™ SEPTEMBER/OCTOBER 2020
the publication for healthcare sales & marketing leaders™
TOP 50 PHARMA COMPANIES IN THIS ISSUE
PHARMA COMPANIES AbbVie, Terumo, Endo and other execs on Sales/Regulatory Cooperation MedTech Innovator Awards DENTALEZ CEO on Reinvigorating the Dental Sector Antares, GSK and Flexion execs on AI and Commercial Pharma, Biotech and MedTech Review from Evaluate Bringing In Great Talent in Tough Times
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TABLE OF CONTENTS
Publisher’s Letter..............................................................................................................................................4 Editor’s Letter.....................................................................................................................................................5 Editorial Board....................................................................................................................................................7
ARTICLES Spotlight: DENTALEZ CEO Heather Trombley on Reinvigorating the Company.........................9 Roundtable: AbbVie, Terumo, Endo and Helen of Troy Execs Discuss how Commercial and Regulatory Can Work Together Effectively.................................................. 13 Top 50 PharmaCompanies.......................................................................................................................... 23 Pharma, Biotech and MedTech Half-Year Review from Evaluate Vantage................................ 27 Industry Trends: By The Numbers............................................................................................................ 43 Talent Trends: How to Find and Attract Great Talent in Tough Times........................................ 45 How Commercial Can Best Use AI: a Veeva Summit Talk.................................................................. 51 Motivideos: To Use In Your Meetings..................................................................................................... 57 Why I Work in Healthcare: Covid Heroes in Their Own Words........................................................61 Innovation: MedTech Innovator Awards................................................................................................ 65
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Publisher’s Letter
ABOVE AND BEYOND Once again, we are featuring the top 50 pharmaceutical companies, measured by global revenue. The rise of the industry to $1.2T in 2019, was encouraging and exciting and is tempered by what is to come with this pandemic. Much of what we see going on this year has to do with the Covid-19 crisis, the search for a vaccine and attendant therapies for the millions affected. CARI KRAFT
But what’s happening outside of the Covid-19 realm? Let’s dig down and look at what else the top companies are doing.
Pfizer, for instance, received 54% of its 2019 revenues from sales of anti-infective products in China, including its antibiotic drug Sulperazon. Its joint venture with GlaxoSmithKline (GSK) brings their consumer healthcare businesses together. Roche has a roster of new medicines, including Ocrevus, Hemlibra, Tecentriq, and Perjeta. Tecentriq in the oncology segment and Actemra/RoActemra and Esbriet in immunology contributed significantly to the company’s revenues. Novartis’s innovative medicines division contributed 79% of its revenues, with Sandoz accounting for the remaining 21%. It acquired the Japanese business Aspen Global Incorporated, merged with The Medicines Company, and acquired Xiidra dry eye medication from Takeda. Merck’s 2019 revenues in were primarily driven by its oncology, human health vaccines and animal health divisions, and it has received approval for ERVEBO® (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire ebolavirus, RECARBRIO™ for complicated urinary tract infections and ZERBAXA® for pneumonia J&J pharmaceutical division revenues grew by 3.6%, driven by the immunology ($13.95B) and oncology ($10.69B) portfolio. GlaxoSmithKline merged its consumer healthcare unit with that of Pfizer, and its 10% yearon-year growth in 2019 revenues was driven by increased sales of Shingrix, a shingles vaccine, respiratory drugs Trelegy and Nucala, and HIV drugs Dovato and Juluca. Sanofi thrives on sales of its insulin drug Lantus®, deep vein thrombosis medication Lovenox®, and antiplatelet medication Plavix®. AbbVie continues to benefit from its flagship rheumatoid arthritis drug Humira, which accounted for 58% of the company’s revenues, plus IMBRUVICA, MAVYRET, VENCLEXTA, Lupron, and Creon. Takeda’s 2019 revenues grew due to its acquisition of Shire, bringing it presence in the gastrointestinal and neuroscience markets, among others. All this while many of those companies are also investing in Covid-19 vaccines and therapies. It’s a broad, complex, amazingly active field. We’re proud to be part of it. 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 2020 | 4
Letter from the Editor
The Test A young woman I know came down with a set of symptoms earlier this year. The good news is that it wasn’t Covid-19 related. The bad news is that no one knows, even after many examinations and tests, exactly what it is. Presenting with dizziness and a number of GI issues, her healthcare journey has been long and frustrating. She has been to a primary, a gastroenterologist, an ENT, two neurologists, an ophthalmologist, a psychiatrist, a neuro-ophthalmologist, an infectious disease specialist, a balance center and a vestibular therapist. This last professional has provided the most relief, but it is only part of a complex treatment regimen that includes anti-anxiety and other medications. Thank NEIL GREENBERG goodness she’s feeling better, but this could be a chronic condition. At 25, that’s a lot to deal with, especially if you’re used to robust good health and had no hint of this before. Why do I mention this? Because dizziness and GI problems are relatively common, and you would expect that somewhere in that menu of specialists someone would be able to clearly identify what’s going on and provide treatment and reassurance. How much more challenging is it, then, to go after a completely new disease, one that is threatening and occasionally deadly, one that can spread quickly, against which there is no defined countermeasure (yet), and little in the way of protection? Yet that is the conundrum we face. And, in the face of this rude surprise, the healthcare industry has risen to the challenge and is making extraordinary progress. Around the world, companies, governments, universities, organizations and other entities are working around the clock, both to treat patients and to discover a weapon against Covid-19. There are dozens of trials, many of them promising, and we may have a vaccine faster than one has ever been discovered before. In a chaotic time like this, we keep saying things like “You could not make this up.” Even novels and movies about epidemics have not had plots as frightening and inspiring as what we are experiencing in real life. But that’s what has brought us to the amazing proof of what people can do when faced with an implacable enemy that must be defeated. And it’s the greatest test of the wisdom, determination and communal effort that our industry has ever had to deal with. Here’s to everyone on the front lines, and behind the scenes. We owe them more than we will ever be able to repay. 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.
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the publication for healthcare sales & marketing leaders™
Editorial Board Chris Bergstrom President, AmalgamRx
Publisher Cari Kraft Editor Neil Greenberg Creative Director Hedy Sirico Digital News Rick Cataldo Digital News Chris Manning Associate Publisher Natalie Newcamp EDITORIAL BOARD: Kristen Sharron-Albright Head of Marketing, Noven Pharmaceuticals Chris Bergstrom President, AmalgamRx Sebastian “Sebby” Borriello Vice President, Chief Commercial Officer SK Life Science Maria Finlay, MBA Director of Channel Marketing, Incyte Nick Gurreri Vice President New Products, Alexion Pharmaceuticals, Inc. Paul Murasko Sr. Director, Digital Customer Interactions, Ipsen Biopharmaceuticals Bob Roda President and CEO, Hemosonics
© 2020 CL Media Inc., Philadelphia, PA CL Media is not responsible for any unsolicited contributions of any type. Unless otherwise agreed in writing, CL Media retains all rights on material published in HS&M for a period of one year after publication and reprint rights after that period expires. Email ckraft@hsandm.com.
To advertise in HS&M, please contact Natalie Newcamp at nnewcamp@hsandm.com
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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.
Paul Murasko Sr. Director, Digital Customer Interactions, Ipsen Biopharmaceuticals Paul is a senior commercial leader with a 25+ year cross-functional career in healthcare that has bridged operations, sales and marketing, He is currently responsible for leading and building Ipsen’s capabilities to help the organization improve the effectiveness, efficiency and engagement of all digital interaction with healthcare professionals, patients and caregivers. Previously, Paul was Sr. Director of MultiChannel Marketing for Sunovion Pharmaceuticals and led a team responsible for non-personal promotion, digital strategy and execution, as well as the telesales team. He also was with Johnson & Johnson, primarily in the Medical Device and Diagnostics (MD&D) space. While Director of Digital Marketing at J&J, he created DePuy’s first multi-company digital marketing team, led the digital integration for $19.8 billion acquisition of Synthes, and was chairman of the Digital Acceleration team for the MD&D sector.
Sebastian “Sebby” Borriello Vice President, Chief Commercial Officer SK Life Science Sebby currently serves 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 Ortho-McNeil Pharmaceuticals, Inc.
Editorial Board Bob Roda President and Chief Executive Officer, Hemosonics Robert A. Roda (Bob) joined HemoSonics in February 2020 as the company’s President and CEO, bringing more than 25 years of global experience developing and commercializing innovative diagnostic and medical device products and services. Most recently Bob Roda served as President and CEO of Menarini Silicon Biosystems, Inc, a diagnostic and biotech company focused on the use of liquid biopsy and predictive diagnostic tests for the treatment of cancer patients. Prior to that position he was Vice President and General Manager at Becton Dickinson where he led the medical and procedural solutions business in the US. From 1998-2012, Bob held positions of increasing responsibility at Johnson & Johnson in both the medical device and diagnostic sectors, with his last role being WW VP Marketing in Immunohematology, Donor Screening and Clinical Laboratories at Ortho Clinical Diagnostics, a J&J company. Bob earned a Bachelor of Arts degree in Economics from the University of Rhode Island and completed Executive program course work at Kellogg Graduate School of Management.
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 bio¬pharmaceutical and medical device industries. Nick has held executive positions at Medgenics, Insmed, Pfizer, Pharmacia and Bristol-Myers Squibb.
Maria Finlay, MBA Director of Channel Marketing, Incyte Maria Finlay has over 24 years of brand marketing, sales leadership, operations, and market access experience. She recently completed the Wharton General Management Program, and has led multiple cross-functional initiatives at Johnson & Johnson, AstraZeneca, Teva Oncology and Incyte. With experience across 7 therapeutic areas, Maria has launched multiple small and large molecule products throughout her career. Maria currently leads Oncology Channel Marketing strategies and tactics directed towards large organized Community Oncology customers, Hospital Systems, GPOs, and Payers. A results-driven professional with a passion for culture, engagement, diversity and inclusion; Maria has been awarded multiple President’s Club awards in sales and marketing, as well as a J&J Rising Star and an HBA Luminary Award.
Kristen Sharron-Albright Head of Marketing, Noven Pharmaceuticals Kristen Sharron-Albright 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. 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.
HS&M SEPTEMBER/OCTOBER 2020 | 8
EXECUTIVE SPOTLIGHT
Reinvigorating the 800 lb. Gorilla: the DENTALEZ Story Over 100 years in the industry, DENTALEZ was a major player in dental equipment — until about twenty years ago. But they didn’t keep up with digital advancements and other customer needs, and ultimately became just another of many competitors in the field. That is, until Heather Trombley joined them. Heather had a background with some heavy hitters in medtech, particularly a long and successful career at GE, where she felt on top of the world, working at a first-class company. She was Regional Sales Manager for GE Consumer and Industrial before being tapped as Global Product Manager for GE Healthcare for a patient monitoring division, formerly under other ownership that now wanted some GE DNA. That meant more focus on rigor and metrics, plus an emphasis on the market. Heather focused on solving problems for customers. 9 | HS&M SEPTEMBER/OCTOBER 2020
In addition to enjoying the challenge of managing product lines, she fell in love with healthcare, recognizing it as a field that had a distinct purpose-driven nature. Later, as VP and General Manager at Conmed Corporation, Heather gained insight into the orthopedic sector of the healthcare industry. When she joined DENTALEZ as President and COO, she recognized that there were similarities in channel distribution and other aspects of her Conmed experience that she could carry over to dental. DENTALEZ had a strong focus on operations and manufacturing, but she saw that it did not have a
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EXECUTIVE SPOTLIGHT strong voice-of-customer understanding, and its marketing needed improvement. She recognized a need to shift the culture to being more purpose-driven – communicating a mission to improve oral healthcare and the company’s role in that mission. She began a program of understanding the customer and defining value. DENTALEZ had lost relevancy and market share, despite still being a recognized player. A related problem was that most of the industry professionals who had regarded DENTALEZ highly in its heyday were retiring, and the company didn’t have the same reputation among new graduating dentists who were establishing their practices. How could they make a difference? The major strategy was to leverage that understanding of customer needs. Since DENTALEZ was regarded as solely a “me too” manufacturer, Heather saw they could adopt advanced technology and help make the practice of dentistry easier and more efficient and start to be recognized as a leader. Dentists use numerous devices that they cannot repair or maintain themselves, so they depend on the distributors to provide service. But that service often takes time to employ, and requires a visit to the office to work on the machines. Heather set out to accomplish three targets: accelerating the technology in their products, accommodating smart tech, and integrating all this to provide a more efficient practice. Her steps were to get in line with trends in the industry, modernize their products with a focus on simplifying and being able to scale practices and
effectively message the benefits of these new products. One important insight was that understanding the macro trend of measuring patient outcomes. If DENTALEZ made that goal a part of their mission to enable the dentist to focus on the patient and outcome versus the equipment necessary for a procedure, they could attract the attention of dentists who are on the same page. This involved taking some of the “noise” out of the system – making equipment easier to use, set up, more reliable, and maintenance and repair quicker and easier. So DENTALEZ created an innovative process of being able to identify problems and malfunctions remotely, cutting down on repair time and cost. This significantly reduces downtime for the dentist and improves patient outcomes. They also built into the value proposition techniques that were common in other parts of the industry but lacking in dentistry, like video training on demand for the service people at their distributors. LAUNCHING THE LINE Once they had these elements in place, the task was to launch the new DENTALEZ – the company that would solve the problems of both distributors and dentists, and create messaging that went beyond the old technical-service productfeature focus. An attendant complication, though, was that the launch was scheduled for February 2020, just as the pandemic was becoming a global problem, affecting healthcare especially. Unlike other healthcare professionals, dentists
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could not do much in the area of telehealth. Their services need to be delivered in person, and it took a while for many practices to figure out the best safety procedures to accommodate patients and to procure PPE. So DENTALEZ had to determine what to do in the meantime to address the problems of their audience. As it happened, the customer-focus part of Heather’s strategy was exactly the solution needed. They embarked on a campaign that educated dentists – not just on the use of products, but on the whole scope of running a practice, so that DENTALEZ was now seen as a valued partner to turn to in a difficult time. The development of remote monitoring and diagnostics was additionally important. Now you didn’t need a technician to come to the office, dragging out assessment and repair. DENTALEZ had people who could alert the dentist to maintenance needs and speed up the process of getting back into operation. This was pivotal in reducing unnecessary exposure and improving efficiency. Under their new Aeras Intelligent Platform line, for instance, DENTALEZ provides actionable information, accurately, quickly and conveniently. Every Aeras product collects and shares data, streamlining standard-of-care processes. Creating new connections between vital equipment and key practice operations, Aeras has cloud-based diagnostic capability that forewarns staff and service teams, allowing for targeted diagnosis and service planning – all of which can be done remotely, improving service effectiveness and eliminating
unproductive visits to the office. This allows the company to deliver state-of-the-art dental practice solutions for interconnectivity, choice and control. They went public with the launch at the Chicago Dental Society Mid-Winter Meeting, with new corporate branding and design, a new booth design, and their strategy and mission unified and codified. It was all aimed not just at product/feature messaging, but at addressing what the market needed. DEALING WITH THE PANDEMIC Obviously, the Covid-19 crisis affected everything that DENTALEZ and their customers needed to do. DENTALEZ started providing virtual training sessions, putting out information available on any mobile devices. They held digital meetings, leveraging video to communicate quickly, graphically and powerfully to sales partners and dealers. They helped these people understand how to market to dental offices without having to walk through the door. But another part of the plan was to adapt their internal culture to the process. Heather had to get her own staff accustomed to digital communication and marketing. The old style was to get on a technician’s training schedule and send a trainer out with the product and teach them how to use it. Their distributors have over 800 technicians, so this could be time-consuming. But with their new web-tool based training, they could speak to larger groups of technicians all at once, providing
training online. Heather says “In the 21st century, this seems like an obvious thing to do, but it was a real pivot for the dental industry.” A great piece of luck was that DENTALEZ had incorporated a scheduling feature into their technology. Now it seemed the product was designed for a pandemic. During long absences, equipment should periodically cycle for optimal performance so it’s immediately available when needed. The DENTALEZ smart scheduling could watch their equipment and keep it automatically turned on and cycled down, so it was ready when needed. GETTING THE MESSAGE OUT The pandemic required the marketing mix to change with free content not only about products, but about processes, such as posts on how to flush your water lines – helpful hints that professionals appreciated. Current relevance was key to their messaging. This all provided numerous benefits. Dentists on the DENTALEZ system could be more competitive, since they had fewer worries about the operation of equipment. The dentists and the distributors had immediate access to technicians and training materials. For DENTALEZ, this also meant that they were getting more feedback from their market, understanding the hurdles that needed to be leapt for both distributors and end-users. This was a paradigm shift for both manufacturer and customer, helping to boost value and visibility of DENTALEZ and its product line.
TALEZ is their use of social media. When dentists are at home more often, they have more time to learn from the information DENTALEZ is putting out and keeping relevant. Heather says “Respecting the distribution channel doesn’t mean you can’t simultaneously be in touch with the dentists directly.” Ultimately, what this meant was that dentists are better prepared, both during downtime and when they get back up to full operation. And they view DENTALEZ as a full partner in their practice. THE OVERALL VIEW All this progress came out of some basic but highly important vision components that Heather has brought to DENTALEZ. First, listen to the customer’s voice. That will tell you where you need to go. Then, align your internal team to those goals. This may require some culture change, but they will appreciate it when the results come in. Finally, keep an eye on the future. Eventually competitors will recognize your success and do their best to catch up. But you always have to be a step or two ahead of them. Heather says “We’re here to make it simpler and easier to practice dentistry. We want to help the dentist focus on the patient and the outcome, not the equipment. That’s our job. Even though we sell through service organizations, we are creating value for all the players.” •
COMMENT
Attendant to the new face of DENHS&M SEPTEMBER/OCTOBER 2020 | 12
ROUNDTABLE
HOW REGULATORY CAN BEST WORK WITH SALES & MARKETING: Execs From Terumo, AbbVie, Endo and Helen of Troy Provide Their Wisdom Our panel of experts: RAJESH S. KASBEKAR
ANDREW STOREY
Global Vice President, Regulatory & Clinical Affairs Helen of Troy, Health & Home Inc.
Head, Regulatory Affairs, Western Europe and Canada AbbVie
ROBERT K. LALLY
HARRIS ROTMAN
Global Vice President, Regulatory Affairs Terumo Aortic
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Vice President, Regulatory Affairs Endo Pharmaceuticals
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ROUNDTABLE In your experience, how does regulatory affairs best work with marketing and sales? Can you give an example of a partnership that had a strong result?
There is an unfortunate concept that sales and marketing are in contention with regulatory in healthcare companies. That may be true at some, where there is grumbling about the restrictions regulatory feels it has to place on what sales and marketing are allowed to do. But, as our panelists demonstrate in this article, at any given company we are all on the same page. We are working toward the same goal of achieving the best financial results…without stepping over lines that could get everyone in trouble. That’s why the best strategy is to start with a cooperative attitude: set some marks that everyone wants to meet, discuss the paths to get there, and be prepared for some give and take to allow for the most efficient results. Read on for more detailed advice from our panel of experts.
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ANDREW STOREY: It is critical that regulatory affairs understand the commercial business and also helps commercial partners understand the regulatory environment and challenges and opportunities. Only through mutual understanding can true synergy be achieved. There needs to be strong alignment early in the development process on what the key drivers for an asset will be and what the strategy is to achieve them. An example of this is gaining crystal clear alignment on what the commercial priorities are for a new label, and then aligning on the strategies. HARRIS ROTMAN: Regulatory always works best with marketing and sales when open communication and trust are generated between the groups. Sales/marketing have to reveal their desires and intentions and regulatory has to resist the urge to just say “no” and always pick the most conservative path (instead, when regulatory tries to find compliant, alternate pathways when challenges occur, great results can present themselves). We recently partnered with commercial in designing the packaging on cartons and containers for one of our newer products. Regulatory kept an open mind on the designs commercial wanted to use and commercial worked with regulatory to modify artwork when we continually received
CREATING STRATEGY WHAT RATING IS BASED ON GLOBAL APPROVAL SYSTEMS HIGH/LOW RISK PRODUCTS
feedback from FDA. At the end of the day, it was successful and both groups took ownership of the final product. RAJESH KASBEKAR: For regulatory affairs and marketing/sales to work best, three key items must be well managed: a good understanding of the business and product strategy, the organizational culture and effective use of risk management. First, a good understanding of business and product strategy is key in ensuring that regulatory and marketing are willing to make departmental tradeoffs in favor of higher goals. It is very important to understand what your source of competitive advantage is: major product innovation at a higher price point, or a me-too product at a lower price point with speed to market. In the consumer mar-
ketplace, there is also “consumer perception� based on the packaging and industrial design of the product. Both regulatory and marketing must take ownership for the success of the product and not for their specific disciplines or departments. The silos then disappear and the teams resolve their constraints to work as one. Second, in terms of organizational culture, aspects such as commitment to regulatory and safety, accountability, all styles produce results, be here now, and a forgiving risk-taking mindset are simple concepts but play a huge role in amplifying productivity within the organization. Third, effective use of risk management tools can hugely facilitate decision making. The regulatory and marketing constraints need to be managed using an effective risk-
management tool for deliberate, carefully considered decisions to get a successful product to market. ROBERT LALLY: Regulatory affairs is an integral part of corporate strategy from product inception through to obsoletion. With marketing it is essential for RA to be fully aware of what the intended indications are for the proposed devices, how that fits with the market place (and with potential predicates/competitors) and into which geographies it is intended. In a previous employment my RA team were engaged with a new device from the get-go, realized it would be an incremental product for US but a breakthrough opportunity for Japan, we liaised with the Japan regulator from inception, addressed all their test requirements (essentially variants on US testing) kept them informed of develop-
HS&M SEPTEMBER/OCTOBER 2020 | 16
ROUNDTABLE ments – net result was shaving at least 2 and probably 3 years off the Japan launch timelines. With sales, RA needs to keep ahead of promotional materials, physician (and sales team) training on products, keep aware of clinical evolution and feedback as seen by the hands-on sales teams. As regulatory requirements change over time these become a burden on the manufacturer but also present an opportunity to communicate the enhancement of the devices to the user groups. In a previous employment we initiated product management teams with RA, QA, R&D, Clinical, Sales and Marketing and became aware of growing off-label use of a long- established device for an indication that had become critical for the physicians and that other comparative devices were not best suited for. Following bench testing and evaluation of the physician clinical papers on this off-label use, we secured full regulatory approval and were thus able to further, almost exclusively, promote the device for that specific indication. How does regulatory impact the commercial side of the business? Can you give an example of a regulatory strategy and how it contributed to revenue? ROTMAN: When R&D and commercial functions communicate well and truly listen to one another, the business always benefits. I think it is dangerous for regulatory groups to be siloed from the rest of the organization. When I worked for very large organizations that had hundreds of regulators, the regulatory strategists were rated on
drug approvals and not necessarily on how well the eventual labeling could be used in promotion as a different regulatory group handled those aspects. I believe regulatory should partner with commercial and clinical groups to plan at the very beginning of a development program the types of studies that will be needed to create the best labeling and promotional claims by the time drug approval occurs. If regulatory can be honest as to promotional prospects early on with the commercial groups, clinical programs can be coursecorrected or key FDA meetings can be planned to drive consensus with the agency well in advance of a product launch. LALLY: A typical example is where a new device is being developed. Long term, the device will have an extensive indication supported by extensive clinical data and bench testing data and be marketed across global geographies. For a breakthrough device many countries have a very slow regulatory approval system (China) whereas others (EU, USA and Japan) have established expeditious pathways where the device has strong potential to improve patient outcomes. It is the role of RA to explore the optimal pathways for the device, work at a corporate level to secure strong relationships with those regulatory agencies and with local key opinion leaders to present the best case for approvals. KASBEKAR: The regulatory function is more like the defensive specialist in a football game. There are numerous studies showing that football games are won more because of defense than offense. In
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human physiology, there are cells that regulate cell function and play a key role in wound healing. In financial portfolio management, it is well known that portfolio return is optimized through risk management-based regulatory function than getting a great return. A regulatory strategy can contribute to revenue, but also depends on operational effectiveness based on the risk profile of the products as well as organizational strengths. Regulatory strategy in an organization with complex high risk products or innovative products may focus more on creating barrier to entry, while strategy in an organization with lower risk products may focus on process agility and speed to market in order to create the competitive advantage. Regulatory strategy in startup organizations with no brand recognition may focus on product innovation and aggressive regulatory paths to market, while the strategy in organizations with a strong brand name may focus more on a conservative regulatory pathway and culture. Regulatory strategy contributing to revenue is based on the least burdensome pathway for new or expanded intended use or indications. Viagra became a blockbuster drug after the indications for use for the drug were expanded to include inducing erections in addition to the original indication of treating chest pain or high blood pressure. Another example is use of a minimalistic regulatory strategy by making cosmetic changes in the product for additional incremental revenue. Both have been effective used for major revenue generation.
What impact has the Covid-19 pandemic had on regulatory and how you work with marketing and sales? LALLY: My RA teams are primarily based in UK and USA though we strongly rely on our corporate RA colleagues around the world for their local submissions and liaison with local regulators. All have been impacted by Covid-19 to some extent. We have a strong corporate value of “It is not about I can’t do it because… our world is about I can do it if…” Most of the RA teams have adopted a work from home approach which has really challenged many in how we modify our home environment to encompass work related equipment, processes and appropriate disciplines even when their children and other family members are also ostensibly home-based. Their work also requires extensive interaction with the R&D, clinical, quality and sales and marketing teams which 10 years ago may not have been achievable, but with today’s technologies we have been able to adapt to a new way of interacting and I am proud to say my RA teams are achieving minimal disruption to the business RA plans. By primarily working from home the teams are also minimizing the congestion in the facility space thus enabling social distancing of those whose roles require them to be at the facility. KASBEKAR: Covid-19 has had a major impact on product development cycles. It has extended product release life cycles for some products and reduced it for others. For example, it has hugely affected clinical recruitment, creating
tremendous uncertainty in terms of product life cycle. It has affected manufacturing due to social distancing and use of PPE. It has reorganized resource utilization at regulatory agencies, who are now more focused on Covid-related products, resulting in increased premarket approval times for nonCovid products. On the other hand, it has also created opportunity for specific medical devices classified as personal protective equipment, by eliminating regulatory requirements altogether. For example, regulatory requirements for devices such as masks, ventilators and thermometers have been considerably curtailed. All these have impacted regulatory and have resulted in conversations with marketing to take a fresh look at product and business strategy. It has resulted in changes in inventory management such as increased inventories, opportunistic Covidrelated product focus, and creative ways of conducting clinicals, to name a few. STOREY: While the business has been able to be fully sustained, unfortunately, many health authorities have had to divert resources to Covid-19 therapies and vaccines, which has led to delays in reviews of some products. These delays need to be mitigated as best as possible and clearly communicated to commercial partners to ensure plans to get the products to patients in need are adjusted and optimized. ROTMAN: Covid-19 has had a dramatic impact on our entire company, including modifying how regulatory works with mar-
keting and sales. As sales representatives were unable to meet live with doctors and their staff, we had to work together to come up with virtual ways for sales calls to occur. The challenge, of course, is that the regulations governing advertising and promotion did not change during this pandemic. We also had to determine how our sales, marketing, and medical staff would engage in discussions with healthcare providers during virtual congresses that took the place of live venues. By partnering with sales and marketing (and our compliance and legal groups) we provided guidance on how regulatorily-compliant sales detailing could occur using virtual meeting tools. It has been a challenge, but we have been very successful so far and have now used these new ways to successfully interact with healthcare providers. What “disconnects” have you seen between regulatory and marketing and/or sales? What strategies have you used to overcome them? STOREY: In the past, disconnects happened when commercial was not consulted early enough. When commercial would come to the table with requests late in the game, it was hard to deliver. Building an agile governance structure is key to ensuring effective communication and alignment. ROTMAN: Trust has to be built between the groups and if it is lost, it is hard to regain. Regulatory has to trust that marketing and sales will be thorough about their intentions and reasons for doing things. The commercial groups have to trust that regulatory will really
HS&M SEPTEMBER/OCTOBER 2020 | 18
ROUNDTABLE hear them and truly try to find solutions to challenging issues. One strategy I use often is to start off all conversations by first stating what I think the other group wants and also stating what I think they are afraid of and what my biases might be. I think many people appreciate this approach; it initiates conversations off in a good way (much better than arguing the regulatory position right off the bat).
and releasing safe and effective products or product changes. Sales and marketing requirements include customer obsession based on product aesthetics, timely delivery, product quality and customer service. Coupled with these two departmental constraints is the program management function or department that has requirements related to deliverables, budget, time and cost.
LALLY: In my current employment the organization is effectively designed to avoid disconnects and all functions operate as a single team. In some older previous employments I have seen RA viewed as the Sales Prevention department and the department of unavoidable overhead – areas where RA presented problems were not involved directly with the business, were not engaged early on in product development, but these were all readily addressed through effective communication, working together in sharing the issues and RA focusing on solutions rather than problems. Adopting a product management strategy has been an effective method for pulling all different perspectives into a common view of what is best for the business and provided cross functional integration.
The strategies I have used or have seen being used effectively are enhanced communication to clearly define the product strategy and how it fits with the business strategy, and then finding creative ways to find tradeoffs to these regulatory and marketing constraints using risk management principles.
KASBEKAR: The major disconnects I have seen between regulatory and marketing have been when the leaders of these functions do not clearly understand the other function’s requirements. The regulatory requirements include following state-of-the-art standards and regulations, producing good quality documentation,
In your experience, how effective have post-market surveillance communications been to marketing and sales? ROTMAN: Very effective. We maintain active lines of communication with our marketing and sales business partners and as we receive FDA or pharmacovigilance safety/labeling changes we work with all teams in the company to implement them. It’s not about commercial groups influencing safety outcomes, which would never happen, but it is about partnering in an efficient way to determine how promotional materials may need to be updated as we learn more about our products in the post- marketing environment. LALLY: By issuing mandates to address an issue – totally ineffective. By working closely with your colleagues in sales and marketing, understanding what they do and
19 | HS&M SEPTEMBER/OCTOBER 2020
what needs to be done and collaborating on creating the optimal communication – highly effective. RA is typically an engineering/ legal/clinical language, whereas sales and marketing are clinician/ commercial languages – the same words can mean different things to the various recipients. One key to these communications is, even if they have a negative message, find the positive aspect without losing the key message. KASBEKAR: Post-marketing surveillance and its associated communications play a huge role in not only managing liability but also improving future product development. These communications can be done through formal channels such as management review, supplier review or informal channels at the core team level. New regulations now require more enhanced post-market surveillance, as well as having a wellfunctioning post-market surveillance program. Well-structured communication is critical to the survival and thriving of an organization. An awareness of these post-market communications by the sales and marketing function can also result in better customer relationships and conduct of regulatory audits in a more effective manner. It also leads to a better understanding of the organization’s product standing in the competitive landscape. Not having an effective post-market communication process (especially with involvement of sales and marketing) can lead to decreased market share and more waste through more expensive correc-
Moving Forward MUTUAL UNDERSTANDING AND SYNERGY
FIND OPTIMAL APPROVAL PATHWAYS BARRIER TO ENTRY, PROCESS AGILITY, SPEED TO MARKET
BEST LABELING AND PROMOTIONAL CLAIMS
tions or removals in the field. For organizations with major brand presence, it could even be harmful to their reputation. STOREY: It is very important to ensure that all post-market information is shared expeditiously with the commercial team to ensure that they have the most up to date information and are able to answer questions posed to them effectively. How have you measured regulatory success in your company beyond approvals? STOREY: Beyond getting an approval, other metrics that are key are the time to approval, the degree to which the approved label contains the information deemed key by the company, and the
health of the partnership with external stakeholders such as health authorities, to name a few. Being a strong partner with internal stakeholders is key in achieving all of these. ROTMAN: Maintaining excellent relations with FDA and health authorities around the world is a primary goal. Ensuring that we help our company navigate through regulatory challenges compliantly and creatively is also something we strive for. When the company constantly comes to the regulatory affairs department for help and advice and wants feedback from its members, it feels like the department is truly providing value. LALLY: Yes, RA is about securing approvals – and maintaining
them as necessary. But it is about developing the RA team members to think about the business, about their colleagues and how we communicate to the cross-functional teams what is required now and what will be required for the future. How best do we predict the future, by influencing and shaping it? We do this by communicating with all involved in our business both internally and in external media – trade associations, industry groups, clinician groups and regulatory authorities. KASBEKAR: Regulatory has a key role to play in the success of the organization as their defensive coordinator. The regulatory function has different roles to play beyond premarket approvals. This is best characterized in terms of certain
HS&M SEPTEMBER/OCTOBER 2020 | 20
ROUNDTABLE key metrics that should be defined in every organization. These key metrics should be connected to the objectives, goals, strategies and measures at the tactical level. Some examples of these metrics include the maturity of the quality management system, the pre-market development, and the post-market surveillance system, as well as the clinical validation process. These are some of the metrics one can use to measure success. Can you relate any incidents in which coordination between marketing/sales and regulatory were well-handled? Can you give an example of the result? ROTMAN: Recently we received approval for one of our products and regulatory and marketing/ sales coordinated on a daily basis months before the PDUFA date. By maintaining constant lines of communication we could “preapprove� promotional pieces and place them in a holding pattern as regulatory proceeded with labeling discussions with FDA. The regulatory strategists in my group would update the regulatory advertising/ promotion review staff as the draft package insert was modified in real time. In this way, Important Safety Information for fair balance and other launch promotional pieces could be developed in advance of the approval date and modified as needed as the FDA review proceeded. By the time we received our approval, much of the review and preparation work had been completed by sales, marketing, and the copy clearance review-
ers (regulatory, medical, and legal) and the meetings that occurred to finalize the promotional pieces were not as burdensome as they would have been without the constant touchpoints we had. And we did this during Covid-19 when we were all working remotely. STOREY: Given strong partnerships, communication and structured processes for gaining alignment, it is possible to manage issues effectively. When something unexpected comes up, such as an unexpected clinical trial outcome or a new safety signal, we can use the foundation of partnership to work through these issues in an agile and effective manner. KASBEKAR: An understanding of the product and business strategy, organizational culture that is committed to safety and regulatory, awareness of the cost of quality, as well as application of risk management techniques are the hallmarks of good coordination between marketing/sales and regulatory functions. In organizations and
21 | HS&M SEPTEMBER/OCTOBER 2020
companies that had these skill sets, I have seen several incidents where this coordination is well handled. A specific example that comes to mind is a product that became a huge global success for us. A clear product vision, an early collaboration between marketing and regulatory counterparts from each region of the world, and effective risk management were evident clearly in the complete life cycle of the product development process at every stage. •
PANELISTS RAJESH S. KASBEKAR Global Vice President, Regulatory & Clinical Affairs Helen of Troy, Health & Home Inc.
RKasbekar@helenoftroy.com Rajesh has been Global VP for Kaz and HELEN OF TROY, HEALTH & HOME for 11 years. He is responsible for product safety, regulatory, product liability, sustainability, and quality system activities around the globe, including the US, EU, Canada, and the Asia Pacific. Previously, he was a Regulatory Manager for Hologic, Inc. and RA/QA Leader for GE. He has also published several peer-reviewed articles and white papers, and has patents pending.
ROBERT K. LALLY Global Vice President, Regulatory Affairs Terumo Aortic
r.lally@terumoaortic.com Rob holds MBA, BSc, C.Eng, and MIMechE degrees. He comes from a mechanical engineering background in petrochemical and risk management industries. Rob has spent the last 30 years in medical device quality and regulatory affairs. He established the first Notified Body in Europe for the Medical Devices Directive, and then led regulatory departments for a number of device industry leaders worldwide. Based in USA since 2004, Rob has extensive experience with regulators in USA, EU, Japan, China, India and Latin America.
TERUMO AORTIC is 100% focused on the aorta, offering a wide range of grafts to address each patient’s unique anatomy.
ANDREW STOREY Head, Regulatory Affairs, Western Europe and Canada AbbVie
andrew.storey@abbvie.com Andrew has been Vice President, Global Regulatory Strategy and Vice President/Head, Regulatory Affairs, US/Canada for AbbVie. Prior to that, he was Head, Regulatory Affairs in the US and Canada for Abbott, and held numerous roles at Cangene Corporation, including Sr. VP, Quality and Regulatory Affairs.
ABBVIE targets specific difficult-to-cure diseases where they can leverage their core R&D expertise to advance science. Their 47,000 employees are scientists, researchers, communicators, manufacturing specialists and regulatory experts located around the globe. They address everything from life-threatening illness to chronic conditions.
HARRIS ROTMAN Vice President, Regulatory Affairs Endo Pharmaceuticals Inc.
rotman.harris@endo.com Harris was previously VP in Global Regulatory Affairs for both Indivior and Shire. At Sanofi Aventis, he served as Associate Director, Regulatory Development. Before that, he was Regulatory Coordinator for Wyeth Pharmaceuticals.
ENDO PHARMACEUTICALS INC., an Endo company, develops and markets high-value, quality branded pharmaceutical products for patients in need. Endo Pharmaceuticals’ specialty portfolio includes products for urology, men’s health, orthopedics and endocrinology.
COMMENT
HS&M SEPTEMBER/OCTOBER 2020 | 22
PHARMACEUTICAL
CLICK HERE TO GET TOP 50 PHARMA COMPANIES
PHARMA COMPANIES TOP 50 PHARMACEUTICAL COMPANIES The top 50 pharma companies continue to show strength, with global drug sales still on the rise. In 2019, the industry saw a $100B increase to a record $1.2T. 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 5% growth rate with a majority (41) of the top companies experiencing an increase in revenue. Pfizer remained in the number one spot, while Roche moved up to take the number two spot over Novartis. Takeda jumped into the top 10 with the acquisition of Shire, pushing Eli Lilly further down. Although the pandemic continues to be an area of great concern, there is good news on the horizon. Moderna, Pfizer, Novavax, AstraZeneca, J&J and many others are
in trials that are showing promise, and there is an expectation that by spring or summer of 2021 we will have a vaccine ready to deliver. Companies are ranked by their 2019 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
23 | HS&M SEPTEMBER/OCTOBER 2020
to create an equal playing field. We also revised 2018 earnings to align “apples to apples” revenue reporting with 2019 figures. Some companies were removed from the list because of mergers and acquisitions. Celene was purchased by Bristol Myers Squibb and Shire was purchased by Takeda. Here’s a snapshot of where the Top 50 (based on 2019 revenue) were at year’s end. We have tracked movement with regard to both ranking and revenue changes as compared with 2018.
PARTICIPATE AND GET THE FULL RESULTS!
HOW ARE YOU DOING $ALARY-WISE? We know this is a question most people ask themselves all the time, and we’re happy to provide you an answer by participating in our 2020 Compensation and Hiring Survey. PARTICIPATE IN OUR 2020 COMPENSATION AND HIRING SURVEY HERE We are pleased to open our yearly survey where we poll key people in the medical device, pharmaceutical, and biotech sectors of the industry to determine compensation trends. The survey is completed in conjunction with Jacobs Management Group, Inc., a leader in executive search for the healthcare industry and all participants receive a survey summary so that you can see how you compare. Please click here to be taken directly to the five-minute survey. The 2020 Compensation and Hiring Survey builds on the feedback from 2019 Survey, highlights of which were published in the MAY/JUNE 2019 ISSUE issue of
HS&M. Companies ranged in size from over $100B to over $10M, and over 80% of the respondents had titles of manager or above. “We continue to receive accolades for this targeted industry report” says Jacobs Management Group, Inc. President, Cari Kraft. “Our results have become one of the key inputs into compensation benchmarks.” All specific survey information and your contact information will be held in strictest confidence. We will email you with the results as soon as they are published.
COMPANY SIZE
For assistance building your team, please reach out to Cari Kraft ckraft@jacobsmgt.com or call Cari at (215) 383-3001.
PHARMA COMPANIES
Companies are ranked by their 2019 revenue as furnished by their annual reports and publicly available sources such as Edgar and Morningstar stock information websites. Figures of non-U.S. companies were converted to U.S. dollars from various currencies.
RANKING COMPANY LOCATION
2019 CHANGE REVENUE IN US$B
1
New York, NY, USA
$51.80
PFIZER
2
ROCHE
Basel, Switzerland
$50.15
3
NOVARTIS
Basel, Switzerland
$47.46
4
MERCK
Kenilworth, NJ, USA
$46.80
5
JOHNSON & JOHNSON
New Brunswick, NJ, USA
$42.20
6
GLAXOSMITHKLINE
Brentford, United Kingdom
$40.81
7
SANOFI
Paris, France
$40.51
North Chicago, IL, USA
$32.75
8
ABBVIE
9
TAKEDA
Osaka, Japan
$30.28
10
MEDIPAL HOLDINGS
Tokyo, Japan
$28.70
11
BRISTOL-MYERS SQUIBB
New York, NY, USA
$26.15
12
ASTRAZENECA
Cambridge, United Kingdom
$24.38
13
Tokyo, Japan
$24.29
14
AMGEN
Thousand Oaks, CA, USA
$23.36
GILEAD SCIENCES
Foster City, CA, USA
$22.45
15
ALFRESA HOLDINGS
16
ELI LILLY
Indianapolis, IN, USA
$22.32
17
BOEHRINGER INGELHEIM
Ingelheim am Rhein, Germany
$21.30
18
BAYER
Leverkusen, Germany
$20.14
19
NOVO NORDISK
Bagsværd, Denmark
$18.31
20
MERCK KGAA
Darmstadt, Germany
$18.11
TEVA PHARMACEUTICALS
Petach Tikva, Israel
$16.89
22 NEW ALLERGAN
Dublin, Ireland
$16.10
23
BIOGEN
Cambridge, MA, USA
$14.38
24
ASTELLAS
Tokyo, Japan
$11.97
Tokyo, Japan
$11.54
21
25 NEW
MEIJI HOLDINGS
25 | HS&M SEPTEMBER/OCTOBER 2020
CLICK HERE TO GET TOP 50 PHARMA COMPANIES
PHARMA COMPANIES
RANKING COMPANY LOCATION
2019 CHANGE REVENUE IN US$B
26
MYLAN
Canonsburg, PA USA
$11.50
27
RECKITT BENCKISER
Slough, United Kingdom
$10.35
28
DAIICHI SANKYO
Tokyo, Japan
$9.03
29
BAUSCH HEALTH
Laval, Quebec, Canada
$8.60
30
OTSUKA
Tokyo, Japan
$8.50
31
CSL BEHRING
King of Prussia, PA, USA
$8.50
32
REGENERON PHARMACEUTICALS Tarrytown, NY, USA
33
TEIJIN
Osaka, Japan
$7.85
34
Bad Homburg, Germany
$7.76
35
EISAI
Tokyo, Japan
$6.40
36
Tokyo, Japan
$6.31
37
ZOETIS
Parsippany, NJ, USA
$6.26
38
GRIFOLS
Barcelona, Spain
$5.72
39
UCB
Brussels, Belgium
$5.51
40
PERRIGO
Dublin, Ireland
$5.42
41
SERVIER
Neuill-sur-Seine, France
$5.17
42
ALEXION
New Haven, CT, USA
$4.99
43
ABBOTT
Chicago, IL, USA
$4.49
44
SUN PHARMACEUTICAL
Mumbai, India
$4.32
YUNNAN BAIYAO GROUP
Kunming, China
$4.27
Florence, Italy
$4.25
45 NEW
FRESENIUS KABI
CHUGAI PHARMACEUTICAL
46 NEW MENARINI 47
$7.86
SUMITOMO DAINIPPON PHARMA Osaka, Japan
$4.23
48 NEW
VERTEX PHARMA
Boston, USA
$4.16
49
MITSUBISHI TANABE PHARMA
Osaka, Japan
$3.49
SINO BIOPHARMA
Hong Kong, China
$3.48
50 NEW
HS&M SEPTEMBER/OCTOBER 2020 | 26
INDUSTRY
Pharma, Biotech and Medtech Half-Year Review 2020 This is condensed from the Evaluate Vantage Pharma, Biotech and Medtech Half-Year Review 2020. The coronavirus pandemic has been the driving force shaping the biopharma and medtech sectors over the first half of 2020. And, while much of the fallout has been predictable, certain events and trends have surprised.
27 | HS&M SEPTEMBER/OCTOBER 2020
INDUSTRY The speed of the recovery, for one, at least on the financial markets. Stock markets crashed as the scale of the Covid-19 outbreak became clear, but the selloff lasted a mere month. By the end of March investors had apparently come to terms with the situation, and by the half-year point most global indices were well on their way to a full recovery, led by healthcare stocks. Incredibly, by April the Nasdaq Biotechnology Index was already setting new highs, as investors rushed to back the sector that promised to deliver vaccines and treatments for Covid-19. Gilead has already won emergency approvals for its antiviral remdesivir, and many more projects are in development. This report summarizes biopharma’s efforts so far, pinpointing the most advanced vaccines and therapeutic approaches that will hopefully follow remdesivir to market. Covid-19 diagnostics, too, have been rushed to market, with industry leaders such as Abbott and Roche being rewarded for their efforts. Tests for the virus will be instrumental in developing vaccines and therapies, binding the fates of
drug and diagnostics developers together. Surging stock markets have kept the IPO window wide open in the US, for example, with biotechs and device makers alike raising decent sums. Another major surprise is how the venture sector has seemingly shrugged off the pandemic. Start-ups in the drug development world were handed a huge $9.7B in the first half of the year, putting 2020 on track to set records. In the medtech arena, too, venture cash has been surprisingly plentiful as investors move to ensure that portfolios are protected against the rough times that might be on the way should the pandemic cause a recession. The biggest dent in activity has been seen in M&A, where restrictions on global travel deterred executives from taking on larger transactions. Smaller deals are happening, but the biggest takeover the pharma world mustered was Gilead’s $4.9B move on Forty Seven. In medtech the effect was even more pronounced, with only two megamergers being signed and device companies across the board having unprecedented difficulty in closing deals.
Figure 1
29 | HS&M SEPTEMBER/OCTOBER 2020
Covid-19: Biopharma’s response Before considering Covid-19’s knock-on effect on business development and general investor sentiment, investors will be aware of one much more obvious way in which the coronavirus pandemic has shaped biopharma: the industry is working on ways to treat or prevent the virus, and the markets have rewarded companies working on such approaches.
The first half of 2020 has marked out the battleground into three broad groupings: vaccines as a primary means of defense; antivirals and other approaches designed to reduce the effects of the virus; and antibodies whose ultimate aim is to cure a patient of an infection. Within each area early leaders have emerged, at least in investors’ eyes. Moderna and Biontech/ Pfizer are seen leading the charge of anti-Covid-19 vaccines, though it is Novavax that has secured the most US government funding. In treatment it is Gilead that has won with an antiviral, while antibody development leaders include Lilly and Regeneron.
Figure 2
The US government’s willingness to put money behind work against Covid-19, showering several vaccine developers with cash in an effort called Project Warp Speed, should not be underestimated. Technically this is a partnership between the US Department of Health and Human Services, the FDA, the NIH, Barda and the Department of Defense, but it basically allocates taxpayer dollars. The US said in May that 14 “promising” vaccine candidates had been chosen for this project from over 100 in development at the time. These undisclosed 14 are being narrowed down to “about seven,” it revealed, representing the most promising candidates from a range
of technology options.
THE HUNT FOR A VACCINE
So far four vaccine makers’ names have been revealed on account of them qualifying for cash awards, which in two cases have exceeded $1B. There is also one non-vaccine beneficiary of Project Warp Speed: Regeneron, whose two-antibody “cocktail” treatment is now in a phase III study.
Five vaccines have generated clinical data so far, and the market seems to have declared the early skirmish a victory for Pfizer/Biontech’s BNT162. This is deemed to have jumped ahead of AstraZeneca and Moderna, while firmly in the must-try-harder camp are the laggards Cansino and Inovio.
The biggest beneficiary so far has been the biotech Novavax, whose status as the best-performing stock of 2020 was confirmed when it was singled out for a $1.6B award in early July. This trumped the $1.2B handed out to AstraZeneca/ Oxford University. two months earlier. (Figure 1)
Vaccine data are pretty meaningless without disclosure of their ability to elicit neutralizing antibodies – at least up to a target level, with the general rule that the higher the better. Neutralizing antibodies are those that are capable not only of binding to virus but also interfering with its ability to infect a cell.
HS&M SEPTEMBER/OCTOBER 2020 | 30
INDUSTRY
Figure 3
Figure 4
31 | HS&M SEPTEMBER/OCTOBER 2020
Equally important is a vaccine’s ability to elicit a CD8+ T-cell response, as it has been hypothesized that to prevent severe Covid-19 infection and generate a long-lasting effect it might be necessary for a vaccine to stimulate cellular as well as humoural (antibody-based) immunity. It is not yet clear what levels of neutralizing antibodies or indeed CD8+ T cells might give protection from the virus, but nevertheless these are becoming important benchmarks in ranking rival vaccine approaches. Safety is also key, given that a Covid-19 vaccine would be expected to be given to a broad patient population, and that some of the most vulnerable patients might also be the least able to tolerate toxicity. Investors should look for an absence of inflammatory symptoms, for instance. (Figure 2)
TREATING THE SYMPTOMS In the Covid-19 treatment arena Gilead’s remdesivir remains the hottest near-term hope. The antiviral has already been approved by the US FDA under emergency use measures, notwithstanding its suboptimal profile and largely unproven efficacy, as evidenced by the numerous perverse clinical datasets it has generated.
A major development occurred on June 19 when Gilead priced the drug – at $2,340 for a five-day course. Gilead investors were thus kept on side, though the US watchdog Icer deemed that the price chosen was only cost effective if remdesivir had a survival benefit – which it has so far failed to show. Little wonder that Gilead moved quickly to claim that remdesivir does indeed show a mortality benefit, on July 10 presenting an analysis comparing the antiviral’s
outcomes data versus what it called a real-world cohort of Covid-19 patients receiving standard of care. Still, a threat is emerging in the shape of dexamethasone, a cheaply available steroid that has managed to demonstrate a survival benefit, according to an NEJM paper on part of the prospective, 15,000-patient, multi-agent Recovery trial run at the UK’s Oxford University. For its part remdesivir has, so far, demonstrated only a marginal benefit. Findings from Gilead’s latest study, in moderately ill patients, suggest that the antiviral has some activity, but that overall it is not a game changer. Clearly no in-depth analysis is possible until the data are published in a peer-reviewed publication. (Figures 3 & 4) THE ANTIBODY APPROACH As potentially the most effective way of treating a person infected
Figure 5
HS&M SEPTEMBER/OCTOBER 2020 | 32
INDUSTRY Figure 6
with Covid-19, antibodies designed specifically to target the virus’s structure are a key area of focus for several companies. Perhaps because of the relatively long timelines and high risk involved, several have wasted no time to start clinical trials.
Regeneron’s two-MAb cocktail, for instance, is entering a phase III prevention trial in 2,000 asymptomatics. This is the Warp Speedfunded project, which is also in phase I studies in hospitalized and ambulatory subjects. The study in
asymptomatics is important because of its potential to make a real difference to healthcare workers and people with close exposure to a Covid-19 patient. Also prominent are two separate Lilly assets, one partnered with Abcellera and the other with Junshi. The former, coded LY-CoV555, is in phase II in 400 mild to moderate Covid-19 patients, comparing it against placebo in a double-blind fashion, with change in day-11 Covid-19 viral load as primary endpoint.
Figure 7
33 | HS&M SEPTEMBER/OCTOBER 2020
The separate Lilly/Junshi project, JS016, which binds a different epitope on the virus’s spike protein, has completed enrolment into a healthy volunteer trial. The spike protein-targeting approach is similar to that of several of Lilly’s competitors. The protein is present on the virus surface, and the virus uses it to dock with the Ace2 receptor on target cells, allowing it to be internalized and infect. The next project into the clinic with this mechanism could come from Vir’s partnership with
Figure 8
GlaxoSmithKline, which has so far identified two lead MAbs. Also keenly awaited is a project under way at AstraZeneca; the hope is that these antibodies can prevent the virus docking, or hit another part of it that leads to antibodymediated destruction. The last two are noteworthy because they are based in part on plasma derived from patients who have recovered from Covid-19 infection. While many companies are making claims about the superiority of their respective approaches, these are of course all based on animal or in vitro data. No comparison will be possible until the first clinical trials read out – and this will not happen for some time yet. DIAGNOSTICS In the medtech sphere, too, Covid-19 had dramatic effects on companies’ fortunes at the half year point. Most obvious beneficiaries were the testing groups, many of whom rushed to develop Covid-19 molecular assays and, later, an-
tibody tests to identify those who may have developed some form of immunity to the virus.
Roche, the world’s largest diagnostics company by test sales, was one of the first off the mark developing a viral RNA test by mid-March. It was soon joined by other big groups such as Abbott, Thermo Fisher Scientific, LabCorp and Hologic. By July 21 over 100 molecular tests for the new coronavirus developed by commercial medtech companies had received individual authorization from the FDA. Despite the wide range of viral RNA tests available and the large production capacity – many companies have stated that they can perform hundreds of thousands of these tests per day – the demand has outstripped supply. With this in mind in mid-July the FDA allowed the pooling of samples, a technique by which nasal swab samples from up to four people are being mixed together before testing. (Figure 5)
Medtech half year review COVID-19 DIVIDES THE BIGGEST MEDTECHS No prizes for guessing the major factor impacting big-cap medtechs’ share price performance across the first half of 2020. Ventilator manufacturers and testing specialists are up and orthopaedics and cardiology groups are down as the pandemic forces hospitals to reorder their priorities.
Intriguingly, though, the top riser had little to do with Covid-19. Blood glucose sensor developer Dexcom was up 85%, buoyed by collaborations and regulatory approvals. The group was hit by the wider stock market downturn in March as the scale of the Covid-19 crisis became apparent, but recovered easily by the end of the month, showing what can be accomplished even in hard times by a group with in-demand technology.
HS&M SEPTEMBER/OCTOBER 2020 | 34
INDUSTRY Figure 9
Figure 10
A look at share price indices covering this sector shows just how catastrophic the first half of 2020 has been. Over the course of last year, these metrics showed growth of around 30%; now they paint a picture of
an industry struggling to find a path through the mire. (Figure 6) Dig deeper and it becomes clear that the pandemic has split the big-cap cohort neatly into winners and losers along subsector lines. Ventilator companies Fisher
35 | HS&M SEPTEMBER/OCTOBER 2020
& Paykel and Resmed were up, as were diagnostics groups, including Biomerieux, Bio-Rad, Sysmex and Hologic, all of which have Covid-19 tests approved in various territories. Fisher & Paykel also benefited from its New Zealand base and listing; the country has
Figure 11
HS&M SEPTEMBER/OCTOBER 2020 | 36
INDUSTRY done a superb job of first containing and then stamping out Covid-19, and the S&P NZX All Health Care index is up 17% so far this year. (Figure 7) The fallers are just as easily delineated. All lost out because their products are used in the kinds of elective procedures that hospitals
and other sites have had to shelve – mostly orthopaedic, cardiac and dental surgery. Hitachi, whose medical business centers on imaging, saw big losses as patients in need of scans stayed away. Orthopaedics companies Smith and Nephew and Zimmer Biomet were hit hard,
Figure 12
Figure 13
37 | HS&M SEPTEMBER/OCTOBER 2020
and Medtronic, active in both the cardiovascular and orthopaedics sectors, also suffered. Even robotic surgery market leader Intuitive Surgical, a perennial stock market darling, was down 4% at the halfyear point. Among the smaller device makers, too, the pandemic has made its
Figure 14
HS&M SEPTEMBER/OCTOBER 2020 | 38
INDUSTRY effects felt – but in a different way. Many of the risers have either their headquarters or their listings in the Far East, whereas the fallers are almost all US-based. The recovery from the virus in many of the earliest-hit countries, and its disquieting resurgence in the US, are major factors in determining these companies’ performance. (Figure 8) MEDICAL DEVICE MERGERS ON PAUSE Thanks to Thermo Fisher Scientific and Invitae, two groups brave enough to push ahead with multibillion-dollar acquisitions during a pandemic, the total value of medical device M&A announced in the first half of 2020 nudged over $16B – though this is still a distressingly low figure. The real shock, however, is not the value of the deals announced, but of those that have been closed.
The medtech deals completed in the first half of 2020 have a total value of less than $2B. This is despite mergers worth a total of more than $21B remaining open. The Covid-19 pandemic seems to have made it harder to hammer out the legal or financial complications of closing deals than it did to conduct the negotiations in the first place. (Figures 9 & 10) The average size of completed mergers is also lower than at any point in the past decade. The mean acquisition size was just $108M in the first six months of 2020; this figure has been erratic over the past 10 years, but shows an overall downturn since 2015. It is also interesting that the two big acquisitions announced in the first half of 2020 were both diagnostics deals. The unveiling of the $12.5B Thermo Fisher-Qiagen deal predates the WHO’s designation of Covid-19 as a pandemic, and thus
Figure 15
39 | HS&M SEPTEMBER/OCTOBER 2020
the deal has little to do with tests for the coronavirus itself – though Qiagen has subsequently developed and launched Covid-19 tests. (Figure 11) As for what the second half of this year might hold, the trends in business development will depend on whether new waves of infections and deaths occur, and their magnitude if they do. If major lockdown measures are eased, M&A activity ought to pick up, and orthopaedics companies might be a hotspot. Companies such as Zimmer Biomet and Smith & Nephew, which have suffered as less urgent surgical procedures have been delayed, might wish to diversify their offering by picking up companies developing emergency trauma products, or even technologies outside their traditional specialties, such as telemedicine or patient monitoring devices.
Figure 16
As for the very largest deals, a resurgence will depend not only on the risk of a major second wave having passed but also on economic factors such as the availability of cheap credit. If the second half of 2020 sees the same number of medtech megadeals announced as the first – two – the industry might be regarded as having got off lightly. (Figure 11) FDA KEEPS THE NEW DEVICES COMING As the FDA grapples with a oncein-a-generation crisis and tries to speed drugs, vaccines, devices
and diagnostics to market, the less pressing business of evaluating and approving non-Covid-19-related medical technologies has taken a back seat. Even so, the number of devices approved by the agency has not dipped as much as might have been feared.
In the first half of 2020 the FDA approved 16 high-risk and 11 lowrisk novel medical devices, putting it only slightly behind its performance last year. As importantly, the speed at which these products made it through the regulatory process has barely slowed. Still, last year saw a slowdown in the sec-
ond half, so medtechs must hope that the FDA is able to keep up the pace in the coming months. In vitro diagnostics make up the majority of products granted premarket approval by the FDA – the type of approval used for products intended to be used in supporting or sustaining human life or preventing impairment of health. Many of these high-risk diagnostics are for viral infections, including hepatitis B and C, HIV and human papillomavirus. Absent from this analysis is any diagnostic for Covid-19 infection or test for immune response. The FDA has
Figure 17
HS&M SEPTEMBER/OCTOBER 2020 | 40
INDUSTRY not granted approval or clearance for any such test – instead these are afforded regulatory oversight in the shape of emergency use authorization, a less rigorous stopgap measure for a time of crisis. It is reassuring that the FDA is still attending to its routine work even as it is under political pressure to rush Covid-19 diagnostics and therapeutic devices on to the US market. Ventilators, for example, are also eligible for emergency use authorization. Provided it can continue to do so during the second half of the year, this is one area in which 2020 could come to be regarded as almost normal.
Pharma and Biotech half year review BIOPHARMA SHARES SHAKE OFF THE PANDEMIC The pandemic was a fleeting affair as far as the stock market was concerned. Biopharma’s key role in fighting Covid-19 did not pre-
vent across-the-board declines in March – with a few notable exceptions – and then the second quarter witnessed an unmistakable return to health.
The revival mirrored broader stock market recoveries and Evaluate Vantage’s quarterly look at the sector’s share prices shows that drug developers of all sizes posted strong gains over the second quarter. In fact, at the half-year stage our universe of global stocks had grown in value over the end of 2019, which is remarkable considering that much of the world is still afflicted by the coronavirus outbreak. (Figure 12) This analysis concerns all listed drug makers covered by EvaluatePharma, from across the world – a cohort of 579 companies. Micro-caps, those with a market value of less than $250m at the start of the year, have been excluded, as have subsectors like medtech or diagnostics; only developers of therapeutics are included.
Figure 18
41 | HS&M SEPTEMBER/OCTOBER 2020
The combined market cap of this group is already greater than at the start of the year. This is real growth: those companies that have arrived via IPO so far in 2020 have not been added, to allow a like-forlike comparison over the year. The next charts, meanwhile, show that all cohorts other than big pharma more than recovered value lost in the first quarter. Among the big caps Merck & Co and Pfizer are feeling the heat, down 15% and 17% respectively at the half-year stage, largely on concerns about replacing existing franchises. (Figures 13 & 14) WHAT PANDEMIC? BIOTECH FLOATS BREAK RECORDS Given the depths of the panic that sent stock markets crashing in late February, the strength and speed of the recovery has been remarkable. And there are few places where this is more evident than biotech IPOs, the statistics around which show few signs of a global pandemic.
Of course, it could be argued that the arrival of Covid-19 spurred much of the demand seen recently for young drug developers; investors have been reminded of the sector’s worth, while chasing potential beneficiaries of the outbreak. Biotech was already on a run before the pandemic hit, however, so this is far from the only explanation for the record sums raised in the second quarter. (Figure 15) This view of the sector concerns only those companies developing human therapeutics – excluding medtech, diagnostics and digital health – so it provides a snapshot of the riskiest end of healthcare. Flotations on all Western exchanges are tracked. The pandemic did cause IPOs to pause for most of March, so to a certain extent the huge second quarter can be explained by companies that were to have gone out that month being pushed back. This result is also down to the huge amount of capital being made available to these firms. The average amount raised by an IPO in the first half came in at $193M, another record. It should be noted that Royalty Pharma’s $2.2B flotation is not included in the tally. (Figure 16)
Outlook With coronavirus capturing investors’ attention, and stock markets seemingly in good health, swathes of the biopharma sector are heading into the second half in a strong position. There are always clouds on the horizon, of course, the pandemic being the most ominous one right now.
For now, the worst projections of impact on the drug development
process have not come to pass. Some clinical trials were suspended and delayed, but most work has got back on track. Businesses are coming to terms with remote working, and while this certainly adds complications the world is adapting. Regulatory processes have, for now, also escaped lightly. Certain reviews have taken longer, but for now the volume of novel drug approvals makes for encouraging reading. The FDA gave a greenlight to 29 novel agents in the first half, in line with the run rate of the past couple of years. (Figure 17) With some very big decisions still to come in the second half of the year, the scope for delays and missed opportunity is real. (Figure 18) While Covid-19 has had a catastrophic impact on many medtechs in the early months of 2020,there are glimmers of hope. Johnson & Johnson and Abbott, for example, saw sharp drops in sales of their non-diagnostic medical devices in the second quarter of 2020 compared with Q2 2019 as elective procedures were deferred, with sales of surgical, orthopaedic and cardiovascular technologies being hit badly. But in both cases the fall was not as bad as had been feared, with signs of an earlier-than-expected recovery in May and June, raising hopes that other companies which had previously forecast big hits to their business will also be able to report good news. Over the longer term, when cases of the coronavirus finally begin to diminish, a new normal will likely be established. Patients will still be wary of hospitals, and volumes of elective procedures might take some time return to levels seen in
prior years. Demand for diagnostics for active Covid-19 infections should fall if vaccines become available, but these assays will become a routine part of triage when a patient presents with breathing difficulties or other Covid-19 symptoms. There will always be a need for antibody tests, too, as they become necessary for establishing whether a vaccine has elicited an immune response. Currently, though, the US is already in the grip of a second wave of infections. If a second wave of deaths manifests, if infection rates rise once more in Europe and Asia, the divide between the medtech industry’s haves and have-nots can only widen. Many of the badly affected groups have been keen to stress that the second quarter was always going to be the toughest period of 2020 and made it clear that they expect sales to increase in the second half. But economies are struggling, and with health insurance linked to employment in countries such as the US, device makers’ 2020 sales seem likely to remain below prior years. • To view the full report, go here.
COMMENT
HS&M SEPTEMBER/OCTOBER 2020 | 42
INDUSTRY TRENDS: BY THE NUMBERS Compiled by Cari Kraft, Jacobs Management Group, Inc.
258
Number of vaccines under development for many conditions. Industry organization PhRMA reports that 258 vaccines are in development in the US, including 108 for cancer, 125 for infectious diseases, 14 for allergies, and two for Alzheimer’s disease. Additionally, there are more than 70 for Covid-19 in the global research pipeline, including six now in human clinical trials. Source: PhRMA, Biopharmaceutical Companies are Researching and Developing Nearly 260 Vaccines, April 2020
15
Number of countries that ship 86% of all drugs Only 15 countries are producing and exporting 86.2% of all medicines, according to 2019 figures. Germany (14.5%), Switzerland (12.2%), The Netherlands (7.9%), Belgium (7.4%), France (6.8%) and Italy (6.3%) all lead the US, which exports 6.2%, valued at $24.3B. Fastest growing are Denmark, Netherlands, Italy and Switzerland. Source: World’s Top Experts, Drugs and Medicine Exports by Country, August, 2020
48
Number of novelty drugs approved by CDER in 2019 The Center for Drug Evaluation and Research (CDER), an FDA-regulated division that deals with drug approvals, approved a record number of novelty drugs in 2019. Novelty drugs are new molecular entities that have the potential to treat diseases with a new pharmacological mechanism. Twenty of these products are considered first-in-class drugs. Some of the new medicines treat conditions such as postpartum depression (brexanolone), or metastatic bladder cancer (erdafitinib). Source: FDA, New Drug Approvals 2019, January 2020 43 | HS&M SEPTEMBER/OCTOBER 2020
80%
Share of drug market held by branded medicines in US In the United States, approximately $511B was spent on medicines in 2019. Sales of brand name drugs account for 80 percent of the total, with around 20 percent spent on generic drugs. Sales of branded generics accounted for 8.8 percent and unbranded generics and 11.2 percent. Source: Statista, Proportion of branded versus generic prescription drug revenues in the United States from 2005 to 2019, August 2020
52%
of telehealth users report barriers Although telehealth services are increasingly being used, largely in response to the Covid-19 crisis, there are still problems with access. Overall customer satisfaction is 860 on a 1000-point scale, but 52% of users say that they experienced limited services (24%), confusing tech requirements (17%), and lack of awareness of cost (15%). In addition, 35% said they had a problem (such as audio issues) during a visit. Source: J.D. Power 2020 U.S. Telehealth Satisfaction Survey
22% Amount of total global pharma represented by emerging markets Emerging markets have grown steadily between 2014 and 2019, from 20% to 22% of worldwide sales. The US has also grown in that period, from 45% to 48%, while Europe has fallen from 22% to 19%, and other markets have decreased from 13% to 11%. Source: Statista, Distribution of the total global pharmaceutical market sales from 2014 to 2019, by submarket, April 2020
20%
Number of doctor visits that will be conducted by telehealth in 2020 Telehealth visits in the US will reach 20% of the total in 2020. The number of people reporting at least one telehealth visit has grown by 57%, and as much as 77% among people with chronic illnesses. The number of physicians listing telemedicine as a skill has increased 20% year-over-year since 2017. Source: Doximity, 2020 State of Telemedicine Report
COMMENT HS&M SEPTEMBER/OCTOBER 2020 | 44
TALENT TRENDS
Identifying, hiring, acknowledging and inspiring great talent in tough times What a complicated web of decisions the pandemic has visited upon us, not least of which are in the workplace. By Cari Kraft, Jacobs Management Group Most company executives now admit that, even when the coronavirus is brought under control, they will be facing a different dynamic in terms of workplace attendance. They are going to have to allow – even benefit from – employees working remotely, at least part of the time. Gartner, the world’s leading research and advisory firm, surveyed 127 HR, legal and compliance professionals, and found that 82% of company leaders are going to permit remote work part-time, and 47% will allow employees to work remotely full-time. Flex days and flex hours will also be part of the new norm. (Figure 1) Figure 1: Company leader intentions regarding flexible working after COVID-19
45 | HS&M SEPTEMBER/OCTOBER 2020
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TALENT TRENDS So what does this change for the companies employing these workers, and for the workers themselves? HR Executive reports that 61% of employees say they’re uncomfortable returning to work, based on a survey by Qualtrics of 2,000 American, British and Australian workers. So safety measures are a must: limiting face-to-face meetings, providing masks and hand sanitizers, limiting attendance at the office. Interestingly, employers do not express a lot of concern over productivity. But they do want to keep a company culture going. “It is critical that employers get their
corporate culture and employee experience right during this period of uncertainty,” said Brian Kropp, chief of research for the Gartner HR practice. “Both facets help ensure organizations achieve the financial, reputation and talent outcomes that will drive business outcomes and competitive advantage.” Another part of attracting and keeping a high-quality workforce is incentive, which is not based merely on compensation and perks. HR Executive found that recognition is very meaningful to most employees. This might be in the form of special acknowledgment, rewards for special efforts,
Figure 2
47 | HS&M SEPTEMBER/OCTOBER 2020
conferring “superstar” status or other ways of signaling their value to corporate goals. (Figure 2) NEW RULES ON HOW TO ATTRACT THE BEST In a recent Harvard Business Review report, it was noted that companies are concerned about how to bring in the best talent in this new atmosphere. Global search firms are benefiting from this focus, and have brought in significantly more business in the last year. One major change is that globalization is shifting, partly due to workers’ desire to tend to family priorities and worries about international travel.
How have industries handled huge changes in the past? In the late 1940s, Hewlett-Packard was undergoing financial difficulties. But instead of tightening their belt, as some companies did, Bill Hewlett and Dave Packard started bringing in top-level engineers recently out of the military. Their philosophy: “How could we afford not to?” Harvard Business School’s Ranjay Gulati, Nitin Nohria, and Franz Wohlgezogen analyzed 4,700 companies across the last three recessions. About 9% emerged better off because of their “progressive” focus. “Rather than thinking in ‘either/or’ terms — you’re either hiring or you’re downsizing — they, like HP following the war, embraced the ‘and,’ understanding they could do both things if they were smart about it.” Most companies, however, take the opposite approach. During the 2008 global financial crisis, a survey of 3,400 executives in more than 30 countries showed a tendency to cut back on recruiting. Nevertheless, it also showed “selective hiring of high-performing employees from competitors as one of the three most effective responses to the previous crisis and the one with the best impact on employee commitment.” HBR recommends asking company leaders and HR people to identify great talent they’ve interviewed in the past few years, and contacting them again. In this time of change, they may be available and interested. People with the right skill sets who didn’t want to relocate may now be open to a remote-work position. They also
point to the value of “soft skills, including inspirational leadership, change management, collaboration, and influencing, as well as the potential to keep growing, learning, and adapting to new circumstances.” Echoing the findings of HR Executive, HBR lists the menu of incentives that may give you leverage. “Pay can be important but research shows that what truly motivates knowledge workers is a high level of autonomy, mastery, and purpose.” Finally, they encourage a closer look at internal talent. THE ROLE OF LEADERSHIP Deloitte recently examined the qualities of leaders that tend to make your company a place talent is attracted to, in both good times and bad. Here are some of their tips: 1 Lead with purpose to create hope and resilience. It unifies people towards a common motivation, and is tied to strong values which builds trust that is needed to navigate continuous change. It also maintains direction and positivity to create a human ideal for a better place. 2 Consider how you and your team can make a difference. Can you lend capacity and leadership to another part of the business or community that is in high demand? Can your workforce’s skills be adapted to support in other ways that may not be so obvious? Think differently about the workforce capabilities you have.
3 Put on your internal radar. The reality of virtual work is upon us—anticipating and adapting to new business demands remains a priority. Sensing, adaptability, and foresight are needed to adjust; the crisis will evolve day to day and over time. Day 1 will be hands on, emergency rapid response. You need to anticipate and plan for the future and post recovery scenarios. Build a specific plan on how you will ramp up your workforce again. 4 Remember your people seek connection, humanity, and compassion. Take the time to ask people how they are doing. People have different reactions to grief, stress, and loss; some want to connect, others want compassion. Allow people to process how they are feeling; book a video call to connect and see people. 5 Create the circle of safety. Our current environment has broken our sense of safety. How are you adapting your business, making tough decisions to not only expand the circle of safety but also build a dynamic where your people feel protected? 6 Don’t forget about you. As the leader, you are expected to look after everyone else but how are you looking after your needs? Seek out support through your connections, mentors, coaches, and advisors so that you have the support you need to remain refreshed, focused, and leading the charge.
HS&M SEPTEMBER/OCTOBER 2020 | 48
TALENT TRENDS THE NEW SKILL SETS In addition, you need to prepare the workforce for the changing times. In Deloitte’s 2020 Global Human Capital Trends study of nearly 9,000 business leaders, 53% said that between half and all of their workforce will need to change their skills and capabilities in the next three years. Asking nearly 1,600 global webcast attendees how their role is changing due to the health crisis, they found that 26% expect to have additional duties and another 12% expect to do more than one role as a result of Covid-19. Deloitte has identified five shifts that will help prepare all of us for the future. 1 A shift from focusing on building skills to a commitment to cultivating capabilities first and skills second. The capabilities they refer to are curiosity, collaboration, creativity, and empathy, which provide workers and organizations with greater flexibility to meet both today’s and tomorrow’s needs, and can help people reskill and reinvent faster and with more sustainability. 2 A shift from developing specific workforce skills to meet short-term needs to tapping into workers’ passions to help solve unseen and future problems. This supports workers’ desire to make an impact, encouraging them to take on challenges to improve their own performance, or promoting a collaborative environment in which workers team up and build relationships with others to gain new insights.
3 A shift from a focus on formal training to an emphasis on learning in the flow of work, meeting workers in their place and time of need. Learning through experience yields better learning gains and retention than traditional classroom instruction. The integration of learning into the flow of work makes it more personal, allowing workers to better receive, digest and leverage the content. 4 Changing how the organization rewards individuals. Once again, this repeats the lessons above about incentives, particularly rewarding workers based on capability development, rather than solely on work output. One Deloitte study found that only 45% of organizations reward workers for developing new skills and capabilities, and even fewer, 39%, reward leaders for developing the skills and capabilities of their teams. 5 The rise of ecosystems. “As the world becomes more connected than ever before, traditional boundaries are blurring and giving rise to different models of work. At the organizational level, we have seen the rise of the social enterprise – an organization whose mission combines revenue growth and profit-making with the need to respect and support its environment and stakeholder network. A key competency of the social enterprise is its ability to listen to and invest in its broader stakeholder network. That means employing a workforce development approach that extends beyond the organization itself. Doing so
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could mean helping prepare your existing workers for high demand occupations in their local areas or in making investments in capability building outside of the walls of your organization to better support the community at large.” OTHER ADAPTATION TOOLS Finally, here are two valuable documents from AstraZeneca that present numerous findings and techniques for the emerging workplace atmosphere. The first is How to Fuel a Positive Culture for Remote Workers, which covers the concerns about telecommuting, maintaining company culture, keeping in touch, and using digital tools more effectively. The second is Effectively Leading Through COVID-19: Leader Toolkit, which examines a leadership mindset and behaviors to navigate uncertainty, and help achieve the desired corporate outcomes. We hope all of this gives you the wisdom, the strategies, and the confidence to grow and improve your workforce in the most challenging era of our lives. •
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| ROUNDTABLE
Execs from Antares, GSK and Flexion On Evolving Commercial Operations to Fully Maximize AI Moderator: BRIAN MAHONEY General Manager Veeva Andi
Speakers:
SAL PAOLOZZA
MADHAVI RAMAKRISHNA
Senior Director, Sales Operations Antares Pharma
HAZIQ HAQUE
Global Head, Commercial Data & Analytics, Pharma Technology GSK
Director, Commercial and Medical IT Flexion Therapeutics
51 | HS&M SEPTEMBER/OCTOBER 2020
ROUNDTABLE Artificial Intelligence, AI, has been one of the key terms bandied about in the industry. But it’s a big category. What does it mean? How does it help us? What’s the relationship between AI and Big Data? The Veeva Commercial & Medical Summit, North America, is the largest commercial and medical affairs event in the life sciences industry, connecting over 1300 professionals. This year it was conducted virtually, and featured over 50 sessions, five specialized tracks, and 47 speakers. The event included this media roundtable on how commercial operations can better use artificial intelligence, conducted by Brian Mahoney, Veeva’s Andi General Manager. Healthcare Sales & Marketing is grateful to Veeva for the opportunity to feature highlights from the interview in this article. Let’s get a little bit about GSK and what you’re doing for AI and some of your organization’s motivation, because you have a very diverse and large program. Madhavi Ramakrishna: One, from a delivery focused standpoint. And the second, of course, from an operational standpoint. There’s a huge agenda coming from the top, particularly in that we are dealing with the COVID crisis and a focus on driving top line growth, more than ever. And of course, making sure that we get the launch effectiveness right. What does that look like in terms of analytics and data? And simply going back to the basics of what do we do to build and automate the routine data insights that we consume on a day-on-day basis. That’s from a delivery standpoint. Moving on to the operational, we always talk about the people, process and technology. What does that mean in terms of advancing our agenda from the basic BI to the more advanced analytics? It’s the AI and machine learning. And
then just getting into the mindset of testing and learning, leveraging our information. There are a couple of different aspects that we are touching on. One, recruiting the right level of talent. Second, making sure that we are, from a mindset standpoint, ready to operate and then capitalize on the data assets that we have probably sitting in our backyard. And of course, making sure that we are able to cohesively think of it as a heat map view of our BI services and capabilities. What does that mature product or capability look like to then be the growth and the performance? Where do we need to invest more? The first step is organizing our house, going back to the drawing board and making sure that we have some of these foundational frameworks. To move into the programs, I think there’s a huge focus around rep effectiveness. What can we do again in the areas of landing the right message on the right channel at the right time to the right customer? It’s our next best program, which essentially touches on the maturity that we need to have as
53 | HS&M SEPTEMBER/OCTOBER 2020
an organization from a data management standpoint, to then being able to apply it to a bespoke need from a market standpoint to then delivering this program at scale. That’s just scratching the surface of what we have going on. In specialty, a lot of initiatives and agendas there, oncology and other key areas of interest where we’re talking about potentially advancing our frameworks or platforms to then leverage the real-world evidence. What does that mean? And all of this is the AI, our maturity or the advancement of our maturity in the AI space. Sal and Haziq, what were your company’s motivations for AI, and particularly how do you see AI driving and changing your business? Sal Paolozza: A year ago, we were launching a branded product in a highly generalized market. In addition, there was a lot of peer pressure around that product. What we wanted to do, and what we accomplished was really to improve our pull-through and provide the assistance to patients to get covered for the product. We were getting information from a lot of sources, some coming in daily. We used Veeva Andi’s AI to prioritize the suggestions that we were sending out to our sales force. That helped with pull through. Depending on the physician, depending on the patient, it would prioritize the suggestion allowing the representative to provide the proper assistance to the practice for pull through purposes and to help patients get access to our product. Since we’ve implemented, we’ve seen nice growth, and obviously we’ve seen a lot of consistency for our product.
Haziq Haque: I think our motivation into the AI space really fit part of our long-term vision, which was improving our business intelligence (BI) landscape. How do we service our main customer, which is our rep? How do we make their lives easier? How do we make their lives more effective? And how do we deliver data in a much better way than what we had been doing? And then we wanted to look into how do we get the insights from our other reporting assets and provide it to our reps, if we have a big dashboard, a large data set that we’re providing them? A lot of the overhead in terms of determining insights, determining key factors in their data was placed back onto them. We want to enhance their insights without drowning them in noise. That’s where that AI component really comes in and shines for us just to say, “Not only are we taking your big dataset, we’re narrowing it down into key information for you.” We’re also taking it a step further and saying, “Here’s the best insight for you today.” It really helped with that prioritization component. The Veeva CRM and Andi helped us sift through the insights.
Our long-term vision is improving our business intelligence (BI). How do we service our main customer, our rep? How do we make their lives easier and more effective? And how do we deliver data in a much better way?
Sal Paolozza: I would like to just add to that. I think the data was always available to all the reps. Obviously you launch products, you have products, you have portals, you have dashboards, you have reports, right? You have a lot of good reps, but with varying expertise when it comes to getting and analyzing information. What AI has really surfaced is getting the same level of information to all reps. This way they can act on it without them having to go in and look through all that noise, which is tons and tons of reports and portals. I think that’s where we succeeded. It’s surfacing the right information at the right time based on the right clients and patients, the demographics. Any surprises or learnings in getting AI going? What about user adoption of AI as a tool for your teams? Haziq Haque: You helped us shift some conversations internally. A big opportunity or shift that we saw was in that conversation between marketing and sales. AI became another tool set for them, another channel for them to engage reinforcement with the reps and reinforcing good behavior. The other side of this that we saw was we were able to take anecdotes from a high performing team and say, “Look, this is a great example. We’ve launched this Veeva CRM Approved Email template that’s really successful in our region. We were able to replicate that key behavior across the whole team. I think it provides a great framework for people to say, “Oh, okay. I get how this works.” It really sets up a nice framework to say, “Here’s our segments. Here’s our actions. Here’s how AI is going to improve
and enhance that interactivity.” That’s been the big shift that I think we’ve seen. Madhavi, you brought up a point about changing rep behavior. How are they adapting to the idea that a machine is giving them suggestions, and what the next best action might be? And is there any pushback from your field teams? Madhavi Ramakrishna: I think this is no different than the machines telling and validating the gut, right? We are experiencing a bit of that. Vary your data suggesting and guiding you along the way. I see this as more of a change management problem and less of an AI or machine learning problem. What we have tried to do is preempt that. When we are trying to deploy these large programs, what are the showstoppers that come along the way? How do we put a structure in place to account for those little nuances? We do have the handoffs or the principle that we are going to centrally guide and establish these frameworks. And then we are going to have locally-led change management teams to push and continue to educate our reps. There’s a huge amount of investment and effort in terms of market engagement, because at the end of the day, you can have all the fantastic programs filled, but if you cannot land them in the hands of users, you’ve essentially failed or delivered a compromised solution. There’s a huge focus around market engagement, making sure that we are continuously training, up until the point of launch of all these programs. And of course, handholding post launch.
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ROUNDTABLE Sal Paolozza: I’ve been nodding because it’s definitely changed management. There’s a lot of training behind it and really explaining the technology and the value. But I want to pause on value. After a year of using these programs, I actually have reps and managers coming and saying, “You know what would be nice? This type of suggestion. We’d like to see these insights.” And the reason is as long as the suggestions and the insights are providing value to the representative, which they can then in turn use to bring value to their accounts, they’re happy to use it. They want to learn it. But I think the trap that you’ve got to avoid is creating more noise. We went through a period where the reps complained. “Way too many suggestions, too frequent,” and so forth. We had to come up with the right balance between the frequency, the prioritization, and the value that we’re bringing through Veeva Andi to the reps. Once we got that, now they’re demanding more insights. And I think that’s the key. Training and value, make sure you’ve trained them on how to use it, and make sure that you’re putting out valuable suggestions. I think that’s key.
We have to quickly adjust, and course correct. What does that framework look like? What are the key KPIs that we need to track and audit? What do those simulations look like if we were to traverse them on an alternate path?
Haziq Haque: We had broad support from the field almost right out of the gate. And I think there were a couple of things that we did differently, and I think in some cases — because of our size and working model — we didn’t have any pushback. We had, in fact, one of our leaders who’s helping us launch say, “This new functionality that we’re putting together and launching to the field, think of it as a virtual assistant.” We focused less on the AI piece of it as we rolled out to the field and the reps, because it makes this thing, from a user experience perspective, such a big concept to kind of wrap your head around. This idea of virtual assistant and that it’s nudging you in the right direction, really resonated, and it really helped with adoption and support for us. I think the other part was we knew our field enough to know that we had to start a little bit smaller. Partially because we were sensitive to this idea of, the reps already get all this information. How is this going to help? We limited the number and the volume of suggestions and insights that we were creating right out of the gate. And we said, “We’ll scale up later.” A combination of those things really helped us avoid any pushback. And I think to a degree with the reps working from home, what was really helpful from an adoption perspective was that they have more time to explore the function and the tools. And it’s creating good behavior now, where they can log into the iPad every day, look at these, dismiss, interact. And when their days get busier, when they start to roll out into the field, it’s a behavior that’s built in.
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When the adoption gets easier with reps and they get more comfortable with the technology, what kind of next steps do you want to take beyond what you have been doing with them? Haziq Haque: For us, it’s creating this environment of continuous improvement and feedback, assuring the reps that the more they put in, the more they can get out. I think that’s a key next action for us — making sure from a field perspective, whether at a home office or headquarters, they understand that. The marketing team, the head of sales, those guys get it. And now there’s this new tool for them to use. But I think from a field and at the rep level, it’s important for them to be able to come back and say, “I’ve got this great working algorithm that I’m finding great success with doctors in the field or accounts in the field.” They get to have input into the process, which is a great motivator to get feedback and continue with our program. I think next steps from an AI perspective is moving into the more advanced analytics areas. How do you take, say Veeva Data Cloud and leverage AI components there to derive insights so that we can do those longer-term research studies? That’s an area that I could foresee many of us as customers moving into. We’ve spoken a lot about building that data ecosystem as your next step. Anything to add there? I know GSK is really thinking not just about next best action, but beyond. Madhavi Ramakrishna: I think we’re going at this as an ecosystem.
We call it the integrated approach to making sure that we are not mushrooming these initiatives and not cannibalizing it. For example, we talk about digital marketing and in the same context talk about next best action. And we confuse the heck out of the folks on the other end. “What do you mean by next best action? How does this tie back to what we are doing on the digital engagement?” Making sure that we have an integrated approach to these initiatives that’ll all target the same persona is very critical. Number two is also, we have to recognize that as much as AI and machine learning is a fantastic way to do value delivery, it is also a cognitive element of your training at the end of the day. It only continues to deliver value as long as it is smarter than what a human can think of. What does that nice balance look like where we continue to build the trust and making sure that the adoption exists? And then of course it is also being applied and actioned on. That’s the critical part. Leading into the measurement, I don’t want to say it’s critical that every bit and piece is premised on AI and machine learning . Test and learn, and of course drive towards an outcome. What does that measurement framework look like? We cannot continue to put our head into the sand and not realize, “There’s no value here.” We have to quickly adjust, and course correct. What does that framework look like? What are the key KPIs that we need to track and audit? What do those simulations look like if we were to traverse them on an alternate path? Building that robustness around the platforms and
tech, and second, of course, taking and tying our functional programs so we’re going at it with a very cohesive approach to try and deliver the top two or three business outcomes or value drivers.
As the suggestions and insights provide value to the rep, which they can then in turn use to bring value to their accounts, they’re happy to use it. They want to learn it. Sal, you guys are actually launching a product during Covid. How does AI play into a launch these days? Sal Paolozza: Well actually, it plays very well into a launch. First of all, from our perspective, I think we’ve been very fortunate to have a lot of Veeva technology. That’s really helped the reps keep up their interaction with their own customers. At the same time, we’re still a small company and we’re taking on new products and we’re looking at different channels. One of the channels we’re looking at is virtual reps for some of our more mature brands. We were able to drop some virtual reps in empty territories. And they were effective from day one. They knew which customers they needed to call on, they knew what they needed to say to these customers.
it out now to almost every brand. We’re actually working on our second brand, and we’ve got a third brand coming. And we’re looking at bringing in some of the data in and building some very interesting suggestions around it. It’s been great. Haziq Haque: I think for us, it’s a little bit of the same, but on a smaller scale. On an AI front, we’re able to execute Covid-specific insights a lot faster into the field. The Veeva CRM Approved Email template and use case had to do with a message around Covid-19. When we first started working with suggestions, it took one of our developers five weeks to turn around a suggestion before this program. To put together that sales algorithm was follow up with this approved email template. I think speed to implementation, feed of connectivity between marketing and sales execution, and then of course enabling, “This is the most important thing that you should consider today.” That AI driven prioritization — that’s value. We were able to react quickly to our business needs. And that’s as we’re wrapping up a pilot and we’re about to launch nationally, we’re able to do these types of changes. And I think that’s impactful. •
COMMENT
It’s really helped to keep up the activity in every territory during Covid, and even with empty territories. It’s been awesome. And we’re looking forward to rolling HS&M SEPTEMBER/OCTOBER 2020 | 56
MOTIVATION
MOTIVIDEOS By Cari Kraft, Jacobs Management Group Back to work…but not back to normal? That’s what life is like for most of us. Kicking off that morning virtual meeting has new challenges. So here is our continuing attempt to help you help your staff, with work at home, self-isolation, confusion, and the other attendant effects of the pandemic. Using any of these to kick off a morning Zoom meeting could help get staff in the spirit for the rest of the day. Tips on Getting Through the Pandemic
Access that Superpower!
Many of your people are still adjusting to the new normal, wrestling with the anxiety of not being in their accustomed place at the office. Here’s how to help them replace feelings of disorientation with calm and dedication.
We’ve all heard of mindfulness. But how do we use it in the course of our normal workday? Here’s a video to share with your team on how to leverage your emotional response to a situation to recognize their superpower.
Staying Motivated
Your brain, your friend
Does your staff do well because they think they’re smart…or because they believe they work hard? Help your staff improve their performance so that they stay focused on the work at hand rather than their self-perception.
No matter how old you are, no matter how much you’ve packed into your gray matter, that brain you carry around is continually able to grow and learn. Here’s some insight on how neuroplasticity can contribute to your team’s performance. Practice, practice, practice.
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.
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ACCESS THAT SUPERPOWER!
YOUR BRAIN, YOUR FRIEND
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INDUSTRY
Why I Work In Healthcare
COVID-19 HEROES: IN THEIR OWN WORDS Every day, people are putting their own lives on the line to fight the pandemic. In this section, we have been showing the faces and telling the stories of these heroes. Here is what some of them have to say in their own words about the work they dedicate themselves to. Compiled from various sources. DENNIS CANALE, 43, physician assistant at Staten Island University Hospital Northwell and NYPD detective Second Grade For the past 16 years I’ve been assigned to the NYPD’s emergency service unit. ESU is an elite SWAT rescue team in the country. This pandemic kind of took me in a different light I walk into the hospital and see the amount of critically ill patients. it feels like a Hollywood movie with people in protective gear that you would never dream of in a hospital setting. I watched one lady pull up and she saw us come to the car all dressed up and she just started crying. I had several people giving prayer hands and a nodding gesture saying thank you, thank you, and they give you the heart sign, and saying thank you so much, thank you so much, god bless you. And it makes you feel good at what you do. It makes you say alright, I’ll go back tomorrow. People who didn’t sign up in the medical field: the physician assistants, the doctors, the nurses, and most importantly the people that clean and repair, the people that are clerical, the people that help all the medical professionals. They didn’t take that job thinking, ‘Hey, I’m going to go out today and put my life on the line.’ I know that as a law enforcement officer I am going to run the risk of death. I know it every day. They don’t. But they’re all there doing it. It’s amazing to watch. LUIGI CAVANNA, 67, head of the oncology ward at Guglielmo da Saliceto hospital in Piacenza, Italy In early March, when the epidemic hit, the situation in the E.R. was extreme. People were coming in all the time, dozens of them, already in serious condition. Beds and stretchers everywhere. One of my patients was in the E.R. for 10 hours and then she signed a paper stating that she wanted to be taken home. She said she’d rather die in her own bed. So I visited her at home and gave her some medicine. Within a few weeks, she got better. That’s when I realized we shouldn’t be waiting for the Covid-19 patients to get to the hospital. We needed to go to people’s homes, even of those with mild symptoms, and treat the disease before it could get worse. I started to drive around the area surrounding Piacenza with my staff on March 10, and initially we visited as many as 15 people a day. Then we gradually became better organized, and now we have three teams and we continue to work also in the hospital. Above all, we stay in touch with the patients and their families, and monitor the course of treatment on a daily basis. So far we have visited almost 300 patients. We can do this thanks to the hospital’s resources and private donations of protective equipment. Every time we enter a patient’s home we wear two gowns, two masks, caps, shoe covers.
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BEN DAVIS, 35, program director and a social worker at Center for Urban Community Services in New York We’re a program at the Center for Urban Community Services (CUCS) working with adults living with serious mental illness. The people in our program have had multiple psychiatric hospitalizations and have tried getting help from clinics and other mental health programs without long term success. The goal of our program is to help our clients thrive in the community without hospitalization and to reach their life goals. If they live in a private apartment we see them at home, if they’re homeless we go and see them on the street, or if they are in a shelter we see them there. We provide psychotherapy, psychiatric care, and assistance with medication and other medical issues. We work with their families, address legal issues, go grocery shopping or help them with cleaning, With Covid-19 our job is different in almost every way. We are looking at all of the things that our clients need and how to prioritize them. Which of those can we only provide face-toface? And which of those can we provide remotely by phone? When we think it is critical we go and see them in person because we need to. This particularly includes delivering and administering medication. We take all the precautions we can when we do this. In less than a week we needed to redesign our entire program and change how we do everything. The folks that we work with are among the most vulnerable in our society. But our clients are survivors. They have been through everything, have lived through things I can’t imagine. They are still here and they’re persistent. I believe that they have that mindset that they’ve been able to get through things before and they’ll be able to get through this now. I try to be optimistic that they’ll be okay. We are there no matter what to help them.
SCOTT GRAY, 49, client center manager at St. Mary’s Food Bank Alliance in Phoenix, Ariz. We went from serving 500-600 people per day to, on average, 1,200 a day. The days start off with us coming in at 7:00 and the line is already going down the sidewalk with people waiting in line for food. And to see the elderly out there with their carts, and a mom with kids and they are standing in line at 7 in the morning… [I’ve] never seen anything like this. The first thing in my mind is what do we have available? How can I make it stretch? Donations have increased a lot. People are shocked when they realize they are getting a basket to take home of supplies for the whole family. They see the basket and say, “This is all for me?” Not only am I feeding my family by working, but the families that are in line are feeding theirs. It’s an awesome feeling. I’m worried that this will become the norm, dealing with this many people. Will the food bank become a place we have to shut down because of social distancing? Or because it gets out of control? What are we getting in tomorrow? If I get sick it would have been for a good cause.
CORNELIA GRIGGS, MD My babies are too young to read this now. And they’d barely recognize me in my gear. But if they lose me to Covid I want them to know Mommy tried really hard to do her job.
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INDUSTRY
Why I Work In Healthcare
COVID-19 HEROES: IN THEIR OWN WORDS DR. ASLAM PARVEZ, 42, and DR. SONIA RANI PARVEZ, 41, physicians in Patiala, India It was Feb. 10, I remember the date, that it started to affect our jobs and we started mentally preparing [for Covid-19]. [Our son] Ayaan was having his final exams, starting on Feb. 18, and the day his exams finished, we took him to visit his grandparents by himself. He had not stayed alone there in the past—it’s nearly 60 miles away from our home, and a 1 hour 30 minute drive. There was no pandemic declaration by WHO at the time, but when he left, we were told to have our teams ready by the state government. I volunteered to post myself in a rapid response team, and Sonia volunteered to work in the Covid isolation ward. We were mentally preparing ourselves for this fight for the last month, and figured our child would be safe with his grandparents. With a short training we were ready. We consider it as an honor to serve our people. Now, we may not see Ayaan for quite some time. We are not planning to get him till the pandemic is over, and after that, we will take quarantine for two or more weeks. Sonia sometimes gets teary eyed while talking to him but he tells his mom to keep going as he is a busy, brave kid. I miss him too but I know he is safe away from us.
CLIFF STRAND JR., 50, employee for White Pony Express in Pleasant Hill, Calif. I’m a product of what White Pony Express does for people. About six years ago, one of our executives found me under a bridge in Richmond, Calif., and brought me baskets of food. I was a strung-out-of-my-mind drug addict with a dark soul, ready to die. He helped me. This is absolutely my mission. It’s not a job. I’m supremely blessed to be able to do this. Not for a minute did I consider staying home during this outbreak. It takes that level of fear down to show people that we’re out here and taking the right precautions. I change my gloves at every location and wear a mask. I delivered food to the local shelter, the Contra Costa Interim Housing Shelter, and there’s over 100 people in there. I know those people; they’re my friends. Now they’re behind a wall to prevent the virus from spreading. It brought me to tears. We’re flashing up heart signs and saying, ‘I love you’ through the wall. I was crying, but it wasn’t because there was fear. There’s love going on in this whole thing.
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DAVID SAUCEDO, 52, nursing home cook I am having to argue for my supplies. It makes me feel secondary, not equal. You are expendable in a way. I deal with patients who are not capable of taking care of themselves, that have dementia. I accepted that head-on because I have two handicapped brothers. I really care for all my patients. Whatever infections they have, it all is going to end up in the kitchen. The Alzheimer’s patients don’t know about “six feet, keep your distance.” They just come up to you, grab you, and sit and talk to you. I need to protect them as much as I need to protect myself. The last thing I want to do is get one of my patients sick or one of my loved ones sick. When I was in the Navy, when we went to war, I was getting paid hazardous duty pay. Okay, I signed up to work in a hospital, I knew germs were going to be there. But, had everyone knew coronavirus was going to come, how many people would have decided not to work in a hospital? To me, it is a hazardous job right now.
SABRINA HOPPS, 46, acute care facility housekeeping aide Housekeepers are the number-one hero. If housekeeping does not clean the rooms correctly, the pandemic will be worse than what it is. I clean patient rooms in the ICU department. Those are the sickest people. It scares me because I can be cleaning a patient’s room and the patient can have the coronavirus and I would never know. I have asthma, and my son has asthma. My son is a cancer survivor. I am petrified to not know what is going on or what the patients have. If I didn’t love what I do, I could have walked away and sat at home, like half the world, and got unemployment. But that’s not me. The patients deserve better. It is me and the other housekeepers who sit and talk with the patients to brighten up their day, because they don’t have family members visiting now. As long as God put me on this earth, I am going to continue to go to work.
ROSINE SARAH ROSANEL, MD Last night I put down my cardiology hat to be an attending/ hospitalist in my hospital, leading codes and rapid responses. All hands on deck to fight Covid-19
COMMENT
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INNOVATION SHOWCASE
MedTech Innovator Awards Companies at the Forefront of the Industry By Neil Greenberg MedTech Innovator is the largest accelerator of medical devices in the world, and the premier nonprofit startup accelerator in the medical technology industry. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. MedTech Innovator matches healthcare industry leaders with innovative early-stage and emerging growth medtech companies for mentorship and support. Founding sponsors include many of the most prominent healthcare companies, among them Johnson & Johnson, Baxter, Olympus Medical Systems Group, W. L. Gore & Associates, Inc. and numerous others. In October, MedTech Innovator held its 2020 MedTech Conference, the largest gathering in the industry, which awards a $350,000 grand prize and four $25,000
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prizes to the winners. There are also several incubator space awards presented from JLABS, bringing the total to prize money to $500,000. Over 1000 applications came in from 45 countries, Here’s MedTech Innovator CEO Paul Grand explaining the organization and the competition:
CALL FOR INNOVATION SHOWCASE NOMINATIONS
Help us share innovation in the industry (and spotlight your organization) by submitting an innovation showcase nomination. Organizations from the Medical Device, Biotech, Pharmaceutical, Device, and Healthcare IT industries are welcome to submit recommendations. Selected innovations will be highlighted in our Innovation Showcase article. SUBMIT A NOMINATION SELECTED SHOWCASE NOMINEES WILL BE CONTACTED FOR FINAL REVIEW BEFORE PUBLISHING.
INNOVATION SHOWCASE
THE MEDTECH INNOVATOR AWARDS: WINNER: RHAEOS, for developing a wearable for the noninvasive monitoring of ventricular shunt function for hydrocephalus patients.
FINALISTS: cellvie, for developing a device-enabled mitochondria transplantation therapy for heart disease.
Circadia Health, for developing a contactless remote monitoring system for early detection of respiratory failure.
Moray Medical, for developing a robotic catheter that makes delivery of therapies inside the beating heart as easy as moving a cursor on a computer screen.
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Lief Therapeutics, for developing a wearable ECG and digital therapeutic for mental health, providing remote patient monitoring with a HIPAAcompliant clinician dashboard.
EXECUTION AWARDS:
Execution Awards are presented in conjunction with AdvaMed Accel’s Virginia Shimer Rybski Memorial Award, which recognizes the potential of a promising entrepreneur or entrepreneurial medical technology company. Here are the winner and the five other finalists:
WINNER: VENA VITALS, for a continuous non-invasive blood pressure monitoring in the form of a soft flexible sticker.
FINALISTS: Aksense, for an early and rapid diagnostic biosensor that eliminates death from healthcare associated infections
MOWOOT, for a novel, purely physical, non-drug and non-invasive solution to treat intestinal transit disorders.
Envision Endoscopy, for developing a novel suturing device for flexible endoscopy for tissue approximation and large defects management.
Forcen, for developing ForceFilm, which provides a digital “sense of touch” in surgical robotics.
Puzzle Medical Devices, for a long-term hemodynamic transcatheter heart pump associated with minimal blood trauma, that allows for safe and efficacious support without open-heart surgery.
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INNOVATION SHOWCASE
BEST VIDEO COMPETITION In addition to competing for product awards, each company in the MedTech Innovator 2020 Cohort created a highly produced 1-minute video to tell you their story. Here are the five finalists in the video category:
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COMMENT
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NEW! AGENCY AND PROVIDER DIRECTORY! Healthcare Sales & Marketing’s New Feature As a value to the industry, we have initiated a project to profile the top agencies so that you have them at your fingertips. We are compiling a digital, searchable, single source to give you access to the who’s who, their strengths, vision for the future, leadership and strategies, so that you can get a better feel as to how they work. We are driven by the input of our readers so please let us know if you have an agency or provider you would suggest we profile. You will see some of the best with links to all their websites, their philosophy and history, as well as what makes them special. This is all in keeping with our goal of having the hottest industry companies and the top thought leaders in in the pages of every issue of HS&M. Our goal is to constantly expand the value we bring to you.
If you would like to be featured, or have an agency or provider to recommend, please reach out to our Associate Publisher, Natalie Newcamp, at nnewcamp@hsandm.com.
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AGENCY & PROVIDER DIRECTORY SEPTEMBER/OCTOBER 2020
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AGENCY & PROVIDER DIRECTORY
Company Overview: Catalyst is an insights-driven healthcare communication agency. Our goal is to help you solve your communication needs no matter how complex. We engage your audiences and drive change by providing solutions that serve as a vehicle for sustainable growth. Address: West Coast 3617 East Broadway, 19 Long Beach, CA 90803 East Coast 4695 Independence Avenue Bronx, NY 10471 Phone Number: 914-318-6351 Website: www.catalyst-agency.com Social Media:
Leadership: Steve Kane Managing Director New Business Contact: Steve Kane skane@catalyst-agency.com 914-318-6351 Year Founded: 1999 Number of People: 12 Service Focus: Healthcare marketing, communications and technology solutions including Disease-state awareness and Clinical education. Areas of Expertise: Branding, Portfolio brand management, Print design, Web design, 3D animation, Web technology, and Business efficiency solutions. What’s New: Long Beach, CA office
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AGENCY & PROVIDER DIRECTORY
Company Overview: Founded by doctors, engineers and data scientists, COTA is committed to bringing a patient first approach to cancer care through the use of real-world evidence. The Company organizes fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA’s platform helps inform decisions and action in oncology. COTA partners with providers, payers, and life science companies to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to make better decisions with the right data, visit cotahealthcare.com. Address: 100 Broadway, 7th floor New York, NY 10005 Phone Number: 866-648-3833 Website: www.cotahealthcare.com Social Media:
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! HS&M SEPTEMBER/OCTOBER 2020 | 74
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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
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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 healthcare communications agency specializing in managed care marketing. We develop customized solutions across the managed markets value chain for a range of customer segments, including payers, health systems, organized provider groups, employers, pharmacists, office staff, and patients. Guided by our expertise in strategy, launch execution, and innovative solutions, we are well equipped to help clients navigate the complex and evolving managed markets landscape. As an integrated part of McCann Health, a global network of companies across 6 continents, we work on multiple cross-portfolio deliverables for our clients. Address: 49 Bloomfield Avenue Mountain Lakes, NJ 07046 600 Battery Street San Francisco, CA 94111 Phone Number: 973-917-6623 Website: www.mccannmanagedmarkets.com Social Media:
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:
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Leadership: Jack Davis Founding Partner Jeff Sweeney Founding Partner New Business Contact: Jeff Sweeney jeff.sweeney@rareexpertise.com (858) 775-4273 Year Founded: 2016 Number of People: 10 Service Focus: Identifying and activating people with rare disorders Parent Company: Independent agency Areas of Expertise: Extensive rare disease experience (21 different brands). Patient identification and activation, HCP and patient education, online influencer networks, a database of rare disease patient journeys. What’s New: In September 2018, Rare Expertise formed a joint venture with SCOUT, a leading healthcare marketing agency focused on orphan drugs and specialty pharmaceuticals, to shorten the time for people with rare diseases to obtain an accurate diagnosis and begin appropriate treatment more quickly.
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Address: 55 Bank Street Morristown, NJ Phone Number: 973-867-6500 Website: www.revhealth.com Social Media:
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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. HS&M SEPTEMBER/OCTOBER 2020 | 78
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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 79 | HS&M SEPTEMBER/OCTOBER 2020
Awards: PM360 Trailblazer Awards PM360 Elite Awards DTC Perspectives Advertising Awards PM360 Pharma Choice Awards Service Focus: Rx EDGE Media Displays: Through our prominent, strategically-placed displayed delivered in a network of 27,000+ retail pharmacies, we help pharmaceutical brands motivate consumers at the most relevant times…when they are actively searching for ways to take care of themselves. Our Media Displays enlighten, engage, and inform. Rx EDGE Unlimited™: This cross-channel solution combines the power of our brick-and-mortar network with premium digital inventory and advanced analytics to bring pharma brands and audiences together. Rx EDGE Unlimited delivers exceptional reach, frequency, and influence. Insight EDGE™: A suite of data resources that the Rx EDGE analytics team applies to every program to ensure that pharma brand messages are seen by the right consumer. Areas of Expertise: We Maximize Impact: Rx EDGE is the only targeted media platform that uses the pharmacy as a consumer’s gateway to immediate information as well as ongoing connections to the pharma brands that are relevant to their healthcare needs. Brands that use Rx EDGE programs see an average script lift of 12.5%. We Align the Right People, Places, and Times: Through our relationships with key retailers, we can access data not commonly available through other marketing service providers − making our Insight EDGE™ targeting platform unique in the pharma marketing space. We Offer Proven Results: Measurement defines the core value we bring to every initiative. Using thirdparty analytics, results are evaluated with a significant level of precision. In addition to a lift in prescription volume, our programs also result in an average return on investment of $8.12. What’s New: Rx EDGE Unlimited™ is a new cross-channel approach that combines Media Display, mobile, and programmatic digital ad placement to boost campaign effectiveness.
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AGENCY & PROVIDER DIRECTORY
Leadership: Jennifer Brekke Principal Raffi Siyahian Principal
San Diego, Atlanta, Chicago, New York
New Business Contact: Raffi Siyahian rsiyahian@findscout.com (858) 538-7777 x251 Year Founded: 1990
Address: 12520 High Bluff Drive Suite 340 San Diego, CA 92130
Number of People: 125
Phone Number: (858) 538-7777
Parent Company: The Stagwell Group
Website: www.findscout.com
Awards: PM360 Trailblazer Agency of the Year Finalist; PM360 Pharma Choice gold award; Humanitarian Awards nominee, Healthcare Marketers Exchange.
Social Media:
Service Focus: Full-service
Areas of Expertise: Rare diseases, specialty pharmaceuticals, orphan drugs. What’s New: In September 2018, SCOUT formed a joint venture with Rare Expertise, a company with proprietary data-driven tools for identifying and activating people with rare disorders, to shorten the time for people with rare diseases to obtain an accurate diagnosis and begin appropriate treatment more quickly.
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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 Social Media:
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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.
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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
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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. HS&M SEPTEMBER/OCTOBER 2020 | 82
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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
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Areas of Expertise: Advanced iPad®and mobile app development, next-generation web development, cutting-edge digital content creation, including the company’s highly acclaimed 3D animation technology, new-media convention booth solutions, augmented reality, virtual reality, patient video testimonials, enhanced slide decks
Leadership: Rick Barker, CEO Jeff Asada, Chief Revenue Officer Kimberly Davis Wells, VP of Client Services Shan Jaffar, VP of Production Kane Kaneboughazian, VP of Animation Suntae Kim, VP of Software Development
Viscira continues to push the envelope in technology by exploring new mediums and hardware platforms like Oculus Go, HoloLens, Leap and MergeCube.
Website: www.viscira.com
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What’s New: Viscira has established itself as a thought leader in using XR technologies to offer unique experiences for patients, caregivers and healthcare providers. The company recently participated in the SF Design Week, and hosted a panel discussion which focused on the opportunities and challenges of storytelling in augmented reality.
