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Managing Your Career – Part 3: Five Modern Medical Affairs Competencies

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Five Modern Medical Affairs Competencies

Dr. Qasim Ahmad, Corporate Officer, Head of Medical Affairs, Japan, Novartis

 

Since joining the pharmaceutical industry (PI) 2 decades ago, I have been lucky to have lived through and experience the exponential growth of medical affairs function, not only in size and ever expanding responsibilities, but also the importance and value it brings to the industry. There are several internal and external factors, contributing in the evolution of medical affairs from a mere support function to becoming a core pillar, and an equal partner with drug development and commercial functions with the PI.

In recent years, we have seen significant and unprecedented advances in biotechnology, delivering novel treatments and data sets, faster than ever before. There is an information overload, which calls for smart and innovative ways to design, analyse, disseminate and communicate the value of evidence, to the right end user (the customers), at the right place and the right time.

Concurrently, health systems across the world are becoming over-burdened, facing considerable sustainability challenges, due financial constraints, ageing, increasing population, changing disease patterns, persisting as well as new communicable diseases (COVID-19) and cost burden of chronic non-communicable diseases, including cancers.

You must also develop command on evolving health care environment and be equipped to meet the challenges associated with growing drug approval complexities and health technology assessment criteria for access. Develop unique competencies and transformative operating models to address these requirements, build capabilities that are ideally suited for medical affairs organization to generate data beyond traditional registration trial safety and efficacy packages, to facilitate evidenced based decisions making based on patient centric, clinically meaningful, health outcomes, access and quality of life real world data (RWD) data sets.

As you think of building your career in medical affairs, keep the above opportunities and challenges in consideration, the following 5 core medical affairs competencies will help nurturing your talent as patient and customer centric medical champions, ready now for future.

  1. Enterprise Perspective
  2. Functional Excellence
  3. Health System Thinking
  4. External Facing Organization vs Internal focused
  5. Effective Leadership & Governance

 

 

1. Enterprise Perspective

Medical Affairs has evolved to be one of the most strategically important and valued functions in a pharmaceutical industry. As successful medical affairs professionals, you need to build the skills and scientific acumen like that of a clinical development expert, while demonstrating the strategic intellect and real life customer oriented mind-set of a commercial leader. You will have to champion cross functional navigation, show enterprise vision, logical and critical thinking, develop broad and long range strategic direction throughout product life cycle and build bridges between unlimited internal touch points as well as external stakeholder.

 

2. Functional Excellence

In order to demonstrate value, your medical affairs competencies should be geared to exceed internal and external expectations, meeting the demands of above mentioned expanding responsibilities, while acquiring new skills and capabilities. You will need an all-rounder approach, adapting new technologies, digital tools, precision medicine approaches, and introduce novel engagement models. Thus continuously striving for medical and operational excellence, not only in designing and delivering high quality clinical trials based on meaning actionable insights, but also excellence in executing deep scientific exchange with medical experts, incorporating the voice of patient, payer and all stakeholders at launch, and across life cycle strategies.

 

 

3. Health System Thinking

In medical affairs, you are perfectly placed to lead, plan and deliver health care solutions and to shape the environment, playing a key role in health systems sustainability. You should build capabilities and competencies to assess health system needs and developing solutions, supporting public health initiatives; disease awareness & educational training programs; research collaborations in area not only limited to company core business (orphan diseases, rare indications, special populations); managed patient access programs and many other patient focused projects, partnering with health system players. You will require special skills for this mind-set shift, and thinking beyond the pill to building trust with the society. This competency is distinctive and vital for future role of medical affairs.

 

4. External Facing Organization

As part of modern medical affairs organization, you should have involvement and ownership across life cycle of assets, from early development to late stage planning. Either you are in field medical teams, medical advisors or MSLs (medical science liaison) role, you are the eyes and ears of the organization to external world. With external customer base expanding beyond prescribers and policy makers, you well have to learn rule of engagement and proficiency to work with providers, payers, private non-state health actors, patients and patient advocacy groups, as they are all taking central stage in health care decision making. This will be the game changers in reversing the traditional internal fixated industry approach to a strategic patient and customer focused, outward facing organization. Building this core competency by incorporating patient journey, stakeholder need assessment and changing health care limitations in your strategies, will enhance collaborations, speed of innovation, resource waste reduction and improved patient outcomes.

 

5. Effective Leadership

Modern medical affairs is not a support function, it is about leading from the front as equal partner with commercial, departing from prior passive back seat mind-set and demonstrate value to the organization through proactive leadership, vision and measurable impact. You will have to steer this transformation from current medical advisory role to leadership status, breaking unnecessary internal silos and taking ownership as well as accountability of business deliverable. Creating this new room within the organization will requires your commitment, change agility, interpersonal skills and inspiring leadership to take on completely new responsibilities or replacing those previously championed by other functions.

 

Conclusion

Traditional sales and commercial models are becoming obsolete, success of future pharmaceutical frameworks relies on vision, foresight and appropriate investment in building medical affairs (MA) talent, ready now for future. With ever changing external landscape, regulations and compliance requirements, the role of medical affairs will continue to grow as the key pillar, vital to achieve organizational objectives. By building these core competencies, you can demonstrate to your leadership, the value medical affairs brings, and its strategic far reaching business impact.

 

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Managing Your Career – Part 2: How To Maximise Your Chances of Success at Interviews

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How To Maximise Your Chances of Success at Interviews

By Alan McDougall, MD, VP, Head of Medical Affairs, Asia-Oceania Region, Astellas

 

Interviews are stressful but you can reduce your adrenaline levels through proper preparation. Medical Affairs has transformed in the last decade and there are a number of key competencies which are sought after and which you should attempt to demonstrate through each and every contact you have with both the recruiter and your prospective employers. Below is a not exhaustive list of the most desirable competencies and behaviours.

 

Communication

The ability to communicate clearly and effectively and through a variety of channels is essential for anyone working in medical affairs. Having a high level of knowledge but an inability to share it or teach it effectively is of little value. Communication also includes using appropriate body language, listening skills and the ability to provide feedback. Make sure every verbal or written contact you have with the company or the recruiter is carefully thought through and proof-read in the case of written contacts.

 

Passion and enthusiasm

Employers want to hire someone who demonstrates a passion to work at their company, sometimes described as being “hungry” for the role. Having the right attitude is often more important than knowledge, because attitude is very hard to train but knowledge can be learned. Carefully word your cover letter and individualise your CV for each job to stress key experiences or skills that are mentioned in the advertisement and job description (JD). Spend time browsing through the company’s corporate website and come armed with pre-prepared questions which are thoughtful and specific to the role and the company. If possible, ask about a recent company press release and the implications (if any) for the role for which you are applying.

 

Technical skills

Medical affairs positions require certain technical skills that are usually listed in the job advertisement or JD. You should already possess many of the skills the company is looking for, at least to some degree. You may not yet be an expert in all of them but there should be a solid foundation upon which you can build. Typically, at interview, these technical competencies will be assessed (presentation skills, therapeutic area knowledge etc.). Take note of the JD, advert and recruiter’s comments and use every contact opportunity to mention where your current technical skills fit the role being offered.

 

Work ethic

It should go without saying that employers expect you to be at work on time, do what you were hired to do, meet targets and deadlines and work to the best of your ability. Sadly, we have all worked with colleagues who do not always meet these basic requirements. Make sure you are early for interviews, meet all deadlines when replying to emails, phone messages etc. and do everything you can to give your prospective manager confidence in your own work ethic. You have only a few contact opportunities with your potential next company and so make sure each one says something positive about you and your personal standards.

 

Flexibility

More than ever before, employees need to react quickly to changing business conditions. Agile companies and agile teams are currently popular subjects in articles written by business thought leaders. Employers need employees who can quickly adapt to change. Come to interview with examples of how you demonstrated your own agility – perhaps covering another role on top of your own, taking on a project about which you had no little or no previous experience and delivering a successful outcome or dealing positively with an unpredictable environmental change.

 

Resilience

We all typically get challenging but (hopefully) achievable goals and deadlines. The key to successful delivery is often being able to work hard and to keep moving forward when you encounter the inevitable and frustrating obstacles that regularly happen in business. Come to interview with examples of how you overcame particularly difficult challenges and show that you did not give up but that you persevered and ultimately met your objectives.

 

Teamwork

Little in the pharmaceutical industry is achieved by a single individual. Roles in medical affairs are becoming more diverse and specialised and therefore there is an increasing need for reliance on your colleagues to get things done. The ability to get on and work collaboratively with others is therefore a key competency. Using real examples, show how you contributed to successful teamwork under challenging circumstances and how you “did not give up”.

 

Life-long learner

As product portfolios and market environments change, there is a need to seek out new information, challenge your beliefs and explore new ways of doing things. Long-held “facts” can change when new contradictory evidence emerges. People who are naturally curious with an interest in learning combined with a willingness to share this with others, make great co-workers. At interview, explain what new skills or knowledge you have learned, how you applied this at work and describe the impact that it made.

 

Problem-solving skills

Managers look for people who are motivated to take on business challenges, ideally with minimal direction. Most of us prefer our employees to “come to us with solutions not problems”. Employees should see when something needs to be done and react accordingly. Come to interview with examples of how you observed an issue at work, took ownership of it and solved it. This can be even more impactful if it wasn’t in your job description in the first place.

 

Loyalty

Employers want people to stay with them for many years due to their financial investment with the recruitment company and the time spent on interviews and on your on-boarding process. Multiple job moves in a relatively short time period with different companies is usually an alarm bell and indicates a risk that you will not stay long if you are even offered the job. If you unfortunately have had several short-term moves recently, make sure that you come to interview with a clear explanation as to why and what you learned. Try hard not to criticise your current or previous companies or managers as this can come across quite negatively, even if you feel you have every right to do so. Employers always prefer someone running towards the role on offer than someone running away from their current job as the former is a positive choice whereas the latter can be simply escaping to “any port in a storm”.

 

Conclusion

It is a truism to say that you only have one chance to make a good first impression and so at interview be well prepared and make sure you have done your homework well in advance. Tell the employer why you really want this job and make sure your passion and enthusiasm come to the forefront. Show your agility, resilience and ability to learn, which are all highly valued competencies by employers. Finally, do remember that all contacts with the employer and recruiter, no matter how trivial, are likely to be judged so make them count!

 

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Managing Your Career – Part 1: A crash course on how to manage your career in Medical Affairs

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Managing your career – Part 1: A crash course on how to manage your career in Medical Affairs

By Cezary Statuch, MD, VP, Medical, International Markets, Biogen

Like many things in life, when managing your career timing is everything, and being in the right place at the right time is important. Knowing whether it is the right time for you to move on is not always easy. The pharma and biotech industries are an attractive place to pursue your professional dreams, and some markets are in great demand for medical affairs talent–so the phone rings more often than ever with calls from headhunters. Unfortunately, at times of high demand for talent the recruiters are less likely concerned if you have completed your career cycle, and if your skill set fits what they are after you will have to deal with serious temptations. Here are a few tips on how to manage your career planning and how to get ready for your next job.

  • Look back and do a quick assessment of your career to date. Understanding your career trajectory, what you have accomplished and where you want to go will significantly help with the challenge. But most importantly understanding your limitations is critical. Only when you know them will you be able to close the gaps. Ask yourself these questions: Have you have been in your current role long enough? Have you completed a career cycle? Have you fully learned the role? “Job jumpers” or “non-stickers” as I call them are very easy to spot. If you happen to have a very short stint in the role, be prepared to provide a compelling explanation why.

 

  • Understanding what the industry can offer is a common challenge for candidates, especially the younger ones. The knowledge of basics of drug development and the commercialization process is crucial as it will help in understanding what opportunities exist in your country/territory and how to navigate them. The industry has evolved dramatically over the past decade and there are many roles now which never existed previously. There is a wealth of resources offering insights into how pharma companies are structured. Many companies offer training in the drug-development process as part of their curricula for employees. If your company does not, look online. Talking to more senior colleagues is also a good source of acquiring that knowledge.

 

  • Compete for the right job, one which matches your skill set. Understand your strengths and create a competitive advantage. Create a simple checklist of attributes/skills which may differentiate you from other candidates competing for this position and sell yourself well.

 

  • Do not be a title junkie! Titles are important as they help to position us in the industry and make us proud of what we have achieved. We all like attractive titles, particularly those which reflect our seniority, but beware of inflated titles which are easy to spot. Do not take the job simply because it offers a higher grade or a more impressive title, as this could easily put your career on the wrong track. Reversing this could take a long time.

 

  • Having a great boss is a big draw, but don’t choose the job purely because of the manager. Follow the job content and opportunity to learn, not the person. Your boss will always remain part of your professional circle and you will always be able to rely on his/her career advice, even if you stop working together.

 

  • Having the right work-life balance is critical for your success, so ask yourself how moving to your next career step will affect your personal life and if you are ready for it. Frequent travel, need to relocate, necessity to work out of hours—these things can seriously impact your job satisfaction.

 

  • Creating the right image is very important and is a process which takes time. You can start with creating a high-quality LinkedIn profile. LinkedIn has become a powerful tool. Read profiles of those whom you respect and admire. Use a professional, high-quality photo and ensure the use of proper English. When you apply, provide a quality CV adapted to showcase your skills for the role for which you are applying.

 

  • Always respond to recruiters but be very transparent about your true intensions. Do not interview if you are not seriously considering the opportunity. Telling recruiters that you are not ready to change the job yet will speak highly of you, proving you to be loyal to your organization and mature about your career goals. They will remember that and will keep you on their radar screen.

 

  • Get help from those around you. Pay attention to relationships and build your social capital. The pool of professionals in the industry is defined, and so is the number of companies. The proverbial “small world” applies to our industry as well, so take care of your reputation, not only within your own company, but most importantly within the industry. Become visible within your organization and outside of it. Build your own pool of advisors, coaches and mentors. They can be peers, but don’t have to come from the same department or the same company.

 

  • Make your company aware of your aspirations; otherwise your manager may assume that you are not interested and therefore not consider you for the job you want. Apply for the jobs which may be a stretch for you even if you think that the probability of getting them is low. It will send a strong message to your manager as to what you aspire to, and will help you and your manager to understand what you need to learn to land the job the next time. Treat every interview as a lesson and always ask for feedback. Unfortunately, providing high-quality, timely feedback for those candidates who failed to get the job is still not a common practice in the industry. If feedback was not provided to you, do not be afraid to reach out to the hiring manager or the recruiter to discuss the outcome of your interview. Constructive feedback is an invaluable source of direction for your future career steps and providing it is not always easy. You may need to be persistent and ask questions as to why the interview was not successful or why you were not chosen. Regardless how well you are supported in your career development, there is one principle which should always guide you: remember that ultimately, you own your career and no one else but you should drive your development.

 

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

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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.

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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/.

 

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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Purpose-driven culture: How to make an impact in a value-driven world

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Executive Vice President & CMO, UCB, Iris Loew-Friedrich discusses the importance of a purpose-driven culture to employee engagement

 

Caring for people – patients and colleagues – coupled with the science are the twin elements that form the foundation of Professor Doctor Iris Loew-Friedrich’s approach to her role. And this aligns neatly with the vision of her employer, global biopharma company UCB, and provides a platform for collaboration both within and outside the organization.

A physician by training, Professor Loew-Friedrich started her professional life at the Frankfurt University Medical School and has always tried to combine patient care with high-quality research. Today she is Executive Vice-President Development and Medical Practices and Chief Medical Officer at UCB, where she provides global strategic leadership across a range of areas.

“I still very much consider myself a physician, so patient care is really at the center of what drives me – and more generally it’s care for people: people living with diseases and also people in our company, in my organization and people in our industry are what motivates me very much.” This approach chimes with the way UCB articulates its vision: “Inspired by patients. Driven by science.” Professor Loew-Friedrich is confident that this “really sends out a message about who we want to be.”

 

Culture is a key driver

She explains: “I think culture is the key driver and so creating a culture that gives colleagues a sense of purpose and the opportunity to make a meaningful impact is important. At UCB, we have one central question that we ask all the time: how will what we do make a difference for patients living with severe diseases? It’s the value-creation topic that is at the center of all of our work.”

And, of course, this vision resonates especially within the Medical Affairs function.

“Our mission in Medical Affairs is to drive the continuous modernization and integration of data from multiple disciplines and sources. Then we need to translate them into actionable insights with scientific integrity, efficiency and transparency so that we optimize the patient and healthcare professional experience. That’s a mission behind which we can all align. We try to ensure that all colleagues in our Medical Affairs practice understand how each of them contributes to this mission and we combine this with forming a culture of high-performing teams.

 

“Everybody is focused on the same purpose of creating value for patients. On top of this, we try to ensure that we are an organization that cultivates learning, innovating and high performance and all of that integrated with opportunities for personal development, recognition, and rewards. It is the entire package that is required to attract the talent for the future and to maintain and develop that talent in our organization.”

Moreover, continuous learning is key to fostering agility and adaptability, according to Professor Loew-Friedrich. “As the environment keeps changing so quickly, the ability of an organization to be agile and to adapt is very important and so these are important traits that we’re looking for when we are hiring talent – a mindset to innovate, to grow, a mindset of continuous learning.”

 

How can the organization attract this type of talent? “We aim to create the sense of purpose, the sense of belonging, and key opportunities for personal development and growth. In line with our practice thinking, we are trying to establish communities of colleagues who either have the same role in the organization or who work in the same geography or who are engaged around the same patient population. So, our communities are aligned on common themes and we see that as a major driver of identification with the Medical Affairs organization and a source of inspiration and learning.”

 

Leadership

Leadership for Loew-Friedrich has always been about empowering people to have maximum impact in a team environment. “I consider myself very much as someone who creates opportunities and empowers people. I believe you cannot be a leader without being passionate about what you are doing. Of course, we need to be very objective in our decision-making.”

Asked about the key capabilities to be developed within Medical Affairs as we move towards value-based medicine, Professor Loew-Friedrich is clear: “From my perspective the biggest topic is probably around creating and mastering medical insights. The second area of focus is collaborating very broadly for evidence generation.

“In terms of generating and mastering medical insights, I think we have already plenty of data available but how do we then use the data to truly generate insights? For me, this means that it’s not about just generating outputs and results, but really going one step further and distilling meaningful insights, providing context and ultimately driving impact. “On the second topic – collaboration for evidence generation – I think we have plenty of opportunity to join forces with academia or other institutions outside of our industry to invest our joint resources into the acceleration of the advancement of medical science. If a medicine gets to a patient in its first indication, there is a vast opportunity in terms of further knowledge and insights being generated: how can we get to the best ideas and how can we turn them into a true win-win situation that will create value for patients? This is where I believe we can collaborate closely with academic institutes, patient advocacy groups and other stakeholders to really get to the best possible outcome.”

 

Professor Loew-Friedrich points out that collaboration will be enhanced by advanced technology. “What I am seeing for the future is that we need to launch artificial intelligence capabilities – so that we use the data to simulate scenarios that will very objectively inform the next steps and ultimately enhance patient care. One of the big topics around collaboration for evidence generation is building on the strengths of human intelligence and artificial intelligence and establishing seamless interaction between both.”

How can we measure our performance in this new world? “Performance management is a topic that we continuously need to evolve and that is not as easy as it sounds. We’re trying to move away from very simple, quantitative measures – number of scientific exchanges, number of publications, impact factors – to measuring the quality of our analytical skills and the insight generation. Getting to meaningful qualitative measures is not an easy task. And I understand it’s not only difficult for UCB, it’s a challenge for the entire industry.”

Finally, the new operating model elevates Medical Affairs from a supportive role into a strategic decision-maker and trusted scientific partner: how is this change manifesting itself within the organization? “We are moving towards an integrated model that provides the Medical team the right space to be a trusted scientific and strategic partner ‘eye-to-eye’. What we need to continue to enhance is leadership and business acumen of our medical colleagues. This is not only about scientific leadership and leadership in insight generation, it’s also leadership in the most classical sense of providing direction, engaging and inspiring colleagues – inside Medical Affairs and beyond. That’s a work in progress and a key competency that we continue to strengthen in the organization.”

 

Prof. Dr. Iris Loew- Friedrich: Career Path

 

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RWE & The Transformational Role of Digital Health

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The digital health revolution implies a clear understanding of strategy, using technology as an enabler to create better outcomes for patients and to power value creation across the healthcare ecosystem. As data specialists, Medical Affairs professionals will be at the forefront of this transformation.

 

The medical world is changing and changing fast. As multiple new technologies start to transform every aspect of the healthcare ecosystem and the lines between biosciences and data science fade, companies need medical leaders who not only understand the latest medical advances but also the potential and scope of data and digital, along with their implications – not least that this new paradigm requires strategists who are comfortable with organizational transformation and who can lead change. Dr Rajni Aneja is one such strategist: she specializes in the crossover between business and technology across a variety of health sectors.

“My training falls at the intersection of business and technology and I have worked across all different healthcare sectors from payer to a consumer digital company to pharma, as well as being involved in an advisory capacity for innovation and strategy in health for MIT and Harvard Innovation Lab, along with Oliver Wyman, and many other start-up companies.

“From an industry standpoint, I am interested in the role of digital facilitating consumer as well as HCP engagement strategies, or patient journeys through a variety of touch points leading to better clinical outcomes, better clinical interactions, better patient experiences, better healthcare provider experiences, as well as better delivery of healthcare.”

 

Technology as an enabler

This approach is all about strategically using digital as an enabler driven by data. “When we create a strategy around a digital experience, it’s not about the technology. I see the technology as an enabler: when you apply the right technology at the right point and have the right interventions designed – either for the provider or patients – that is when it actually is impactful or meaningful.”

Longer term, advances in bioscience and digital technology have the potential to add value to the system in multiple ways: for example, by transforming the R&D process to potentially make it shorter, more specific, and take out cost; by ensuring better health outcomes for patients, bringing forward new treatments more quickly, and generally improving the patient experience; and by providing opportunities for physicians through new options to advance patient care and offering new ways to engage and learn.

Start of the journey

We are only at the start of this journey today but Dr Aneja points to significant potential that already exists. “As a physician, when you see patients in clinics, you’re only seeing 15 to 20 patients in a day. But if you have technologies like telemedicine, where you are delivering consultations on videos, or you’re delivering care to remote areas, your impact and outreach becomes much wider and much more significant.

 

“I see telemedicine as one of the technologies to have gained a lot of momentum, not only for its potential in clinical trials but also for prevention and wellness visits, or even acute care visits. But what’s coming next? I think the future is where data is driving or enabling these technologies, and this is where artificial intelligence or machine learning comes into play. However, if the data is not good enough, anything that is going to come out of it is not going to be good enough: garbage in, garbage out. The importance of data as an asset is that you drive intelligent decision-making and that is only done through insights generated by the power of data that is collected from a variety of technology enablers.” As an example, she cites finding the right patient for the right clinical trial at the right time for the right medical condition, while delivering the right care, all of which can be powered and informed by the data.

Data requirement implies collaboration

Today, real-world evidence (RWE) and data – especially continuous real-time data – sits at the heart of where the healthcare ecosystem is headed, not least in the context of value-based health design and care delivery, where (especially in the US) the system is moving from volume to value, and there is more emphasis on better outcomes. This implies that data can be both shared and combined effectively, and also that RWE – including data directly from the consumer, say from wearables – can be integrated with historical data and combined with real-time analytics.

“There’s an evolving trend that we’re seeing: in the last two to three years pharmaceutical companies have started to work very closely with the payers. But the industry is becoming disrupted and I think all these stakeholders can learn from each other to say: ‘How am I going to be a leader in the game instead of a follower?’”

The trend within the healthcare sector is asking for more integration of data and collaboration between organizations – joining the dots – to generate insight from the payers as well as from pharma and from consumers. “This is a collaborative effort around value-based care and an outcome-based approach, which will lead to better patient care and better clinical trials. But there are many challenges remaining before this data utopia becomes reality, including a lack of agreement on definitions of what constitutes value. What is considered good-quality data, data privacy, data governance and data security and many others factors would play a vital role in shaping the thought process as we move along this transformation journey.”

 

HURDLES…

So, what are the hurdles? The regulatory environment is one, but regulators and government are increasingly aware of the need to advance. We have seen the introduction of the 21st Century Cures Act; as well as statement from FDA commissioner, Scott Gottlieb about the importance of digital health and real-world evidence, and there are efforts now around guidance from the governing bodies. Commercial sensitivity is another issue, but industry is increasingly acknowledging the need for collaboration – perhaps through neutral consortium – to harness the power of data and analytics. As an example, Dr Aneja cites the NEWDIGS project, through MIT’s Center of Biomedical Innovation, which brought together various pharmaceutical partners in a neutral, non-biased, cohesive setting. However, she acknowledges that “we’re taking baby steps and are in exploration mode with a desire for more collaborative models, and not yet ready for prime time yet.”

 

…AND BENEFITS

And what about the benefits? There is clearly substantial value in a system that encourages us to learn about the patient – not least, greater customization, personalization, and simplicity for the patient. This encompasses patient-reported outcomes, behavioral profiles, social, and other demographic data leading to consumer segmentation, which in turn can deliver on targeted interventions and interactions.

Dr Aneja elaborates: “I’ll give you an example. Rajni is a 40-year-old female who runs every day and is pretty healthy and motivated and doesn’t take any medicine, but is very interested in her well-being. Because of the combination of data from different sources, we can create a profile of what Rajni wants, what Rajni needs, how we engage her, how we motivate her and do that on a continuous long-term basis; and data can enable targeted, personalized interventions – interactions that are actually applicable to Rajni, not one-size-fits-all. Data can help you get to that level of granularity, but I always say that with a word of caution: we’re not there yet. But that doesn’t mean that we can’t get there; it’s just that we’re on our way to this kind of transformation.”

And this opens up a whole world of further possibilities: Rajni might be part of a cohort that you could segment in the context of preventative health and screening, and so on. So there’s an opportunity to gain a depth of insight into individual patients within a population. “Imagine if you could understand, in your population, who are my well people? Who are my sick people? Who are the people who are very, very motivated? Who are people that actually need a lot of nudging because they’re not motivated? With the years of data, you have the ability to be not only predictive but at some point can be prescriptive, especially for precision medicine.”

Beyond this, digital needs to make life simpler and more convenient for patients. Healthcare is already becoming more consumer-centric. “I think it’s already happening. You already have Uber Health; we have telemedicine solutions; we have remote monitoring; we have wearables and sensors. I think the trend that we see is consumers becoming more involved in taking responsibility for health; they’re becoming more informed. Consumers want to manage their health, want to see their healthcare data, and want to be equally responsible for decision-making.

 

THE FUTURE

What needs to happen going forward? “I think it’s an industry shift.” There is recognition that we need to accelerate this process, according to Dr Aneja. In conclusion, she sees a significant role for Medical Affairs within this new environment – as the conduit of the digital transformation. MA can help define the problems we are trying to solve, along with the data sets and technology that will enable a solution. “They are absolutely vital. You would not create an initiative in a silo; technology is an enabler. Ultimately the insights coming from MA about what problems we need to create an effective solution for will lead to better patient outcomes as well as better patient experience.”

 

 

“It actually allows you to apply the right interventions to the right patient at the right time, which is critical.”

Biography

Rajni Aneja is an MIT Connection Science Fellow, healthcare strategist, public speaker, and transformative change agent with expertise in population health management and digital health. She serves as an adviser to a variety of health and wellness organizations. Dr Aneja encompasses various vantage points as a clinician, executive, adviser, entrepreneur, speaker and technology advocate serving in senior leadership roles. These include Chief Medical Officer for WebMD health, EVP of Joslin and a strategic executive and transformation leader at Humana. Most recently she contributed to the building of a digital consumer strategy at Novartis. Dr Aneja received her MD from Research Medical Center in Kansas City and her MBA from the University of Massachusetts.

 

17 1

Medical Affairs: Future Custodians of Digital Health?

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Organizations should take a strategic approach to digital health solutions and also treat them with the same level of rigor applied to traditional therapies.

 

We are living in a data-driven digital world, and the pharmaceutical industry has not been immune to the multi-billion dollar promise that digital therapeutics holds. Within the industry, the consensus is that it is a case of when, not if, digital health solutions become the norm.

The phrases digital health, health technology, mHealth and digital therapeutics have taken their place in the pharma vernacular. And as the paradigm shift towards the ubiquity of digital health solutions continues apace, Medical Affairs must once again reflect on its own evolving role and consider how it can drive digital health by innovating and creating.

Improving outcomes

According to Alex Butler, co-founder of Foundry³ the future value of digital is going to be the use of technology to improve clinical outcomes, patient outcomes and to help healthcare professionals improve the provision of care.

The linear approach of a “pill for every ill” has been expanded immeasurably by the application of mobile health, digital health and digital therapeutic solutions, Butler tells Elevate. Addressing key health challenges of the 21st century such as chronic disease, access to care, health inequalities and ageing populations, becomes not only possible but accessible and affordable.

“The ubiquity of mobile devices now means that we have an opportunity through these digital technologies to improve health outcomes: through basic communication services, but also highly innovative services with regard to tracking and sensor development, measurement of biometrics and delivery of medical services.” He suggests that the vision for digital health is nevertheless relatively straightforward: “It’s not just about providing information, but rather providing integrated services that are proven to improve clinical outcomes.”

Digital therapeutics, Butler adds, are prescribable digital programs or interventions that should be shown to improve outcomes. “They’re called therapeutics because they already have some form of evidence base behind them in a more traditional sense, mostly because they’ve derived out of cognitive behavior therapy and mindfulness where there’s already a lot of evidence for these programs.”

 

 

Proliferation of applications

The sheer velocity of the digital revolution means that in in recent years we have seen not only more advanced capability, but increased application in areas of previously unmet need. Metabolic disorders, psychiatric disorders, and cardiovascular health, among others, have seen their management transformed dramatically by digital health solutions, notes Butler.

Health technology companies, academia, HCPs, and patients – as well as pharmaceutical companies – are delivering these digital solutions successfully. Butler highlights a couple of examples, including GlycoLeap’s diabetes system. “This tracks the obvious things like your activity, your nutrition, your glucose levels and your body mass index, but also combines it with a behavioral psychologist and nutritionist that you can access at any time. Basically, you get a personalized diabetes management program through your smartphone app, which would never have been dreamed about 10 years ago.”

There’s also Omron’s smartwatch which measures blood pressure with clinical accuracy at the push of a button. “This can actually take your blood pressure through the watch strap alone and you can link it to AliveCor, an FDA-cleared medical-grade EKG”.

“Essentially, an everyday person can have what would have been not really possible outside of a cardiology department on them all of the time in their own home.” Even if this was available years ago, it would have cost tens of thousands of pounds, he adds.

 

 

Three-part strategic approach

The key role of Medical Affairs in driving the proliferation of these solutions necessitates a strategic approach. According to Butler, a model of clinical significance, behavioral change and user need must be applied to the development of digital health initiatives.

“Certainly, in the early days of strategically designing any kind of program or initiative, a requirement is that there’s clinical relevance. The days of just ticking a box, or even more than ticking a box, just providing information to patients about the disease through a different channel or on the phone (as opposed to a leaflet) is not really the point of what we’re trying to do with this.”

People tend not to respond to information; rather, the vast majority of decisions in healthcare are emotional decisions and Butler contends that we need contextual support in order to fundamentally change our behavior. Proven clinical outcomes – as well as patient outcomes, which he says are “at least as important” – must therefore be an inherent part of the digital health offering.

Behavioral change is another essential element. Butler explains that in the majority of digital health interventions, particularly in the management of chronic disease, the focus is on trying to help people to slightly modify or change their behavior. “Which, sometimes at least, can drastically improve outcomes. Again, if the program doesn’t have a genuine element of behavioral change in there, or you don’t understand what behaviors you’re trying to modify or support, then it’s probably a red flag that it’s unlikely to be successful.”

User need is the third and final part of this strategic approach, and although it seems obvious, Butler says it can often be omitted completely.

“What’s the actual value for the individual, patient or, more importantly, person that’s using this tool? Even if it’s easy to understand why the pharmaceutical company or even the healthcare professional might want someone to do something, it’s not always obvious why you, as a person, would want to partake in a lot of these things.”

He reels off examples of digital health being superfluous at best, pointless at worst: “data entry systems, diary systems without any obvious value, requirements to complete tasks with degenerative diseases without any kind of user value or interventions that can actually improve your outcome.”

Even with a strategic approach, there are inherent challenges for any pharmaceutical company developing any kind of digital solution. Ultimately, an initiative should be sustainable for that particular organization, and must be given adequate investment of both time and resources, Butler advises. “If you’re not doing something that is sustainable for your organization or meeting your commercial objectives, then it’s unlikely to have any traction over any period of time. Obviously, we know that these things need investment, care and nurturing over years, not just the scope of one motivated person. For example, if you’re working in a disease area where for clinical trial purposes you would like to be able to better track outcomes and you can use digital health tools to do that, then that’s obviously going to be sustainable, especially if you have a long pipeline in the disease area, or it’s incredibly important that you do everything you can to help people stay on the medication, or not to relapse in a condition.”

 

Medical uniquely equipped to lead digital development

Butler agrees the future custodians of the vast majority of high-level digital investment will be Medical Affairs and says they must take an active interest in driving the strategy and the implementation of these programs. “At the very least, Medical has to have a key involvement, because this is talking in many ways about doing the same things that you would do for a medicine with regards to bringing that scientific rigor into the design of the program and into the evidential proof that these things have an impact on patients.”

This poses both ethical and compliance challenges, says Nicholas Broughton, an independent consultant in pharmaceutical ethics and compliance. For some in Medical Affairs roles, the word “digital” immediately evokes thoughts of banner adverts, one-too-many email campaigns, or health professional websites seen as commercial tasks that require medical review and approval, he tells Elevate.

“The problem is that this ‘one-bucket’ perspective on digital means that the ‘commercial produce/medical review’ approach is extended into digital activities where it is not appropriate. Provision of digital health solutions is one such area. To me, these are health interventions that solve problems for patients and there is a very clear analogy with the health interventions we call medicines. We have a moral duty to protect patients using such interventions from harm, respect their autonomy and maximize the benefit they can gain.”

Broughton echoes Butler, saying if something is being developed digitally to improve patient care, then it must be understood what the need is, how to prove benefit and how to avoid harm. The ethical implications must be crystal clear. “We can’t afford, as an industry, to provide health interventions that have flaky reasoning, no proven value and which may misinform or mislead and threaten patient safety.”

Yet he is adamant that despite the myriad ethical and compliance obstacles, Medical Affairs are uniquely equipped to lead the development and introduction of digital health solutions in all their guises.

“The skills and knowledge to develop useful interventions and prove they work and are appropriately safe – be they medicines or digital health solutions – lie in the medical and development functions in pharma. By all means, let our marketing colleagues provide ideas and input and promote what we produce, but scientists and health professionals in industry must lead development.”

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