It’s no secret that major forces have pushed the pharmaceutical industry to think differently about how it operates and how it can deliver greater value to society. The good news is that we’re seeing more connected, more agile and more outcomes-focused organizations arise from the disruption.
R&D teams have increasingly broken free from traditional scientific silos through increased internal collaboration and external partnerships with biotech and academia. They have embraced transformative science and technological advances and we are starting to see a new generation of medicines forged by our enhanced ability to capture, interpret and apply data.
Our engagement models have also adapted to changing stakeholder needs. More specialty products with more complex data mean that our clinical and access stakeholders are demanding deeper scientific exchanges to understand the patient impact and value to society.
What’s changed in Medical Affairs?
Like many pharma companies, the role of Medical Affairs at Astellas has transformed in recent years, from a support function to a strategic organization to internal and external stakeholders.
Today, Medical Affairs is comprised of the most important and valued capabilities in the business, playing the role of key connector between internal pharma and external stakeholders.
We are driving scientific exchange and evidence generation with an ever-expanding external stakeholder community of healthcare professionals, scientific experts, health authority bodies, payers and patients.
Our role is not just limited to knowing what these stakeholders want and need. We’re fulfilling information needs through data-generation (clinical trials and real-world data analyses), data sharing through publications, medical information and scientific exchange, pinpointing the investments and activities that will drive the biggest impact for each of these groups. The result, ensuring the safety, efficacy, value and real-world utilization of our therapies are fully understood.
As Medical Affairs integrates its wealth of external insights into a consolidated and aligned strategy to guide its own global activities, it also needs to align with Commercial and R&D colleagues. Through governance and operational excellence, Medical Affairs ensures information needs and data are shared across organizations, as and when needed, to enhance the effectiveness and impact of all respective groups.
Leading value creation in the future
As our operating environment has changed, Medical Affairs has become a more business-savvy, scientifically influential, connected and agile function. While we’re making great progress, companies like Astellas know that the disruption won’t stop.
New challenges lie ahead, such as our ability to address wider societal issues and to create value for a variety of stakeholders that is wider than ever before. Another key challenge for us will be the use of artificial intelligence to generate data from combined big data sources, such as clinical health records, real-world data and the variety of ‘omics’ data sets. This information will need to be delivered in an increasingly digitally-savvy way, for example via interactive medical information websites and other digital channels.
We also know that downward pricing pressures are unlikely to go away. We will need to demonstrate how innovations create value to a wider variety of stakeholders than ever before. So, every commercial decision will have greater consequences.
With this mind, I believe that Medical Affairs professionals must continue to build on the range of capabilities that enable them to act as orchestrators of company strategy with R&D and Commercial functions. Central to this is effective leadership. Medical Affairs leaders need to be ready to interact with the C-Suite and inform corporate strategies because it is helping companies to make smarter decisions and focus performance measures on patient-centric outcomes. And that’s value creation that makes a real difference.
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Eileen Sawyer didn’t always intend to work in pharma—in fact, she hadn’t ever planned to have a career in science.
Growing up in a Boston suburb, neither of her parents worked in the sciences. Her dad was a computer programmer and her mom edited college textbooks. But the family was always passionate about the natural world. Sawyer recalls spending family vacations at national parks, identifying plants and animals together. She’s a self-proclaimed science nerd. She loves the details and especially translating those details to application. Quality science is where it all begins.
In high school, she says she was a ‘big reader,’ and planned to become a writer. In college, that idea changed when she developed an interest in psychology. She loved learning how people think, and she especially liked studying the connection between psychology and biology.
Eileen Sawyer, Vice President, Global Medical Affairs, UniQure
As part of her studies, Sawyer took an introduction to a neuroscience class—and fell in love with it. She enjoyed combining hard science with an understanding of psychology to discover why people are the way they are. It had a storytelling flavor that appealed to the writer in her.
She started working towards her Bachelor of Arts in Neuroscience, and spent her summers interning in labs that studied animal behaviour. Her new career goal became discovering connections between the brain and behavior that could improve healthcare, and after college, she pursued a PhD in Neuroscience research. She hoped to make scientific advancements that would contribute to development of new drugs to help people.
The Right Fit
However, after her PhD, Sawyer began questioning if academia was the right fit. She continued on to her post-doc but felt frustrated. Their team was doing pre-clinical drug discovery, but there were stacks of studies sitting in file drawers waiting to be published. It was great science, but she longed to work more directly on creating new medicines. After all, she had gotten into science to help people. She realized that more than anything, she wanted to work closer to patients—and have a greater impact on their care.
That’s when she made the leap into pharma. Initially, she started by doing some freelance science writing and editing on the side. But the more she got to know the world of pharma, the more she realized that the best place to have the type of impact she wanted was in one of those companies itself, directly working on bringing new drugs to patients. To open up new opportunities, she tried old fashioned networking—asking people about what they do and reaching out to leaders in the industry. She got involved with associations in medical writing and communications and applied to dozens of jobs.
Months later, she got a call about an editing job. But by that point, she realized she didn’t want to just write—she wanted to work inside pharma. She declined the role and continued networking and applying.
The Call
Eventually, she got the call she was looking for—an interview at Alexion in scientific communications. The team that was hiring was preparing to launch a product for bone disease. The condition was rare, and severe. Babies were born with no mineralization in their bones and died because their chest couldn’t support breathing. Of course, the work was completely different from neuro, as it was all below the neck. Still, Sawyer knew immediately that she wanted to help.
The position at Alexion was a formative experience. Sawyer had a mentor she admired, and a role that allowed for plenty of exposure to all of medical affairs, from launch preparation to strategy. Their team worked in that crucial space between the science and the impacts on actual people. In real time, she got to witness science turning into effective medicine—medicine that made tangible impacts on patients.
She loved every minute of it.
After the drug was launched, Sawyer began looking for her next step, knowing that she wanted to find another role with the same level of impact. She found the perfect answer—working on gene therapy at uniQure.
When Sawyer started at uniQure as Director of Scientific Communications, it was small company with no Medical Affairs department. Six months into her tenure, she became the firm’s first Director of MA, and for the first two years in the role, she was a one-woman department. More recently, she has been able to build out the team and increase their impact.
Now, she leads more than seven people with different MA specialties ranging from communications and field medicine to health economics and strategy.
Removing Barriers
Sawyer’s MA team is focused on removing barriers to access to gene therapy. The barriers for patients fall into two main categories:
Knowledge
The health care provider or the patient either does not understand gene therapy or has misperceptions about it and how it can treat the condition. They may not even know a drug is in development. The answer to this challenge? Education.
Evidence barriers
Justifiably, patients and doctors have questions about the treatment. The MA team needs to work to understand those questions, bring them back inside to find answers, and then take those solutions back to the patients. Sometimes, this process requires supplemental studies or health outcomes research.
Sawyer saw a clear key to removing those barriers—listening to patients and physicians. To ensure they were receiving adequate feedback on their work, Sawyer and her team started early, reaching out to patients and physicians while publishing and announcing results from the phase 1 study.
As it turned out, listening to patients changed the team’s entire development program. From the conversations, they learned that the community wanted something completely different from the gene therapy than was expected. So, they went back to the drawing board, totally changing the design of the program.
Sawyer was responsible for presenting the change to thought leaders, MDs and top patient advocates. When she revealed the news at a small scientific meeting after the company announcement, there was an audible gasp in the room. The leaders didn’t think regulators would permit this type of change. However, when she heard from the community that provided the feedback, Sawyer was reassured that they had made the right decision. Patients and physicians were so pleased to see that the company responded to their comments, and it completely transformed their attitude towards partnering with uniQure.
“Our goal was to deliver what they need,” says Sawyer. “They saw that.”
Patient Input
Now, uniQure has patients provide input into everything from their protocol to their patient materials and scientific steering committees. Again, and again, Sawyer has seen them contribute remarkable insights the MDs hadn’t thought about. She recalls one patient at a steering committee who pointed out an issue with the wording in a particular passage. It mentioned barrier protection during sexual contact, and he asked, “How are you defining sex? How inclusive are you being?” The team used his feedback to rewrite the section with more inclusiveness and clarity.
The uniQure team after defending the switch to AMT-061 at the European Medicine Agency. Sawyer is sixth from right.
“Sometimes, wearing the medical hat you forget to think about how it would play in the real world. What does it really mean for someone’s life?” she says.
Sawyer is making it her life’s work to focus on the patient—the most important stakeholder in drug development. She wants to help them take ownership over their care and make informed decisions. To do that, they need access to information—both directly and via access to educated health care providers. Her team presents scientific findings at patient meetings as well as medical meetings, and they engage with patient association leaders around science and policy. They even involve patients in economics and outcomes research. The goal is to foster true partnerships while developing each drug.
“At the end of the day, it’s about giving the patient control,” Sawyer says. “The best scenario is for a patient to have many options and be empowered to choose the best choice for them. The role of pharma in this setting is to equip them with the tools to make those decisions.”
Throughout her career, she has never lost the desire that drew her to pharma. It’s the desire to turn cool science into medicine and make something that matters—something that will make someone’s life better. For her, a great day is one where she has the chance to talk to a physician and hear a patient story. Learning about the tangible impacts that the science is making on patients is what keeps her coming back.
We had a chance to sit down with Eileen. Enjoy watching our interview to see how she responds to questions about:
How her team partners with patients to provide better options for their care
What leaders can do to keep the fire of purpose burning within their people
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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.
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4 Sr Director, Oncology Medical Training AstraZeneca
5 Global Scientific Training Merck & Co
6 Head, Global Medical Affairs, Clinical Development and HEOR, Connected Care Philips
7 VP, Medical Affairs Medline
8 National Director, Psychiatry MSLs, US Field Medical Allergan
9 VP, Customer Strategy – The Medical Affairs Company
10 Director, Filed Medical Excellence Astellas Medical Affairs Americas USA
11 Field Based Medical Affairs, Head, Respiratory GlaxoSmithKline
12 Integrated Leader, Medical Affairs, Pre-Clinical, & Clinical Research DePuy Synthes Spine, (J&J)
13 Director US Medical Affairs Callidiatas Therapeutics
ABSTRACT
The evolving role of Medical Sciences Liaisons (MSLs) was extensively discussed in multiple presentations and workshops at the March 2020 Medical Affairs Professional Society (MAPS) Global Annual Meeting in Miami, Florida. Executive leaders with domain expertise in building and managing Field Medical teams shared their experience and views on the value proposition of these roles and how a changing healthcare and industry landscape is influencing differentiation of and new opportunities for this role. The leaders also recognized the increased need for specialized training and how adult learning principles along with integration of new creative digital tools could help enhance engagement, performance and career growth. This article formalizes these learnings, providing best practices for MSLs in the context of the ongoing pandemic and beyond.
INTRODUCTION
MSLs represent a core function of Medical Affairs, acting as the medical face of the organization to provide deep sub-specialty knowledge to healthcare providers and other external stakeholders. MSLs’ primary responsibility focuses on the three pillars of Medical Affairs, i.e. Scientific Exchange, Evidence Generation, and Evidence Dissemination. As such, a primary function of the MSL role is to build and execute an engagement plan in an expanding thought-leadership network. Currently, both the development of these plans and the actions that allow MSLs to deliver on their promise are undergoing sea change.
Over the last decade, healthcare delivery has undergone sweeping reforms. Emerging trends now focus on substantially better cost, quality, and outcomes as the new parameters to demonstrate significant healthcare value. Patients are now at the center of making their healthcare decisions and are demanding data transparency, easy/convenient access, and personalized products and services. Increased need for data transparency and availability has given rise to disruptive technologies and technological advances in the form of advanced data analytics, artificial intelligence, machine learning, digitization, new social media platforms, etc. Alongside these societal and cultural changes, stricter regulations and adjustments to healthcare policy (e.g. changing insurance landscape, use of Real World Evidence, new European Union (EU) regulations, increased scrutiny on drug pricing and rebates, etc.) are driving new ways of thought and action in the healthcare landscape. Meanwhile, the promise of new technologies driving basic and translational research have led Pharmaceuticals and MedTech industries to renew their focus on R&D and scientific advances, leading to personalized medicine breakthroughs in drug-device combinations, small molecule therapeutics, biologics, immunotherapy and diagnostic biomarkers, regenerative medicine and many more areas of advancement in the life sciences industry.
With these dynamic changes taking place in the healthcare landscape, the traditional role of an MSL as a bridge between internal company stakeholders and the outside medical community now needs to expand to encompass new competitive skillsets focusing broadly on Products, People, Personal & Platforms (“4Ps”). The following description of these 4Ps is not meant to be comprehensive, but rather is an attempt to start a new conversation about these core areas to better equip MSLs with a forward-looking understanding of the skill sets needed to succeed in the current and future disrupted healthcare landscape.
PRODUCT
Due to increased need for personalized medicine (as described in part above), complex treatment options require deep therapeutic area expertise, which for MSLs includes the following:
Understand the therapeutic area landscape and the complex treatment options
Understand the clinical research and clinical practice specific to the therapeutic area
Understand the patient journey and needs of patients in the patient-centric model of care
Understand the marketplace including product competition and current/future scientific advances in the therapeutic landscape
Understand the economic value of the drug or device in consideration, including current and future drug/device pricing along with improvement in clinical and quality of life functional outcomes
Understand (and first generate) clinician and patient insights on current evidence needs and demands.
Understand how to share these insights internally to support new indications, new target markets, and possible new clinical development approaches including RWE studies, investigator-initiated studies / research (IIS/IIRs), comparative effectiveness studies, etc.
PEOPLE
The model of proscriptive medicine in which treatment decisions were made almost solely by healthcare providers has given way to a new model in which patients are collaborators or even drivers of treatment choices, often taking into account quality of life alongside quantity of life. This shift results in new stakeholders, including but certainly not limited to the following:
New patient populations based on personalized/individual disease traits, disease incidence, etiology, pathogenesis, clinical outcomes
Integrated delivery networks (IDNs) & payors, market access and reimbursement groups, accountable care organizations (ACO’s), ambulatory surgery centers (ASC’s), patient advocacy groups, pharmacy & therapeutics committee (P&T), value analysis committee (VAC) with non-clinical leadership decision makers (e.g. supply chain, finance, quality, IT, peri-operative services, etc.)
Digital KOLs, real-world physicians/surgeons and specialists, local/community HCPs (supported by community focused MSL teams i.e. Community Medical Liaisons)
PLATFORMS
Along with new Products and new People are new Platforms that offer significant opportunity for MSLs to reach stakeholders with new creative digital tools for scientific engagement and education, including the following:
Public-facing and HCP-facing digital media including articles, podcasts, social media, virtual events, and even thought-leader forums such as TED talks and other curated communication events
Emerging tools for data visualization and scientific knowledge exchange including advanced data analytics, artificial intelligence/machine learning, virtual and augmented reality. Of course, along with the ability to generate more data and increasingly granular data, MSLs are challenged to discover and utilize innovative ways to customize data for external and internal information consumers
Virtual communication platforms, e.g. Zoom, WeChat, Salesforce, Google hangout, etc. These digital platforms allow MSLs to interact with geographically diverse stakeholders including HCPs, KOLs, advisory boards, patients, payors, and internal/external audiences, but also present the challenges associated with communicating complex information without face-to-face interaction.
PERSONAL
The paradigm shift in the industry, requires MSLs to adapt their practices through specialized training including continuous learning for role proficiency, along with enhanced performance and career growth. The following considerations can guide organizations and individuals in their development of training programs and curricula. MSL training should be:
Practical and able to be used immediately
Tech-based, flexible & available 24/7
Available in all formats
Consumable as individual, low-commitment offerings but placed within a larger framework
Collaborative and engaging, with learning enhanced by coaching and mentoring, games,accountability partnering, collaborative case study reviews, etc.
With reduced burden of learning (cognitive load) to improve learners’ experience, for example bysimplifying messages, keeping trainings relevant to the role and accounting for time constraints.
Furthermore, trainings designed to help MSLs build the skillsets needed to keep pace with changing market, social, technological and regulatory conditions should include assessment and certification requirements, often including the following:
Comprehensive certification, which includes disease area and product knowledge, communication skill, presentation skill, knowledge of relevant policies, compliance, and SOPs
Modified manager certification based on field visits by manager to observe a Field Medical Professional interacting with Scientific Managers and Key Decision Makers
Emerging assessment tools such as Axonify, an adaptive microlearning gaming experience that uses brain science techniques to build employee knowledge
The Four 4 Ps: Considerations for MSL Training Design
SUMMARY
Innovations in science, data and digitization have transformed the healthcare landscape, leading to the emergence of new decision-makers and stakeholders. Alongside these innovations are shifts in culture and society that see patients playing a more active role in their treatments. These shifts are not hypothetical – they are here. The evolving healthcare environment presents both opportunity and challenge for MSLs to further differentiate their competencies, for example through specialized understanding of the therapeutic landscape, healthcare networks, and the requirements and desires of a diverse population of stakeholders. Through proactive engagement with new learnings, MSLs have the opportunity to broaden their vision, role and influence. These new skills will allow tomorrow’s MSLs to elevate performance across medical engagements to optimize experiences and outcomes for physicians and patients.
This publication represents the consensus opinions of the authors and various members of MAPS, but does not represent formal endorsement of conclusions by their organizations
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By: Kirtida Pandya1, Jacqueline Waldrop2, Maria E. Vassilakis3, Marc Sirockman4, Deirdre Jordan5, Ogün Sazova6, Patricia Jassak7, Tim Mikhelashvili8, Sarah Funderburk9, Ivan Desviat10
Executive Director and Head, Medical Services and Operations, Sandoz, A Novartis Division
Director, Oncology Grant Officer, Global Medical Grants, Worldwide Medical & Safety, Pfizer Inc.
Senior Director, Medical Affairs, Standards and Excellence, Astellas
President, MedEvoke
Global Medical Affairs Excellence Lead, Sandoz, A Novartis Division
Medical Director, Napp Pharmaceuticals, UK
Director, IME and External Medical Affairs, Astellas
CEO and Co-Founder, Amedea Pharma
Medical Insights Director, Caudex, a McCann Health Company
Director Medical Education & Outcomes Excellence, Abbvie
ABSTRACT
In the Medical Affairs Professional Society (MAPS) community, external medical education can be categorized based on the extent of influence and industry involvement; however, it should always have the ultimate goal of optimizing patient care and improving health outcomes. Medical Affairs (MA) professionals take the lead to reach this goal by establishing external education programs to address knowledge, competency, or performance gaps. Educational strategies are implemented while fully complying with all applicable laws and codes and considering variables such as regional differences. External medical education demands are continuously evolving, and MA needs to continue to evolve with these changes to establish effective education strategies. Furthermore, the swift change to virtual education platforms due to the current COVID-19 pandemic requires speed and agility across stakeholders. The adaptation of medical education tactics will ensure effective healthcare professional (HCP) education, which will ultimately lead to improvement of patients’ healthcare.
INTRODUCTION
The central mission of external medical education is to provide unbiased education to enhance healthcare professionals’ (HCP) knowledge, skills and competencies to improve patient outcomes. But what role do Medical Affairs (MA) professionals have in its creation and dissemination? The following article provides a brief overview of external medical education and gives insight into the integral role of MA professionals.
WHAT IS EXTERNAL MEDICAL EDUCATION?
External medical education can be defined as diverse educational approaches provided to various stakeholders, such as HCPs, payers, patients, and caregivers, through education initiatives that aim to address identified knowledge, competency or performance gaps. Medical education may address therapy area and disease education gaps through scientific conferences, company-led education, continuing medical education (CME) grants and fellowships or diverse collaboration with scientific and patient advocacy societies (https://community.medicalaffairs.org/on-demand-conferences, The Role of Medical Affairs in External Medical Education: A Roadmap, Slide 11).
THE PATIENT FOCUS OF EXTERNAL MEDICAL EDUCATION
In its simplest terms, the primary goal that unites the entire industry across its MA functions is better patient care. In a systematic literature review of 39 studies, Marinopoulos et al. showed that independent medical education was indeed effective in improving the clinical outcomes of patients1. This was supported by Cervero and Gaines, who found that CME improves physician performance and clinical outcomes2.
MA professionals play a major role in the education needed to improve physician performance and patient outcomes. Based on their insights from diverse channels, they identify knowledge and competency gaps, and unmet medical needs. These can be addressed and translated into education for all stakeholders. MA professionals communicate and disseminate fair-balanced information that is important in guiding relevant strategies or tactics; however, their exact role varies depending on the level of independence of the approach and the extent of direct involvement, policies, and compliance requirements.
THE DIFFERENT TYPES OF EXTERNAL MEDICAL EDUCATION
INDEPENDENT MEDICAL EDUCATION
Independent medical education is supported through grant funding and is planned and implemented without the influence or control of the commercial supporter. Programs can be either funded through unsolicited grants, where third parties submit proposals, or through grants submitted in response to a Call for Grant Applications (CGA) or Request for Proposals (RFP). A wide variety of educational strategies are used at different lifecycle stages of a medicine or device. In the earlier stages it is crucial to assess the needs of healthcare providers and begin to close knowledge gaps, while the peri- and post-launch stages require predisposing, enabling and re-enforcing educational methods (Figure 1)3.
Figure 1. The planning of external medical education is aligned to the life cycle stages of a medicine. QI, Quality Improvement.
To strive for success, MA professionals are advised to keep the end goal in mind, thereby following a “backward planning” strategy. The final ideal state is identified first, then potential knowledge and competency gaps are identified, and finally, budget is allocated to a grantmaking strategy. MA professionals must also take into account the therapeutic landscape and other compounds/products in the specified area of interest.
Unsolicited independent medical education grants have historically utilized a reactive transaction where companies accept unsolicited proposals from accredited providers. MA professionals have had to change their approach to be able to proactively influence the healthcare landscape across a broad spectrum of stakeholders’ perspectives. Supporting needs assessment projects and extensive information-gathering must be used first to inform an effective independent medical education strategy, whether grants are submitted spontaneously or in response to a CGA or RFP.
COMPANY-LED MEDICAL EDUCATION
Company-led medical education is another widely used form of external medical education. These activities are organized by individual pharmaceutical companies and might involve scientific committees, and/or independent scientific and professional organizations. Examples include scientific symposia, patient educational programs, company-sponsored meetings, and educational websites, among others.
Like independent medical education, company-led education is bound to the highest standards for quality, transparency and ethics in medical learning. Content must be relevant, credible, and timely, addressing educational gaps through a sound instructional design and outcome measure plan.
Regulatory agencies have diverse views on the classification of medical education developed by the pharmaceutical/biotech/device industry. Medical education and educational materials are rarely defined by their intent, but by the originator or the supporter. In this regard, industry-developed education/educational materials are considered promotional in many markets regardless of their nature and the internal function that develops them.
Medical education may play a role in influencing the market growth of therapeutics by increasing the awareness of disease states, treatments, and changing guidelines. However, the overall intent of medical education must not be to promote company products, devices, or solutions, but to improve HCPs’ knowledge of relevant data and integrate this into clinical competencies and skills which optimize patient outcomes.
It is important to note that various functions within the industry develop educational materials and scientific programs. While the medical education developed by the MA function does so in a scientific, non-promotional manner, there are components of education regularly developed or used by industry’s commercial function to complement their solutions with a primary intent to increase market share and sales of a product.
Legal and compliance implications in defining and implementing company-led education are extensive and are not addressed in this article. The MAPS Focus Area Working Group (FAWG) on External Education will be addressing these topics in an upcoming Standards and Guidance document and future e-Learning modules.
ASSESSING OUTCOMES AND HURDLES IN EXTERNAL MEDICAL EDUCATION
MA professionals need to measure the impact of educational initiatives on clinical practice and patient outcomes. Assessing relevance and effectiveness should be a continuous process throughout planning and implementation of an activity and needs assessment insights should inform the outcomes assessment plan. Activities should be continuously assessed for relevance and effectiveness and modified when needed. Moore and colleagues proposed a model of outcomes assessment that can aid MA professionals when evaluating activities for their impact on HCP performance and patient outcomes4.
To achieve positive outcomes for patients and healthcare systems, MA professionals need to be aware of potential hurdles they may encounter. Not only do they have the responsibility to ensure delivery of high-quality medical education externally, but they must also find a way to demonstrate the importance and positive impact of medical education to internal stakeholders. Furthermore, where previously physicians had the lead in making treatment decisions, due to rising healthcare costs, decision-making power is gradually shifting to a new set of stakeholders e.g., nurse practitioners and physician assistants who are helping to drive cost containment. It is crucial to be aware of regional differences affecting external medical education tactics (Figure 2). Variations in standard of care, availability of therapeutic products, and region-specific regulatory processes must be acknowledged when designing educational programs.
Figure 2. Regional differences in external medical education. CE, Continuing Education; CPD, Continuing Professional Development; HCPs, Healthcare Professionals.
WHY EXTERNAL MEDICAL EDUCATION NEEDS TO ADAPT
External medical education is rapidly evolving, and MA professionals must be ready for swift changes. Healthcare scientific data continue to increase and originate from an ever-expanding range of sources such as real-world evidence and social-listening programs. The need for external education supporting HCPs as they decipher and incorporate this information requires adaptive education strategies. Medical education is part of HCPs’ lifelong professional development and must address learning needs most relevant to their daily practice5. Increasing transparency in the industry requires data generation and dissemination around external medical education programs, particularly transfers of value (TOV) to HCPs. Additionally, patient advocacy groups are more frequently included in decision-making, maximizing patient insights and directing education strategies towards a more patient-oriented approach.
The recent rapid transition to virtual learning has enhanced disseminating educational content during the ongoing COVID-19 pandemic. MA professionals must adapt to challenging times and find new, diverse ways to generate, and disseminate educational content effectively to support HCPs’ and patients’ needs. A “one size fits all” approach is inadequate for virtual content when delivering medical education in the current situation. A tailored, agile approach aligned to the appropriate setting and audience will allow MA professionals to provide successful digital education and establish the most suitable forum within which to improve timely data dissemination. The right information and education delivered in the appropriate format to HCPs will translate into enhanced and more effective patient care, ultimately improving patient health outcomes.
CONCLUSION
MA professionals are uniquely positioned to serve as factual, impartial, trusted partners who align company strategy to meet healthcare stakeholders’ and patients’ needs. They lead implementation and support of external education with the goal of improving patient outcomes. Gathering internal and external stakeholder insights while keeping the end goal in mind will transform the ever-changing relevance and value of MA strategy and tactics. Thus, as the field of external medical education evolves, MA professionals must adapt accordingly by keeping abreast of the latest healthcare institutional system changes, regulatory codes and compliance needs, regional differences, and technology advances. This will ensure that our key stakeholders (HCPs) have access to quality, evidence-based scientific data to address education gaps to optimize patient care and impact health outcomes.
REFERENCES
Marinopoulos, S. S. et al. Effectiveness of continuing medical education. Evid Rep Technol Assess (Full Rep), 1-69 (2007).
Cervero, R. M. & Gaines, J. K. The impact of CME on physician performance and patient health outcomes: an updated synthesis of systematic reviews. J Contin Educ Health Prof 35, 131-138 (2015).
Rogers, E. M. Diffusion of innovations (1st ed.). The Free Press of Glencoe Division of The Macmillan Co., 60 Fifth Avenue, New York 11, N. Y. (1962).
Moore, D. E. J., Green, J. S. & Gallis, H. A. Achieving desired results and improved outcomes: Integrating planning and assessment throughout learning activities. Journal of Continuing Education in the Health Professions 29, 1-15 (2009).
Davis, D. A., Barnes, B. E. & Fox, R. D. The Continuing Professional Development of Physicians: From Research to Practice. AMA Press (2003).
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/08/22-1.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-09-21 19:07:532023-11-13 10:11:22Medical Affairs Improves Patient Outcomes Through External Medical Education
By João D. Dias1, Cesar Sanz Rodriguez2, Raphael T.B. Tan3
1 Medical Affairs & Clinical Development, Haemonetics S.A., Switzerland, Medical Affairs Professional Society (MAPS) MedTech Focus Area Working Group (FAWG) EMEA Co-Lead
2 Medical Affairs, MSD International GmbH, Switzerland, MAPS MedTech FAWG EMEA Co-Lead
3 International Medical Executive Consultants (IMEC), The Netherlands, MAPS MedTech FAWG member
ABSTRACT
This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations. The European Regulations ask for an increased effort from manufacturers to generate and communicate clinical evidence on the safety and performance of their Medical devices, In vitro-diagnostics and Drug Device Combinations. In conjunction with increased quality standards they make a compelling case for Medical & Scientific Governance with a prominent role for Medical Affairs in many pre- and post-market processes. A transformation of Medical Affairs into a strategic business function makes the medical device industry an exciting place to be for Medical Affairs professionals.
INTRODUCTION
For over two decades, Medical devices and In-vitro Diagnostics have been regulated in Europe by Directives for MEDICAL DEVICES (MDD) and IN VITRO DIAGNOSTICS (IVDD)1,2,3 that were published in 1993 and 1998 respectively. A separate Directive for Active Implantable Medical Devices (AIMD) was published in 1990 with a last revision in 2009. According to these Directives, devices are approved for the European Single Market only after having obtained CE Mark for which manufacturers need to demonstrate conformity to essential requirements relating to the device’s performance and safety for patients and users. After public consultation by the European Commission in 2008 it became clear that an update of the Directives was needed, one reason being the simple fact that new technologies such as companion diagnostic devices were not yet covered. The need for revision gained traction after incidents with breast implants, transvaginal meshes around 2009 and metal-on-metal hip prostheses a couple of years later. Eventually, the revision process that started in 2012 resulted in the Medical Device Regulation (MDR) in which MDD and AIMD were combined and the In Vitro Diagnostics Regulation (IVDR)4,5. The new Regulations were published in 2017, with May 25, 2017 as the official date of entering into force. A transition period to full implementation of the MDR and IVDR was allowed for three and five years respectively, which means the MDR applies from May 26, 2020 and IVDR from May 26, 2022.
So far so good… and then the COVID-19 crisis struck Europe, right at the moment when the medical device industry and notified bodies are transitioning to the new Regulations. Therefore, in order to “take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus,” the European Commission has decided to move back the date on which the new MDR would fully apply by one year, to 26 May 2021. MedTech Europe, the European trade organization of medical device manufacturers, has advocated for a similar delay for the IVDR.
Since the early days of the global COVID-19 crisis the medical industry has made a so far unseen effort in finding (bio-)pharmaceutical solutions, developing vaccines and reliable test kits. Simultaneously, in an attempt to address the relative shortage of masks and intensive care equipment such as ventilators, traditional medical device manufacturers ramped up production. Although regulators accommodate the surge of new devices by fast tracks and exemption rules, new devices are subject to meticulous assessments of performance and safety. And rightly so, since national policies to curb transmission of the virus rely on the quality of diagnostics and personal protection equipment. Especially important is the scrutiny in assessing new medical devices which are intended to be used in the management of the most vulnerable and severely ill COVID-19 patients who end up in hospitals and ICUs.
MEDICAL DEVICE REGULATION (MDR)
In general the new Regulations devices, improve traceability and transparency and define stricter requirements to clinical evidence and post-market surveillance. The MDR now also regulates devices for cosmetic purposes such as colored contact lenses and cosmetic implant devices. The introduction of Unique Device Identification should improve traceability, and transparency is created by the European Databank of Medical Devices (EUDAMED) where all mandatory regulatory documentation on each device is kept and updated. Manufacturers must re-certify devices in accordance with the new regulations and update their technical documentation accordingly with special attention to higher clinical requirements for class III and implantable devices. A shift of focus from a mere pre-market perspective towards a life-cycle approach also includes stricter requirements regarding post-market surveillance, post-market clinical follow-up and vigilance.
This brings us to the Clinical Evaluation, which lies at the basis of CE mark approval and the life-cycle approach. It is defined as “a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety performance, clinical benefits of the device when used as intended by the manufacturer.” The Clinical Evaluation process is described in a MEDDEV (MEDical DEVices) guidance document. MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Although these MEDDEVs are not legally binding, it is expected that their guidance be followed, ensuring the uniform application of the various elements of the directives/regulations. MEDDEV 2.7/1 rev. 46 is the guidance document with regards to Clinical Evaluation and is prescriptive on the process, the required qualification of the evaluators and the contents of a Clinical Evaluation Report (CER).
The CER should “describe the intended clinical benefit and provide evidence of safety and performance” where performance is defined as “the ability of a device to achieve its intended purpose as stated by the manufacturer.” This report describes the risk profile of the device based on the technical documentation and provides an appraisal of all available clinical data related to safety and performance. Any evidence gaps and residual risk need to be addressed in Post-Market Clinical Follow Up (PMCF) studies to demonstrate long-term performance safety. The results from the intensified surveillance are laid down in the Periodic Safety Update Report (PSUR, mandatory for Class IIa/b and III) and Summary of Safety and Clinical Performance (SSCP, for implantables and Class III). These documents must be uploaded in EUDAMED, which allows public access to the SSCP.
Although European market approval of new devices can still be obtained by referring to clinical data of predicate equivalent devices, the MDR explicitly lists criteria by which equivalence can be claimed from a technical, biological and clinical perspective. The equivalence under the MDD was less well defined. Under the MDR, the predicate device must have a similar design, use the same materials and come in contact with the same tissues and body fluids, and be used for the same clinical indications. If a device does not meet these criteria, manufacturers need to generate their own clinical evidence with appropriate clinical investigations.
CE Marking requires Notified Body involvement for most medical device classes and is related to implementation of a Quality Management System, which must include plans pertaining to Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF). For non-sterile Class I devices, manufacturers can conduct the conformity assessment themselves and basically self-certify. For Class I devices that are sterile, measuring or reusable surgical instruments as well as for all higher device classes, oversight of a Notified Body is required. In the end, it is the Notified Body that issues a CE Marking Certificate and ISO 13485 Certification. Only with these certificates in place the manufacturer can prepare a Declaration of Conformity and put the CE Mark sign on their products and labelling.
IN VITRO DIAGNOSTICS REGULATION (IVDR)
In Vitro diagnostics (IVDs) are medical devices with which tests are performed using human specimens such as urine or blood. Familiar examples of such devices are pregnancy tests and tests for determining the level of glucose or cholesterol in the blood. The current directives distinguish between medium risk and high-risk lists of IVDs. Those IVDs not captured in these lists are automatically classified as low risk. Obviously more stringent market authorization procedures with Notified Body oversight apply to high risk IVDs. Whereas in the past only a minority of IVDs required involvement of a Notified Body, under the new classification an estimated 90% will now require it. The IVDD had some gaps and this binary system was thought to be no longer sufficient. Hence, like for the MDR, a risk-based approach classification was introduced based on the severity of the disorder tested for and possible consequences of an incorrect test result. Instead of two lists, the new IVDR now distinguishes four categories, Class A (lowest risk), Class B, Class C, and Class D (highest risk) and dictates that Class B and above IVDs will require oversight from a Notified Body as part of their conformity assessment.
Aside from the risk-based classification, it will not surprise you that the new IVDR has more features in common with the MDR. As is the case for medical devices, the IVDR requires clinical evidence and post-market performance follow-up. This will require a Performance Evaluation plan and report for all IVD Classes, which will describe how to demonstrate scientific validity, analytic performance, and clinical performance.
COMBINATION PRODUCTS/DRUG DEVICE COMBINATIONS
Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine. In the European Medicines Agency (EMA) view, if the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under Directive 2001/83/EC7 or Regulation (EC) No 726/20048. However, MDR’s Article 117 brought some relevant additions. First, two categories were defined: (a) Integral, where the medicinal product and the device form a single integrated product (e.g. pre-filled syringes and pens) and (b) Co-packaged, where the medicinal product and the device are separate items contained in the same pack (e.g. reusable pen for insulin cartridges). Next, Article 117 also incorporated some relevant amendments to Directive 2001/83/EC to ensure combination products comply with the medical device legislation. Per MDR’s Article 117, the marketing authorization application should include a CE certificate for the device or an opinion from a Notified Body on the conformity of the device (except for non-sterile, non-measuring and non-reusable surgical Class I devices).
Probably as a reaction to the rapid growth of combination products in recent years and the need to bring further clarity in this area, in June 2019 EMA released for public consultation a draft Guideline on Quality Requirements for Regulatory Submissions for Drug-Device Combinations9. The aim of this Guideline is to clarify expectations laid down in Directive 2001/83/EC and address the new obligations in the MDR. EMA makes it clear that the Notified Body assessment and marketing authorization review would not result in duplicate assessments. The former will review the device alone, while the latter will ensure the safety and efficacy of the drug are not compromised by the inclusion of the device part. The consultation period ended in August 2019 and EMA is now due to finalize the Guideline in the second quarter of 2020.
It is also worthwhile making a reference to medical devices which may contain an ancillary medicinal substance to support the proper functioning of the device (e.g. drug-eluting stents). These products should comply with the medical device legislation. Yet, the manufacturer should also seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralized procedure for the authorization of medicines. For other substances, the Notified Body can seek the opinion from EMA or a national competent authority. Of note, EMA has recently issued a Consultation Procedure for Ancillary Medicinal Substances in Medical Devices.
Companion diagnostics are seen by EMA as in vitro diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. Applicable regulations were discussed above. Yet, before the Notified Body can issue CE Marking, it must seek a scientific opinion on the suitability of the companion diagnostic to the medicinal product concerned from EMA or a national competent authority, as appropriate. Similarly, a scientific opinion would also be needed for some other medical devices made of substances that are absorbed by the human body to achieve their intended purpose. These devices are normally introduced into the human body via an orifice or applied to the skin. Last, we should not forget the so called “borderline products”. These are complex healthcare products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements. The European Commission publishes the ‘Manual on borderline and classification in the Community regulatory framework for medical devices’ which provides examples and recommendations for determination of classifications. National competent authorities classify borderline products either as medicinal products or, for example, as medical devices on a case-by-case basis based on the product’s composition and constituents, its mode of action and its intended purpose. This determines the applicable regulatory framework.
THE OPPORTUNITIES FOR MEDICAL AFFAIRS: MEDICAL & SCIENTIFIC GOVERNANCE
The new European regulatory environment (MDR, IVDR and EMA guidance on Drug Device Combinations) in conjunction with expanded quality standards for MedTech products and a rapidly changing reimbursement landscape are intensifying the need for a Medical Affairs role in the product lifecycle management. Furthermore, the increased trade organization’s guidelines as well as a more complex competitive environment in which the direct comparator might not be another MedTech product but instead a Drug or a Drug Device Combinations, all work favorably for Medical Affairs to step up its game and demonstrate its value in many regards.
The traditional competencies of Medical Affairs are still required to produce the new mandatory regulatory deliverables (Clinical/Performance Evaluation Report, Periodic Safety Update Report, Summary of Safety and Clinical Performance). However, more than ever Medical Affairs involvement needs to be formalized for various other key processes ranging from product development to device application. In order to give real meaning to patient and customer centricity, the inclusion of Medical Affairs contribution is indispensable with regard to, for instance, risk analyses, claims development and identifying user training needs.
In addition, medical and clinical research functions must lead in the development of coherent and affordable clinical research programs that serve regulatory compliance, reimbursement and commercial adoption purposes. The increased effort the companies must make to generate clinical evidence will undoubtedly put strain on human and financial resources. The careful planning and design of studies should avoid waste in time and money while providing the evidence the business needs in a timely fashion. Therefore, as non-inferiority assessments are giving space to superiority assessments, an increased is expected in reliance for regulatory purposes on less conventional evidence generation strategies such as registries, collaborative research and investigator lead studies.
Furthermore, ensuring the safe application of current devices, medical communication and interactions with healthcare stakeholders and health authorities, collecting and weighing medical intelligence on future directions in healthcare all require medical scientific oversight. The medical scientific oversight will be fundamental in the advancement of the company’s innovation agenda as the bar is higher than ever, as are the associated entry and maintenance costs.
CONCLUSION
The new environment makes a compelling case for installing a structure for Medical and Scientific Governance and a proactive strategic role for Medical Affairs. This in turn opens the discussion on how to develop and organize competencies around organizational capabilities that relate to the development of innovative and relevant devices, the substantiation of medical-clinical and health economic claims and ultimately oversight to ensure safe and appropriate use. Thus, we argue that now is the time to engage in captivating thought exercises about whether a company’s fabric with a prominent role of Medical Affairs adds to the organizational capability and resilience to handle current and future challenges.
This publication represents the consensus opinions of the authors and various members of MAPS, but does not represent formal endorsement of conclusions by their organizations
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/09/EU.MedTech.ELEVATE.Featured.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-09-03 11:58:472024-04-25 12:51:34A Compelling Strategic Role for Medical Affairs in the Context of the new EU MedTech Regulations
1Global Medical Lead, Psychiatry, Servier; 2Executive Managing Director, Scientific and Medical Affairs, Syneos Health; 3Director, Medical Affairs Syneos Health
ABSTRACT
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.
KEYWORDS
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 Planning
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.
To be of service to Medical Affairs and the broader organization, a strategic plan must be a living document that is flexible enough to incorporate new insights and maintain relevancy in the face of changing priorities and dynamics.
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
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 is a capability associated with adapting to change and uncertainty by applying previous lessons learned.
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.
Mapping Learning Agility Behaviors to Medical Affairs Strategic Planning Processes
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.
SUMMARY
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.
REFERENCES
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.
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/06/Learning.Agility.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-06-18 03:57:492023-11-13 10:18:47Learning Agility: An Emergent Capability for Future-Proofing Medical Affairs Strategic Planning
By: Lilly Stairs1; Annick de Bruin, MBA2; Diane Maloney, JD3a; Peyton Howell, MHA4; Roslyn F. Schneider, MD, MSc5; Leonard A. Valentino, MD6
1Founder & Principal, Patient Authentic; 2Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP); 3Associate Director of Policy, US Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), MAPS Patient Centricity Focus Area Working Group member; 4Chief Commercial & Strategy Officer, Parexel International; 5Principal, RozMD Patient Affairs Consulting, MAPS Patient Centricity Focus Area Working Group member; 6President and CEO, National Hemophilia Foundation (NHF), Professor, Rush University, MAPS Patient Centricity Focus Area Working Group member
aThis article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Introduction
Patient centricity was a key theme that emerged in several of the plenary presentations and workshops at the March 2020 Medical Affairs Professional Society (MAPS) Annual Meeting in Miami, Florida, and is reflective of broader strategic goals in the biopharmaceutical industry. As MAPS Board Member Danie du Plessis noted in his presentation on the Value of Medical Affairs, Medical Affairs professionals are well positioned to ensure that the voice of the patient is heard in their organizations, and true patient partnership is part of the overarching strategic vision.
Two events at the Annual Meeting specifically focused on this theme and provided not only a cross-functional perspective on the current state of patient centricity in our industry but also practical examples for Medical Affairs professionals to implement patient-focused approaches in their everyday work. The sessions sparked considerable interest, and attendance was particularly high at the plenary session, with over 450 MAPS participants attending live and virtually.
Plenary Session: Beyond Patient Centricity: True Patient Partnership in the Pharmaceutical Industry
Workshop: Patient Engagement in the Pharmaceutical Industry: Different Perspectives
The events were spearheaded by MAPS Patient Centricity Focus Area Working Group Co-Leads, Tricia Gooljarsingh, PhD (Momenta Pharmaceuticals) and Jamie Kistler, PhD (Parexel International), with support from Isabelle Bocher-Pianka (Ipsen). The Working Group, comprising Medical Affairs professionals, as well as representatives from nonprofit patient advocacy organizations, regulatory agencies (US Food and Drug Administration [FDA]), and patient-focused consultancies, was established 2 years ago to provide a platform to advance the patient centricity agenda in the MAPS organization and share best practices for pharmaceutical engagement with patients.
This article provides highlights from the plenary session, which included a multidisciplinary panel of speakers with broad and deep expertise on the topic. The cross-functional approach reflected the collaboration that is foundational for true patient engagement and partnership in the pharmaceutical industry. The faculty members represented a range of organizations and interests, but all share a passion for improving patient engagement and empowering Medical Affairs professionals with the information and tools necessary to “move the needle” in our industry. A more comprehensive manuscript is in development with the goal of expanding on the information provided in the plenary session and extending the reach of these valuable insights and perspectives to a broader audience (including patients, Medical Affairs professionals, and healthcare providers). This article will feature interviews with the speakers to provide further depth and insights, including case studies and examples of current best practices.
The plenary session was moderated by Dr Len Valentino, President and CEO of the NHF, who introduced the session with the mantra “not for patients without patients.” Len provided an overview of the agenda and learning objectives
Review increasing public and patient awareness and education around clinical trials
Discuss the impact of patient engagement from a patient/patient advocate perspective
Outline current and future FDA Center for Biologics Evaluations and Research (CBER) initiatives to enhance patient and public engagement in the drug development process
Identify best practices for pharmaceutical/medical device industry engagement with patients (appropriate initiatives that align with patient needs)
As both a clinician and a leading patient advocate, Len brought his own insights and experience to the discussion as to why patient centricity and collaboration among multiple stakeholders is so critical.
“All of us are here because our products or devices are used by patients. We need to understand what is most important to patients in our drug and device development, and collaboration is key to get this information. Not just collaborating internally with commercial organizations, HEOR, Clinical Operations, and Clinical Development but with the most important stakeholder—the patient. The patient voice should be part of all those programs and weaved through each stage of the drug development plan.”
He added that Medical Affairs is uniquely qualified to influence or directly drive patient centricity as “many of us are clinicians, and therefore our background has always been focused on the patient and patient care.”
In the opening presentation, Annick provided insights from a biennial global research study conducted by CISCRP that included 12,450 respondents, of whom 3600 were actual clinical study volunteers. The 2019 CISCRP Perceptions and Insights Study monitored trends in perceptions in clinical research among the general public and collected information about clinical trial experiences.1
Interestingly, perceptions around clinical trials have not changed substantially since the initial study in 2013, and, while people consider research to be very important, this often does not translate to active participation in clinical trials. This remains a key issue for the research community.
Annick shared insights from the data regarding what channels are most effective in overcoming barriers. A patient’s relationship with their doctor was found to have the greatest impact on willingness to participate. Technology and decentralization of studies also provide opportunities to reduce patient burden and involve more patients in clinical trials. For example, travel time to clinics was reported as a major burden impacting participation, especially among young people (Figure 1).
Annick concluded with the advice, “No one size fits all. Everybody wants different options to make sure clinical trial participation fits into their lives with minimal disruption.”
Annick’s perspective on the current state of patient and public involvement and awareness of clinical trials was followed by a very personal insight into the key success factors in engaging with patients. Lilly Stairs was diagnosed with 3 autoimmune conditions—Crohn’s disease, psoriatic arthritis, and psoriasis—all within a 6-month period, and her experience inspired her to become a patient advocate and engage with other patients, patient advocacy organizations, and pharmaceutical industry partners to affect change.
In her presentation, Lilly emphasized the need for the pharmaceutical industry to learn from other consumer-facing industries. In particular, she highlighted that we need to ensure a clear understanding of the end user’s needs, something she feels we have not traditionally done consistently in healthcare. She also stressed the importance of engaging with all patients and not just advocates.
“While it’s important to talk to the advocates who are able to give you high-level strategic input, it is also really critical to engage with the everyday patient who will have valuable insights and feedback. Patients are ready to engage around their healthcare. They are excited and eager to share their thoughts and experiences to move the needle and create a better tomorrow for all patients.”
Her presentation included the key principles of how we should engage with patients (Figure 2).
The importance of metrics was emphasized throughout the presentation, as well as demonstrating the value of patient advocacy to the business. Lilly provided examples in which patient advocacy work has resulted in a clear measurable impact.
“During my tenure as Head of Patient Advocacy at Clara Health, I was asked to look at a pre-screener for a lupus clinical study that was struggling to complete enrollment. It was so confusing and complex that patients were not getting through the screening stage. By working with autoimmune patients to improve the screener alongside other patient-centric tactics, recruitment speed was increased by 400%, saving a trial on the brink of shutting down.”
This presentation provided a unique opportunity to gain an insight into the work that the FDA is doing around patient centricity. Diane emphasized that patient engagement is important across all organizations in the FDA, from the Commissioner’s Office to the Product Centers, and they collaborate and meet regularly on cross-cutting patient issues (Figure 3).
She stressed that the FDA fully recognizes that patients are experts on what it is like to live with their conditions and are “uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation.”
One key patient engagement activity within the FDA is the Patient Focused Drug Development (PFDD) initiative. In total, the FDA has convened 24 PFDD meetings on specific disease areas, which are attended by a cross section of stakeholders, including patients, advocates, researchers, drug developers, and healthcare professionals. The goal of these sessions is to listen to patients’ perspectives on their disease, symptoms, and treatment options. A key learning from these meetings is that many patients want to be as active as possible in the work to develop and evaluate new treatments. FDA also actively participates in PFDD meetings led by patient organizations focusing on many disease areas.
She encouraged anyone who hasn’t attended a PFDD meeting to try to do so as it provides a valuable insight into a key way in which the FDA engages patients in the drug development process. The meetings can be attended remotely, and summaries are available on the FDA website.
Diane spoke passionately about the commitment of everyone in the FDA to put patients at the heart of everything they do. She said, “We do what we do because we want safe and effective products for patients, and we want them available in a timely way.”
Peyton did not mince her words about why it is so important for the biopharmaceutical industry to drive a customer-centric approach to drug development.
“Even before the impact of COVID-19, there was real urgency to make clinical trials more patient centric. There are currently 40,000 clinical trials recruiting in the US, and 80% are delayed due to recruitment problems. 85% of clinical trials fail to retain enough patients.”
In her presentation, Peyton focused on Patient Centric Protocol Optimization (PCPO), which is one of the key areas in which her organization has seen encouraging results. PCPO is a framework to solicit feedback from patients and study sites to ensure that patient needs are met. This approach can include patient surveys, web listening, and patient burden analysis. A case study on PCPO was included in the related MAPS workshop presentation presented by Jamie Kistler and Tricia Gooljarsingh.
“This process has revealed that a lot of previous assumptions were wrong. We used to obtain feedback from site nurses as opposed to patients themselves, and our assumptions around patient burden and preferences were often incorrect.”
She also emphasized the increasing importance of decentralized trials and shared an example of a decentralized trial patient journey (Figure 4). While every journey is different depending on the patient and the therapy area, what is similar is the need to start engaging with patients early. She also highlighted the importance of using mobile options and other technology in decentralized trials. COVID-19 has been a catalyst to support innovation in the application of decentralized clinical trial tactics such as telemedicine visits and home nursing.
Looking ahead, she urged that there is still a lot more that can be done and asked everyone in the room to have a voice. “This community can really play a key role in driving forward the innovations to make trials more patient centric.”
Looking ahead, Peyton is excited about the following opportunities:
Patient advisory councils
Mock trial visits
Patient concierge (for example helping with transport or reimbursement issues, which can really impact a patient’s ability to stay in a study)
Patient communities (especially after the trial has finished, which can also provide valuable real-world evidence data)
Digital ethnography research (the study of people in a real-world environment where researchers collect behavior data from participants either in a mobile or online environment)
Alternative care sites
As the final speaker, Roz emphasized that in this multidisciplinary collaboration, Medical Affairs is uniquely positioned to drive organizational change where patient centricity resides at the core. “We can all embrace the concept of patients as one of our most critical stakeholders, but that doesn’t mean people see its relevance to what they do every day. To advance a cultural shift, it needs to start with the organization’s ‘why,’ and this needs to align with the different functional groups.”
She recommended creating “sharing platforms” where information and insights from the various patient-related activities taking place across an organization are shared and utilized to inform the overall patient engagement strategy. She urges that this intelligence should not just come from thought leaders and healthcare providers but from a wider network, including umbrella organizations, industry coalitions, health authorities, etc. The “cycle of learning” is further supported by demonstration projects so key learnings can be shared with these external networks in a non-competitive way.
Roz stressed the importance of leadership endorsement saying, “It won’t happen unless you have significant leadership endorsement at every level across the company. If you don’t have that endorsement, patient engagement will be the first thing that’s dropped, so you need to ensure what you are doing is core to the business.”
Concluding on metrics, she referenced some important tools that can be used by Medical Affairs professionals and cross-functional partners (these are included along with other key resources in the related MAPS Annual Meeting workshop available on-demand at https://community.medicalaffairs.org/on-demand-conferences):
Patient Engagement Quality Guidance: Developed by the Patient Focused Medicines Development, a global multistakeholder coalition, this provides 7 domains of what patient engagement quality should look like. It can be used as a planning tool but also provides assessment criteria. https://patientfocusedmedicine.org/wp-content/uploads/2018/10/PFMD_OnePager_v2.pdf
Clinical Trials Transformation Initiative prioritization tool for sponsors and patient groups: This tool helps patient groups and clinical research sponsors identify high-value opportunities to work together (Figure 5). https://prioritizationtool.ctti-clinicaltrials.org/
Concluding the plenary session, Dr Len Valentino noted, “Having listened to the presentations today, what comes across loud and clear is the importance of understanding the patient journey and involving the patient early in the process. Medical Affairs can create the narrative that tells the story of the patient that allows all the other functions to do their jobs better by focusing on what is important to the patient.”
Acknowledgements
The authors wish to acknowledge Tricia Gooljarsingh, PhD (Momenta Pharmaceuticals), Jamie L. Kistler, PhD (Parexel International), and Isabelle Bocher-Pianka (Ipsen) for their contributions to the concept, design, and content development for the MAPS Annual Meeting patient centricity plenary session and workshop and this accompanying Elevate article. They would also like to recognize the significant effort made to ensure that those unable to attend in person due to COVID-19 travel restrictions could participate remotely and engage in discussions. Editorial support for this article was provided by Patricia Barnfather (Barnfather Communications, Ltd) and Diane Neer (Parexel International).
Reference
CISCRP. (2019). 2019 Perceptions & Insights Study. Boston: Center for Information and Study on Clinical Research Participation.
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/08/2-1.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-06-17 19:13:032023-11-13 10:19:01Beyond Patient Centricity: True Patient Partnership in the Pharmaceutical Industry
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.
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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.
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/06/Joseph.Eid_.Interview.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-06-10 20:56:342023-11-13 10:19:37Interview: The Value of Medical Affairs
Practical Tips for Virtual Interviews and Onboarding During COVID-19
COVID-19 has wildly accelerated our transition to remote interviews, onboarding, and virtual work. Your organization will quickly fall behind the 8 ball if you don’t adapt. Pharmaceutical and biotech companies can’t afford that risk. For the Medical Affairs industry, what’s the alternative to virtual hiring right now? Hazmat suit interviews? If employees can produce great work in an office, they can produce great work anywhere. There’s just one catch – how can you determine if a potential employee is capable of great work when you haven’t met them in person? How can our industry interview and hire reliable team members virtually rather than face-to-face?
As someone who has helped lead the recruitment charge since the outbreak of coronavirus, I have actionable advice for any Medical Affairs team attempting to hire through the pandemic.
In short – if you don’t trust someone enough to hire them remotely, you shouldn’t trust them to work for your organization in any capacity. Epidemiologists from every corner of the world are hiring right now (in dozens of different languages) to make new discoveries via remote technologies like Zoom. Your team can do the same. They just need to know how.
Most hiring managers believe that face-to-face interviews help manifest a certain personal connection. They’re absolutely correct. However, it’s downright reckless to base hiring decisions off of this alone. Such a connection is nothing more than a measure of likability rather than a consideration of legitimate factors like work history, education, and subject matter expertise. If anything, virtual interviews bring these important qualities front and center.
If your virtual hiring process is to succeed, your company must have specific processes in place. Most remote interview setups motivated by a global pandemic aren’t going to be wildly productive unless these are followed.
Video chats should be the preferred medium for your hiring process. Webex, Skype, Zoom, and Google Meet all do the same thing. Choose whatever tool you believe is easiest to navigate and understand. Whatever you select – consistency matters for new recruits and employers alike. Don’t alternate between platforms.
Most individuals have a natural (albeit, slightly narcissistic) tendency to spend half their Zoom call looking at themselves to make sure everything appears alright on their end. Stop doing that! Resist the urge! Start making digital eye contact, instead.
Lighting is important during video interviews. Whether it’s a home office with blinding amounts of natural light or a poorly lit room that looks like a cave, you need to find a happy medium for your interviews. Simple light fixtures behind the camera can easily solve any darkness problem. If your image is too bright, just ensure the screen isn’t facing a window.
In a typical face-to-face interview, informal ‘get to know you’ questions only occur in the first 3-5 minutes of a conversation. We suggest you ask three times as many of these informal questions when speaking with potential remote candidates. This can help build a certain foundation of understanding and trust that would otherwise be forfeited due to a lack of physical presence.
The personal qualities that companies seek in remote employees differ slightly from the qualities of a standard medical affairs hire. If you think they may need to start their first day from a home office, look for stories where they were calm under pressure or quick on their feet. Seek out personality traits such as dedication, resourcefulness, and adaptability.
Cornell University recently conducted workplace research on the topic of virtual hiring. They partnered with Fortune 500 companies like IBM, Citigroup, and Cisco – all organizations with significant remote work experience. These three enterprises listed self-motivation, self-discipline, effective communication, and tech-competency as the professional traits most correlated to remote success.
Good interview questions might involve asking how they intend to structure their first day of work. How do they intend to meet co-workers? How will they seek to better understand their work and the company culture? It’s equally important that your team has the answer to these questions, as well.
Burnout, isolation, work-related anxiety, lackluster cultures – they’re all very real risks for remote onboarding, but they’re avoidable. Companies new to these remote processes will prop up workflows that barely scrape by because they don’t yet know a better way.
Here is the better way:
Hiring teams should over-communicate every step of the way. Explain your anticipated schedule to potential hires so they know what to expect. Share all pertinent information with them.
Managers should make a list of roadblock issues. Adopt a ‘continuous improvement’ mindset to resolve these issues for future onboarding classes. You should always seek to learn more.
Teams can have high expectations for candidates while simultaneously recognizing that this is a stressful time for your entire team. Be professional – but understanding. If a dog barks or a kid screams during the interview, it’s not a negative sign. It’s life.
Remote hiring may seem intimidating if your company isn’t yet accustomed to such a practice, but thousands of teams make it work. Some just do it better than others. Now is the time for Medical Affairs professionals to get [remote]ivated!
https://entafm9p96o.exactdn.com/wp-content/uploads/2020/08/13-1.png?strip=all&lossy=1&ssl=1321845Medical Affairshttps://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.pngMedical Affairs2020-05-18 12:45:492023-11-13 10:21:08Practical Tips for Virtual Interviews and Onboarding During COVID-19
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In short – if you don’t trust someone enough to hire them remotely, you shouldn’t trust them to work for your organization in any capacity. Epidemiologists from every corner of the world are hiring right now (in dozens of different languages) to make new discoveries via remote technologies like Zoom. Your team can do the same. They just need to know how.
Video chats should be the preferred medium for your hiring process. Webex, Skype, Zoom, and Google Meet all do the same thing. Choose whatever tool you believe is easiest to navigate and understand. Whatever you select – consistency matters for new recruits and employers alike. Don’t alternate between platforms.
