November / December 2019

™ NOVEMBER/DECEMBER 2019

the publication for healthcare sales & marketing leaders™

TOP 100 HEALTHCARE COMPANIES IN THIS ISSUE

HEALTHCARE COMPANIES

Olympus Executive Director of Marketing on Focusing on People Smiths, Transentrix, Bausch, Tandem Execs On the Role of Regulatory Affairs Sr. Sales Director of Lilly on Lessons Learned NEW FEATURE! Talent Trends KPMG Report on Medical Devices Cleveland Clinic Top Ten Innovators

FINDING EMOTIONS IN EVERY MOLECULE, CELL, PATHOGEN, AND ANTIBODY At AbelsonTaylor, we get emotional about science.

For us, there’s real emotion buried in everything from molecules to K-M curves. So we get down to the cellular level to find emotion in the science that lets us tell a human story. One that HCPs will connect with. Because we’re not just inspired by science— we feel the data.

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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 Spotlight: Peter Crowley, Olympus Executive Director of Marketing.............................................9 Roundtable: Smiths, Transentrix, Bausch, Tandem Execs on Regulatory .................................. 13 Top 100 Healthcare Companies.................................................................................................................. 21 KPMG Report on Medical Device Outlook to 2030............................................................................ 29 Industry Trends: By The Numbers............................................................................................................ 37 Motivideos: To Use In Your Meetings..................................................................................................... 39 Talent Trends: Cari Kraft on the Salary Ban.......................................................................................... 43 Great Minds: Naji Gehchan, Sr. Sales Director of Lilly, on Lessons Learned in War................ 47 Innovation: Cleveland Clinic Top Ten........................................................................................................ 51 Agency and Provider Directory.................................................................................................................. 57

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Publisher’s Letter

A Young Industry The reason Healthcare Sales & Marketing features so much news about developments and the state of the industry in healthcare is not just because that’s well-within our sphere in publishing this magazine. It’s because we want to bring our readers the latest news from your peers.

Consider this: it has been less than 100 years since the first major discoveries in this field were made. Insulin – 1922 by Frederick Banting, Charles Best and John Macleod, who won the Nobel Prize for their discovery. Penicillin – 1928, Alexander CARI KRAFT Fleming, which began the steady march of antibiotics to combat all kinds of bacterial infections that previously had no cure. In 1948 another giant leap occurred – Sidney Farber discovered that aminopterin could induce remission in children suffering from acute lymphocytic leukemia. In 1952 chlorpromazine, the first antipsychotic medication, was introduced by Rhone-Poulenc. In 1955 – Jonas Salk and the polio vaccine. In the same year, McNeil Laboratories gave pain management a boost with Tylenol Elixir for children, the first alternative to aspirin.

In the grand scheme of things, this immense field, which is now responsible for alleviating suffering worldwide, is still in its early stages. Recent discoveries in the nascent fields of neurology, biotechnology and gene therapy are just the latest in a long list of novel treatments opening hopeful horizons for millions.

Our Top 100 Healthcare Companies includes 44 pharmaceutical companies, 43 medical device (medtech) companies, 9 biotech companies and 4 companies that span the categories. We measure these, as always, by their worldwide revenues. But that’s only because the importance of any one company or product cannot be gauged easily by other yardsticks. That measure is individual, evaluated by every patient, every life saved, every pain reduced, or illness conquered.

The Top 100 Healthcare Companies’ overall revenue total was $1.261 trillion USD, and the overall revenue grew by 5% from 2017. Could Banting, or Fleming, Farber or Salk have foreseen how much progress would be made in less than a century? Probably not. But we owe them a salute for being pioneers in what is today the world’s most important field, of which we are very proud to be a part.

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

Cari Kraft, Publisher

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

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HS&M NOVEMBER/DECEMBER 2019 | 4

Letter from the Editor

The Whole Compendium Of Change Where are the inspiring changes coming from in medicine? Well, they’re being developed all over, and we found a peek into them in a recent special section of the Sunday New York Times. Herewith, a summary of their coverage.

Rebecca Onie, founder of Health Leads, offers the idea that has already gained traction in the profession: treating the whole patient. She tells the story of a boy who was examined to determine the source of his weight loss. After many tests, it turned out he just wasn’t eating enough. Specialization had interfered with what might be a normal inquiry: Are NEIL GREENBERG you hungry? Ms. Onie says the place to start with a patient is to look at the person’s entire world – not just at what we assume to be a “medical” problem.

Antoni Ribas, UCLA professor of medicine and a lead researcher in developing Keytruda, expands on that viewpoint by noting that empathy should also be a component of an exam. He has been spectacularly effective in the cancer immunotherapy area, with results not dreamed of by other physicians.

Sergiu Pasca, a professor of psychiatry and behavioral sciences at Stanford, has advanced the science of brain chemistry by transforming skin cells into stem cells and then into the type of brain cells in the cerebral cortex.

Rather than arranging them in layers in a petri dish, he allowed them to grow into ball shapes. These balls then “communicated” with each other.

Luhan Yank, co-founder of eGenesis, a start-up research company, has improved on a process that has been developing for years: the use of pig organs that can be transplanted into humans. Fear of transmitting pig viruses to humans had halted this practice in the 1990s, but now genome science has allowed Dr. Yang’s team to edit out the viruses and create safer transplants.

These are amazing discoveries, and here’s one of the most eye-opening aspects: Ms. Onie is 40, Dr. Pasca is 36, and Dr. Yang is only 32. The oldest is Dr. Ribas…at 52.

What does this mean? Perhaps many things. That we can stop worrying about Gen X and the millennials, because they’re just fine. That whatever needs to be accomplished is in good hands. That our universities and medical centers are not stymied by worries about what comes next, because they’re doing it.

The only thing that bothers me is that these kids are making me aware of how much I haven’t accomplished! But they’re reason to be proud of healthcare and its future.

We try to keep up with all this, and bring you the people who have a grasp on change. We hope that it will be informative, and assist you in furthering the work you do every day. Let us know what topics will be most useful to you!

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

5 | HS&M NOVEMBER/DECEMBER 2019

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.

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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 Associate Publisher Natalie Newcamp 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

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.

Sebastian “Sebby” Borriello Vice President, Chief Commercial Officer SK Life Science Sebby currently servies 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.

© 2019 CL Media Inc., Philadelphia, PA

Maria Finlay, MBA

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.

Director of Channel Marketing, Incyte

To advertise in HS&M, please contact Natalie Newcamp at nnewcamp@hsandm.com

7 | HS&M NOVEMBER/DECEMBER 2019

Maria has over 20 years of commercial marketing, sales leadership, women’s leadership and operations experience. She has led multiple brand marketing and cross-functional teams at Johnson & Johnson, AstraZeneca and Teva Oncology before joining Incyte; where she is in charge of access and reimbursement strategies and tactics, advancing impact with payers, PBMs, state societies, federal channel, pathways, GPOs, community oncology strategic accounts, and hospital system business stakeholders.

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 healthcare 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 achieving high 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 NOVEMBER/DECEMBER 2019 | 8

EXECUTIVE SPOTLIGHT

Olympus Executive Director of Marketing, Peter Crowley, on Improving Patient Outcomes by Keeping the Focus on People

The nature of our business is ultimately tied up in improving patient outcomes. Helping people should be at the center of everything we do. Peter Crowley walks the walk. He draws from his sales background, along with four key principles he has developed, to keep people, whether it is the patient or his team, at the center of everything he does.

Peter is currently the Executive Director of Marketing, Urology, for Olympus Americas Incorporated.

In that role, he focuses on better patient care through innovation.

Peter has been a marketing and sales professional at Covidien/ Medtronic and Boston Scientific, covering vascular products, metal stents, biliary therapeutics, dilation and more. But describing Peter as just a marketer or sales professional explains only a small part of his experience and impact in the medical device industry. A longtime innovator, he was fortunate to be part of an internal start-up at Boston Scientific, called Endovations, to introduce a single-use endoscope and then later a single use choledoscope called SpyGlass.

Additionally, Peter has several patents in his name across several specialties.

At Olympus, he is intent on nothing less than transforming the business through improving the

culture and driving best in class technology.

With patients and people at the focus, Peter shared with us his four keys to success. They are: focus on improving the patient’s quality of life; manage the end users’ needs and challenges; utilize true innovation; and build and enhance his own team’s culture.

THE PATIENT Peter’s connection to and focus on the patient goes back to his days on the road as a medical sales rep. He remembers driving hours through a snowstorm, having been called to the bedside of a patient with pancreatic cancer. The surgeon needed support and in-servicing during a procedure involving insertion of a Biliary Metal stent. Rushing to the OR, Peter was stopped by the wife of the patient.

“Are you the stent guy?” she asked.

He acknowledged he was.

“They’re going to put a stent in my husband today. How’s it going to go?”

It was a powerful moment. Of course, he couldn’t offer a medical opinion to this anxious woman, but he did his best to reassure her.

The chance encounter stuck with him as a reminder that he wasn’t in the stent business, he was in the saving lives business. He left the hospital later, in a reflective state.

That event would underscore a lot

9 | HS&M NOVEMBER/DECEMBER 2019

of what he did from that point on.

Given the impact, it is ironic that he later was in charge of marketing for the same stents business in his early product marketing career. His experiences in the field reinforced how important he knew medical devices were to patients and their families.

UNDERSTANDING END USER NEEDS AND CHALLENGES For positive patient outcomes, Peter emphasizes the importance of understanding his products’ end users’ needs and challenges, whether that user is the physician or the patient. In thinking about the patient as the product’s end user, Peter uses an example of men living with benign prostatic hyperplasia (BPH) and how an Olympus product could provide better outcomes. “A patient has a choice between getting a new therapy with unproven procedure outcomes, often requiring a catheter for several weeks of discomfort, or undergoing the gold standard in BPH surgery, Plasma TURP. This is a real quality of life situation, and we have to think like those patients – what would they choose?” For each patient, there is a complex equation that determines what will provide the desired outcome: timing, age, potential side effects, etc. Patient education is important.

Olympus directs patients interested in learning more about BPH to PlasmaButton.com to support

education and identify specialized physicians in their area.

Physicians also act as important end users of Peter’s products.

He discussed the importance of removing bias from everything his team possibly can, including interviews with Key Opinion Leaders (KOLs). Good science, to Peter, all starts from the beginning with the way you gather information about your end users’ needs.

We all have biases and beliefs. The trick is to try and suspend these when conducting any market research. Leading questions, interviewing with an audience, forcing questions into responses without a sliding Likert scale – these are all classic mistakes in market research. Best in class is offering the evaluation with choices and then repeating the sequence multiple times with variations (blinded if possible). An example in guidewire development would be to have a physician navigate difficult strictures in an anatomical model, while adjusting core wire stiffness, flexible durometer segments and tip materials and length. Can the physician detect these subtle differences and demonstrate a performance difference?

Peter and his team are diligent about testing products and gaining feedback about products while using the cleanest possible research tools.

the disease state itself. “That’s the only way to improve outcomes and see the whole spectrum of patient care,” Peter says. “It’s about quality of life.”

One example of simplicity is Olympus Narrow Band Imaging to aid in the visualization of bladder tumors. Unlike other techniques, there are no dyes or drugs injected and there is no additional cost. The surgeon simply pushes a button on the video processor in order to see via the use of different light spectra. That helps identify areas with increased vascularity that could be bladder tumors.

“Patients can live for years with bladder cancer, seeing their urologists for regular screenings and having additional tumors removed, avoiding the more serious removal of the entire bladder,” Peter says. “Our NBI technology enables targeting of these tumors without the need for dyes or drugs.

It’s less costly, more comfortable for the patient and can be used with any patient at any time.”

Also important is not falling in love with the “invented here” component of a technology. “Sometimes it’s better to build it internally but sometimes it’s better to acquire it,” Peter notes. “Is it a core competency? Do we have the skill set? Let’s make the best decision for the right reasons.”

A new technology, whether homegrown or acquired, has to serve the very specific purpose you are aimed at, or it doesn’t make sense.

The same is true of all aspects of a therapeutic approach. “Is there good science behind it? Have you done your due diligence? What’s the five-year data? What’s the bench science? And ultimately, does it provide the value proposition we’re trying to achieve?”

THE TEAM Finally, there’s the task of building the right team, internally and externally. Bringing in the right expertise extends to both the external partners you work with (such as thought-leading physicians) and

TRUE TO INNOVATION With respect to technical innovation, Peter doesn’t necessarily orient toward the latest, glitziest, priciest technology. He makes a clear-headed examination of what will work best to solve the problem, even if it’s very traditional methods or technology. “Simplicity often wins over complexity,” he says. It’s part of being an expert not just in the technology, but in HS&M NOVEMBER/DECEMBER 2019 | 10

EXECUTIVE SPOTLIGHT the team you build around you. Peter resists the use of the verb “manage” to describe what you do with teams. “You manage finances and projects, not people. We identify the right people and give them as much latitude and trust as we can to be true owners of their business.

“In building a best in class team and culture, you need to focus on diversity of skills, background and approaches. We have always said that we never want a full team of traditional MBAs or an entire team of ex-sales, but a blend of skills, backgrounds and approaches that lift a team up with open minds.

“When we bring in the right mix of talent, we need to give them the freedom to inject their own wisdom. Millennials teach us something new every day! Those with years of experience can read a situation differently because they learned lessons earlier in their career.” This is the secret behind why his teams have a passion for the work they do. They experience ownership. “My job is to set the ultimate goal. The team’s job is to offer ways to get us there. We focus on positivity and potential.” Peter’s team radiates unity, respect and fun.

He sees the process as a Man on the Moon mission. “We set a clear target, define the deliverables, and set the team free.” He recalled the analogy that John F. Kennedy described of encountering a janitor at NASA. The president asked the worker what his job was. “To help get a man on the moon!” was the response. “No contribution is unimportant. We have an antihierarchical approach. Anyone can say anything, which of course makes it incumbent on me not to bias the team in advance.”

To try and foster this team unity, the team will occasionally get together for team building activities on- or off-site. “We can never find enough time for team and personal development; this is one of the traps of business as priorities add up.” Still, Peter works through the team to identify team building events like escape rooms, an activity he calls “Forest through the Trees,” or off-site charitable events.

Every month, his team nominates one Marketer of the Month for the MOTH award. These add up to a culture of fun and recognition.

“We go through a lot of exploratory activity with our KOLs, whether during advisory board meetings or one-offs. We do a literature search, look at other companies in the space, and brainstorm a lot of potential approaches.” Again, this demands putting bias aside. Peter is always looking for the next question to ask: “How can we improve the test method? How can we approach the procedure differently?

Do we really understand performance in the real world versus the lab? Do we understand the experience of both the physicians and the patients?” This rigor opens windows to an open and unencumbered analysis of the situation.

Above all of this is the overriding Olympus True to Life campaign

and company culture, which Peter explains is built on these core values: • Agility • Empathy • Unity • Long-term view • Integrity “If you have consulted the KOLs, come to fully understand the market, learned how to improve the outcomes, and minimized your biases – you will live the core values and arrive at the Ultimate Value Proposition,” Peter says.

The final step for a marketer, of course, is how to communicate the chosen messaging, through promotion and advertising, social media, print, the sales team, direct to patient, direct to physician or direct to societies. “GPOs and IDNs are also becoming more critical in our decision making, as are buyers like Amazon and technology providers. It’s a massive, complex market.”

But complexity can be navigated using a clear vision. “Promote value to patient care. It’s not about the product or the company. It’s about the patient outcomes.” Peter is proud to work for Olympus and is truly excited about the future of his team and organization. •

Boys and Girls Club of Atlantic City accepting bikes assembled by the Urology team during a national sales meeting.

11 | HS&M NOVEMBER/DECEMBER 2019

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ROUNDTABLE

THE REGULATORY ATMOSPHERE: Execs From Smiths, Transenterix, Bausch and Tandem Offer Insights Our panel of experts: GARY BARRETT

LIBETTE LUCE

VP Regulatory Affairs, Quality Systems and Compliance Smiths Medical

Senior Director Regulatory Affairs Bausch Health Companies

STEPHANIE FITTS

MICHAEL SARRASSIN

Vice President Regulatory Affairs, Quality Assurance, Clinical Research and Compliance TransEnterix, Inc.

13 | HS&M NOVEMBER/DECEMBER 2019

Senior Director for Regulatory and Clinical Affairs Tandem Diabetes Care

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ROUNDTABLE Like almost every other part of our industry, regulatory affairs is growing and changing. With pressures coming from impending compliance with EU MDR standards, drug pricing reform, and FDA pre-certification programs, it is no wonder regulatory affairs teams are busy. Regulatory affairs professionals are also often busy filling open roles. As some of the hardest to fill in the industry, it is no surprise that Jacobs Management Group’s annual Compensation and Hiring Survey found that companies spend an average of 7 months filling a regulatory role. This all falls on top of regulatory’s already time-consuming and very important primary function of getting approvals through. To keep it all in check, regulatory needs support within the organization.

This is where sales and marketing come in. We sat down with top regulatory leaders whose experience ranges from device to pharma, consultant firms to industry, and companies big to small. These regulatory professionals made it clear that: regulatory affairs and sales and marketing need to work as a team, from the very beginning of the product development process, in order to find success, shared language around a product and its claims is key, sales success is indicative of regulatory success, and much more. Read on to hear from the best!

In your experience, how does regulatory affairs view marketing and sales?

GARY BARRETT: Regulatory affairs views marketing and sales as valuable sources of information and as partners. The regulatory process must include marketing and sales at the initiation of any project in order to know expected base claims and other expectations. Without understanding what the device is intended to be sold/marketed as, it is impossible to accurately gauge what a registration should look like. Conversely,

once a device is on the market, marketing and sales provide crucial information for post-market surveillance and clinical evaluation. As MDR rises to prominence, this information is more and more crucial. This reinforces the holistic nature of the med device business.

STEPHANIE FITTS: Generally, we regard marketing and sales as internal customers, and, like all customers, they can sometimes be challenging. Regulatory tries to get the right products approved in the right market with the right claims so that sales and marketing can bring in revenue. The timeframes

15 | HS&M NOVEMBER/DECEMBER 2019

for each department are extremely different which leads to frustration on occasion.

LIBETTE LUCE: In my experience, I value marketing and sales very much, as they support the continued success of an organization. I have always engaged both departments early in product development to ensure that there is alignment between R&D and the commercial units.

MICHAEL SARRASIN: I generally view marketing and sales quite favorably. They are integral parts of the success of any company, and you have a really good idea as to how successful your company is by way of how successful your salespeople have been. Although a somewhat simplistic view, product sales and market acceptance provide the most basic and raw data for how well a company is doing.

What “disconnects” have you seen between regulatory and marketing/sales?

FITTS: When a product is being developed, the sales and marketing teams try their best to indicate which markets are critical for market access. Regulatory then works with R&D to get the right testing and documentation in place for regulatory submissions, which can take months or even years. A common disconnect is that either the sales/marketing strategy shifts over time, or the market itself changes or becomes more known to the sales/marketing team.

Often, regulatory cannot shift quickly enough to get new or different testing and make regulatory submissions in time to respond as quickly as sales/marketing would like. Another common disconnect

is the claims that the sales/marketing teams would like to make regarding the product. New claims can take additional R&D testing or even new market authorizations prior to being launched. Regulatory has difficulty understanding why these claims cannot be market tested and finalized alongside the product development timeline and instead are developed closer to the launch phase. The lack of alignment can result in R&D having to test all over again – and, worst case, regulatory having to apply for new market authorization.

BARETT: The development of silo mentality is prevalent in many companies. The separation of functions into specific “camps” with individualized priorities and disconnected goals is the result.

SARRASIN: Most disconnects for me with marketing and sales have always arisen in terms of where is the gray area and how can we use it, work with it, and where the guard rails are. Questions seem to arise from where the nuances are in terms of discussions, and from educating on how certain phraseology can be used, but other phraseology, although seemingly similar, may in fact be significantly different. This has always been an issue, and it relates to the amount of time that would be needed to fully understand the limits of commercial speech, especially considering any marketing limitations placed on the device/drug’s indications dictated by FDA. LUCE: The repeated “disconnects” that I have seen between these sectors are the distinctions between the “needs” and “wants” from marketing/sales as they relate to

DISCONNECT BETWEEN REGULATORY AND MARKETING/SALES STRATEGY SHIFTS IN MARKETING PRIORITIES ORGANIZATIONAL RISK

DEFINING SUCCESS

product claims. As we begin early stages of development, we discuss the Target Product Profile (TPP) and competitive landscape of the product in development. In regulatory, it is my responsibility to obtain the best label based on the data for approval for market entry and patient access. It is my responsibility to adjust the regulatory strategy and communicate that to my cross functional team in R&D to ensure that the clinical studies reflect the appropriate endpoints to use as the basis for product claims.

How can regulatory foster better two-way communication with marketing and sales?

SARRASIN: The easiest way for regulatory to foster better communications with marketing and sales has always been, in my opinion, to keep an open-door policy, give clear direction and application on guidelines to likely FDA interpretations of regulations, guidances, etc. It’s also important for regulatory to be able to discuss the risks intelligently with market-

ing and sales regarding associated pathways that may be utilized for marketing and marketing communications. Most marketing and sales groups would like a clear and reasonable discussion of the risks at hand, rather than a pedantic, overbearing simplistic discussion of how much jail time one would get.

BARRETT: The communication needs to be two-way; regulatory cannot be expected to constantly be the bridge builder. This requires both sides to realize the needs of the business over individual goals. It is pointless for one group to succeed if the other fails. The important objectives are those of the company, not individuals. This needs to be realized by both management teams and overlaps need to be reinforced. If this requires dedicated time and/or resources, then it needs to be a priority.

LUCE: To foster better two-way communication between marketing and sales is to do it often.

Competitive landscape and product positioning is highly variable

HS&M NOVEMBER/DECEMBER 2019 | 16

ROUNDTABLE in this marketplace. I need to know if commercial priorities have changed or if there is an interest in different data for a product. I only have the ability to modify a development strategy and/or program if I know what the focus of a product claim(s) is, so that clinical studies can be adjusted as required. Additionally, I need to assess the risk the organization is willing to take on a development program if there is a shift in product scope, i.e., patient population, treatment, etc.

FITTS: It comes with building relationships between the teams.

If you can establish yourself as someone who is interested in their processes and invested (as we surely are) in their success, then in the heat of a contentious issue, you can draw on that trust.

How have you measured regulatory success in your company beyond approvals?

LUCE: The way in which we can measure regulatory success beyond approval is by patients’ access to the drug via sales and distribution data, but moreover seeing the repeated safety and efficacy of a drug for the patients via annual reports. As regulatory professionals, we want to ensure the continued safety of an efficacious treatment to patients.

FITTS: As a maker of medical devices that are also capital equipment purchases by a hospital, we measure utilization of the product during market introduction as a measure of success. Utilization means both that the product is sold to customers and also that the product is then used by those customers to the benefit of the patients. If the sales are not there, or if the product is abandoned due

to not having clinical utility, then the product will have a short life.

It could mean that regulatory did not get a broad enough indication for use, or that companion products are needed to make the system more useful. Either way, there are lessons for the team moving forward when armed with this metric.

BARRETT: We measure through integration and the success of other groups. If regulatory succeeds in getting a registration but sales fails to land accounts, then the company loses despite regulatory’s success. The obverse is that sales cannot sell what is not approved.

Extrapolating to the first question, if sales wants to sell a device for a pediatric indication but this was not communicated, then regulatory will not have tailored the submission, due to poor communication; the approval is useless.

Communication is key.

SARRASIN: Although approvals are key indicators for the regulatory group itself, other factors weigh heavily, including relationships with the agencies and trust that has been built between the regulatory group and the agencies, which reflects on the company as a whole. Also providing the company with a ”benefit of the doubt” scenario should it ever be needed. I also think that trust and those fostered relationships translate to success internally as well. Having a regulatory group that is trusted and reliable is easily integrated into the other aspects of the company, including marketing and sales, speeding the process of product design, development, and review.

17 | HS&M NOVEMBER/DECEMBER 2019

How early should regulatory be involved in the marketing/sales process, and to what extent?

LUCE: The question that should be raised is the opposite. How early should commercial (marketing/ sales) become involved on a development program within R&D, specifically regulatory? The answer is as soon as possible. What regulatory looks for from commercial as soon as a development program gains traction (e.g., ready to begin Phase I studies) is the Target Product Profile (TPP). The TPP is the foundation for the product labeling, specifically, the product’s indication and claims. Regulatory will need to know the competitive landscape of the product and the overall positioning of the product to provide an accurate regulatory/ development strategy plan. In short, regulatory needs to obtain alignment from commercial at very early stages of development to ensure that the clinical development program reflects the needs and desires of commercial for a product.

FITTS: Regulatory and sales/marketing need to be active members of the product development team from the beginning as requirements are being decided. Strategy is as much what you are NOT going to do as what you ARE going to do. So being involved in features, claims, and markets for the new product as it is developing can help alleviate frustrations down the road.

BARRETT: Start at initiation and continually through the process.

Likewise, marketing should be included in the registration process, ensuring that the claims matrix meets the needs of the company.

Moving Forward EARLY INCLUSION BETWEEN REGULATORY AND MARKETING/SALES

ADJUSTING CLINICAL STUDIES

BUILDING TRUST/ TWO-WAY COMMUNICATION

SARRASIN: For me, as early as possible, to set the right expectations in terms of regulatory review and regulatory requirements.

Regulatory should be part of the design and development team in order to chart the course that needs to be taken to approval/allowance.

What does regulatory want marketing and sales to know with respect to product information that may not be off-label and how that can be best communicated?

SARRASIN: The only thing I would say is that I would like marketing and sales to not feel bound by convention. Bring your ideas to regulatory to review and make recommendations, and discuss risk. And to regulatory I would advise that the discussions not always end in ”No,” but with suggestions on how to exploit the advantages you have without running afoul of the law.

BARRETT: Marketing and sales need to know that off-label promotion is not ”pushing the envelope”; that just because competitor X has that specific claim on their advertising brochure does not mean we can include it; that ”best in the world” and ”preeminent design” are not supportable claims. The first class in any marketing course lays out that the goal of marketing is to sell a result or emotion rather than a product – that does not apply in med devices. Go to a conference; the majority of marketing literature is a picture of a device, the device name, the company name and the booth. There is a reason for that.

LUCE: We continually provide clinical data to marketing and sales regarding information that is on-label through results of clinical studies and clinical paper authored by our medical affairs department.

Informing marketing and sales in real time when information is

ALIGNMENT OF GOALS AMONG DEPARTMENTS

available is crucial to the launch of a program. Commercial is also well aware of the information that will be in the product labeling during the time of NDA preparation and throughout the FDA review process of a marketing application at the very latest. The shell of the product labeling is well known prior to the initiation of Phase 3.

FITTS: The concept of fair balance, if it can be truly understood and embraced by the sales/marketing team, can go a long way toward bridging the understanding between the teams.

Can you relate any incidents in which coordination between marketing/sales and regulatory were well handled? Can you give an example of the result?

FITTS: In one instance a particularly organized marketing manager was preparing for a US launch of a product. She had first developed and market-tested a

HS&M NOVEMBER/DECEMBER 2019 | 18

ROUNDTABLE series of claim “areas” such as ergonomic benefits and cost. Then, once she had her concepts that tested well with customers, she worked to develop imagery and text for claims. At this point she pulled in regulatory and we worked collaboratively to either modify text or commission test reports to substantiate her most needed claims. We developed a claims matrix to speed the review of launch materials – and this matrix (of claims, images, and the substantiation proof source) was released in document control. With this tool, launch materials review was extremely efficient and timely. Regulatory could meet a 48-hour review turn around commitment as long as there were no different claims or images on launch materials. We were happy to review novel claims and images, but for these we would not hold ourselves to the 48-hour commitment. This launch went very well in that the sales team had professional-looking, consistent tools to drive messaging with customers.

SARRASIN: We were in a very compressed time frame, in conference with FDA, working on an approval of certain labeling claim negotiations. I specifically brought marketing into the meeting to provide a perspective to the discussions so FDA could hear where we wanted to go with the approval. It was successful in that the approval was granted with deference to marketing’s certain requests.

BARRETT: Key to the process are communication and discussion. Regulatory needs to stop saying “it’s hard to explain…” and marketing needs to understand that the guidance documents do not portray an exact answer. The FDA needs to clarify its position on a number of issues with regard to marketing.

LUCE: My best example was during labeling negotiations with FDA during NDA review. Providing commercial a seat at the table informing them of FDA’s recommendation to a label that may limit claims is essential. Additionally, regulatory can be the expert in explaining the level of risk in responding back to FDA with either accepting agency’s recommendations or providing a rebuttal and proposed wording to obtain the label desired. Having regulatory as the sounding board for commercial is always helpful during labeling negotiations, so that there are no surprises in the label for product launch. •

19 | HS&M NOVEMBER/DECEMBER 2019

PANELISTS GARY BARRETT VP Regulatory Affairs, Quality Systems and Compliance Smiths Medical

Gary began his career as a scientist at Triton Systems and Nimblegen before moving on to become MEMS Project Manager at IBT. After stints at KEMA Medical as Senior Project Manager, Merit Medical as VP Regulatory Affairs and DEKRA Certification B.V. as Business Development Manager, he moved to AngioDynamics as Senior VP for QA and RA. In 2018 he joined Smiths as VP Regulatory Affairs, Quality Systems and Compliance. gary.barrett@smiths-medical.com

SMITHS MEDICAL is a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets.

Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, their products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for support in managing chronic illness.

STEPHANIE FITTS Vice President Regulatory Affairs, Quality Assurance, Clinical Research and Compliance TransEnterix, Inc.

Stephanie had experience as Clinical Program Manager at Medtronic and Senior Director of Regulatory Affairs and Regulatory Compliance at Stryker Orthopaedics, then was named VP of Regulatory, Quality and Compliance at Baxano Surgical. Following that, she was a quality and regulatory consultant for OBX Associates, working with small med device companies. She moved to TransEnterix in 2015, where she has

been responsible for the successful first marketing applications to the U.S. FDA for a complex electromechanical device system. sfitts@transenterix.com

TRANSENTERIX is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients, while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. TransEnterix also developed the SPIDER device and the SurgiBot System, a singleport, robotically enhanced laparoscopic surgical platform.

LIBETTE LUCE Senior Director Regulatory Affairs Bausch Health Companies

Libette was Associate Regulatory Affairs at Schering-Plough Research Institute, a sales representative for Novartis, Associate Regulatory Affairs at Hoffman-LaRoche, and Senior Manager of Regulatory Affairs at Forrest Laboratories/Allergan and Amarin. After becoming Director of Regulatory Affairs at Valeant Pharmaceuticals, she accepted the position of Senior Director of Regulatory Affairs at Bausch in 2017.

Libette.Luce@bauschhealth.com

BAUSCH HEALTH manufactures and markets a broad range of branded and generic pharmaceuticals, over-the-counter (OTC) products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetic devices) directly or indirectly in more than 90 countries and regions, including the United States, Canada, Europe, the Middle East, Africa, Asia Pacific and Latin America. Each day, their products are used by up to 150 million people around the world. Their portfolio of products covers eye health, gastrointestinal diseases and dermatology.

MICHAEL SARRASSIN Senior Director for Regulatory and Clinical Affairs Tandem Diabetes Care

While at Tandem Diabetes, Michael has led the Regulatory/Clinical Affairs Groups that prepared numerous groundbreaking FDA PMA submissions for the Artificial Pancreas, Alternative Controller Enabled Infusion pump, the first interoperative approved insulin infusion pump for children and adults, and remote device updating for more complex algorithms. He began his career with the Millipore Corporation in Bedford MA, working on PMA and 510(k) applications for various medical products. He has held director and vice president level positions in regulatory, quality, and clinical affairs at Whalen Biomedical, Kimberly Clark, Lysonix, and the DAKO Corporation. His background includes expertise in worldwide regulations and their implementation, as well as the management and conduct of various complex clinical studies and marketing applications worldwide. msarrasin@tandemdiabetes.com

TANDEM DIABETES CARE is a public US medical device manufacturer. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy. The company’s goal is to make the lives of people with diabetes better through relentless innovation and revolutionary customer experience. Its strategy is to excel in its area of expertise and partner with other technology leaders to create the best options available. These partnerships include leading researchers in the artificial pancreas space, where Tandem technology has been used worldwide.

COMMENT

HS&M NOVEMBER/DECEMBER 2019 | 20

HEALTHCARE

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

HEALTHCARE COMPANIES

TOP 100 HEALTHCARE COMPANIES Pharmaceutical, Medical Device, Biotechnology

Combing through our previous lists of the Top 50 Pharmaceutical, Medical Device and Biotechnology companies, we have compiled the Top 100 Healthcare Companies of 2019. This year we find 44 pharmaceutical companies, 43 medical device (medtech) companies, 9 biotech companies and 4 companies that span the categories, with a combination of pharma, biotech and device divisions. We also have some new entries, including Thermo Fisher in the top 20 and Allergan, which came in at #30, after a busy year of acquisitions. As in previous years, the Top 10 is comprised of predominantly pharmaceutical players, with the exception of Medtronic, which came in at #9, one spot down from last year.

Pharmaceutical companies continue to dominate the Top 100 Healthcare companies in terms of revenue. This year, 66% of the total Top 100 revenue comes from pharma companies. This is up 4% from last year’s ratio. While the overall revenue of the Top 100 increased, we see fewer individual companies with an increase from last year. 30% of the Top 100 companies moved up the ranks from 2017 to 2018, while 51 decreased, 14 stayed the same and 5 were new to the list.

The Top 100 Healthcare Companies’ overall revenue total was $1.261 trillion USD. Revenue

growth brings good news as the trends continue to be on the upswing. The Top 100 Healthcare companies’ overall revenue grew by 5% from 2017. Each industry is in a period of continuing growth, with a 1.5% growth rate for Top 50 Pharmaceutical companies, 9% for Top 50 Biotech companies and 11% for Top 50 Medical Device companies. While some sectors grow more quickly than others, we are happy to see progress in each area.

Companies are ranked by their 2018 revenue as furnished by their annual reports and publicly available sources, Edgar and Morningstar stock information websites

21 | HS&M NOVEMBER/DECEMBER 2019

(figures of non-U.S. companies were converted to U.S. dollars from various currencies using end of the year exchange rates for 2018).

Companies are categorized by their predominant revenue source and their own characterization per publicly available sources.

We also have some new entries, including Thermo Fisher, who we had missed in previous reports, in the top 20. Additionally, Allergan appears as a new company, due to its recent merger with Actavis, who held the 27th spot in last year’s Top 100 Healthcare.

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Companies are ranked by their 2018 revenue as furnished by their annual reports and publicly available sources such as Edgar and Morningstar stock information websites. Figures of non-U.S. companies were converted to U.S. dollars from various currencies.

HEALTHCARE COMPANIES

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

RANKING COMPANY LOCATION

1

JOHNSON & JOHNSON

2018 REVENUE IN US$B

New Brunswick, NJ, USA $67.70

2

ROCHE

Basel, Switzerland $65.00

3

PFIZER

New York, NY, USA $53.65

4

NOVARTIS

Basel, Switzerland $51.90

5

MERCK

Kenilworth, NJ, USA $42.29

6

SANOFI

Paris, France $39.44

7 8

GLAXOSMITHKLINE ABBVIE

9

MEDTRONIC

Brentford, United Kingdom $39.29 North Chicago, IL, USA $32.75 Dublin, Ireland $30.60

10

MEDIPAL HOLDINGS

Tokyo, Japan $28.69

11

ALFRESA HOLDINGS

Tokyo, Japan $28.69

12

FRESENIUS MEDICAL CARE

Bad Homburg, Germany $26.42

13

ELI LILLY

Indianapolis, IN, USA $24.56

14

NEW

THERMO FISHER

Waltham, MA $24.36

15

AMGEN

Thousand Oaks, CA, USA $23.75

16

BRISTOL-MYERS SQUIBB

New York, NY, USA $22.56

17

GILEAD SCIENCES

Foster City, CA, USA $22.13

18

ASTRAZENECA

Cambridge, United Kingdom $22.09

19

PHILIPS

Amsterdam, Netherlands $20.74

20

Ingelheim am Rhein, Germany $20.02

21

DANAHER

Washington, DC $19.89

22

Fairfield, CT $19.78

23

TEVA

Petach Tikva, Israel $19.69

24

BAYER

Leverkusen, Germany $19.16

25

Chicago, IL $18.87

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Companies are ranked by their 2018 revenue as furnished by their annual reports and publicly available sources such as Edgar and Morningstar stock information websites. Figures of non-U.S. companies were converted to U.S. dollars from various currencies.

HEALTHCARE COMPANIES

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

RANKING COMPANY LOCATION

2018 REVENUE IN US$B

26

NOVO NORDISK

Bagsværd, Denmark $17.14

27

MERCK KGAA

Darmstadt, Germany $16.98

28 29

TAKEDA

BECTON DICKINSON

Osaka, Japan $16.30 Franklin Lakes, NJ $15.94

30 NEW ALLERGAN

Dublin, Ireland $15.79

31

SHIRE

Basingstoke, England, UK

32

Dublin, OH $15.58

33

SIEMENS

Munich, Germany $15.33

34

CELGENE

Summit, NJ, USA $15.28

35

STRYKER

Kalamazoo, MI $13.60

36

BIOGEN

Cambridge, MA, USA $13.45

37

CARDINAL HEALTH

ASTELLAS

$15.70

Tokyo, Japan $11.86

38

MYLAN

Canonsburg, PA USA $11.43

39

BAXTER

Deerfield, IL $11.08

40

BOSTON SCIENTIFIC

Marlborough, MA $9.82

41

RECKITT BENCKISER

Slough, United Kingdom

DAIICHI SANKYO

Tokyo, Japan $8.48

BAUSCH HEALTH

Laval, Quebec, Canada $8.38

42

43

44

ESSILOR

45

TEIJIN

$8.93

Charenton-le-Pont, France $8.26 Osaka, Japan $8.10

46

ZIMMER BIOMET

Warsaw, IN $7.93

47

CSL BEHRING

Victoria, Australia $7.92

48

B. BRAUN

Melsungen, Germany $7.90

49

OTSUKA

Tokyo, Japan $7.45

50

OLYMPUS

Tokyo, Japan $7.17

25 | HS&M NOVEMBER/DECEMBER 2019

the publication for healthcare sales & marketing leaders™

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ctor of ecutive Dire Olympus Ex g on People on Focusin Marketing ch, sentrix, Baus Smiths, Tran n the Role of O s ec Ex Tandem Affairs Regulatory ly on rector of Lil Di s le Sa .

Sr arned Lessons Le Trends URE! Talent NEW FEAT l Devices rt on Medica KPMG Repo n Te inic Top Cleveland Cl Innovators

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19 CEMBER 20

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Companies are ranked by their 2018 revenue as furnished by their annual reports and publicly available sources such as Edgar and Morningstar stock information websites. Figures of non-U.S. companies were converted to U.S. dollars from various currencies.

HEALTHCARE COMPANIES

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

RANKING COMPANY LOCATION

51

2018 REVENUE IN US$B

REGENERON PHARMACEUTICALS Tarrytown, NY, USA $6.71 CARL ZEISS

Oberkochen, Germany $6.66

52

53

3M

Saint Paul, MN $6.02

54

ZOETIS

Parsippany, NJ, USA $5.83

55

EISAI

Tokyo, Japan $5.76

56

TERUMO

Tokyo, Japan $5.36

57

Tokyo, Japan $5.28

58

GRIFOLS

Barcelona, Spain $5.13

59

HITACHI

Tokyo, Japan $4.93

60

London, United Kingdom $4.90

61

HOYA

CHUGAI PHARMACEUTICAL

SMITH & NEPHEW

Tokyo, Japan $4.88

62 NEW SERVIER

Neuill-sur-Seine, France $4.81

63

Dublin, Ireland $4.73

PERRIGO

64

SUMITOMO DAINIPPON PHARMA Osaka, Japan $4.26

65

ALEXION

New Haven, CT, USA $4.13

66

SUN PHARMA

Mumbai, India $4.09

67

SHIP HEALTHCARE HOLDINGS

Suita-Shi, Japan $4.05

68

DENTSPLY SIRONA

York, PA $3.99

69

MITSUBISHI TANABE PHARMA

Osaka, Japan $3.87

EDWARDS LIFESCIENCES

Irvine, CA $3.82

INTUITIVE SURGICAL

Sunnyvale, CA $3.72

70

71

72

UCB

Brussels, Belgium $3.68

73

ILLUMINA

San Diego, CA, USA $3.33

74

HOLOGIC

Marlborough, MA $3.22

75

MALLINCKRODT

Dublin, Ireland $3.22

27 | HS&M NOVEMBER/DECEMBER 2019

Companies are ranked by their 2018 revenue as furnished by their annual reports and publicly available sources such as Edgar and Morningstar stock information websites. Figures of non-U.S. companies were converted to U.S. dollars from various currencies.

HEALTHCARE COMPANIES

CLICK HERE TO GET THE TOP 100 HEALTHCARE COMPANIES

RANKING COMPANY LOCATION

76

77

KYOWA HAKKO KIRIN SHIONOGI VERTEX PHARMACEUTICALS

2018 REVENUE IN US$B

Tokyo, Japan $3.16 Osaka, Japan $3.14 Boston, MA, USA $3.05

78

79

NIPRO

Osaka, Japan $2.99

80

DRÄGER

Lübeck, Germany $2.97

81

ENDO INTERNATIONAL

Dublin, Ireland $2.93

82

VARIAN MEDICAL SYSTEMS

Palo Alto, CA $2.92

83

HILL-ROM

Chicago, IL $2.85

84

SONOVA

Stäfa, Switzerland $2.81

85

BIOMERIEUX

Marcy l’Etoile, France $2.77

86

GETINGE

Gothenburg, Sweden $2.72

87

STERIS

Mentor, OH $2.62

88 NEW SYSMEX

Cho-ku, Japan $2.57

89

Les Ulis, France $2.54

IPSEN

91

COLOPLAST

Humblebaek, Denmark $2.53

92

TELEFLEX

Wayne, NJ $2.45

93

HARTMANN

Frankfurt, Germany $2.42

94

RESMED

San Diego, CA $2.30

95

BIO-RAD

Hercules, CA $2.29

96

Telangana, India $2.25

97

FUJIFILM

98 NEW

THE COOPER COMPANIES

Pleasanton, CA $2.53

90

DR. REDDY’S LABORATORIES

IDEXX LABS

Tokyo, Japan $2.22 Westbrook, ME $2.21

99

NOVOZYMES

Bagsvaerd, Denmark $2.19

100

Smørum, Denmark $2.14

WILLIAM DEMANT

HS&M NOVEMBER/DECEMBER 2019 | 28

INDUSTRY

KPMG REPORT ON MEDICAL DEVICES 2030

KPMG International’s Global Strategy Group has issued a report looking at the prospects for the medical device sector to 2030.

They note that the overall picture looks positive, although rising healthcare costs and new competition will be counterbalancing factors. Below are the excerpts: to see the entire report, go here.

29 | HS&M NOVEMBER/DECEMBER 2019

INDUSTRY (Figure 1)

entirely different industries – are disrupting the sector by harnessing data to take ownership of customers, patients and consumers. In this volatile new marketplace, today’s device players are in serious risk of being stuck in the middle of the value chain, as mere commodity producers.

Technology innovation at an unprecedented pace: Patient and consumer data sharing technologies will be further complemented by a host of innovations across the following medical device categories:

DON’T GET STUCK IN THE MIDDLE Unbearable pressures disrupt status quo: The medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly US$800 billion by 20301. These projections reflect increasing demand for innovative new devices (like wearables) and services (like health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets – particularly China and India. (Figure 1) Despite these apparently attractive prospects, a shadow hangs over the sector in the form of a relentless downward pressure on pricing. Governments around the world are desperately trying to reduce the cost of healthcare – especially in the most expensive part

of the system: hospitals. They want to pay less for medical devices and see proof of greater value in terms of better patient outcomes.

Responsibility for many purchasing decisions has already moved from clinical to economic buyers. Short- term respites like the 2-year US excise tax moratorium on medical devices notwithstanding, pricing appears to be going in one direction only – down. Further uncertainty lies ahead, with the new European Medical Device Regulation in 2020 and regulations in China that are designed to spark local innovation.

These developments present a quandary for medical device companies that have historically concentrated on manufacturing and research and development (R&D), but are now seeing healthcare budget restrictions and new reimbursement regimes continue to snip away at margins. On top of this, new players – some from

31 | HS&M NOVEMBER/DECEMBER 2019

Innovative surgical interventions like autonomous robots and intelligent balloon catheters will enhance outcomes of complex surgeries and enable new forms of minimally invasive surgeries. Stryker has placed large bets in this space, given their strong orthopedics focus. In March 2017, the company launched the robotic-arm assisted total knee arthroplasty application for use with its Mako robot system. The technology is the first of its kind for total knee replacement, gained FDA approval in 2015 and is now commercially available for use in the U.S.2 Ingenious diagnosis and imaging will utilize DNA, nanobots and Artificial Intelligence (AI) to speed up diagnosis, imaging and importantly, subsequent care decisions.

Some of the aforementioned new entrants will be at the forefront of introducing AI into healthcare delivery. Already, Google is working on using deep learning, a branch of AI, to recognize patterns in a huge number of digital representations of images in order to detect signs of cancer in breast cancer

(Figure 2)

biopsies3. The technology is still in its nascent stage of R&D but has the potential to make a big impact on the imaging segment.

Drug delivery and patient monitoring will personalize and minimize invasiveness of drug delivery, through devices like biostamps and smart inhalers. Several pharmaceutical and technology companies are currently developing

connected inhalers. These smart devices will not only send the patient medication reminders (thereby improving adherence) but also transmit data to their physicians, enabling more personalized and preemptive care. Novartis has partnered with Qualcomm Life to develop an internetconnected inhaler (known as the next generation Breezhaler) that

can send information to a cloudbased big data analytics platform which healthcare providers can use to treat patients with chronic obstructive pulmonary disease (COPD). The company plans to launch the Breezhaler in 2019 following manufacturing, testing and regulatory approval4.

HS&M NOVEMBER/DECEMBER 2019 | 32

INDUSTRY (Figure 3)

33 | HS&M NOVEMBER/DECEMBER 2019

Assistive care and therapy services – like the bio-hybrid kidney – will minimize the need for certain services (e.g. dialysis) and also reduce many of the patient risks associated with today’s systems. Researchers at the University of California have developed a first prototype of an artificial implantable kidney the size of a coffee cup. It contains microchip filters developed by silicon nanotechnology and living kidney cells that will be powered by a patient’s own heart, further ensuring a zero percent chance of organ rejection5.

These are just some of the many exciting ways in which technology will impact the medical devices sector by 2030. Deal strategies over the coming decade should therefore include cross-sector opportunities, to identify winning partnerships that can radically transform healthcare delivery through better care at lower costs.

New markets: Although the US will continue to dominate the medical device industry in 2030, crossing US$300 billion in sales6, the top five markets will also include China (in second place, with more than 25 percent of the global market at over US$200 billion7) and India (fifth largest, with over US$40 billion in revenues8). China and India are already growing at twice the pace of the overall market, driven by healthcare reform, local government incentives and overall rising demand for healthcare9. Both countries are also fast becoming innovation hubs – India is already known as the global center for frugal engineering, producing a number of indigenous (and low cost) devices with global market potential.

The diverse nature of different emerging markets calls for indi-

vidual entry strategies tailored to specific in-market needs. Key success factors include localizing innovation and manufacturing, adapting to country-specific distribution models and sales channels, investing in local technology infrastructure and collaborating with domestic value chain stakeholders. Medical device companies will need to be prepared to invest for the long run, adding complexity and uncertainty to their expected pay-offs – but inaction could see them missing out on potentially lucrative opportunities.

While China and India are obvious choices to establish and strengthen presence, other markets should consistently be evaluated as they continue to grow over the coming decade. (Figure 4) STAYING AHEAD IN 2030 So what does this all mean for your medical device company?

(Figure 4)

HS&M NOVEMBER/DECEMBER 2019 | 34

INDUSTRY

(Figure 5)

What can you do to kick-start journey towards 2030, and realize the “Reinvent-Reposition-Reconfigure” strategy? In order create a winning configuration going forward, companies should consider following recommendations: Define your new value proposition: Decide the combination of products, services and intelligence

which differentiate your company in the minds of customers, patients and consumers. Offerings should be designed following a “user-back” rather than a “deviceforward” approach. Constantly evaluate and upgrade the global portfolio. Prevention should be considered more important than treatment and cure over the coming decade, with companies delivering far beyond the device –

35 | HS&M NOVEMBER/DECEMBER 2019

increasingly to consumers, in addition to physicians and patients.

The value proposition in 2030 will not translate solely into revenues and margins – it will mean protecting and creating market share.

And it will involve relationships based on trust, where medical device companies are not just servicing their customers, but advising them along each step of their individual care journey.

Invest smartly: Proactively understand the impact of future technologies on your global business. Be open to new ideas and pilots in order to test concepts, with the corresponding ability to fail fast and scale quickly as needed. By investing in a strong interoperable digital infrastructure and harnessing data, companies can both expand their business models and position themselves to compete in a transformed environment. A strong decision framework should support build versus buy choices, and a robust technology roadmap should inform the pathway from data to intelligence.

Medical device companies should also continuously incorporate learnings from industry peers as well as best practices from other sectors.

Collaborate and establish an ecosystem Executing on business and operating model choices will likely require capabilities from an expanded external network. While M&A activity intended to build scale and diversify portfolio will continue, the shift to services and intelligence should generate deal activity focused on establishing corresponding capabilities, both within and outside the value chain.

Companies will need to institute a systemic process to identify strategic alliance partners and an internal capability to effectively manage their ecosystem. Collaborate widely, including cross-sector, conduct joint experiments and even consider coopetition to meet the goals for your chosen configurations.

Adopt a flexible, modular organizational structure: This doesn’t mean that large multibillion dollar corporations should operate as start-ups, but it requires active steps towards a more agile and nimble organizational structure. In a dynamic environment, medical device companies will need to react quickly to market opportunities and move at “deal speed” to realize value from growth transactions. Processes should be streamlined and people empowered. While ensuring adequate levels of governance by segment, allow for faster decision making – especially as it relates to the portfolio (products, services and intelligence) and technology.

Don’t let your past dictate your future: Challenge the traditional ways of operating your business, and try novel approaches. Develop a deeper understanding of the end user and their emerging needs, and create different scenarios of how your business might look like in 2030. By attempting to disrupt themselves, medical device companies can stay a step ahead of emerging competitors and not wait for the ‘how to win’ playbook to be rewritten. It is entirely possible (and probable) that in the future, a multi-thousand dollar machine will be displaced by a portable device that costs less than US$100. •

1 Market size extrapolated from World Preview 2016, Outlook to 2022, EvaluateMedTech, October 2016 http://info.evaluategroup.com/rs/607-YGS-364/images/mt-wp16.pdf 2 Stryker launches Mako robotic platform total-knee application, Mass Device, 14 March 2017 http://www.massdevice.com/stryker-launches-mako-robotic-platform-total-knee-application

Google Can Help Detect Breast Cancer Using Artificial Intelligence, MIT Technology Review Pakistan, 6 March 2017 http://www.technologyreview.pk/google-can-helpdetect-breast-cancer-using-artificial-intelligence 3

4 Qualcomm expands collaboration with Novartis for connected COPD therapy, Qualcomm Press Release, 5 January 2016 https://www.qualcomm.com/news/releases/2016/01/05/qualcomm-expands-collaborationnovartis-connected-copd-therapy 5 No More Dialysis, Scientists Have Developed A Bionic Kidney, Medical-Online, 3 April 2017 http://www.medicalonline1.com/2017/04/03/nomore-dialysis-scientists-have-developed-a-bionickidney 6 USA - Overview of medical device industry and healthcare statistics, Emergo website, accessed on 15 November 2017 https://www.emergogroup.com/resources/marketunited-states 7 China - Medical Devices, China Country Commercial Guide, US export.gov website, accessed on 15 November 2017 https://www.export.gov/article?id=China-MedicalDevices

India can be among world’s top 5 medical devices markets, Business Standard, 15 February 2017 http://www.business-standard.com/content/ b2b-pharma/india-can-be-among-world-stop-5-medical-devices-markets-himanshubaid-117021500535_1.html 8

9 China - Medical Devices, Country Commercial Guide, US export.gov website, accessed on15 November 2017 https://www.gov/article?id=China-Medical-Devices Manufacturing in India: A Sunrise Segment, Khaleej Times, 30 January ibef.org/arab-health-2017/ download/EEPC-IBEF-Arab-Health-Supplement30-Jan-201.pdf

COMMENT

HS&M NOVEMBER/DECEMBER 2019 | 36

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

$795B

Projected global medical device sales by 2030 The medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly $800B by 2030. These projections reflect increasing demand for innovative new devices (like wearables) and services (like health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets.

Source: Medical Devices 2030 KPMG, January 2019

54

Average number of new products launched in coming years The past five years have seen an average of 46 new product launches per year in developed markets. This is expected to rise to an average of 54 from now through 2023, with an annual average of $45.8B spent to accomplish that.

Source: The Global Use of Medicine in 2019 and Outlook to 2023 IQVIA Institute Report, Jan 29, 2019

60.8M

Americans currently on Medicare The number of Americans on Medicare has been steadily rising, from 58.5M in 2017 to over 60M in 2019. Of these, over 45M also have Part D coverage.

Source: CMS.gov

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53 MILLION

Americans who are likely to use technology to manage health Of all U.S. adults, how many use technology to manage their health?

It’s estimated that 22%, or 53 million, are considered “health tech adopters.” Of these, 76% are under 50, 46% have a college degree, 40% are multicultural, and 35% are caregivers.

Source: Kantar MARS Consumer Health Study Database, May 2019

#1 Family medicine is most soughtafter specialty for physicians The most-requested assignment for healthcare practitioners in 2018-19 was family medicine, continuing a 13-year trend. This was followed by psychiatry, nurse practitioner, OB/GYN, internal medicine, radiology and hospitalist.

Source: Merit Hawkins 2019 REVIEW OF PHYSICIAN AND ADVANCED PRACTITIONER RECRUITING INCENTIVES

COMMENT

80%

Medtech companies using sophisticated incentive methods In a recent study, 80% of respondents measured the performance of their salespeople against using sophisticated quota-setting methods, such as a weighted index and time-series trending. Trips, contests and SPIFFs have been used as incentives for many years, but this year we saw a 50% increase in the use of longterm incentive grants, intended to promote consistent longer-term performance and loyalty. Also, non-cash rewards, such as points to spend on merchandise, are increasingly leveraged to promote longer-term, sustainable performance and loyalty.

Source: ZS Incentives Practice Research Study, October 2019

89%

Healthcare executives who are currently experimenting with one or more DARQ technologies The next generation of technical products and services is going to be DARQ technologies: Distributed ledger, such as blockchain; AI, or artificial intelligence; XR, or extended reality, which allows machines to operate cognitively; and Quantum, which crunches complex data sets. Most healthcare companies are already investigating one or more of these.

Source: Accenture report on DARQ Power, June 2019

HS&M NOVEMBER/DECEMBER 2019 | 38

MOTIVATION

MOTIVIDEOS

By Cari Kraft, Jacobs Management Group You arrive at work refreshed and ready. Or not. You start your day dedicated to the tasks before you. Or not. Every day is different. But we can give the morning a boost with the right messages from these wonderful experts and artists. See what video resonates most with the inspiration you want to give your staff.

How to Have a Good Conversation

How to Win Friends and Influence People

When you net it all out, a large part of our success is based on our ability to impact others which happens in conversation. This TED talk from Celeste Headlee gives short fun insight into how to have a good conversation. Great to share with sales and marketing team or anyone else for whom influence is a big part of the job. You can start at 4 minutes in and still get the whole gist.

We’ve all read the book or taken the class. But for those of us who haven’t here are some highlights in a short video. Show this to your team as a quick refresher of Carnegie’s classic ideas.

You Have Charisma!

Professor Morela Hernandez from the University of Virginia dissects the 3 simple components of inspiration. This is a great short review for you to show to your team in a morning meeting.

Saving Henley’s Heart & Lungs A quick pick-me-up and a great reminder of why we work so hard to create the products that we do. This is ideal to use to kick off a sales meeting.

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 30+ 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 39 | HS&M NOVEMBER/DECEMBER 2019

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How to Have a Good Conversation

You Have Charisma!

41 | HS&M NOVEMBER/DECEMBER 2019

How to Win Friends and Influence People

Saving Henley’s Heart & Lungs

HS&M NOVEMBER/DECEMBER 2019 | 42

TALENT TRENDS

Talent Trends: Keeping Yourself Safe When Navigating the Salary Ban As a leader, you’re always juggling numerous initiatives. From deadlines to budgets, conferences to trade shows, presentations to meetings, your days are filled, even without the time spent hiring. Building your team is a big job.

It is, in fact, a job in and of itself, and one you must do on top of your regular responsibilities. We’ve been hearing your suggestions and, as a result, came HS&M’s newest feature, Talent Trends. From Jacobs Management Group’s 30 years in life science executive search, Cari Kraft, President & CEO, will be sharing her experience as you build your team.

43 | HS&M NOVEMBER/DECEMBER 2019

I thought it would be only appropriate to begin by keeping you out of harm’s way. One of the critical issues everyone is currently facing is how to address the legal ramifications around candidate compensation. The recent salary history regulations have turned a key part of the hiring process upside down.

With a new focus on gender inequality in the workplace, specifically in areas having to do with compensation, these new laws prohibit prospective employers from requesting current salary information from candidates. As such, in many states it is now illegal to ask a candidate’s current salary.

While not a federal, nationwide law, the salary history bans at the state level are growing. Companies of every size are affected. In fact, 8 out of the top 10 Americanbased companies on our Top 100 Healthcare Companies list are touched by a ban in their headquartered state. Many of our clients have been changing their policies, enacting them nation-wide, and training their employees to protect themselves and limit their liability.

Below are our top 5 tips for keeping yourself and your organization safe under these new laws. Please note that I am not a lawyer and in no way am attempting to give you legal advice. I cover the information below to prompt you to delve deeper.

TIPS 1 Know What You Can’t Ask Make sure you and everyone that interviews a candidate knows what you can and cannot ask. For example, in many states, you can ask a potential employee what his/her salary expectations are, whereas you cannot ask the candidate his/ her current salary. In some states, however, you are allowed to clarify

compensation once a candidate voluntarily discloses it. You can see how this can get confusing as the majority of our organizations operate in multiple states. Making sure you are clear about what you can or can’t ask and having a company-wide policy is becoming more and more critical to keeping yourself out of a lawsuit.

2 Have a Plan for Documenting Sensitive Candidate Information In some states you still can take into consideration a candidate’s compensation, as long as they volunteer it. However. you can’t ask them for it. Having a procedure for noting and storing that type of information as an applicant goes through the process is not something that is typically thought through. It is critical to make sure you keep a record that this information was in fact volunteered and not in any way asked for. Our clients use a variety of applicant tracking systems to manage interviewing and hiring and if your system is flexible enough, you can use it as a repository. Make sure you and your team are clear on how and where you will document this information. The best way to keep yourself ahead from any potential of legal issues in the future is to have good, solid documentation.

3 Know What You Must Answer Many of our clients don’t realize that in some states, cities, and counties, you are required to answer the question, “What is the compensation range for this position?” Make sure you know if you are in one of those locations. And, if so, know what you are going to say so everyone on the interview team gives a cohesive answer.

Staying out of the crosshairs is not

only about what you don’t do, but also about what you make sure to do. So, make sure everyone on the team has a consistent and clear party line as to how to address this question.

4

Inform Your Offer Process

The salary ban has thrown a new wrinkle into the offer process. In the days before the salary history bans, for the most part, you knew the candidate’s current compensation and were able to take that into consideration when putting together an offer. Now, it’s even harder. How do you make sure your offer is competitive and enticing and that you are not overpaying? At Jacobs Management Group, we developed a new method to help our clients’ navigate the offer landscape, adjusting some of the steps. For the most part, this means moving steps earlier in the process to having qualifying conversations, while not going too quickly to spook candidates.

Adjusting the timing of your procedure can make the difference in wasting your time with candidates who are not going to say yes and/ or missing out on top potential candidates.

5

Manage Your Weakest Link

You’re only as strong as your weakest link. There are many people involved in interviewing candidates, some just on the periphery. If one of your interviewers isn’t aware of this current litigious climate and asks a candidate about their compensation history, they could create a risk for you and your entire company. The hiring process brings together different functional groups, seniority levels, and even different companies if you utilize any sort of outside agencies. Make sure you have everyone who will interact with a candidate

TALENT TRENDS

Fisher Philips, Pay Equity Interactive Map

apprised of the current laws so that you can ensure consistency across the board, lessening any future potential liability.

The above tips were a quick overview to highlight the issues involved in navigating the new salary bans. As you can see, a lot of it is covering the bases about the musts and must-nots in order to protect yourself. If you would like more information or insight, I am happy to connect. We are also putting together a webinar on this topic. You can use this link to connect with Cari Kraft, president and CEO of Jacobs Management Group, an executive search firm specialized in the medical device and pharmaceutical spaces.

GETTING A VISUAL In addition to our top tips, I thought that it would be helpful to include a visual representation of where salary bans are in effect and the different types of them. Above is a map overviewing the salary bans geographically. As of October 31, 2019, there are 17 state-wide bans and 19 local bans. The image highlights the state and local authorities that have implemented pay-equity laws and salary history bans.

THE VARIETY IN SALARY BANS Because the salary ban regulations have been enacted at the state, local and county level, the specific laws vary. I thought it might be helpful to include some samples below.

45 | HS&M NOVEMBER/DECEMBER 2019

• Employers may not ask, whether on an application or otherwise, about a job applicant’s wage or salary history, including compensation and benefits. Employers also may not conduct searches of publicly available records. Finally, employers may not rely on known salary history information in setting pay.

• Employers may not request applicants’ pay history. If that information is volunteered, employers may only confirm it after a job offer has been made.

• Employers may not ask about an applicants’ pay history until after an offer of employment is extended. Employers also are prohibited from using prior compensation to

set pay, except for current employees moving to a new position with the same employer.

• Employers may not request information about previous wages. Only under limited circumstances may they confirm prior pay and rely on that information in setting pay.

• Employers are barred from requesting information about past compensation and benefits until after a job offer is made.

• Employers may not seek pay history. An employer may only confirm pay history if, at the time an offer of employment is made, applicants or current employees respond to the offer by providing pay history to support a wage or salary higher than that offered by the employer.

• Employers may not ask applicants about their salary history and may not rely on known salary histories. Employers also must, upon reasonable request, provide a pay scale for a position for which an applicant has been provided a conditional offer of employment.

• An employer may not seek information about a prospective employee’s pay history until after a job offer has been negotiated.

• Employers are prohibited from asking about applicants’ salary histories, and they cannot rely on that information unless volunteered by the applicant. The law does not apply to internal applicants.

• Employers may not ask about an applicant’s pay history, unless it was voluntarily disclosed.

• Private and public employers are banned from seeking a candidate’s pay history. Even if an employer already has that information or an applicant volunteers it, it still can’t be used in determining a new hire’s pay. The law also requires employers to give applicants pay scale information if they request it.

• Employers may not refuse to hire, interview, promote or employ a job applicant based on the applicant’s decision not to provide pay history.

What does this mean for you? Getting smart about these new regulations and making the appropriate internal adjustments should not affect your ability to add great talent to your team. As you can see though, it is important that you know the laws in your county, city, or state to guard yourself against any legal consequences. •

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COMMENT HS&M NOVEMBER/DECEMBER 2019 | 46

PHARMACEUTICAL

Great Advice From Great Minds:

Senior Sales Director at Lilly and Company on the Lessons He Learned in War Naji Gehchan is on a mission to improve life. Formerly the Chief Marketing Officer & Business Unit Director for France, Benelux & North West Africa at Eli Lilly and Company, he is now Senior Director of Sales for Lilly Diabetes USA. We are honored to share his story in print.

The interview, by Jill Donahue that every day was a bonus,” he explained. He was surrounded by people who loved him and that made him feel safe. And this set him up to appreciate the importance of trust and love at home and at work.

A few years ago, Naji was sitting in a workshop at Disney University in Orlando. As an icebreaker, the facilitator asked each participant for their first childhood memories. While others recounted their love for Disney characters, Naji’s first memory was about war. Born in Beirut, Lebanon during the civil war, Naji remembers moving around to avoid bombings, seeing his parents’ house destroyed and then rebuilding everything.

“It was a lovely childhood,” Naji reflected sincerely. “Excuse me?” I asked. He went on to explain that his parents instilled in him and his sister the joy of living; even on the toughest days. “We experienced joy daily and had the attitude

As a little boy, Naji watched Red Cross volunteers come every day to help his grandfather who was burned during the war. He had always wanted to join the Red Cross.

They were the helpers through his childhood, and he wanted to be a helper too. It was a natural choice for him to pursue medicine in school.

He joined the Red Cross while still in school. Naji wanted to be on the rescue team. After 60 hours of training he received a certificate to be a rescuer, but he had no idea about the lessons yet to come. It was the ultimate school of leadership, where everyone has a single purpose and common values. Naji compares this to his work today where he strives to feel the bond within the teams working together on the noble goals of ensuring patients receive the treatments they need.

He remembers being on the first rescue team after a terrorist bomb-

47 | HS&M NOVEMBER/DECEMBER 2019

ing in Beirut. “I had just a couple of seconds to make the decision for myself and my team.... do we risk our lives to save others? We went full steam ahead and spent the next 6 hours finding and saving survivors. That was a defining moment. My life has been dedicated since then to serving patients and leading teams and organizations toward the noble purpose of making life better.”

As a physician he did not have a positive image of pharma. That all changed when, from business school, he had an internship at J&J. This is where he discovered the real pharma. “I loved it,” he said.

“I saw that I could have impact on thousands and millions of lives – bringing something so valuable to society and community,” he added.

He chose Lilly because of their values. He loved how they develop people and their strong ethics.

He felt the people had the same values as his. And he loved their history eradicating polio, developing insulin and the great marketing they had. He decided to try it, on a short-term contract in clinical research, medical affairs, then leading a launch in medical.

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PHARMACEUTICAL Naji Gehchan, Eli Lilly: interview with Jill Donahue - Excellerate

That was 10 years ago. He then wanted to move to commercial as he believed he could impact more lives there, both inside and outside the organization. He became the Business Unit Head of Cardiology and now is the Senior Sales Director for Lilly Diabetes USA. THE SEVEN LESSONS There are seven big lessons he took from his childhood, adolescence and young adulthood in a wartorn country that he brings to his leadership today. In Naji’s words: 1 Resilience – Sometimes things are tough. We need to turn the page and rebuild. The faster we figure out how to take the positive from a terrible story, the better.

Everything can be rebuilt. When I was 9 years old, the war was over, we started rebuilding. Then war hit again when I was in med school.

My resolve was even stronger to help and rebuild. And the amazing piece? We always build better then before!

2 Imagination – It is essential to have an environment where you can really imagine. Every time you think you can’t, just imagine.

Imagine there are no more patients suffering from psoriasis in the world. Now what do we need to get there? What if we’re crazy enough to imagine a world without psoriasis?

3 Safety –Many times, organizations assume that people know what they need to know – but often they don’t. No one feels safe enough to say, “I just don’t know.”

This is a big problem. Safe environments are critical to provide for people to speak up and ask for help.

49 | HS&M NOVEMBER/DECEMBER 2019

4 Trust - To build trust is a continuous journey. In the Red Cross, we trusted each other, we trusted our organization and the communities we served. It was mutual trust. We need to build that trust in our work environment. It should be theoretically so much easier here than at the Red Cross.

But still, people in our organizations don’t always trust that their leaders or their teammates have their back. I always knew my Red Cross teammates would come and save me and they knew the same of me. I want that kind of trust in my pharma teams.

5 Teamwork – The trust I talked about creates the essential teamwork the patients need us to have. We all have different backgrounds and different roles, but together we are serving patients

– one common goal. The more we team together, the better we can serve patients.

6 Feedback - It was the small but consistent things we did in the Red Cross that led to improvements. We never left the ambulance without debriefing. We always learned from what went well and what didn’t – both individually and collectively. We built our strength as a team. Now, in business, we have so many disclaimers but we’re all on the same team – we want to help people get better. We need to focus on this. Trust is again critical to this.

People need to genuinely believe and trust in you and be open to giving and receiving feedback so we can all improve.

7 Love and care - If you don’t genuinely care for each other, what is there? Our current world is in desperate need of love, hope and integrity. I want to bring loving and caring into our culture.

Last year it was my #1 priority to spread love in the organization. I said it to the exec team and to my team and they looked at me like I was crazy. But it started to spread.

Now many people talk about it and it is funny to see the number of heart and smile emojis shared in the organization. We all need to feel that we are cared for.

When asked what he loves most about his work now, Naji answered simply, “I am serving patients.”

They launched two products faster than anticipated with this obsession of getting those innovations to patients who need it.

Those medicines have changed thousands of patients’ lives. In the clinical data they could see it was dramatically improving lives “and

the team stood up to the challenge” and got it in patients hands faster then ever in France.

In every single meeting, he starts with patients; how many patients they are impacting and what feedback they are getting. Even in his KPIs, he looks at how many patients they helped. “Every single time I go back to this purpose.

I always end meetings with this question ‘Would a patient really care?’,” he explained. “If the answer is no, don’t put your energy into it.

If it is yes, put your energy there.

Let this be your decision tree,” he advised.

WHAT DOES THE FUTURE HOLD? His personal vision is to impact more and more people. “My future will take me to wherever I can impact more people. I want to impact healthcare in the communities I serve, I belong to or I come from.

Whether it’s a molecule, or anything to improve their care, their health knowledge like the startup we cofounded for the MENA region, I will always be looking for where I can have the biggest impact to improve patient care.”

He says “Live your why - whatever it is - strive for it, spread love along the way – life is too short and so unpredictable to spend one more second doing something you are not passionate about and ready to die for – literally.”

Thanks to Naji for sharing his incredible journey. How lucky for us in pharma and for us as patients around the globe that his path brought him to pharma where he is indeed helping others – as he set out to do as that small boy in wartorn Lebanon. •

Jill Donahue Principal, Excellerate Author, Engage Rx: The 3 Keys to Patientfocused 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 patient-focused ways and co-founded The Aurora Project, a global patient-centricity group. She also serves as Associate Editor of Healthcare Sales & Marketing.

Jill.Donahue@excellerate.ca

COMMENT

HS&M NOVEMBER/DECEMBER 2019 | 50

INNOVATION

The Cleveland Clinic Top 10 Innovations Every year at this time, the Cleveland Clinic gets out its crystal ball and reveals what it believes will be the most important advances in medicine in the coming year.

These were selected by a panel of Cleveland Clinic physicians and scientists, led by Michael Roizen, M.D., Emeritus Chief Wellness Officer at Cleveland Clinic, and announced at the 2019 Medical Innovation Summit in October in Cleveland.

“Healthcare is ever changing and we anticipate that these innovations will significantly transform the medical field and improve care for patients at Cleveland Clinic and throughout the world,” said Dr. Roizen.

Here, in order of anticipated importance, are the Top 10 Medical Innovations for 2020:

1.

DUAL-ACTING OSTEOPOROSIS DRUG Osteoporosis is a condition in which bones become weak and brittle, effectively increasing their risk of breaking. With osteoporosis, the loss of bone occurs silently and progressively – often without symptoms until the first fracture. Providing more bonestrengthening power, the recent FDA approval of a new dual-acting drug (romosozumab) is giving patients with osteoporosis more control in preventing additional fractures.

2.

EXPANDED USE OF MINIMALLY INVASIVE MITRAL VALVE SURGERY The mitral valve allows blood flow from the heart’s left atrium to the left ventricle. But in about one in ten individuals over the age of 75, the mitral valve is defective, causing the action of regurgitation. Expanding the approval of a minimally invasive valve repair device to a population of patients who have failed to get symptom relief from other therapies provides an important new treatment option.

51 | HS&M NOVEMBER/DECEMBER 2019

The only Awards to focus on what matters – value for patients and HCPs. December 11th, The Bellevue Hotel, Philadelphia

www.eyeforpharma.com/awards-evening/

INNOVATION

3.

INAUGURAL TREATMENT FOR TRANSTHYRETIN AMYLOID CARDIOMYOPATHY A disheartening cardiovascular disorder, ATTR-CM is a progressive, underdiagnosed, potentially fatal disease in which amyloid protein fibrils deposit in, and stiffen, the walls of the heart’s left ventricle. But a new agent to prevent misfolding of the deposited protein is showing a significantly reduced risk of death. Following Fast-Track and Breakthrough designations in 2017 and 2018, 2019 marked the FDA approval of tafamidis, the first-ever medication for treatment of this increasingly recognized condition.

4.

THERAPY FOR PEANUT ALLERGIES It’s a terrifying reality for 2.5 percent of parents – the possibility that at any moment, their child might be unable to breathe due to an allergic reaction. Though emergency epinephrine has reduced the severity and risk of accidental exposure, these innovations are not enough to quell the ever-present anxiety. But development of a new oral immunotherapy medication to gradually build tolerance to peanut exposure holds the opportunity to lend protection against attack.

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5.

CLOSED-LOOP SPINAL CORD STIMULATION Chronic pain is a terribly frustrating condition, and a large reason for prescription of opioid medication. Spinal cord stimulation is a popular treatment for chronic pain through which an implantable device provides electrical stimulus to the spinal cord. But unsatisfactory outcomes due to subtherapeutic or overstimulation events are common. Closed-loop stimulation is allowing for better communication between the device and the spinal cord providing more optimal stimulation and relief of pain.

6.

BIOLOGICS IN ORTHOPAEDIC REPAIR After orthopedic surgery, the body can take anywhere from months to years to recover.

But biologics – cells, blood components, growth factors, and other natural substances – have the power to replace or harness the body’s own power and promote healing. These elements are finding their way into orthopedic care, allowing for the possibility of expedited improved outcomes.

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INNOVATION

7.

ANTIBIOTIC ENVELOPE FOR CARDIAC IMPLANTABLE DEVICE INFECTION PREVENTION Worldwide, roughly 1.5 million patients receive an implantable cardiac electronic device every year. In these patients, infection remains a major, potentially life-threatening complication. Antibiotic-embedded envelopes are now made to encase these cardiac devices, effectively preventing infection.

8.

BEMPEDOIC ACID FOR CHOLESTEROL LOWERING IN STATIN INTOLERANT PATIENTS High cholesterol is a major concern for nearly 40 percent of adults in the U.S. Left untreated, the condition could lead to serious health problems like heart attack and stroke. Though typically managed with statins, some individuals experience unacceptable muscle pain with statins. Bempedoic acid provides an alternative approach to lowering of LDL-cholesterol while avoiding these side effects.

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9.

PARP INHIBITORS FOR MAINTENANCE THERAPY IN OVARIAN CANCER PARP, or poly-ADP ribose polymerase, inhibitors block repair of damaged DNA in tumor cells which increases cell death, especially in tumors with deficient repair mechanisms. One of the most recent important advances in ovarian cancer treatment, PARP inhibitors have improved progression-free survival and are now being approved for first-line maintenance therapy in advanced stage disease. Several additional large-scale trials are underway. PARP inhibitors are set to make great strides in improving outcomes in cancer therapy.

10.

DRUGS FOR HEART FAILURE WITH PRESERVED EJECTION FRACTION Heart failure with preserved ejection fraction (HFpEF) – also known as diastolic heart failure – is the condition in which the ventricular heart muscles contract normally, but do not relax as they should. With preserved ejection fraction, the heart is unable to properly fill with blood – leaving less available to be pumped out to the body. Currently, recommendations for this treatment are directed at accompanying conditions and mere symptom relief. But SGLT2 inhibitors, a class of medications used in the treatment of type 2 diabetes, is now being explored in HFpEF – alluding to a potential new treatment option.

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NEW! AGENCY AND PROVIDER DIRECTORY! Healthcare Sales & Marketing’s New Feature As a value to the industry, we have initiated a project to profile the top agencies so that you have them at your fingertips. We are compiling a digital, searchable, single source to give you access to the who’s who, their strengths, vision for the future, leadership and strategies, so that you can get a better feel as to how they work.

We are driven by the input of our readers so please let us know if you have an agency or provider you would suggest we profile. You will see some of the best with links to all their websites, their philosophy and history, as well as what makes them special. This is all in keeping with our goal of having the hottest industry companies and the top thought leaders in in the pages of every issue of HS&M. Our goal is to constantly expand the value we bring to you.

If you would like to be featured, or have an agency or provider to recommend, please reach out to our Associate Publisher, Natalie Newcamp, at nnewcamp@hsandm.com.

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AGENCY & PROVIDER DIRECTORY NOV/DEC 2019

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Company Overview: Arteric is a an award-winning pharmaceutical and biotechnology digital marketing agency.

We connect patients, caregivers, and healthcare professionals to the health information they need so that patients live longer healthier lives.

We accomplish this by exploring the boundaries of the possible, and creating life-changing experiences through feature-rich, defect free technology that works everywhere and every time, while delivering customer delight and driving revenue for our customers. We are the digital agency that will propel your clinical trials recruitment, premarket shaping, disease state education, brand launch, or brand revitalization forward with digital insights and execution that cannot be matched.

Address: 475 Springfield Avenue Summit, NJ 07901 Phone Number: 201-558-7929 Website: https://arteric.com Social Media:

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AGENCY & PROVIDER DIRECTORY

Leadership: Hans Kaspersetz President & Chief Strategist Kevin Doherty VP Finance Lloyd McGarrigal Software Development Manager Daryn Henry Creative Director New Business Contact: Hans Kaspersetz President & Chief Strategist 201-546-9902 hans@arteric.com Year Founded: 2012 Number of People: 25 Areas of Expertise: Focus: data science and analytics; digital NPP strategy; advanced technologies, eg AI and ML; and value delivery.

Core capabilities: Digital brand strategy · Channel optimization · SEO/SEM · Data · Social media · UX and Design · Medical/brand content · Website development · Software engineering · Analytics · CRM/Salesforce/Veeva What’s New: https://www.mmm-online.com/home/channel/sponsored/victory-at-search-create-brand-content-in-thelanguage-of-the-audience/

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AGENCY & PROVIDER DIRECTORY

Company Overview: Catalyst is an insights-driven healthcare communication agency. Our goal is to help you solve your communication needs no matter how complex. We engage your audiences and drive change by providing solutions that serve as a vehicle for sustainable growth.

Address: West Coast 3617 East Broadway, 19 Long Beach, CA 90803 East Coast 4695 Independence Avenue Bronx, NY 10471 Phone Number: 914-318-6351 Website: www.catalyst-agency.com Social Media:

Leadership: Steve Kane Managing Director New Business Contact: Steve Kane skane@catalyst-agency.com 914-318-6351 Year Founded: 1999 Number of People: 12 Service Focus: Healthcare marketing, communications and technology solutions including Disease-state awareness and Clinical education.

Areas of Expertise: Branding, Portfolio brand management, Print design, Web design, 3D animation, Web technology, and Business efficiency solutions.

What’s New: Long Beach, CA office

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AGENCY & PROVIDER DIRECTORY

Company Overview: Founded by doctors, engineers and data scientists, COTA is committed to bringing a patient first approach to cancer care through the use of real-world evidence. The Company organizes fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA’s platform helps inform decisions and action in oncology. COTA partners with providers, payers, and life science companies to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to make better decisions with the right data, visit cotahealthcare.com.

Address: 100 Broadway, 7th floor New York, NY 10005 Phone Number: 866-648-3833 Website: www.cotahealthcare.com Social Media:

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Leadership: Mike Doyle — President & Chief Executive Officer • Andrew Nordon, MD — Chief Medical officer • Elizabeth Rushforth — Chief Legal Officer • Bernard Chien — Chief Technology Officer • Vivek Kumar — Senior Vice President, Operations and Delivery • C.K. Wang, MD — Senior Medical Director, Clinical Oncology • Elizabeth Lamont, MD — Senior Medical Director, Outcomes Research New Business Contact: Jaimee Ryan 617-733-5509 Jaimeeryan@cotahealthcare.com Year Founded: 2011 Number of People: 100 Areas of Expertise: Cancer care, real-world evidence, real-world data, precision medicine, oncology, technology.

What’s New: COTA recently won the Health Tech Challenge at the eyeforpharma conference in Philadelphia! Our senior medical director, Dr. C.K. Wang discussed how real-world evidence can answer key questions in cancer care. COTA has some exciting news coming down the pipeline, so be sure to check back on our social pages for updates and news announcements including a brand new website!

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AGENCY & PROVIDER DIRECTORY

Company Overview: LiveWorld is a digital agency specializing in social media delivering healthcare marketing and customer service solutions that help companies build stronger patient and healthcare provider relationships. We provide consulting, strategy, and creative along with human agents, conversation management software, and chatbots for digital campaigns and social media programs. Our clients include AbbVie, AstraZeneca, BMS, Pfizer and Zoetis among others.

Address: 4340 Stevens Creek Blvd.

Suite 101 San Jose, CA 95129 Phone Number: 800-301-9507 Website: www.liveworld.com Social Media:

Leadership: Peter Friedman, Co-Founder & CEO David Houston, CEO Martin Bishop, VP of Client Services Dawn Lacallade, Chief Strategist Jena Dengrove, VP & Creative Director Jason Liebowitz, VP New Business Development Jason Kapler, VP of Marketing Frank Chevallier, VP of Software Products Lisa Sutton, Chief Nurse, Clinical Operations

New Business Contact: Jason Liebowitz VP New Business Development jason@liveworld.com (347) 276-2644 Year Founded: 1996 Number of People: 35 Parent Company: LiveWorld Areas of Expertise: LiveWorld provides a full range of services and software that help pharma brands build and operate effective, compliant social media programs that positively impact business goals and patient outcomes. LiveWorld guides and enables branded conversations that create emotional connections with customers, resulting in action, sales and advocacy. We help our clients gain share of mind and heart through social media engagement across digital marketing, sales and online customer care.

What’s New: LiveWorld was recently named “One to Watch” in MM&M’s Top 100 Healthcare Agencies Magazine.

Read the press release: https://www.businesswire. com/news/home/20190903005540/en/LiveWorldNamed-%E2%80%98One-Watch%E2%80%99MMMs-Top-100

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AGENCY & PROVIDER DIRECTORY

Company Overview: McCann Managed Markets is a strategic healthcare communications agency specializing in managed care marketing. We develop customized solutions across the managed markets value chain for a range of customer segments, including payers, health systems, organized provider groups, employers, pharmacists, office staff, and patients. Guided by our expertise in strategy, launch execution, and innovative solutions, we are well equipped to help clients navigate the complex and evolving managed markets landscape. As an integrated part of McCann Health, a global network of companies across 6 continents, we work on multiple cross-portfolio deliverables for our clients.

Address: 49 Bloomfield Avenue Mountain Lakes, NJ 07046 600 Battery Street San Francisco, CA 94111 Phone Number: 973-917-6623 Website: www.mccannmanagedmarkets.com Social Media:

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Leadership: Kim Wishnow-Per President New Business Contact: Roshan Rahnama roshan.rahnama@mccann.com 862-777-0742 Year Founded: 2002 Number of People: 66 Parent Company: The Interpublic Group Awards: 2016 Healthcare Network of the Year—Lions Health 2017 Healthcare Network of the Year—Lions Health 2018 Med Ad News Best Managed Markets Campaign Areas of Expertise: Market access, above-brand solutions, patient access and reimbursement, pharmacy, and integrated pull-through.

What’s New: We have an additional office in California Brand/initiative wins: 12

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Offices in San Diego and New York Address: 5780 Brittany Forrest Suite 1000 San Diego, CA 92130 Phone Number: (858) 775-4273 Website: www.rareexpertise.com Social Media:

AGENCY & PROVIDER DIRECTORY

Leadership: Jack Davis Founding Partner Jeff Sweeney Founding Partner New Business Contact: Jeff Sweeney jeff.sweeney@rareexpertise.com (858) 775-4273 Year Founded: 2016 Number of People: 10 Service Focus: Identifying and activating people with rare disorders Parent Company: Independent agency Areas of Expertise: Extensive rare disease experience (21 different brands). Patient identification and activation, HCP and patient education, online influencer networks, a database of rare disease patient journeys.

What’s New: In September 2018, Rare Expertise formed a joint venture with SCOUT, a leading healthcare marketing agency focused on orphan drugs and specialty pharmaceuticals, to shorten the time for people with rare diseases to obtain an accurate diagnosis and begin appropriate treatment more quickly.

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Address: 55 Bank Street Morristown, NJ Phone Number: 973-867-6500 Website: www.revhealth.com Social Media:

AGENCY & PROVIDER DIRECTORY

Leadership: Bruce Epstein, Brian Wheeler, and Bruce Medd, Managing Partners New Business Contact: Bruce Epstein bruce.epstein@revhealth.com 973-867-6502 Year Founded: 2006 Number of People: 151 Service Focus: Full-service advertising agency providing strategic consulting, campaign development, personal and non-personal communication.

Parent Company: RevHealth, LLC Awards: RevHealth’s creative expertise has been recognized in 2018 with wins from Communicator, Digital Health, RX and PM360. We are also a 3-time Med Ad News Category II Agency-of-the-Year Finalist and MM&M gold winner Areas of Expertise: Strategic and tactical planning; global professional advertising and promotion; US consumer advertising and promotion; provider, patient, and sales representative education; brand naming and lexicon development; digital innovation, development, and implementation; market access strategy and execution.

What’s New: As we continue to expand our business, we have opened an additional office in Morristown.

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AGENCY & PROVIDER DIRECTORY

Company Overview: We connect pharmaceutical brands to the right consumers from the moment they begin their search for health options in our premier network of pharmacies and continuing to do so wherever their healthcare path may take them. Rx EDGE Media Network is a leader in the healthcare marketing industry with over 18 years of experience delivering hundreds of successful campaigns for pharma brands.

Even as media consumption becomes increasingly dispersed, the pharmacy exists as the single mostoften visited healthcare destination in the lives of Americans, and combined with digital technologies, it produces an exceptionally broad reach.

Address: 111 Water Street East Dundee, IL 60118 Phone Number: 800.783.7171 Website: www.rxedge.com Social Media:

Leadership: Nate Lucht, President and CEO nathan.lucht@leveragepointmedia.com New Business Contact: Michael Byrnes, EVP Sales Michael.byrnes@rxedge.com 610.431.7606 Year Founded: 2000 Parent Company: LeveragePoint Media | LLC

Awards: PM360 Trailblazer Awards PM360 Elite Awards DTC Perspectives Advertising Awards PM360 Pharma Choice Awards Service Focus: Rx EDGE Media Displays: Through our prominent, strategically-placed displayed delivered in a network of 27,000+ retail pharmacies, we help pharmaceutical brands motivate consumers at the most relevant times…when they are actively searching for ways to take care of themselves. Our Media Displays enlighten, engage, and inform.

Rx EDGE Unlimited™: This cross-channel solution combines the power of our brick-and-mortar network with premium digital inventory and advanced analytics to bring pharma brands and audiences together. Rx EDGE Unlimited delivers exceptional reach, frequency, and influence.

Insight EDGE™: A suite of data resources that the Rx EDGE analytics team applies to every program to ensure that pharma brand messages are seen by the right consumer.

Areas of Expertise: We Maximize Impact: Rx EDGE is the only targeted media platform that uses the pharmacy as a consumer’s gateway to immediate information as well as ongoing connections to the pharma brands that are relevant to their healthcare needs. Brands that use Rx EDGE programs see an average script lift of 12.5%.

We Align the Right People, Places, and Times: Through our relationships with key retailers, we can access data not commonly available through other marketing service providers − making our Insight EDGE™ targeting platform unique in the pharma marketing space.

We Offer Proven Results: Measurement defines the core value we bring to every initiative. Using thirdparty analytics, results are evaluated with a significant level of precision. In addition to a lift in prescription volume, our programs also result in an average return on investment of $8.12.

What’s New: Rx EDGE Unlimited™ is a new cross-channel approach that combines Media Display, mobile, and programmatic digital ad placement to boost campaign effectiveness.

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AGENCY & PROVIDER DIRECTORY

Leadership: Jennifer Brekke Principal Raffi Siyahian Principal

San Diego, Atlanta, Chicago, New York

New Business Contact: Raffi Siyahian rsiyahian@findscout.com (858) 538-7777 x251 Year Founded: 1990

Address: 12520 High Bluff Drive Suite 340 San Diego, CA 92130

Number of People: 125

Phone Number: (858) 538-7777

Parent Company: The Stagwell Group

Website: www.findscout.com

Awards: PM360 Trailblazer Agency of the Year Finalist; PM360 Pharma Choice gold award; Humanitarian Awards nominee, Healthcare Marketers Exchange.

Social Media:

Service Focus: Full-service

Areas of Expertise: Rare diseases, specialty pharmaceuticals, orphan drugs.

What’s New: In September 2018, SCOUT formed a joint venture with Rare Expertise, a company with proprietary data-driven tools for identifying and activating people with rare disorders, to shorten the time for people with rare diseases to obtain an accurate diagnosis and begin appropriate treatment more quickly.

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AGENCY & PROVIDER DIRECTORY

Company Overview: Silverlight Digital is a New York-based digital media agency that adopts a consultative approach to helping healthcare, pharmaceutical, retail, travel and other brands reach their desired audience online.

The agency was three-times named an MM&M 100 Agency and a recent finalist for MM&’s Small Healthcare Agency of the Year Award. As a Premiere Google and Bing Partner, Silverlight Digital receives tier one support from publishers and through direct site partnerships and hosts a popular healthcare client roundtable at Google’s New York offices each year.

Silverlight Digital is a certified woman-owned business by The Women’s Business Enterprise National Council (WBENC).

Address: 15 E. 32nd Street 3rd Floor New York, NY Phone Number: (646) 650-5330 Website: www.silverlightdigital.com

Leadership: Lori Goldberg CEO and Founder Michael Ackerman SVP and Managing Director New Business Contact: Michael Ackerman, SVP and Managing Director mackerman@silverlightdigital.com Year Founded: 2013 Number of People: 20 Areas of Expertise: Capabilities include digital and multi-channel media strategy, media planning and buying, SEM, SEO, video, mobile, behavioral insights, analytics, influencing payers and point-of-care audiences, specialty journal publishers, social media, programmatic and more.

Segments, where we specialize, include rare diseases, clinical trials, biopharma, online pharmacy delivery, conference targeting and well-established brands.

What’s New: We host an annual healthcare conference at Google’s New York offices. Contact us for a chance to be added to the guest list.

Social Media:

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AGENCY & PROVIDER DIRECTORY Year Founded: 2018 Number of People: 24,000 Service Focus: CRO, CCO

Company Overview: Syneos Health is the only fully integrated biopharmaceutical solutions organization.

The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies INC Research and inVentiv Health we bring together approximately 24,000 clinical and commercial minds to help our biopharmaceutical customers shorten the distance from lab to life.

Address: 1030 Sync Street Morrisville, NC 27560 Phone Number: 919-876-9300 Website: www.syneoshealth.com Social Media:

Leadership: Alistair Macdonald Chief Executive Officer New Business Contact: Colleen Burns VP, Communications BD & Market Development colleen.burns1@syneoshealth.com 919-227-5772

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Areas of Expertise: Our CCO (Contract Commercial Organization) capabilities are the broadest and most robust in the industry delivering flexible, targeted, multi-channel programs designed to produce a higher likelihood of launch success. Areas of expertise include: Advertising, Behavioral Insights, Brand Commercialization, Brand Naming and Development, Clinical Field Teams, Commercial Recruiting Solutions, Communications, Deployment Solutions, Digital and Social Media, Health Economics and Outcomes, Medical Affairs Transformation, Medical Communications, Promotional Field Teams and Support, Public Relations, REMS & Risk Management, Reputation and Risk Management, Syndicated Market Research & Insights, Training and Learning Solutions and Value and Access.

What’s New: Custom Teams to Help You Navigate the Shifting Market Landscape, Create and Communicate Value and Optimize Access: Syneos Health Value and Access provides customers with an integrated team custom-built to meet the needs of your product from clinical development to LOE, including Real World Evidence, Value Access and Medical, Consulting, Risk Management and Payer Communications and Access Marketing.

Actionable Insights & Tools for Healthcare Brands to Optimize Patient Reach and Engagement: We Resist: The Surprising Truths About Motivating Behavior Change, a new book by Syneos Health experts, Kathleen Starr, PhD, Managing Director of Behavioral Science, and Leigh Householder, Managing Director, Innovation, Syneos Health Communications, to book examines decades of research ranging from the latest experiments to proven truths that reveal why people resist healthcare change and how to move from resistance to action.

Fully Optimized Field-Facing Commercialization Solutions - Syneos Health Deployment Solutions delivers a customized, integrated mix of promotional and educational channels purposefully designed to ensure successful commercialization.

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Address: 12809 Mirabeau Pkwy, Spokane Valley, WA Phone Number: 509-242-0767 Website: www.NextIT.com Social Media:

Leadership: Michael Southworth, GM Tracy Malingo, SVP Product Strategy Joe Dumoulin, CTIO Mitch Lawrence, SVP Commercial Sales New Business Contact: Nick Genatone ContactNextIT@Verint.com Phone 509.242.0767 Year Founded: 2002 Number of People: 270 Service Focus: Conversational AI, Intelligent Assistants Parent Company: Verint

AGENCY & PROVIDER DIRECTORY

Awards: AI Breakthrough, Best Overall AI Solution • NextGen Innovation of the Year • eyeforpharma Most Valuable HCP Initiative • Fierce IT Healthcare Fierce Innovation Award • PM360 Innovator, Product Pick • PM360 Marketing Initiative of the Year Areas of Expertise: Verint Next IT, a division of Verint, is the team the life science community counts on for intelligent solutions to modern healthcare problems. We unlock the value of human relationships with the power of conversational AI. Verint Next IT has delivered the broadest portfolio of AIpowered, conversational Intelligent Virtual Assistants configured for Diabetes, Multiple Sclerosis, Parkinson’s disease, and Women’s Health, with several more launching in the coming months. The technology is configured to improve health outcomes, provide access for patients and caregivers to product and health literacy, connect physicians to patient data, and improve the overall experience for patients, healthcare providers, and consumers. To learn more, visit www.NextIT.com.

What’s New: • “Ask Sophia’, Novo Nordisk’s new online and smart speaker intelligent assistant, available 24/7 on Cornerstones4Care. com and Amazon Alexa via “Ask Digital Sophia” for diabetes questions • UCB’s New PD Coach App “April” launched to support those living with Parkinson’s Disease, available in Apple and Android app stores. April address specific challenges that Parkinson’s patients and their caregivers may face – including the ability to learn and adjust to language and vocabulary for patients with dexterity and speech issues.

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AGENCY & PROVIDER DIRECTORY

Company Overview: Viscira is an innovative, full-service digital marketing and technology firm. We are all things digital with an exclusive focus on the life sciences industry. We are Digital for Life.

The Company’s key digital solutions include 3D MOD and MOA animations, advanced iPad® and mobile applications, disease education and product websites, interactive tradeshow solutions, and virtual and augmented reality experiences.

New Business Contact: Jeff Asada jasada@viscira.com 415-848-8012

Viscira has been a Veeva partner since 2012, and maintains an agency certification Level 4.

Address: 200 Vallejo Street San Francisco, CA 94111 Phone Number: 415-848-8010

Year Founded: 2007 Number of People: 120 Service Focus: Specialized Digital Marketing Agency for Life Sciences Parent Company: WPP Awards: Communicator Awards • Telly Awards • PM360 Trailblazers Awards • Davey Awards • Rx Club Awards

Social Media:

Areas of Expertise: Advanced iPad®and mobile app development, next-generation web development, cutting-edge digital content creation, including the company’s highly acclaimed 3D animation technology, new-media convention booth solutions, augmented reality, virtual reality, patient video testimonials, enhanced slide decks

Leadership: Rick Barker, CEO Jeff Asada, Chief Revenue Officer Kimberly Davis Wells, VP of Client Services Shan Jaffar, VP of Production Kane Kaneboughazian, VP of Animation Suntae Kim, VP of Software Development

Viscira continues to push the envelope in technology by exploring new mediums and hardware platforms like Oculus Go, HoloLens, Leap and MergeCube.

Website: www.viscira.com

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What’s New: Viscira has established itself as a thought leader in using XR technologies to offer unique experiences for patients, caregivers and healthcare providers. The company recently participated in the SF Design Week, and hosted a panel discussion which focused on the opportunities and challenges of storytelling in augmented reality.