Apr15

Mindfulness: An Age-Old Concept in a Bright, Shiny New World

yoga officeIf you asked others to define mindfulness, you’d likely hear a variety of responses, the most common of which might be relating the term to a Buddhist concept. Mindfulness indeed originated thousands of years ago, and for those who conceptualize it this way, a quote from the well-known author Thich Nhat Hanh illustrates the point well. He said, “Walk as if you are kissing the earth with your feet.” Too esoteric? This is far from the only interpretation of the word.

A more practical and relevant definition for business is simply: awareness. We all know full well the challenges in today’s environment, particularly within the rapidly evolving healthcare space. The digital age isn’t coming, it’s here, but all of its obstacles and opportunities are still being pulsed out over time as we answer some questions and then inevitably raise more. As if our own world isn’t changing quickly enough, that of our clients is right there beside it, equaling if not outpacing the transformation we’re experiencing. One of the keys to all of this—to recognizing the hurdles and also to overcoming them—is mindfulness (yes, that 2,000+ year old practice).

Mindfulness facilitates a more complete view of what’s around us. It compels us to consider our immediate and long-term challenges, and the resources we have available to address them. But it also encourages us to put ourselves in the shoes of our clients, to become more connected to (in other words, aware of) their work climate, and that always makes for better, more creative and insightful work.

But it is more than just awareness. Going back to the more obscure definitions, it’s about being supremely present, the result of which is the ability to recognize beauty and connectedness in the world. The more of that we see, the more impassioned we become and the more driven we are to contribute to it—through our work, but also through our hobbies, our families and our friends.

So let’s make a pact to be more mindful and to reap the rewards, personally and professionally. Become more familiar with and aware of your working environment and that of your clients, work after hours at home and even monitor those devices as needed, and you will be a better, more valuable professional for it. But when the job is done, continue to practice that mindfulness by being fully present and invested in whatever you’re doing after work. It helps us all, even those who love every waking second of their job, to unplug and recharge. There are few things that clients love—and need, especially in today’s healthcare landscape—more than an eager and fresh perspective ready to confront their most formidable challenges.

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Also posted in agency life, behavior change, Creativity, Mental Health, Personal Reflections | Tagged , , , , | Leave a comment
Mar11

SXSW 2014: Technology and Health

SXSW_Logo_2013_BlackBG_CS

In Part 1 of his SXSW blog series, Robert Egert recaps some of the SXSW themes that are transforming the way the world looks at healthcare.

Massive—that’s the first thing you need to understand about the SXSW experience. At any given time, there are 30 to 50 events to choose from taking place in multiple locations throughout downtown Austin. This means that, unlike conventional conferences, each individual attendee cuts his or her own path through the events by selecting and reselecting from the nearly unmanageable array of keynotes, panel discussions, presentations, and workshops.

Events that feature celebrity speakers or that focus on hot topics can fill up quickly. Dashing from event to event, waiting in long lines, and striking up random conversations en route is part of the experience. Many events include audience QA, so if it suits your fancy you can become part of the public conversation, even if you aren’t an official presenter.

Here’s a highly personal recap of the themes, issues, and events that impressed, stimulated, and/or frightened me:

BIOMETRICS

The Idea: The pervasive collection of quantified biometric data will transform healthcare.

Wearable, implanted, and otherwise applied technologies will collect vast amounts of data on each of us throughout the day and night regardless of where we are or what we are doing. The collected data won’t only be sent to our phones—it will also be shared with physicians and aggregated into an ever-expanding library of health data.

This library can be used to evaluate the impacts of lifestyle choices on health and longevity (how much of what kinds of exercise must you do to reduce hypertension?). They can also measure the impact of pharmacologic therapies (which drug was more effective?), they can help identify disease patterns (what patterns around comorbidity should be looked at?), and they can provide real-time reports on just about anything you want to know about human behavior and health.

Why this is important:

If we combine biometrics with the predictive capabilities of DNA analysis, we’ll be able to obtain a detailed image of our individual health within the larger social context.

CROWD-SOURCED DRUG DISCOVERY

The Idea: Crowd-sourcing health studies and clinical trials.

Current approaches to drug testing and conducting health studies are expensive, slow, and cumbersome. What if we used crowd-sourcing to answer quantifiable health questions?

Jessica Richman, who is the founder of uBiome, a start-up that uses a crowd-sourced approach to collecting scientific health data, proposes that we dramatically change our approach to scientific inquiry. She suggests that with the right protocols and infrastructure in place, crowd-sourcing will be used to speed the evaluation of new products, measure the effectiveness and safety of products already in-market, and obtain quantifiable data on the health impacts of lifestyle choices.

This approach promises to allow us to quickly and efficiently collect larger data sets than ever before. But with this comes the responsibility to maintain processes and checks to maintain scientific integrity.

Why this is important:

It can dramatically reduce the cost of conducting health and drug studies, and it can generate libraries of data for ad hoc inquiry and analysis.

SXSW Series:

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Feb28

How Can Self-monitoring Best Support Behaviour Change?

3907691Some of today’s biggest public health challenges, such as obesity and  heart disease, can be linked to personal lifestyle decisions. Governments have tried tackling these issues with smoking bans and taxes on high-fat foods, with moderate success. However, personal health behaviour change is needed to make a significant, lasting impact. Can self-monitoring of health information be the answer?

Studies in diabetes, hypertension, medication compliance and weight loss have shown that patients who successfully self-monitor their activities and set personal goals enjoy improved health outcomes and better adherence to treatment 1-6. We now have an abundance of apps and wearable technology at our fingertips to comprehensively track numerous aspects of our lifestyle, analyse results and observe improvements over time. These self-monitoring tools can then be easily integrated into social health networks so that we can share experiences, track our progress against that of our peers, and give and receive advice on how to succeed.

It is estimated that there are more than 40,000 health and fitness apps available. But with this bewildering variety of choice, how can we know which ones will encourage lasting behaviour change?

Easy does it

The apps which make the process of data upload as effortless as possible for the end user are the ones most likely to catch on in the long-term. Devices that automatically record data and synchronise it with online analysis programmes in real time provide a seamless transition and are not hampered by general forgetfulness or lack of time.

Keep it simple

Health information needs to be engaging, and simple enough to be universally accessible. The average person is likely to find sorting the data that matters from what doesn’t time-consuming and intellectually daunting—in fact, many patients who have to actively monitor a condition like type II diabetes don’t always fully engage with self-monitoring for these very reasons.7

Be realistic

Establishing aspirational but realistic goals and providing reinforcing feedback can help bring self-monitoring systems to life and make them personally meaningful.  A recent study into self-monitoring to improve diabetes treatment found that the main concerns patients had with the system were disappointment with unmet expectations and difficulty fitting the programme into the demands of daily life. 1

Collaborate

Ideally, fitness or health tracking app developers should collaborate closely with specialist healthcare providers and device makers as well as social scientists who understand how to bring about behaviour change. Such cross-fertilisation could result in truly useful tools that track fitness alongside other health metrics, such as blood sugar levels or medication adherence.

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1.  Barlow J, et al. Self management approaches for people with chronic conditions: a review. Patient Education Counseling 2002;48:177–87.

2.  Benhamou PY. Improving diabetes management with electronic health records and patients’ health records. Diabetes Metab 2011;37(Suppl 4):S53–6.

3.  Dennis EA, et al. Weight gain prevention for college freshmen: comparing two social cognitive theory-based interventions with and without explicit self-regulation training. J Obes 2012;2012:803769.

4.  Parker R, et al. An electronic medication reminder, supported by a monitoring service, to improve medication compliance for elderly people living independently. J Telemed Telecare 2012;18:156–8.

5.  Ralston JD, et al. Patients’ experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ 2004;328:1159.

6.  Wagner PJ, et al. Personal health records and hypertension control: a randomized trial. J Am Med Inform Assoc 2012;19:626–34.

7.  Choose Control Survey. Choosing to take control in type 2 diabetes. Available at: http://www.diabetes. org.uk/Documents/Reports/Choose_Control_report.pdf (Last accessed May 2013).

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Feb18

Taking the Pulse…Tuning In to the New Patient Network

1741356 sA guest blog post from Craig Martin – Chief Executive Officer of Feinstein Kean Healthcare, an Ogilvy & Mather Company

Most of us are far too young to remember the early days of television. What I do recall from my childhood is that three networks owned the airwaves, large numbers of people followed a small number of notable programs, and the screen turned to fuzz at midnight. You made note of the TV Guide schedule, and you adjusted your schedule to the TV shows that interested you. The networks and the stars were in charge.

A lot has changed since then, obviously. There are now countless networks, and seemingly limitless numbers of shows. Reality television has made stars of “ordinary” people. And the digital age has made scheduled programming obsolete—the content follows you and adjusts to your life and device of choice, not the other way around.

Why wax nostalgic about the evolution of broadcast television? Because I believe a similarly dramatic transformation is under way in our field. The old channels and choices are fading to fuzz. A new era is dawning.

For years, healthcare PR relied on a few channels and reliable choices to reach, inform, and market to patients. On behalf of our clients, we used traditional media (earned and paid), events, celebrities and big disease education programs to build awareness and get patients to “talk to their doctors about…”

Today—as more of the burden of choice, comparison, and cost gets shifted to patients, as diseases become more and more categorized via genomic analysis and molecular diagnostics, as medical practice and health become more universally digitized, and physicians and pharma become more responsible for outcomes vs. treatments—the traditional big, broad-channel approaches are becoming less relevant and effective as a means of reaching more and more narrowly defined populations of patients.

These trends are leading to the establishment of entirely new channels and networks, made of up patients identified and aggregated virtually through the sharing of personal medical information and data. In other words, the audience is creating the network, and continually informing the programming through the data they share. Now, rather than casting a wide net via mass media and hoping a narrow audience will be watching, we will have ready-made networks, open 24/7, waiting if not demanding to be engaged. This opens up new frontiers for micro-targeted, real-time communication and measurable engagement, based almost exclusively on digital content and social influence.

Not long before the holidays we learned that Feinstein Kean Healthcare (FKH) and a select group of partners won a million-dollar government grant to develop a “patient-powered research network” for the multiple sclerosis community. This is an exciting development, but not because of the money. This new kind of network represents the leading edge of the transformation I’ve described, and we’re now right at the forefront as well.

In the days and months ahead, we’ll continue to evaluate the pace and progress of change, and work to assure that our thinking and services are aligned with where the world is headed. Naturally, we don’t want to get too far out ahead of the trend, but we must be informed and equipped to lead when the market is ready.

I believe, as this new era unfolds, we will find there are many exciting opportunities ahead for us to engage differently and far more meaningfully with patients.

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Feb7

The Age of Wearable Health Technology Is Upon Us

5240666It used to be that technology that conforms to the human body and seamlessly integrates into your environment was stuff of science fiction movies. But if we’ve learned anything over the past 10 years, we know that science fiction is rapidly become science-fact. If you wanted to see what the near future held, all you had to do was tune in to the numerous news feeds covering the 2014 Consumer Electronics Show (CES) January 7–10. If there was one trend that seemed to be on every manufacturer’s mind, it was wearable health technology. In fact, CES expanded exhibitor floor space by 40% just for digital health and fitness exhibitors, many of whom were showcasing wearable personal devices.

CES is known as an event where electronics manufacturers like Samsung preview the mainstream consumer electronics that will drive the holiday shopping season. It’s the place where the industry goes to see everything from the latest web-connected refrigerators to the latest mobile chips. And the news from this past CES convention was no different. In the past, consumer electronics companies have been focused on portable, mobile technologies. With the mainstream adoption of smartphones and tablets, consumer electronics companies have continuously tried to innovate by going smaller. It was this evolution from compact, mobile personal technology to wearable technology that was on full display this year at CES. There were smart watches, smart jewelry, and smart glasses, and even mention of integrating technology into fabrics. There was a visible trend toward fashionable, smart, wearable health devices. The core technologies and functionality in many of the wearable gadgets on display were fairly similar, mostly informational apps and health and fitness monitoring, but it was the emphasis on style and technology as an accessory which spoke to how health technology will be more seamlessly integrated into everyone’s everyday life.

After years as a novelty, in 2013 wearable health tech began gaining wider adoption. From primetime TV commercials for the Samsung Galaxy Gear—a watch reminiscent of Dick Tracy’s clunky walkie-talkie wristwatch—to coverage of the debut of Google Glass on local news channels, wearable technology was noticeably all over news and pop culture. You couldn’t take a ride on the New York City subway without seeing at least 5 people with some kind of fitness tracker on their wrist or hip. And those who didn’t have a dedicated tracker likely had some kind of fitness or health-focused app installed on their smartphone. In fact, wearable tech adoption grew from 3% in 2012 to 13% 2013, and that growth has been fueled by growing consumer interest in fitness and personal health monitoring and tracking. As consumers have increasingly begun to take control of their own health, adoption of wearable devices to help them do so has grown. Gartner predicts that the fitness and personal health monitoring trend will grow to a $1.6-billion industry in 2014 and to $5 billion by 2016. As we saw at CES, consumer electronics manufacturers are doing their part to give the trend momentum by making the wearable devices easy to use, fashionable, and less pricey, hoping to appeal to a much wider consumer base. And it’s not just the consumers who will see the benefits of devices that are easier to have and use. New opportunities will continue to arise for healthcare professionals and pharmaceutical companies to play a direct role in wellness and health behaviors through these wearables. As open software standards become more prevalent across devices, it’ll be easier for healthcare marketers to customize programming to suit clients’ needs and integrate wearables into a more personalized patient experience. Here at Ogilvy CommonHealth Worldwide, we’ve already begun to explore how this new channel for engagement can be used toward patient education and adherence. Next Christmas, don’t be surprised if your grandparents or teens ask Santa for a fashionable wearable health device.

What about you? Do you currently own a wearable personal health or fitness device? How has this affected how you manage your and your family’s health?

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Jan10

Flexing Our Creative Muscles

flexing our muscles thumbnailIt takes lots of hard work and dedication to achieve your goals for a healthier lifestyle. It focuses on nutrition, physical activity and resiliency, and is individualized to your specific needs. Running the Ogilvy CommonHealth Imaging department is comparable to this in many ways, as I apply the same approach in servicing all Art and Creative Directors. Expectations are high, utilizing our confidence, capabilities and talent to deliver.

It Starts With Healthy Living
Just as in planning my daily and weekly workout routine, the Imaging team prepares by being mentally and physically fresh. It’s important to keep up with the latest technology and current software and hardware upgrades. Every day is a learning experience, especially in the CGI environment.
Wellness in the Imaging Department
The team keeps in top shape by utilizing powerful 3D graphics and software. This has allowed us to take our imaging capabilities to the highest levels conceptually and to produce final printed or digital art.
Increased Strength and Endurance
Creating and conceptualizing art for new brands and new business pitches requires an extreme amount of strength and endurance. We take creative teams’ and individuals’ ideas to a whole new level, allowing them to achieve their visions and ideas, and bringing them alive through the Imaging team’s strength, expertise and resources.
Preparation and Mental Toughness
It takes extreme preparation and execution from our digital artists to create that perfect and unique piece of art. Understanding the “why” is more important than the “how.” In order to create a realistic 3D image, it requires an understanding of why an object looks a certain way in the real world or in specific environments.
Connect With Us
We have evolved traditional retouching into a combination of digital imaging, 3D modeling, animation and motion graphics, to create dynamic, compelling still and motion images. Our strength is in our passion to move ahead and be the best in our industry. Other agencies can’t keep up with the healthy lifestyle of the Ogilvy CommonHealth Imaging team and that’s why we’re flexing our creative muscle.

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Dec19

Unleash Your Passions

thumbnailAs the year comes to another busy end we find ourselves working long hours to ensure we meet the needs of our clients, but look forward to the hope and promise of a new year. The New Year is the time to reflect on the changes we want to make and resolve to follow through on those changes. As we think about those resolutions, let’s take a moment to reflect on the corporate culture of Ogilvy & Mather as laid down by David Ogilvy.

“Some of our people spend their entire working lives in Ogilvy & Mather. We try to make it a stimulating and happy experience. We put this first, believing that superior service to our clients depends on the high morale of our men and women.”

Ogilvy CommonHealth Worldwide is an organization filled with hardworking, creative and smart individuals. In fact, we often find ourselves defined by what our job roles are; account managers, copywriters, art directors, finance directors, medical directors, and more. But we are so much more than a job description. Underneath it all, we are all individuals with personal goals, passions, with a desire to better ourselves and the world around us. We are all poised for greatness. This greatness lies within us—deep within, we are painters, poets, caregivers, entrepreneurs, mentors, performers, advocates, athletes, and so much more.

Often the demands of our day job and life in general get in the way of achieving our personal goals, or passion projects, as I like to call them. But, especially in a creative business like advertising, we have to ensure that the pressures of the daily grind are not counterproductive to our creative spirit, the lifeline of our work. As such, we really need to make the time to pursue our passion projects. Our personal passion projects can provide a much-needed creative outlet and an escape from the demands of the day. Ultimately, making the time for our side projects will allow us to unwind, gather perspective and experience, and center ourselves.

But aside from the personal satisfaction that can be gained, passion projects loop back into work life, fueling professional inspiration. It is no secret that high performance and job satisfaction are tightly linked with the need to gain control of our personal and professional lives, to learn and create new things, and to be better at what we do. Driven by personal fulfillment, those who pursue passion projects are highly engaged and will work more efficiently and effectively.

So as we reflect back on the past year and resolve to make changes for 2014, let’s think about those side projects we are passionate about. It’s time to let those passion projects brewing beneath the surface grow into valuable opportunities both personally and professionally. If you give them a chance, you’ll get the pleasure of working with highly motivated people who are happy at their jobs. In the new year, I resolve to pursue my hobby of painting more vigorously… What will you do? Consider acting on your passion project as part of your New Year’s resolution.

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Dec10

Asia and the Art of Pervasive Perseverance

singapore thumbnailIn less than two months, a religious festival takes place that is so fantastically crowded and celebratory that it seems unreal. Officially listed as the largest human gathering in the world, the northern Indian city of Allahabad at the confluence of the Yamuna, Ganges and Saraswati rivers will witness as many as 100 million people participating in an ancient Hindu festival known as the Kumbh Mela. The pilgrimage, which dates back millennia, attracts a staggering 10 million people in a single day, who congregate by the Ganges’ banks to ritually bathe in its sacred waters.

The Atlantic’s Quartz website places this event in an easier-to-understand global perspective: “Imagine the entire population of Shanghai—about 23 million—camping on a 4×8 kilometre field. Add to that mass of humanity every last man, woman and child in New York City and you’re getting closer to the Kumbh’s expected attendance.”

Some 3,000 miles away at nearly the same time, the world will also witness the biggest annual human migration, known as Chun Yun (or Spring Festival Migration). Some 700 million Chinese, or roughly half the country’s population, are expected to make 2.85 billion passenger trips during the 40-day period to celebrate Chinese New Year with their families.

What is it that drives hundreds of millions of people, an ocean of humanity, voluntarily through unimaginable hardships—sickness, disease, loss of life even—every year? On one side, the biggest “act of faith,” while on the other the biggest need to just “be back home.”

These two events define for me the spirit and tenacity that is Asia—the need for inspiration, the need to define oneself in a community, affecting in turn the way lives and health are managed.

A recent new study revealed that the average Singaporean has a particularly high desire for inspiration, albeit on a more material scale. Indeed, 69% of Singaporeans want to be inspired when they shop/read/surf, compared to only 49% of Europeans and 51% of Americans—but then the “kiasu” Singaporean culture is what keeps it so vibrant.

In a separate study, in Tier One China cities, when comparing the cost of a critical vaccine against pneumococcal infection vs a new iPhone 5C, it’s no surprise that Jobs’ inspirational device won hands down. The seemingly everyday contradictions with which Asia works start to become a way of life for us who call this part of the planet home. It doesn’t seem unusual, just the way it’s meant to be, really…

How, then, do we apply the norms of behavioural-change communication in an environment as diverse and fragmented as Asia Pacific? Where religion, environments, languages—along with budgets and regulations—are both simultaneous drivers and barriers, be that to an oncologist in the Philippines or a midwife in Indonesia, a GP in Beijing or a regulatory official in Sydney.

Asia forces you to innovate, to find a new way, to uncover an insight that is universal in application and precise in its expression. In a way, Asia offers us a sort of social petri dish in which we can incubate ideas/tactics/strategies in ways not thought of before. Big ideas with small budgets, with the ability to change or save the lives of millions…now isn’t that a challenge worth waking up to?

The formal launch of Ogilvy CommonHealth Asia Pacific in a way is representative of everything we see, hear, feel and smell in this region. From many brands operating as one; from 6 different countries working in unison; from Med Ed & PR to Branding & Creativity. We’re looking ahead to 2014 with hope, promise and most importantly the chance to help define Asian health communications in ways not thought of before.

Join us in this journey, as we rediscover Asia Pacific through the lens of health behaviour change. Reach out and offer your thinking, your ideas. Tell us whenever you’re making a visit: you have a place to call home across the region—India, Singapore, Hong Kong, Shanghai, Beijing, Tokyo and Sydney. The closer we become, the sooner we’ll realise just how small the world really is. Even the taste of Balut or Durian won’t seem so bad (well, maybe those are two things that just cannot make sense any which way you look at it).

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Dec3

In the Ring

in the ringThere is a Spanish expression that goes: It is not the same to speak of bulls as it is to be in the bull ring. I’ve always liked it, because it seems to capture quite fundamentally the difference between being a spectator and a participant, an observer and an actor. I have paid my money and taken my seat at any number of events, sporting and otherwise; the few times I’ve been the one in the ring, literally or metaphorically, it was a considerably greater investment of self at that moment, and it occupied a lot more of my attention.

Often, I believe that the truth in this phrase applies to our line of work, medical communications, most clearly in the case of patients. We can argue or opine or assume what is best for someone facing difficult medical decisions, based on what we know and see, but until we are facing the same or similar situations and choices, it’s all just theory. Debating a hip replacement, or putting a child on therapy for ADHD? It’s easy to have an opinion, but much harder to know that it’s your choice to make, and your consequences to live with if you choose wrong.

This is why fellow patients are such critical sources of information for patient-centered decision making; it is the value of “experience by proxy,” of hearing from someone who faced the same challenges and choices that you did, and who is now living with those choices, that makes YouTube one of the most important channels for health information.

But what of the healthcare professional? Are they not, too, bullfighters in their own right, making decisions that deal with death and life, in big ways and small, every single day? I find myself in too many meetings in which we deliberate over the patient journey and decline to do the same for the physician, reducing them to a sentence or two, a professional epigraph and no more: “Neurologists like puzzles; psychiatrists don’t like touching patients; oncologists are like chefs.” These basic insights are helpful, up to a point, but I don’t believe that they capture what it’s really like to diagnose a patient with Alzheimer’s disease, bipolar disorder, or prostate cancer, not once, but many times a month, a week, or even a day. I’ve never done it, but as a field researcher have been an observer to many intricate, challenging moments that take place in hospitals and offices, and more than once, as a translator, have been asked directly, “What would you do?” The answer is never easy, and with the fourth wall down, you find yourself wondering if you are capable of making the right call.

It is these moments that most stick with me, as bringing home the gravity of the daily work of healthcare professionals. And I often try to remind myself of these feelings when discussing how best to reach a professional audience, to help them or to change the way they see a specific disease, or treatment, or test. We can make recommendations, but they have to live with the consequences of success or failure if they follow them. If we want to communicate effectively with our professional audiences, it is worth remembering that they face bulls every day; mostly, we just talk about them.

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Nov12

Pharmaceutical Medicine: Moving From Molecule to Market

moleculeThe emerging discipline of pharmaceutical medicine trains a wide-angle lens on the process of drug development. It integrates the science, regulatory requirements, clinical development, commercialization and business affairs, drug safety surveillance and reporting under one umbrella. By definition, it is the discipline that considers drug development from molecule to market.

After 15 years in the pharmaceutical advertising/medical communications industry, during the past 2 years, I had the opportunity to pursue a graduate degree in Pharmaceutical Medicine accredited by Hibernia College of Dublin, Ireland. Uniquely, this program is the result of collaboration between the European Community and the European Federation of Pharmaceutical Industries and Associations, which includes many pharmaceutical industry partners.  My peers were professionals from Medical Affairs, Regulatory Affairs, Sales, and other departments in pharmaceutical company sites around the world, and the professors included company veterans from several relevant disciplines. Coursework covered regulatory requirements and pathways in all major jurisdictions worldwide and course content included modules such as Discovery and Formulation of New Medicines, Regulatory Affairs, Clinical Trials, Knowledge Management & Statistics, Health Economics, and Pharmacovigilance.

The relevance of this training to our industry is shown clearly by examples of the trends in drug development and regulation that are examined and form an integral part of the course.

For example, were you aware of the existence of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)? This partnership between the regulatory authorities and the pharmaceutical industry of Europe, Japan, and the United States, initiated in 1990, seeks to foster greater harmonization of the scientific and technical aspects of drug registration to ensure that safe, effective and high-quality medicines are developed and registered in a manner that makes the most efficient use of resources (eg, minimizing the use of research animals and avoiding unnecessary duplication of clinical trials). The international Medical Device Regulators Forum seeks to perform the same role of regulatory harmonization in the medical device sphere. With economic globalization and the consolidation of the pharmaceutical industry and allied services internationally, it is necessary for us and our pharmaceutical industry partners to factor these initiatives into strategic planning.

In another development, and seemingly without much fanfare, in September 2013, the European Commission announced approval of Inflectra™ (Infliximab), Europe’s first biosimilar monoclonal antibody for the treatment of inflammatory conditions. Inflectra™ is a biosimilar to Remicade®—a drug with US$2 billion European sales in 2012— and is the first monoclonal antibody to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. The FDA is in the process of elaborating regulations for the approval of biosimilars in the United States under the Patient Protection and Affordable Care Act.  The emerging global biosimilars market will be an important area of strategic interest for many of our pharmaceutical industry partners.

Knowledge of and an ability to evaluate and navigate the evolving healthcare space is the concern of pharmaceutical medicine and the business of our industry.

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