December 2017 / January 2018

™ DECEMBER 2017/JANUARY 2018

the publication for healthcare sales & marketing leaders™

HEALTHCARE COSTS: HOW WE CAN HELP IN THIS ISSUE Cleveland Clinic’s Top 10 Medical Innovations Driving Revenue at Pfizer, Astra Zeneca and now Mylan Our Role in Driving Down Costs Astellas Success Secrets Can Digital Drive Revenue Creative Success at Teva and Syneron Novartis Builds a Stronger Brand

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TABLE OF CONTENTS Publisher’s Letter..............................................................................................................................................4 Editor’s Letter.....................................................................................................................................................5 Editorial Board....................................................................................................................................................7

ARTICLES Executive Spotlight: Adele Gulfo, a leader at Mylan, Pfizer and AstraZeneca............................9 Roundtable: How We Can Help Contain Costs....................................................................................... 13 Cleveland Clinic: The Top 10 Innovations for 2018............................................................................. 23 How Digital Can Drive Revenue................................................................................................................. 27

By The Numbers.............................................................................................................................................. 33 Success Secrets from Astellas Canada President Michael Tremblay........................................... 35 Motivideos........................................................................................................................................................ 39 Novartis Builds a Stronger MS Therapy Brand.................................................................................... 45 More Effective Creative for Teva and Syneron ..................................................................................... 51

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Publisher’s Letter

What Are You Grateful For? Here we are, halfway between Thanksgiving and Christmas, a season in which we are all encouraged to count our blessings. But having the blessings is just the beginning, the lucky part. Recognizing them, and being grateful for them, is the real skill.

We all know people who can grumble over the slightest inconvenience (what we sometimes call “first world problems”). It’s a blessing in itself to be able to see things in perspective and enjoy what you have.

And that becomes all the more important when life hands you challenges. Being in this industry, we are keenly aware of how many people are struggling with conditions and diseases, short- and long-term, that steal from their ability to live fully. That’s why quality of life has become such an important goal in healthcare. We want to help patients to make the most of each day.

CARI KRAFT

Even more poignant is the fact that, sooner or later, we will all come up against these challenges, affecting a loved one…or ourselves.

And that’s why we run the Cleveland Clinic’s Top 10 Innovations every year. These are just the tip of the iceberg of advances emerging across the healthcare landscape, therapies and inventions that often took genius and years to develop, and that will alleviate suffering for so many around the world.

Making diabetes more manageable. Reducing the effects of sleep apnea (which can have serious effects on sufferers). New frontiers in gene therapy. Cutting back on artery-clogging cholesterol. Improvements in vaccines, breast cancer therapies, and more. Somewhere on that list is a leap forward that will affect someone close to you, or perhaps is doing so already.

And there are many more, further down the list, attacking the thousands of ills that beset us. We often feature these in HS&M when we celebrate the contributions of leaders in the industry. It’s these innovations that keep us all inspired, that make us feel a part of the progress being made all the time in healthcare.

I’m thankful for all of it, and for the opportunity to make these innovations known to others. I hope you are, too.

And always, please keep the feedback coming. It all goes to making the magazine better for all of us.

Cari Kraft, Publisher

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HS&M DECEMBER 2017/JANUARY 2018| 4

Letter from the Editor

A Big Thank You to Our Contributors This being the gift-giving season, I want to acknowledge and thank all those who have been so generous to us as to offer the gift of their wisdom, experience and opinions over the last few years.

NEIL GREENBERG

There are too many to thank individually (and apologies to those who don’t appear here), but I’ll start with Alex Azar. Recently nominated by President Trump to head up Health and Human Services, he was featured in these pages this past July. In our interview with Alex, we found him thoughtful, measured, and ready to admit the problems of the industry while recognizing the triumphs. He is not doctrinaire, and has the requisite resumé to understand the challenges of HHS and deal with them capably. We wish him well.

Courtesy of our well-traveled and well-connected Associate Editor Jill Donahue, we have heard from bestselling authors and noted speakers like Jonah Berger (Contagious), Daniel Pink (Drive), Adam Grant (Give and Take), Keith Ferrazzi (Never Eat Alone), Charles Duhigg (The Power of Habit, and a Pulitzer Prize winner in journalism), and more.

Top executives have appeared in HS&M. Terry Bromley of Crawford Healthcare, David Epstein of Novartis, Paul Perreault of CSL Behring, Deborah Waterhouse of GSK, Benson Smith of Teleflex, Eric Halvorson of Comeg, Phil Croxford of Gamma Medica Inc., and others from J&J, Bayer, Pfizer, Lilly, Abbvie, Boehringer Ingleheim, Nestlé Nutrition, Sanofi, BMS, UCB, Janssen, Teva, Roche, Astellas, Otsuka and a long list of others.

We also appreciate the consultants from ZS and IMS, who provide in-depth metrics about trends; commentators like Peter Pitts of the Center for Medicine in the Public Interest; our friends at eyeforpharma and exl (why are event companies too humble to capitalize their names?); insiders like Scott Nelson, Medsider founder who brings us great interviews from the med tech sector; and of course our distinguished editorial board, some of whom also contribute content—we’re looking at you, Chris Bergstrom, Maria Finlay and Kristen Sharron-Albright.

Finally, thanks to our loyal readership, which grows with every issue. You are the reason we pound out these pages, and we appreciate your interest and your feedback. A happy holiday season to all, and please enjoy the perspicacious pearls from our distinguished contributors in this holiday issue.

As always, we continue to look for the value of your contributions. Let us know if you have an idea for an article—the people we write for are the people who write for us.

Neil Greenberg, Editor To become an HS&M contributing author or provide feedback, please email me at ngreenberg@hsandm.com.

5 | HS&M DECEMBER 2017/JANUARY 2018

THERE ARE SOME THINGS PEOPLE JUST WON’T TELL YOU BUT THEY’LL TELL US IN CONFIDENCE. AND WE’LL TELL YOU. There are a lot of opinions people never offer you about your company. What the pain is. What you could be doing better. What they think of your competition. How to talk to them effectively.

Big corporations get these answers through expensive research. Small to medium-sized companies don’t have that luxury. That’s why we created the Private Process . It’s a quick, cost-effective way of compiling information that people will offer us in complete confidence. Then we assess the results and give you the insight you need to adapt your sales and marketing messages accordingly. ©

For details on how the Private Process works, and the kinds of answers you can get, contact us now at ngreenberg@hsandm.com.

™

Editorial Board

the publication for healthcare sales & marketing leaders™

Chris Bergstrom Publisher Cari Kraft Editor Neil Greenberg Contributing Editor Jill Donahue Creative Director Hedy Sirico Digital News Rick Cataldo Digital News Chris Manning Sales Director Andrew McSherry EDITORIAL BOARD: Kristen Sharron-Albright Head of Marketing at Noven Pharmaceuticals Chris Bergstrom Associate Director, Digital Health Expert at Boston Consulting Group Sebastian “Sebby” Borriello Vice President, Chief Commercial Officer SK Life Science Lewis Chapman Vice President, Global Commercial Operations AllCells, LLC Maria Finlay, MBA Associate Director of Oncology Marketing, Teva Oncology Nick Gurreri Vice President New Products at Alexion Pharmaceuticals, Inc. Bob Roda VP and General Manager at BD © 2017 CL Media Inc., Philadelphia, PA CL Media is not responsible for any unsolicited contributions of any type. Unless otherwise agreed in writing, CL Media retains all rights on material published in HS&M for a period of one year after publication and reprint rights after that period expires.

Email ckraft@hsandm.com.

To advertise in HS&M, please contact Andrew McSherry at amcsherry@hsandm.com

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Associate Director, Digital Health Expert at Boston Consulting Group Chris brings almost two decades of commercial expertise as an entrepreneurial executive at large medical device and high-growth digital health companies, and he provides “on the ground” advice for implementing digital health solutions. He currently serves as the expert on digital health at The Boston Consulting Group (BCG). Before joining BCG, Chris was the chief commercial officer (CCO) at WellDoc, a pioneer in digital health. He also held progressive roles at P&G, Roche, and Becton Dickinson. Chris was a senior advisor to several digital health innovators, including MyOwnMed, LiftOff Health, HelpAround, Heart Beam, iSageRx, and Alere Home Monitoring. He also advised the Leona Helmsley Charitable Trust and the Saatchi & Saatchi Wellness Board. Chris holds two digital health patents and has won multiple awards.. Chris holds a Bachelor of Science degree from the Kelley School of Business at Indiana University and earned his MBA from Columbia University.

Sebastian “Sebby” Borriello Vice President, Chief Commercial Officer SK Life Science Sebby is currently service as the Vice President, Chief Commercial Officer at SK Life Science.

Sebby’s career has included executive sales and marketing positions at Cempra, Mentor Worldwide LLC, Johnson & Johnson Healthcare Systems Inc., Ethicon, Inc. and OrthoMcNeil Pharmaceuticals, Inc. Sebby received his B.A. in Public Administration from St. John’s University in ‘81, and received his M.S. in Organizational Dynamics from the University of Pennsylvania in 2001.

Maria Finlay, MBA Associate Director of Oncology Marketing, Teva Oncology Maria has over 20 years of commercial marketing, sales leadership and operations experience. She has led multiple sales, women’s leadership, and cross-functional teams at Johnson and Johnson, AstraZeneca, and Teva Oncology. Maria has experience collaborating to launch and grow small and large molecule products across seven different specialty therapeutic areas.

Bob Roda

Editorial Board

President and CEO, Menarini Silicon Biosystems Bob Roda is a senior commercial executive with extensive experience in delivering business growth and profit in the medtech and diagnostics sectors of healthcare. He currently serves as the President and CEO of Menarini Silicon Biosystems, where he is responsible for driving the commercialization of novel cancer diagnostics. Previously, Bob held a variety of roles of increasing commercial responsibility at Becton Dickinson. Most recently, he was VP and General Manager of the MPS business unit as well as leading the commercial integration of the CareFusion acquisition. Bob also had a successful career within the MD&D sector at Johnson & Johnson. His diverse background includes positions in business development and senior leadership roles in sales and marketing at Johnson & Johnson Medical, Inc., Ethicon, Inc. and Ortho-Clinical Diagnostics. While at J&J, Bob also served as the executive sponsor of the Commercial Leadership Development Program as well as the chair of the VP Marketing Council for all of MD&D. Bob is a highly respected, successful global leader with proven abilities in diverse disciplines. He holds a Bachelor of Arts degree from The College of Business Administration at the University of Rhode Island.

Lewis Chapman Vice President, Global Commercial Operations, AllCells, LLC Lewis Chapman is currently the Vice President, Global Operations at AllCells, LLC. He has spent over thirty years in health care management. He served as VP of Global Strategic Marketing at BioMarin Pharmaceutical from 2007 to 2012, where he was responsible for strategic marketing and product portfolio analyses, and implemented medical education, brand enhancement and sales support programs on a worldwide basis. He oversaw the global launch of Kuvan, which in the U.S. was 112% to budget in 2008, the first year on the market. Previously, he worked with Alpha Inntech Corporation as Vice President Global Sales and Marketing, where global sales grew 26% in 2004 and 22% in 2005 under his leadership. Lewis started his career with Eli Lilly & Company, with roles at Syntex and Genentech, where he was responsible for the global commercial launch of Activase (t-PA), the largest biopharm product launch in the history of the industry up to that time (first year sales $187 million).

Nick Gurreri Vice President New Products, Alexion Pharmaceuticals, Inc. Nick Gurreri is a business leader and General Manager with over 25 years of consistently achievinghigh performance and profitability through strong leadership and cohesive team building in the biopharmaceutical and medical device industries. Nick has held executive positions at Medgenics, Insmed, Pfizer, Pharmacia and Bristol-Myers Squibb. Nick received a BS in Mechanical Engineeringfrom the University of Delaware, and also acquired a Master of Science in Information Assurance at Carnegie Mellon University.

Kristen Sharron-Albright Head of Marketing, Noven Pharmaceuticals Kristen Sharron-Albright, the current Head of Marketing at Noven Pharmaceuticals, was until recently VP Sales and Marketing, Anti-Infective Marketing and Institutional Sales Specialty Care Business Unit at Pfizer. She is an experienced business leader with 20 years of experience in the pharmaceutical and biotechnology industries. She has a strong track record of delivering results in highly competitive and complex markets. Starting her career in sales at Eli Lilly, she then held positions of increasing responsibility at Lilly, Neurogen, and Pfizer, where she was responsible for sales and marketing in a franchise business model. In her spare time she volunteers, serves on the leadership committee for her church, and enjoys hiking.

HS&M DECEMBER 2017/JANUARY 2018| 8

EXECUTIVE SPOTLIGHT

She launched Lipitor at Pfizer, and drove $4B at AstraZeneca.

What will she do for Mylan?

A commercial leader, a woman, and a scientist walk into Mylan… And they’re all Adele Gulfo.

Adele is Executive VP and Head of Global Commercial Development at Mylan, one of the world’s leading global generic and specialty pharmaceutical companies. Being both a scientist and a corporate leader is unusual in the industry. Need we mention that she is also notable as a woman who is both? But that’s just the tip of the iceberg in her rather breathtaking career.

At AstraZeneca, she was Vice President of Healthcare Innovation and Corporate Strategy and Vice President of Business Development and Design. She grew Toprol-XL sales from $200 million to $2 billion and launched the cholesterol-lowering medicine, Crestor, bringing it to over $2 billion in a highly competitive market. She led the AstraZeneca Healthcare Innovation Center, which drove business growth and improved the delivery and management of healthcare. She collaborated with numerous sources— venture capital-backed startups, global giants, research institutions, technology players—to develop the mission of the center: to improve the patient experience through earlier diagnosis, broader treatment options, improved adherence, and enhanced interventions.

Following that, at Pfizer, she served as President of US Primary Care and Regional President of Latin America in the Emerging Markets Business Unit. Under her, their Latin American business achieved more than $3 billion in revenue.

She developed the medical and public education campaigns and the launch for Lipitor, another cholesterol-lowering agent that became the world’s most successful medicine.

And that’s not even counting her positions at Warner-Lambert, where she partnered with the American Heart Association, the National Institutes of Health, and leading academic institutions in developing award-winning medical and public education programs that helped to establish the significance of lowering cholesterol in preventing and managing heart disease.

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Today, she also serves as Director of Bemis, Inc., a global supplier of flexible packaging used by leading healthcare and other companies worldwide. She is a member of the Industrial Advisory Board at Cleveland Clinic Innovations, an innovation adviser to Partners HealthCare, and a Director of Volunteers of America, Greater New York, Inc. Through its hundreds of human-service programs, Volunteers of America supervises over 55,000 people who affect the lives of over two million in more than 400 communities in forty-six states, Washington, DC, and Puerto Rico.

“We build schools; we teach people who have lost their way,” she says.

“It is about helping people get on the right path.”

But we’re not done yet. She has been awarded five U.S. patents for innovative packaging designed to

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EXECUTIVE SPOTLIGHT help patients adhere to their medicines. She frequently speaks at leading industry and business conferences, including The Wall Street Journal’s Women in the Economy: An Executive Task Force conference, and has been featured in Fortune, Forbes, BusinessWeek and the Wall Street Journal. She is a member of the C200—the preeminent organization of women business leaders—the National Association of Female Executives, and the Healthcare Businesswomen’s Association. Adele is especially proud of receiving the 2012 C200 Luminary Award for Corporate Entrepreneurship.

WHAT CHALLENGES ARE LEFT? PLENTY Adele Gulfo is far from finished. In fact, she has barely taken a breath.

At Mylan, she is examining not just basic treatment, but the broader area of assisting patients in improving their health and wellness.

Adele is helping COPD patients to manage their condition. She tells us that “One way is by developing phone apps that monitor breathing daily, ask how patients are feeling, and provide feedback to their HCPs.” Another area of focus is diabetes.

“Healthcare systems need to make sure these patients stay healthy by adhering to their course of therapy,” she notes. “It’s also in the best interests of the industry, which has had to pay $500 million in penalties for hospital readmissions within 30 days. Patients respond to positive reinforcement, and there are apps that do that, as well.”

She points out that the American Heart Association looks for companies that measure clinical data, and have metrics to prove the value of their apps. “Venture capitalists have invested $3 billion in first half of 2017 in digital health, so you know something is working there. We can’t keep blaming cost of medications for non-adherence.

There’s a lot more to the equation.”

She refers to Mylan’s corporate culture as “wonderfully unconventional” in its dedication to patients.

“Mylan is a cause, not just a company.”

One of the things that drew her to Mylan was its focus on people.

She refers to Mylan’s corporate culture as “wonderfully unconventional” in its dedication to patients. “Mylan is a cause, not just a company.” Evidence of this is that “more 40% of people globally living with HIV/AIDS who are receiving treatment depend on a Mylan product.” Mylan is also active with public policy, advocacy organizations and government, helping to provide access to treatment.

SUPPORTING STEM Not surprisingly, she is also a passionate advocate for women getting STEM (Science, Technology, Engineering and Math) educational opportunities and going on to work in pharma. Although

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women are 46% of the U.S. labor force, they comprise only 26% of the STEM workforce, and of course even fewer in the executive ranks. “To address this problem, intervention is required at the grade and high school levels,” Adele says. “Hands-on experience that excites and entices must spark initial interest and make a STEM education a desired pathway for female students. Having obtained their undergraduate and graduate degrees in STEM, we need young women to see female role models who have leveraged their STEM training to secure vital, powerful and influential C-suite roles. If you can’t envision it, you can’t pursue it. I know from firsthand experience, sharing my personal story with female science majors, the dramatic eye-opening impact we can offer.”

The U.S. Bureau of Labor Statistics indicates that STEM occupations, on average, earn higher salaries and have higher employment rates than non-STEM jobs. What Adele finds more exciting is that “STEM education and job experience can be leveraged to secure corporate leadership positions and boardroom spots, where we also see a significant shortage of women.”

Adele sees this effort as having wide-ranging implications for all of society, not just female STEM students or the healthcare industry. “For example, until women researchers became involved, mastectomies, not lumpectomies, were the mainstay of breast cancer treatment. Without women researchers, we would not know HIV to be the virus that causes

AIDS. Before women scientists engaged in cardiovascular research, it was not considered a major health threat to women. We now know that cardiovascular disease is the number one killer of women, but drugs were developed for men— animal models used to select and advance drug candidates were not tested in female mice. Yet, pathophysiologically, there are significant differences between men and women that only recently are being explored, again, because of the involvement of women scientists.”

IT BEGAN EARLY How did she become inspired to achieve all this? “When my father, who was a mechanical engineer, observed my interest and aptitude in math and science he quickly became my biggest champion,” she says. “His support of my achievements and positive reinforcement throughout elementary, middle and high school provided the initial catalyst for me to pursue STEM education. This combined with growing up in New Jersey, the ‘nation’s medicine chest,’ made a career in STEM not only attainable, but also, desirable. Again, if you can’t see it, you can’t pursue it.”

“I now see the inflection points where intervention can be critical for women: advocating for yourself, taking risks, working outside your comfort zone, making personal sacrifices, and seeking stretch assignments and special projects”

She started out at academic institutions and research labs in serious scientific roles, but also saw the importance of understanding the business side of medicine. “My foundation in science gave me the discipline, problem-solving skills and intellectual curiosity to pursue a career in the pharmaceutical industry.”

But she got a lot of pushback from people who felt a scientist was not qualified, didn’t understand marketing or sales, and had the wrong skills for corporate leadership.

Fortunately, she didn’t take that seriously. She saw how to commercialize products, and, more important, how to expand therapies to larger populations of patients.

Going back to school for her MBA, she emerged fully prepared to helm launches of some of the most famous brands we know today.

She found her voice in corporate meetings, realizing what skills she could bring to the table—understanding the science and connecting with opinion leaders. Launching Lipitor gave her the insights into how to bring a product to market and assume a strategic role. “It was a heady experience, to influence the life of millions,” she says. That experience motivated Gulfo when she decided to make the jump to Mylan, She was inspired by the company’s mission to deliver better health for a better world.

“From my current perspective, I now see the inflection points where intervention can be critical for other women,” she says. “These include advocating for yourself, taking risks, working outside your comfort zone, making personal sacrifices, and most important, seeking the stretch assignments and special projects that get you noticed by a broad range of people in the company.”

She has noticed that women

frequently don’t ask for what they want or can accomplish in corporate America. Adele believes that this will change with the emerging coterie of role models for STEMinclined women.

One of those is Mylan CEO, Heather Bresch, who has inspired Adele. “At Mylan we have a bold mission: to provide the world’s 7 billion people access to high quality medicine. We know this is possible if we continue to encourage half the talent pool not to sit on the sidelines, but to be captains on the field.”

THE FUTURE OF THE INDUSTRY Adele Gulfo has a multi-faceted vision for how we must go forward.

Just a few of her key observations: • The blockbuster model is not sustainable, and the industry faces heightened regulatory hurdles, pricing pressures, and challenges to its reputation • We are finally moving to more value-based care, which will be supported and enhanced by technology and innovative thinking • Women empowering and supporting one another is more important than ever, and their advancement in all industries will help everyone • She wants to make people inspired to come to work every day.

She describes the work they do at Mylan as “personal” and “meaningful” and considers it an honor to be part of a company so aligned with her own values She says of her outlook, “You have to want to save lives around the world. It is not just about your product. You need the powerful culture of a purpose-driven company. That’s the true beauty of Mylan. Making a positive impact around the world really is personal to everyone who works here.” •

HS&M DECEMBER 2017/JANUARY 2018| 12

ROUNDTABLE

Containing Costs: How We’re All Involved Our panel of experts: BRENT SAUNDERS Chairman, President and CEO Allergan

JESSICA GROSSMAN, MD CEO Medicines360

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MICHAEL BANKS, MD President MDea and The Doctor’s Channel

PETER PITTS President Center for Medicine in the Public Interest

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ROUNDTABLE There is no hotter topic in healthcare than the overall costs incurred by all involved, especially the patients. In fact, it’s one of the most complex, confounding, and contentious issues on the national landscape today. And it involves healthcare companies, insurance providers, government agencies, advocacy groups…not to mention all of us consumers. As is often noted, healthcare currently represents about 18% of U.S. GDP, projected by the CMS to rise to 20% by 2025. This is significantly more than any other industrialized country, and needs to be brought under control.

Obviously, in sales and marketing, we cannot directly impact all the influences on healthcare costs, but we can wrestle with some of them. We do this both as professionals and as citizens, especially out of concern for the investment in our personal health and that of our families. We face these issues every day because our companies suffer both the effects of rising costs, and the negative PR that attaches itself to our industry, often unfairly.

To tackle this Gordian knot of challenges, we have reached out to a wide variety of knowledgeable people across the industry for their wisdom.

Unlike our usual roundtable, which includes a list of questions that all panelists are invited to answer, we set down just the major one for this article: how can healthcare costs be reasonably handled, by all parties involved? Each of our contributors approaches this from a unique point of view, so we present here a wide range of solutions.

We hope this is informative and inspirational to you. It’s something we cannot ignore, and must engage with if we are to improve our effectiveness, profitability and image.

Our thanks to this distinguished group of experts who have offered their thoughts on a very complicated topic.

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FOCUS ON THE SOCIAL CONTRACT

BRENT SAUNDERS Chairman, President and CEO Allergan

“I believe pharmaceutical companies have a social contract in America, to make sure we continue to invest money in R&D, to raise drug prices in a very responsible way, and make sure we can grow our business for our shareholders. And I believe all those things can live in harmony, and in the vast majority of the pharmaceutical industry they actually do.”

That was my spontaneous answer to a question about our industry, thrown at me by Jim Cramer, when I appeared on his show Mad Money.

Shortly afterward, on vacation with my family, I found us engaged in a discussion about what “social contract” meant. I started thinking about industry’s commitment to finding equilibrium between the need to invest in innovation and pricing treatments so they are accessible and affordable. Then I shared the idea with my colleagues Alex Kelly, EVP Corporate Affairs and chief communications officer; Bill Meury, EVP and chief commercial officer; and Bob Bailey, EVP and chief legal officer and corporate secretary. There was enough enthusiasm about what it meant that the concept just snowballed.

Like most of us, I think pharma doesn’t deserve the bad press it gets when one or two outliers make bad or greedy decisions. I

RAMPANT DRUG PRICES

LIMITED ACCESS CONFUSING INFORMATION REGULATORY UNPREDICTABILITY

also think that the industry needs to showcase the good it does. I didn’t mean to become the avatar of this idea, though, which is why I kept conversations about it informal at first. But we did start to consider what an industry code might look like, or maybe just a standard for Allergan.

Moving up the chain, we got buyin from the executive leadership team, then the board of directors, and there was enough approval

and momentum that we ultimately wanted to share it with our 18,000 employees. (Executives from other biopharmaceutical companies seem to think we had a committee and a deliberate strategy to put this thing out. Wrong. If it had happened that way, it would have been a gargantuan undertaking dragging on for months or years.)

On Sept. 6, 2016, I put up a post to my CEO blog with the contract in it. The next day we had one of

our quarterly town hall meetings.

And I saw how the employees really connected with the contract and the pride they had from their company taking a position on important issues. That definitely ranks as one of the most gratifying experiences I’ve had in my biopharmaceutical career.

Sending notice to our B2B customers, pharmacy benefit managers (PBMs) and health insurers, I thought it might get some additional comment. But I never

HS&M DECEMBER 2017/JANUARY 2018| 16

ROUNDTABLE expected it to go global, as it did.

We heard from our field sales force, and their customer physicians. At the American Academy of Ophthalmology (AAO) annual meeting a few weeks later, I had hundreds of customer interactions, and almost everyone was aware of the contract, most pointing to the commitment of not increasing drug prices beyond 10 percent. But that’s only a small piece of it, and there are many other important items. The single-digit-annualprice-increase became the headline, but there’s so much more.

You can read the contract at the link above, but here are the Cliff Notes. It’s built on four principles: • Invest and Innovate—identifying needs, invest in life-enhancing innovations, use our Open Science model to access inventions outside of Allergan, rewarding all the partners involved • Access and Pricing—commit to making our branded treatments accessible and affordable while meeting the “invest and innovate” target simultaneously; do not engage in price gouging; limit price increases to single digits once a year; and more • Quality and Safety—monitor the safety before and after submission to regulators; act on new safety data immediately; keep the supply flowing through proper manufacturing capacity • Education—for physicians, so that our medicines are used for the right patients under the right conditions The contract now has a life of its

own. Novo Nordisk, AbbVie, Eli Lilly & Company, and Valeant Pharmaceuticals have adopted it, and Merck and J&J have their own versions. We want others to one-up us, so that it evolves and improves all the time. It’s either that, or we leave the task of cost containment to government. And no one wants that.

It’s not a hard concept to understand or endorse: price medicines in a way that makes them accessible while providing sufficient profit to encourage future investment.

Innovation. Lower overall cost or damage of disease. An appropriate return on capital.

And, honestly, I think there’s little downside. “Risk” is deciding what R&D projects to fund, what acquisitions to make, which people to hire or promote. Doing what is right and standing up for what you believe in is not a risk. It’s a benefit—to everyone.

A NON-PROFIT MODEL TO HELP KEY POPULATIONS

JESSICA GROSSMAN, MD CEO Medicines360

The need for better women’s health care is critical. In a recent Kaiser Family Foundation study, disturbing facts appeared. Approximately one in five women ages 18-64 were uninsured (18%). Four in ten lowincome women had no insurance.

One in four (26%) had to delay or forgo care in the past year. Nearly two-thirds (65%) of uninsured women, 16% of women with private insurance and 35% of women with Medicaid said they delayed

17 | HS&M DECEMBER 2017/JANUARY 2018

or went without care because they could not afford it. Nearly three in ten women have had problems paying medical bills in the past year (28%). Many women can’t find the time (23%) or take time off work (19%) to get their care. Onequarter of all women, regardless of income, reported that lack of time to go to the doctor was a reason they went without care.

Patients can often face challenges in accessing the medicines they need. Industry has long worked to provide solutions and ensure patients can access medications, but existing models don’t always work—for patients or for the health system. Innovative models are needed to ensure all patients have access to the medicines and the life-changing health benefits they provide.

Medicines360 has pioneered a new business model: we are a mission-driven, global non-profit pharmaceutical company working to ensure cost doesn’t stand between women and the medicines they need. Medicines360 reinvests proceeds from our IUD to make it available at a very low price to safety-net clinics and eliminate the cost barriers that too many women face. Our self-sustaining model is designed to achieve important public health benefits.

The power to avoid unintended pregnancy is essential to women’s health. In 2011, forty-five percent of the pregnancies in the U.S. were unintended, accounting for 2.8 million pregnancies annually.

Reducing the rate of unintended pregnancy is a national health goal.

Not only may unintended pregnancies have negative financial impacts on the lives of individuals, but they also pose a significant financial burden to society. Sixtyeight percent of the births resulting from unintended pregnancies are paid for by public insurance programs, primarily Medicaid (based on data from 2010). Annual government expenditures resulting from unintended pregnancies equal $21 billion annually.

For a range of social and economic reasons, most individuals and couples want to plan the timing and spacing of their childbearing and to avoid unintended pregnancies, which also have a public health impact: births resulting from unintended or closely spaced pregnancies are associated with adverse maternal and child health outcomes, such as delayed prenatal care, premature birth, and negative physical and mental health effects for children.

For these reasons, reducing the unintended pregnancy rate is a national public health goal. We’re working on it, and we are encouraged by the work of others who are addressing the myriad women’s health issues in the U.S. and worldwide.

REFERENCES: www.guttmacher.org/factsheet/unintended-pregnancyunited-states www.guttmacher.org/sites/ default/files/report_pdf/publiccosts-of-up-2010.pdf www.cdc.gov/reproductivehealth/unintendedpregnancy/pdf/ contraceptive_methods_508. pdf

EDUCATE, EDUCATE, EDUCATE

MICHAEL BANKS, MD President MDea and The Doctor’s Channel

Pharmaceutical and biotechnology companies have myriad opportunities to mitigate cost pressures facing the U.S. health system.

These cost drivers have been well documented and include increasing expenses for physicians and hospitals, higher drug prices, use of expensive technologies, fragmented care, unhealthy behavior, and lack of alignment of incentives within solution providers.1 Healthcare companies can deliver programs to patients, providers, and payers that focus on prevention, drive appropriate use of (and adherence to) medication, increase transparency in drug costs for both physicians and patients, focus on evidence-based medicine and long-term outcomes, and facilitate physician understanding of the costs of care.

The healthcare community has promoted and enrolled patients in unbranded disease state awareness programs (eg, asthma.com, arthritis.com) and can provide support for non-profit initiatives that have potential to prevent disease and reduce costs. These initiatives can include education on health topics such as nutrition, exercise, mindfulness, other lifestyle interventions, and the importance of vaccinations. The utilization of new technology can play a leading role, as evidenced by UnitedHealthCare’s deployment of a wellness program called Motion,

where users can earn rewards of up to $1,500 in healthcare credits for activities completed on their Fitbit Charge 2 wearable fitness device.2 Supporting educational programs for physicians and access to price transparency for patients can help improve decision-making.

We recently partnered with two organizations focused on delivering information on costs of care and transparency along the care continuum. Amino (Amino.com) provides free access to a searchable database of the costs of procedures performed by nearly every doctor in the U.S., aggregated from billions of Medicare and private insurance reimbursement claims.

Costs of Care (costsofcare.org) develops and curates educational materials that aim to help clinicians make decisions that deliver better care at a lower cost. Costs of Care, in partnership with the University of Chicago, has developed four free, CME-accredited, 15-minute modules to support clinicians in their efforts to deliver high-value healthcare to their patients. The modules demonstrate common pitfalls, as well as practical solutions, in having cost conversations with patients and colleagues.3 Topics of the courses include: • First, Do No (Financial) Harm: Having Value Conversations with Patients • GOTMeDS: Having Value Conversations with Patients about Medication Costs • Value Conversations with Clinicians

HS&M DECEMBER 2017/JANUARY 2018| 18

ROUNDTABLE • Costly Conversations: Having Value Conversations with Supervisors and Consultants

MAKE THE FDA PREDICTABLE AND INNOVATIVE

Clinicians who complete all four parts of the Costs of Care “Value Conversations” training will have their accreditation acknowledged on their Amino doctor profile on amino.com.4, 5

President Center for Medicine in the Public Interest

As a society, it is important that physicians and patients have appropriate education and access to tools to ensure they understand the costs of treatment and the value of the care that is delivered.

REFERENCES: www.beckershospitalreview. com/finance/9-drivers-of-highhealthcare-costs-in-the-u-s. html 1

www.cnbc.com/2017/01/05/ unitedhealthcare-and-fitbit-topay-users-up-to-1500-to-usedevices.html 2

www.thedoctorschannel.com/ view/costs-of-care-cme-module-1/ 3

https://amino.com/blog/finding-doctors-who-know-howto-have-the-cost-conversation/ 4

www.modernhealthcare. com/article/20171024/ NEWS/171029941/low-valuecare-persists-five-years-intochoosing-wisely-campaign 5

PETER PITTS

Dr. Scott Gottlieb’s still nascent tenure as FDA Commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy—predictability and imagination.

Let’s start with predictability.

Generally speaking, regulators love ambiguity. It gives them almost limitless authority. But there are significant unintended consequences, not the least of which is the resultant lack of confidence by innovators to invest in new and more complicated development programs writ large, and specifically those for non-biologic complex drugs (NBCDs) and biologics.

Minus a brightly lit regulatory pathway, the costs associated with these products will not come down anytime soon. The Gottlieb FDA has made bringing first-to-market generics and biosimilars a priority.

Bravo. When people ask how the FDA can impact drug costs, this issue is at the top of the list—and it’s due in no small part to Dr. Gottlieb’s understanding that a predictable FDA process facilitates speedier marketplace competition.

“Imagination” and “Regulatory Policy” are not often used in the same sentence. But, the Gottlieb FDA is changing that. Scott recognizes that the agency must advance their relationships with the indus-

19 | HS&M DECEMBER 2017/JANUARY 2018

tries it regulates. That doesn’t mean fewer in-depth reviews or strident actions. What it does mean is that the FDA is doing a better job being a first-among-equals intramural partner. From patient-focused drug development, to biomarker vetting, responsible off-label communications, new approaches to pain management, and the regulatory science required for validating real world evidence, Commissioner Gottlieb is steadily moving the agency away from it’s traditional angst in “not invented here” regulatory conversations. He’s not only imagining an FDA that is both regulator of and colleague with industry; he’s working to make it a reality.

Speaking to the Senate Appropriations Committee, Gottlieb announced the FDA is launching a Medical Innovation Access Plan designed to facilitate biomedical innovation. The Commissioner positioned the plan as a tool to lower healthcare costs by reducing expenditures on costly diseases.

“Ultimately, the most tangible way we’re going to reduce healthcare costs is by finding new and better treatments for vexing diseases like diabetes and cancer and neurodegenerative ailments like Alzheimer’s,” he said.

Gottlieb also suggested the initiative could lead to lower drug prices by reducing regulatory uncertainty and eliminating unnecessary regulatory costs. Drugs, Gottlieb said, “are priced to some measure of the cost of the capital—including the investment capital—that’s required to discover and develop them. And

Moving Forward FOCUS ON PRICING

FOCUS ON UNDERSERVED POPULATIONS

FINANCIAL EDUCATION FOR PHYSICIANS AND PATIENTS

the risk and time and cost of the regulatory process are a big part of that equation.” The Commissioner’s plan will include a “broad range of steps we’ll take to make sure that our own regulatory tools and policies are modern and risk based—and designed to facilitate the development of potentially breakthrough new treatments.”

One focus of the plan will be targeted drugs for rare diseases or disorders for which there is no effective therapy. Within six months, FDA will issue new guidance on the clinical evaluation of targeted therapies for rare disease subsets.

Per the Commissioner, “This new policy will address the issue of targeted drugs, and how we simplify the development of drugs targeted to rare disorders that are driven

by genetic variations, and where diseases all have a similar genetic fingerprint, even if they have a slightly different clinical expressions.” The guidance will clarify circumstances in which FDA may approve a cancer drug based on its molecular mechanism of action rather than the specific tissue or organ where tumors occur. It will also help sponsors develop drugs for rare subsets grouped by laboratory testing, so they can be studied in a single clinical trial.

Gottlieb also committed FDA to, within 90 days, clearing its backlog of 200 pending Orphan Drug designation requests. He said the agency would respond within 90 days to all future requests for the designation. As part of the plan, FDA will update guidance docu-

REGULATORY CERTAINTY

ments on clinical trial enrichment strategies and adaptive trial designs. The agency will also “take a fresh look” at policies to support the qualification of biomarkers and the use of pharmacogenomics in early phases of clinical trials.

Dr. Gottlieb’s intimate knowledge of the health industry psyche— viewed by some as his greatest flaw—is actually his most unique and important asset. He recognizes that predictability is power in pursuit of the public health and, in imagining an FDA that can (indeed must!) color outside the lines, pays heed to Bertrand Russell’s maxim that, “Science may set limits to knowledge, but should not set limits to imagination.” •

HS&M DECEMBER 2017/JANUARY 2018| 20

ROUNDTABLE

MEET OUR PANEL OF EXPERTS BRENT SAUNDERS

JESSICA GROSSMAN, MD

Chairman, President and CEO Allergan

CEO Medicines360

Brent Saunders is Chairman, President and Chief Executive Officer of Allergan plc. He has served as a Director, CEO and President since July 2014. He was elected Chairman in 2016. Previously, he served as Chief Executive Officer and President of Forest Laboratories and as a Director of Forest since 2011. Prior to that, he was Chief Executive Officer of Bausch + Lomb, a leading global eye health company. Brent has also held several leadership positions at Schering-Plough, including President of Global Consumer Health Care, and was named head of integration for the company’s merger with Merck & Co. and for ScheringPlough’s acquisition of Organon BioSciences.

He has also been head of Compliance Business Advisory at PricewaterhouseCoopers LLP, Chief Risk Officer at Coventry Health Care and Senior Vice President, Compliance, Legal and Regulatory at Home Care Corporation of America. Brent serves on the Board of Directors of Cisco Systems and RWJBarnabas Health, and is a member of the Business Council and PhRMA.

ALLERGAN PLC, headquartered in Dublin, Ireland, is a global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

21 | HS&M DECEMBER 2017/JANUARY 2018

Jessica Grossman, MD, is the CEO of Medicines360, and a board member since 2011. Jessica is a seasoned industry executive with a proven track record leading successful women’s health companies. As a medical technology executive, she brings a wealth of experience in product development and commercialization and the ability to accelerate profitable business models. Prior to joining Medicines360, Dr. Grossman served as president and Founding CEO of Sense4Baby, Inc., where she closed a $4-million series A investment and within 18 months of joining the organization led the company to a successful acquisition following FDA clearance, CE mark, and early commercialization. Dr. Grossman was also Founder and President of Gynesonics, an early stage medical device company focused on minimally invasive solutions for women’s health, where she raised over $22 million in venture capital financing. Under her leadership, they invented and developed the first intrauterine ultrasound guided radiofrequency ablation device for fibroid tumors. She has also been a Medical Director at Ethicon Endo-Surgery. She holds numerous patents and has published several peer reviewed articles. jgrossman@medicines360.org

MEDICINES360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. www.medicines360.org

MICHAEL BANKS, MD

PETER PITTS

President MDea and The Doctor’s Channel WAVE Life Sciences Ltd.

President Center for Medicine in the Public Interest

Michael Banks, MD, attended the University of Connecticut for medical school and completed his residency in internal medicine at the University of Chicago Hospital. But then he left clinical medicine for a career in medical education.

He is the president and co-founder of MDea, a creative medical education company in NYC, and The Doctor’s Channel, known as the “educational YouTube for doctors.” Michael serves as a Managing Director of BESTMSLs, a contract MSL organization, where he brings medical and technology expertise to field organizations. He is also one of the founders of the physician recruiting firm DrCruiter.com. Michael was selected as one of the “Best Doctors in America” (as voted by his mother, Ilene Banks).

THE DOCTOR’S CHANNEL has been providing a network of physicians with timely, practical and “to the point” content in the form of educational, lifestyle and free CME videos since 2007. The Doctor’s Channel creates and distributes content to HCPs and can provide physician level data on engagements. www.TheDoctorsChannel.com MDEA is a medical education company with a reputation as one of the most creative in the industry.

MDea provides meeting planning and content for various types of meetings (advisory boards, speaker training meetings, investigator meetings, and local dinner meetings), online, direct mail and rep-delivered sales and marketing tools, and video production services. www.MDeaNY.com

A former member of the United States Senior Executive Service, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management.

He served on the agency’s obesity working group and counterfeit drug taskforce and as a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, The Boston Globe, The Washington Times, The Chicago Tribune, The Chicago Sun Times, The San Francisco Examiner, Investor’s Business Daily, The Baltimore Sun, The Economist, Nature Biotechnology, The Journal of Life Sciences the BBC World Service, Fox News, and The NewsHour with Jim Lehrer, among others.

He is a Visiting Lecturer at the École Supérieure des Sciences Économiques et Commerciales, and has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University ppitts@cmpi.org

THE CENTER FOR MEDICINE IN THE PUBLIC INTEREST is a nonprofit, nonpartisan research and educational organization that seeks to advance the discussion and development of patient-centered health care.

COMMENT HS&M DECEMBER 2017/JANUARY 2018| 22

INNOVATION

Cleveland Clinic Top 10 Medical Innovations of 2018 Taking a great deal of pride in our industry, we like to run this annual feature showing the Cleveland Clinic’s Top 10 picks for the upcoming medical innovations expected to emerge in 2018. These are presented at the annual Medical Innovation Summit organized by Cleveland Clinic Innovations, the development and commercialization arm of Cleveland Clinic. The list is selected by a panel of Cleveland Clinic physicians and scientists. Amid the difficulties, controversies, struggles and challenges healthcare faces all the time in this country, it’s inspiring to step back and say Yes, we’re doing something that will change millions of lives. Yes, we have a purpose much greater than ourselves or our careers. Yes, what we strive for every day truly matters.

23 | HS&M DECEMBER 2017/JANUARY 2018

WHEN IT COMES TO CHANGING THE STANDARD OF CARE,

WHERE DO YOU START?

You start with courage. With insights and inspiration.

With the intent to actually change behavior, not just mindshare.

With the ingenuity and vision required to influence the actions of physicians, patients, and consumers.

STRATEGY | CREATIVE | ENGAGEMENT

When each one of these triggers align and deploy – that’s a

© 2017 precisioneffect. All rights reserved.

INNOVATION

1. Hybrid Closed-Loop Insulin Delivery System Hailed as the world’s first artificial pancreas, the hybrid closed-loop insulin delivery system helps make Type 1 diabetes more manageable. FDA approved in late 2016, this new technology enables direct communication between the continuous glucose monitoring device and insulin pump to stabilize blood glucose at an unprecedented level. The technology replaces the “open loop” concept that requires patient to use information from their continuous glucose monitor to determine how much insulin to inject. Experts are optimistic that the outcomes demonstrated in Type 1 diabetes will accelerate a similar product for Type 2 diabetes patients in the near future. https://youtu.be/A0kDqPCi1fU

2. Neuromodulation to Treat Obstructive Sleep Apnea

Sleep apnea, the most common sleep disturbance, impacts 21 million Americans and can lead to high blood pressure, heart disease and stroke. While the continuous positive airway pressure device, (C.P.A.P.) is the gold standard treatment, it is estimated that more than 40 percent of sleep apnea patients refuse to wear the device. Companies are now marketing an implant that delivers stimulation to open key airway muscles during sleep. Controlled by a remote or wearable patch, the technology acts like a pacemaker, helping to synchronize the intake of air with the action of the tongue. These neuromodulation systems have had positive results in clinical testing. https://youtu.be/cu1AeHUZIuY

3. Gene Therapy for Inherited Retinal Diseases In 2018, the FDA is anticipated to approve a new gene therapy for inherited retinal diseases (IRDs). The ability to deliver a new gene to targeted cells in the body via viral “vectors” is expected to provide visual function improvements in some patients with IRDs. Caused by biallelic RPE65 mutations, these rare genetic conditions result in progressive vision loss and blindness. Currently, there are no FDA-approved treatments for them. This innovative gene therapy delivers a “normal” working copy of the gene that results in a functional protein. Researchers place this gene inside a modified virus and this “vector” delivers it to retinal cells. In 2017, the FDA awarded orphan drug status to RPE65 gene therapy, and recently a panel of U.S. health advisers recommended approval for this approach. https://youtu.be/kFQyjnmKHro 25 | HS&M DECEMBER 2017/JANUARY 2018

The Industry’s Only Conference Covering Strategies to Build Disease Awareness Campaigns April 4–5, 2018

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INNOVATION

4. The Unprecedented Reduction of LDL Cholesterol Low-density lipoprotein (“LDL”) cholesterol is known as bad cholesterol, bringing about fatty deposits that can clog arteries. With certain new drug combinations, LDL levels are reduced by 75%. While this stat is remarkable, many patients and doctors wonder how low is too low? A number of trials have been in progress recently testing this theory. So far, the floor has yet to be found. New studies reported a 20 percent reduction in the risk of cardiovascular death, myocardial infarction or stroke for patients who took statins combined with a new class of cholesterol-lowering drugs (PCSK9 inhibitors) to reach ultra-low LDL levels. https://youtu.be/yHNl4hY7n-I

5. The Emergence of Distance Health Extending the healthcare environment to the patient’s home has been a goal for decades. Removing geographic barriers to care can result in timelier, more efficient, optimal outcomes as well as significant cost savings. Due to an increase in connectivity through mobile technology and consumer demand, hospitals are getting ready for widespread adoption in 2018. These technologies are also expanding beyond the simple two-way video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition. Over 19 million patients are projected to use these remote monitoring devices in 2018. https://youtu.be/fe0pYUXvM5Y

6. Next Generation Vaccine Platforms Developing just one vaccine is estimated to cost $200 million and take at least 10 years. The toughest challenges, however, often lie in timing and delivery. With the recent Ebola and Zika outbreaks, it was clear that the process needs to be expedited.

In 2018, innovators will be upgrading the entire vaccine infrastructure to support the rapid development of new vaccines, as well as breaking ground on novel mechanisms to deliver new and existing vaccines to vast populations. For example, innovators are perfecting the use of freeze drying vaccines which can allow shipment to more remote locations. Companies are finding faster ways to develop flu vaccines using tobacco plants, insects and nanoparticles. At the point-of-care, innovators are thinking outside the syringe. Oral, edible and mucosally delivered vaccines, intranasal vaccines, and vaccine chips are all under development. In 2018, a Band-Aid-sized patch for the flu vaccine is expected to be on the market. These new ways of developing, shipping, storing and vaccinating are being swiftly connected to stave off current and future diseases and epidemics. https://youtu.be/pHJChnGTd4A 27 | HS&M DECEMBER 2017/JANUARY 2018

PARTICIPATE AND GET THE FULL RESULTS!

HOW ARE YOU DOING $ALARY-WISE? We know this is a question most people ask themselves all the time, and we’re happy to provide you an answer by participating in our 2017 Compensation and Hiring Survey.

PARTICIPATE IN OUR 2017 COMPENSATION AND HIRING SURVEY HERE We are pleased to open our yearly survey where we poll key people in the medical device, pharmaceutical, and biotech sectors of the industry to determine compensation trends. The survey is completed in conjunction with Jacobs Management Group, Inc., a leader in executive search for the healthcare industry and all participants receive a survey summary so that you can see how you compare. Please click here to be taken directly to the five-minute survey.

The 2017 Compensation and Hiring Survey builds on the feedback from 2016 Survey, highlights of which were published in the FEBRUARY/MARCH 2017 ISSUE

issue of HS&M. Companies ranged in size from over $100B to over $10M, and over 80% of the respondents had titles of manager or above.

“We continue to receive accolades for this targeted industry report” says Jacobs Management Group, Inc. President, Cari Kraft. “Our results have become one of the key inputs into compensation benchmarks.”

All specific survey information and your contact information will be held in strictest confidence. We will email you with the results as soon as they are published.

COMPANY SIZE

For assistance building your team, please reach out to Cari Kraft ckraft@jacobsmgt.com or call Cari at (215) 383-3001.

INNOVATION

7. Arsenal of Targeted Breast Cancer Therapies

lead to the collateral damage of healthy cells.

The most full-scale attack on breast cancer is currently underway. The tried-and-true treatment mechanisms—via hormone therapy, chemotherapy and radiation—are still valuable options for prolonging life. But these treatments are often not enough to keep cancer at bay, and can also

2018 marks the year that targeted therapies are most widely used to treat breast cancer. A variety of new targeted treatments, such as PARP inhibitors for patients with specific mutations in BRCA1 or BRCA2, and novel CD K 4/6 inhibitors for ER-Positive/HER-2-negative breast cancer are having positive outcomes in clinical trials. Additionally, HER-2 targeted agents continue to show benefit in this subgroup of HER-2-positive patients. Experts believe the results from these studies are pointing to an increasing survival rate, and perhaps the eventual end of chemotherapy for a significant population of breast cancer patients. https://youtu.be/vlZy7aMVamU

8. Enhanced Recovery After Surgery

gery strategies, and delivering impressive results.

For decades, the pre-and post-surgery routine has been standard for nearly all procedures: no eating before surgery; use pain medications; and stay in bed during recovery. After substantial growth in hospital readmissions and an opioid epidemic, innovators are overhauling post-sur-

Several centers have been developing the concept of “fast-track” or “enhanced” recovery after surgery. Research indicates that ERAS (“Enhanced Recovery After Surgery”) protocol that permits patients to eat before surgery, limits opioids by prescribing alternate medications, and encourages regular walking reduces complication rates and speeds recovery. These protocols can reduce blood clots, nausea, infection, muscle atrophy, hospital stay and more. https://youtu.be/2B9WrtZFePw

29 | HS&M DECEMBER 2017/JANUARY 2018

9. Centralized Monitoring of Hospital Patients Hospitals have long struggled with “alarm fatigue,” when busy caregivers become desensitized to the constant noise emanating from cardiac telemetry monitoring systems.

Reports indicate that up to 44 percent of inpatient cardiac arrests are not detected appropriately. Centralized monitoring has emerged as the answer, as part of a “mission control” operation in which off-site personnel use advanced equipment, including sensors and high-definition cameras to monitor blood pressure, heart rate, respiration and more. Complex data are assimilated to trigger on-site intervention when appropriate while filtering out unimportant alarms. In 2016, results from the CMU’s first 13 months of using the standardized criteria were published showing that there’s real hope of reducing rates of redundant or less significant alarms while improving clinical outcomes. Since then, further innovation has yielded a system that can double the number of monitored patients per technician, improve clinical outcomes, and decrease communication transit times. https://youtu.be/AyJMK3hSU5w

10. Scalp Cooling for Reducing Chemotherapy Hair Loss

patients’ lists of worries.

Newly diagnosed cancer patients have a lot to process.

For women, the inevitable loss of hair is often one of the hardest. There is a new technology making its way to the U.S. that is looking to eliminate this problem from some

“Scalp cooling”—which works by reducing the temperature of the scalp a few degrees immediately before, during and after chemotherapy—has been shown to be effective for preserving hair in women receiving chemotherapy for early-stage breast cancer. The scalp cooling system was FDA approved in May 2017. https://youtu.be/CC8Z7ONcwrA

FOR MORE INFORMATION ON THE ANNUAL TOP 10 MEDICAL INNOVATIONS LIST VISIT: http://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations.aspx.

HS&M DECEMBER 2017/JANUARY 2018| 30

MEDICAL DEVICE

What If Digital Could Drive Revenue?

And overcome legal and regulatory issues? It can.

By Chris Bergstrom, Associate Director, Digital Health, The Boston Consulting Group & Bradley Merrill Thompson, Member, Epstein Becker & Green, P.C.

The whole healthcare industry is wrestling with how to handle the new world of digital capabilities. We know the benefits are there—we just don’t always know how to maximize them.

What if digital could truly drive revenue? What if regulatory, in the digital era, did not seem like such a high hurdle?

What if you could strategize the messaging precisely to each doctor? What if you could help them with psychographics, demographics, therapeutic best practices, and patient segment strategies? One HCP’s top patient issue about hypoglycemia might be diet, while another’s might be dosage. What if your sales reps’ calls were providing insight to their specific patient population? You can use digital to address all these concerns individually.

And, from a marketing point of view, what if you could use digital to show enhanced product differentiation, especially with respect to specific patient popu31 | HS&M DECEMBER 2017/JANUARY 2018

lations? Even down to evidence of drug interactions and patient profiles?

As a follow-on benefit, what if you could show payors value by demonstrating how medications are being used, and that they are paying only for drugs that are taken, minimizing fraud, waste and abuse?

Finally, what if legal and regulatory were your advocates, rather than your stumbling blocks? Adverse events are a major concern, but these vary with regard to real world evidence vs. clinical trials. What if you could work with legal and regulatory to present this evidence in its best light? And have the muscle and firepower to ask questions that would leap the hurdles?

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Cheryl MacDiarmid

Markus Leyck Dieken

President U.S.

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Head of Pharmaceuticals, Americas Region

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Bayer

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Jason DeGoes

Terri Young

Tolga Tanguler

Sue Mahony

David Blair

Executive Vice President, Chief Marketing Officer

Senior Vice President, Global Patient Solutions

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President, North America, Rare Diseases

Senior Vice President & President

Head of Industry

UCB

Teva

Bristol-Myers Squibb

Pfizer

Lilly Oncology

Google

See the full agenda at eyeforpharma.com/philadelphia

MEDICAL DEVICE Digital tools offer an opportunity to revolutionize care. The industry is desperate to offer new value to patients, providers and payors, and digital can unlock both clinical and economic outcomes.

Just as one example, digital tools can demonstrate optimal titration, tactics that promote adherence, symptom management and other value-added metrics.

So why aren’t we moving faster on this front?

One impediment is fear of regulatory consequences. The root of the problem is a lack of regulatory clarity. Without this, risk-averse organizations sit on the sidelines and watch entrepreneurs (painfully) navigate the way.

No doubt there are valid issues to manage and unknowns to navigate.

At the same time, at least some regulatory fears are rooted in myths rather than facts. By busting these myths, we can more confidently enter the digital health market.

TOP 5 MYTHS 1 Bio/pharma companies must report adverse events in any databases they touch.

2 Any bio/pharma software must be approved via a supplemental NDA. 3 Any clinical trial software will be regulated as a medical device.

4 Companion digital health developers always create regulatory risk for bio/pharma.

5 FDA wants to tightly regulate bio/pharma software.

WHY, IN THE INFORMATION AGE, DO WE HAVE THESE MYTHS? Establishing new regulatory guidance in the fast- and ever-changing digital landscape is understandably challenging for the FDA. Over the last several years, at the request of industry groups, the FDA has published several new guidance documents addressing such topics as mobile medical apps, products used for wellness and technologies that serve as digital accessories to medical devices. For some, these documents have been tremendously helpful. However, further clarity is needed, especially in areas related to bio/pharma.

For example, the industry wants to help doctors get the right patient to the right medicine at the right time.

Yet, although the FDA announced its intentions to publish a guidance document for clinical decision support software back in 2011, it’s not out yet. As of last July, FDA was predicting it will be out in 2018, seven years after they started. The pace of technology is simply outrunning the agency’s processes and resources.

Fortunately, new FDA Commissioner Scott Gottlieb recognizes the problem*. Over the summer, in a blog post the commissioner observed that FDA still owes industry guidance on several important topics. He emphasized the guidance will take the brakes off investment and innovation.

*For further comment on FDA guidelines, see Peter Pitts’ comments in our roundtable in this issue.

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Sometimes, encounters with the FDA on a specific fact pattern end up getting overgeneralized to other technologies to which they were never intended to apply.

While we wait for more clarity, we have no choice but to rely on an oral system of “folklore.” Each conversation is based on that individual’s perspectives. As the information is passed on through an organization, it tends to get simplified and the nuances of policy get stripped away. And sometimes, encounters with FDA on a specific fact pattern end up getting overgeneralized to other technologies to which they were never intended to apply. At the end of the day, the “rules” frequently get misunderstood.

Repeated often enough. These myths go unchallenged, and are accepted as fact.

LET’S BEGIN BY TAKING A DEEPER LOOK AT THESE REGULATORY MYTHS 1 Bio/pharma companies must report adverse events in any databases they touch.

What we’ve seen is that this is the number one digital health project killer. Companies seem scared to death that they will be held responsible for reporting any adverse event (AE) that could be gleaned even conceptually from any database the company touches. But that’s simply not true. It’s an overgeneralization of a rule that is much more complex and nuanced.

Despite the huge amounts of data around the world accessible through the Internet, the FDA has not chosen to make companies responsible for all they might be able to find. Instead, it limits companies’ responsibility to information (1) known to company representatives or (2) contained on company-sponsored websites.

Specifically, the FDA advises: “…applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them. However, if an applicant becomes aware of an adverse experience on an Internet site that it does not sponsor, the applicant should review the adverse experience and determine if it should be reported to the FDA...”

You can manage AE reporting responsibilities and at the same time pursue aggressive digital health strategies. For example, using structured data collection, such as menu choices instead of free text boxes, can avoid accidental AE collection, provided there is a medical opinion that the structured data cannot constitute an AE. On the other hand, understanding real-world evidence and patient preferences and concerns can be a powerful knowledge base for commercial and research purposes. If a company chooses to embrace this data, there are ways to efficiently and effectively manage reporting obligations. To avoid a misunderstanding, the company should communicate to the FDA their more aggressive data collection strategy.

The FDA is sophisticated enough to put that information in context and not overreact.

but it won’t be FDA-regulated as a medical device.

2 Any bio/pharma software must be approved via a supplemental NDA.

We are watching plenty of companies get software cleared through means other than a supplemental NDA, for example a 510(k).

There is a variety of pathways through the FDA for software. And it is a basic principle of the FDA that those pathways are available depending on the intended use of the software, as opposed to who the applicant is. A drug company submission will not be treated differently just because the submitter is a drug company. We are watching plenty of bio/pharma companies get software cleared through means other than a supplemental NDA, for example a 510(k). Consider, for example, Lilly’s Go Dose software and Sanofi’s My Dose Coach. For medical device software, the key is for the bio/pharma company to develop software that has a generalized intended use, not focused on only its own drug products.

3 Any clinical trial software will be regulated as a medical device.

This depends on whether the software is being evaluated for its safety and effectiveness. If (1) the software is not being evaluated, (2) the safety and effectiveness of the drug doesn’t depend on the software, and (3) the software is simply used in the data collection or management of the clinical trial, the software is not a medical device.

To be clear, in those instances the software typically will require some sort of validation under the bio/ pharma quality system, and may need to comply with things like electronic signature requirements,

4 Companion digital health developers always create regulatory risk for the industry.

The default mode for the industry is to treat every collaborator as a supplier, and then subject those companies to the supplier controls under Good Manufacturing Practices. But that instinct is unlikely to be a suitable approach when collaborating with digital health companies. Due diligence is important, but that doesn’t mean we are our brother’s keeper. There are plenty of instances in the law where we are not responsible for what others do.

There are ways to preserve enough distance to limit a company’s responsibility, but not saddle a software company with the burdens that apply to the drug manufacturer. For example, in many cases a healthcare company can take a minority equity position in an innovative startup company, and allow that startup company to grow and blossom without saddling it with the healthcare company’s quality system, advertising and promotion restrictions, or adverse event reporting requirements. This may allow the software company to focus on agile and quick iterations that struggle under traditional

HS&M DECEMBER 2017/JANUARY 2018| 34

MEDICAL DEVICE regulation. The healthcare company can then acquire more of the digital health company later on when much progress has been made and the strategic value becomes clear.

We are not advocating sleightof-hand. There are ways to do this honestly and legally, keeping enough distance between the two parties that the digital health company is allowed to have adequate freedom. This will require new ways of thinking about partnerships and business models.

5 FDA wants to tightly regulate bio/pharma software.

To be sure, there are individuals at FDA’s Center for Drug Evaluation and Research (CDER) who would like to regulate software more than companies would like, and in fact more than their colleagues in the Center for Devices and Radiological Health (CDRH). But on the whole, the FDA seems to want to take a light touch, and that view is picking-up steam under Commissioner Gottlieb. He has been adamant that software should be overseen with a light touch.

Further, over the last few years the FDA has already down-classified medical device data systems and several other forms of software. The agency is also granting so-called de novo requests to down-classify software in other cases, for example computerized behavioral therapy devices for psychiatric disorders.

And manufacturers of high risk medical devices are finding that digital accessories are no longer automatically subjected to the highest degree of regulatory control.

On the whole, the FDA seems to want to take a light touch, and that view is picking-up steam under Commissioner Gottlieb. He is adamant that software should be overseen with a light touch.

Many people at the FDA see great public health benefits to these technologies. This is frankly the most excited we’ve ever seen the FDA. They truly want to foster safe innovation that leads to better clinical and patient reported outcomes.

But the drug regulators at CDER and device regulators at CDRH operate fairly independently, making it difficult to ensure alignment.

This creates undue confusion and risk. Fortunately, industry leaders are reaching out to FDA to begin a dialogue on how we can achieve better alignment between the two centers.

AN APPROACH TO DRIVING DIGITAL BY BUSTING THE REGULATORY MYTHS IN YOUR ORGANIZATION Let’s say your company comes up with a creative, out-of-the-box digital health strategy that promises to greatly improve care for patients, but someone in the company raises a regulatory concern based on what they’ve heard. Does the project need to die?

Here’s a pathway that we’ve seen succeed in overcoming regulatory myths:

35 | HS&M DECEMBER 2017/JANUARY 2018

1 CHALLENGE: First, someone must respectfully challenge the doctrine. This can take courage, and often a trusted third party, such as a consultant, can effectively initiate this challenge.

2 RESEARCH: Get someone to research it. All law is written.

Anything that isn’t written isn’t law. It’s opinion. If it turns out that the doctrine is unwritten opinion, try to find where the opinion originated. Some sources are more credible than others, and above all, continue to probe deeper if you hear “because we’ve never done that” or “that’s how we’ve always done it.”

3 GET CREATIVE: Once you understand what is written, analyze whether there are nuances of the law that can be used to achieve the objective of the digital health strategy. Get creative in compliance.

Complex rules mean there is often a variety of approaches that can achieve compliance. Keep in mind, “we can’t” often can be overcome by implementing new processes or procedures.

4 BENCHMARK: If the law is too general and doesn’t answer your specific question, and you fear the FDA will take a contrary view, compare notes with your peer companies at trade associations or coalitions. Often, one company’s experience is quite different from another’s, and rather than base your strategy on only your company’s interactions with the FDA, see if you can base your strategy on the collective industry’s experience with the agency.

5 CONSIDER APPROACHING THE FDA: Evaluate the merits of seeking the agency’s viewpoint,

or proceeding based on the company’s existing information.

Be mindful that once you ask the question, an individual FDA employee’s answer will be difficult to ignore even if it may not align to the consensus FDA point-ofview.

6 APPROACH: If you determine FDA input is necessary, approach the agency in the right way. Start with an exploratory contact to assess the agency’s true views on a given matter. For example, a coalition might probe the FDA by saying “we think the agency’s position is X.” It is not unusual to then find that the coalition did not understand the agency’s position at all. Even an industry’s collective wisdom can be wrong.

7 DON’T BE VAGUE: Avoid overly abstract discussions. Put a fact pattern in front of the FDA to get a concrete answer. You’d be surprised how often the answer is one you didn’t expect.

8 ADVOCATE: Once you have figured out the agency’s true, current position, you can proceed or advocate for change if you disagree, but that is a topic for another day…

Bottom line, there is a systematic way to debunk a myth. Sometimes it’s easy. Sometimes it’s hard and takes time. But if you have a digital health strategy worth pursuing, and the only thing holding you back is an FDA uncertainty, it often makes sense to challenge historical understanding of regulatory policy. Patients’ lives are counting on digital health innovation, and you may just be surprised how passionately FDA agrees with that. •

Chris Bergstrom Associate Director, Digital Health, The Boston Consulting Group Chris directs digital health initiatives across large payer, provider, med tech and bio/ pharma companies. He leverages the best of BCG Consulting, BCG Digital Ventures, BCG Gamma Data-Science, and B.Capital to help clients formulate a strategy, build a solution, and jointly invest in greenfield ventures or new business units.

The Boston Consulting Group (BCG) partners with clients in solving the hardest problems challenging their businesses, and the world, by channeling the diversity of its people and their thinking, as well as a shared commitment to uncovering the truth.

The solutions they develop in partnership with clients transform not just companies but also entire industries and even segments of society. BCG has more than 90 offices in 50 countries, more than 14,000 employees, more than 900 partners, and more than 20,000 alumni.

Bradley Merrill Thompson Member, Epstein Becker & Green, P.C. Bradley counsels medical device, drug, and combination product companies on a wide range of FDA regulatory issues. He serves as Chairman of the Board of EBG Advisors, Inc., a Washington, D.C., based consultancy that takes a multidisciplinary approach to helping health care and life sciences companies navigate the many obstacles that they face. EBG Advisors is a network of international attorneys, regulatory affairs professionals, reimbursement experts, engineers, clinicians, quality systems advisors, and other professionals who specialize in providing coordinated guidance and solutions across various segments of the health care industry.

Epstein Becker & Green, P.C., is a national law firm with a primary focus on health care and life sciences; employment, labor, and workforce management; and litigation and business disputes.

Founded in 1973 as an industry-focused firm, Epstein Becker Green has decades of experience serving clients in health care, financial services, retail, hospitality, and technology, among other industries, representing entities from startups to Fortune 100 companies. Operating in offices throughout the U.S. and supporting clients in the U.S. and abroad, the firm’s attorneys are committed to uncompromising client service and legal excellence.

COMMENT

INDUSTRY TRENDS: BY THE NUMBERS Compiled by Cari Kraft, Jacobs Management Group, Inc.

$800M—$1.2B

Typical cost of a clinical trial The cost of clinical trials continues to climb, while the success rate of getting approval for a new medication is only around 12%.

Source: Research and Markets, Global Clinical Trial Management System (CTMS) Market 2017-2021

$102.43B Expected value of mHealth market in 2022 The mHealth market size is anticipated to grow at a CAGR of 32.5% from now to 2022, reaching over $102B. Source: Zion Market Research, “mHealth Market by Devices, by Stakeholder, by Service,

by Therapeutics, and by Applications: Global Industry Perspective, Comprehensive Analysis, and Forecast, 2014-2022”

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41

%

Women holding leadership positions in healthcare The healthcare industry leads all others in the advance of women in leadership positions, although women are 60% of the workforce, and represent over 50% of graduates in related studies. Still, women in all STEM fields are less represented across other industries Source: Source: LinkedIn, “The Lack of Female Representation in STEM Starts Early, And That Needs to Change”

2X Increase in chances of Type 2 diabetic patients getting heart disease Type 2 diabetes patients are more than twice as likely as the general population to get cardiovascular disease, and may live seven to eight years less. Making the situation worse, less than half of people with diabetes are aware of it.

Source: CMS (Centers for Medicare/Medicaid Services), Office of Enterprise Data & Analytics, January 2017

2 of 10 2 of the Top 10 in Deloitte’s Technology Fast 500 are healthcare companies Deloitte has ranked its 2017 North America Technology Fast 500, and found that two healthcare companies, Aratana Therapeutics and Theravance Biopharma US, make the Top 10, Aratana at a 31.24% growth last year, and Theravance at 21.426%. Seven others in the Top 10 were software companies, and one was in communications.

Source: Deloitte, “2017 North America Technology Fast 500.”

$23.88B

Projected size of genomics market by 2022 Markets and Markets anticipates that the genomics industry will grow from $14.71B in 2017 to $23.88B in 2022, at a CAGR of 10.2%. This will be driven by R&D activity, demand for personalized medicine, and shrinking costs of sequencing services.

Source: Markets and Markets, “Genomics Market by Product and Services (Instruments/Systems, Consumables, Services), Technology (Sequencing, Microarray, PCR), Process (Library Preparation, Sequencing, Data Analysis), Application (Diagnostics)—Forecast to 2022”

86%

COMMENT

Number of millennials who have health insurance The number of millennials who now have healthcare coverage tops 86%, with 85% saying it is absolutely essential or very important.

This is greater than the number with home internet access (74%) or a mobile phone data plan (66%). Most get coverage through the access provided by the ACA. Source: Benenson Strategy Group, “Millennials Sound Off on Healthcare”

HS&M DECEMBER 2017/JANUARY 2018| 38

PHARMACEUTICAL

Great Advice from Great Minds: Success Secrets from Michael Tremblay, President of Astellas Pharma Canada Michael shares why he has such a big smile

By Jill Donahue, Principal, Engage Rx

What were you doing in 1975? Maybe you were still just a twinkle in your father’s eye! Or maybe you, like Michael Tremblay, were wearing bellbottoms and rockin’ it out to Captain and Tennille! 1975 is when Michael started carrying the bag. Quick math, that’s 42 years that he has been contributing to the health of millions of people.

Enjoy the wisdom that comes from a look back at an esteemed career culminating with leading Astellas Pharma Canada as President and chairing Innovative Medicines Canada (similar to PhRMA in US). And find out why this was his best year yet!

WHAT MADE HIM LOVE HIS WORK SO MUCH? The penny dropped the first time he met patients and heard their before and after stories. After that, everything he did referenced back to the patient. Not only did it help him create great results for patients and his companies, it made him really enjoy what he was doing! And it just kept getting better!

39 | HS&M DECEMBER 2017/JANUARY 2018

WHY WAS THIS THE BEST YEAR YET? Michael said that at Astellas Pharma Canada, they are on the verge of something very unique; helping more of their people understand their purpose. And that is incredibly rewarding.

About three years ago he started a customer centricity initiative at Astellas. He brought in companies like Four Seasons, IBM and boutique companies with outstanding performance vs. larger competitors, to tell their success stories. This morphed into their patient strategy.

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PHARMACEUTICAL When they looked back at what they had been doing to be successful (they have had steady growth every year for 18 years!), they realized that they did something differently. This difference was rooted in their core value of patient focus.

They added Customer Centricity to their strategic core initiatives which were owned by leadership team. They did surveys and brought in patient groups. At the same time, US colleagues, unbeknownst to Michael, had independently converged on the same strategy. When they realized this, they began working together to co-develop their approach.

WHAT IS THE BIGGEST CONTRIBUTOR TO SUCCESS OF THIS INITIATIVE? Everyone is talking about being patient centric but not everyone is achieving the success that Michael is seeing. We asked him what is it that they are doing differently. He said that as much as this initiative was top-down driven to start, the strategies were built from their people up. Michael firmly believes that people must buy into customer centricity.

“When it comes to patient centricity, this isn’t an initiative, it’s a cultural shift,” says Michael.

It must be embedded within the organization. Building patient centricity as a cultural tenet has allowed it to flourish. As a testament to the success of embedding it in their culture, Michael reports that the number one thing we hear our people love is our focus on the patient.

IS CUSTOMER CENTRICITY A COMPETITIVE ADVANTAGE?

some impact on patients and they need to connect with that.

“Absolutely!” says Michael, “it’s one of our key long-term strategies. It also pays dividends in the short term as it’s a major driver of employee engagement at Astellas.”

“It’s not up to me to tell them their connection to their purpose. They need to identify it. Once they have identified that, then all the great ideas should be generated. I can’t do that for them,” says Tremblay.

This resonated with me. Just last month a top pharma rep said to me “You likely don’t remember but six months ago I was in your ‘Power of Purpose’ session at our NSM.” She went on to admit to me that, at the time, she was planning on leaving her organization. She had felt her patient-centric values were not in sync with her company’s values.

When she realized her company was putting their actions behind their words by helping the team connect to their purpose, she stayed. She was happy to report that she is now happier, more engaged and, not surprisingly, top sales rep in her region.

WHAT SHOULD OTHERS START TO DO DIFFERENTLY? Michael thinks that while the cultural shift to patient/customer centricity must be supported and modeled by leadership, it needs to be built by the people. When you empower your people around their purpose/the patient, great things happen. You can’t tell them to focus on the patient and what specific actions they should take to achieve that. Much better and more long-lasting ideas will be created by them once they connect with their purpose. Everything they do, in office or in field, has

41 | HS&M DECEMBER 2017/JANUARY 2018

He suggests you look at how to get people involved. Good news, he says, is that they are going to love it because it changes how they think about their work. Isn’t that what we are all seeking… to make a difference?

“The goal is that we would like all of our employees—every employee—to understand what they do to impact the patient and how they individually can help patients.”

To keep it alive, we need ideas generated from all the levels of the organization. If all our people are thinking about ideas, they WILL be generated. Empowering people around their purpose is the key to success.

WHAT IS HIS VISION FOR THE FUTURE? He narrowed it down to three things: 1. Short term wins are that employees will jump all over this initiative and find their stronger purpose. They will be even more engaged.

2. Creative ideas that we never thought possible will be generated and acted upon.

3. Patients will trust that Astellas is with them on their journey and a new relationship will evolve.

Mike Tremblay Interview—EngageRx

WHAT SHOCKED HIM ABOUT A RECENT INITIATIVE DONE

BY INNOVATIVE MEDICINES CANADA? Nearing the end of his career, Michael wanted to make sure he left not only Astellas in great shape but he felt a duty to give back to the industry that had served him and his family so well. He stepped up to chair Innovative Medicines Canada.

The single biggest thing he was excited about was the initiative they undertook over the past year.

With the help of Ernst and Young, they embarked on a project to quantify the value that innovative medicines and the companies that develop them make, from an economic perspective. For the very first time they had a set of data that illustrates the economic footprint that member companies have on our country. Michael said:

“We were shocked—in a very good way—by the substantive contribution we are making to the Canadian economy.”

“Now that we know the impact our industry has on the economy of Canada, we can work with patients, healthcare providers and government to create an environment which serves patients and society optimally. This piece of the equation had always been missing. The hope is that this data will change the conversation.”

Michael will be retiring early in 2018. We would like to acknowledge and thank him for his incredible impact on our industry and his contribution to so many people both inside and outside our industry. Like a light from a bright star, the impact of Michael’s work will be seen for years to come! •

Jill Donahue Principal, Excellerate Author, Engage Rx: The 3 Keys to Patient-focused Growth Co–founder, The Aurora Project Jill, HBa, MAdEd, is a keynote speaker, author and thought leader who has authored two books on Influencing in patientfocused ways and cofounded The Aurora Project, a global patientcentricity group. She also serves as Associate Editor of Healthcare Sales & Marketing.

Jill.Donahue@ excellerate.ca

COMMENT

HS&M DECEMBER 2017/JANUARY 2018| 42

MOTIVATION

MOTIVIDEOS

By Cari Kraft, Jacobs Management Group Since our inception, one of the most-viewed features of HS&M has been Motivideos, a compendium of inspirational, informative and funny short pieces that can kick off a meeting and get your staff ready to face their challenges with brio. As a holiday gift to readers, here are a few of the most popular, most meaningful videos we’ve featured over our history.

Crazy or Genius?

Coaching for No’s

Inspirational (?) moments from some of your favorite movies, all blended together in one incomprehensible speech. Your staff will pick up on it and remember others.

Getting a positive or a negative response largely depends on how we frame a situation. Since we are wired to focus more on the negative, it takes practice to accentuate the positive. This is a great one for any manager or to use at a meeting.

We All Could Learn a Lesson From Her No matter what you think about positive affirmations, you have to admit that this feels good. What do you do to start your day? (Just be careful on that vanity!)

Validation An interesting short to get your team focused on more effective person-to-person communication in customer situations. An inspiration, a romance, a lesson in how to improve interactions, one smile at a time. Try it out yourself!

Submissions are welcome. If you have one you like, email a link to me at ckraft@jacobsmgt.com.

Cari Kraft leads a team of master level recruiters at Jacobs Management Group, celebrating 20+ years of executive recruiting in the healthcare (pharmaceutical, medical device, biotechnology) and high-tech industries, nationally. Prior to joining Jacobs Management Group, Ms. Kraft has held positions as a Senior Sales Executive, Director of Business Development and Director of Marketing. She also has deep knowledge of the technology/startup fields, having been in the industry through the rise of the Internet. Ms. Kraft is a University of Pennsylvania/Wharton alumnus holding a degree in economics and decision sciences. Cari can be reached at ckraft@jacobsmgt.com.

COMMENT 43 | HS&M DECEMBER 2017/JANUARY 2018

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Crazy or Genius?

Movie speeches to kick off conversation about get-up-and-go

We All Could Learn a Lesson From Her: Out of the mouths of babes oft comes wisdom

45 | HS&M DECEMBER 2017/JANUARY 2018

Coaching for No’s: How to change the focus to a positive response every time

Validation: Make a customer smile today

HS&M DECEMBER 2017/JANUARY 2018| 46

INDUSTRY

Why I Work In Healthcare

GRIT at the 2017 Healthcare Businesswomen Association’s Leadership Conference Women came together from all over the world to learn, grow and be inspired at the HBA conference in Philadelphia, November 6-8, 2017.

The theme of the meeting was GRIT (Gratitude, Resilience, Innovation and Trust), borrowed from the best-selling book GRIT by keynote speaker Angela Duckworth. Her journey from manager to teacher to psychologist taught her the value of this important trait. In the TED Talk below, Angela discusses how she came to realize, through research in all kinds of environments, that the primary predictor of success was grit: passion and perseverance for long-term goals. Talent, IQ, experience and other attributes count, but what makes the most difference is determination and follow-through over the long run.

Also exemplifying grit at the conference were these dedicated professionals, whom we recruited in our continuing campaign to show all the different ways people in healthcare contribute to the betterment of our profession and our world. •

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cement Advancement Advanc itment Commitmentto the Commi Congratulations ement 2017 HBA Engagement ACE Award HonoreesEngage

Advancement Advancement Bristol-Myers Squibb Network of Women (B-NOW) Commitment Commitment Engagement Engagement athenahealth Women’s Leadership Forum

ement tment ement

Advancement HBA’s ACE award Commitment recognizes stellar women’s Engagement

Advanc Commi Engage

leadership initiatives that strengthen the advancement, commitment and engagement of Advancement Advancement women’s careers in the Commitment Commitment healthcare industry.

Engagement

Engagement

Advancement Commitment View a list of previous ACE award recipients and learn more at HBAnet.org Engagement #HBAimpact #4GenParity

MARKETING

How Novartis Built a Stronger Brand in MS Therapy

By Jerry Allocca, Founder and CEO of Connected Culture, Inc.

Novartis, one of the world’s most prominent pharmaceutical companies, has a long, established history of successful marketing campaigns. Many of their consumer brands are household names: Benefiber, Ex-Lax, Excedrin and Keri Skin Care. They also market a long list of prescription pharmaceuticals and are known as a global leader in eye care and generic products. Among the many strengths of Novartis is their ability to leverage multiple marketing channels to reach target audiences and increase awareness of certain brands. This is certainly the case for their drug Gilenya, developed to treat symptoms of multiple sclerosis.

49 | HS&M DECEMBER 2017/JANUARY 2018

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MARKETING

Gilenya is the trade name for fingolimod, an immunomodulating drug that reduces the rate of MS relapses. First synthesized in 1992, the drug was approved by the Food and Drug Administration in 2010 as the first oral disease-modifying drug to reduce relapses and delay disability progression in patients with relapsing forms of MS. Today, Gilenya generates more than $3.1 billion in annual sales for Novartis and is ranked second for sales in its top 20 pharmaceutical products.

THE SHIFT TO DIGITAL MARKETING For many years, pharmaceutical companies, including Novartis, primarily focused on print advertising, in-office collateral and branded identity items to increase physician and patient awareness.

While having strong ad campaigns and a consistent collection of printed assets remain important, they now are only two components in an increasingly complex matrix

of marketing channels and digital initiatives required to stay competitive.

In the challenging field of healthcare marketing, patients now are bombarded by messages across online and offline channels. In other words, it’s no simple feat to break through the noise and deliver a message that resonates and propels potential users of the drugs to take the next step in their journey. Today, the most effective way to build a healthcare industry brand is to take an omnichannel approach to marketing that is driven by a clear goal of creating a consistently powerful and unified brand message across every channel.

MORE THAN MULTICHANNEL For most pharmaceutical and healthcare companies, it takes a proverbial village to manage the multiple marketing channels now in play. This typically involves cross-departmental effort and the talents of strategists, project man-

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agers, content producers, technical teams, legal experts and analysts.

With so many cogs in the marketing wheel, it can be very easy to slip into generating siloed marketing campaigns that at best aren’t congruent and at worst downright contradictory. In the case of Novartis’ campaigns for Gilenya, they use multiple social media channels, along with a dedicated website, patient forums and inoffice brochures, along with other marketing tools. This requires ongoing management and analysis to maximize return on investment (ROI).

DELIVERING A CONSISTENT MESSAGE ACROSS CHANNELS While Novartis is an expert in providing a consistent message, not every company is as skilled at the art of omnichannel marketing.

Inconsistent, multichannel marketing is one of the most difficult challenges facing today’s leading healthcare brands. With sprawling websites, a growing number

of social media channels, email campaigns, libraries of patientfacing content and more, it’s no wonder that messages often aren’t consistent and connected. Yet, this is what is needed to reach patients today and build brand loyalty that generates consistent revenue that supports ongoing research and development. The bar has been set high, and healthcare provider and patient expectations are only going to rise as new marketing channels continue to be introduced. The healthcare companies that can build logical, compelling journeys based on consistent, omnichannel marketing efforts have a distinct competitive advantage over those that continue to create disparate marketing campaigns.

FROM MULTICHANNEL TO OMNICHANNEL This leads to an important question. What is the best way to make the vital shift from providing siloed multichannel marketing to delivering seamless, omnichannel marketing? This is the challenge facing every healthcare brand.

It starts with making the commitment to shape every facet of marketing to guide the patient or healthcare provider on a consistent, well-thought-out journey.

While this can seem like an overwhelming goal to achieve, it can be accomplished with the right set of strategies and tools.

MEASURE DATA ACROSS CHANNELS Marketing has become incredibly data-driven thanks to the countless digital solutions that provide real-time analytics that can guide

business decisions. Yet, most healthcare companies are still analyzing data from each channel individually. Although, it’s important to understand the return on investment of each channel, there also needs to be a universal source of truth to gain a true omnichannel perspective. With digital channels, the line between service and marketing has been blurred. CRM and automation solutions, such as Salesforce and MS Dynamics 365, are now being integrated with contact center systems and marketing and sales operations to understand customer journeys that are likely to begin on a website and continue via a mix of digital and voice channels. Even channels that were considered to be focused solely on service, such as IVR systems, need to be considered in a broader marketing perspective because of the melding of marketing and service. Thus, it’s important to look at the big data picture, as well as drilling down into specifics of each channel.

LISTEN AND RESPOND By capturing data from every interaction across every channel, Novartis and others with omnichannel capabilities can understand and continuously track key journey patterns. Through customer journey mapping, messages can be refined and marketing campaigns can be fine-tuned for optimal success. Key points within journeys can also be identified where there are opportunities for cross-selling, up-selling or disseminating beneficial information.

Advancements in big data and predictive intelligence are enabling this to happen on a scale that has

never been possible before. For example, Salesforce is now using predictive intelligence to automatically personalize content by observing behaviors on websites, in emails and on mobile channels.

Using continuous machine learning algorithms, the right content can be predicted and distributed on the right channel to increase clicks, time on site, conversions and more.

With this information, journeys can also be optimized for value.

Data may indicate that patients seek information about a medication on a website but drop off if online chat isn’t available. A solution would be to provide a pop-up window on the most trafficked pages that directs patients to other communication channels or to a self-service knowledge center that provides answers to common questions. Another example would be a printed piece of collateral encouraging a patient to check out an online forum for more information and support. The key is identifying the most common journeys and ensuring that each step is optimized for the patient’s success.

This may mean modifying or even eliminating channels and touchpoints where there are frequent drop-offs. The key is keeping the conversation going in a beneficial way.

DEVELOP MESSAGING AND INFORMATIVE CONTENT THAT ADDRESSES SPECIFIC PROFILES AND THEIR JOURNEYS With this deeper level of understanding of consumer actions and decisions, Novartis and others are

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creating richer profiles in which to build targeted campaigns. For each primary journey type, they are considering what messaging and type of content will resonate with patients while always staying consistent and on target across channels.

STAY ON TOP OF NEW MARKETING OPPORTUNITIES WITHIN A GROWING NUMBER OF COMMUNICATION CHANNELS While there is still tremendous value in the doctor patient relationship, the conversation on the topic of a patient’s healthcare is now being held on many more communication channels. A patient may reach out with a question about a medication via a Facebook visitor post. If they want additional information, they will appreciate the ability to get answers via instant message or to be able to call directly from a branded Facebook page. New social media platforms

also are likely to be added to the mix. It’s important to be able to reach those patients who are using them.

There are also new technologies, such as chatbots and virtual assistants, which can find information and interact with patients via a chat interface. While not every patient may feel comfortable with this channel of communication, younger generations that have grown up around technology may prefer their speed and convenience.

An important part of omnichannel marketing is being able to identify the channels that are currently being used and those that are gaining or lagging in popularity. With this information, you can not only help build better patient journeys, you can also determine where to invest resources for more targeted and personalized marketing.

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MAKING IT WORK There is not one standard formula for building an omnichannel strategy. Particularly in the healthcare industry, what will work for one can be downright detrimental to another. For pharmaceutical leader Novartis, promoting Gilenya on select channels has been successful, and they continue to evolve the brand by adding new ways to communicate with patients. Today, Gilenya is used by nearly 30,000 MS patients in the United States.

And, Novartis has identified their responsibility to provide informative content, as well as marketingdriven messaging, for those with multiple sclerosis and their loved ones.

With omnichannel marketing, messaging and brand identity can be amplified by reaching consumers across channels. While this approach takes much more diligence in terms of ensuring consistency and clarity, it can deliver more powerful results and ultimately greater returns. •

the publication for healthcare sales & marketing leaders™ Jerry Allocca Founder and Chief Executive Officer of Connected Culture, Inc. Jerry is the founder and chief executive officer of Connected Culture, Inc. (www. connected-culture.com). In those roles, and as a nationally recognized authority on digital media, Jerry leads an award-winning team of internet specialists focused on helping clients, primarily marketing directors, develop attention-getting and revenuegenerating digital marketing programs.

He is also an author, teacher, trainer and frequent industry speaker on a range of social media and internet-related topics.

Jerry wrote “CONNECTED CULTURE: The Art of Communicating with the Digital Generation” (www.ConnectedCultureBook.com), a digital marketing playbook, as well as a series of free, plain-English e-books, ranging from “The Marketing Director’s Guide to Facebook Marketing Profitability” to “Why Aren’t We on Page 1 of Google?” Since 2012, he also has been a digital marketing instructor at Hofstra University Continuing Education. He is active in numerous charities, non-profit organizations, business groups and trade associations, including the International Association of Business Communicators (IABC), the Public Relations Professionals of Long Island (PRPLI), and The Direct Marketing Association of Long Island (DMALI.) In 2015, he was awarded IABC-LI’s “Communicator of the Year” award.

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CREATIVE STRATEGY

More Effective Creative for Teva and Syneron

By Stephen Neale, Senior Vice President, Executive Creative Director, AbelsonTaylor

Over the years I’ve read many industry articles in which creative directors (and clients) evaluate what they consider to be great work. Not just attractive or interesting, but creative that truly works. What I’ve always wanted to see is how that work came to be. How did the idea begin? How did it grow and develop?

Who strategy was involved?

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When I was first promoted to a creative leadership position, I was always looking (in vain) for content about how other teams were creating breakthrough work from the ground up, not just what the work looked like at the end.

So I’d like to pull back the curtain a bit on a couple of award-winning campaigns I’ve worked on. With thanks to our clients for allowing us to share the details, I’ll describe what the concepts looked like when they were “born,” how they were nurtured and developed into larger ideas, what was considered, kept or discarded, and how the concepts were eventually propelled into greatness.

TEVA ONCOLOGY FRANCHISE Teva was starting to expand its presence in oncology when the company approached us with a couple of therapies just being launched or in latestage development. The company really wanted to make a name for itself in the space, emphasizing its dedication to patients. Of course every pharma company wants to appear patient-centric, but Teva’s growth into a company with a full portfolio of oncology products provided substantive underpinning to the idea of being dedicated to patients. So our campaign goal was to establish that Teva is a company that sees through to the individual person within each cancer patient.

One of the ideas that caught our imagination in the first round of review was to create an anthemic statement from the patient’s perspective— something along the lines of “I can beat cancer”—and build around it. But that seemed a little, well, ordinary. And it wasn’t sufficiently focused on

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CREATIVE STRATEGY Teva’s goal of treating the individual—we wanted to bring out a connection with real, individual patients. And that brought us to the idea of roles. Cancer patients aren’t just patients, they are fathers and mothers, daughters and sons, sisters and brothers—real people with real names and families and others who care for them. So the question became how do we draw out and emphasize those personal roles in the context of oncology?

The answer, it turned out, had been staring us in the face all along. During one of our discussions, complete with all those long oncology terms, someone in the room noticed that the word mother could be found inside chemotherapy. And that became the foundational idea behind our campaign—finding the individual inside the verbiage of cancer and cancer treatment. So we set a team of copywriters to work finding names and roles within the language of oncology.

What I particularly enjoyed about this was that it became a pure thought exercise in language and creative copywriting. Many marketers, especially in healthcare, tend to think in terms of images first, which isn’t necessarily wrong because images can be far more engaging than words. Images can also be easier to get past regulatory review than words. But marketers can never forget how important language is, which was brought home to us as we turned our minds to the words of oncology and found all sorts of other words and names inside them. That offered Teva a way to communicate

that its interest in cancer patients goes beyond their disease, embracing the things in their lives that truly define them, such as their roles as mothers, pops, sisters and sons. It was—it is—a powerful and arresting statement.

But of course the words alone weren’t enough. We needed to find a way to place all this in a visual context that would complement and support it. Most importantly, we didn’t want the backgrounds or the colors or the photography to get in the way of those wonderful headlines. We started out with black and white photographs, but wanted something unique, something that would suggest people who might be going through chemotherapy or rebounding on the way back from aggressive cancer treatment. So that’s why we used soft color pushes in the final campaign images, to suggest that the individuals are returning to full vibrancy. And once the words and images came together, we knew it was right. We sent several ideas to Teva, but as soon as they saw this one they said, “This is it.

It’s perfect.”

SYNERON CANDELA ULTRASHAPE BODY CONTOURING UltraShape is a technology that uses ultrasound energy to noninvasively destroy fat cells in the body. When we first started working with the brand, our basic goal was to communicate how easy it is to get a flat stomach by using UltraShape to get rid of stubborn belly fat. But as our account plan-

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ners dug deeper into consumer insights, we realized there was more to it than just “easy.” People were willing to work for their dream bodies, in fact many were already killing themselves in the gym. But no matter how many crunches they did, they still couldn’t shed those last few pounds. Simply looking at a magazine rack can illustrate this point: six-pack abs galore, workout routines, diets, 10 steps to a flat tummy. It’s neverending because no one is achieving it and most of these regimens require a fair amount of commitment, some barely distinguishable from torture. Whereas UltraShape was easy—lay back, relax, do absolutely nothing for an hour, and let the doc melt your belly fat.

For something like this, comparisons can be a particularly powerful communication tool.

Our first idea was a straight comparison—on one side, three visuals of the “fitness pub” path to a flat stomach (crunches mostly), and on the other side, three visuals— before, during, and after—of the UltraShape process. The trouble was that it was too busy to be arresting. It was clever and could get a smile out of the viewer, if the viewer took the time to look at the whole thing. So we needed to find a way for it to be more visually engaging, more quickly.

Then came the idea of creating two separate ads, one a crunch demonstration and one for UltraShape, with the character from the first actually leaving her ad to go look at the UltraShape ad.

This, we thought, was both clever and arresting, but it was still a

little too complicated and had the major drawback of not being able to work well in multiple media.

Having a character move from one ad to another might look great in print, but doing it online or in a mobile setting would be difficult.

A side-by-side comparison still seemed like it could work, but everything we’d done was still too busy, and we wanted the visual to immediately drive home the fundamental insight of how easy UltraShape is. Then, in the course of developing the two-ads model and the research that went with it, we realized something important.

Our audience wasn’t just doing crunches, they were doing everything—the workouts, the diets, all of it—to get that flatter stomach.

We needed to simplify our message and use the power of every channel at our disposal to communicate our alternative to those extremes.

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The UltraShape campaign grew web sessions 15 percent, page views 25 percent, and visits to the UltraShape Physician Finder 29 percent What made this campaign work, I believe, was a combination of simplicity and real sympathy for its audience. We knew that people were going to all sorts of extremes to lose that last bit of belly flab, and that perhaps on some level they knew how extreme their actions were. So the campaign was half a good-natured tease, a little different in each channel, and half an offer of a better pathway to the same result.

SPEAKING OF RESULTS . . .

So we threw out all the “steps” and boiled it down to two remarkably similar images—the woman lying flat about to do crunches, and the woman lying flat about to undergo an UltraShape treatment. Both were shot from overhead, with the tagline, “Get a flatter tummy without flat-out torture.”

Simple, arresting, easy to understand. And unlike the previous iteration, this one was perfect for multiple media.

Since the two images were so similar, we were able to create a slider bar that online users could toggle to shift back and forth between crunches and UltraShape.

And we created short videos that compared the ludicrous popular physical routines of the moment—including the Hula Hoop workout and Bikram Yoga in 100-plus-degree temperatures—to the simplicity and ease of UltraShape.

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It bears repeating that the proof of good creative is the success of the campaign it supports. The Teva and UltraShape campaigns were successful because they quickly connected with people on an emotional level, made a memorable impression, were campaignable, and triggered a positive response.

The results were good by numeric metrics—the UltraShape campaign grew web sessions 15 percent, page views 25 percent, and visits to the UltraShape Physician Finder 29 percent. And the results were good by subjective measures—the Teva campaign, launched at the annual meeting of The American Society of Clinical Oncologists, received uniformly positive feedback

from physicians who attended the exhibit. The effectiveness of the campaign was perhaps best summed up by an oncologist from the Midwest who simply said, “I can never think about chemotherapy the same way again.” •

Stephen Neale Senior Vice President, Executive Creative Director AbelsonTaylor Stephen’s philosophy for a great creative campaign is simple—make a human connection. Connecting with customers is a common theme at AbelsonTaylor as Stephen, who leads a group of 90 award-winning creatives, continually encourages and mentors agency teams to push into new creative territory. He is frequently invited to judge awards competitions and occasionally writes articles on creativity for industry publications. Stephen joined AbelsonTaylor as a young designer seeking to make a difference, which he did early in his career with the Hytrin Balloon ad in 1993. The campaign, which used a water-filled red balloon clipped with a clothespin to communicate the feeling of an enlarged prostate, changed the face of medical advertising, lifting creativity out of its sameness and connecting with physicians in a powerful and whole new way. The campaign was inducted into the Medical Advertising Hall of Fame in 2015.

Stephen.Neale@abelsontaylor.com AbelsonTaylor is the largest independent medical agency-of-record in the world. Established in 1981, the company serves pharmaceutical, biotech and health-and-wellness companies, creating award-winning brand experiences in broadcast, print and digital. To learn more, visit abelsontaylor.com and follow the company on Twitter and Facebook.

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