September / October 2019 by Healthcare Sales and Marketing Magazine

™ SEPTEMBER/OCTOBER 2019

the publication for healthcare sales & marketing leaders™

TOP 50 PHARMA COMPANIES IN THIS ISSUE

PHARMA COMPANIES

Sanofi, Dompé, Viela Bio and SK life sciences execs on Commercial Launches Daiichi Sankyo CEO on Innovation and Improvement IQVIA’s Global Use of Medicine Outlook for 2023 IDEA Pharma’s 2019 Most Innovative Companies Report

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.

™

the publication for healthcare sales & marketing leaders™

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

ARTICLES Great Minds: Daiichi Sankyo GM and CEO Patrik Grandits on Innovation and Improvement........................................................................................................................9 Roundtable: Sanofi, Dompé, Viela Bio and SK life sciences Execs on Commercial Launching....................................................................................................................................11 The Top 50 Pharma Companies List.......................................................................................................... 21 IQVIA’s 2023 Outlook for Global Medicines........................................................................................ 27 Industry Trends: By The Numbers............................................................................................................ 39 Motivideos: To Use In Your Meetings......................................................................................................41 Why I Work in Healthcare............................................................................................................................ 45 Top 10 Most Innovative Companies......................................................................................................... 47 Agency and Provider Directory.................................................................................................................. 55

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Publisher’s Letter

Pharma is Booming: The Top 50 Pharma Companies List As usual, we are encouraged by our review of The Top 50 Pharma companies, as we are by every other sector in the industry. As we note in our article, global drug sales are on the rise, and the pharmaceutical industry saw a $100B increase. The Top 50 continue to comprise nearly 70% of the total global market. What drives all of this growth is a complicated equation. What we call the “pharmerging” markets are contributing greatly to growth and profitability. They will encourage more launches worldwide than ever before, especially as developing countries CARI KRAFT pay more attention to the health conditions of their populations. For instance, six Middle Eastern countries (Kuwait, Qatar, Saudi Arabia, Bahrain, UAE and Lebanon) are among the top 10 globally in terms of type-2 diabetes prevalence. Meanwhile, the ongoing problem of rising healthcare costs actually has a silver lining. The dramatic increase in spending on healthcare across the board is forcing governments and the industry to bring these costs down, particularly through innovations like wearable technology. Demands for new evidence and definitions of positive health outcomes are also increasing. A PricewaterhouseCoopers LLC report said “The growing conflict between drug access and affordability will create fresh pressure for data that show these expensive medications work better than others and are worth the premium.” Account managers, sales reps and patient engagement specialists are collaborating with quantitative analysts or bio-informaticists to tailor new drug information for each different audience. There’s also an enhanced focus on collaboration to share wisdom and best practices. Additionally, there is an uptick in the introduction of new medications. According to IMS Health, nearly 200 new drugs are forecast to be launched in the next five years, with a high number of new molecular entities (NMEs) expected to be launched annually. These and other factors are driving the healthy growth rate. We will continue to track and report this news to our growing audience of leaders. Watch HS&M for further developments!

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

Cari Kraft, Publisher

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HS&M SEPTEMBER/OCTOBER 2019 | 4

Letter from the Editor

What’s Working — And What Isn’t At the Center for Drug Evaluation and Research (CDER) of the FDA, Director Janet Woodcock has some disquieting observations on the healthcare industry: “It’s not working, and it won’t work in the future.” She recently said to an audience of industry execs at Breakthroughs in Medicine “I don’t want to bum everyone out. The science is fabulous, but that’s not enough.” What was she talking about? Mostly pricing, but a lot more. She said that putting a premium on secrecy was driving up the cost of research, while avoiding studying important NEIL GREENBERG aspects of the drug when there is no clear commercial gain to be had. “You can’t just develop breakthroughs and then throw them over the wall to practitioners,” she said. “We need the whole system to evolve and change if we’re going to help every patient feel better and live longer. Is the guy living under the bridge going to get a $2-million CAR-T cell curative treatment?” she asked. “If that guy can’t get the drug, then we’ve failed.” Curiously, she echoed a sentiment we hear often from the biggest companies today: “The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.” What’s the cure? Woodcock called for major reforms in the scientists’ relationships with regulators, doctors and one another. In addition, she said the process of creating and commercializing a drug suffers from corporate secrecy. When the science is valuable and “not to be shared,” drug trials are fragmented and costly. She also pointed to patient access. Other industries focus on making their products cheaper. But in healthcare, high failure rates and expensive clinical trials have led to drugs far beyond the financial reach of those in need. There’s also a conflict between the increased focus on rare diseases and a move away from conditions like cardiovascular illness, addiction and antimicrobial resistance, now less attractive candidates for research, even though they affect far more people. She urged everyone to leverage big data — such as electronic health records — to study those diseases with efficient, universal protocols. Lots to consider. And a lot of it is already happening. She’s on our side — but it’s obvious that we have to take reform seriously. 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.

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THERE ARE SOME THINGS PEOPLE JUST WON’T TELL YOU BUT THEY’LL TELL US IN CONFIDENCE. AND WE’LL TELL YOU. There are a lot of opinions people never offer you about your company. What the pain is. What you could be doing better. What they think of your competition. How to talk to them effectively. Big corporations get these answers through expensive research. Small to medium-sized companies don’t have that luxury. That’s why we created the Private Process . It’s a quick, cost-effective way of compiling information that people will offer us in complete confidence. Then we assess the results and give you the insight you need to adapt your sales and marketing messages accordingly. ©

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

™

Editorial Board

the publication for healthcare sales & marketing leaders™

Chris Bergstrom Publisher Cari Kraft Editor Neil Greenberg Contributing Editor Jill Donahue Creative Director Hedy Sirico Digital News Rick Cataldo Digital News Chris Manning 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.

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

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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.Â He has spent over thirty years in health care management. He served as VP of Global Strategic Marketing at BioMarin Pharmaceutical from 2007 to 2012, where he was responsible for strategic marketing and product portfolio analyses, and implemented medical education, brand enhancement and sales support programs on a worldwide basis. He oversaw the global launch of Kuvan, which in the U.S. was 112% to budget in 2008, the first year on the market.Â 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 SEPTEMBER/OCTOBER 2019 | 8

PHARMACEUTICAL

Great Advice From Great Minds:

Sales Innovation from Daiichi Sankyo GM and CEO Daiichi Sankyo’s General Manager & CEO for the Nordic Region, Patrik Grandits, on his experience building up the oncology entity across Europe The interview, by Jill Donahue

Patrik Grandits can’t leave things alone. Which is good. Wherever he has worked, he shakes up, improves and advances the corporate agenda. When he was a General Manager at Allergan, he was accountable for sales and marketing in over 20 countries across Europe and Eastern Europe, managing breast and facial products in both medical devices and pharmaceuticals. He introduced new budget and business planning tools, and achieved 15% growth in 2008 and 25% growth in 2009. At Alpha Future Technologies, as managing director, he had full P&L responsibility for global strategic business development, business planning, financial forecasting, product/project development and investors/business alliance management. In his years as Business Unit Head at Hospira, he was accountable for the oncology, hospital and immunology biosimilars business in over 25 countries. Then, as Global Head Product & Portfolio Strategy for Oncology at Sandoz, he instituted their global oncology business plan, and transferred a mature Novartis oncology product portfolio into the Sandoz business model.

No one can accuse him of a lack of ambition. After having built up the Daiichi Sankyo oncology entity and expanded into the Nordics, Patrik is currently Daiichi Sankyo’s General Manager & CEO for the Nordic Region. “We are continuously building up and expanding in both our European and our Nordic entities. Innovation is paramount in all that we do, from pursuing new medicines and new methods of drug discovery and delivery, to achieving excellence throughout our organization by continuously examining new ideas.“ One of Patrik’s achievements is the development and implementation of a new and innovative key account business model called “The Account Engine Model.” As is true of many of our interviewees, he is a passionate proponent of a focus on the needs of the patient. “We have to make sure we have the greatest talent we can get, and then deliver value to customers,” he says. “We must lift our engagement to patients.”

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When we interviewed him, he was here to visit their U.S. team to discuss and share their European approach. There is a common understanding between U.S. and Europe that to put the patient in the center of our approach is essential. “How do we transform our thinking around customer centricity?” Patrik says. “There are many paths. Having the right mindset. Changing the way we incentivize staff. Improving how we engage with patients. I learned early that you need to ask the right questions and have a willingness to listen in order to get the right answers.” An example is the restructuring of the sales incentive system to focus on team targets rather than individual sales projections. This relieves each rep of the pressure to focus only on selling, and allows them to focus on the bigger job: listening and educating. It’s a long-term vision for where they want to be. They are in the process of measuring the impact

MyCancerTherapy site

they have made on the entire value chain. The organization is now attentive to NPS, Net Promoter Score, which measures customer experience and predicts growth from that metric. “We measure the impact on patient outcomes,” Patrik told us. One component of this is the MyCancerTherapy site, a video information portal for patients with cancer. The portal also provides FAQs, a glossary and links to support organizations. My Cancer Therapy translates medical jargon into understandable language that is meaningful to patients. Daiichi Sankyo is doing this in over 20 languages. The videos with leading physicians cover three main categories — chemotherapy information, side effects and daily life — and received a tremendous amount of positive feedback. “Patients have just received a diagnosis of a devastating disease,” says Patrik. “We have to be aware of the patient’s state of mind when working with our customers: the questions, the anxiety, and the concern about what to do next. We help patients understand what can happen and what the treatment path is about, in their own language.” This path of getting away from selling toward educating drives measurement toward what impact they have made with patients. A small but important aspect is

Patrik Grandits

that the sales staff are now called Healthcare Development Managers. That helps change their attitude toward the way they conduct themselves. Instead of employees being narrowly defined, they are now people who represent to doctors the entire Daiichi Sankyo vision — that they care. Asking questions rather than “selling” allows them to deploy the appropriate research, the details to satisfy those question. “Nobody wants us just to tell them why our drug is better. They want help with their specific concerns,” Patrik says. “It’s not about you making a sale. It’s about us making an impact. This is transformational. We are a learning and growing organization.”

He made the analogy of having a first-in-class drug to having a highperformance car. It’s wonderful to have a Ferrari, but you’re not going to win if you don’t have the drivers who understand how to pilot it. “You have to be powerful at asking questions, learning how to create value for the people you’re speaking with. Much of what we are facing today is around ambiguity and uncertainty, but we deal with that by learning and focusing on the right education.” We have learned in our studies on patient centricity that only about 20% of leaders have that belief. Those who do have experienced what Patrik has: “Miracles can happen.” •

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 SEPTEMBER/OCTOBER 2019 | 10

ROUNDTABLE

LAUNCH EXCELLENCE: Execs From SK life science, Sanofi, Dompé and Viela Bio Talk About Achieving Commercial Success DOMINIC MARASCO, RPH

Our Moderator:

EVP, Global Business Development, Commercial Solutions Syneos Health

Our panel of experts: SEBBY BORRIELLO Vice President and Chief Commercial Officer SK life science

KEVIN BUCKLE Former Associate Vice President, Cardiovascular Portfolio US Marketing Sanofi

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ASHLEY KLINE General Manager, Country Head Dompé US

BILL RAGATZ Vice President, Head of Commercial Viela Bio

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ROUNDTABLE When asked what’s changed about commercialization in the last decade, more and more companies are answering simply: “What hasn’t?” From the development of strategy across the commercial continuum to composition of medical and sales field teams, companies commercializing an asset are facing new hurdles and shortened timelines. And they’re looking for help. The complexity of conversations — with payers, advocacy groups, patients, HCPs and regulatory bodies — has increased as value definitions vary. Audiences can even change based on who will be paying for increasingly costly, though often more effective and targeted, therapies. Stakeholder demands and barriers to access are higher than ever. When we analyzed biopharmaceutical companies launching their first product, no successful launches were achieved by any company that spent less than 75% of their launch year forecasted revenue in the year before launch. And, while each launch is unique, there are key elements of “excellence” that can help. These include: • Ensuring common language among cross-functional groups • Aligning vertical functions in a matrix organization • Establishing a common standard • Empowering organizations to deliver on expectations • Enabling best practices and innovation But some organizations still haven’t optimized their teams for excellence: research suggests that less than a third of new products meet commercial expectations, with 72% falling short of revenue targets.

This roundtable focuses on new commercial realities with perspectives from executives with experience ranging from emerging companies to large top 10 pharma/biotech. Whether using an outsource partner, going it alone or somewhere in between, these executives understand the critical factors for commercial success. Here they share the benefit of their experience with you. How are launch challenges today different from what they were five or ten years ago? BILL RAGATZ: The two biggest areas of change are access for representatives and reimbursement. Getting quality time with an HCP has always been a challenge but it has gotten even tougher in the past few years with more offices and institutions having severe limitations or being closed to reps. Good reps find a way to get quality time, but marketers need to arm them with high quality materials to ensure that the time is well spent and that the HCP sees the benefit of continued interactions. From a reimbursement perspective, payers are getting more aggressive and bolder in their actions to encourage adherence to their formularies. There is a need to begin thinking about the value story and value proposition earlier in development so that the right data will be available at launch to support positive reviews shortly after approval.

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SEBBY BORRIELLO: Some of the biggest changes have been driven by payers and managed care plans. Ten years ago, regulatory approval was a critical success factor and enough to trigger payer review and a coverage decision immediately. Now approval isn’t sufficient in many cases. Payers are waiting as long as six to twelve months to see how the product performs and how the medical community responds to make coverage decisions. They are looking beyond basic safety and efficacy for other demonstrations of value and this is a very big, foundational change we have to account for to ensure a successful launch. Physicians also are no longer considered the only decision makers, and they don’t represent the last step in the process, before patients can get their medicine. Also advanced practice providers, such as nurse practitioners and physician assistants, as well as pharmacists, are more engaged today in the decisionmaking process and patient care. KEVIN BUCKLE: The biggest difference, quite simply, is that expectations are being placed on the new assets you’re bringing to market. In areas such as diabetes and cardiovascular, for example, it requires much greater expenditure and investment in safety trials, efficacy trials and so forth. And expectations for a return on that investment are higher. Five or 10 years ago, you were able to have a gradual build, and get a nice return for your brand over a period of time. Today, companies are living quarter to quarter. As for what determines success at launch? It’s very simple: Have you clearly fulfilled an unmet need — safety, efficacy, convenience, compliance, or quality of life? That said, today’s

focus on rare diseases does signify a shift in which market access and payer access will play a much bigger role, for a number of reasons. First is that the government is going to be the largest payer in the US, between Medicare/Medicaid and Baby Boomers aging. Secondly, a lot of the markets Big Pharma played in are now truly commoditized--whether it’s hypertension, diabetes, or anti-infectives. To create something perceived as valuable to the patient or the physician is more difficult because the payer will put in hurdles to dictate generic use prior to the new innovation. That’s why pharma and biotechs are focusing in on rare disease. There’s true unmet need. But it’s in small, narrowly focused therapeutic areas. In one sense this is a shame because you won’t see innovation in big markets. Diabetes will continue to be a huge burden on the healthcare system. Cardiovascular disease is still the leading cause of death in the US. I don’t think you will see as much innovation in those areas. It’s because of where we’ve gone with the commoditized markets focused on price only. ASHLEY KLINE: Drug development is very costly, and surprises can extend timelines. At Dompé we have a mantra that we “need to plan for success, while also building the company to last.” In the past, the focus was on investing early and big to come out of the gate fast. Today, the focus is on greater adaptability and building competencies so that we are quickly able to integrate new information. The advent of more publicly available data has enabled companies to considerably speed up launch planning, and we have used this to our advantage. Proj-

ACCESS

REIMBURSEMENT

INTERNAL VS. EXTERNAL CAPABILITY

EVIDENCE

ects that might have taken months to do a few years ago can now be done in half the time, enabling teams to start later. For our recent launch, we aligned across the organization on a controlled market entry, with a focus on a limited group of prescribers, to get feedback on the drug’s performance and learn from the early commercial cases. The physician community responded positively to this, partnering with us and helping us shape our approach. This experience has fundamentally changed the way that I think about bringing products to market. Our research shows that the top five concerns for biopharma companies three years prior to launch are: market access strategy; manufacturing/supply chain readiness; building a commercial organization/function; stakeholder engagement; and building a medical organization/function. What was your company’s biggest concern three years prior to launch? Where were you investing most heavily at that time?

ASHLEY KLINE: Launch strategies are not one size fits all, and one company’s risk area could be another company’s strength. At Dompé we invest heavily in capabilities that are strategically important to the future of the company, and we regularly challenge each other on rent versus buy versus build discussions. That doesn’t mean that we do everything in-house, but we have the discussion. For example, we have invested heavily in CMC over the last decade and we built a plant in L’Aquila, Italy, to manufacture the global commercial supply of Oxervate. On the other hand, we knew that we would need a lot of extra hands to support the U.S. launch in our first year. Instead of building a large organization, we decided to super-charge a smaller team by adding resources from a handful of trusted vendors. Over time we are slowly insourcing some functions while continuing to rely on external support for others. Bottom line, planning a launch takes careful time and resource allocation. I always remind the team that projects tend to take all of the time that you have; starting an

HS&M SEPTEMBER/OCTOBER 2019 | 14

ROUNDTABLE activity earlier doesn’t necessarily mean that you will finish sooner. KEVIN BUCKLE: I’ve been involved with the PCSK9 inhibitor drugs for lowering cholesterol, and also in anti-obesity products. Market shaping and market development were crucial in this 3-year time frame prior to launch. Like other companies we invested to understand KOLs and the payer landscape, and also invested in educating the market. To take an older example, think about the investment Pfizer had to make in educating the marketplace before launching erectile dysfunction drugs. Because of the amount of investment required to create the product, the appetite for market development and market shaping three years prior to launch is less. It comes down to the amount of money you have to spend on incremental trials to get the product to market. Your break-even and profitability is being pushed out even further. It’s hard to justify investing in market-shaping or supply chain readiness and these other concerns you listed because of the pressure about what the returns are going to look like after the launch. BILL RAGATZ: Finding the right balance between building a launch organization early (before completion of the Phase III study) while dealing with the uncertainty of the trial results is a challenge. From a philosophical perspective, market access is an area that has been supported early and fairly heavily, as there was a clear understanding of the implications of not being prepared on that front (though the challenge of exactly how to invest still exists). The timing of building a launch organization (from both a

medical and commercial perspective) and the level of support has been a big challenge, especially when entering a new therapeutic area. With resources being constrained, there was always a pull to invest more in the products that drive the bottom line today versus preparing for what will drive growth tomorrow. With the funds that are devoted to launch preparations, early on we have spent heavily on market/customer understanding work to be sure we fully understand not only what our customers are doing but why they are doing it. This then drives our marketing strategy and later on, our market development programs. SEBBY BORRIELLO: SK life science’s heritage has been in drug discovery; we are relatively new as a commercial company. So, we’ve invested most heavily in communicating who and what SK life science is — about our transformation from a drug discovery company to a fully integrated company with a commercial team, and about our commitment to CNS and being a leader bringing products to market in this category. What type of evidence do companies need to generate to support a new treatment’s value proposition? SEBBY BORRIELLO: One of the challenges in this regard is that there really are no clear-cut guidelines on what evidence is sufficient from payer to payer or hospital to hospital. With an epilepsy drug, for example, will they value fewer seizures or fewer hospital visits? You have to work much earlier in the process to identify the evidence that will be of most value to payers and make sure you generate

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that in time for launch. A problem with that is in many companies, commercial and clinical are still too siloed from each other and market access isn’t being discussed early enough in clinical development. But at the end of the day the main problem we face — one that is particularly relevant in the CNS space — is the ambiguity about the outcomes that will be acceptable to payers. BILL RAGATZ: The more differentiated the product, the greater the need to provide meaningful support to prove it to your customers. While most companies focus on the value proposition for payers and prescribers, the patients are becoming more and more important in medication selection and need their own value proposition — one that may be very different from the one for HCPs. It is important that patient value discussions (along with that for payers and HCPs) occur while designing the Phase III trial, as this is the time to create the most robust support for the value proposition. Additional support can then be generated while the Phase III trial is ongoing. ASHLEY KLINE: A launch is always a big undertaking, but it’s an additional challenge when you are working in an area with few treatments, or on a disease where your drug represents a paradigm shift. We are the first company to commercialize a drug that is based on recombinant human nerve growth factor (rhNGF), and our product is also the first approved therapeutic for a rare eye disease. We worked very closely with the FDA throughout the development process, which is especially important when you are launching the first product for a rare disease. Our

breakthrough therapy designation opened a helpful channel of communication and gave us visibility into what we would need to provide in order to be successful. KEVIN BUCKLE: There’s a Catch-22 because these days it’s truly geared toward the payer. A class of drug like PCSK9 inhibitors has a clear benefit in reducing LDL cholesterol, greater than any statin can achieve, and with fewer adverse events. It’s a monoclonal antibody so it’s targeted, and you don’t have the off-target effects that occur with statins. But the value proposition wasn’t clear. Do you really need to have your LDL below 50? Some doctors say it just needs to be below 100. The medical community was saying it just needs to be a percent reduction from the baseline. Lacking any consensus, the payers didn’t understand the value proposition. They put up tremendous hurdles to push this treatment option further down the treatment chain to ensure that physicians would maximize using statins before going to the more expensive option. They didn’t have the data to clarify what it meant to reduce your cholesterol even further. It really hurt the class. The payers pre-positioned this class as an expensive agent to reduce cholesterol, when you can maximize statins to do the same thing. The companies had to go back and get mortality data. Now let’s look at the next generation of the PCSK9 inhibitors—a drug called inclisiran, from the Medicines Company. They’re not coming to market because they are mandated to have the mortality data. It makes sense from a clinical perspective. But you have now added a tremendous investment into bringing that product

to market, after you already spent hundreds of millions on the Phase III data. It delays your launch by another three years. The pressure to get a return on investment increases as you strain to prove medical relevance and get a clearer handle on your value proposition. It’s the right thing to do for the consumer and the physician, but it puts the manufacturer in a tough spot because they won’t see a profit for quite some time. Now when they get to market, they’re competing against generics. Yet they need to achieve volume to at least break even on the investment. Something has to give — and that’s why they’re going to rare diseases. How has your field force composition changed in the past five years? What impact has that had on your organization? BILL RAGATZ: The field roles are getting more specialized. Understanding our customers’ needs -- beyond the HCP to the office staff and others that they interact with — and how to most efficiently fill them has led to the creation of other field-based roles beyond the traditional rep (e.g., nurse educators, reimbursement specialists, thought leader liaisons, etc.). This has created the challenge of ensuring that objectives, KPIs and incentives are specific for each field-based employee but are also tied and are consistent with the overall goals for the brand to ensure teamwork. The lack of time and/or access to prescribers makes interactions with others more important. KEVIN BUCKLE: We partnered with Syneos Health on this, and they did a really nice job. The value of marching armies of people out there to broad audiences is over.

There’s no value. There’s no time. The expense is enormous. The customers don’t have time to see all these reps. So, what have we done? We’ve narrowed the focus, narrowed the footprint, become more efficient and effective. The time a physician has in front of a patient is becoming shorter and shorter because of the managed care environment. Time to spend with a representative is even less. The doctor says “I’m only seeing this one representative and there has to be value in that one meeting”-- as opposed to having five reps call on that one physician. It’s the reach-and-frequency model that’s completely changed. There’s much more focused, intimate engagement with physicians, whether that’s personal promotion or nonpersonal through social media and other channels. It’s more responsive to the customer and it’s happening because we can’t send in the primary care armies any more. Focused and intimate is the way to go, and that’s really where a group like Syneos Health has been able to help--because that’s their expertise. What were some of your company’s biggest lessons learned in product launches in the past three years? What activities had the most impact? ASHLEY KLINE: By hiring strong leaders and making Dompé a place where we all wanted to work, we have been able to continuously attract strong talent, which has been the key to exceeding our goals. In a start-up culture, roles are changing frequently, and sometimes you do a job with fewer people than might be ideal. We designed many of the roles here to span multiple functions, and we aimed to hire and cultivate teams of agile learn-

HS&M SEPTEMBER/OCTOBER 2019 | 16

ROUNDTABLE ers with adaptive learning traits. Our leaders are coaches who help people rise to the occasion and build confidence when teams are learning new skills. When we interview, we want to hear about how a prospective employee has tackled a new challenge or sought to work on a project outside of their job description. Learning agility and curiosity are two incredibly important features we look for, and we have had a lot of success hiring people where we see opportunities for them to grow in their current role and who are also open to taking on new challenges. SEBBY BORRIELLO: It’s critical to get out of the gate fast — within the first three to six months — and do whatever it takes to ensure there is enough supply and that patients can get the product regardless of coverage. It’s important of course that the product is safe and that it works, but after that the ultimate critical success factor is, can patients get it? That’s where manufacturers need to work hard to both ensure sufficient supply and facilitate access. They may need to even consider covering the cost of the product until reimbursement plans are finalized. KEVIN BUCKLE: It has to do with expectations. We set up these forecasts to deliver revenues that just aren’t realistic. It’s because the model has changed, but the lessons haven’t been learned. To try to show positive product contribution on an asset two years after launch is just silly. Organizations have to make sure their expectations are aligned with what the market will accept in terms of product uptake. The reason it doesn’t happen is because the executive team has to consider what

the company is signaling to Wall Street. If you have lower revenue targets why are you investing so much? If you have a high revenue target, a certain percentage has to be on your operating expense, your marketing and sales investment. If you lower that target, you may not get the advertising and promotion dollars or share of voice for your sales force. Back in the day, you would set lofty goals knowing you would get a bigger investment. Big Pharma had multiple blockbusters, so they could think big and invest big. Today those revenue streams are gone. Now suddenly you’re trying to bank on these new assets, but the investment tolerance is less. BILL RAGATZ: Going beyond measuring and tracking success across a variety of different metrics to also identifying what would be the predefined triggers (using leading indicators where possible) to determine if the launch was going significantly better or worse than our original plan and agree upon potential response actions. If we had diverged significantly from original plans, these pre-agreed responses options allow for us to shorten the internal discussions and more quickly make any adjustments needed. How is the commercial model changing? What are the biggest organizational changes that are taking place? SEBBY BORRIELLO: It depends on what your vision for the company is and whether it’s a vision for the short-, mid- or long-term. For startup biotech companies, the vision could be to launch the product and be acquired. In this case, you need to determine if you want to invest in building out your own in-

17 | HS&M SEPTEMBER/OCTOBER 2019

ternal commercial organization and if it’s the best use of your organization’s resources. Organizations now have more of a choice about whether to outsource some of the commercial capability. If the vision is to become a fully integrated company, you’ll build a commercial organization accordingly. To avoid siloes between the clinical and commercial models, make sure conversations are happening earlier between both groups, as well as with other stakeholders such as regulatory. For example, prior to making large investments in the clinical trials, have all the stakeholders meet and review the plan. Each can provide what may be important to include that would help differentiate themselves in the market. BILL RAGATZ: The biggest challenge is how to stay nimble and be able to wade through (and often piece together) all the data that is available to determine quickly what represents a real trend and therefore requires some type of action and what is just noise in the market. The number and diversity of data sources that is available today is amazing but can be overwhelming. It is important to be sure to find strong employees who are adept at managing and sorting through these sources to not only be able to create a story about what is happening but also determine the implications for the brand’s strategy and execution. Other key areas of change are the continually evolving area of digital marketing and how best to utilize it to augment your personal promotion plans (especially as access to HCPs gets more difficult) and the continued rise and importance of patients as being key decision makers in their personal healthcare decisions.

Moving Forward STRONG LEADERS/STRONG TALENT

ASHLEY KLINE: Our industry continues to be more customercentric, which includes prescribers, patients, and caregivers. We make decisions based on the specific needs of a community, and “need not precedent,” is one of the operating principles at Dompé. There is increasing pressure on physicians to see more patients and increase productivity, and more medicines than ever are available for a growing list of common and rare conditions. As a result, physicians expect information from pharma companies to be available on-demand, and this is changing the way that companies should think about how they can facilitate meaningful clinical exchange. For example, when we thought about the best way to provide information to physicians, we built the roles for our field team from the physician perspective. We hired an experienced group of key account managers and MSLs who provide in-person education, we are pairing them with investments in virtual capabilities that can play supporting roles. We are experimenting with new capabilities today so that we can pioneer new commercial models for assets that are still in development. KEVIN BUCKLE: You’re embracing more multichannel marketing than ever before. The model has changed, with reach-and-frequen-

CLARITY OF VISION

FOCUS ON NEEDS

cy and armies of sales professional not being perceived as valuable to the customer. So you focus your personal promotion and sales force in a more efficient and effective way, factoring in digital and social. You’re now investing more heavily to complement personal promotion. You’re seeing investments in complementary channel marketing budgets that never existed ten years ago. The sales rep is also changing. If you look at the heyday of pharma, all they did was hire pharmacists to talk about the package insert and the clinical data. As pharma grew, baby boomers were aging and the US was thriving — let’s look at the 80s as an example — it was about grabbing business and commercial people. You would take people fresh out of school with no sales experience, or alternatively, people who had nothing but sales experience. But now the job goes to somebody who has both. They have to have clinical background or at least an understanding, plus the ability to sell and influence. A packet insert cannot sell itself. You need promotional efforts to influence the prescriber to either

STREAMLINE SUPPLY CHAIN

change or engage in a therapeutic area or product. It needs to be a combination of both. But even back in the day, diversity mattered. If you had a diverse group in a district, those were the ones who were successful. This person was an RN, this one a pharmacist, this one had equipment sales, this one had a clinical background or had worked personally with cancer patients. Today, that aspect is the same: the more diverse the team is, the greater your chance of success. What are the pros and cons to commercial outsourcing? What are your key criteria for determining the right partner? SEBBY BORRIELLO: The pros to outsourcing are that it can help you scale up quickly. It can also help mitigate some risk in the event the product doesn’t get approval. It also gives you the opportunity to start with a team, get to know them and if things go well, eventually integrate them further into the organization. Some of the cons that can arise when working with CSOs include the uncertainty that contract sales employees may have about the longevity (and

HS&M SEPTEMBER/OCTOBER 2019 | 18

ROUNDTABLE stability) of the assignment and whether there will ultimately be an opportunity for them to join the organization. The problem this may cause is recruiting talent. If they are given an opportunity to work for a well-established company versus a company that is just starting out and not making them employees from the start, it may create the impression that they are not committed for the long term. It may not actually be the case, but that may be the way it is perceived. In addition, if your goal is to be a fully integrated company, it will likely require licensing and/or acquiring assets. Some may be more apt to make a deal with a company that has its own commercial organization, and view a company’s use of a CSO as an indicator of less stability or greater uncertainty. KEVIN BUCKLE: The key criterion is the people. What type of leaders do you have in an organization, what type of business people, how strong is the science, what is the profile of the employees? And the more diverse in terms of experience, the better. Who has been in front of accounts like McKesson or Aetna? Who has been in hospitals? Who has actually helped a patient administer chemotherapy, because maybe they worked as a nurse at some point? All those things add tremendous value. And when you think about the pros of outsourcing, inevitably you think about the costs of bringing an asset to market. It’s enormous — higher than ever before. Now you need to bring in sales forces and new commercial models to launch the product — all of which is very difficult. So why not partner with somebody who’s got the relationship, the expertise and the market knowledge, and enlist their expertise in delivering the value proposition to customers? The pros include managing overhead, shared responsibility, shared accountability, even shared risk and shared cost. In return you’re inheriting immediate expertise, immediate credibility, immediate value to the customer because the outsourcer already exists in the marketplace. The pros by far outweigh the cons. And you’ll see this model is the dominant way moving forward. ASHLEY KLINE: True — the people are what is most important to achieving success. Outsourcing is often necessary, and finding the right partner is critical to having a fruitful, two-way relationship. We also talk about building a “kitchen cabinet,” our analogy for our network of formal and informal advisors who are experts in their fields, who we call on for advice and strategic support. The right collaborators offer fresh perspectives and challenge the team, but also seamlessly integrate into the organization. Leadership skills and the company culture are critical, whether they come from a partner or your executive team. We look for leaders who are known for fostering an environment where people stay on and follow leaders from position to position. Strong leadership attracts strong talent, both from within the organization and from outside it. •

19 | HS&M SEPTEMBER/OCTOBER 2019

MODERATOR DOMINIC MARASCO, RPH

EVP, Global Business Development, Commercial Solutions Syneos Health

Dominic is an entrepreneurial executive with career strengths in C-suite strategy development, commercial operations, strategic business development, alliance management and financial resourcing within the pharmaceutical, biotech and medical device industries. Previously Executive Director for US Sales for Amgen’s neuroscience business unit after a stint as Executive Director and Global Commercial Head for Amgen biosimilars, he has a proven track record in commercial and clinical field force operations, management and P&L oversight. Dominic is a new board member of the Health Policy and Management Executive Council at the Harvard T.H. Chan School of Public Health, and for two years he has served as Adjunct Associate Professor of Pharmaceutical and Health Economics at the USC School of Pharmacy.

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 — Syneos Health brings together approximately 24,000 clinical and commercial minds to help biopharmaceutical customers shorten the distance from lab to life.

PANELISTS SEBBY BORRIELLO Vice President and Chief Commercial Officer SK life science

As an experienced sales and marketing executive in the pharmaceutical industry, Sebby has overseen the commercial launches of numerous therapies, managed marketing strategies for various brands, and trained successful sales teams. At SK life science, he is focused on evolving the company from an R&D-focused entity into a commercial organization. Prior to joining SK life science, Sebby served as VP, Market Development at Cempra Pharmaceuticals and in various roles in sales and marketing at J&J for 26 years.

SK LIFE SCIENCE, INC. (SKLSI) is committed to accelerating the development of next-generation treatments for disorders of the central nervous system (CNS). Established in 1993 and located in Paramus, NJ, it is a U.S. subsidiary of SK Biopharmaceuticals, Co., Ltd. (SKBP), a company focused on discovery, development and commercialization of innovative medicines. Both SKLSI and SKBP are a part of SK Group, the third largest company in Korea and a global leader in the energy, chemical, semiconductor and telecommunications industries. KEVIN BUCKLE Former Associate Vice President, Cardiovascular Portfolio US Marketing Sanofi

Kevin is a proven, results-driven commercial leader with over 25 years of pharmaceutical industry experience. His experience includes nearly two decades of U.S. and Global marketing expertise across numerous therapeutic areas (Cardiovascular, Diabetes, Women’s Health & Obesity) with brands at varying scale and lifecycle. Kevin spent more than 16 years working for Sanofi in various roles and was most recently the U.S. Marketing & Commercial Head for Multaq, a therapeutic treatment option for patients with atrial fibrillation.

COMMENT

ASHLEY KLINE General Manager, Country Head Dompé US

Last year Ashley built the team that launched Oxervate (cenegerminbkbj), which is a novel biologic medicine for the rare eye disease neurotrophic keratitis. Oxervate is the company’s first product to be sold in the U.S. She has previously been a consultant to the Retina World Congress, and had several roles at Genentech, including Director of Corporate Strategy and Commercial Planning, Group Product Manager for Franchise Operations, and Go 2 Market Pilot Lead for Lucentis.

DOMPÉ is an Italian bio-pharmaceutical company that focuses on innovation in primary care, biotech and rare diseases. It’s engaged in the development and distribution of ethical drugs and self-medication, adjuvants, medical devices and cosmetics, and in the fields of vitamin and mineral supplements and personal hygiene. The therapeutic areas include cardiovascular, gastrointestinal, paediatrics, neurology, urology, ophthalmic, stomatology and respiratory. BILL RAGATZ Vice President, Head of Commercial Viela Bio

Bill is in charge of building and leading the commercial organization for Viela Bio. With more than 20 years of commercial experience, he has continually demonstrated a passion for building strong teams with highly engaged employees and delivering results. Bill has led numerous launches during his time at AstraZeneca, Boehringer-Ingelheim and Merck in the areas of autoimmunity, oncology, cardiovascular and respiratory.

VIELA BIO is a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, collectively referred to as autoimmune diseases. Its approach seeks to redefine the treatment of autoimmune diseases by focusing on critical biological pathways shared across multiple indications. They believe that this approach, targeting the underlying molecular pathogenesis of the disease, allows the development of more precise therapies, identifies patients more likely to respond to treatment, and pursues multiple indications for each product candidate. HS&M SEPTEMBER/OCTOBER 2019 | 20

PHARMACEUTICAL

CLICK HERE TO GET THE TOP 50 PHARMA COMPANIES

PHARMA COMPANIES

PHARMA IS BOOMING:

The Top 50 Pharma Companies List The Top 50 Pharma companies list is back and the industry did not disappoint this year. Global drug sales are on the rise. As a whole, the pharmaceutical industry saw a $100B increase to reach $1.2 trillion. As in the past, the top 50 make up almost a whopping 70% of the total global market. While the Top 50 is not growing at the same rate as the global market, it is still increasing year after year. We saw a 1.5% growth rate from 2017 to 2018 with a majority (31) of the top companies seeing an increase in revenue. Looking geographically, 87% of Top 50 companies which are based in the US saw an increase in revenue in 2018. This is compared to 50% in Europe and 92% in Japan. From 2013 — 2017 the top markets in the EU grew by 4.4%, the US by 7.3% and South American and Asian by 11.5% and 10.2% respectively. Like in 2017, big multi-billion dollar mergers and acquisitions were put on the back burner. Compa-

nies instead opted for more bolton acquisitions, minimizing risk. 81% of 2018’s M&As were made up of these bolt-on acquisitions. That is not to say there were no megadeals in 2018. Most notably, Takeda acquired Ireland-based Shire for $62B. That deal officially closed in January of 2019, so we still include Takeda and Shire as separate entities in the 2018 report. Prior to the deal with Takeda, Shire handed off its oncology business for $2.48B to France’s Les Laboratoires Servier in April 2018. Here’s a snapshot of where the Top 50 (based on 2018 revenue) were at year’s end. We have tracked movement up and down the list with regard to both ranking and revenue changes as compared with 2017. Companies are ranked by their

21 | HS&M SEPTEMBER/OCTOBER 2019

2018 pharmaceutical revenue as furnished by their annual reports and publicly available sources (figures of non-U.S. companies were converted to U.S. dollars from various currencies, using end of the year exchange rates for 2018). From companies with multiple sectors, only pharmaceutical revenues were extracted from reports to create an equal playing field. We also revised 2017 earnings to align “apples to apples” revenue reporting with 2018 figures. Companies that had revised 2017 revenues from last year’s report include: Abbott (which split from Abbvie in 2013 but, until recently, retained some of their pharmaceutical products) and Fresenius (misreported in previous years as including their non-pharma revenue).

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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.

PHARMA COMPANIES

CLICK HERE TO GET THE TOP 50 PHARMA COMPANIES

RANKING COMPANY LOCATION

2018 REVENUE IN US$B

PFIZER

New York, NY, USA

$53.65

NOVARTIS

Basel, Switzerland

$51.90

ROCHE

Basel, Switzerland

$43.26

MERCK

Kenilworth, NJ, USA

$42.29

JOHNSON & JOHNSON

New Brunswick, NJ, USA

$40.70

SANOFI

Paris, France

$39.44

GLAXOSMITHKLINE

Brentford, United Kingdom

$39.29

ABBVIE

North Chicago, IL, USA

$32.75

MEDIPAL HOLDINGS

Tokyo, Japan

$28.69

ELI LILLY

Indianapolis, IN, USA

$24.56

AMGEN

Thousand Oaks, CA, USA

$23.75

ALFRESA HOLDINGS

Tokyo, Japan

$23.74

BRISTOL-MYERS SQUIBB

New York, NY, USA

$22.56

ASTRAZENECA

Cambridge, United Kingdom

$22.09

GILEAD SCIENCES

Foster City, CA, USA

$21.68

BOEHRINGER INGELHEIM

Ingelheim am Rhein, Germany

$20.02

BAYER

Leverkusen, Germany

$19.16

TEVA PHARMACEUTICALS

Petach Tikva, Israel

$18.90

NOVO NORDISK

BagsvÃ¦rd, Denmark

$17.14

MERCK KGAA

Darmstadt, Germany

$16.98

TAKEDA

Osaka, Japan

$16.30

ALLERGAN

Dublin, Ireland

$15.79

SHIRE

Dublin, Ireland

$15.49

CELGENE

Summit, NJ, USA

$15.28

BIOGEN

Cambridge, MA, USA

$13.45

23 | HS&M SEPTEMBER/OCTOBER 2019

Connecting Leaders in Medical Device, Biotechnology, Pharmaceuticals and Diagnostics with Expert Consultants who have “Been There and Done That.” ND

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PHARMA COMPANIES

CLICK HERE TO GET THE TOP 50 PHARMA COMPANIES

RANKING COMPANY LOCATION

2018 REVENUE IN US$B

ASTELLAS

Tokyo, Japan

$11.86

MYLAN

Canonsburg, PA USA

$11.43

RECKITT BENCKISER

Slough, United Kingdom

$8.93

DAIICHI SANKYO

Tokyo, Japan

$8.48

VALEANT PHARMACEUTICALS

Laval, Quebec, Canada

$8.38

TEIJIN

Osaka, Japan

$8.10

FRESENIUS KABI

Bad Homburg, Germany

$7.49

OTSUKA

Tokyo, Japan

$7.45

CSL BEHRING

King of Prussia, PA, USA

$6.83

26 27

REGENERON PHARMACEUTICALS Tarrytown, NY, USA

$6.71

ZOETIS

Parsippany, NJ, USA

$5.83

EISAI

Tokyo, Japan

$5.76

UCB

Brussels, Belgium

$5.30

CHUGAI PHARMACEUTICAL

Tokyo, Japan

$5.28

GRIFOLS

Barcelona, Spain

$5.13

SERVIER

Neuill-sur-Seine, France

$4.81

PERRIGO

Dublin, Ireland

$4.73

ABBOTT

Chicago, IL, USA

$4.42

SUMITOMO DAINIPPON PHARMA Osaka, Japan

35 36

$4.26

ALEXION

New Haven, CT, USA

$4.13

SUN PHARMACEUTICAL

Mumbai, India

$3.93

MITSUBISHI TANABE PHARMA

Osaka, Japan

$3.87

MALLINCKRODT

Dublin, Ireland

$3.22

KYOWA HAKKO KIRIN

Tokyo, Japan

$3.16

SHIONOGI

Osaka, Japan

$3.14

25 | HS&M SEPTEMBER/OCTOBER 2019

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o and pé, Viela Bi Sanofi, Dom ecs on ex es nc ie SK life sc l Launches Commercia Innovation yo CEO on Daiichi Sank t en em and Improv Medicine obal Use of IQVIA’s Gl 23 20 r fo ok Outlo Most ma’s 2019 IDEA Phar Report Companies Innovative

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The Global Use of Medicine in 2019 and Outlook to 2023

EXCERPTS FROM IQVIA’S REPORT ON THE INDUSTRY For the full report, see here GLOBAL PREDICTIONS • Global spending on medicines reached $1.2 trillion in 2018 and is set to exceed $1.5 trillion by 2023 • Invoice spending in the United States is expected to grow at 4–7% to $625–655 billion across all channels, but net manufacturer revenue is expected to be 35% below invoice and have growth of 3-6% as price growth

slows on both an invoice and net basis • Net drug prices in the United States increased at an estimated 1.5% in 2018 and are expected to rise at 0–3% over the next five years • China reached $137 billion in medicine spending in 2018, but will see growth slow to 3-6% in the next five years as central government reforms to expand

27 | HS&M SEPTEMBER/OCTOBER 2019

insurance access to both rural and urban residents, as well as expansions and modernizations of the hospital system and primary care services, have been largely achieved and efforts shift to cost optimization and addressing corruption • Medicine spending in Japan totaled $86 billion in 2018, however, spending on medicines is expected to decline from -3 to 0% through 2023,

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FST EAST AGENDA PREVIEW The DTC Pharma Social Media Diet Brandie Linfante, SVP, Engagement Strategy, Ogilvy Health Martha Maranzani, SVP Content Strategy, Ogilvy Health Peter Muscarella, Senior Account Executive, Snapchat Social Media, Snap Inc. Educating & Driving Action in Millennials through Unbranded Social Media Lyndi Hirsch, Senior Director, Head of Consumer Marketing, Dermira Carla Harbrink, SVP, Management Director, FCB Health Deirdre Noonan, Director, Communications Design, Healix Patient Influencer Perspectives on Pharma Digital Engagement Laurel Netolicky, VP, Business Development, WEGO Health Patient Thought Leaders TBD Social Ad Creative: Findings from 11,000 Facebook Ads Brad Einarsen, Senior Director, Social Media, Klick Health The Augmented Reality Future of Healthcare Fred Church, Founder, Format Analytics

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ATTEND OUR 2019 FALL AWARDS

R S P E C T I V E INNOVATOR AWARDS

AGENCY VANGUARD AWARDS R

DTC INNOVATOR AWARDS October 21, 2019 | Hanover Marriott | Whippany, NJ

DTC AGENCY VANGUARD AWARDS October 23, 2019 | The Liberty House | Jersey City, NJ

Celebrate some of the best and most innovative people in the world of DTC marketing

Honor some of the best creative minds working at advertising agencies in the DTC space

The DTC Innovator awards are designed to honor people who work in the world of DTC marketing making products and properties that help promote and improve DTC marketing effectiveness. A nominee is someone whose innovative ways improve the DTC landscape by helping pharma promote their life-saving products to consumers.

This award is for elite marketers from advertising agencies. This award helps recognize the faces behind successful DTC campaigns and patient programs. Agency executives will be selected based on actual accomplishments, influence on future DTC launches or campaigns, and/or recognized contributions and service to patients as well as the DTC industry.

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INDUSTRY due to the effect of exchange rates and continued uptake of generics and offset by the uptake of new products • The number of new products launched is expected to increase from an average of 46 in the past five years to 54 through 2023, and the average spending in developed markets on new brands is expected to rise slightly to $45.8 billion in the next five years, but represent a smaller share of brand spending • The impact of losses of exclusivity globally is expected to be $121 billion between 2019 and 2023, with the United States accounting for just under 80% at $95 billion • By 2023, biosimilar competition in the biologics market will be nearly three times larger than it is today, but the key events are underway from earlier patent expiries, except the expected 2023 entrance of biosimilars to adalimumab (Humira) in the United States • Specialty share of total medicine spending will reach 50% by 2023 in most developed markets as the majority of new medicines have been and will continue to be in specialty classes GLOBAL MARKET Global spending on medicines reached $1.2 trillion in 2018, up from $1.1 trillion in 2017, and is set to be just under $1.3 trillion by 2019, with 4–5% growth globally. Global spending is expected to exceed $1.5 trillion by 2023 as the market grows in mid-single digits (see Exhibit 1).

Global growth of medicine spending through 2023 will primarily be driven by developed markets and their adoption of a wave of newly launched innovative products. Global growth will be driven to a lesser extent by expanded access and use of medicines in pharmerging markets, with China alone approaching the combined spending level of the five major European markets. Growth in the United States will be driven by new products and (at a lower level than prior years) by pricing shifts, and will be offset by losses of exclusivity, along with the emergence and growth of biosimilars. U.S. MARKET Spending on medicines is expected to reach over $600 billion on an invoice basis in 2023, including spending in all channels (e.g., retail pharmacies, hospitals, doctors’ offices), and on all product types (e.g., small molecules, biologics, brands, generics, biosimilars). As invoice spending does not reflect off-invoice discounts and rebates, the trend looking at invoice prices can differ substantially from the trend after deducting those discounts and rebates. Net manufacturer revenue growth in the U.S. market is expected to be 2–3% in 2019, down from a high of 10.3% and 9.1% in 2014 and 2015, respectively. Overall invoice spending growth is expected to rebound in 2023 to 6.0% up from a low of 1.2% in 2017, although net manufacturer revenue growth is expected to be 1–2% lower than invoice growth at this time (see Exhibit 5). This increase in spending growth is expected to be driven by a substantial rise in the number of

29 | HS&M SEPTEMBER/OCTOBER 2019

launches of new medicines, but will be offset by losses of market exclusivity of branded products. Real net per capita medicine spending is expected to grow at 0–3%, about a percentage point lower than the 2.8% growth seen over the prior five years when adjusted for population, economic growth and manufacturer concessions (see Exhibit 6). U.S. PRICING TRENDS Drug pricing in the United States is a complex interaction between the prices set by manufacturers, negotiation with payers, competition between both branded and generic products and the design of public and private insurance programs that ultimately determine how much is paid by patients, payers and the government. These dynamics include both the prices set at launch and price changes that occur yearly (or more frequently) and the statutory and negotiated concessions manufacturers make afterwards. There has been significant attention given to the list prices of recently launched drugs, especially with the shift in innovation to specialty, orphan and oncology areas that often have higher prices. The median annual cost for new medicines in many of these therapy areas has risen to tens or hundreds of thousands of dollars in recent years and, in particular, oncology and orphan drugs can be expected to have median prices well above $100,000 per year by 2023 (see Exhibit 7). In the next five years, it is expected that launch prices could increase at a slower rate through a combination of factors including:

• Price competition with other innovative brands as seen already in hepatitis C and PCSK9 therapeutic classes • Independent review of pricing from bodies like the Institute for Clinical and Economic Review (ICER) or others with similar impact, and the effect

of price transparency initiatives more generally • Recent level of breakthrough (e.g., CAR-T therapies, immune checkpoint inhibitors, etc.) will not be repeated as much as in past five years, i.e., breakthroughs will be more incremental

Price increases by manufacturers on established products have drawn public attention, as some have been deemed excessive by the public and policy makers. In the past two years, a range of companies made commitments to reduce list price increases for branded medicines, which are now below

HS&M SEPTEMBER/OCTOBER 2019 | 30

INDUSTRY

6% per year on average, and are expected to remain in the 4â&#x20AC;&#x201C;7% range within the next five years (see Exhibit 8). The net prices manufacturers receive for these drugs have grown more slowly as off-invoice discounts, rebates, statutory payments under the Affordable Care Act and the value of patient coupons have offset invoice price growth. Net prices increased at an estimated 1.5% in 2018 and are expected to rise at 0â&#x20AC;&#x201C;3% over the next five years. Included in this overall average are the potential for some companies and products to have net price declines in the face of competitive markets. Additionally, net price growth was below inflation in the wider economy in 2018; an occurrence expected to continue for the next five years. NEW PRODUCTS Globally over the past five years

there has been a significant increase in the number of and spending on new active substances, particularly in the developed markets where they have historically launched first. Between 2014 and 2018, the average spending on new branded medicines was $43.4 billion. New products launching between 2019 and 2023 are expected to have a slightly higher overall level of spending, approximately $45.8 billion, but will likely represent only 6.7% brand spending, down from 8.2% between 2014 and 2018 (see Exhibit 14). There is a wide range of particularly important treatments expected to be launched in 2019 and 2020, with the biggest impact of those launches in the subsequent year. Along with the increasing number of launches, the type of products continues to shift to specialty, orphan, biologic and oncology products. Specialty is expected to rep-

31 | HS&M SEPTEMBER/OCTOBER 2019

resent nearly two-thirds of newly launched medicines over the next five years, and oncology approximately 30% (see Exhibit 15). Orphan drugs could represent 45% of new active substances should the level of FDA orphan designations for in-progress research and breakthrough designations produce successful launches at current, historic rates. With these shifts in the type of products launching, price per patient is likely to be increasingly high, while the number of patients treated by these therapies will be fewer. The increasing use of biomarkers to segment and treat appropriate patients will characterize more launches, and while not all products can be categorized as precision medicines, there will be more precision treatments in specialty, orphan and oncology therapeutic areas. The oncology pipeline includes 748 drugs in late-stage clinical

development, including over 300 mechanisms of action and 53 next-generation biotherapeutic projects. It is likely that 70â&#x20AC;&#x201C;90 oncology products will launch in the next five years, which would be a significant increase over the 57 launched in the past five years. New drugs could emerge for a range of other diseases with large

unmet needs, such as Alzheimerâ&#x20AC;&#x2122;s disease, but recent setbacks in this therapy area suggest the likelihood is low. Other notable areas include first-time treatments for diseases like nonalcoholic steatohepatitis (NASH), novel approaches to migraines (including the CGRP inhibitors), neuromuscular diseases, autism and other develop-

mental disorders, and a range of molecular targets for cell and gene therapies. LOSSES OF EXCLUSIVITY The expected impact of losses of exclusivity (LOE) for branded medicines in the developed markets is expected to peak in 2019 and will be driven by events in

HS&M SEPTEMBER/OCTOBER 2019 | 32

INDUSTRY

33 | HS&M SEPTEMBER/OCTOBER 2019

2018 as in 2019, including the U.S. approval for seven biosimilars in 2018 (see Exhibit 16). Overall, the impact of LOE is greater for small molecules versus biologics, although the impact of biosimilar competition will grow significantly for biologics through 2023. For example, the impact of LOE in developed markets for small molecules will be larger in the next five years at $121 billion, compared to $105 billion from 2014â&#x20AC;&#x201C;2018, a 15% increase (see Exhibit 16). However, the impact of LOE for biologics is expected to increase two-and-a-half-times to approximately $17.0 billion from 2019 to 2023, up from $6.9 billion in the period 2014â&#x20AC;&#x201C;2018. The impact of biosimilars has been driven by continued uptake in Europe to-date, but the introduction of biosimilars in the United States has accelerated since late 2013, and an even greater impact is expected through 2023. For example, the leading product by global revenue, adalimumab (Humira), is current-

ly facing biosimilar competition in Europe and will see biosimilar competition in the United States in 2023. By the end of 2023, only two of the current top 20 original brands, nivolumab (Opdivo) and pembrolizumab (Keytruda), will not be facing generic or biosimilar competition. In total, much of the LOE impact through 2023 derives from the U.S. market, which is expected to account for $95 billion of the approximately $121 billion in brand LOE (see Exhibits 16 and 17). The largest individual product to face LOE in the United States is expected to be adalimumab (Humira), with estimated biosimilar entries expected in late 2023, which will delay the bulk of the impact into 2024 and beyond. Despite a larger absolute amount of impact on brand spending as a result of market growth, the impact of LOE on a percentage basis will be about the same in the United States over the next five

years as it was between 2014 and 2018: 4.1% of the branded market. In the overall developed group of countries, the impact of LOE will decline from 3.9% of brands in the past five years to 3.6% in the next five. This difference in impact belies the differing dynamics and timing of LOE in the United States compared to the other countries. BIOSIMILARS Across developed markets, the bulk of the biosimilar impact has been outside the United States. Biosimilar dynamics in the next five years will be driven by molecules that already have or will soon have competition, with the introduction of new competitors and further market penetration of existing biosimilars. The adoption and introduction of biosimilars in Europe will continue at a faster pace than in the United States until later in the decade. Across developed markets, there will be fewer losses of exclusivity and associated market entry by biosimilars after

HS&M SEPTEMBER/OCTOBER 2019 | 34

INDUSTRY

35 | HS&M SEPTEMBER/OCTOBER 2019

2019, until the next major event with the entrance of adalimumab (Humira) biosimilars in the United States in 2023 (see Exhibit 18). By 2023, U.S. policies are expected to encourage more biosimilar applicants to file and to reshape reimbursement dynamics that have

hampered early uptake of some molecules. In order to maximize savings, countries will need to ensure that incentives for challengers to enter the markets are substantial enough, and that policies that encourage providers and patients

to use biosimilars are sufficient, while maintaining safety. The relatively slow adoption of biosimilar policies in the United States has delayed the potential savings from these medicines, but the larger delays have come from the patent protections for major originator

HS&M SEPTEMBER/OCTOBER 2019 | 36

INDUSTRY

biologics and the lack of development challenges associated with smaller revenue molecules. There are currently $11.3 billion in spending in the United States for biologics launched more than ten years ago, and there is little prospect that any of these products will face biosimilar competition in the next fifteen years as their revenues are each below $1 billion and/or below $150 million per year (see Exhibit 19). However, biosimilar competition is expected for some biologic molecules launched in the past ten years, despite having no announced biosimilar research to date. Competition for these molecules is likely because their revenues currently total $81.6 billion and could grow further before they face biosimilar competition, and is spread relatively evenly in the years between 2024 and 2033. While biosimilar introductions in the United States have lagged be-

hind Europe, and only five originator biologics have seen biosimilars launched in the United States by 2018 (somatropin*, filgrastim, infliximab, insulin glargine, pegfilgrastim), many more are expected over the next five years. To date, biosimilars in the United States have generated some systemic savings, but greater savings will require more competitors per molecule and more molecules facing competition. By 2023, the part of the biologic market with competition from biosimilars will be nearly three times larger than it is today, and the presence of that competition will result in nearly $160 billion in lower spending over the next five years, or about 10% of the cumulative spending that would have been in that period, if the expected new biosimilars did not reach the market (see Exhibit 20). SPECIALTY PRODUCTS Specialty medicines spending will

37 | HS&M SEPTEMBER/OCTOBER 2019

reach $475â&#x20AC;&#x201C;505 billion in developed markets by 2023. Specialty medicines are those that treat chronic, complex or rare diseases and are costly, either directly or through the distribution, care-delivery or follow-up treatments required. The specialty share of total medicine spending will approach 50% by 2023 in most developed markets (see Exhibit 21) as the majority of new medicines have been and will continue to be in specialty classes. Some developed markets, notably Spain and Australia, continue to focus on efforts to contain the growth in specialty medicine spending. Most markets are balancing specialty growth with offsetting savings in traditional products and are achieving lower overall growth rates. The growth in specialty spending is expected to increase spend across developed markets from $336 billion in 2018 to $475â&#x20AC;&#x201C;505 billion in 2023 (see Exhibit 21).

• In response to stakeholder perceptions in the United States that they are paying inappropriately high costs for medicines, the federal government has proposed a sweeping set of pricing reforms for government programs with varying levels of impact and probability of being enacted

The ten developed markets represent 66% of global spending with specialty share of spending across the countries rising from 42% in 2018 to 50% in 2023. The growth will be disproportionately driven by the five largest specialty therapeutic classes: oncology, autoimmune, immunology (which includes interferons, immunosuppressants and immunoglobulins), HIV and multiple sclerosis. These five classes will drive 74% of specialty growth over the five year period (see Exhibit 22). Specialty represents a smaller share in pharmerging markets, averaging 13% in 2018 and rising to 14% through 2023. WHAT TO WATCH 2019 TO 2023 • A range of novel technologies, such as induced pluripotent stem cells (iPSC) and CRISPR/ Cas9, and others involving modified cells or gene-modification tools are under development, will treat limited patient populations and raise important questions for healthcare stakeholders around cost and accessibility • Mobile apps are increasingly submitted to the FDA for clearance or approval. These prescription digital therapeutics (DTx) are a new emerging

treatment modality with indications and disease-specific treatment effectiveness claims in their prescribing labels • In the past decade, philanthropic organizations focused on neglected tropical diseases have made significant progress and many of the clinical development programs they have started or supported are beginning to result in drug approvals • Over the next five years, life sciences companies will continue to develop and invest in artificial intelligence, machine learning and deep learning programs leading to breakthroughs impacting the discovery and development of medicines • Manufacturers of new medicines where safety has been well demonstrated, but additional or alternative uses of drugs have not yet been approved, will incorporate real-world evidence to support approval for novel indications • Pharmaceutical companies will continue hiring specialists in patient care and patient advocacy, building health advocacy roles internally with most of the top 20 pharma companies having a senior level patient advocacy role by 2019

• There will be more emerging biopharma companies (EBP) launching new medicines in the next five years due to shifts in strategy as well as the rising absolute number of active R&D compounds, with more than one-third of drugs launched in the next five years brought to market by EBP companies • The next five years likely pose a number of challenges to biopharmaceutical companies, with payer actions on prices looming, and it remains to be seen whether these companies can repeat their past successes in terms of revenues and cost management • Existing policies and new legislation will likely impact opioid prescribing and use through 2023, and the dynamics around prescription opioids, and issues around illicit drug use and overdoses, will remain complex and challenging to address. A range of likely scenarios around opioid prescribing trends include a continuation of the ongoing rapid declines in use or a pattern of convergence around current lower-use states. •

COMMENT

HS&M SEPTEMBER/OCTOBER 2019 | 38

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

$842B $629B

Global drug sales by 2024 Over the next five years, global drug sales are expected to climb by 6.9% CAGR (compound annual growth rate), growing from this year’s $629B to $842B in 2024. Source: Evaluate Pharma World Preview 2018, Outlook to 2024

$69.82B

Total R&D expenditures by U.S. companies in 2018 United States healthcare companies spent over $69 billion in research and development last year, followed by Switzerland ($20.95B), Germany ($13.34B), the UK ($11.01B), and France ($6.95B). This was approximately 19.26% of revenue for U.S. companies. Johnson & Johnson spent the most, at $10.8B. Source: Zymewire, “Big Pharma R&D Spend Fiscal Year 2018,” July 2019

88.7% 39 | HS&M SEPTEMBER/OCTOBER 2019

Healthcare Quality and Access Rating for U.S. The Kaiser Family Foundation compared industrialized countries in terms of their Healthcare Quality and Access Index Rating (HAQ), and found that the Netherlands came in first, at 96.1%, followed by Australia, Sweden, Japan, Austria, Germany, France and the United Kingdom. The United States trailed all of those, with an 88.7% rating. Source: Kaiser Family Foundation, “Measuring performance on the Healthcare Access and Quality Index for 195 countries,” The Lancet, 23 May 2018

30.4 MILLION

Uninsured people of all ages in U.S. Over 30 million people of all ages, about 9.4%, were uninsured in 2018 in the U.S. This was a significant decrease from the 48.6 million uninsured in 2010. Source: Centers for Disease Control and Prevention, National Center for Health Statistics, “Health Insurance Coverage,” 2018

14% Expected growth in healthcare jobs from now until 2028 Across all healthcare occupations, there will be an anticipated 14% growth by 2028, faster than that of any other sector, and representing about 1.9 million jobs. Source: Bureau of Labor Statistics, Occupational Outlook Handbook: Healthcare Occupations, 2018

COMMENT

87%

Patient influencers who say social media is critical to future of patient communities In a WEGO Health study of patients and social media, it was found that 87% of patient influencers say social media is critical to decision making, 88% have shared medication experience, and 70% visit patient groups to stay informed (vs. only 3% who visit pharma websites). Source: WEGO Health, “Patient Influencers Perspectives on Social Media,” May 2019

$300B

Potential savings from IoMT The Internet of Medical Things could save the healthcare sector as much as $300 billion, according to a Goldman Sachs study. That breaks down into $200 billion from remote patient monitoring (for heart disease, COPD, asthma, diabetes, etc.) and $100 billion from telehealth in both routine and psychological care. Behavior modification in obesity, smoking and other areas could add even more. Source: Goldman Sachs Global Investment Research

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MOTIVATION

MOTIVIDEOS By Cari Kraft, Jacobs Management Group There is a concept that none of us really knows the struggles others are wrestling with — just as they don’t know ours. One of the purposes of our Motivideos feature is to help you start your morning meeting with something thoughtful, something that will help your team get through the day with optimism, purpose — and a curiosity about what’s going on in the minds of others — through teamwork, leadership, purpose, and utlizing failure. HAPPINESS VS. JOY

Saving Patient Lives

There is something in this short video for everyone. An interesting perspective to have when designing a motivation strategy for your team. Clips to use in a motivational meeting. Or, a different type of insight for developing your strategy.

A reminder of why we work in this field. Because of the advances we make as an industry, people’s lives are lengthened, strengthened, and saved. Listen to some personal stories of patients who survive because of what we do.

Resilience in the Face of Failure

Teamwork Makes the Dream Work

Thomas Edison once said about inventing the light bulb “I haven’t failed. I’ve just found 500 ways that didn’t work.” Amazon founder Jeff Bezos talks here about his “billions of dollars of failures” — but none of those deterred him from getting up and going forward. It is important to remind our team that our failures can be the greatest teachers on how to practice resilience and find success.

We can all do more when we work together. Show your team how removing the “me” and thinking of “we,” how much more we can achieve. How much more we can do for our organization, or clients, and our patients. 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 41 | HS&M SEPTEMBER/OCTOBER 2019

Multi-Stakeholder Commercial Model SUMMIT

December 2-3, 2019

Revere Hotel Boston Common Boston, MA

 Engage in an interactive panel discussion that determines common themes, values, and risks between stakeholders  Network with a variety of healthcare stakeholders, including pharmaceutical professionals, patient advocates, physicians, payers, healthcare providers, and policymakers  Hear from patient advocates and patient-centric companies about the benefits of a patient-centric business model

CONFERENCE CHAIRS

ATTENDEE BENEFITS

Gain a Competitive Advantage by Creating a Patient-Centric Commercial Business Model That Incorporates the Values of All Stakeholders

Fasiha Haq

Global Medical Education Advisor, Executive-Level Strategy and Execution ELI LILLY AND COMPANY

Michael J. Ruggiero

Senior Vice President, Global Healthcare Policy and External Affairs CSL BEHRING

 Identify the latest data-driven approaches used to drive customer-based value

FEATURED SPEAKERS INCLUDE

 Analyze the marketplace and understand why the traditional commercial model needs to be updated

John Alter Vice President, Patient and Health Impact Lead, Hospital Business Unit PFIZER

Christopher Mancill Senior Vice President and Head of Market Access and Policy MORPHOSYS U.S., INC

Raquel Cabo Vice President, Global Market Access OVID THERAPEUTICS

Jennifer Muszik U.S. Commercial Learning Lead BIOGEN

John Doyle, Ph.D. Vice President, Global Healthcare Innovation Lead PFIZER

Doug Stover Vice President, Global Head of Patient Experience and Technology Practice UCB

Rebecca Kirch Executive Vice President, Healthcare Quality and Value NATIONAL PATIENT ADVOCATE FOUNDATION

Tamar Thompson Head, Federal Executive Branch Strategy and State Government Affairs BRISTOL-MYERS SQUIBB

15% Discount Code:HS&MVIP To register, call +1 866-207-6528 or visit https://exlevents.com/multi-stakeholder-commercial-model-summit/

HAPPINESS VS. JOY

Resilience in the Face of Failure

43 | HS&M SEPTEMBER/OCTOBER 2019

Saving Patient Lives

Teamwork Makes the Dream Work

HS&M SEPTEMBER/OCTOBER 2019 | 44

INDUSTRY

Why I Work In Healthcare

Another edition of our series on the passion that goes into the profession. Women in the field from the Healthcare Busineswomenâ&#x20AC;&#x2122;s Association (HBA) share their passion for making a difference in healthcare.

Priya Patil, J&J

Natasha Milinovikj, Daiging Lin, Pfizer

Phoebe Neely Ciulla, TEVA

Nakissa Serry, Toni Citera, Celgene

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Suzanne Gurtler, ZHAW

Neha Soni, IQVIA

Kathy Schaefer, Mallinckrodt

Heather Flaherty and friends, ThinkGen

Deb Gonzalez, Alexion

Monica Fitzgerald, Christina Risatti, BMS

HS&M SEPTEMBER/OCTOBER 2019 | 46

INNOVATION

Celebrating the most innovative companies in healthcare Innovation is a huge category, covering discovery, strategy, marketing, sales, and numerous other disciplines within healthcare. For the last nine years, Idea Pharma has put together The PII, the Pharmaceutical Innovation Index, which aims at ranking companies in their ability to bring products to market and commercialize them successfully, and utilizes a range of clinical, regulatory and commercial metrics to do this, ranging from the corporate level down to individual products. The best news is that most of the upward trending comes from the introduction or expansion of new therapies, an area that has presented difficulties in recent years. Read the details and youâ&#x20AC;&#x2122;ll see that there is no shortage of robust discovery going on these days. Sources include company websites, third party institutions (e.g. FDA, clinicaltrials.gov), syndicated and analyst reports, etc., which are analyzed and rolled up at company level for innovation and commercialization, and ranked.

Fuller details are available in the PII White Paper, which discusses in greater depth the metrics themselves and also highlights where individual companies excel, or do poorly. OVERVIEW 2018 marked an important year in pharma, with key industryshaping events. We witnessed a record high number of novel drug approvals, suggesting an industry that is boosting productivity while improving collaborations with regulators to progress thera-

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pies through the regulatory finish line. But a good proportion come from small- to mid-sized biotechs (39 of the 59 approvals were from companies which are outside the top 30). Are the smaller players tipping the scale on productivity? Well, maybe, but some of the big pharma companies were also rather busy last year. Pfizer managed to push four new oncology drugs through approval, marking the highest number of novel drug approvals in the industry, while other big pharma players, including Merck, BMS, Astra-

The only Awards to focus on what matters â&#x20AC;&#x201C; value for patients and HCPs. December 11th, The Bellevue Hotel, Philadelphia

www.eyeforpharma.com/awards-evening/

INNOVATION Zeneca and Roche, were entangled in an immuno-oncology (IO) race, marking 2018 as a rich year in IO developments with numerous key trial data readouts, including in the highly sought-after lung cancer market. Other big topics that dominated the industry last year included drug pricing, China and its sheer significance as a key growth market, and a new era of digital innovation sweeping pharma.

to grow, thanks to a megablockbuster approval it scored last year with HIV therapy Biktarvy, a drug which combines integrase inhibitor bictegravir, emtricitabine and tenofovir alafenamide, and which is expected to reach sales as high as upwards of $7B. Also last year, Gilead extended approval of its CAR-T therapy Yescarta in Europe for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (MLBCL), and beat its rival Kymriah in securing a discount deal with NHS in England.

Gilead took the top spot for the first time, having gained one place each year from 2016 onwards. A combination of factors drove this achievement, including a newly approved antiviral therapy, expected to become a blockbuster, and significantly strengthening one of their key therapy area portfolio strategies, along with approval of its CAR-T therapy Yescarta in the EU. Gilead was boosted by an outstanding freshness index score, measuring the proportion of revenue generated from drugs approved in the past five years. Gilead’s 60% Freshness Index rating is more than twice its nearest rivals and compares to an average across the top 30 companies of just 11%. Gilead reported total sales of $21.7B for 2018, down by roughly 15.5%, but with a considerable proportion coming from its HIV portfolio, which actually grew in sales, bringing in $14.6B compared to $13.0B in 2017. The good news is sales are expected

Climbing up from fifth place in 2018, AbbVie showed it was able to strike an encouraging level of clinical innovation, profitable business decision-making and financial security. While they will likely have exclusivity in the US until 2023 based on patent protection, AbbVie has been playing strong strategic defense with their market-leading Humira throughout 2018, lining up seven biosimilar agreements with copycat companies seeking to gain a piece of the $12.36B of US sales generated by Humira in 2017, as well as the additional $6B ex-US markets. Big winners for AbbVie came in the form of Imbruvica and Orilissa. Over the course of 2018, Imbruvica added to its already prominent profile with positive Phase III trials in CLL in combination with Gazyva (beating out

49 | HS&M SEPTEMBER/OCTOBER 2019

Gazyva and chemotherapy) and topping the gold standard chemo combo in CLL with the Imbruvica/ Rituxan pairing. With the significant challenge to AbbVie’s Humira coming from biosimilars in just a few years, all eyes were on pipeline candidate Orilissa to help fill the void. AbbVie received approval of blockbuster hopeful Orilissa for the treatment of pain associated with endometriosis in July and was able to announce additional strong data in additional indications just a few short months later. In November, Orilissa also delivered for AbbVie with a pair of Phase III wins in uterine fibroids supporting the bid for expanding the regulatory reach of the highly anticipated compound.

The biggest shake-up in this year’s top 10 PII companies’ list is Eli Lilly, jumping 10 places. The company had two new drug approvals last year. The first was Emgality, a drug approved for the preventative treatment of migraine in adults. Lilly has high hopes for this new treatment as the drug cut migraine days at least in half for two-thirds of patients in clinical testing and comes with the convenience of a once-monthly injection. Soon after, Eli Lilly quickly managed to secure a breakthrough designation for the drug in prevention of episodic cluster headache thanks to positive Phase III trial data. The company’s strong commitment in helping patients with

headache disorders is evident, and once again, last year it reported a filed application for Lasmiditan — a new drug for the acute treatment of migraine, and if this drug is approved it will mark a significant development for patients suffering with this condition. Lilly scored a second new drug approval in 2018, this time for its new drug Olumiant: which is a therapy indicated for adults with moderate to severe rheumatoid arthritis. The drug is launching in a highly competitive market and it will have to bear the weight of some of the caveats of its approval, as only the lower dose of the drug was approved and the drug will launch with a black-box safety warning. Its immunology star Taltz had an outstanding year in 2018, and the company has plans to continue expanding the therapy to more patients. Earlier in the year, Lilly published positive Phase III topline data for Taltz in patients with ankylosing spondylitis — a form of arthritis that primarily affects the spine. Later in the year, the drug stole the spotlight as it reported beating AbbVie’s Humira, the world’s number one selling drug, in a head-to-head Phase IIIb/IV superiority study in treatmentnaïve patients with active psoriatic arthritis. In oncology, its recently launched drug Verzenio picked up an approval for use in combination with an aromatase inhibitor in previously untreated, postmenopausal women with HRpositive, HER2negative breast cancer. Cyramza, which had previously failed a Phase III trial back in 2014, came back with a winning strike in second-line patients with HCC (Hepatocellular Carcinoma) who express high levels of a particular biomarker (AFP) which the com-

pany says is a predictor of poor prognosis.

Pfizer lands at the 4th spot, largely pushed forward by their four FDA approvals this past year. Pfizer closed out 2018 on an FDA hot streak, collecting approvals on Daurismo in newly diagnosed AML, a pair of approvals in nonsmall cell lung cancer with their highly selective second generation EGFR, and Lorbrena — Pfizer’s answer for ALK-positive resistant patients and follow on for Xalkori. Finally, Pfizer was able to get the nod from the FDA for their PARP inhibitor, Talzenna, in metastatic breast cancer. The aggressive expansion in oncology will aim at offsetting the effect of generics eroding Pfizer’s longtime blockbuster Lyrica, which lost its patent exclusivity in June 2019. Lyrica was responsible for approximately $3.5 billion in 2018 revenue in the US alone, a sum that is expected to drop as much as 30% in 2019. Pfizer is also overcoming Lyrica losses by delivering beyond expectations with their existing portfolio. Drugs such as Prevnar have exceeded consensus projections, generating $1.53B in a single quarter; up over 7% during the same period in previous years. Additionally, Pfizer has managed to bolster their positioning in kidney cancer with a “breakthrough” designation for its combination of PD-L1 Bavencio (co-developed with Merck KGaA) and Inlyta. The designation is for previously untreated renal cell carcinoma patients and should aid a speedy path to market for the pair of assets.

The challenge is to think of Merck outside the context of Keytruda. Keytruda stole the spotlight once again in 2018, as the year marked an important milestone win for the IO star, when for the first time the sales of Keytruda surpassed those of Opdivo. Merck reported Keytruda brought in nearly $7.2B in sales in 2018, while BMS reported year-end sales of $6.7B for Opdivo. Overall, Merck’s total sales grew by 5.1%, driven heavily by 47% growth in Keytruda’s sales alone. The PD1 inhibitor picked up a number of approvals last year including one in rare skin cancer Merkel cell carcinoma, in patients with hepatocellular carcinoma who have been already treated with Nexavar, a groundbreaking approval in first line squamous NSCLC in combination with chemo for patients regardless of PDL1 level making it the first in its class of PD1/PD-L1 to achieve this type of indication. Additionally, it achieved an expanded full approval in combination with pemetrexed and platinum chemo for first-line patients with metastatic nonsquamous NSCLC, an approval in 3rd line for patients with a rare type of non-Hodgkin lymphoma, as well as became the first of its class of PD1/PD-L1 to gain an approval in cervical cancer. Although the IO drug hit one setback in bladder cancer, where it and its rival Tecentriq were restricted by the FDA to patients who aren’t eligible for cisplatin-containing chemo and whose tumors express a predetermined level of PD-L1.

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INNOVATION The company also rolled out a string of promising positive data that could pave the way for more potential Keytruda label expansions in the coming months, including positive OS data against chemo in previously-treated patients with esophageal carcinoma whose tumors express PD-L1, challenged Opdivo with positive data in post-surgery melanoma patients as well as with positive combo data in kidney cancer, new monotherapy data in 1st line NSCLC patients with any level of positive PD-L1, and Phase III data in head and neck cancer make a strong case for use earlier in previously untreated patients. Aside from Keytruda, Merck got 2 new HIV-1 therapies approved last year: Delstrigo which is a three drug combination once-daily tablet indicated as a complete regimen for treatment-naïve adult patients, and Pifeltro which was approved to be used in adjunction with other antiretroviral agents for the treatment of HIV-1 infection in previously untreated adult patients.

Touting one of the year’s most significant upward leaps, Sanofi comes in at #6 overall — up nine places from ranking 15th in 2018. The upward trend can be linked to several high-performing drugs as well as acquisitions that were closely tied to successful commercialization opportunities. Sanofi started the year with mo-

mentum from their first immunology drug Dupixent as well as Kevzara in moderate to severe rheumatoid arthritis. Dupixent represented a paradigm-shifting innovation in atopic dermatitis, taking a bold approach to treatment through the development of a biologic, requiring significant physician, payer and patient education to help the entire market update how they think about treating the disease. To boost the success of Dupixent even further, Sanofi received an approval for its use in severe asthma — a move that analysts expect could add as much as $2.5 billion in peak sales. The approach of Kevzara to the market was markedly different right from the launch. The Interleukin 6 Receptor Antagonist (IL6R) was launched as a mechanistically-differentiated and 30% price undercut to the marketdominating TNF-alpha drugs. Over 2018, additional big wins in rare blood disorders and the cardiovascular arena helped propel Sanofi up the Index. Sanofi has continued to drive development of their Praluent injection, reporting positive Phase III data from their ODYSSEY ESCAPE trial and submitting a fourth quarter sBLA with the hopes of having the drug approved for reducing the overall risk of major adverse cardiovascular events (MACE), which includes heart attack, ischemic stroke and death from coronary heart disease. In the rare blood disorders space, Sanofi was able to capitalize on their first product from the Ablynx deal. Cablivi received an EMA approval for the treatment of thrombotic thrombocytopenic purpura (aTPP) — the first-ever therapy

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indicated for the disease — which is anticipated to yield peak annual sales of $500 million. In the US, the drug has received an FDA “Fast Track” designation for the same indication and is being supported by their Phase III Hercules trial as well as a three-year follow up that is currently ongoing.

Up 3 spots from their 2018 PII ranking of 10th, Novo Nordisk was able to combine impressive financial gains with multiple clinical trial and regulatory wins for a solid innovative and profitable 2018. Novo continued their upward trend of both revenue and net income that has been consistent over the past 5+ years. The company posted gains of 4.59% in revenue and 5.82% in net income over the previous 2017 financials. The overall positive trend came from success across the Novo portfolio, including sales increases of 6% for Victoza, 42% increase for Saxenda and 8% for Tresiba. Additionally, Novo Nordisk was able to expand the sales of their total GLP-1 franchise by 10% with the successful launch, and quick traction, of Ozempic. Novo made several moves to bolster its portfolio in 2018, including new launches and sales boosting data. Ozempic launched in February of 2018 and is Novo’s latest entry to their GLP-1 franchise. The once-weekly has already reached

a 26% market share and is available in 11 European countries and North America. Novo demonstrated the accuracy of the adage “the best defense is a good offense” in 2018 with Tresiba and their oral semaglutide. Operating in an increasingly competitive field with growing payer pressures necessitates innovation and continued portfolio vision and execution. The company was able to further entrench Tresiba through label expansions which set their differentiating safety value in a class by itself. While Ozempic represents the big 2018 launch for Novo, their oral semaglutide candidate is their next big shot on goal. They were able to generate several clinical wins in type-2 diabetes and obesity to help unseat incumbent competitors Januvia and Victoza. Novo is expected to file their oral semaglutide early in 2019 using a priority review voucher, further driving their market dominance.

Roche landed in the exact same position in this year’s PII, as it celebrated some wins and suffered some setbacks in 2018. The commitment to its three key major therapy areas (oncology, neuroscience, and immunology) was evident. The company’s sales grew 7% from the previous year, bringing in 56.8B CHF in 2018. During the first half of 2018, Roche posted positive Phase III data, demonstrating that in combination with chemo it cut the risk of disease worsening or death relative to chemo alone for first line patients with squamous NSCLC,

although its glory was short lived as Merck’s Keytruda posted more impressive data for its identical study. Then Roche challenged rival Merck, with positive Phase III data from its IMpower130 study where it demonstrated that its PD-L1 Tecentriq in combination with chemo and Celgene’s chemo drug Abraxane improved overall survival in front line patients with metastatic non-squamous NSCLC versus the standard of care chemotherapy alone. Later in the year, the company posted positive Phase III survival data in previously untreated SCLC patients, where Tecentriq in combination with chemo beat chemo alone in significantly extending patients’ lives. Later in the year, the company followed with another win, this time in triple negative breast cancer, where Roche posted positive data in combination with Celgene’s Abraxane in these tough-to-treat patients. In liver cancer, Roche picked up a breakthrough designation for Tecentriq in combination with Avastin in treatment-naïve patients, while in kidney cancer it pulled its application, as according to the company “results were not sufficient to support an extension of indication”, while suffering a setback with the FDA restricting its use in bladder cancer. Rising star Venclexta, which Roche shares rights to with AbbVie, won an approval in combination with Rituximab in relapsed CLL patients with or without 17p deletion. Later in the year, the drug gained FDA approval in newlydiagnosed previously untreated AML patients who are ineligible for intensive chemotherapy. Outside of oncology, Roche celebrated a label expansion of its haemophilia drug Hemlibra which is now indicated to treat all haemophilia A patients. Additionally,

the company scored a big drug approval last year — its next generation flu drug Xofluza, although it remains to be seen whether the benefit of the drug will be meaningful enough to outcompete Tamiflu generics. The company posted key 5-year data for its blockbuster MS (Multiple Sclerosis) therapy Ocrevus, demonstrating that early initiation of the therapy reduced disability progression in patients with relapsing MS (RMS) and primary progressive MS (PPMS). Finally, the company celebrated the approval of a new formulation of its blockbuster drug Xolair, which now conveniently comes in a pre-filled syringe form for both allergic asthma and chronic idiopathic urticaria (CIU).

After placing in the top 3 in the 2018 PII, Novartis has taken a step back in 2019, falling 6 places to the 9th position. This regression is due to several areas not being quite as successful as previous years, rather than any singular driving force; that being said, overall 2018 was a very successful year for the company. Novartis was able to continue to grow into their leadership role in the CAR-T arena, adding DLBCL as an approved indication for Kymriah. Despite their best expansion efforts however, the novel therapeutic approach has failed to meet analyst expectations — generating ~$76 million in its first year on market and falling considerably short of the lofty $159 million target that Wall Street set at the beginning of the year. In addition to the slow start, manufacturing troubles have compounded

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INNOVATION the issue, making expansion efforts challenging. In Europe, the drug fared better, earning a thumbs up from England’s cost-effectiveness watchdogs just days after Gilead’s competitor Yescarta was rejected, providing Novartis with a headstart ex-US. There is a strong hope for Kymriah success in 2019 as the pipeline is set to tackle several additional leukemia and lymphoma indications that should keep Novartis highly competitive in the CAR-T race. Several additional big moves help to keep Novartis in the top 10 this year, including their approval and fast success of Lutathera. After buying out Advanced Accelerator Applications at the end of 2017, Novartis was able to get a first quarter approval of Lutathera, the first peptide receptor radionuclide therapy to win U.S. approval, for the treatment of somatostatin receptorpositive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Since the approval early this year, the penetration has been remarkable in this rare disease space, with nearly 1,200 doses administered across 85 stateside centers (according to the Novartis 3Q Investor Presentation). Given the rarity of this particular digestive tract cancer, CEO Vas Narasimhan has called the launch a “really explosive performance” racking up over $160 million in sales its first year. Novartis closed out a commercially successful year by posting a 54% increase in net profit over 2017- an upward trend they hope to continue in 2019 with their strong commercialization efforts and additional label expansion.

GlaxoSmithKline continued their steady climb up the pharmaceutical innovation index in 2018, moving up 3 spots to squeak into the top 10 (GSK has averaged a +3 annual increase on the PII between 2016 and 2018). GSK showed moderate yet healthy growth in 2018 with a 2% increase in overall sales compared to the previous year. A key driver of their growth came from new products. One standout was the new shingles vaccine, Shingrix, which received approval in Europe in early 2018, building on its initial 2017 FDA approval. The vaccine saw unprecedented demand in its first year on the market, generating £784 million in sales (globally). However, the drug company may have suffered from too much success, with GSK failing to meet the insatiable demand that led to a Shringrix shortage beginning in the second half of 2018 and persisting into early 2019. Another 2018 win came from the impressive HIV data GSK posted. GlaxoSmithKline’s ViiV Healthcare showed that the combination of their two drugs, Tivicay (dolutegravir) and Epivir (lamivudine) were able to suppress viral loads as well as standard triplet therapy across two Phase III clinical trials. This remarkable data could ultimately transform the way HIV is treated, changing HIV treatments from a 365 days per year dosing to just 12. Paring back treatment to just two drugs could also help patients to see fewer side effects over time. GSK also reaffirmed its commitment to oncology in 2018, acquiring the oncology-focused compa-

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ny, Tesaro, and investing heavily in several in-house oncology pipeline assets. Though the company faces headwinds with key products going off-patent, the new focus on oncology could help steer GSK toward a more promising future. FINAL THOUGHTS ON PII PERFORMANCE Congratulations to those who finished out 2018 strong and at the top of our list, especially those who have been models of consistent innovation and forwardthinking in their development and commercialization practices. 2018 saw a large amount of returners in the top bracket of our PII index, with only a handful of new companies rising into the top 10. In fact, seven of the 2018 top 10 managed to retain this status, while we had 3 newcomers (Sanofi, GSK and Eli Lilly) break into the top tier. In 2017, we first noted a shift of big pharma pushing out smaller companies from the top spots — in reviewing 2018, that shift has developed into a notable trend in our rankings. Will Big Pharma continue to take big risks and push the envelope on innovation? Or will biotechs and other smaller companies leverage their agility to ‘wow’ us with new and different approaches to the many challenges faced in today’s market? We are interested to how this will play out in 2019 and beyond. To view the full report, and see what companies occupy PII positions 11-30, please visit the dedicated website at ideapharma.com/pii. •

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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.

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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. Whatâ&#x20AC;&#x2122;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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Company Overview: McCann Managed Markets is a strategic health care 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. Whatâ&#x20AC;&#x2122;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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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. HS&M SEPTEMBER/OCTOBER 2019 | 64

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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. Whatâ&#x20AC;&#x2122;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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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: Conversational AI, Intelligent Assistants

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 67 | HS&M SEPTEMBER/OCTOBER 2019

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. 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 68 | HS&M SEPTEMBER/OCTOBER 2019

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

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.

HS&M SEPTEMBER/OCTOBER 2019 | 69

September / October 2019

Articles inside

Celebrating the most innovative companies in healthcare

IQVIA’s 2023 Outlook for Global Medicines

Editorial Board

Great Minds: Daiichi Sankyo GM and CEO Patrik Grandits on Innovation and Improvement

Motivideos: To Use In Your Meetings

Industry Trends: By The Numbers

Editor’s Letter