This special 75-minute MAPS Global Town Hall focuses on the challenges that are arising from the global Covid-19 pandemic and the emerging opportunity for Medical Affairs to provide strategic leadership.
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 Now Murali compares this might-as-well approach to the biopharmaceutical industry’s traditional (and increasingly outdated) model of brand planning.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.
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.
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.
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.
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.
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