Learning.Agility

Learning Agility: An Emergent Capability for Future-Proofing Medical Affairs Strategic Planning

/in , , , , , /by

Download the full article.

By: Simon Kyaga1; Keith Morris2; Kiely Flanigan3

1Global Medical Lead, Psychiatry, Servier; 2Executive Managing Director, Scientific and Medical Affairs, Syneos Health; 3Director, Medical Affairs Syneos Health

 

ABSTRACT

This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. In essence, learning agility is a set of skills, competencies, and mindsets that support our capability of “knowing what to do when we don’t know what to do.”1 Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. Through the enablement of learning agile behaviors, the approach to strategic plans can be made with an eye toward ongoing reflection and updates. We define four descriptive behaviors (contextual curiosity, vision-driven adaptability, educated risk taking, and accountable learning) that match up to MAPS best practices in strategic plans and then discuss how to apply those learning agility behaviors. We conclude with future recommendations for the development and application of learning agility.

 

KEYWORDS

Learning agility, strategic plan, strategic thinking, medical strategy, capabilities enhancement

 

The COVID-19 pandemic has accelerated the need to develop Medical Affairs capabilities in learning agility. Not unlike various industry shifts over the years that have impacted the role of Medical Affairs, we’ve experienced a shift in the way Medical Affairs organizations are responding to changes affecting the execution of strategic plans. Field Medical is learning to engage stakeholders virtually and support HCPs in new ways as they engage with their patients through new technologies. Clinical trials adopted new protocols to protect patients and sustain recruitment. Conferences and congresses were postponed. Organizations are seeking flexible resourcing models to manage downturns in business and leveraging downtime to upskill team members. All of these changes have required an openness to change and the development of new skills to learn new ways of achieving our work objectives. We are now not only shifting how we do our Medical Affairs work, but also planning for a “new normal” as we navigate doing business virtually.

 

Yet, however uniquely disruptive COVID-19 has been, it is still only one more example of the bucket of business disruptions that have affected the skills, knowledge, and capability needs within Medical Affairs work. At the heart of the changes asked of us and our teams is learning agility. As a core capability associated with managing ambiguity and “knowing what to do when you don’t know what to do,” learning agility is particularly relevant and useful in developing adaptive and dynamic Medical Affairs strategic plans that stand the test of change and disruption.1

 

Learning agility in strategic planning is important because by incorporating learning agility behaviors and mindsets into the development and implementation of Medical strategic plans, teams are better able to pivot and innovate, as needed, to changing internal and external dynamics, while remaining in alignment to the overall medical vision and business objectives.

 

This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. We then define four descriptive behaviors that map to aspects of Medical Affairs strategic plans and discuss how to apply those learning agility characteristics.

 

Medical Affairs Strategic Planning

Medical Affairs strategic plans include both intellectual components, such as situational analyses and medical strategies, as well as tactical components, including tactical and operational plans, and assessment and measurement metrics.2 Medical plans are important because they guide decision making across the organization and support the communication and assessment of Medical Affairs’ efforts and impact.

 

Medical Strategic Planning is an integral part of setting strategic direction and articulating the tactics for driving Medical Affairs value and impact for patient and organizational outcomes. But, how do you create a realistic and viable strategic plan given a VUCA (volatile, uncertain, complex, and ambiguous) Medical Affairs ecosystem? What brings Medical strategic plans to life beyond and ensures it gets referenced more than once a year in the annual planning process? How do we make the strategic plan content memorable and keep it top of mind with our key audiences? We suggest that the secret to effective Medical Affairs strategic plans is learning agility.

 

In a Medical Affairs context, learning agility brings key behaviors and mindsets into the Medical planning, development, and execution processes that ensure the content contains relevancy and resonance for the organization. Although variations exist between companies in terms of influences affecting the strategic planning process (e.g., preferred timing of Medical support of launches, products, therapeutic area considerations, and operational competencies versus strategic positioning priorities), the Medical Affairs strategic planning process reflects multiple stakeholder insights, business objectives alignment, and tangible data for strategic decision making. The strategic plan is not intended as a fixed manual that is reviewed once a year.

 

To be of service to Medical Affairs and the broader organization, a strategic plan must be a living document that is flexible enough to incorporate new insights and maintain relevancy in the face of changing priorities and dynamics.

 

There are several descriptive behaviors team members can use in approaching the development, communication, and operationalization of strategic plans to support success:

 

Each of these behaviors is based on the capabilities needed to design, communicate, and execute on a strategic plan. The descriptiveness of the terms reflects a desire to position these learning agility behaviors as both foundational and aspirational. Learning agile behaviors are both critical for the here and now in performing work, but also for guiding toward the future and inspiring learning and development.

 

Learning Agility

Learning agility is relatively new to the Medical Affairs scene, but it is starting to see more traction as our industry seeks to build capabilities in individuals and teams to navigate and harness the rapidly changing nature of Medical Affairs. Originally used to develop the managerial capabilities of high-potential, high- performing talent, learning agility can be applied not only at the individual level, but also at the team and organizational levels, and is associated with higher levels of organizational performance.3,4 For purposes of this article, we’ll focus on developing learning agility at the individual level and use the following definition:

 

Learning agility is a capability associated with adapting to change and uncertainty by applying previous lessons learned.

 

Learning agility requires both adaptive readiness to change and proactive innovation in times of ambiguity.5 In essence, learning agility activates the value and impact of Medical Affairs strategic planning components (i.e., situational analysis, medical strategy, tactical and operational plans, and assessment and measurement metrics) despite change and shifting expectations internally and externally.

 

When it comes to Medical Affairs strategic plans, it is no longer sufficient to rely on the intellectual and tactical domains of competence. Successful Medical Affairs strategic plans reflect a collective organizational capability—an integrated representation of knowledge, skill, and mindset—that brings to life within the plan the flexibility to adapt, learn, and pivot toward changing needs. Learning agility is the “how” behind the “what” of Medical Affairs strategic plans.

The integration of learning agility and Medical strategic planning is important to how both strategic and day- to-day operational decisions are made. This is even more important today as Medical Affairs is being asked to communicate and demonstrate its impact and value within competing priorities from more diverse and increasingly challenging internal and external stakeholder needs. In addition, due to COVID-19 disruptions, including closed conferences, Medical Affairs is forced to reconsider how to communicate and how to balance between strategy and tactics in an uncertain environment.

 

 

Mapping Learning Agility Behaviors to Medical Affairs Strategic Planning Processes

 

Using the strategic planning framework developed by MAPS, the section below looks at the fundamentals of Medical strategic planning and suggests related learning agility behaviors and mindsets that are instrumental to both intellectual and tactical outcomes. The learning agility behaviors form a kind of permeable flexibility and protection that ensures the strategic plan is created and maintained with maximum adaptiveness (as seen in the above diagram). Learning agility brings strategic plans to life and articulates specific behaviors that support the strategic plan having bigger impact through greater relevancy. A strategic plan must be relevant to have impact and the learning agility behaviors associated with MAPS’ four elements of strategic plans makes them applicable for the teams using them.

 

 

Medical Strategy figure

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY

 

In this article, we have identified learning agility as an emergent capability that brings to life and ensures the relevancy of Medical Affairs strategic plans. Specific applications were discussed for each learning agility behavior in context to its associated strategic planning element. The importance of developing the skills and mindsets to navigate change, uncertainty, and disruption are evident, now more than ever with COVID-19, and important to developing the capabilities to harness the future, whatever may come within Medical Affairs.

 

REFERENCES

1. Hallenbeck, G., & Santana, L. (2019). Great leaders are great learners: How to develop learning-agile high potentials. Center for Creative Leadership white paper, 1-16.

2. MAPS Annual Conference (2020). The importance of Medical strategic planning. Conference presentation: Miami, 1-23. Access in the Community Portal.

3. De Meuse, K.P. (2017) Learning agility: Its evolution as a psychological construct and its empirical relationship to leader success. Consulting Psychology Journal: Practice and Research, 69(4), 267–295.

4. McCann, J., Selsky, J., & Lee, J. (2009). Building agility, resilience and performance in turbulent environments. People & Strategy, 32(3).

5. Doeze Jager-van Vliet, SB, Born, MPh, & van der Molen, HT (2019). Using a portfolio-based process to develop agility among employees. Human Resource Development Quarterly, (30), 39–60.

6. Bourgoin, A. & Harvey, J-F. (2018). Professional image under threat: Dealing with learning–credibility tension. Human Relations, 71(12), 1611–1639.

 

Download the full article.

Joseph.Eid .Interview

Interview: The Value of Medical Affairs

/in , , , , , , /by

Joseph Eid, MD, SVP, Head of Global Medical Affairs at Bristol Myers Squibb, describes how Medical Affairs can ensure representation of the patient voice in product development, and the positive shift and elevated prominence Medical Affairs is achieving within companies.

 


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

 

Download the Presentation

Members may also download a PDF copy of Dr. Eid’s panel discussion on The Value of Medical Affairs from the MAPS 2020 Global Annual Meeting as well as a recording of the session in the Community Portal.

 

View the White Paper

You may also view our latest white paper on the Communicating the Value of Medical Affairs, by clicking here.

4

COVID-19: Best Practices & the Future of Medical Affairs – Medical Affairs as a Whole

/in , , , , , /by

As experts with a deep knowledge of our medicines, medical technologies, and therapeutic area science, Medical Affairs is uniquely placed to help the industry and healthcare community navigate through these unusual times. While remaining flexible and agile to meet changing needs and requirements today, we can also begin to look forward to see how to flourish in the new normal.

Turning challenges into opportunities

Medical Affairs always puts patients first, and that will not change. But there are opportunities for improvement that can make the most of the current situation.

  • This is a make-or-break scenario for relationships—ensure your interactions are highly relevant and healthcare professionals (HCPs) will remember you in the future
  • HCPs may be more willing to engage with Medical Affairs as a trusted source of medical and scientific information
  • Conversations should be more focused and impactful
  • Expedite reviews of research proposals to ensure patient access to medicines and medical devices
  • Look for opportunities to work cross-company to meet the needs of patients, HCPs, and professional societies

 

Best practices during the pandemic

We are all getting accustomed to working virtually—here are some best practices to help you and your colleagues:

  • Encourage, rather than demand, virtual HCP interactions
  • Utilize vendors with expertise in virtual meetings to convert face-to-face meetings such as advisory boards
  • Be flexible and tolerant should technical issues arise during an engagement
  • Master the four Cs of virtual engagement: CONFIDENCE, CONTROL, CREDIBILITY, and CONNECTIVITY
  • Be aware of meeting fatigue, for yourself and others

 

Be Medical Affairs at its best!

  • Stay connected with your strategic partners, internal and external
  • Identify and ensure delivery of data and medical information that your HCPs and patients need
  • Liaise with professional societies and patient organizations to ensure external stakeholder needs are met
  • Help your HCPs not to feel overwhelmed—give them the information they need when they need it, and no more

 

FLOURISHING IN THE NEW NORMAL

How Medical Affairs as a profession emerges from this crisis depends on us and our actions. We can anticipate some longer-term changes that will help us flourish in the new normal, allowing us to do even more good for patients, HCPs, and medicine.

  • Identify what information your HCPs and their patients will need in the post-COVID world, and work to obtain and disseminate it
  • Continue to keep your interactions with HCPs focused and valuable
  • Consider what pressures your HCPs will have after the pandemic and how you can best support them
  • Continue to keep patients at the center of everything you do

 

Based on presentations given by Dr. Charlotte Kremer, Dr. Robin Winter-Sperry, Dr. Tamas Koncz, Dr. John Pracyk, Dr. Peter Piliero, and Dr. Joseph Eid during the MAPS Global Town Hall webinar on April 21, 2020.

Global.Town .Hall .COVID

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

/in , , , , , /by

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. By strengthening our understanding within the pharmaceutical industry of how Medical Affairs can support HCPs and patients in these times, this Town Hall will help to achieve industry-wide alignment on the issue and might even save lives.

 

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/

Launch Readiness 2020: Ensuring Strategy And Value From Global To Local Perspectives

Launch Readiness 2020: Ensuring Strategy And Value From Global To Local Perspectives

/in , , , , , , /by

This MAPS podcast introduces listeners to social listening to gather insights and discusses implementation, value and technologies.

Read more
Mars.Venus .ELEVATE

Medical Devices are from Mars, Pharmaceuticals are from Venus. What can we learn from each other?

/in , , , , , /by

Medical devices and pharma: two sides of the same coin; significantly different but part of the same larger ecosystem. Dr. John Pracyk discusses the implications for Medical Affairs professionals.

 

So why have we called this piece Medical Devices are from Mars; Pharmaceuticals are from Venus? According to Dr. John Pracyk, it is a useful metaphor based on the classic relationship guide by Dr. John Gray: Men Are from Mars, Women are from Venus. Expanding on the analogy, he explains that the majority of Medical Affairs professionals in the medical device sphere are surgeons, whereas pharma is dominated by physicians. Beyond this, of course, there are other significant differences that stem from a close alignment between medical devices and therapeutic expertise.

 

Dr. Pracyk, who is Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, for DePuy Synthes – Spine (part of the Johnson & Johnson stable), says: “It’s important because Medical Affairs is now aligning towards the fact that you’re most likely going to be working in an operating company in line with your sub-specialty training and board certification, along with operative proficiency and clinical practice experience, which will be at least a decade or more. After that you begin to have the skill set that industry is looking for. That’s decidedly different than Medical Affairs in pharmaceuticals, where there is a much more diverse range of clinical experience and educational backgrounds.

 

“In other words, to deliver the most value to the device industry we can only make the transition once we are board certified and bring a wealth of clinical practice experience to the table.”

 

Meanwhile, in pharmaceuticals, the classical model is an internal medicine residency with sub-specialty fellowship, or research training, followed by a highly variable period of time in clinical practice. Some physicians forgo residency and clinical practice entirely and make the transition to industry immediately following medical school or, alternatively, a post-doctoral research fellowship, while others have had meaningful careers in healthcare consulting.

 

The differences between devices and pharmaceuticals is especially significant from the perspective of the new European Medical Device Regulation that was passed on May 26, 2017 and comes into full effect on May 26, 2020, after a three-year phase-in period.

 

“Medical device companies need medical directors that have specific subject-matter surgical expertise that reads directly to the product portfolio. Why? Because the MDR credentials section has become more stringent, as have the state-of-the-art requirements – these require medical affairs surgeons to have deep clinical insights into a specific therapeutic area, as they are medically responsible as signatories for the Clinical Evaluation Report, (CER) which is the formal application for the CE mark in the European Union. For example, as a spine fellowship-trained neurological surgeon, it is quite appropriate that I lead medical and clinical affairs for our spine platform. Similarly, orthopedic  surgeons lead trauma and joint reconstruction, whereas an  otolaryngologist leads our ENT platform.”

 

Beyond this, there are further differences between devices and pharmaceuticals in terms of Medical Affairs’ scope of responsibility. “Typically, Medical Affairs in pharmaceuticals is primarily involved once the drug has launched. Clinical Affairs is responsible for all the pre-launch activities such as R&D and drug development. In devices,  Medical  Affairs spans that entire spectrum from initial ideation and front-end conceptualization through the stage-gate, development process, bringing that product to market and then launching it. It doesn’t stop there, as once it is in the field, maintaining it through its lifecycle and then removing from the market is also our responsibility. Medical  Affairs in devices is subdivided into two major divisions, 1) Franchise, which is responsible for product development through the R&D pipeline all the way up to launch, and 2) Lifecycle, which picks up the product at launch and  manages it through its entire lifespan on the market. We typically refer to it as ‘pipeline and portfolio ’: pipeline being franchise, portfolio being lifecycle.

 

“In pharmaceuticals, Medical Affairs is predominantly involved in the post-launch affairs, getting the product to market, medical communications, scientific engagements with KOLs, for purposes of studies, clinical trials, publications, podium presentations, and supervising all of the field medical professionals, such as medical science liaisons (MSLs).

 

“In devices, we are both internally and externally facing. For example, we work closely with Health Economics & Market Access (HEMA), to establish evidence of differentiated value to position products to successfully navigate value analysis committees (VACs). Similarly, we often oversee clinical investigational studies and investigator-initiated studies that support our products for purposes of safety and performance for our regulatory authorities. Internally, we work with R&D, Quality, Regulatory, Global and Regional Marketing in helping our colleagues understand what it’s like on the hospital and surgeon side of the equation.

 

“When I was practicing, I was the surgeon champion on the VAC for my health system. Now, I use that prior clinical and hospital administrative experience to help guide our interactions as a device manufacturer with the VACs of our customer hospitals and integrated delivery systems. Simply put, it is different ends of one vary large supply chain. Not surprisingly, I have also been involved in engaging our own contract manufacturers through speaking engagements and moderating panels at the Orthopedic Manufacturers Technology Exposition and Conference (OMTEC), as I now need to learn about how supply chains in industry work, while reciprocally informing our contract manufacturers on the global transition taking place clinically from volume to value that ultimately impacts their businesses as well.

 

Medical Affairs informs strategic decision-making

Medical Affairs is increasingly becoming a strategic partner for both commercial and R&D teams. “One way to look at this is through a go-to-market strategy that is refracted through the lens of three evidentiary audiences. The first is regulatory, where we must place the product ‘in country’. Next is hospitals/integrated delivery networks, where were we need to work with the VACs to get the product ‘on contract ’. Thirdly, we must secure reimbursement from the payers, whether they be private, commercial insurers, or government entities. As you can see, Medical Affairs is involved in a very broad range of medical and scientific engagement activities.

 

Diverse skillsets 

Medical Affairs professionals in devices are fewer in number and require a very diverse skillset, whereas Medical Affairs in pharmaceuticals are far larger in number and, historically have been around much longer. “When you consider the sheer numbers of Medial Affairs in pharmaceuticals, both internally and with the MSLs in the field, it is literally an army. Conversely, on the devices side, we’re more of a ‘special forces’ model, where you just have a few people who are very specialized, but cross-functionally trained in diverse areas, which is a force multiplier.

 

So how hard is it to obtain the specialist knowledge and overcome the significant shortage of talent? Surgeons coming into Medical Affairs often have skillsets that are much in demand, beyond their specialist clinical expertise. For example, time spent learning how to develop a practice and building business acumen are highly prized in industry.

 

“Many physicians and surgeons are now going to business school to get their MBAs, while others have been involved in hospital leadership committees or have commercialized devices as an entrepreneur. These transferrable skills are valuable when you consider the range of activities that Medical Affairs delivers against: namely, understanding business operations, manufacturing, finance, accounting, communications, strategic development, and pre-clinical and clinical research – and being able to navigate the spectrum from bench top, to small animal, large animal, and ultimately first in human. Not surprisingly, surgeons who possess these essential business, research and clinical skills will meet with great success in devices.”

 

Leaving clinical practice

In pharma it is not uncommon for clinicians to maintain some form of clinical practice, which can take a variety of forms from an occasional clinic, to volunteering, or mission work. However, due to both legal and healthcare compliance issues, surgeons working in devices must stop operating and close their clinical practice upon entering industry. For a surgeon, who has spent years acquiring a unique set of skills this is a huge deal. Fortunately, maintenance of operative skills is accomplished through a variety of cadaver settings: wet labs, validation labs, and prototype testing.

 

Yet, there is one remarkable upside, according to Dr. Pracyk. “Believe it or not, we can secure visiting professor privileges anywhere in the world that permits us to scrub into surgery with key opinion leader surgeons – not to clinically perform the operation (in fact, we are specifically prohibited from touching the patient), but more importantly to observe, learn, and distill out the critical insights that help identify and address true unmet needs. The simple fact that this worldwide peer-to-peer surgeon exchange occurs from within the operative field is absolutely amazing.”

 

Lessons on both sides

“I think what pharmaceuticals can learn from the device side is that we are very good at these cross-functional skills.” Flipping it around the other way, what can devices learn from pharma? “I think pharmaceuticals has a much more thorough and deep understanding of ‘patient centricity’.

 

“In devices, the surgeon is the proxy for the patient. However, with the concept of surgeon employment and the advent of spine and brain institutes in neurological surgery or musculoskeletal institutes in orthopedic surgery, the multidisciplinary model of care is taking hold. Ultimately, the patient will be at the center of what we do and a more comprehensive approach to care redesign will certainly elevate patient centricity globally as the medical devices sector continues to learn, share and advance care more holistically like our pharmaceutical colleagues.

 

16 1

How to Reframe Strategy and Compete on Outcomes

/in , , , , /by

“The way to understand it is that a dinosaur in a fur coat is not a mammal.”

Competing on outcomes means designing entirely new systems of health engagement that link and satisfy three perspectives simultaneously: the payer plus the provider plus the consumer (patients and caregivers).

 

Organizations seeking to create “value” in the new outcomes-based healthcare world require a profound change of mindset. They need to incorporate “big design” thinking to help transform the way they engage with a $7 trillion healthcare market undergoing structural change. This has less to do with the promise of digital and emerging technologies, as it does with understanding that digital – while transformative – is a means to an end, not the end. In healthcare, it’s value innovation first, technology innovation second.

That’s the view of John Singer, Global Head of Health Industry Strategy, Innovation and Technology at Wipro, whose remit is to help clients reframe their market and business strategies to succeed in the new environment.

Navigating this transition space takes a new frame of reference that dissolves boundaries and spans the entire organization – not just a digital bolt-on to the current state – and requires solving for fragmentation and continuous health engagement, at scale. It has many facets encompassing co-creating new models of care with customers, care delivery innovation that weaves in the social determinants of health, as well as technology and digital. “We’re working with one pharma around strategic transformation of their business, helping them understand how you compete on value, not the technical merits of a me-too drug. These are much deeper sorts of conversations than just, say, applying new technology to old business models. One way to understand it is that a dinosaur in a fur coat is not a mammal.”

A significant issue is that product classes with fundamentally new performance profiles – and costs – (such as we see in precision medicine) can’t be dropped into an existing business model and expected to work. The business model – how value is created, captured, and delivered – needs to be reinvented to support the new proposition [1].

“The space of opportunity is for industry to be the catalyst, to lead strategically and be the drivers of change. For instance, if you take a look at what the NHS is asking of pharma, it is to come to the institution with new ideas and ways to co-create new models of care and sustainable systems designed around patient needs.”

As an example of this new approach, Singer points to the recent deal between the NHS and Merck Germany involving the company’s Mavenclad MS drug. (See sidebar 1: NHS outcomes-based pricing deals)

“Merck was trying to get Mavenclad on formulary, but NICE was pushing back, saying they already had enough MS drugs. So Merck went back and reframed their value strategy, essentially positioning themselves as an information service. They asked what if we were to collaborate with you and build out an entirely new infrastructure to capture and analyze real-world evidence across the disease state – not necessarily specific to Merck’s drug, but going ‘above brand’ and co-creating an entirely new capability to enable new insights and better outcomes in multiple sclerosis. Because of that, NHS said okay, and Mavenclad made it on formulary. It’s a great example of value innovation first, technology innovation second.”

[1] Josh Suskewicz and Moni Miyashita,“3 Business Models That Could Bring Million-Dollar Cures to Everyone,” Harvard Business Review, November 12, 2018 https://hbr.org/2018/11/3-business-models-that-could-bring-million-dollar-cures-to-everyone.

 

Sidebar 1:
NHS outcomes-based pricing deals

NHS England unveiled two bespoke pricing deals with pharma companies at the FT Global Pharma and Biotech conference in London on November 10, 2017. Chief executive Simon Stephens personally announced the two deals and confirmed that such “commercial access agreements” will become a permanent part of the UK pharma market.

NHS England’s motivation was that drug costs were rising faster than general costs and there was a perception that it didn’t always get the best value. An agreement with Merck Germany ensured the availability of its multiple sclerosis drug Mavenclad (cladribine) as part of an outcomes-based pricing agreement. The drug is expensive, with a list price of £2,047.24 per 10mg tablet (albeit that this will be discounted). However, the outcomes-based agreement will mean the NHS will only have to pay for medicines for those patients who respond to the drug.

Going forward, the NHS is looking to pursue more creative and flexible arrangements with pharma. Stephens was quoted as saying: “I think it is a precedent-setting deal, in as much as it includes shared risk in what we hope are going to be very strong outcomes. That is the kind of process we would like to see more of.”

Reference: Andrew McConaghie, “NHS England chief hails ‘precedent setting’ outcomes deal with Merck,” Pharmaphorum, November 10, 2017, https://pharmaphorum.com/news/nhs-england-chief-hails-precedent-setting-outcomes-deal-merck/.

 

“Those are the kinds of strategic transformations and collaborative innovation models that we see as a new feature to the operating environment, and which are reflective of what pharma customers are looking for – it’s almost more B2B. And then, obviously, the technology stack that goes into that story, including the digital component (both existing as well as emerging) as well as what you can invent, all comes into play in terms of building out that roadmap and that new value proposition.

“But the bigger story is all about leadership: how should the pharma industry step outside of itself and understand how they can co-create a new value strategy in a way the competitors can’t. The story’s going to be less drug-based or less brand-based, versus how can they explore above-brand strategies, collaborating and designing entirely new systems of population health engagement, weaving in the social determinants of health and then managing that system over an extended period of time in terms of generating the evidence, removing the administrative burden.

“We’re working with a pharma company to basically design an entirely new system of health in the State of Missouri, as well as in Korea. And these are very large initiatives – it’s first looking at designing an entirely new infrastructure and then managing that infrastructure in a way that’s going to drive business value. And by infrastructure, I mean how do you connect the payer data, the electronic health record data, and the provider data in a way in which you have those things flowing freely between the pieces – and how do you add value onto that and then how you monetize that?”

Summarizing this approach, Singer says: “I would say, in general, what we’re seeing globally across all of those sectors is a shift from product-based business models to how they can reposition themselves strategically and almost become like an information service in some cases.” Integral to this is for pharma to understand the barriers to full digital adoption and stepping away from the narrow view that the business is simply about how to research, manufacture and sell drugs.

“That’s not the same thing as an outcomes-based model where the drug is a component. And then how do you understand service and experience? And how do you navigate that transition space where the conversation, the dialogue and the business opportunity are becoming much bigger than that, and you’re actually involved in shaping new models of care delivery, which is what the Merck example was. To illustrate this, Singer offers the example of a Netflix-style subscription model for the reimbursement of hepatitis C drugs in the State of Louisiana, developed in conjunction with Gilead, Merck and AbbVie (See sidebar 2: Louisiana subscription-based payment model).

 

Sidebar 2:
Louisiana subscription-based payment model

Louisiana has rolled out a potential solution to help it afford the high cost of hepatitis C drugs. This “subscription-based payment model” sees it partnering with pharmacos to pay a fixed annual cost for unlimited access to drugs to treat Medicaid recipients and prisoners. In a request for comments on the proposal, the state notes that the patients are underserved by current payment systems, and that the model could benefit the state and drug-makers alike. Louisiana Department of Health Secretary Rebekah Gee said in a statement that such a model “would create an incentive for us to find and treat as many people as possible.” Gee noted the proposal “would guarantee a fixed purchase price for a contracted period of time, and would allow the drug manufacturer to expand their product reach into populations that otherwise would not have received treatment.”

Reference: Eric Sagonowsky “Louisiana seeking comments on ‘Netflix’ model for hepatitis C drugs,” FiercePharma, Aug 16, 2018, https://www.fiercepharma.com/pharma/louisiana-seeking-comments-netflix-model-for-hep-c-drugs.

 

He adds: “Again, this touches on the thing that you’re looking for in terms of digital health because you can’t create a Netflix-like subscription model unless you’re really having a digital conversation, a technology conversation, an AI, automation, and data conversation. But all of that has to happen simultaneously and interactively with the business and market conversation.”

So what needs to be done to make this happen? Singer reemphasizes the importance of being able to ‘paint both sides of the fence’ at the same time. This is about thinking new thoughts to create new ideas. “It’s a mind-set shift; it’s a cultural shift. A good example of those two things is that Merck US just hired a new chief digital officer from Nike to bring something like a digital sixth sense to the organization.”

 

Reinventing the role of Medical Affairs

Turning to the specific role of Medical Affairs in this new paradigm, Singer views this as an opportunity to position Medical Affairs not simply as technical product advisers around one drug, but as a source of value to demonstrate to physicians, payers, patient groups and key opinion leaders how to improve outcomes. As the demand for real-world evidence grows, so too will the demand for new scientific understanding of disease.

He sees a transformation from Medical Affairs into “medical value teams”, able to communicate scientific evidence with insight and impact on care delivery, while building long-term relationships with a variety of stakeholders. “You’re almost changing the concept of science so that you’re really evaluating information and ‘specialized cognition’ as an asset to the business, and having conversations and content and new evidence around that.” In the new conversation (which is going to be less about branding a promotion in detail and more around the science or new models of care) this will likely be led by Medical Affairs and the MSLs globally.

In conclusion, Singer argues that “value” in healthcare remains largely unmeasured and misunderstood – and this is an opportunity: whoever does the better job at designing value systemically will be the winners strategically. He stresses the importance of rethinking market strategy and segmentation based around health economics and outcomes modelling. “The faster you can build up that outcomes story and that new economic argument, the more successful you’re going to be selling that in.”

 

Biography

John Singer is Global Head of Health Industry Strategy, Innovation and Technology at Wipro. He brings more than 25 years’ experience in marketing and strategic innovation across all dimensions of the global health sector, including medical device, pharmaceutical, biotechnology, payer and provider clients. He specializes in reconfiguring markets and helping clients navigate the transition space to compete on outcomes.

Singer argues that Medical Affairs is perfectly positioned to drive value-based outcomes, transitioning pharma into new business models and away from an industrial-era view of “market” bounded within the context of discovering, pricing, manufacturing and promoting the technical merits of a physical product (i.e., drug brand), to a model based on embedding “drug” within entirely new systems of health engagement. He is also a guest lecturer on health system innovation and pharmaceutical market strategy at leading organizations and business schools, including Cambridge University, ESCP Europe, the RAND Corporation and McGill University.

 

 

Rise.Medical.ELEVATE

The Rise and Rise of Medical

/in , , , , , /by

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.”

 

Agility Medical Affairs Strategy

Building Agility into Medical Affairs Strategy: Global-Regional-Local Dynamics

/in , , , , , , /by

Recognize why networking and alignment is key to a successful Medical Affairs strategic plan; discuss the steps involved in strategic planning process and associated tools and templates; describe Global-Regional-Local alignment and implementation… where do you start? Select which functions you include when building your global Medical Affairs strategy.

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