February / March 2018

™ FEBRUARY/MARCH 2018

the publication for healthcare sales & marketing leaders™

ANNUAL SALES & MARKETING SALARY SURVEY IN THIS ISSUE Our Annual Compensation and Hiring Survey Roundtable: J&J, Shire, Sunovion and Others on Launching a Product Executive Spotlight: Shockwave Medical Founder on Innovation and Attracting $120M in Financing How Sanofi and Microsoft Use Tech to Help Medicine Allergan CMO on Unmet Patient Needs Integra LifeSciences On New Requirements for Medical Devices RB’s Mucinex Uses Augmented Reality A 2018 Industry Outlook: Recent Launches, Trials to Watch, M&A Activity, Top 10 Drugs and more

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the publication for healthcare sales & marketing leaders™

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

ARTICLES Executive Spotlight: Shockwave Medical Founder on Innovation and Attracting $120M in Financing.............................................................................................................9 Roundtable: Lessons on Launching ........................................................................................................... 15 Annual Sales & Marketing Salary Survey from Jacobs Management........................................... 25 RB’s Mucinex Uses Augmented Reality.................................................................................................. 35 Industry Trends: By The Numbers.............................................................................................................41 Sanofi and Microsoft on Tech Innovation and Medical Insight....................................................... 43 Motivideos: To Use In Your Meetings.....................................................................................................49 Why I Work in Healthcare............................................................................................................................ 53 Great Minds: Gavin Corcoran, CMO of Allergan.................................................................................. 55 Integra LifeSciences on New Requirements for Medical Devices.................................................. 59 2018 Industry Outlook: Recent Launches, Trials to Watch, M&A Activity, Top 10 Drugs and more................................................................................................... 65 Top Four Healthcare Industry Trends...................................................................................................... 71 3 | HS&M FEBRUARY/MARCH 2018

Publisher’s Letter

Compensation. And Beyond.

CARI KRAFT

As usual, I’m very proud to present the Jacobs Management Group’s Annual Compensation Survey in this issue. In very uncertain times (and these are more uncertain than most), we all like to measure our performance, and this is done on several levels. How are we doing compared to the colleagues immediately around us? How is our advancement based on the expectations we have had? And, finally, what does our career look like in the general context of the industry? We hope the snapshots in our charts help provide some answers, at least for that last question.

As we mention in the article, there are many influences pulling in different directions: policy changes, transformative technologies, value-based pricing and how companies are instituting patient-centric approaches. Still, we see growth both on the company and the compensation level.

Questions remain about the “why” of various vectors. Both sales and marketing position turnover was even greater in 2017 than in 2016. Medical device reps are more highly rewarded than those in pharma and bio. Sales and marketing force sizes continue to grow at a healthy pace. Why? The answers are complex, due to many influences.

Perhaps the most concerning data are those around poor hiring decisions. There are many unfilled positions, and even where seats are occupied there are numerous mis-hires. This represents a major cost to companies, both in direct financial terms and in lost opportunities and wasted time. The industry needs to improve its reliance on the wisdom of recruitment experts.

An equally important factor is the “beyond” aspect of compensation. As you can see from another article in our ongoing series, “Why I Work in Healthcare,” there is a lot that drives us beyond salary, bonuses and benefits. The messages in these photos tell a powerful story. This is the area that continues to inspire us, as we engage with people all over healthcare who truly devote a lot of passion and care to the work we do.

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 FEBRUARY/MARCH 2018| 4

Letter from the Editor

What Next?

NEIL GREENBERG

We recently read about the work of a scientist named Fritz Haber, who helped develop the Haber–Bosch process between 1894 and 1911. Never heard of Haber? You should have. He may be the reason you’re here to read these words today. His process led to the production of nitrogen-based products like fertilizers. At that time, the work of economist Thomas Malthus predicted that subsistence would never be able to keep up with the exponential growth of the world population. In other words, in a few generations billions of us would starve. Haber’s discovery made it suddenly possible to fertilize and grow much larger agricultural yields, capable of feeding our global citizenry.

That’s just one example of the many amazing leaps that science has brought us. In healthcare, for instance, where would we be without the work of Edward Jenner, Louis Pasteur, Jonas Salk and Albert Sabin in vaccines? Success in surgical procedures depended greatly on the likes of William Morton in anesthesia and Joseph Lister in antisepsis. Sir Alexander Fleming’s work in antibiotics was just the beginning of a long string of miracles that today fight bacterial and viral illnesses like AIDS. Wilhelm Röntgen’s breakthrough work in X-rays brought us to the modern era of imaging that helps identify and fight many of the ills that were previously invisible without dangerous surgery. The history of painkillers goes back centuries to natural remedies like opium, but it’s only been in the last few decades that pain management has emerged as its own science, precisely identifying and treating the numerous kinds of discomfort we experience.

We live in a seemingly magical age in which so many diseases and conditions that have beset humankind for eons are now under control. And yet there are so many more—cancer, diabetes, Alzheimer’s, congenital conditions—that continue to challenge us. Then there’s the threat of the superbugs, mutated versions of microscopic beasties that are immune to our best weapons.

But the history of our battle is one of continual victories. Waiting and watching and working for the next triumph is what healthcare is all about. What a fascinating industry to be part of.

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 FEBRUARY/MARCH 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 © 2018 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

7 | HS&M FEBRUARY/MARCH 2018

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 FEBRUARY/MARCH 2018| 8

EXECUTIVE SPOTLIGHT

Shockwave Medical Founder on Innovation and Attracting $120M in Financing This article was adapted from an interview with Daniel Hawkins by Scott Nelson, cofounder, Joovv and founder, Medsider In 2009 it seemed that there were numerous medical devices available to address peripheral vascular disease— from self-expanding stents to plain balloon angioplasty, atherectomy, drug-coated balloons, and others. What, then, inspired Daniel Hawkins and his Shockwave cofounders, John Adams and Todd Brinton, to enter what looked like a crowded marketplace?

Insight. But before we get to that, a little background.

Daniel grew up in what he describes as a “medical entrepreneurial household.” His father is a primary care physician who began his practice out of their Philadelphia home, treating a lot of Department of Public Assistance patients.

Daniel and his brother and sisters did the coding on the DPA forms, and Daniel moved on to his own entrepreneurial pursuits, from selling Christmas tree clippings to operating soda machines. That paid for his Wharton undergraduate studies. He was simultaneously fascinated by both science and business. When he discovered what 9 | HS&M FEBRUARY/MARCH 2018

venture capital was, he joined a leveraged buyout house upon graduation from Wharton. He became attracted to the deals they made in medtech. “The prospect of being able to move the clinical needle on millions of patients versus one at a time, like my father, was compelling for me, very compelling,” says Daniel.

He went back to business school at Stanford, and afterward investigated medical technologies, medtech and medical devices.

Around that time, angioplasty balloons were $600 apiece, stents hadn’t been invented yet, and the hottest areas were orthopedics and interventional vascular. Daniel

says “I was fortunate enough to get a position in marketing at ACS, Advanced Cardiovascular Systems, a division of Eli Lilly at the time.

I joined there pre Palmaz-Schatz Stent, so that was a long time ago.

The first indication of that stent was abrupt closure, or threatened abrupt closure, that comes from high-pressure dilation of the vessel due to calcium. The IVUS studies, intravascular ultrasound studies, in the mid-90’s confirmed all of that and really, that laid the groundwork for what I later traded on when I came up with the notion for what is now Lithoplasty, to avoid those dissections and see if we could get better results long term. I’ve stayed in it and have been fortunate enough

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EXECUTIVE SPOTLIGHT to be involved in a number of significant startups along the way.”

He held senior roles in general management, marketing, and business development with a number of private and public companies.

Daniel started the marketing department at Intuitive Surgical, where he guided product feature development for the da Vinci Surgical Robot and developed key foundational marketing strategies for the company. He has also held senior leadership and/or founder roles with Endologix and Calibra Medical, which is now part of J&J. Today he holds over 100 patents and applications, and is president and CEO of Shockwave Medical, where he continues innovating.

“In 2009, drug-coated balloons were emerging; they were not yet in the forefront as they are today,” Daniel says. “Back then there were varying versions of scoring balloons, like AngioScore balloons and other types of specialty balloons, high-pressure balloons, and atherectomy. Then there were balloon expandables and self-expanding stents. The challenge with all of the non-stent technologies, which we identified in 2009, is that they are not addressing the fundamental issue of calcification embedded in the vessel wall. Balloons put pressure on the calcification, but really overstretch the soft tissue on the other side of the vessel, and then create vessel injury.”

Daniel described other problems, such as restenosis, the inability of existing technologies to reduce blockage under a clinically meaningful 30%, and the high possibility that a stent will ultimately be needed anyway.

11 | HS&M FEBRUARY/MARCH 2018

“What we realized with Shockwave is that the physics of high-speed pressure waves is completely different than constant high pressure that you get in regular balloons.

High-speed pressure waves travel through the soft tissue and do not disrupt it, do not create the injury that is very common with scoring balloons or high-pressure balloons. Instead, it actually creates cracks in the calcification.

Great products are purchased, not sold. If you create a fantastic product, users will come to you.

“You can think of them as expansion joints…we inflate the balloon just a little bit. Frankly, very gently.

What we’re doing is expanding those cracks in the calcification and therefore the vessel without the injury that everybody else gets, and we’re in fact, getting stent-like results without stents.”

But even with an innovative product, the path to market is not easy.

Where is Shockwave today? They are CE marked in Europe, and FDA cleared in the United States.

In November of 2016 they raised a $45 million Series C. They had six-month results in the second peripheral vascular study in 60 patients done in Europe and New Zealand, and at that point had achieved a 30-day outcome in their first coronary study using lithoplasty for the treatment of coronary vascular disease prior to stent placement. They began their early

commercial activities in Germany in the peripheral vascular space.

LEARNING FROM THE BEST Daniel talked about some of the mentors who influenced him, such as Fred Moll, co-founder of Intuitive. A small group of executives would meet every Tuesday for a “Critical Path” meeting to assess progress toward their milestones CEO Lonnie Smith, and current CEO, Gary Guthart, were always there, along with Fred Moll. “We thought we were pretty far along, frankly, centering down to our final design, and Fred came into the meeting — I’ll never forget this day — and said, ‘I think we have a problem. I think our vision system is inadequate.’ That was a very material statement to make at that point, because we were marching along with a set of presumptions.

“The issue was very fundamental.

For a physician to be able to trust a robot, they need to be able to see perfectly. Be able to discern tissue edges in the different tissue planes, the resolution needed to be there.

The problem is that there was no existing camera system at the time that could solve the problem.

We literally had purchased one of every camera system available worldwide and none of them was good enough.

“Fred put out there that we should create our own, as if we didn’t have enough to do, right? What made us think we could do that? It was a hand-wringing moment. Fred said, ‘Wait a minute, isn’t the real reason why none of these cameras work because they need to make them lightweight because the procedures are an hour or two hours long

and a human has to hold it? We don’t have that constraint; we can make this thing 30 pounds because we have a robot holding it.’ The second that statement was made, everything changed.

“We removed weight as a constraint, and when that happened, we were able to fast forward to the best laparoscopic vision system available on the market. The second we were able to make that and put it in the system, it became crystal clear what you were looking at and the physician community raved about the vision system and their sense of control and accuracy. Fred was 100% right that that was a need, and he was a 100% right to test the assumption.”

A MAJOR BREAKTHROUGH Daniel was an entrepreneur in residence at Three Arch when he came up with the concept for applying lithotripsy to arterial plaque. We asked him about the lightbulb moment for that breakthrough.

His colleague John Adams was working on identifying the root cause for a product failure, and as part of that investigation he put the two leads for a pacemaker in a beaker full of water. As it turns out, he created lithotripsy, but he didn’t know what it was at the time. He shattered the beaker and there was water all over a high voltage table.

“So he realized he had a problem, and he figured out ultimately that it was lithotripsy. He shared that anecdote with me and while I found it interesting, there was no particular utility at that time. My job as an entrepreneur and residence was to look at unmet clinical needs and, with John, either invent or license a technology to solve

those needs. And then Three Arch and Prospect Ventures would fund a company around that if everybody agreed. Fast forward about six months and I happened to be looking at the angioplasty market and came across some specialty balloons that claimed that they were able to, with differential pressure, crack calcium. I am not a physicist, nor am I a scientist, but again, being scientifically-minded, that didn’t make good sense to me.

“I started wondering what would actually crack the calcium, and then I remembered John broke the beaker with electricity. So I looked at lithotripsy a bit more, and I suggested it to John and I asked him if he thought it would work and he said, ‘Not only will it work, it will work great and the pressure waves will be so fast, they won’t pop the balloon. They’re faster than the speed of sound.’”

John was right. It worked perfectly.

They then identified the opportunities in the peripheral vascular space, and created a prototype that leveraged existing technologies.

Todd Brinton, an M.D., helped with the clinical view of the performance requirements, designing the protocol for first in-human trial, and developing the relationships with clinicians along the way.

“John kept us pointed straight from a technical perspective and I served, if you will, as program manager and head of marketing and CEO and all of that together to drive the creation of the first prototype, the builds, the testing, the verification, the animal testing the like, etc. Once we finished all of that, we went into the clinic and headed a very successful first inhuman experience.”

FOUNDING SHOCKWAVE Even with success like that behind him, the path to founding Shockwave was rocky. Daniel heard from potential investors that “You shouldn’t start with the periphery. It’s a graveyard of dead technologies.” Between 2008 and 2009, Daniel, John Adams and Todd Brinton acquired the intellectual property out of the incubator because Three Arch and Prospect did not want to move forward with the idea.

What propelled them to pursue it anyway? Science fiction author Robert Heinlein famously said “Always listen to the experts. They’ll tell you what can’t be done and why. Then go ahead and do it.”

As an entrepreneur, you’ve got to listen to advice that other people have, and then very often, you need to deliberately not follow it.

Daniel took a similar attitude.

“As an entrepreneur, you’ve got to listen to advice that other people have, and you’ve got to gather all the data you possibly can, and then very often, you need to deliberately not follow it,” says Daniel. “Why? Well, it was going to be difficult to create a device that had lithotripsy in it, make it deliverable, make it small enough to get through the vasculature, through a blockage, and be able to deliver the therapy.

Peripheral vessels are bigger. Because of the risk profile, peripheral vasculature had a greater chance of a 510(k) pathway versus a PMA pathway.

HS&M FEBRUARY/MARCH 2018| 12

EXECUTIVE SPOTLIGHT “Because there is such an enormous need in the periphery, we had a very wide margin of potential benefit. So if we were able to go halfway to optimal, given how wide that margin was, we would be incredibly successful. In the coronaries, the margin is a lot tighter because devices have gotten better.

In the periphery, we had greater opportunity to be able to create a solution that, with a relatively lower bar, could show a benefit.

We trusted our gut.”

FINANCING STRATEGY In Shockwave’s recent rounds of financing, which drew a more enthusiastic response than their first round, we were curious about getting a variety of investors involved.

He told us “The first institutional investor was Sofinnova out of Paris. They were the first money in Core Valve and a great visionary group. When we broadened our footprint in the Series B in 2015, that’s when we first brought in strategics, and we brought in crossovers and the like. We had in fact, strategic offers for the entire round in a non-diluted fashion.

We are in a business that is very, very strategically significant. So we had an offer on the table for that. At the 11th hour, terms got inserted into that deal which were not attractive, so we walked away from it. What we tried to do from the very beginning was lay the groundwork for a long-term play in the company. We believe we’ve got a company that has staying power. We believe we have an opportunity to be a very successful standalone organization.

13 | HS&M FEBRUARY/MARCH 2018

“While we did want to have a strategic involved, what we did not want to do is have just one.

That’s really the reason why we ultimately ended up with two different strategics. The reason why you bring in crossovers is to set up for future rounds of financing, not the least of which is a public offering. In our Series B, we brought in quite a number of crossover funds.

As it turns out, in our series C, there was a great interest to complete the round from inside investors and the only new investor that we brought in was T. Rowe Price, again for the exact same reason of setting ourselves up for a future public offering.”

A lot of their investors have also been publicly quoted as saying they believe Shockwave can become a company that is able to sustain itself, versus traditional medtech startups that are gobbled up early in their life cycle. What does Daniel think of as the future for Shockwave?

“Our future is going to be defined by how we perform clinically, and of course, how we perform commercially. In the very near term, we’re going to start what turns out to be history’s first randomizedcontrolled study in peripheral vascular calcified lesions. So really, our specialty is calcium. In the legs, there’s lots of it. Half of the patients have it. Surprisingly, there’s never been a randomizedcontrolled trial of one technology against another one to treat those patients.

“I didn’t realize that we were going to be the first one until some reporter told us that, frankly. We think it’s the right thing to do.

We’re doing the right clinical work going forward, with at least 330 patients kicking off very shortly.

With that, we intend to demonstrate the capabilities and usability of the Lithoplasty system versus angioplasty and recognize those differences across a very broad patient set.

LESSONS LEARNED We asked Daniel about some of the wisdom he has acquired over a long career in medtech. Here’s a summary: 1 Focus on true needs—not wants, desires or vitamin pills.

He calls the true needs “painkillers.” In the case of Shockwave, for example, avoidance of vascular injury.

2 Keep the function of technology as simple as possible. “At Intuitive Surgical, the robot was incredibly complicated. It started off [in 1999] with 2,700 parts on the bill of materials. It had 1.1 million lines of software code. That’s a lot of complexity. But in the end, what it was is something the surgeon looked into, saw the operative field, put their fingertips into the tip of a controller, and moved their hands like they’re operating with their fingers. What we really did is use complexity to make the experience simple. Now, what problem did we actually solve? We allowed the physician to operate in an open surgical environment, but do it through a hole the size of a trocar.” Trocar-based surgery is minimally invasive. What the physician needed to do was advance their capabilities in spite of the restriction of that tiny hole. Daniel explains that Intuitive removed the

restriction. “That was a pain killer, and they made it incredibly easy to use, and that’s the reason why it ultimately took off.”

What we really did is use complexity to make the experience simple 3 Check your core assumptions at every point in development, because correcting mistakes early is much easier than doing it further down the line.

“One of the things I find more often than anything else is when there’s disagreement among very bright, experienced people about a direction, very often they’re operating under different core assumptions. One of the things I will often do is get back to, ‘What are your assumptions?’ They’ll list them, and I’ll say, ‘Take away that constraint. Take away that other constraint. Now, what would you do?’ That’s exactly how we ended up with the device that we did at Shockwave because my engineers were saying there was a constraint; we couldn’t get more than one emitter in a balloon. I asked them to remove a couple of constraints; now it’s limitless. I didn’t know how to solve it, they did. All I really did was remove that constraint.”

FINAL THOUGHTS Daniel’s favorite business book?

The 22 Immutable Laws of Marketing. His favorite advice from it is if you’re not number one in a category, create a category in which you can be number one

The CEOs he admires? Obviously Fred Moll is one. “He continues to identify the pain-killers and remove barriers. Omar Ishrak from Medtronic. I’ve been extremely impressed with the culture that he’s been able to create, the quality of people in that organization, the consistency of the messaging, and the capabilities within the organization. Mike Mahoney for what he’s been able to do in terms of the turnaround of Boston Scientific. He launched them into the number one position in stents and pushed the entire franchise forward. And Mike Musallam. His vision for what became TAVR and acquiring Sapient early, and then the management of that has been nothing short of spectacular. He’s created an incredible amount of value for shareholders and incredible therapy categories for patients.”

And the advice he’d give his 30-year-old-self? “Number one, two, three, four and five is trust your gut. Your gut is never truly wrong. When you trust your gut properly at those high-intensity moments, it won’t fail you.”

Another poignant bit of Daniel’s wisdom is that great products are purchased and not sold. “If you create a fantastic product, users will come to you.” That’s what he experienced at Intuitive, and what they’re enjoying at Shockwave. •

Scott Nelson Cofounder, Joovv Founder, Medsider Scott is a self-described medtech enthusiast and currently leads all commercialization initiatives for Joovv, a company he cofounded in 2015. Prior to his work with Joovv, Scott held sales and marketing leadership positions with some of the largest medical device companies in the world, including Medtronic, Covidien, Boston Scientific, and C.R. Bard. He is also the founder of Medsider, which helps ambitious doers learn from proven medtech thought leaders. His work with Medsider has been featured in publications like Forbes, MassDevice, MedCity News, and MD+DI. Scott also serves as an advisor to the Medical Devices Group, which includes over 300,000 members worldwide.

COMMENT HS&M FEBRUARY/MARCH 2018| 14

ROUNDTABLE

THE LAUNCH: Lessons from Experts’ Experience at Shire, J&J, Sunovion and More Our panel talks about how to launch a brand successfully Our panel of experts: DAVID BAKER

HARRIS KAPLAN

President DB BioPharma Consulting

Managing Partner, Red Team Associates

PAUL MURASKO

SHALINI SHARAD

Senior Director, Multi-Channel Marketing Sunovion

Partner, Commercial Launch Excellence & Patient Centricity Wipro

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DTC National

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APRIL 18-20, 2018 BOSTON, MA The SheraTon BoSTon hoTel

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Largest annual conference focused solely on direct-to-consumer Rx marketing

ABOUT THE AGENDA Our industry is under a constant strain to optimize spending while still effectively reaching consumers and patients. The 2018 DTC National agenda will feature the latest insights, research, and case studies on all aspects of DTC (direct-toconsumer) pharmaceutical marketing. We will host several innovative presentations around behaviorism, neuroscience, and the insights you can glean from such advanced research – which will be revealed for the first time at the DTC National. Our stage will also serve as the setting for in-depth discussions on media spend optimization, improved ad creative, and how to develop programs that truly impact a patient’s health.

This year’s agenda will also feature three focused tracks: Media Mix Efficiencies, Supporting the Patient Experience, and Cultural Intelligence. Our event will conclude with the Digital & Social Media Symposium on the third and final day of the DTC National. This will feature presentations from leading experts and major platforms in a workshop-style format, allowing you to have a more direct connection with those shaping the way for your future campaigns.

FEATURED SPEAKERS

Prof. Olivier Oullier EMOTIV

Salma Jutt Orexigen Theraputics

Alisa Lask Nestlé Skin Health (Galderma)

Mark Miller Symphony Health

Keith Hopps Takeda

Dan Stein Crossix Solutions

Douglas E. Hough, Ph.D. Johns Hopkins Bloomberg School of Public Health

Pat MacWilliams Google

Joy Bauer, RD NBC Today Show & Verywell Contributor

Danielle Salowski Facebook

USE PROMO CODE HS&M10 BEFORE MARCH 30TH AND GET 10% OFF FULL CONFERENCE PASSES

www.dtc-national.com

ROUNDTABLE Doing the research. Finding the funding.

Recruiting patients for the trials. Conducting the trials. Filing the applications. The negotiation. The strategies. The competition. The hopes and dreams.

There is no more stressful—and potentially fulfilling— activity in our industry than launching a product. Here we speak to a panel of people who have been intrinsic to numerous launches, from many angles. If you’re involved somewhere in the process right now, maybe this wisdom can help you sort out your own challenges.

What are the major hurdles in launching a product in your sector today?

DAVID BAKER: What has changed over time is that managed care has increasingly more influence on the success of new product launches. Several novel products have been approved and launched in the past several years and seen their uptake stunted by poor formulary access and reimbursement.

Payers seem increasingly willing to just say no and not reimburse new products for six months or more unless they see clear clinical advantages or receive substantial discounts that put the net price of these new products in line with the current standard of care treatments.

We are seeing early signs of valuebased contracting with payers for specialty products where the payer gets money back for patients who don’t respond well to the medication. However, it is still early days for such agreements and it will take some time to see how those arrangements work for both the pharma companies and the payers.

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I also believe that the highly publicized pricing levels and increases of a few outlier products, and frankly, “bad apples,” has further tarnished the pharma industry’s reputation and put everyone on watch regarding their pricing approach with their new product.

HARRIS KAPLAN: I agree with David’s point. As someone who has worked with a number of clients on launches, I think the major challenge faced by most companies is achieving a desired level of managed markets access to enable prescribing. That problem is exacerbated by the fact that over half of physicians are now employees, which means they will follow or adhere to protocols established by a hospital or plan vs. being able to decide freely what drug to use to treat a particular patient.

PAUL MURASKO: I believe the major challenge is the ever-changing healthcare landscape. We cannot launch products the same way we launched a product five or even two years ago. I am sure that is not news to anyone, however change is tough and sometimes pharma and

medical devices are slow to change from what has worked in the past.

A great example of this change is the ever-growing importance of EHRs. In the past it was enough to get you new product on formulary and sell your physician. That is no longer the case. You now have to make sure it is in the EHR and can be easily accessed by your physicians in their normal work flows. Understanding this channel—its update schedule, ensuring your product is in their favorites, providing the appropriate educational support—is now critical to a successful launch.

SHALINI SHARAD: It’s an era of consumerization and a “more aware patient” who seeks second opinion from Dr. Google. Some of the challenges in launching a product arise when a traditional sales and marketing model is followed.

This model would focus on heavy promotions into the doctor’s office in order to achieve the launch year win. Traditional customers are targeted through front line field reps without focus on the pyramid of other stakeholders who influence perceptions of the product.

This model lacks information on disease management that a patient is seeking today and hence is not successful beyond the launch year.

How is launching a product for a smaller indication different from launching one for a larger indication?

HARRIS KAPLAN: Smaller indications require a greater degree of focus and execution as there’s little room for error. However, beyond that, there’s often greater opportunities to innovate in smaller indications than larger ones because

it’s possible to know the customers better and understand the unmet need and the value your product brings.

MANAGED CARE INFLUENCE

DAVID BAKER: I don’t see a major difference in the effort for a smaller vs. larger indication.

Perhaps there are differences in the size of sales force support required and there may be a need for better targeting and efforts spent on patient identification with a smaller indication.

PRODUCT PRICING LEVELS

PAUL MURASKO: I don’t distinguish much between a big or small indication; I distinguish between new indication and new product launch. Each requires tremendous coordinated cross-functional efforts and solid strategy. However, I believe that a new indication to an existing established product requires different and sometimes less key deliverables compared to a full launch, which requires taking a product from development through the pre-commercial phase and then to commercialization.

What are some of the successful strategies for streamlining the launch timeline?

DAVID BAKER: This is a major challenge. In the past companies would start investing money and building launch teams much further in advance of an approval.

However, with more small companies launching products, they can’t always invest by blindly assuming success. Even larger companies have had high profile late stage development failures in recent years that may make them hesitate to fully invest in a launch before they are more confident that they will gain approval on time.

PAUL MURASKO: A key compo-

RISING LAUNCH COSTS REGULATORY ATMOSPHERE

nent of any launch is communication and teamwork across the various teams. Although a launch may be led by the brand team, if there is not alignment and full support from the other key groups the launch will not go smoothly and can fail. Just as we need alignment between the sales and marketing teams, it is also paramount to ensure there is tremendous coordinated effort between the precommercial and commercial teams to ensure a smooth transition and successful launch.

SHALINI SHARAD: Launch campaigns should start from Phase II or III of clinical trials. Disease management campaigns in the trial phase through the use of digital and internet solutions can help key opinion leaders with treatment information, who further influence other stakeholders in the ecosystem. Moving beyond traditional launch strategy and focusing on disease education, awareness, better QALY (quality adjusted life year), and a more engaged payer and patient can prepare for a successful launch well ahead of

time. A well-educated network of healthcare ecosystem participants would prepare the product market for commercialization and longterm prescription as well as reimbursement.

HARRIS KAPLAN: True. My favorite is building product anticipation in advance of the launch by informing relevant audiences of a new drug or therapeutic modality that might be in development.

Done well, this can accelerate product uptake.

What products or categories have you worked on, and what were the significant markers of progress along the way?

PAUL MURASKO: I have led product launches in med device as well as supported med device and pharma launches (both new product and new indications) through my role leading the digital center of excellence and multi-channel marketing. A significant change over recent years is the importance of a solid digital strategy that leads to a flawless execution of the required customer experience. And HS&M FEBRUARY/MARCH 2018| 18

ROUNDTABLE by customer I am referring to all key customer segments, not just patient and HCP. Digital can no longer be an afterthought. It is key to driving a successful launch or new indication release.

HARRIS KAPLAN: In working on the development and launch of over 100 new products, including many that have become household names, what I see is that the successful launching of new products has become more complex, involving many more stakeholders, such as payers and patients in addition to physicians. Sadly, while companies devote entire teams focused on understanding each of the relevant customers, only 10% of new products achieve their pre-launch forecasts. What’s needed is a more integrated view of how each of the stakeholders interact with and impact the other. One approach I’ve seen recently was the appointment of a launch czar whose job it was to develop a cohesive and comprehensive strategy across all of the stakeholder groups. More companies should take this approach.

SHALINI SHARAD: I have worked on different archetypes such as “specialized oncology drugs” and “stand out from the crowd.” The strategy and commitment in a rare disease product launch is different from “stand out from the crowd,” where there is a need to create edge.

It is important to take a customercentric view which is organized around market stakeholders, and continuous learning in real time as the market evolves. Is the product working to maximize value for all stakeholders? Digital health is a key component in enabling a 19 | HS&M FEBRUARY/MARCH 2018

multi-factorial launch that focuses on treatment benefits to patient and outcome-based contracting with payers. A commitment to unmet needs, barriers, the patient journey, access for orphan drug patients, are all important factors. Populations that lack timely healthcare access can be reached through digital patient support solutions and can be a success factor for launch uptake. Partnership with advocacy groups provides access and support to patients and helps them manage everyday life tasks better. Investing in realworld evidence, typically in the case of products like specialized oncology rare disease drugs, helps with market access. All this can be achieved if from development onward patient-centric design is maintained that can continue through commercial stages.

DAVID BAKER: I’ve worked on hypercholesterolemia, osteoporosis, migraine, ADHD. The classic launch metric was New Rxs, often weekly New Rxs. Now we have New Patient Start data, New to Brand, and Switching data, which is an even earlier indicator. One of the most interesting metrics I have seen in recent years is coupon redemptions. Once coupons are adjudicated in the pharmacy, the data can be almost instantly made available to a company through their coupon vendor/partner, which can provide an even earlier read. The trends here provide tremendous insight.

Now that launching a pharma product costs upwards of $2 billion, according to some estimates, how and with whom are companies collaborating to keep those costs manageable?

DAVID BAKER: I think pharma companies, out of necessity, are putting more pressure on their agencies/strategic partners to keep hourly rates and total hours down.

And I think a lot of tactics which used be standard practice, but perhaps of questionable return, are being pared back. One example: giant, fancy exhibits and medical meetings. You still see them for many product launches, but my observation is that companies are spending less here.

HARRIS KAPLAN: There are a lot of elements in this $2B number, including drugs that have failed in development. But critical collaborators are the company’s advertising and medical education agencies. A movement from expensive media such as TV to less expensive and more focused digital approaches will be key to both keeping costs down as well as reaching audiences who no longer watch traditional TV (Superbowl excluded) but spend time and get ads through social media channels.

PAUL MURASKO: The closer the marketing team is to the clinical and managed markets team, the better the launch. Launches are a team sport. Also the old pharma playbook of massive TV and spend to drive in Rx (Humira was one of the first) is now inefficient and has more waste than benefit. The need is to be hyper-focused on the data that holds the insights and behaviors of each customer target and execute to that. Finally, accept innovation from all your partners; but filter it with the eye on the long game…which may only be 18-24 months, but these days, 18 months in marketing and launches is a lifetime.

Is there a significant effort to identify orphan population indications in order to fast-track a launch?

DAVID BAKER: There is a significant effort to identify orphan populations because of the attractiveness of those indications— more easily targeted populations, smaller sales force requirements, stronger regulatory exclusivity, and favorable pricing. I think it is the overall attractiveness of orphan indications that is driving the push there, not the ability to fast-track a launch. While orphan indications generally require fewer and smaller studies, the time to enroll and complete those studies is typically longer, and ultimately time to launch may not be shorter than with non-orphan indications.

HARRIS KAPLAN: Orphan and rare diseases have been a hot market in the last five years, spurred on by a development tax credit.

The opportunity to get a high price per patient due to the limited population, fast track designation from the FDA and possibly a priority review voucher all have accelerated interest in orphan drugs.

The challenge going forward is with the tax credit now gone and payers beginning to push back on high prices (note challenges faced by both Vertex with its CF portfolio and Sarepta with Exondys 51), will pharma’s interest in this sector begin to wane?

SHALINI SHARAD: There is a significant effort to access patients who are geographically spread and to ensure that they have access to medicine & treatment they need. Due to a small population size of orphan patients, pharma is

also trying to access markets and patients through managed entry agreements. This strategy helps in early patient access and a better reach to orphan patients. It also helps in reimbursement from the payer as value of the treatment is proven through real world evidence.

How are the specific challenges different for getting a pharma, device, or digital product to market?

PAUL MURASKO: Some would argue the challenges among the three are very different, but I believe the core challenges are universal. Change is the norm, and that is unnerving to an industry with such long established rules and roles. A great example of this is Samsung as the manufacturer of the first truly challenging biosimilar. Samsung? Yet they did it.

HARRIS KAPLAN: Drugs typically have a much greater and longer degree of patent protection than devices, which can usually be more readily imitated. So devices need a shorter time between launch and peak than drugs. They also usually have a lower cost of development, and sales rarely achieve the revenues associated with the most successful drugs. In the old days, a physician could just order the new device. No longer. Devices used in the hospital need to be presented to the VAC (Value Analysis Committee) which comprises procurement, finance, and various members of the medical staff.

Companies don’t present directly but a physician advocating use is required to make the presentation. That, in and of itself, is a huge challenge. As a result, many de-

vices have lagged in market uptake which has significantly hurt the ROI of newly launched products in the sector.

Diagnostics is a broad category.

There are those aimed at populations directly such as Exact Sciences Cologuard, which can be used to diagnose early signs of colorectal cancer and reaches a broad population who may be unwilling to undergo a colonoscopy. Some diagnostics are really prognostic, indicating potential risk of patients developing a certain diseases such as Myriad Genetics BRACA1 and 2 for breast cancer, or Astute Medical, which flags early risk of acute kidney injury to patients in the hospital. And still others support the utilization of drugs by identifying which patients will get the best response to a particular therapy. This latter category has become vital for many high-priced drugs as a means of controlling the overall cost of the drugs to the payers.

SHALINI SHARAD: Patients want to access disease management information through internet and social channels. They are looking for a solution to meet their everyday complications, unmet needs, financial access, lack of confidence on treatment, etc. Companies are launching many “drug-devicedigital” personalized care solutions for patients. Challenges arise as these solutions have objectives like improved adherence, better patient access, improved health outcomes, better quality of life(QOL), however the regulatory blueprint has still not caught up to such innovative launches. A strict regulatory process to govern launches which deal with sensitive patient health HS&M FEBRUARY/MARCH 2018| 20

ROUNDTABLE information is a challenge the industry is trying work on.

DAVID BAKER: The regulatory requirements for a device are generally much lower than with a pharma product, however, the companies developing devices typically have fewer resources and are judged by investors much more strictly on sales performance and growth from an earlier timepoint.

In other words, investors won’t attribute much value to a device or its owner until it is approved, launched, and generating a sales trajectory. With a device, there is often more latitude in promotional messaging, however this is counterbalanced by the challenge of having a physician buy and bill a device and integrate it into their practice, and reimbursement for a course of treatment which may require multiple visits can also be quite challenging for a new device.

For digital products, the challenges include the uncertain regulatory environment with very few precedents or regulatory pathways that have been paved. Reimbursement is also a whole new world with payers, and figuring out the pricing model with physicians and patients can be quite challenging, especially in a world where most of us are used to free apps for our phones and tablets.

How has the regulatory atmosphere changed to assist or impede the launch?

DAVID BAKER: Over the past few years, the regulatory approval process seems to be fairly similar, although perhaps more challenging. Recent commentary and even action since Scott Gottlieb became FDA commissioner has been en21 | HS&M FEBRUARY/MARCH 2018

couraging and we may see a more favorable approval environment.

On the other hand, the regulatory promotional environment continues to get tougher with norms for claims and other promotional language becoming stricter. Much of this seems to be self-imposed by company medical-legal-regulatory boards, perhaps as the industry has become tired of OIG (Office of the Inspector General) investigations that carry much more serious consequences than NOV (Notice of Violation) or warning letters from FDA. HARRIS KAPLAN: While it’s too early to assess what the appointment of Scott Gottlieb will mean, the number of approvals in 2017 was quite high and there is a promise of a more expedited approval process going forward.

SHALINI SHARAD: To impede the innovative “drug-devicedigital” personalized care launch, CDRH has established Digital Health Program. This promises to provide clarity and guidance on regulations around digital health outreach and developing and implementing digital health technologies. This will provide regulations around mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Commissioner Gottlieb has said “The plan outlines the FDA’s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures), adding expertise to the digital health unit and initiating the FDA Pre-cert

pilot program.”

Who in the industry do you admire for doing innovative things to get products to market affordably or quickly?

SHALINI SHARAD: Pfizer launched its Alzheimer treatment Aricept with a focus on virtual nurse support, disease management & medication adherence.

Aricept became world’s best-selling treatment with $4B in revenue in 2009. Zoladex by TerSera therapeutics is a three-month injectable prostate cancer treatment. Some of the unique tactics were targeting urologists and not oncologists, changing Rx behavior, and getting prior authorization/reimbursement from third party insurers along with federal government. Merck launched Gardasil and focused on educating women on the connection between cervical cancer and HPV through digital and social health platforms and population health management.

HARRIS KAPLAN: I think Kite Pharmaceuticals (recently acquired

by Gilead) should be held up as an example of a company that received approval of its breakthrough CAR-T therapy utilizing much less capital than is normally the case.

Other companies, wishing to accelerate uptake of their new products, are shifting to value based payments where payers only pay if the drug or device works. Novartis most recently has done this with its CAR-T program, and Medtronic has implemented similar programs to accelerate uptake of some of its devices. While it’s still early for these programs, we can expect to see more of these in the future.

PAUL MURASKO: There are a

Moving Forward lot of good examples. If I were to pick one it would be Merck and its launch of Januvia. One of the reason for this success was its new commercial model, focused more on targeted and coordinated HCP communication through the field, e-detailing and video detailing, as well as an approach to digital that was significantly ahead of its competitors at the time.

DAVID BAKER: I am very eager to see how the rollout goes for Spark Therapeutics’ new genetic treatment, Luxturna, for a rare blindness condition. As a potential one-time treatment, it will be interesting to see how their bold pricing and reimbursement approach is accepted.

What are some of the lessons we have learned based on recent history?

PAUL MURASKO: The clinical and commercial teams should begin working together at least 36 months before launch. And by together, I mean a degree of collaboration that is still the exception rather than the rule in pharma.

They must align on the endpoints that will represent maximal value to payers, providers, and patients at launch and which will be the directional beacon throughout development and commercialization.

They must work together to forge a comprehensive, integrated, datainformed roadmap with specific plans for each function — regulatory, medical affairs, distribution, market access, marketing, sales, and patient engagement — along with the major milestones for each function. (E.g., distribution plan 12 months prior to launch, medical affairs plan nine months prior,

DIGITAL FIRST

STAKEHOLDER INTERACTION

REDUCE COLLABORATOR AND MEDIA COSTS

payer engagement plan six months prior, sales plan three months prior, etc.) This roadmap formalizes what each function is accountable for, what they can expect from other functions, and most important the aligned metrics, incentives, and processes by which they will be measured and which will drive collaboration. Needless to say, none of this happens without direct and ongoing C-level leadership that sets the expectation of collaboration across silos… and, until the organization’s DNA is rewritten in collaborative terms, meets regularly with clinical and commercial leadership to ensure that it happens.

HARRIS KAPLAN: Neither payers nor patients are morons. They are perfectly willing to pay premiums for products that deliver real value, and not all differentiation represents value. So the challenge is understanding what is valuable to each of the stakeholders and building that into the product’s pivotal clinical trials so the label at launch highlights the product’s differentiation. The battle for market share is often fought and won before Phase III. This presents a difficult tradeoff. The more differentiated

CONTINUOUS LEARNING

the label a company aims for, the higher the potential risk that the product will miss its endpoints and the greater the cost in both time lost and money spent. Our company works with many smaller companies bringing commercial perspective and implications to help them make these tradeoffs.

The challenge is one of pay now or pay later. Companies introducing a new product using a placebo comparator vs. a recognized and widely used standard of care will likely face significant hurdles getting payer acceptance and patient willingness to pay post-launch.

DAVID BAKER: Start early, don’t assume managed care will be enthusiastic about paying for your product, do payer research, be prepared to accept more narrow or second line indications to get established. Lesson: Don’t just assume that they will put your product on Tier 3 from launch because it is novel. Be prepared to experience much lower net-gross ratios and prepare your finance team and management accordingly. On the other hand, despite managed care’s objection to co-pay coupon programs, they haven’t found a truly effective way to stop them. • HS&M FEBRUARY/MARCH 2018| 22

ROUNDTABLE

MEET OUR PANEL OF EXPERTS DAVID BAKER

HARRIS KAPLAN

President DB BioPharma Consulting

Managing Partner Red Team Associates

David is President of DB BioPharma Consulting LLC, a life sciences consulting practice with a focus on marketing, commercial assessment, and business development.

David served as interim CEO of Alcobra from June—November 2017, during which he led the strategic M&A process leading to the reverse merger of Alcobra with Arcturus Therapeutics and the divestiture of Alcobra’s ADAIR developmental ADHD compound. He originally joined Alcobra as Chief Commercial Officer in 2014, responsible for all aspects of pre-launch marketing planning and business development. Prior to joining Alcobra, he worked at Shire for 10 years, most recently as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. He led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process.

Previously, he served as Global General Manager for Vyvanse® where he led the launch of Vyvanse, led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, he served as Vice President of Marketing for all of Shire’s ADHD products. From 1990-2004, David worked at Merck where he held positions of increasing responsibility in marketing, sales, market research, and business development. He has been directly involved with the marketing of five prescription drug brands with annual sales in excess of $1 billion each. david@dbpharmaconsult.com

23 | HS&M FEBRUARY/MARCH 2018

Harris Kaplan is Managing Partner at Red Team Associates, a life sciences commercial strategy consulting firm. Harris is also the CEO of Healogix, a leading industry marketing research and strategic planning company, and was formerly the co-founder of Migliara-Kaplan Associates which was the largest custom marketing research company in pharma before it was acquired by TNS (now Kantar). Having worked on the launch and development of over 100 Rx products, Harris has spoken frequently and authored a number of articles on developing and launching new products. He was selected as one of PharmaVoice’s 100 most inspiring leaders in 2011. harris.kaplan@redteamassociates.com

RED TEAM specializes in helping clients maximize the value of their product assets and works with companies that have both early stage and on the market products.

The commercial and financial success of companies like Kite Pharma, Vertex Pharmaceuticals, Sarepta Therapeutics, and a host of others is a testament to the value Red Team creates for its clients.

PAUL MURASKO

SHALINI SHARAD

Senior Director, Multi-Channel Marketing Sunovion

Partner, Commercial Launch Excellence & Patient Centricity Wipro

Paul leads NPP, digital strategy and execution as well as the telesales team for all Sunovion brands. Previously he was with Johnson & Johnson, primarily in the Medical Device and Diagnostics (MD&D) space. While Director of Digital Marketing for J&J, he lead the digital integration for $19.8 billion acquisition of Synthes and was chairman of the Digital Acceleration team for the MD&D sector.

An innovative healthcare marketing and sales leader, he is experienced in digital strategy, integration and activation, with a solid understanding of the digital ecosystem to drive business results, achieve efficiencies, and build a competitive advantage.

Paul.Murasko@sunovion.com

SUNOVION has contributed clinical advances and new treatment options, and has led advocacy and educational initiatives with cross-sector coalitions focused on the advancement of research, innovation and improvements in healthcare. Its contributions include pioneering a unique approach to discovery in the CNS space based on a systems neurobiology platform that facilitates rapid clinical development; actively supporting the introduction and passage of legislation for patient protection, and championing efforts to codify the six protected classes in Medicare Part D in the U.S.; developing and supporting leading advocacy programs, working with national advocacy partners in the U.S. including the Be Vocal: Speak Up for Mental Health, COPD Together, and Talk About It for Epilepsy! initiatives.

Shalini is a thought leader, author & speaker on patient centricity. Changing healthcare has motivated her to focus on newer ways to engage patients and drive better outcomes. She holds IP on patient engagement solution which has helped in innovative commercialization of drugs from Phase II to launch excellence, enhancing patient adherence, driving better patient-doctor relationships, and improving health outcomes/QOL/QALY solution sets in value-based care/FDA digital health regulations.

She has implemented commercial solutions in many pharmaceutical organizations across clinical and commercial programs - CVM, oncology, CNS, respiratory, and specialty/rare disease. shalini.sharad@gmail.com

WIPRO LIMITED is a leading global information technology, consulting and business process services company that harnesses the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help clients adapt to the digital world. Wipro is recognized globally for its comprehensive portfolio of services and strong commitment to sustainability and good corporate citizenship. It has over 160,000 dedicated employees serving clients across six continents. It offers IT, platforms & consulting solutions to the healthcare and life sciences industries.

COMMENT

HS&M FEBRUARY/MARCH 2018| 24

COMPENSATION AND HIRING

HOW AM I DOING? Annual Compensation Survey

The Jacobs Management Group Salary Survey Growth is mixed in this very interesting political climate. As the forces that drive our industry change, our compensation and hiring statistics show a variety of growth pockets.

Despite the uncertainties from a variety of areas such as policy changes, transformative technologies, value-based pricing and the pull to redesign organizations with patient-centric approaches, compensation continues to grow. Our industry is solid and we are happy to present these statistics, gathered from over 600 people and over 500 companies. Here is the current snapshot of how your colleagues are doing in terms of compensation: the 2018 Jacobs Management Salary Survey results.

From Jacobs Management Group CEO and HS&M Publisher Cari Kraft: The 2018 results show solid compensation figures in the midst of questions regarding our overall industry economics. Here are a few of the highlights about how sectors are changing, how compensation is affected, and where to expect growth:

25 | HS&M FEBRUARY/MARCH 2018

• Sales turnover remains extremely high with medical device still at 16%, and pharmaceutical and biotech at 15% (up fom 14% and 11%). Marketing team turnover almost doubled to 12.9% compared to the prior 7%. Biotech marketing turnover is the highest at 17% • Medical device reps have taken back the lead in top rep compensation with totals averaging over $280K, up from $259K. Biotech top rep compensation dropped to $229K • The cost of poor hiring decisions increases, and the number of vacant positions remains high. The cost of a mis-hire in sales is approximately $80K and in marketing it’s $85K. The monthly cost for leaving any commercial position is just about even, with each open sales position costing on average $49K, and an open marketing position costing on average $50K • The highest growth is coming from pharmaceutical marketing at 9%, followed by biotech sales at 5.5%

SURVEY POPULATION This report summarizes the results from the Jacobs Management Group, Inc. Compensation Survey conducted in 2018. The target audience, as in the past years, was key leaders in the medical device, pharmaceutical and biotechnology industries with a focus in the marketing and sales arena.

Results were compiled from over 600 individual responses, representing over 500 companies. Companies ranged in size from over $100B to under $10M and were categorized into four main sectors: pharmaceutical, biotechnology, medical device, and healthcare vendor. Over 60% of respondents had titles of manager or above.

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COMPENSATION AND HIRING GROWTH CONTINUES AMID THIS UNCERTAIN CLIMATE! The continued good news is that both sales and marketing teams are forecast to grow across all sectors.

Sales force growth increased to 5.5% across all sectors, with medical device and biotech tied with growth rates of 6.4%. This is a change from our last survey which had the industries growing in the order of biotech, pharma, and medical device. Pharmaceutical companies still have, on average, the largest number of reps per company, at an average of 1,099 reps, as compared with the average across all the healthcare sectors of 640. The timeframes for sales promotions remained the same at approximately four and a half years, a consistent metric for the past three survey sets. Average sales income increases approximately 6% per year.

AVERAGE SALES FORCE SIZE

% SALES FORCE GROWTH

Medical device sales growth has picked up to match biotech, which each grew by 6.4%, followed by pharmaceutical, with a steady growth of 5.5%.

29 | HS&M FEBRUARY/MARCH 2018

COMPENSATION AND HIRING MARKETING TEAM GROWTH HOLDS STEADY AT 8%

BREAKDOWN OF MARKETING TEAM SIZES

Marketing teams continued to grow, holding a pace of 8%. The average marketing department now has a team of 140. The average training period for a marketing team member is close to three months. The typical marketing professional is moving up faster with an average of being in their position for a little over 2.8 years before being promoted, up from 3.75 in our last report.

Marketing professional travel has increased a bit, up to 31% travel as compared with prior 28%.

PHARMACEUTICAL MARKETING TEAMS ARE EXPERIENCING THE FASTEST GROWTH Pharmaceutical marketing team growth has outpaced medical devices. Pharmaceutical marketing growth is up to 10% from 6% in our last survey, while medical device growth has dropped from 9% to 8%. Biotech growth has increased from 3% to 4%. Healthcare vendor growth has remained at 1%.

% MARKETING TEAM GROWTH

31 | HS&M FEBRUARY/MARCH 2018

MARKETING DIRECTORS NOW EARN OVER 66% MORE THAN PRODUCT MANAGERS MARKETING TEAM COMPENSATION COMPARISON

Marketing directors earn, on average, 66% more than product managers. However, the increase is coming more from bonuses. In our last report, 66% of the differential came from base salary, which has now dropped to 50%. Product managers’ bonuses are, on average, 17%, while marketing directors’ are 27%. Product managers on average have a total compensation of $139K, marketing managers $164K, and marketing directors $232K.

TOP MEDICAL DEVICE REPS TAKE BACK THE COMPENSATION LEAD Medical device reps have taken back the lead in top rep compensation, with totals averaging over $280K, up from $259K. Biotech top rep compensation dropped to $229K. Across the board, top sales reps’ earnings dropped from an average of $232K to 217K, while first year reps’ earnings increased slightly to an average total of $123K over 120K. Top sales reps’ and first year reps’ base salaries differ by an average of $44K. Sales reps’ commission payment timing has hardly changed, as 44% of sales rep commissions are paid monthly, 50% are paid quarterly.

FIRST YEAR/TOP REP EARNING COMPARISON

HS&M FEBRUARY/MARCH 2018| 32

COMPENSATION AND HIRING MONTHLY COST OF AN OPEN SALES POSITION

IT’S EVEN MORE EXPENSIVE TO LEAVE POSITIONS OPEN Each month a sales position remains open costs the company $49,024, which has remained fairly static from report to report.

The average cost of hiring the wrong sales person remains close to $80k.

MONTHLY COST OF AN OPEN MARKETING POSITION

Each month a marketing position remains open costs the company $50,150, up from just over $37,000 in our prior report. The cost of hiring the wrong person is almost double, costing a little over $85,000.

33 | HS&M FEBRUARY/MARCH 2018

AND IT TAKES ON AVERAGE 4.5 MONTHS FOR SALES HIRES AND 5 MONTHS FOR MARKETING HIRES, COSTING COMPANIES ROUGHLY $220,000 PER OPEN SALES POSITION, AND $250,000 PER OPEN MARKETING POSITION. First year sales rep positions fill the fastest and take just over 3 months, a month faster than our last report. Top sales rep, national accounts and sales director positions take longer at close to 5 months. Product management and marketing management positions take 4 months, and marketing director positions take over half a year.

AVERAGE TIME TO FILL A SALES POSITION

AVERAGE TIME TO FILL A MARKETING POSITION

Marketing positions take on average 5 months to fill.

CLICK HERE FOR FULL SURVEY RESULTS

COMMENT Jacobs Management Group, Inc., a leading healthcare industry search firm, undertook this 2018 Compensation Survey specifically for the medical device, pharmaceutical, biotechnology, and healthcare vendor sectors to provide our clients with specific quantifiable compensation data. This article presents the high-

lights of that survey. Please click below to get the full survey report, or email Cari Kraft for further details, or to provide input for what you would like to see in the 2019 Survey. We would appreciate knowing if this has been helpful to you.

HS&M FEBRUARY/MARCH 2018| 34

PHARMACEUTICAL

MUCINEX® Uses Augmented Reality to Win in a Crowded Marketplace How new technology helps drive the decision-making process.

By Johnelle Whipple, Director, Healthcare Marketing, US, RB

Imagine recommending an old spy movie you love to a friend. You go on and on about the action and old romance, and your friend seems genuinely excited about it— they love spy movies, too. The next time you see them, though, your friend tells you that they hated the movie you suggested. It’s a huge bummer that your tastes differ so much. The thing is, they watched the wrong movie and neither of you know it.

35 | HS&M FEBRUARY/MARCH 2018

Register now

2018 Woman of the Year event Thursday, 3 May, 2018 New York Hilton Midtown HBAnet.org

PHARMACEUTICAL Now tell me if this sounds familiar: staring down a dozen aisles at the store looking for that one medicine your doctor recommended. The crowded cold, cough, and flu aisle contains hundreds of products. It’s difficult for anyone to navigate, let alone a sick and clouded patient.

Nine out of 10 people typically purchase the over-the-counter medication recommended by their healthcare provider (HCP)1, but more often than not they get confused by the vast amount of choices at the store.

Without specific or written instructions, the recommendation may be easily forgotten or misconstrued.

Some products may be labeled by the symptom they treat and some call out the active ingredient, which may seem like a foreign language to consumers. To add to that, HCPs may not even be aware of the confusion and chaos their patients are facing because they report that they hardly visit these retailers themselves.

RB, the company that manufactures MUCINEX®, is dedicated to helping HCPs help their patients.

Historically, marketers employ one-dimensional but realistic solutions like ads, coupons, and coupons that HCPs can pass on to their patients. But RB realized that patients were still getting confused in the aisle and that they could step in to make communication clearer between HCPs and patients, and help patients feel satisfied with their product choice.

To ensure that patients are getting the product their HCP intended, success depended on HCPs experiencing the cough and cold aisle 37 | HS&M FEBRUARY/MARCH 2018

themselves. So RB devised a marketing method to place them in this cluttered environment without even having to leave their office.

Their strategy? Awareness through engagement.

Engagement can be a powerful tool when trying to influence customers’ decisions or actions. When an audience truly engages with a story, they connect better to it. Using technology such as augmented reality, virtual reality, chat bots, and interactive websites, brands can facilitate better storytelling. For RB, augmented reality provided interactivity at an accessible stage.

Augmented reality is a technology that integrates computer-generated images and the real-world in a composite, and often realistic, view.

Social media apps often utilize this technology, such as filters on Snapchat, Instagram, and Facebook stories.

For any brand’s first dive into such an interactive and engaging experience, using best practices and insights is vitally important for success. For a lesson on the principles of engagement, RB turned to an unexpected partner: the gaming industry.

RB knew it was taking a non-

challenge came readily: how do you improve the HCP and patient communication?

• Lesson 3: Accomplishment is more satisfying if you offer a reward. Rewards don’t have to be monetary, real or pretend. Rewarding a user can span from offering new levels of challenge to an upbeat winning song, or an appealing “Splat!”

traditional step into an emerging domain of marketing. Many healthcare marketers fear that “gamification” can trivialize the suffering of their target patients, but in reality, it offers an opportunity for HCPs to understand illness in a different way.

LESSONS LEARNED So what lessons from the gaming industry did RB apply?

• Lesson 1: No matter the technology behind it, make your program experience-centric. This means to put the user’s wants first, rather than your messages. Here, RB made sure that the app would fit well into a natural conversation between reps and healthcare providers. Did it feel intrusive, or a valuable use of their time?

• Lesson 2: To motivate users to “play,” you must offer a challenge.

This is another way to hone in on your user’s wants. In RB’s case, the

The methods used by game developers have a profound effect on engagement, memorability, and sales—and therefore seemed important lessons as RB constructed an experience that would resonate with HCPs. DECISIONS BEGIN AT THE POINT OF CARE Launched at the beginning of the cold and cough season, sales representatives use this app to show the HCP what a chaotic and confusing situation patients face every time they encounter the retail shelf.

On the representative’s tablet, the room digitally gains a few crowded shelves.

Now comes the interactivity. The rep begins by asking the HCP for a verbal recommendation of a cold medication for a patient with specific cold symptoms.

As the HCP suggests which product this patient needs, the representative inputs their key words and the app illustrates how a patient would view the shelf.

The more specific the HCP gets with their instructions to the patient, the shelves appear simpler.

Products that do not conform to the description disappear, and the correct ones remain and become easier to identify. There’s even a fun twist where Mr. Mucus, the MUCINEX® brand’s animated HS&M FEBRUARY/MARCH 2018| 38

PHARMACEUTICAL spokesperson, rates the HCP on the clarity of their direction to the patient.

HOW THE APP BENEFITS THE PRODUCT This tool has a threefold purpose: • to add creativity to the sales representatives’ interactions with HCPs • to help HCPs understand how and why their patients are getting confused at the retailer • to help HCPs give memorable and specific recommendations for the product that would best benefit the patient Though RB is the first to utilize augmented reality in the cold and cough category, other healthcare marketers are slowly waking up to how this popular engagement strategy can create meaningful engagement for their brands. Immersive, game-like apps are popping up all over to illustrate benefits of specific medicines, to highlight patient types, to improve the medical convention experience, or even to provide training for HCPs. The major benefit of this technology in particular is being able to create an enhanced version of the real world. Augmented reality reaches across multiple senses in a way that video can’t: specifically, touch. It feels more realistic and helps people process information, make decisions, and engage and interact with a story.

So far, RB has found their new augmented-reality experience to be a hit with sales representatives and HCPs. Since the launch in October, sales representatives are using this application with HCPs and their office staff, as well as a new audience: 39 | HS&M FEBRUARY/MARCH 2018

clinicians in urgent care centers (UCCs).

Sean Atchison, an RB representative, meets with healthcare providers in a territory that includes Brooklyn and Staten Island. He says he was unsure of the app at first, thinking healthcare providers would see a game instead of recognizing the benefit of this memorable experience. However, after toying with it, he finally brought it up during a conversation. “Do you ever have patients report back to you that they couldn’t find the product you recommended?”

Not surprisingly, many healthcare professionals say they have. Atchison brings up the augmented reality app, and the doctor immediately recognizes the need for such a training tool. “It’s something they have never seen before,” he says. “They see the value, as it comes through with the symptom type.

This app broke it down for them—you can link a specific product with the certain symptom.”

“I tell them, ‘I hear these same coughing sounds coming from your patients in the office, right now.’” Atchison feels confident that the healthcare providers he calls on will now have a better appreciation for what their patients face when leaving the office.

But ultimate victory can be summed up in just one HCP’s realization: “I can see how it can be very confusing for my patients. I’ll try to be more specific in my recommendations.”

This success story has an important lesson: empathy can inform technology, and technology can encourage empathy. For HCPs, having an understanding of the confusion in the cold/cough aisle made them more likely to give specific and detailed recommendations that would benefit their patients. For RB, gathering data about where recommendations were going wrong helped them understand the communication gap between HCPs and patients. • AccentHealth. The value of physicians in the OTC marketplace. 2014.

1

Johnelle Whipple Director, Healthcare Marketing, US RB Johnelle Whipple is the US Healthcare Professional Marketing Director at RB, leading marketing strategy and activation across over-the-counter (OTC), supplement, and sexual well-being categories. She has over 20 years’ experience in healthcare, including consumer/professional marketing. She spent time at Merck and Johnson & Johnson where she worked on Rx products, nutritionals/nutraceuticals, supplements, vitamins, OTCs, and skincare brands. johnelle.whipple@rb.com Reckitt Benckiser Group plc (RB) is a British multinational consumer goods company headquartered in Slough, England. It is a producer of health, hygiene and home products. It was formed in 1999 by the merger of the UK-based Reckitt & Colman plc and the Netherlands-based Benckiser N.V. RB’s brands include the antiseptic brand Dettol, the sore throat medicine Strepsils, the hair removal brand Veet, the immune support supplement Airborne, the indigestion remedy Gaviscon, the air freshener Air Wick, Calgon, Clearasil, Cillit Bang, Durex, Lysol, Mycil, and Vanish. In 2017, RB merged with Mead JohnsonTM Nutrition, a global leader in pediatric nutrition that develops, manufactures, markets and distributes more than 70 products in over 50 markets worldwide. The company’s mission is to nourish the world’s children for the best start in life. Mead Johnson’s Enfa family is a world leading brand franchise in pediatric nutrition.

COMMENT HS&M FEBRUARY/MARCH 2018| 40

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

6.5%

19,000,000+

Number of Medicare beneficiaries in Medicare Advantage This represents 33% of the total members enrolled in Medicare.

There are 2,317 Medicare Advantage plans available nationwide.

Source: Kaiser Family Foundation, October 2017

68%

2018

2008

Increase in DOs in the US The number of osteopathic physicians (DOs) has surged 68%, and the number of osteopathic medical students is up 85% in the last decade, representing about 25% of all medical students. This may help close the gap between physician supply and demand, estimated at between 61,700 and 94,700 physicians by 2025, according to the American Association of Medical Colleges.

Source: Osteopathic Medical Profession Report, 2017

41 | HS&M FEBRUARY/MARCH 2018

Projected 2018 rise in medical costs Medical costs in the employer insurance market will go up about 6.5% this year, the first increase in three years. This price is a significant driver of medical costs, and PwC indicates that healthcare spending is growing faster than the economy, a trend that isn’t sustainable.

Source: PwC’s Health Research Institute (HRI)

87% Doctors whose top concern was rising cost of care for their patients This finding has risen dramatically, from 59% in 2016 to 87% in 2017. Other major issues: wider access to therapies, repeal of individual mandate, and a belief there will be cuts to Medicare and Medicaid.

Source: InCrowd physicians’ predictions research, November 2017

$136B

47,495 Estimated size of Internet of Medical Things (IoMT) in 2021 Standing at only $60 billion in 2014, this market is expected to increase by a CAGR of 12.5% in the next few years to $136B. The Internet of Medical Things refers to the medical devices and applications that collect data and provide it to healthcare IT systems through online computer networks. There are currently 3.7 million in the IoMT. Source: Allied Market Research

Newborns in study of home cardiorespiratory monitoring The FDA approved use of ingestible digital trackers in aripiprazole pills as a way to monitor medication use after over 47,000 newborns were monitored for six months with the sensors. The device has the potential to not only alert caregivers to potential life-threatening events, but to also provide insight into vital-sign variability in healthy infants. The study showed high parental acceptance. Prospective studies are warranted to further evaluate its applications in the high-risk newborn population.

Source: SAGE Journals, Initial Experience and Usage Patterns With the Owlet Smart Sock Monitor in 47,495 Newborns. December 4, 2017

55%

Americans who mistakenly believe health insurance or Medicare will pay for long-term care In a survey of 2,065 U.S. adults 18 and older, OneAmerica reports that a majority believe Medicare or health insurance will be sufficient to cover assistance with daily living due to illness or injury, either in-home or in a care facility, for longer than 90 days. But neither of these will provide for those needs. The results show more education is needed.

Source: Harris Poll on behalf of OneAmerica Financial Partners, August 2017

COMMENT HS&M FEBRUARY/MARCH 2018| 42

MARKETING

Sanofi and Microsoft: Tech Innovation Meets Medical Insight

By Bozidar Jovicevic, VP, Global Head Digital Medicines, Sanofi and Professor Iain Buchan, Director of Healthcare Research, Microsoft

Based on an article by Danielle Baron, “Medical Meets Machine.”

BozidarJovicevic will be speaking at eyeforpharma Philadelphia 2018.

In his book The Tipping Point, Malcolm Gladwell writes about that magic moment when “an idea, trend, or social behavior crosses a threshold, tips, and spreads like wildfire.”

Those in the know say that the use of technology in medicine is currently at that tipping point. With the potential to fundamentally change the practice of medicine 43 | HS&M FEBRUARY/MARCH 2018

over the next decade, this will also transform how pharmaceutical companies interact with and support healthcare professionals.

Healthcare is currently “low-resolution,” says Professor Iain Buchan, newly-appointed Director of Healthcare Research for Microsoft in the UK and Professor of Public Health Informatics at Manchester University.

“We know a lot about patients when things go wrong, when they come into the clinic and details are taken, we get a snapshot in time.

At higher resolution, the view extends across the patient journey, tapping into the rhythms of life. A very important rhythm is medication behavior, about which very little is truly known.”

He says that in a more connected

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INDUSTRY LEADERS SPEAKING AT PHILADELPHIA 2018

Jim Robinson

Fabrice Chouraqui

Paul Navarre

Carsten Brunn

Cheryl MacDiarmid

Markus Leyck Dieken

President U.S.

President U.S.

CEO

Ferring Holding

Head of Pharmaceuticals, Americas Region

Senior Vice President, Primary Care, US

Senior Vice President, Global Head, CNS

Astellas

Novartis

Bayer

GSK

Teva

Bharat Tewarie

Jason DeGoes

Terri Young

Tolga Tanguler

Sue Mahony

David Blair

Executive Vice President, Chief Marketing Officer

Senior Vice President, Global Patient Solutions

Worldwide General Manager, Cardiology

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

MARKETING and predictive world, we will look at therapeutics within the context of biology, behaviors and environments. “We are on the verge of a really interesting journey for clinical therapeutics and patient experience, which will allow us to have high definition healthcare.

This will treat the patient journey and not just the stops along the way.”

For example, stratification will become ever more accurate with advancing biological knowledge leading to more precise care when coupled with technological advances, such as AI and personalization. Buchan explains that complex models of patients and as much as individual behaviors when it comes to treating an illness.

With such pervasive technology, transparency will come to the fore.

“Today, if I go to my GP or look online for treatment options, it is hard to see how uncertain those options are. It may be that current evidence can’t determine whether treatment A or B is best for me.

In this equipoise situation, the most transparent answer from the doctor, or the algorithm I consult before making the appointment, is: Don’t know: Would you like to enter a study to discover the best treatment in this situation, helping patients like you? The very nature of the consultation needs to change, and the right AI could underpin this evolution.” admits Buchan.

He continues by explaining that this connectivity will expose the

45 | HS&M FEBRUARY/MARCH 2018

“invisible” individual pharmacology of each patient, including the timing of medicines, and the “meta-medication” of lifestyle factors such as diet, alcohol, physical activity and sleep patterns.

“This will lead to a more purposeful connection between physician and patient. We are moving towards a world where personal health data and algorithms provide a view of the road ahead for your health, whereas old-style medical records were more of a rear-view mirror of healthcare,” forecasts Buchan.

“We know a lot about patients when things go wrong.”

“If patients donate data to be learned from, healthcare systems have a duty to harness those data for better therapeutic understanding and development. Separate systems for post-marketing surveillance, clinical trials and prescribing quality management, etc. are wasteful—they need to merge into ‘bigger brains’ at the core of health systems.”

It’s clear this goes much deeper than the average patient support program. These algorithms will become an inherent part of any new therapy, meaning the success of a drug will not simply be down to the molecule, he asserts. “It is wasteful to support medication adherence in diabetes, for example, without using the same patient

contacts to influence diet and physical activity.” These algorithmdrug combinations could potentially show up different subgroups of people who need a different type of therapy, so the boundaries between drug development and discovery may blur.

Unsurprisingly, this type of intelligent medicine means the physician’s role will change irrevocably, with a collaborative effort needed across tech, pharma and medicine.

“As patients get more insights into what is happening in the body from recent medications and behaviors, feedback loops are created, which could lead to better outcomes. However, this kind of disruptive observation will also pose challenges in trial design for researchers and regulators.”

Physicians and patients will interact differently, and across all channels, says Buchan. “Trust is central. Trust not only in preserving patient privacy but also in making fullest use of personal data for the healthcare choices that can and should be computed.”

All this heralds a dramatic change in how pharma communicates with key stakeholders—patients, health care professionals, and regulators.

Bozidar Jovicevic, VP, Global Head Digital Medicines, at Sanofi, is emphatic when he says the traditional sales channels used by pharma are evaporating.

“The number one commercial channel for years and decades has been sales reps, visiting physicians

and influencing them to prescribe drugs. Pharma companies use many other channels, but that has been the most impactful channel for years. That channel is slowly dying, for two reasons. Doctors are either closing their doors to sales reps or else limiting the visit to just two minutes– you have sales reps driving around in their cars with a price per visit being between $300-500 and maybe making five sales calls per day. That adds up to spending just ten minutes with physicians each day, which is really not impactful.”

All this heralds a dramatic change in how pharma communicates with key stakeholders—patients, health care professionals, and regulators.

The question for pharma is what are they going to do about it? They need new ways of promoting drugs and engaging with physicians, and ultimately a brand new channel through which they can reach them.

Jovicevic does not hesitate. “We know that the doctors are increasingly spending time online to stay up to date. In Europe, 63% of physicians spend more than six hours online each week, in order to stay up to date on developments in their fields. Physicians are spending time online and they are clos-

ing their doors to pharma offline.”

Yet he freely admits that pharma is “notoriously bad” for engaging with physicians online in a meaningful and sustained way. “In the online world, it is easy for physicians to stop engaging at any point if it is not meaningful or relevant to them. In other words, if pharma is not relevant to them in the first 10 seconds, all they need to do is close the tab/window. It takes one click.

“For physicians, one problem they face is the overwhelming amount of content available. They are finding it difficult if not impossible to stay up to date due to the vast proliferation of data and the escalating number of trials published each year. This is one issue where pharma can be helpful.”

Ultimately, he says, it is about adding value to physicians and building goodwill. “This could be providing education—it means talking about something not necessarily to do with their drugs, but this will then build up goodwill and form a relationship and get permission to talk about their products, what I call ‘permissionbased marketing’.

Pharma has to shift its online approach from an unwelcome pest to a welcome guest.”

Another problem for pharma when engaging with physicians in a multichannel world, is their lack of expertise in this area, according to Jovicevic; “In the pharma world there is a very small number of solid digital marketeers, people

who understand online engagement, analytics, traffic, conversions, psychology, etc. There is also a lack of digital leaders who both have skills and can lead the digital transformation.”

”Pharma has to shift its online approach from an ‘unwelcome pest to a welcome guest’ by providing value to physicians,” says Jovicevic.

This is further compounded by pharma’s largely legacy-driven approach to product development in IT, he warns.

“Most IT platforms need to be common (one platform customized for each country but still one platform) and cloud-based. Pharma needs to adopt agile processes and leave the waterfall behind. On top of this, the top 20 countries in a big pharma organization may use five different CRM systems, so it is very difficult to harmonize and create a global, digital multichannel strategy. When you add to that building of many non-common online platforms each country is building its own apps, developing its own engagement platforms for physicians.” According to Jovicevic, organizations need to create special innovation teams or groups, which enjoy their own relatively high level of autonomy.

These should be fundamentally separate from the rest of the organization—he even recommends HS&M FEBRUARY/MARCH 2018| 46

MARKETING a separate building. Executive sponsorship is key—without this, the innovation will continue to fall foul of mid-management overthinking.

A centralized legal and compliance team devoted to digital issues should also be established.

The example that companies should follow in terms of centralizing their different digital content offerings is already out there—a little site called Facebook. Jovicevic laughs: “When you log into Facebook everything is there, not separate apps for each country—it is all accessible with the one password and it adapts to your own needs.”

When it comes to content, ultimately it is about finding the “white space.” Pharma must analyze the online content and platforms that physicians are already using and then use this to find another opportunity. One clear opportunity lies in the aggregation of content—by collecting and curating the vast swathes of online content already out there, this would make it easier for the individual physicians to digest.

Jovicevic would know about aggregating content—he was central in pioneering the first global eCongress platform for medical econferences while at Novartis. This gathered the best content from the huge number of medical conferences held each year and hosted it on a platform called VivindaTV that he says looks like “the Netflix of medical conferences.” It included the latest breaking abstracts, videos in real-time, chat forums 47 | HS&M FEBRUARY/MARCH 2018

(in development), all personalized to the doctor’s interests and/specialty. “This was of huge value to physicians and is a good example of finding the white space (confirmed by NPS score of 71 from physicians using the platform).”

Another key element is not to “over-engineer” the innovation.

It is Jovicevic’s belief that in large pharma companies, or any heavily regulated industry, innovation “breaks” at middle management level, and also legal and compliance. A long process of de-risking as the innovative project moves

through a large corporation means the resulting success might be so minor that it is ultimately inconsequential, he says.

“Large companies are designed to execute proven business models— they know their stuff. They know how to sell, how to produce, how to talk to customers. Innovation works very differently—you are searching for a business model, you are testing. Companies need to build a prototype, test, tweak, and try again.” •

SEVEN SALIENT STRATEGIES:

1 Learn more about the patient journey and

medication behaviors

2 Use AI to change the nature of the consultation

and create a more purposeful physician/patient interaction

3 Connect medication adherence to diet and

physical activity

4 Make online engagement with physicians

relevant and meaningful

5 Adopt agile IT processes to harmonize a global,

digital multichannel strategy

6 Create innovation teams with more autonomy

7 Have a centralized legal and compliance team

dedicated to IT issues

the publication for healthcare sales & marketing leaders™ Bozidar Jovicevik VP, Global Head Digital Medicines, Sanofi Bozidar Jovicevik has served as Regional Europe Brand Director for Novartis Switzerland, Senior Global Product Director and Global Head of Medical Affairs for Novartis, and is currently Vice President, Global Head Digital Medicines for Sanofi.

He will be speaking at eyeforpharma Philadelphia 2018 on ‘How to Gain Competitive Advantage With a More Holistic Solution Around Your Product.”

Iain Buchan Director of Healthcare Research, Microsoft Iain Buchan has been a rheumatological doctor for the National Health System (NHS) in the UK, a research associate at the University of Cambridge, and Special Registrar in Public Health at the NHS. He is currently Director of Healthcare Research for Microsoft Research and Professor of Public Health Informatis and Director at the University of Manchester.

COMMENT

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HS&M FEBRUARY/MARCH 2018| 48

MOTIVATION

MOTIVIDEOS

By Cari Kraft, Jacobs Management Group Ready to get moving? All charged up for today? How about your staff? Here, as usual, are some meeting-kickoff videos that will get brains in gear and spark conversations.

6 Minutes To Start The Day Right

Marketing vs. Sales—Funny!

Great motivational meeting opener. Tips on adjusting your attitude, getting your priorities right, setting off on the right track.

Funny, somewhat glib icebreaker for a sales and marketing meeting. The odd, amusing and often contradictory things we hear ourselves say in the office.

Pump Yourself Up in 136 Seconds—with Expert Dan Pink

The Psychology Behind Focusing on the Positive

An unusual trick to pump yourself up—asking yourself the right question that will lead to the day’s success.

A great launching pad to have your team deal with adversity. Compelling stories of leveraging strengths to boost happiness.

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 49 | HS&M FEBRUARY/MARCH 2018

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6 Minutes To Start The Day Right: Get going!

Pump Yourself Up in 136 Seconds: The right question

51 | HS&M FEBRUARY/MARCH 2018

Marketing vs. Sales—Funny!: The weird things we say

The Psychology Behind Focusing on the Positive: Use your strengths

HS&M FEBRUARY/MARCH 2018| 52

INDUSTRY

Why I Work In Healthcare More answers to the most important question

People in our industry are often at or near the top of the learning and dedication ladder. They are well-educated, hard-working, intelligent and passionately devoted to their work. In short, they could have chosen any one of several demanding careers. They chose to work in healthcare. That’s why we decided last year to highlight the many drivers that brought people to their career decisions, and that keep them at the task every day. We have been to many industry events, and at each one ask attendees to give us a brief response to Why I Work in Healthcare. Last December, we were at the exl Content Marketing for Life Sciences conference, and here are just some of the inspiring answers we got from professionals in all aspects of our industry. •

53 | HS&M FEBRUARY/MARCH 2018

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PHARMACEUTICAL

Great Advice From Great Minds: Allergan CMO On Unmet Needs And Our Contract With Patients Dr. Gavin Corcoran, CMO of Allergan talks with Jill Donahue, Author EngageRx Imagine being an infectious disease specialist back when a diagnosis of HIV/ AIDS was a death sentence. And imagine experiencing the transition, when these patients survived thanks to new medicines. Living this first-hand fueled the fire in Dr. Gavin Corcoran to make a difference for huge populations of patients, millions of them, not just one patient at a time. So Gavin left his practice to join pharma. And we’re glad he did! Now as Chief Medical Officer at Allergan he is making that difference.

55 | HS&M FEBRUARY/MARCH 2018

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PHARMACEUTICAL Gavin Corcoran—Eye For Pharma Philly 2017-18—EngageRx

“Patients are waiting!” Dr. Gavin Corcoran tells his team. That’s what drives him every day.

We talked to him about: 1. What he’s most excited about for 2018 2. The key take-away messages he shared from his presentation on unmet patient needs 3. How he is helping Allergan people be patient-centric 4. How the Allergan Social Contract can change our industry

WHAT IS HE MOST EXCITED ABOUT AROUND HOW HE IS MAKING A DIFFERENCE FOR PATIENTS? Gavin talks about six star projects Allergan has in development to meet unmet needs. He emphasized that these projects are not approved yet but gave some insight of what’s around the corner. For example, one that is under review right now is for treatment of uterine fibroids, which will offer an alternative to surgery for women.

Another product he is excited about is one which treats depres-

57 | HS&M FEBRUARY/MARCH 2018

sion within hours instead of the weeks required with current therapies. Imagine the difference this can make for patients with depression or those who may be suicidal.

HIS TALK AT EYEFORPHARMA PHILADELPHIA WAS MEANT TO DELIVER WHAT KEY MESSAGES? He explains that unmet medical needs can be interpreted in so many ways. It is not simply a disease without a medication to treat it—it’s much bigger than that. It can be that the medication

requires dosing that is challenging.

He urges us to have a broad look at what unmet medical needs are.

If patients can’t access it, or the patient can’t get to a doctor, the medication might as well not exist. Simply put, medications don’t work in patients who don’t or can’t take them.

He is pushing his team to be thoughtful and ask patients what matters to them. They have found that convenience is often the biggest unmet need and may be more important for patients than new mechanisms of action.

Bottom line, make the treatment fit in the patient’s world by having a deep understanding of their needs. What we think the goal should be may not be how the patient understands it. Instead of talking about patients, talk with patients. That’s the only way we can answer their real needs instead of the perceived needs we imagine.

HOW IS HE HELPING THE ALLERGAN COMMUNITY BE MORE PATIENT CENTRIC? Gavin explained that they have a bold culture about patients. This goes through to their customerfacing teams who are all focused on how they can help patients.

They have created a 360-degree view to educate physicians with a blended team. This creates the complete picture to best treat patients.

WE HAVE COVERED THE ALLERGAN SOCIAL CONTRACT AND ITS IMPACT IN HS&M. HOW DOES HE SEE IT?

Gavin explains that this Social Contract summarizes not just what they believe at Allergan, but also defines their promise to serve patients. Gavin assures us that every person in Allergan is committed to this contract. It starts at the top with their CEO, he says, and runs all the way through every single person in the organization.

This Social Contract has four pillars with an underlying foundation of trust. They live by it and are motivated by it. Everything they do goes back to fulfilling this promise with everyone they serve. The four pillars that they commit to are: 1. Innovation—they will invest to find and meet unmet needs 2. Pricing—no increase of more than 10% per year 3. Quality and Safety—highest quality and transparent 4. Education—thinking of every way possible to help people know everything about their products Thank you, Allergan and thank you, Gavin for raising the bar! The expectations are much higher for patients and HCPs that they will get what they need and have transparent collaboration.

Allergan is encouraging other companies to join them by creating their own social contracts.

Imagine the difference this could make in our ability as an industry to be a vibrant, important part of the healthcare ecosystem. This just may be that pivotal innovation that has the potential to make the world of difference. •

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

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MEDICAL DEVICES

Integra LifeSciences and Veeva Systems on New Requirements for Medical Devices How global compliance requirements will impact the device sector

By Melonie Warfel, VP of Medical Devices & Diagnostics, Veeva Systems

A decade ago, the pharmaceutical industry experienced a shift in its operating model as a result of paradigm-shattering market dynamics and new regulations.

The shockwaves continue to impact many large organizations, as specialty biotech companies enter the market, driving rapid innovation, globalization, and increased competition. Now, the medical devices and diagnostics industry (MDDI) is the next in line for dramatic change.

Just as the pharmaceutical industry enjoyed steady growth in the 1990s, the medical device and diagnostics industry has maintained attractive operating margins between 23% and 25% in recent years and 5% annual growth.1 Established players compete successfully in the global market by applying common busi59 | HS&M FEBRUARY/MARCH 2018

ness models without much need for differentiation.

Now, however, disruptive change is knocking on the industry’s front door largely due to increased regulatory scrutiny worldwide.

New compliance requirements are expected to significantly impact medical device and diagnostics opera-

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MEDICAL DEVICES tions very soon. Beginning March 2019, the 2016 revision to ISO 13485 will require the incorporation of risk management into every aspect of the quality management system. Additionally, the European Commission ratified new medical device regulations for all European member states, while the U.S. Food and Drug Administration (FDA) released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment.

Significantly, the new FDA 510(k) requirements for device clearance make the submission process more rigid and complicated. Also known as Premarket Notifications, the FDA 510(k) submission specifies unique content and format provisions for a range of medical device types and classifications to demonstrate that the product is safe and effective. In Europe, the stricter Medical Device Regulation (MDR) will replace the EU’s current Medical Device Directive and came into effect in May 2017 with a three-year transition period. MDR addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

“An increased concern for public safety is prompting big changes,” explains Andrew Tummon, director of global clinical affairs at Integra LifeSciences Corporation, a world leader in medical technology, including orthopedic products, surgical instruments, 61 | HS&M FEBRUARY/MARCH 2018

and neurosurgical devices, implants, instruments and systems.

“By 2020, the devices industry must show clinical evidence for the effectiveness and safety of both new and existing products. The EU previously required a clinical evaluation report and literature review for many products. These reports involve the assessment and analysis of clinical data pertaining to the medical device to verify its clinical safety and performance.”

Tummon remarks that companies will need to make hard decisions on determining which existing products are worth investing money to conduct clinical studies that meet new EU requirements.

To get a CE Mark—an indicator that the product has met specifications—is going to be more difficult in the future. The new regulations will force a jump in the number of clinical studies conducted, impacting costs, processes, outsourcing strategy, and even organizational design. “Overall, new medical device regulations will require a significant change in operating processes for global medical device companies or anyone that sells into Europe,” notes Tummon.

INTEGRA’S GROWTH STORY Integra LifeSciences has grown immensely in recent years, especially through its $1 billion acquisition of Codman from J&J. Integra’s orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. The company offers a broad portfolio of implants, devices, instruments and systems used in neurosurgery,

neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. As a leader in med tech, it has to keep up with the latest technological advances if it is to meet its goals.

Like too many in the med tech sector, Integra used to be largely paper-based, but is now upgrading most of its enterprise technology and moving to the cloud to leverage cost-efficiency and flexibility.

Additionally, Integra and others in med tech may have to “weed out” some of their existing products to meet the new regulations, putting more pressure on such tasks as their need to conduct more multi-center pre-clinical trials and post-approval studies done with optimal efficiency.

Most important, Integra is dedicated to reducing uncertainty for surgeons, who make thousands of decisions every day and have no time to waste. This, too, depends on a rapid upgrade in technology, efficiency and collection of data.

PAPER VS. VAPOR— TECHNOLOGY REMAINS STUCK IN THE 90S Even as MD&D companies bring remarkable innovations to market, they have largely relied on dated technology—maintaining manual, paper-based processes and homegrown, on-premise legacy systems.

For example, many continue to use email to share documents and information. Traditionally, these organizations have been less motivated to invest in new enterprise

systems because their businesses have enjoyed attractive operating margins between 23% and 25% with 5% annual growth. Plus, more companies in this space tend to be smaller and have had less of a need for solutions designed to improve speed and agility. In Europe, for example, 95% of MDDI companies are considered smallto medium-sized—less than 250 employees—and the majority of these employ 50 people or fewer.2 However, a sharp rise in adverse events has prompted more increased regulations and strictly enforced modus operandi. In 2015, the FDA issued a total of 3,525 Form 483 Inspectional Observations to 924 medical device companies relating to 21 CFR Part 820 and issued 121 warning letters—a significant rise from a decade ago.

While forecasts indicate global MDDI growth at a CAGR of 5.3% through 2020, operating margins are predicted to decline by eight points if companies don’t pivot direction in response to this more highly-regulated market environment.1 There’s a high-growth, $475+ billion industry at stake, and Europe, where there are nearly 25,000 medical technology companies, is growing even faster than the U.S. 2,3 GETTING AHEAD OF THE CURVE Modern technology will be the game changer in ensuring compliance with new global regulations while gaining greater efficiencies throughout the device development process.

Aging infrastructures and paperbased solutions or outdated software will not take these companies

into the future. While innovative in medical product development, many medical device companies are conservative about technology and continue to use email to share documents and information. These systems don’t support efficient file sharing, collaboration, or broad visibility. They also are risk-averse and inefficient as clinical and other team members waste valuable time going in and out of static documents to make changes and inputs that reduce productivity and overall program progress. Additionally, many device company’s quality management systems do not meet the new ISO requirements, forcing upgrades.

Most important, these legacy systems are inherently inflexible and cannot adapt to changing regulations or market conditions. Data is often trapped in multiple systems, or on paper only, so companies cannot get a comprehensive view of status. Most do not provide a detailed audit trail to support growing requirements throughout the different stages of device studies.

“With automated processes and capabilities to complete tasks in real time, from anywhere, we can optimize staff time and clinical research associates can more easily execute their jobs.”— Andrew Tummon, Director of Global Clinical Affairs, Integra Life Sciences

“As medical device companies are forced to conduct more clinical studies, advanced technology becomes critical,” Tummon points out. “It’s not sustainable to hire more and more people to manage increased numbers of studies.

At Integra, we want to completely eliminate paper and paper-based processes, automate, and generate reports at the press of a button.

With streamlined processes and capabilities to complete tasks in real time, from anywhere, we can optimize staff time and clinical research associates can more easily execute their jobs.”

NEXT-GEN TECHNOLOGY OPENS NEW DOORS Modern systems provide the framework for more collaborative and transparent document and data management across all functions.

As companies outsource more specialized work to third-parties and communicate more regularly with regulatory authorities, nextgeneration cloud solutions offer an easily accessible platform that allows various stakeholders to edit, review, and approve documents without pulling from multiple sources. Most importantly, tasks are documented through the entire product life cycle, establishing an audit trail from the moment a record enters a system until archival. Status updates are automatic and easily referenced through a dashboard. With built-in metrics, companies can generate reports for both internal and external use and capture valuable insights on performance.

Advanced technologies knock HS&M FEBRUARY/MARCH 2018| 62

MEDICAL DEVICES down the silos to provide transparency into workflows and document lifecycles across therapeutic groups and, externally, with outsourcing partners who formerly stood outside the corporate firewall. This is particularly important now as medical device companies will need to engage with more external partners to handle increased regulatory requirements. Transparency is essential to control quality and bring together regulatory information.

“Increased number of trials will trigger more companies to outsource work to contract research organizations (CROs) rather than build large internal staffs to manage studies, notes Tummon. “As such, we will require CROs to use our cloud-based eTMF and clinical trial management systems. By owning the data and trial master file, we can better assess vendor performance and track progress.

The ultimate responsibility for regulatory compliance always lies with the medical device company.”

TAKING IT TO THE (MULTITENANT) CLOUD In an effort to leverage new technologies, many device companies have stacked disparate applications onto legacy systems. As a result, no one is working the same way, resulting in inconsistent data definition, data capture, and processes.

Moving forward, many medical device companies are enforcing a “cloud first” policy that eliminates the need for infrastructure and software investments to control costs and simplify management of the IT solution. With cloud providers responsible for upgrades 63 | HS&M FEBRUARY/MARCH 2018

and maintenance, IT staff can concentrate on core business activities.

Piloting new technology becomes cheaper, easier, and faster.

“Just as the pharmaceutical industry realized, the devices industry can benefit from cloud platforms that allow companies to manage more with less,” says Tummon.

“Plus cloud applications allow us to work smarter and from convenient locations. Remote workers and frequent travelers can upload reports in real time from investigative sites, hotels, anywhere…saving time and improving accuracy.”

The key is to adopt a multitenant cloud solution rather than a hosted

or single-tenant cloud system.

Multitenancy is cloud’s hallmark and the defining factor that enables dramatic economies of scale, explained at right. While one software application serves different “tenants” or companies, authorized users can only access their data and their unique instance of the application. Traceable and constantly current, data is always ready for an audit. Companies can integrate a suite of applications onto a single cloud platform to enable transformation across clinical, quality, medical, and commercial business processes.

Multitenant Cloud Defined To explain a multitenant cloud, think of a neighborhood community versus an apartment complex. In the neighborhood, homeowners maintain their own property within a community much the same way that a customer in a singletenant cloud structure manages a dedicated server to run their own version of an application. In the apartment or multitenant model, maintenance and upgrades are handled by a third party. However, owners can customize their apartments any way they want. Much the same way, the provider of a multitenant cloud solution handles all system upgrades, which are transparent and automatic to the user but customers can customize their version or “instance” of the software to meet their needs.

Applications are scalable to meet users changing requirements. It’s this multitenancy that delivers all of the highly touted benefits of cloud technology, like cost efficiency and flexibility.

“Just as the pharmaceutical industry realized, the devices industry can benefit from cloud platforms that allow companies to manage more with less.” ~ Andrew Tummon A multitenant cloud solution like Veeva CRM saves companies from having to purchase expensive hardware, troubleshoot problems, or maintain the infrastructure. The provider handles all system upgrades, which are transparent and automatic to users who benefit from always working on the latest application release.

Because the model is scalable, companies can quickly make changes and deploy new features and functionality in response to regulatory changes, market fluctuations, and technology innovation. In a client/server environment, a simple field change may require weeks to months of reconfigurations and data migrations. Changes in a multitenant cloud system take just minutes.

“As new regulations force medical device companies to conduct more clinical studies to remain in compliance, new technology platforms will help them to work more efficiently,” Tummon concludes. “While medical devices remain a high-growth area in terms of innovation, next-generation technology is the key to working smarter, faster and maintaining the competitive edge.” • SOURCES: 1. AT Kearney “Medical Devices: Equipped for the Future?” https://www.atkearney.com/documents/10192/5227116/Medical+Devices++Equipped+for+the+Future.pdf 2. Medtech Europe, “The European Medical Technology Industry, in figures,” pg. 21. http://www.medtecheurope.org/sites/default/files/resource_items/files/ MEDTECH_FactFigures_ONLINE3.pdf 3. Deloitte & Company, “2017 Global Life Sciences Outlook: Thriving in today’s uncertain market,” pg. 9. https:// www2.deloitte.com/content/dam/Deloitte/global/ Documents/Life-Sciences-Health-Care/gx-lshc2017-life-sciences-outlook.pdf

Melonie Warfel VP of Medical Devices & Diagnostics Veeva Systems Melonie has more than 25 years of technology experience, with expertise across multiple verticals— including life sciences, healthcare, manufacturing, and government. As vice president of medical device & diagnostics at Veeva Systems, she is responsible for MD&D strategy, customer engagement, business development, strategic alliances, and market adoption. Before her role in MD&D, Warfel was vice president of Vault platform, where she was responsible for new market development, solution identification, customer engagements, and go-to-market activities.

Prior to joining Veeva, Warfel spent six years building and growing the life sciences practice at l Pegasystems, and 19 years at Adobe Systems, where she drove the development of the company’s vertical business strategy. melonie.warfel@veeva.com Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 550 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit veeva.com.

COMMENT

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PHARMACEUTICAL

EP Vantage 2018 Preview

By Amy Brown, Edwin Elmhirst, and Jon Gardner

You are always asking us give you a pulse on the industry. One of the leading industry sources is Evaluate with their research on commercial intelligence. In this issue we include highlights from their 2018 Preview, which has a great deal of in-depth data on what to expect in all sectors of the industry. The full report can be found here. ~ Editor The biopharma sector is approaching 2018 in a position of strength.

Novel medicines are reaching the market more quickly than ever before; in the past few years large and small drug developers have successfully launched transformative products in a number of therapy areas; investor support for private and public companies is strong; and global demographics signal rising demand for healthcare.

But for those looking ahead, what should alternative hypotheses test? That 2018 holds even more promise? Or that the pace of progress is unsustainable? There are arguments to be made for both statements. On the regulatory front, it looks unlikely that the US FDA will swing towards a more conservative stance; the past few years have seen concerted efforts to speed approvals of the most urgently needed new medicines and,

65 | HS&M FEBRUARY/MARCH 2018

more recently, low-cost generics.

There are perhaps more uncertainties in Europe, which is grappling with the relocation of the European Medicines Agency post-Brexit.

But even here the regulator has made attempts to become more transparent and proactive.

Over the past few years, these regulators have ushered in groundbreaking medicines that promise to shift the outlook for patients suffering from a wide variety of chronic and acute conditions— and reward their developers richly.

Many of these scientific leaps forward—like CAR-T or RNA therapies—are expected quickly to become commercial success stories. But how these new launches actually fare in markets that are increasingly sensitive to cost will be closely watched in 2018.

On many measures, 2018 should start strongly for the biopharma

sector: closely watched stock indices are not a million miles off 2015’s peak, demand for IPOs and secondary fund raisings is strong, and the coffers of venture investors are well stocked. The need for large companies to stock pipelines will never wane, while regulators are sending industry a clear message—deliver the innovation and we will approve it.

Here are some highlights from the report: REGULATION, LAUNCHES AND PIPELINES “R&D successes and failures are probably going to be the biggest driver of sentiment next year, all other things being equal,” says Ben Yeoh, senior portfolio manager at RBC Global Asset Management.

“The immuno-oncology space continues to be a barometer— there will be a lot of attention there.” (figure 1)

(figure 1)

(figure 2)

HS&M FEBRUARY/MARCH 2018| 66

PHARMACEUTICAL

(figure 4)

67 | HS&M FEBRUARY/MARCH 2018

(figure 3)

• The FDA green-lighted 46 novel drugs in 2017, which are forecast to be generating more than $32bn in US sales in five years’ time. (figure 2) Other products to watch in immuno-oncology: • Bristol’s Checkmate-227 • The overall survival result from AstraZeneca’s Mystic study, which failed to hit on progression-free survival at the first reading .

• Roche’s surprising hit on progression-free survival in the Impower-150 trial in November. If Tecentriq’s advantage over a wellestablished treatment regimen is confirmed, Roche will find itself in

a strong position. (figure 3) In addition to immuno-oncology, other news that could generate headlines in 2018: • Spark’s progress with what is likely to be the first gene therapy in the US • Roche’s newly approved novel hemophilia treatment, Hemlibra (emicizumab) • CAR-T therapies Yescarta and Kymriah: initial uptake of these cutting-edge therapies will be closely watched to help evaluate the future value of these and rival therapies –and help judge whether Gilead’s $12bn acquisition of Kite was worth it. (figure 4)

MONEY AND MARKETS— DEALS, FINANCING AND VALUATIONS (figure 5) • M&A expectations were brought into sharp relief during October’s tumultuous third-quarter earnings season for many large cap biopharma companies. Missed expectations and mounting concerns for the growth prospects of the likes of Celgene and Biogen, for example, caused a significant selloff • Complaints about unrealistic valuations have been cited as a reason for the quiet M&A scene.

Whether asset prices are too high remains an ongoing debate.

(figure 5)

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PHARMACEUTICAL

(figure 6)

PAUSE OR PULLBACK IN BIOPHARMA? • Three years of pharma-bashing have yielded almost no US action on drug pricing and even President Trump appears to have lost interest. His appointment of a former Lilly executive, Alex Azar, as Health and Human Services secretary is surely another positive sign for the sector • The checkpoint inhibitors Keytruda and Opdivo arrived in 2014 and in only two years had cumula-

69 | HS&M FEBRUARY/MARCH 2018

tively generated revenues of $8bn • In 2017, sales of the five antiP(L)-1 antibodies now on the market are expected to reach $10bn • There is plenty in the pipeline that could go right next year.

Regulatory stances are unlikely to shift suddenly, and truly innovative therapies are being reimbursed.

Throw in a couple of big deals and an absence of aggressive pricing rhetoric, and the outlook improves even more. (figures 6-9)

“If you look at the pace of R&D, there has probably never been a better time for a lot of science,” says RBC’s Mr. Yeoh.“We’re curing cancers that we’ve never cured before, we’ve got new drugs for MS, new treatments for diabetes.

Costs aside, we are still making progress on human health.”

That progress will continue in 2018, however confident investors are feeling.

(figure 7)

(figure 8)

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PHARMACEUTICAL (figure 9)

TOP FOUR HEALTHCARE INDUSTRY TRENDS FOR 2018 As an addendum to the EP Vantage 2018 Preview, here’s further prognostication about the year ahead, compiled by the sales enablement experts at Seismic in a survey of 200 healthcare and life sciences professionals in marketing, sales, IT and operations.

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COMMENT HS&M FEBRUARY/MARCH 2018| 72