Global.Town .Hall .COVID

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

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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/

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Podcast: European Union Medical Device Regulations (EUMDR)

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Click a thumbnail below to listen to the episode.

 

Episode 1: Host John Pracyk, MD, PhD, MBA, Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes – Spine | Johnson & Johnson Medical Devices Companies welcomes Philip Desjardins, JD, Vice President, Global Regulatory Affairs Spine and Medical Device Regulatory Policy, DePuy Synthes | Johnson & Johnson Medical Devices Companies, and Drilon Saliu, PharmD, MBA, Head, Medical, Clinical and HEOR, Connected Care, Philips, to share insights into the importance of compliance with the new European Device Medical Regulation (EUMDR), including key deadlines for compliance.

EUMDR MedTech Podcast 2

 

Episode 2: Host John Pracyk, MD, PhD, MBA, Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes – Spine | Johnson & Johnson Medical Devices Companies welcomes Philip Desjardins, JD, Vice President, Global Regulatory Affairs Spine and Medical Device Regulatory Policy, DePuy Synthes | Johnson & Johnson Medical Devices Companies, and Drilon Saliu, PharmD, MBA, Head, Medical, Clinical and HEOR, Connected Care, Philips, to continue their comprehensive discussion of: Covid’s impact on EUMDR; USFDA and EUMDR global regulator comparison; short and long term impacts; how Brexit might impact the UK’s regulatory oversight; the importance of investing in top talent; new capabilities that are required; the importance of leading with influence; and, evidentiary compliance planning and budget impact.

 

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

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

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Objectives:

What is Strategy Related to Launch?

  • • Medical Affairs Launch Readiness
  • • What is the role for Medical Affairs in launch readiness?
  • • Who is part of launch readiness and how is it accomplished?
  • • Execution of Global Strategic Plans at the Regional Level
  • • How do local affiliates impact the global strategy?
  • • Demonstrating Value & Impact for Medical Affairs
  • • What performance measures (KPIs) can we use to refine strategy?

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The Human Touch: The Real Issues Behind Burnout

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The Human Touch: The Real Issues Behind Burnout

Executive stress has come under scrutiny recently, most pointedly in an open letter published by Arianna Huffington, founder of the Huffington Post, to Elon Musk, in which she appealed to him to change the way he works to be more in line with the science of how humans are most effective.

The letter came hot on the heels of the Tesla chairman and chief executive’s anguished New York Times interview where he broke down multiple times as he recounted the excruciating pressure he was under in what he named “the most difficult and painful year of my career”. Asked if the exhaustion was taking a toll on his physical health, Musk answered: “It’s not been great, actually. I’ve had friends come by who are really concerned.” The public admission subsequently sparked a tumble in Tesla shares.

Huffington decried Musk’s 120-hour weeks and continued with an argument calculated to break through his denial – science. Musk is nothing if not a scientist, so Huffington asked him to look at the science of human overwork and sleep deprivation: “The science is clear. And what it tells us is that there’s simply no way you can make good decisions and achieve your world-changing ambitions while running on empty.”

 

“To cite just one study, after 17-19 hours without sleep, we begin to experience levels of cognitive impairment equivalent to a blood alcohol level of 0.05%, just under the threshold for being legally drunk. No business leader would hire people who came to work drunk, so don’t model that behavior for your employees.”

The missive drew a Twitter response from Musk. “You think this is an option. It is not.” Huffington, founder of wellness website Thrive Global, where she published the open letter, refuses to accept that. In fact, she sees a lesson here for us all. “This is not about sleep, or about slowing down, or about asking Elon to chill out under a mango tree,” she said in a statement shared with CNN. “It’s about how we can unlock and sustain our peak performance, and see solutions and opportunities where others can’t.”

 

The running debate highlights some key points. “Firstly, people who are burnt out are the last to see it and it takes others, family members or friends to point it out to them,” says Lewis Garrad, Business Lead for Employee Experience Research at global consulting firm, Mercer. “Secondly, there’s the question of whether it’s an employer’s responsibility or that of the individual.”

Huffington would argue that burning out is not the price of success. “As all the recent scientific findings show, the opposite is true,” she said, noting people “perform better” when they “take time to refuel and recharge.”

 

Picking up the pieces

According to Jenn Fenwick, Founder of Rebel Road Executive Coaching, who frequently coaches stressed-out executives, it comes down to sustainability. “There’s a balance between the duty of care of the employer to support the employee and the responsibility of the individual to manage their own health and wellbeing. Frankly, in my experience, leaders are frequently left out at sea, especially during extremely stress-inducing times like transitioning into more senior positions. The employer is often not forthcoming in terms of providing onboarding support, and employees are left floundering – not sleeping, experiencing severe anxiety due to lack of internal support, lack of clarity around the role, and this ‘all-or-nothing’ approach where the employee forsakes all health and wellbeing activities in order to prove to their employers that they made the right decision in hiring them.”

It’s a considerable cost to the employer. “Many often leave because of burnout. In this one case, it was going to lead to losses of £200,000 if this particular senior Medical leader resigned – not to mention the impact on team morale if she left. As a coach, I’ve had a lot of experience of rescuing situations where leaders are on the point of leaving due to overwhelm. Employers need to provide better support particularly at flashpoints like transitioning to new roles, or during mergers and takeovers where people can suffer due to lack of communication from the top and insecurity surrounding the continuity of their role. But employees also need to learn how to self-care,” says Fenwick.

 

A tailored approach

While well-managed wellness programs are beneficial in redressing the onset of workplace stress and burnout, they often target the wrong cohort. “You’ll often see the highest uptake in these wellness programs are among those that least need them – the people who are typically health-conscious anyway and are into health and fitness. The likely burnout candidates may not take up these initiatives and this is where we need to have a more personalized approach to the issue of burnout. Are there other stressors at play within the overall culture? Are there other stressors at play, which are impacting on employees’ stress levels, like financial concerns? Tailored programs – for example, financial security programs – may be appropriate in this instance so it’s vital to acknowledge that one-size does not fit all. We need a very tailored approach to the issue,” says Garrad.

Christina Maslach, creator of the Maslach Burnout Inventory and author of The Truth About Burnout, has identified six “mismatches” that make a person more likely to burn out – and only one of these factors is too much work. “It is a common belief that there is just one dimension to job stress, work overload. Indeed, overload is often considered to be a synonym for stress. But in our burnout model, overload is only one of six mismatches in the workplace. And it’s not always the most critical, especially it things are going well in some of the other areas.” (2) Maslach cites five other triggers than can lead to burnout, including lack of control, insufficient reward, lack of community, absence of fairness, and conflict in values.

 

Mental health strain

The health and safety precautions applied to an employee’s physical health apply equally to their mental health. Jeffrey Pfeffer is professor of organizational behavior at Stanford University Graduate School of Business. In his most recent book, Dying for a Paycheck, he writes:

“The workplace profoundly affects human health and mortality, and too many workplaces are harmful to people’s health – people are literally dying for a paycheck.”

Pfeffer cites extensive examples from across the globe of the negative effects toxic work practices have had on people – to the point, in some cases, of pushing them to suicide. Other examples given include serious health effects such as collapsing from fatigue, developing a dependency on anti-depressants, or substance abuse. (3)

“For men, prolonged exposure to work-related stress has been linked to an increased likelihood of lung, colon, rectal, and stomach cancer and non-Hodgkin lymphoma. Moreover, we are increasingly understanding the mechanisms linking stress to disease.”

Pfeffer namechecks a few positive cases throughout the book. He cites companies such as Southwest Airlines, Toyota, and SAS Institute for their resistance to layoffs, and Patagonia and Aetna for progressive policies regarding healthcare insurance and work-life balance.

 

His response to corporate wellness programs as a salve to reduce burnout is that they are largely ineffectual, mainly because they focus on the wrong things. “We know, from extensive research summarized in Dying for a Paycheck that individual behaviors such as overeating, smoking, excessive alcohol consumption, and drug abuse are related to the stress, including workplace-induced stress, that individuals experience. So instead of trying to get people to engage in healthier individual behaviors, workplace wellbeing initiatives would be more effective if they focused on preventing the stress-inducing aspects of work environments that cause the unhealthy individual behaviors in the first place. Simply put, companies need to build cultures of health – and that begins by creating work environments that help people thrive both physically and psychologically. Not on trying to remediate the harm that toxic workplaces inflict through limited-intervention ‘programs’.” (4)

The solution is simply the flip side of his data: it’s providing more job control, reducing work-family conflict, being fair to employees and providing social support at work. It’s also avoiding lay-offs; Pfeffer quotes evidence that while layoffs “increase fear and stress, they do not lead to higher profits, productivity, stock price, innovation or quality.”

 

Creating safe, supportive human environments

For Danie du Plessis, it’s time to bring workplace stress out into the open. The Executive Vice President of Medical Affairs at Kyowa Kirin, du Plessis has a strong background in coaching and mentoring, with a heavy emphasis on employee health and wellbeing.

He explains: “In the UK, there has recently been a huge emphasis on mental well-being in the workplace, including support from the House of Windsor. This is great and can unfortunately also have a downside of not seeing the bigger picture and how many factors influence an individual’s resilience. Both individuals and employers have responsibilities. Employees need to take time to understand their own purpose in life, in the first instance, and how that relates to the work they are doing and their career aspirations (a great coaching/mentoring conversation). They need to be aware how they manage problems, emotions and their own physical well-being, and be prepared to change their own behavior if the status quo does not serve them well. This will increase their resilience and fulfillment. It is quite amazing how often resilience becomes a key conversation in coaching and mentoring. Sadly, many people are scared to be open at work and discuss this with their managers.”

According to du Plessis, employers need to create a safe space for employees to be themselves at work and be vocal about the fact that it is OK to be human. “Offering access to different programs that inform the journey of growth towards managed resilience is the ideal – either in-house or through third parties. I believe this should be the norm for all companies and organizations, while one should appreciate that different size companies will have different offerings. What is in it for the company? Resilient employees perform better and retain their aligned passion for the purpose of the company, which is why they joined in the first place. It becomes easier to really be present (which links again with mindfulness and mental well-being). This takes the term ‘presenteeism’, coined by Professor Cary Cooper, a psychologist specializing in organizational management at Manchester University in the UK one step further. And by default, absenteeism decreases which reduces workload on co-workers. Having a reputation of caring about employees can in no perceivable way harm any organization.”

 

Psychologically safe versus fearing the next round of layoffs

Prioritizing your employees over the short-term goals of your company can be the best strategy in the long run, according to Simon Sinek, author of Leaders Eat Last.

“The irony is when our top priority is to take care of our people, our people will take care of the numbers. People-focused companies outperform numbers-focused companies over the long-term dramatically.”

When organizations take care of their employees to such an extent, they make them feel safe. And according to Simon Sinek, the natural response to feeling safe is to offer trust and cooperation.

“Charlie Kim, who is the CEO of a company called Next Jump, a tech company in New York City, makes the point that if you had hard times in your family, would you ever consider laying off one of your children? We would never do it. Then why do we consider laying off people within our organizations? Charlie implemented a policy of lifetime employment. If you get a job at Next Jump, you cannot get fired for performance issues. In fact, if you have issues, they will coach you and they will give you support, just like you would if one of your children came home with a C from school.”

 

Ben Whitter, Founder and CEO of World Employee Experience Institute, suggests that both employees and employers have a role in creating the conditions for burnout to occur. “The thing about some companies, and the tenure figures from Silicon Valley bear this one out, is that they can create a fantastic workplace experience, but in return, they expect EVERYTHING an employee’s got to give, which is very intense and challenging to sustain over the long-term. The increasing numbers of people opting to work freelance within the gig economy is an indicator that people want to take back control of their life and work to hours that suit them. Companies are responding with various flexible working arrangements, and also the four-day week is growing in popularity, to deliver stronger productivity that can be sustained by the employer and employees. Work and life are converging at a rate we haven’t seen before, and everyone needs to get ready for radically new ways of working within the economy.

Employees are no longer resources to be exploited and commanded, they are now allies in a shared mission to co-create experiences that deliver better results. For Whitter, the future of work and HR is human and this human touch is where we need to get to. “A quote I love from Trudy Purchase (an Employee Experience Award Winning Learning & Development Manager) is: ‘“Don’t judge the quality of an employer by how they treat you on your best day. Instead, judge them by how they treat you on your worst day.’ And in return for that humanity you get a whole lot more: discretionary effort, loyalty, creativity, innovation, because if you treat me like this, I’ll give you everything I have. It certainly beats free snacks or fußball tables.”

 

Read Huffington’s entire letter HERE

References:

1: Why Companies Should Care About Employee Health and Wellness,

https://spectrumwellness.ie/resources/companies-care-employee-health-and-wellness/.

2. “The Six Causes of Professional Burnout and How to Avoid Them,” https://www.forbes.com/sites/johnrampton/2015/05/13/the-6-causes-of-professional-burnout-and-how-to-avoid-them/#7953ffcf1dde.

3. “One the brink: Burnout in the workplace,” https://www.irishexaminer.com/breakingnews/lifestyle/healthandlife/on-the-brink-burnout-in-the-workplace-857855.html.

4. Jeffrey Pfeffer on his new book Dying for a Paycheck, https://www.personalbrandingblog.com/jeffrey-pfeffer-new-book-dying-

paycheck/.

 

Professional Education, Capabilities and Identity in Medical Affairs

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Objectives:

MA has seen an exponential growth over the last decade as it value and place within the pharmaceutical industry is being realised. The evolution of MA from a support function to strategic partner has changed the direction of MA and also required an evolution of skill sets for the roles which underpin MA.

As a profession, there is still a void with a globally recognised advanced scientific qualification, capability frameworks across the main 3 role types and accreditation.

This collaborative webinar aims to discuss available postgraduate courses and insights from alumni into how their qualification helped advance their understanding of pharmaceutical medicine and their career.

  • • Understand what educational opportunities are open to MA professionals and also those aspiring to enter the profession
  • • Comprehend the content of programmes and how it relates to roles
  • • Discuss the future of MA in terms of universal recognition of a base qualification which can then be regionally adapted

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Podcast: Transitioning between Pharma and MedTech…And Vice Versa

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Click a thumbnail below to listen to the episode. 

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Mars.Venus .ELEVATE

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

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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.

 

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Driving the Next Wave of Digital Innovation in Healthcare for Medical Affairs

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Fireside Chat with Mary Alice Dwyer and Shaji Kalathil

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Healthcare has the potential to be radically transformed by digital technology and we believe that the most competitive pharmaceutical companies in the coming decade will leverage data and digital technologies to drive differentiating services and will be in the forefront of pushing the boundaries of digital innovation in healthcare. These leaders will generate and analyze vast volumes of research and real-world data to discover transformational medicines and will excel at communicating scientific evidence to stakeholders. They will help physicians navigate in a far more sophisticated and complex healthcare ecosystem and help them make difficult decisions that are the right decisions for patients. Medical Affairs teams can become a strategic force for pharmaceutical companies in this journey with their deep scientific knowledge, disease understanding, and the healthcare technology advancements that aid in the betterment of the entire medical industry.

Mary Alice Dwyer, MAPS Executive Leadership Committee member and Lead of the Digital Focus Area Working Group, Principal Consultant, Medical Innovation and Insights and former Vice President, Global Medical Excellence and Patient Centricity, Global Medical Affairs, AstraZeneca and Shaji Kalathil, Executive Director, Global Head of IT for Medical Affairs, Bristol-Myers Squibb discuss how advancements in transformative technologies are driving a new wave of digital innovation opportunities for healthcare.

“There is a tremendous opportunity for Medical Affairs to be leaders in advancing digital innovation and truly change how they engage Health Care Providers and patients. Through the strategic implementation of digital innovation, Medical Affairs can embrace technology that will transform not only what we deliver, but how we engage with HCPs and patients.  Exploring technologies like AI and ML and other innovative tools will further define the impact Medical Affairs can have.” –Mary Alice Dwyer

 

“These are exciting times in the pharmaceutical industry with fast- paced digital innovation and the potential to transform the Medical Affairs customer engagement model and data generation capabilities with disruptive technologies, artificial intelligence and advanced analytics. I also envision significant advancements in “beyond the product” digital solutions and services for complex therapies in the future that will improve patient outcomes and Medical Affairs becoming the custodian of these services.” –Shaji Kalathil

 

How do you foresee the evolution of the Medical Affairs customer engagement model in the future and the impact of digital innovation in healthcare?

Mary Alice:
Medical Affairs leaders continue to expand their role in “customer” engagement, whether the customer is the health care provider (HCP) or the patient.  While Medical Affairs has always been responsible for Thought Leader or KOL engagement, it is often viewed from the perspective of what information Medical Affairs could provide to the HCP.  As teams begin to explore digital solutions and new ways of engaging, it opens the opportunity to think from the “customer” point of view.  This new perspective enables Medical Affairs to approach information exchange from a “customer experience perspective”.  Digital Innovation in healthcare enables Medical to engage in scientific exchange in new and unique ways and deliver what the “customer” wants, when and how they’d like to receive it.  Ultimately, Medical Affairs needs to anticipate what the HCP or patient needs, so their experience is optimized. We need to plan for a truly personalized approach to our scientific engagement.

The expectation to deliver information in new and innovative ways has been set by the customer and is a high bar for Medical Affairs to achieve.  Our customers (HCPs and patients) experience seamless information access in their daily lives and expect that same experience in their professional and healthcare interactions.  People expect to search for answers when it is convenient for them, they like multiple sources of information, and they want answers quickly.  A key challenge for Medical Affairs is to be easily accessible and be the trusted source of information.

Shaji:
I am really thrilled about the possibilities for transforming the Medical Affairs customer engagement model with digital technologies. We now have an influx of innovations in the pharma industry, especially in Oncology, making incredible strides toward better and safer treatments for patients. Science is delivering a large amount of knowledge that will help us understand diseases that have until now been beyond our reach. Today, technology is giving us tools to capture vast amounts of patient data and genetic information, which will fuel an unprecedented expansion of biomedical research. This will continue to shift pharmaceutical innovation into higher gear especially with the foray into new scientific innovations such as cell therapy. Medical Affairs is in a prime position to advance the understanding of these highly complex therapies for the healthcare community and support patient centric outcomes. The power of digital technologies, big data and artificial intelligence can be strong drivers to achieve this goal and we need to seize this opportunity.

There are three key areas with great opportunities to apply healthcare technology advancements and transform the Medical Affairs customer engagement model.

1.Delivering exceptional customer experience focused on science through a deeper understanding of medical insights, physician journey, preferences and needs from all digital touchpoints, AI-powered engine to predict best engagement plans & actions, real time digital interaction tools and beyond the product digital services & solutions.

2.Seamless connection of our digital medical information assets with external digital channels for healthcare professionals (EMR solutions, Patient Care Management Solutions, Physician Digital Networks etc.) to communicate highly scientific medical information at the point of care in real time.

3.Use of artificial intelligence models and machine learning technologies to enrich and expand the utility of real world evidence, and generate faster, more precise insights.

 

There seems to be great interest on the topic of customer insights generation by Medical Affairs to shape strategy and impactful customer engagement. Can you share your perspectives?

Mary Alice:
Medical Affairs has a tremendous opportunity to impact how our organizations understand the healthcare landscape as well as the HCP and the patient’s perspective. We are in a unique position to engage decision makers, understand the clinical healthcare environment and patient experience. Digital innovation in healthcare would further our ability to not only capture these insights, but to also analyze and identify trends. The insights that Medical Affairs team gathers can improve the understanding of how the medicine is being used and the potential need for further data. These insights can improve clinical programs and launches. Technologies such as machine learning and artificial intelligence, will enable us to gather, analyze and interpret these insights. The growing importance of Medical Affair’s role with Real World Data further cements the need for digital tools to manage this amount of data. For Medical Affairs to shape strategy and impact customer engagement we must capture, analyze and incorporate robust insights. Digital tools will be critical to enable this capability.

 

How do you think digital innovation can advance the medical insights capabilities?

Shaji:
Digital innovation in healthcare can play an impactful role in transforming the medical insights capability in two areas – the way our customer facing teams in Medical Affairs collect medical insights as well as the approach to analyze the unstructured insights to understand emerging trends on unmet medical needs, and clinical practice. The first part is pure technology automation with the opportunity to create an exceptional digital user experience for the medical insights collection and collaboration processes. The second part of analyzing medical insights for uncovering trends is a classic use case to leverage artificial intelligence capabilities – We can use Natural Language Processing (NLP) to synthesize these insights and understand emerging trends that will speed up the analysis and help drive timely, proactive actions, and impact strategy. The fast paced innovation in the NLP space will help us position this approach to add more business value in the future.

Together these solutions can create a powerful “digital medical insights engine” that will influence Medical Affairs customer engagement strategy and strategic decisions in Commercial and Clinical Development.

 

If you look towards the future (5-10 years) what areas of Medical Affairs would you see as completely transformed by the digital innovation of healthcare and how will you describe the business impact of this transformation?

Mary Alice:
I believe all parts of Medical Affairs have the opportunity to transform, both by improving operational efficiency and through delivering a more tailored “customer-focused” engagement.  I believe these innovations will improve our communications and engagements.  One of the most immediate opportunities is in Medical Information and exploring a move to on-demand information provision.  Also, the area of promotional material review is an area that is ready for utilization of artificial intelligence and machine learning.

If I look 5 to 10 years into the future, Medical Affairs will have made great progress, including getting the right infrastructure in place.  Important areas such as having a customer master, the ability to tag data and information and having an external web presence will be customary.  We’ll be exploring virtual reality and augmented reality in education and training.  We’ll be perfecting opportunities in areas like digital publications.  We will be increasing the automation of routine functions that enable the highly trained Medical Affairs staff to focus on scientific opportunity. Medical Affairs will be utilizing digital to create websites that create unique opportunities to engage HCPs and patients.  Medical Affairs will be a trusted source of information, providing education and optimizing knowledge transfer.

 

What are the most promising innovations you are seeing in the technology landscape that can transform Medical Affairs?

Shaji:
There is no better time than now to embrace disruptive digital technologies in the pharma industry. I am most excited about three technology trends with the potential to transform Medical Affairs digital capabilities and help improve patient outcomes.

1. Advanced digital customer engagement technologies that can deliver personalized experiences and innovative services for the healthcare professionals based on their needs and preferences in real time will have a profound impact on accelerating their understanding of safe and appropriate use of our medicines and the underlying science.

2. The pace of advancements in AI and specifically natural language processing/understanding (NLP/NLU) will dramatically increase. We are going to see some major breakthrough innovations in the NLP/NLU space in the coming years that will surprise everyone and mimic the advancements in image recognition/deep learning, powering the driverless car revolution. This will also have positive implications on how we use the voice technologies to enhance personalized services for customers. We will transition to an “AI-fueled” customer engagement model in Medical Affairs with more matured customer intelligence datasets that will leverage next generation digital tools. This will help the Medical Affairs colleagues in engaging with their customers more effectively by better understanding their needs and by providing access to the most relevant scientific data at the right time.

3. Patient data analytics will become key to clinical decision support, quality measure performance, improved patient care and demonstrating value. We will need to position scientific exchange with the ability to combine, analyze, and interpret disparate data sets to support the interactions with stakeholders and ultimately to improve patient outcomes. This will involve use of real-world evidence, electronic medical records, curated sets of aggregated data on various disease types and novel sources of data, such as genomics in combination with innovative ways of mining and interpreting that data.

 

There is a lot of buzz about the possibilities with artificial intelligence in pharma. How do you envision the digital innovation of healthcare impacting Medical Affairs with advancements in artificial intelligence?

Mary Alice:
Medical Affairs is consistently being expected to work with growing amounts of data, whether this data comes from insights, Real World Data, or working with the “data lake”. Artificial Intelligence is critical for analyzing large data sets and it will be important for Medical Affairs to have the capability to utilize these tools.  I believe these technologies will transform how we understand the clinical environment and decision making, how we deliver information, and engage HCPs, Payers and Patients.  These technologies will enable us to improve our ability to deliver a more tailored approach to everyone we interact with because we are basing those interactions on evidence.

Shaji:
Artificial Intelligence has great potential to drive up productivity and enhance several core aspects of the pharma business from disease diagnosis and drug discovery to more effective scientific exchange with healthcare professionals. Specifically there are opportunities in Medical Affairs to leverage natural language processing and machine learning AI capabilities for analyzing trends from medical insights, generating insights for precision treatment & improved patient outcomes with real world evidence, engaging with the healthcare professionals using voice technologies, and helping the customer facing medical teams to present the most value-added scientific information based on customer needs and preferences. Advancements in machine learning and high quality customer data for Medical Affairs can lead us to “Scientific Engagement Advisor” digital solutions akin to the ”Next Best Action” concept in Financial Services and “Recommendation Engines” concept in Retail/Streaming Media. This will help predict effective customer engagement strategies to empower the MSLs (medical scientific liaisons) based on previous engagement experiences, medical insights and all customer data points. The importance of having good quality data to drive your AI solutions should not be underestimated, especially given the fact that the customer data for Medical Affairs is largely in unstructured format. I am very optimistic about these uses cases for Medical Affairs that should redefine positive customer experience and ultimately help the patients.

We should be mindful about the tendency to blindly chase after shiny technology objects without really connecting them to real business problems. Often times this is highly visible in the artificial intelligence space with exuberant claims on possibilities and the result is a major gap between visionary/lofty discussions on on the digital innovation of healthcare and actual delivery of digital solutions for customers and patients on the frontlines. We need to be very cautious about falling into this “innovation bubble trap” and rather should focus on driving impactful ideas to reality with a fail fast approach.

 

We are seeing an increasing number of technology innovators focusing on healthcare. How do you foresee this external innovation fueling Medical Affairs in driving transformative digital capabilities?

Shaji:
There are considerable opportunities to build more effective partnerships with pure play technology companies that will address complex problems in healthcare. We need to think in terms of bringing each other’s strengths to the table and co-creating digital solutions. Pharma has a unique understanding of the challenges physicians and patients are facing and can help guide these partners. At the same time these digital technology partners can offer new technology capabilities that will help us reimagine the type of solutions we can deliver to our customers and patients. Digital therapeutics is an area where we are seeing success, and there are advancements in improving diagnoses, adherence, disease awareness, and self-management of conditions. Creating strong, co-development partnerships with core technology companies and healthcare technology startups does not happen in a flash. It is important to define a common value proposition with these type of partnerships and we need to look through the lens of co-developing solutions, not just funding startups. These mutually beneficial partnerships can drive a culture of innovation in larger pharma organizations as well.

We also need to closely watch and adapt digital innovations from other industries with similar business capabilities such as

  • Retail industry for online & in-store digital customer experience
  • Hospitality industry for enhanced service automation tailored on individual preferences
  • Financial services for personalized wealth management & virtual customer interactions
  • Aerospace industry for operational excellence in predictive maintenance & fuel monitoring through big data analytics

 

What are the most important factors leaders like you should take into consideration for success in driving digital innovation of healthcare for Medical affairs?

Mary Alice:
To ensure success in driving the digital innovation of healthcare, many factors need to be in place.  Leaders need to be ready to build the right capabilities and this might involve changes in structure.  These new capabilities can be built by bringing in external resources, working with internal resources or training current staff.  One critical question for the future will be how Medical Affairs will build the expertise to incorporate digital innovation in how we do our daily jobs.  I don’t think we can go this alone.  We’ll need to partner across the enterprise to leverage unique expertise (eg IT, data analytics, etc).  Many Medical Affairs teams are bringing in non-traditional Medical Affairs capabilities by hiring employees with background in areas such as data science.  Roles with this expertise bring a unique skill and by embedding these roles in the Med Affairs team and encouraging partnerships an innovative environment is created.  Many Medical Affairs teams are also partnering with their internal data and analytics team. This partnership is uncovering new opportunities, especially as companies establish huge sources of data across the enterprise.

A critical area that is often overlooked is the need to free up time for the Medical Affairs leaders and their teams to explore how this new innovation will change how they deliver their accountabilities. Digital innovation in healthcare is a transformational change and how it impacts the team and their work needs to be considered.  Another area that requires the investment of time is considering how the team will engage senior leaders to get traction and funding on their projects.  These are important aspects that must be considered if Medical Affairs is to be successful in driving digital innovation.

Shaji:
The most important focus with any digital innovation journey should be on driving differentiation and competitive advantage. We need to think beyond the “easy to chase digital innovation concepts” and elevate the innovation thinking process to truly transformative ideas that will address our biggest business problems and significantly improve customer experience. Essentially, we should dial up the emphasis on transformational innovation. In order to accomplish this, the leaders should create an entrepreneurial environment for ideation and development of these ideas. This will require a deeper dive into the core business value drivers for Medical Affairs with the right talent to understand the innovative technologies and an “artistic approach” to imagining the possibilities, often connecting the dots between multiple business value drivers and the disruptive potential of the latest technologies. A deep-rooted culture based incentive system (leaders encouraging to take big leaps forward and providing sponsorship for experimentation with cover for expected failures) is also necessary to drive this shift.

Driving digital transformation in Medical Affairs also requires a broader enterprise mindset compared to other functions. Since Medical Affairs is very closely connected to R&D and Commercial, it is important to visualize the concepts of digital innovation in healthcare through an enterprise lens and have an “outside in” perspective (such as customer experience alignment with touchpoints beyond Medical Affairs) for solutions targeted for customers and patients.

Finally, we will need to educate the executive leadership team on how technology is impacting their business, engage them in imagining the possibilities, and make them strong digital advocates by bringing them along the innovation journey.

 

 

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