MAPS speaks with Beat Sümegi, SVP Medical with Sanofi, about major areas of change and the need to help Medical Affairs professionals build new skills to succeed in this world of increased responsibility and opportunity.
Pete Piliero, MD, moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans.
Medical Affairs’ role in securing a bright future for pharma is undeniable, yet many before have struggled to bring forth concise and consistent descriptions that communicate the full range of benefits and expertise that Medical Affairs (MA) brings to the table. As a result, the wider understanding of MA’s role is not where it should be. To that end, this white paper explores the role and value of MA, backed up with commentary from industry leaders, as we define clear pillars of MA that communicate its true value. What’s more, we propose a short elevator pitch that MA professionals can use to quickly yet succinctly describe the importance of MA for every successful pharma venture in the future.
OVERVIEW:
The COVID-19 pandemic is affecting Medical Affairs professionals around the world, and each team is responding in different ways. During this live Global Town Hall, we will discuss how Medical Affairs can continue to function during the COVID-19 pandemic, as well as share industry best practices and consider how Medical Affairs could change post-COVID-19. Through patient-focus and peer-to-peer relationships with HCPs, Medical Affairs professionals have a unique role in ensuring the safe and effective use of medicines, vaccines and medical devices, and are also positioned to bring invaluable insights from the field into ongoing R&D. By strengthening our understanding within the pharmaceutical industry of how Medical Affairs can support HCPs and patients in these times, this Town Hall will explore how the role of Medical Affairs can be expanded to maintain quality in a rapidly evolving clinical environment, helping to achieve industry-wide alignment on the issue and potentially saving lives.
Join this webinar for insights from industry-leading experts. This series including follow-on webinars will equip MAPS members and MA professionals worldwide with the tools to fulfill the opportunity for Medical Affairs strategic leadership during the Covid-19 pandemic and beyond.
MAPS Members have access to view and download the slides from this presentation.
CLICK HERE TO VIEW AND DOWNLOAD SLIDES IN THE COMMUNITY PORTAL
SPEAKERS:
Rachele Berria
Vice President and Medical Head, US BioPharmaceuticals
AstraZeneca
Eric Mortensen
Head Gastrointestinal Clinical Development, R&D
Janssen Immunology
Tamas Koncz
Chief Medical Officer, Inflammation and Immunology
Pfizer
Isma Benattia
VP, Europe Medical Affairs
Amgen
Terry Griesing
VP, Head of North America Medical Affairs, Internal Medicine
Pfizer
Ann Hartry
VP, HEOR
Lundbeck
Audrey Krolicki
Senior Director, Head of Scientific Publications
Astellas
Danie du Plessis
Executive VP Medical Affairs
Kyowa Kirin International
AGENDA
| Time | Title | speaker |
| 9:00–9:10 EDT | The Opportunity for Medical Affairs Strategic Leadership | Chair: Tamas Koncz |
| 9:10–9:20 EDT | Evidence Generation: Ensuring Speed and Quality During Rapid Decision-Making |
Ann Hartry |
| 9:20–9:30 EDT | Evidence Dissemination: The New World of Publications and Virtual Congresses | Audrey Krolicki |
| 9:30–10:05 EDT | Audience Q&A and Panel Discussion
What has changed for Field Medical? What hasn’t changed? What are the needs now, and in the future? How can the return-to-field be balanced with continued virtual interactions? What are the key adaptive strategies, innovations and practices? |
Full Expert Panel |
| 10:05–10:15 EDT | Closing: The Opportunity for MA is Here and Now | Tamas Koncz |
By: Matthew McLoughlin, DVM, MBA1; Marieke Jonkman, PharmD2; Milana Zivkov, MD, MSc3
1Medical Affairs Professional Society (MAPS) Insights Focus Area Working Group (FAWG) member; 2Medical Science Liaison, QED Therapeutics, MAPS Insights FAWG member; 3Senior Director, Insights and Training Global Lead Medical Communications, Medical Affairs, Astellas Pharma, MAPS Insights FAWG Lead
In March and April 2020, the MAPS INSIGHTS Focus Area Working Group (FAWG) conducted two surveys. The surveys were sent to all MAPS members but were set up to identify pharmaceutical industry-based respondents only (Survey 1) and among them, those who are directly responsible for insights (Survey 2). After collating and analysing the results, this paper provides a brief overview of the survey’s objectives, results and analysis, as well as suggested next steps.
INSIGHTS FAWG conducted two surveys; the first survey focused on demographics, Medical Affairs (MA) roles involved in medical insight generation, and the prevalence of dedicated insights functions in MA. The second survey focused on the specific insight functions within MA organizations, their approaches to insight generation, and the storage, sharing, and use of insights within different companies.
Survey 1 had 95 responses, and Survey 2 had 40 responses. 29% of respondents to Survey 1 were MSLs, and 53% of respondents to Survey 2 worked at an affiliate level. See full results for survey 1 HERE and for survey 2 HERE.
From the results, we draw the following initial conclusions:
The number of responses was limited given the total MAPS membership (N=3,448), and responses may have been skewed towards MSLs’ perspectives on insight generation. Additionally, the surveys did not address company-specific perspectives as only individual MAPS members participated. Compliance aspects, including CRM governance, another vital area of interest for insights generation, were not included within the scope of these surveys.
Notwithstanding the limitations mentioned, we did identify several overarching themes in the responses across the two surveys:
The purpose of generating medical insights is to build a better understanding of the needs and drivers of the behaviour of patients and HCPs so that strategies and tactics can be tailored to address the needs of these stakeholders in the most effective way. If insights are not documented, shared, and used effectively through relevant action and assessment of resulting impact, then the process risks becoming futile. To succeed, pharmaceutical companies will require a framework that enables a process-based collection of medical insights from different sources, subsequent collation, review and analysis. Furthermore, an integrated report that both MA functions and other senior decision-makers find useful and on which they provide feedback is essential.
INSIGHTS FAWG will, as part of the 2020-2021 activities plan, endeavour to develop a common framework that pharmaceutical companies can use to achieve a more consistent and effective approach to generating medical insights as a principal driver for strategy shaping and choice of tactics.
Elevate is a publication of the Medical Affairs Professional Society (MAPS).
By: Simon Kyaga1; Keith Morris2; Kiely Flanigan3
1Global Medical Lead, Psychiatry, Servier; 2Executive Managing Director, Scientific and Medical Affairs, Syneos Health; 3Director, Medical Affairs Syneos Health
This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. In essence, learning agility is a set of skills, competencies, and mindsets that support our capability of “knowing what to do when we don’t know what to do.”1 Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. Through the enablement of learning agile behaviors, the approach to strategic plans can be made with an eye toward ongoing reflection and updates. We define four descriptive behaviors (contextual curiosity, vision-driven adaptability, educated risk taking, and accountable learning) that match up to MAPS best practices in strategic plans and then discuss how to apply those learning agility behaviors. We conclude with future recommendations for the development and application of learning agility.
Learning agility, strategic plan, strategic thinking, medical strategy, capabilities enhancement
The COVID-19 pandemic has accelerated the need to develop Medical Affairs capabilities in learning agility. Not unlike various industry shifts over the years that have impacted the role of Medical Affairs, we’ve experienced a shift in the way Medical Affairs organizations are responding to changes affecting the execution of strategic plans. Field Medical is learning to engage stakeholders virtually and support HCPs in new ways as they engage with their patients through new technologies. Clinical trials adopted new protocols to protect patients and sustain recruitment. Conferences and congresses were postponed. Organizations are seeking flexible resourcing models to manage downturns in business and leveraging downtime to upskill team members. All of these changes have required an openness to change and the development of new skills to learn new ways of achieving our work objectives. We are now not only shifting how we do our Medical Affairs work, but also planning for a “new normal” as we navigate doing business virtually.
Yet, however uniquely disruptive COVID-19 has been, it is still only one more example of the bucket of business disruptions that have affected the skills, knowledge, and capability needs within Medical Affairs work. At the heart of the changes asked of us and our teams is learning agility. As a core capability associated with managing ambiguity and “knowing what to do when you don’t know what to do,” learning agility is particularly relevant and useful in developing adaptive and dynamic Medical Affairs strategic plans that stand the test of change and disruption.1
Learning agility in strategic planning is important because by incorporating learning agility behaviors and mindsets into the development and implementation of Medical strategic plans, teams are better able to pivot and innovate, as needed, to changing internal and external dynamics, while remaining in alignment to the overall medical vision and business objectives.
This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. We then define four descriptive behaviors that map to aspects of Medical Affairs strategic plans and discuss how to apply those learning agility characteristics.
Medical Affairs strategic plans include both intellectual components, such as situational analyses and medical strategies, as well as tactical components, including tactical and operational plans, and assessment and measurement metrics.2 Medical plans are important because they guide decision making across the organization and support the communication and assessment of Medical Affairs’ efforts and impact.
Medical Strategic Planning is an integral part of setting strategic direction and articulating the tactics for driving Medical Affairs value and impact for patient and organizational outcomes. But, how do you create a realistic and viable strategic plan given a VUCA (volatile, uncertain, complex, and ambiguous) Medical Affairs ecosystem? What brings Medical strategic plans to life beyond and ensures it gets referenced more than once a year in the annual planning process? How do we make the strategic plan content memorable and keep it top of mind with our key audiences? We suggest that the secret to effective Medical Affairs strategic plans is learning agility.
In a Medical Affairs context, learning agility brings key behaviors and mindsets into the Medical planning, development, and execution processes that ensure the content contains relevancy and resonance for the organization. Although variations exist between companies in terms of influences affecting the strategic planning process (e.g., preferred timing of Medical support of launches, products, therapeutic area considerations, and operational competencies versus strategic positioning priorities), the Medical Affairs strategic planning process reflects multiple stakeholder insights, business objectives alignment, and tangible data for strategic decision making. The strategic plan is not intended as a fixed manual that is reviewed once a year.
There are several descriptive behaviors team members can use in approaching the development, communication, and operationalization of strategic plans to support success:
Each of these behaviors is based on the capabilities needed to design, communicate, and execute on a strategic plan. The descriptiveness of the terms reflects a desire to position these learning agility behaviors as both foundational and aspirational. Learning agile behaviors are both critical for the here and now in performing work, but also for guiding toward the future and inspiring learning and development.
Learning agility is relatively new to the Medical Affairs scene, but it is starting to see more traction as our industry seeks to build capabilities in individuals and teams to navigate and harness the rapidly changing nature of Medical Affairs. Originally used to develop the managerial capabilities of high-potential, high- performing talent, learning agility can be applied not only at the individual level, but also at the team and organizational levels, and is associated with higher levels of organizational performance.3,4 For purposes of this article, we’ll focus on developing learning agility at the individual level and use the following definition:
Learning agility requires both adaptive readiness to change and proactive innovation in times of ambiguity.5 In essence, learning agility activates the value and impact of Medical Affairs strategic planning components (i.e., situational analysis, medical strategy, tactical and operational plans, and assessment and measurement metrics) despite change and shifting expectations internally and externally.
When it comes to Medical Affairs strategic plans, it is no longer sufficient to rely on the intellectual and tactical domains of competence. Successful Medical Affairs strategic plans reflect a collective organizational capability—an integrated representation of knowledge, skill, and mindset—that brings to life within the plan the flexibility to adapt, learn, and pivot toward changing needs. Learning agility is the “how” behind the “what” of Medical Affairs strategic plans.
The integration of learning agility and Medical strategic planning is important to how both strategic and day- to-day operational decisions are made. This is even more important today as Medical Affairs is being asked to communicate and demonstrate its impact and value within competing priorities from more diverse and increasingly challenging internal and external stakeholder needs. In addition, due to COVID-19 disruptions, including closed conferences, Medical Affairs is forced to reconsider how to communicate and how to balance between strategy and tactics in an uncertain environment.
Using the strategic planning framework developed by MAPS, the section below looks at the fundamentals of Medical strategic planning and suggests related learning agility behaviors and mindsets that are instrumental to both intellectual and tactical outcomes. The learning agility behaviors form a kind of permeable flexibility and protection that ensures the strategic plan is created and maintained with maximum adaptiveness (as seen in the above diagram). Learning agility brings strategic plans to life and articulates specific behaviors that support the strategic plan having bigger impact through greater relevancy. A strategic plan must be relevant to have impact and the learning agility behaviors associated with MAPS’ four elements of strategic plans makes them applicable for the teams using them.
In this article, we have identified learning agility as an emergent capability that brings to life and ensures the relevancy of Medical Affairs strategic plans. Specific applications were discussed for each learning agility behavior in context to its associated strategic planning element. The importance of developing the skills and mindsets to navigate change, uncertainty, and disruption are evident, now more than ever with COVID-19, and important to developing the capabilities to harness the future, whatever may come within Medical Affairs.
1. Hallenbeck, G., & Santana, L. (2019). Great leaders are great learners: How to develop learning-agile high potentials. Center for Creative Leadership white paper, 1-16.
2. MAPS Annual Conference (2020). The importance of Medical strategic planning. Conference presentation: Miami, 1-23. Access in the Community Portal.
3. De Meuse, K.P. (2017) Learning agility: Its evolution as a psychological construct and its empirical relationship to leader success. Consulting Psychology Journal: Practice and Research, 69(4), 267–295.
4. McCann, J., Selsky, J., & Lee, J. (2009). Building agility, resilience and performance in turbulent environments. People & Strategy, 32(3).
5. Doeze Jager-van Vliet, SB, Born, MPh, & van der Molen, HT (2019). Using a portfolio-based process to develop agility among employees. Human Resource Development Quarterly, (30), 39–60.
6. Bourgoin, A. & Harvey, J-F. (2018). Professional image under threat: Dealing with learning–credibility tension. Human Relations, 71(12), 1611–1639.
Joseph Eid, MD, SVP, Head of Global Medical Affairs at Bristol Myers Squibb, describes how Medical Affairs can ensure representation of the patient voice in product development, and the positive shift and elevated prominence Medical Affairs is achieving within companies.
If the video above does not play, or to view full screen, CLICK HERE to open in a new window.
Download the Presentation
Members may also download a PDF copy of Dr. Eid’s panel discussion on The Value of Medical Affairs from the MAPS 2020 Global Annual Meeting as well as a recording of the session in the Community Portal.
View the White Paper
You may also view our latest white paper on the Communicating the Value of Medical Affairs, by clicking here.
As experts with a deep knowledge of our medicines, medical technologies, and therapeutic area science, Medical Affairs is uniquely placed to help the industry and healthcare community navigate through these unusual times. While remaining flexible and agile to meet changing needs and requirements today, we can also begin to look forward to see how to flourish in the new normal.
Medical Affairs always puts patients first, and that will not change. But there are opportunities for improvement that can make the most of the current situation.
We are all getting accustomed to working virtually—here are some best practices to help you and your colleagues:
Be Medical Affairs at its best!
How Medical Affairs as a profession emerges from this crisis depends on us and our actions. We can anticipate some longer-term changes that will help us flourish in the new normal, allowing us to do even more good for patients, HCPs, and medicine.
Based on presentations given by Dr. Charlotte Kremer, Dr. Robin Winter-Sperry, Dr. Tamas Koncz, Dr. John Pracyk, Dr. Peter Piliero, and Dr. Joseph Eid during the MAPS Global Town Hall webinar on April 21, 2020.
Overview:
The COVID-19 pandemic is affecting Medical Affairs professionals around the world, and each team is responding in different ways. During this live Global Town Hall, we will discuss how Medical Affairs can continue to function during the COVID-19 pandemic, as well as share industry best practices and consider how Medical Affairs could change post-COVID-19. By strengthening our understanding within the pharmaceutical industry of how Medical Affairs can support HCPs and patients in these times, this Town Hall will help to achieve industry-wide alignment on the issue and might even save lives.
Objectives:
The objective of the Town Hall is to discuss and communicate best practices that can be applied to Medical Affairs departments across companies, with a specific focus on the ongoing global COVID-19 pandemic.
If the video above does not play, or to view full screen, CLICK HERE to open in a new window.
Members may also download a PDF copy of the slides in the Community portal. Not a member and wish to access the slides? Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/
