Murali Gopal Featured

Why Good Science is Good Business: A Conversation with Murali Gopal, MD

/in , , , , , , , , , , , /by
Murali Gopal

Murali Gopal, MD, Vice President | Global Medical Department at Mallinckrodt

Murali Gopal, MD, remembers being a young clinician in the bygone era of giveaways during conference meetings when he would walk by pharma booths and pick up a water bottle or a tie or whatever they may be giving away. Would he ever wear the tie or use the water bottle? Probably not. But it cost him nothing and so why not? Now Murali compares this might-as-well approach to the biopharmaceutical industry’s traditional (and increasingly outdated) model of brand planning. As Vice President of the Global Medical Department at Mallinckrodt Pharmaceuticals, he is helping his organization evolve into a future that includes the contributions of science and business to attain the goal of innovation. Here the Medical Affairs Professional Society (MAPS) talks with Murali about the strategy he uses to guide this change – Integrated Brand Planning – which he not only credits with bridging the gap between science and business in biopharmaceutical organizations, but sees as a philosophy that has led to his personal development as a leader and decision-maker.

MAPS: Okay, you have to start by telling us how brand planning is like stocking up on conference giveaways.

Murali: Think about what happens when Medical Affairs comes over and says we can generate X, Y and Z data for an asset  – if you’re a Commercial person and you’re trying to maximize the opportunity of the molecule, and have no financial downside or obligation…why wouldn’t you take all options? It’s the same mentality as conference swag: If you can get something for nothing, you do it. That may have worked well without today’s challenges. But now companies that still use this model place themselves at a disadvantage.

MAPS: You’re saying this model of saying yes to all possibilities for a new drug leads to inefficiencies?

Murali: Yes, I am saying that, and that it also leads to increased costs and the need for increased resources. At a previous position, we ended up with 7,000 different promotional materials for one molecule in one year. Some were used once and some just sat in warehouses. A handful of them would be the key materials that were used over and over.  It was as if we were creating things for the sake of creating things and not focusing on what the external stakeholder may have felt was most compelling or intriguing.  Another example can be that perhaps the organization may determine they need some data without fully understanding that it may take five years to conclude a particular study, or may cost, say, $3 million dollars.

MAPS: And how is Integrated Brand Planning different?

Murali: With Integrated Brand Planning, or what some organizations call the General Manager model, the GM becomes responsible for the profit and loss of a molecule. What this means is that everything becomes visible. Commercial, safety, R&D all becomes visible, because they’re all centered around some level of cost. It forces the organization to align on their priorities and to create targeted strategies.

MAPS: It sounds like you’re talking about a more integrated flow of information between science and business during brand planning?

Murali: Traditionally the separation between science and business was intentional. Many scientists felt, and some may still feel, that science and business need to be separated and if Medical Affairs or Commercial has input to science, it takes away some of the scientific credibility. I like business but I’m a scientist at heart – I want to be measured against the science we engage in, and fortunately the GM model allows us to do both so that I can continue to grow my business acumen as well.

MAPS: What do you mean?

Murali: Let’s say our end goal is innovation – we live longer today because innovation helped us learn to deal with illnesses that would have killed us in our 30s and 40s. And look at the effect of the cholesterol medicine race in the cardiovascular space, heart transplants, etc. or the vaccine industry in general. The biopharmaceutical industry has always struggled to articulate the impact of innovation on society. But combining the business impact and scientific development aspects together, we can now measure and even predict how a therapy is going to provide value, as well as, to understand its economic impact so that we can make better decisions.

MAPS: You’re saying business has a role in innovation?

Murali: Certainly. At a previous position, we hired a top scientist in their field to work with a new molecule. He had great relationships, knew the unmet need, knew what the molecule could do, but he didn’t take into account what other companies were doing, or the needs of payor organizations, or the high level of focus on pricing at that time. When we got ready to introduce the molecule, the potential price and utilization scared the payors – they said it was going to break the healthcare system and that we would need to somehow restrict  who is eligible for the therapy, and if we couldn’t do that, possibly no one would get it. Our internal leader couldn’t accept these business realities and the drug was by many measures unsuccessfully launched. For me, that was a very poignant experience. The fact is, you need relationships with scientific leaders, but to run a therapeutic area, you need just as much acumen on the landscape and business side to marry with the scientific aspects to be successful.

MAPS: This sounds like a cautionary tale of science overbalancing business, but of course we have cautionary tales in which business overbalances science as well.

Murali: I believe there are companies out there increasing profitability and cost because they can, but there are also companies trying to do the right thing, and it all gets lumped together. Integrated Brand Planning creates checks and balances.

MAPS: Oh, interesting! And how is that?

Murali: It’s about collaboration at the stage of annual planning. Instead of Commercial proposing studies to R&D, or R&D proposing studies to Commercial, with Integrated Brand Planning, it’s a collaborative, open discussion from the start. Scientists don’t need to also be MBAs and Commercial doesn’t need to hold PhDs, but the dialogue helps scientists elevate their business acumen, and Commercial elevate their scientific acumen. You need the perspective of external stakeholders as well. Most companies will put the patient or a disease at the center of what they do, then you have your organization or company’s resources sitting in the next circle around this center, but  there’s an external circle as well that includes:  advocacy groups for that therapeutic area, politicians, KOLs in academia, clinicians, etc. This brings the awareness and impact of patient journey and access journey into the planning process.

MAPS: It sounds challenging to help organizations transition from the traditional, siloed way of doing things into this new model of collaboration. What do you do to help generate this?

Murali: Three things. First, I’m trying to educate the scientific organization this can work and not to be afraid, but rather to embrace it. Second, I’m trying to explain what good actually looks like by walking through my  own process of evolution from previous experiences at other companies – maybe by seeing how it’s worked elsewhere, we can skip some of the painful learnings. Third, I try to lead by example by sitting in wherever I can as a leader for the Medical organization.

MAPS: With collaboration comes complexity…

Murali: These actions have helped me develop not just as a better leader, but as a better individual. Balancing business and science in this collaborative process of brand planning helps me to not look at things as only black and white. It affects how I approach complex challenges. Sometimes in a discussion, you find out how complex something is and it surprises you through all of the aspects that may need to be considered and planned for. That’s fun for me. How we work together to solve complex problems is fundamentally interesting to me. And when you’re constantly looking at all these variables to make decisions, you get better at it, not just with regard to business decisions, but life decisions as well. When there are things that are hard to pick between, you can use the same mentality to make a well-rounded decision. It might sound strange, but after engaging and leading in this process for so many years, I feel like I ruminate on decisions a lot less, and that I am more secure in my decision-making ability. Don’t get me wrong, it takes effort. You can go through the motions and not get anything out of it. But I dug into it. I really wanted to unpack how far we could take commercial and scientific collaboration and I think it’s facilitated my growth as a leader and attaining this level in my career and in my life.

 

Charlotte Op Ed Featured

MAPS Board Chair, Charlotte Kremer: Why The Strategic Rise of Medical Affairs Is Central to Pharma’s Future Success

/in , , , , , , , , , , , /by

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.

 

Charlotte Kremer

8/18/16 10:06:55 AM — Astellas portrait session. Charlotte Kremer © Todd Rosenberg Photography 2016

Charlotte Kremer, M.D.

EVP, Head of Medical Affairs,

Astellas Pharma Inc.

Eileen Sawyer Featured

Eileen Sawyer: Big Reader, Science Nerd and Medical Affairs Leader in Gene Therapy

/in , , , , , , , , , /by

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

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.

UniQure

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
  • What she sees for the future of Medical Affairs

 

 

This article is graciously contributed by Excellerate: Patient-Focused Engagement for Pharma.

MedStrat Podcast 2 Featured

PODCAST: Executive Leadership Perspectives on MA Strategic Planning – Episode 2

/in , , , , , , , , , /by

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.

Read more
Sumegi Featured

The Future of Medical Affairs: A Conversation with Beat Sümegi, SVP Medical, Sanofi

/in , , , , , , , , , , /by

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.

Read more
Disruption Opportunity Webinar Featured

Disruption to Opportunity: The Next Digital Frontier for Medical Affairs and Healthcare with the New Normal

/in , , , , , , , , , , , /by

This Webinar features Medical Affairs and leading technology thought leaders exploring emerging trends and viewpoints on the next frontier for digital in Medical Affairs and the broader healthcare environment with the “New Normal”.

Read more
MedStrat Podcast 1 Featured

PODCAST: Executive Leadership Perspectives on Medical Affairs Strategic Planning – Episode 1

/in , , , , , , , , , , , /by

Pete Piliero, MD, moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans.

Read more
22 1

Medical Affairs Improves Patient Outcomes Through External Medical Education

/in , , , , , /by

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

  1. Executive Director and Head, Medical Services and Operations, Sandoz, A Novartis Division
  2. Director, Oncology Grant Officer, Global Medical Grants, Worldwide Medical & Safety, Pfizer Inc.
  3. Senior Director, Medical Affairs, Standards and Excellence, Astellas
  4. President, MedEvoke
  5. Global Medical Affairs Excellence Lead, Sandoz, A Novartis Division
  6. Medical Director, Napp Pharmaceuticals, UK
  7. Director, IME and External Medical Affairs, Astellas
  8. CEO and Co-Founder, Amedea Pharma
  9. Medical Insights Director, Caudex, a McCann Health Company
  10. 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.

External Medical Education Figure 1

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.

Regional Differences Medical Education

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.

Elevate Medical Education

REFERENCES

  1. Marinopoulos, S. S. et al. Effectiveness of continuing medical education. Evid Rep Technol Assess (Full Rep), 1-69 (2007).
  2. 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).
  3. 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).
  4. 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).
  5. Davis, D. A., Barnes, B. E. & Fox, R. D. The Continuing Professional Development of Physicians: From Research to Practice. AMA Press (2003).
MA2.0.Digital.Therapeutics

Medical Affairs 2.0: Innovating Medical Affairs for Digital Therapeutics

/in , , , , , , , /by

This MAPS webinar presents an overview of the current and near term Digital Therapeutics landscape and details real-world applications of Digital Therapeutics to illustrate potential in driving transformation of clinical practices to improve patient outcomes.

Read more

Connect with Us

602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073

© 2025 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.

Subscribe to MAPS Newsletter
MAPS Program Support Services
Policies and Positions