PODCAST: Expert Engagement — Driving the Strategic Impact of Medical Affairs
MAPS in conversation with Robert Groebel, VP Global Strategy, MONOCL, and Danie du Plessis, VP Medical Affaris, Kyowa Kirin
MAPS in conversation with Robert Groebel, VP Global Strategy, MONOCL, and Danie du Plessis, VP Medical Affaris, Kyowa Kirin
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.
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.
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.
Sawyer’s MA team is focused on removing barriers to access to gene therapy. The barriers for patients fall into two main categories:
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.
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.”
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:
This article is graciously contributed by Excellerate: Patient-Focused Engagement for Pharma.
In this second of two podcast episodes, Pete Piliero moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans and Resourcing of a Medical Affairs Plan.
MAPS speaks with Beat Sümegi, SVP Medical with Sanofi, about major areas of change and the need to help Medical Affairs professionals build new skills to succeed in this world of increased responsibility and opportunity.
Pete Piliero, MD, moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans.
Download the full article here
By
Ajit Patwardhan, MD1, MBA; Robin Winter-Sperry, MD2; Dannielle Heuer3; Stephen Valerio4; Urvashi Vashee5; Drilon Saliu, PharmD, MBA6; Greg Christopherson, PhD7; Irma Saliu, PharmD8; Kyle Kennedy9; Michelle Powell, PharmD10; Chris Brock, PharmD11 ; John B Pracyk, MD, PhD, MBA12; Joe Medicis, PharmD13
1 Physician – Surgeon, Medical Affairs Executive – Baxter International, Integra LifeSciences, NLT Spine, Paradigm Spine
2 President, Scientific Resilience; MAPS 2020 Co-Chair
3 Director WD Communications
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
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.
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.
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:
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:
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:
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:
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:
The Four 4 Ps: Considerations for MSL Training Design
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
Download the full article here
By: Kirtida Pandya1, Jacqueline Waldrop2, Maria E. Vassilakis3, Marc Sirockman4, Deirdre Jordan5, Ogün Sazova6, Patricia Jassak7, Tim Mikhelashvili8, Sarah Funderburk9, Ivan Desviat10
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.
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.
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).
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.
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 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.
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.
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.
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.
Scientific communication platforms have rapidly evolved to serve as the foundation of a consistent and effective cross-functional Medical Affairs communication plan. These platforms are a necessary tool in the arsenal of all Medical Affairs professionals, and the MAPS Standards and Guidance document provides clarity on developing and implementing scientific platforms for all Medical Affairs professionals, ranging from novice to expert.
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.