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

October 15, 2020/in Competency, Strategy, Overview & Vision, ACCESS, Open Access, Elevate Articles, Content Hub, Content HUB Featured, Leadership & Management Skills, SEARCH BY TOPIC, Medical Strategy & Launch Excellence, SEARCH BY TYPE/by Medical Affairs

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 Now Murali compares this might-as-well approach to the biopharmaceutical industry’s traditional (and increasingly outdated) model of brand planning.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.

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

October 13, 2020/in Competency, Strategy, ACCESS, Overview & Vision, Open Access, Elevate Articles, Content Hub, Content HUB Featured, Leadership & Management Skills, SEARCH BY TOPIC, SEARCH BY TYPE, Medical Strategy & Launch Excellence/by Medical Affairs

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.

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

October 6, 2020/in Competency, Strategy, Overview & Vision, ACCESS, Open Access, Elevate Articles, Content Hub, Medical Communications, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

Eileen Sawyer didn’t always intend to work in pharma—in fact, she hadn’t ever planned to have a career in science.

Growing up in a Boston suburb, neither of her parents worked in the sciences. Her dad was a computer programmer and her mom edited college textbooks. But the family was always passionate about the natural world. Sawyer recalls spending family vacations at national parks, identifying plants and animals together. She’s a self-proclaimed science nerd. She loves the details and especially translating those details to application. Quality science is where it all begins.

In high school, she says she was a ‘big reader,’ and planned to become a writer. In college, that idea changed when she developed an interest in psychology. She loved learning how people think, and she especially liked studying the connection between psychology and biology.

Eileen Sawyer, Vice President, Global Medical Affairs, UniQure

As part of her studies, Sawyer took an introduction to a neuroscience class—and fell in love with it. She enjoyed combining hard science with an understanding of psychology to discover why people are the way they are. It had a storytelling flavor that appealed to the writer in her.

She started working towards her Bachelor of Arts in Neuroscience, and spent her summers interning in labs that studied animal behaviour. Her new career goal became discovering connections between the brain and behavior that could improve healthcare, and after college, she pursued a PhD in Neuroscience research. She hoped to make scientific advancements that would contribute to development of new drugs to help people.

The Right Fit

However, after her PhD, Sawyer began questioning if academia was the right fit. She continued on to her post-doc but felt frustrated. Their team was doing pre-clinical drug discovery, but there were stacks of studies sitting in file drawers waiting to be published. It was great science, but she longed to work more directly on creating new medicines. After all, she had gotten into science to help people. She realized that more than anything, she wanted to work closer to patients—and have a greater impact on their care.

That’s when she made the leap into pharma. Initially, she started by doing some freelance science writing and editing on the side. But the more she got to know the world of pharma, the more she realized that the best place to have the type of impact she wanted was in one of those companies itself, directly working on bringing new drugs to patients. To open up new opportunities, she tried old fashioned networking—asking people about what they do and reaching out to leaders in the industry. She got involved with associations in medical writing and communications and applied to dozens of jobs.

Months later, she got a call about an editing job. But by that point, she realized she didn’t want to just write—she wanted to work inside pharma. She declined the role and continued networking and applying.

The Call

Eventually, she got the call she was looking for—an interview at Alexion in scientific communications. The team that was hiring was preparing to launch a product for bone disease. The condition was rare, and severe. Babies were born with no mineralization in their bones and died because their chest couldn’t support breathing. Of course, the work was completely different from neuro, as it was all below the neck. Still, Sawyer knew immediately that she wanted to help.

The position at Alexion was a formative experience. Sawyer had a mentor she admired, and a role that allowed for plenty of exposure to all of medical affairs, from launch preparation to strategy. Their team worked in that crucial space between the science and the impacts on actual people. In real time, she got to witness science turning into effective medicine—medicine that made tangible impacts on patients.

She loved every minute of it.

After the drug was launched, Sawyer began looking for her next step, knowing that she wanted to find another role with the same level of impact. She found the perfect answer—working on gene therapy at uniQure.

When Sawyer started at uniQure as Director of Scientific Communications, it was small company with no Medical Affairs department. Six months into her tenure, she became the firm’s first Director of MA, and for the first two years in the role, she was a one-woman department. More recently, she has been able to build out the team and increase their impact.

Now, she leads more than seven people with different MA specialties ranging from communications and field medicine to health economics and strategy.

Removing Barriers

Sawyer’s MA team is focused on removing barriers to access to gene therapy. The barriers for patients fall into two main categories:

Knowledge

The health care provider or the patient either does not understand gene therapy or has misperceptions about it and how it can treat the condition. They may not even know a drug is in development. The answer to this challenge? Education.

Evidence barriers

Justifiably, patients and doctors have questions about the treatment. The MA team needs to work to understand those questions, bring them back inside to find answers, and then take those solutions back to the patients. Sometimes, this process requires supplemental studies or health outcomes research.

Sawyer saw a clear key to removing those barriers—listening to patients and physicians. To ensure they were receiving adequate feedback on their work, Sawyer and her team started early, reaching out to patients and physicians while publishing and announcing results from the phase 1 study.

As it turned out, listening to patients changed the team’s entire development program. From the conversations, they learned that the community wanted something completely different from the gene therapy than was expected. So, they went back to the drawing board, totally changing the design of the program.

Sawyer was responsible for presenting the change to thought leaders, MDs and top patient advocates. When she revealed the news at a small scientific meeting after the company announcement, there was an audible gasp in the room. The leaders didn’t think regulators would permit this type of change. However, when she heard from the community that provided the feedback, Sawyer was reassured that they had made the right decision. Patients and physicians were so pleased to see that the company responded to their comments, and it completely transformed their attitude towards partnering with uniQure.

“Our goal was to deliver what they need,” says Sawyer. “They saw that.”

Patient Input

Now, uniQure has patients provide input into everything from their protocol to their patient materials and scientific steering committees. Again, and again, Sawyer has seen them contribute remarkable insights the MDs hadn’t thought about. She recalls one patient at a steering committee who pointed out an issue with the wording in a particular passage. It mentioned barrier protection during sexual contact, and he asked, “How are you defining sex? How inclusive are you being?” The team used his feedback to rewrite the section with more inclusiveness and clarity.

The uniQure team after defending the switch to AMT-061 at the European Medicine Agency. Sawyer is sixth from right.

“Sometimes, wearing the medical hat you forget to think about how it would play in the real world. What does it really mean for someone’s life?” she says.

Sawyer is making it her life’s work to focus on the patient—the most important stakeholder in drug development. She wants to help them take ownership over their care and make informed decisions. To do that, they need access to information—both directly and via access to educated health care providers. Her team presents scientific findings at patient meetings as well as medical meetings, and they engage with patient association leaders around science and policy. They even involve patients in economics and outcomes research. The goal is to foster true partnerships while developing each drug.

“At the end of the day, it’s about giving the patient control,” Sawyer says. “The best scenario is for a patient to have many options and be empowered to choose the best choice for them. The role of pharma in this setting is to equip them with the tools to make those decisions.”

Throughout her career, she has never lost the desire that drew her to pharma. It’s the desire to turn cool science into medicine and make something that matters—something that will make someone’s life better. For her, a great day is one where she has the chance to talk to a physician and hear a patient story. Learning about the tangible impacts that the science is making on patients is what keeps her coming back.

We had a chance to sit down with Eileen. Enjoy watching our interview to see how she responds to questions about:

How her team partners with patients to provide better options for their care
What leaders can do to keep the fire of purpose burning within their people
What she sees for the future of Medical Affairs

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

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

October 1, 2020/in Competency, Strategy, Overview & Vision, ACCESS, Open Access, Elevate Articles, Evidence Generation, Content Hub, Medical Communications, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

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.

Global Town Hall: An Opportunity for Medical Affairs Strategic Leadership During the Pandemic and Beyond

July 28, 2020/in Competency, Strategy, Overview & Vision, SEARCH BY TYPE, Open Access, COVID-Related, On-Demand Webinars & Town Halls, Field Medical/by Medical Affairs

OVERVIEW:

The COVID-19 pandemic is affecting Medical Affairs professionals around the world, and each team is responding in different ways. During this live Global Town Hall, we will discuss how Medical Affairs can continue to function during the COVID-19 pandemic, as well as share industry best practices and consider how Medical Affairs could change post-COVID-19. Through patient-focus and peer-to-peer relationships with HCPs, Medical Affairs professionals have a unique role in ensuring the safe and effective use of medicines, vaccines and medical devices, and are also positioned to bring invaluable insights from the field into ongoing R&D. By strengthening our understanding within the pharmaceutical industry of how Medical Affairs can support HCPs and patients in these times, this Town Hall will explore how the role of Medical Affairs can be expanded to maintain quality in a rapidly evolving clinical environment, helping to achieve industry-wide alignment on the issue and potentially saving lives.

Join this webinar for insights from industry-leading experts. This series including follow-on webinars will equip MAPS members and MA professionals worldwide with the tools to fulfill the opportunity for Medical Affairs strategic leadership during the Covid-19 pandemic and beyond.

MAPS Members have access to view and download the slides from this presentation.

CLICK HERE TO VIEW AND DOWNLOAD SLIDES IN THE COMMUNITY PORTAL

SPEAKERS:

Rachele Berria

Vice President and Medical Head, US BioPharmaceuticals

AstraZeneca

Eric Mortensen

Head Gastrointestinal Clinical Development, R&D

Janssen Immunology

Tamas Koncz

Chief Medical Officer, Inflammation and Immunology

Pfizer

Isma Benattia

VP, Europe Medical Affairs

Amgen

Terry Griesing

VP, Head of North America Medical Affairs, Internal Medicine

Pfizer

Ann Hartry

VP, HEOR

Lundbeck

Audrey Krolicki

Senior Director, Head of Scientific Publications

Astellas

Danie du Plessis

Executive VP Medical Affairs

Kyowa Kirin International

AGENDA

Time	Title	speaker
9:00–9:10 EDT	The Opportunity for Medical Affairs Strategic Leadership	Chair: Tamas Koncz
9:10–9:20 EDT	Evidence Generation: Ensuring Speed and Quality During Rapid Decision-Making	Ann Hartry
9:20–9:30 EDT	Evidence Dissemination: The New World of Publications and Virtual Congresses	Audrey Krolicki
9:30–10:05 EDT	Audience Q&A and Panel Discussion What has changed for Field Medical? What hasn’t changed? What are the needs now, and in the future? How can the return-to-field be balanced with continued virtual interactions? What are the key adaptive strategies, innovations and practices?	Full Expert Panel
10:05–10:15 EDT	Closing: The Opportunity for MA is Here and Now	Tamas Koncz

COVID-19 – A MAPS Global Town Hall: Best Practices & the Future of Medical Affairs

April 22, 2020/in Competency, Strategy, Overview & Vision, Open Access, COVID-Related, On-Demand Webinars & Town Halls/by Medical Affairs

Overview:

Objectives:

The objective of the Town Hall is to discuss and communicate best practices that can be applied to Medical Affairs departments across companies, with a specific focus on the ongoing global COVID-19 pandemic.

If the video above does not play, or to view full screen, CLICK HERE to open in a new window.

Members may also download a PDF copy of the slides in the Community portal. Not a member and wish to access the slides? Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

The Rise and Rise of Medical

April 30, 2019/in Overview & Vision, Competency, Strategy, Open Access, Elevate Articles, Leadership & Management Skills/by Medical Affairs

Can Medical professionals step up to a more strategic role? Dr. Ameet Nathwani discusses the need to define and measure our contribution, and why we must join together as a community to reshape the future of healthcare.

As technology advances inexorably transforming the healthcare landscape, Medical is poised for a more strategic role within pharma – that’s the view of former Chief Medical Officer of Sanofi, Ameet Nathwani. However, nobody with whom he works closely would be surprised to learn that he is not a fan of the term “Medical Affairs”.

“This harks back to an understanding of the way that Medical functions used to work about 15 or 20 years ago, which was much more around supporting the scientific base of the commercial organization. I prefer to just refer to the Medical function as it has evolved and expanded enormously; it’s a much more strategic function now and where it sits in Sanofi, reporting directly to CEO level speaks loudly to the progress made in this regard.”

New dynamics in the healthcare ecosystem

Underpinning this evolution are a series of distinct trends (see Figure 1) including the digital health revolution, the empowerment of the patient, and a requirement for continuous evidence generation. He explains: “It takes seven to eight years to develop a drug and, in that time, the healthcare system, the digital technologies, the innovation available, the way physicians practice, what the expectations of patients are, may have all fundamentally changed. So the question is: is the biologically innovative drug still relevant to patients and the healthcare system at the end of a long development process? And how do we ensure that digital health technology – the superconvergence of mobile, social, biometrics, genomics and AI – is being capitalized in everything we do? We see integrating digital health as a fundamental role of the Medical organization; from building a drugs-plus type of approach, through to real-world evidence is something the Medical function has to master.”

Taking control of RWE

Another driver of Medical’s current transformation is the requirement for continuous evidence generation. This is the melding of Real World Evidence (RWE), digital health, post-approval evidence and patient insight. “At Sanofi, Medical is in charge of the Real-World Evidence platform. We’ve built it and we, in turn, provide a service to R&D, Medical teams and Market and Patient Access. We should be able to move earlier into development, by leveraging the RWE platform for adaptive registration approaches to new products. With a really effective Real-World Evidence platform, good analytics and a transparent network, you could set up a very comprehensive, continuous observational program that continually helps to refine the benefits and risks of our products in real life as well as uncover new indications.”

Nathwani thinks how we maximize RWE will define the Medical function’s strategic value in the future. “We can’t be regarded as a strategic function if we’re not looking at how we can play a relevant role in the rapidly changing healthcare system. So, as a Medical function, we need to understand and define what the future of Medical should be in anticipation of these changes. How do we re-define ourselves? Where do we get our inspiration from – which other parts of the business or which other businesses do we send our medical teams to for inspiration? For example, are some of our Medical teams spending time at the Consumer Electronics Show, where you can pick up signals on future trends and behaviors of consumers in general – how a view of how these trends could be applied to the health sector? At Sanofi, we spend a lot of time engaging with tech companies to try and get a sense of where they are going and brainstorming on how to apply these to health. The main message is that Medical needs to look at what’s happening broadly in the world of technology, analytics, as well as in the traditional areas of medicine and healthcare, and zealously bring some of those ideas back internally to assess if we can integrate them to help us improve outcomes for patients.”

Measurement for Impact

One of the key challenges for Medical involves clarifying its new remit within the organization. Sanofi has selected nine strategic priorities for the function (see Figure 2), which serve as a roadmap for the transformation within the context of the evolving healthcare landscape. For Nathwani, the clarity this provides is a fundamental first step to making the function more value-driven, from early development right through to the end of the product lifecycle.

“There’s been a reluctance to measure the impact of Medical in the past as there wasn’t a clear definition of what it can achieve. We don’t measure return on investment, as commercial metrics don’t apply. We’ve been through this whole exercise of what we could do and what success looks like and how we measure the value that we bring: have we really made an impact on patients and physicians, have we fundamentally changed healthcare systems, have we introduced a drugs-plus solution that has truly improved outcomes? Do physicians regard the information provided by the Medical organization as credible, is the quality of the dialogue good, has it changed behavior? While complex and not easy to measure, these are the performance measures that we are trying to formulate in each pillar of our activities.”

Culture

Much of the work around redefining Medical’s role within the organization goes beyond just structural issues, and there are considerable challenges around culture and changing roles and expectations. “It’s probably the hardest thing to do right now. A first step is having top-down support. Following that, at the grassroots level, is there a clear roadmap or vision, is the platform that we’re trying to build and the vision for Medical truly understood by all stakeholders at all levels, including within the Medical function? There are many individuals in Medical today who have very different experiences and mindsets, some from a time where Medical occupied a more traditional support function role and maybe some of the teams are not fully convinced that we can truly make a difference to the strategic direction of the organization. It’s vital to get the whole organization on board and that comes from having a strong conviction, and a clearly defined roadmap of how to make this happen.”

A key component of a successful transformation will be an expansion of Medical’s capabilities – to allow a company to understand the patient experience, access, and influence a broad array of external healthcare stakeholders, and to act as a liaison between the medical community and the internal research organization.

“We described the required capabilities of the future Medical organization and we are creating the training platforms to accompany that. And we help them to understand the processes by which you transform. It’s not easy at the country level, where the ‘rubber hits the road’, because the pressure of the business and the resources and experience to lead change is much more difficult to obtain. We have taken the long view, so when we hire today, we try to hire for the future. We try to bring in people who have a better understanding of biotechnology, drug development, are strong on analytics and with a solid grounding in medicine, and where possible, a strong interest in the digital side. It’s tough. We also look for people with a very strong patient-centric focus as the energy and passion these individuals bring to our organization is tremendous, and keeps us grounded in our purpose”.

Together is better

With today’s life science industry now under extreme pressure to deliver superior medical outcomes while simultaneously cutting the cost of drug development, the time is right for Medical organizations to earn their place at the leadership table by creating opportunities to deliver new value for both patients and the healthcare ecosystem. Different companies are at different stages of maturity in terms of their progression towards being a fully-fledged strategic partner. However, the lack of a unified voice is hampering progress, Nathwani suggests.

“Our weakness is the heterogeneity of the role that Medical plays across organizations. We have extremes, from Medical as a well-accepted key strategic partner, right through to other organizations where Medical is probably more in the mainly customer support role. That heterogeneity means that it’s very hard to get alignment. If you look at the R&D organizations across industry, there is more clarity around their value and role. The main R&D leaders regularly meet together in a pre-competitive forum to look at the future direction of R&D and discuss macro trends. We don’t systematically do that across the Medical leaders in industry. There are a few useful platforms, but given the heterogeneity of our roles, the discussions are not consistent and our collective influence and voice is not at the level it could be.”

Nathwani is a strong advocate for Medical Affairs coming together as a community to decide on the future direction of MA. “We need to align on what are the key priorities that we believe Medical should be working towards across industry. For example, can we agree what would be a reasonable way to present the value of Medical internally and externally? Can we agree on what are the areas that Medical should try to drive within organizations – be that digital or drugs-plus or lifecycle management, and so on. Can we agree on the optimal methodologies for collecting and using RWE or utilizing advanced analytics for post-registration studies? What’s our approach on the many industry topics around bioethics?

“For example, in our organization, Medical runs the Sanofi Bioethics Committee, which helps to form company-wide positions on fundamental issues such as data transparency, the way we conduct trials, our approach to patient groups, positions on nanotechnologies or genetic therapies. Medical could be much more instrumental on matters like these if we had a platform across industry which could integrate positions from other companies and gain alignment on them. There’s a lot of areas I think that an organization like MAPS could focus on, to really elevate the Medical organization and its voice in our industry.”

Medical has a window of opportunity to become a strategic function. It needs to make itself relevant to the changing healthcare ecosystem and is well-positioned to do so but it could easily “miss the bus” on this if it carries on as is.

The future of the function is very much in our hands, Nathwani believes. “It depends on what we do next. In fact, I think we’re at a tipping point right now. We either prove our innovative value by adapting to and addressing the external changes happening in healthcare and our industry, or we will continue to remain a mainly support function. There’s a lot to do. If we can, for example, use Real World Evidence platforms to fundamentally change the way we carry out drug development, understand patients and diseases, and leverage these to bring through our biologic innovations faster, more safely and at a reduced cost, that to me will be a remarkable achievement.”