutical, consumer healthcare, and MedTech industries that sits alongside other functions including Research & Development (R&D) and Commercial as one of the strategic pillars of the industry. R&D develops new drugs, devices and diagnostics; Commercial markets and sells these products; and Medical Affairs generates and communicates data that help healthcare professionals (HCPs), payors, policy makers and others make informed decisions that ensure the best use of treatments to benefit patients. In this way, Medical Affairs plays a vital role in providing scientific evidence and understanding to appropriately change clinical practice.
Just as there are many roles within R&D and Commercial, individuals working within Medical Affairs are responsible for many activities, especially including the following:
In this white paper we will discuss various insights that should inform the creation and refinement of the iMC Strategy and Plan (iMC S/P), in addition to the traditional inputs that Medical Communications teams commonly use. The objectives are to (1) explain value of an insights-driven collaborative approach to creating an iMC S/P, (2) elucidate best practices for collecting and synthesizing integrated insights that are relevant to Medical Communications, and (3) operationalizing an insights-driven approach to create and update an iMC S/P.
The use and acceptance of real-world evidence (RWE) in the pharmaceutical and biotechnology industries has increased dramatically in the last 5 years. Approximately 70% of new drug and biologic regulatory submissions to the U.S Food and Drug Administration (FDA) now include RWE.1 Nearly 95% of pharmaceutical industry respondents, in a recent survey by Deloitte, expect RWE to play an important role in their companies by 2022.2 Medical Affairs (MA) professionals are in a unique position to champion the use of RWE internally and communicate its value both internally and externally. This white paper focuses on providing MA professionals with the background and history of RWE, and its potential applications in the biopharma industry, so that they may incorporate this knowledge into their areas of functional expertise, and ultimately, benefit patients and consumers in their healthcare decision-making.
A guide for Medical Communications cross-functional collaboration to develop an Integrated Medical Communications Strategy and Plan (iMC S/P) which is the roadmap for how a Medical Affairs team communicates its product vision and value proposition to internal and external stakeholders.
When quantitative and qualitative Field Medical KPIs and metrics are aligned with the organization’s strategic plan, these measurements demonstrate value. Defining and communicating this value is an essential task as Field Medical solidifies its role as a strategic pillar within the organization.
This paper discusses the sources and uses of non-registrational evidence and describes why Medical Affairs is positioned to lead and own the nRE Strategic Plan.
This position paper is intended outline the roles and responsibilities expected of an MSL and provide clarity on the juxtaposition of MSLs and Sales representatives (SRs) when it comes to scientific exchange versus promotional messaging.
This paper describes survey results from Amgen JAPAC Medical Affairs examining the current state in early 2021 of medical engagement amongst healthcare professionals.
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.