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TOP 10 PIPELINES AGENDA 2019 VALUE OF MEDICINES MEDICAL ADVERTISING HALL OF FAME

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HEALTHCARE COMMUNICATIONS AGENCIES

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STATE OF THE BIOTECH INDUSTRY PAYER ACCESS CUSTOMER/PATIENT EXPERIENCE DTC HBA WOMAN OF THE YEAR A LOOK BACK: 30TH MANNY AWARDS

& MEDADNEWS NEW YORK!

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TOP 200 MEDICINES ONE YEAR AFTER LAUNCH VIRTUAL/AUGMENTED REALITY ARTIFICIAL INTELLIGENCE LIONS HEALTH TAKEAWAYS

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Each issue of MedAdNews will include authoritative content via our popular Special Reports and features with an added emphasis on key themes throughout the year, including Oncology, Rare Disease, Health Tech and more.

Volume 37, Number 5 • October 2018 • medadnews.com • $100

TOP 50 PHARMACEUTICAL COMPANIES

T H E M A G A Z I N E O F P H A R M A C E U T I C A L B U S I N E S S A N D M A R K E T I N G

COMPANY OF THE YEAR

JOHNSON & JOHNSON

The executive management team of this “132-year-old startup” company is

excited about a future that lies beyond the

intersection of science and technology.

AR/VR:Executives from Veeva, Ogilvy CommonHealth, and Viscira off er their perspectives on the growth of and potential for augmented and virtual reality in healthcare marketing

TOP 200 MEDICINES:There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering eff ects of massive patent cliff s in 2012 and 2015.

LIONS HEALTH:The fi fth annual Lions Health took place on June 18-19 along the French Riviera.

From Johns Hopkins to Pfi zer to starting up two companies, Christopher

Bouton, Ph.D., CEO of Vyasa Inc., has made a career of how people think, and how to make machines think like people.

Starting with a Ph.D. is in molecular neurobiology from Johns Hopkins, with an inter-est in computational biology that led to working at a couple of biotechs in the Cambridge area, he was recruited to be the head of integrated. data mining at the Pfi zer Regional Technical Center in Boston.

“I was at Pfi zer for eight years, and that really was a wonderful opportunity to understand the breadth of data in use within pharma companies, and how important the processing of data is important to research,

development, and ultimately and healthcare for these types of companies,” he told Med Ad News.

After leaving Pfi zer, Dr. Bou-ton founded a company called Entagen in 2008, which pro-vides Big Data integration and analytics solutions. Entagen’s technologies were named “In-novative Technology of the Year in Big Data” in 2012 by the Massachusetts Technology Leadership Council and Enta-gen was named a Gartner “Cool Vendor” in the Life Sciences in 2013. Thompson Reuters ac-quired the company in 2013,

After spending two and a half years at Thompson Reuters, Bouton says he was “really bit-ten by the startup bug” and left Thompson Reuters in the be-ginning of 2016.

“I sort of sat back and tried to understand what I wanted to do next,” he say. “And right around that time is when these deep learning technologies started

to become more talked about, and hit their stride in terms of their capabilities. And what was interesting to me about these deep learning algorithms is that in many ways they are based on cortical structure. And so from my neurobiology experience, it was really cool to see an algo-trith that was in part modeled after how the brain works. That was sort of an aha moment.”

In that moment, the concept for Vyasa was born.

“What I am really interested in doing is separating the hype from the reality of what these algorithms are really good at, and then once we’ve identifi ed key paradigm-shifting capa-bilities of these technologies, applying them in a very special-ized way, in the life sciences and healthcare space,” he says.

Bouton says all the hype around artifi cial intelligence, or AI, is being driven by deep learning al-gorithms. “AI, the phrase, is one people have thought about ever since we’ve been using computing machines,” he says. “But what’s happening now is that deep learn-ing algorithms are really driving this round of game-changing ca-pabilities for machines and what they could do.”

Deep learning algorithms “simply weren’t at the level of

capability that they’re at today when I was working at Pfi z-er,” he says. “There are plenty of times when I had hoped we could do at Pfi zer the kinds of things that we can do now. And that comes back to the perfect storm of capabilities all coming together right now. GPU hard-ware is at a level of capability that it’s never been at before, and GPUs are very important for these deep learning algo-rithms; the Big Data phase, learning how to handle large amounts of data, was an im-portant phase for all of us to go through; and then updates to the algorithms themselves are all coming together right now and give us these capabilities that just weren’t ever possible before.”

“We’re all – and I mean by all, I mean humanity – just learning what these things are good for and just how far we can apply these types of capa-bilities,” Bouton says. “It’s real-ly a revolution, a paradigm shift in understanding what a ma-chine can do. And that means that there’s a wide range of low-hanging fruit to apply these algorithms to, and beyond that, a range of capabilities that are going to generate a signifi cant

The Magazine of Pharmaceutical Business and Marketing • medadnews.com • August 2018 • Volume 37, Number 4 • $25

continued on page 6

10 • MED AD NEWS AUGUST 2018

ugmented reality (AR) gained widespread attention the summer of 2016 with the ad-dictive game Pokémon Go.

But these days, AR is not just for fun. This disruptive technology is expected to drive significant changes to businesses across many industries because of its ability to combine the virtual and physical worlds. Specifically, AR transmits a live view of a real-world environment that is augment-ed by computer-generated, 3D images. A digital object can be scaled to fit neatly in a physical environment using an AR ap-plication and camera on a mobile device.

In 2018, AR is moving beyond early experimentation, which merely show-cased AR’s novelty, into more viable business application – especially in the life sciences industry. Innovative com-panies are developing compelling ways to use AR to enhance customer engage-ment, improve education of complex topics, and create powerful, even emo-tive, brand differentiation.

AR is becoming more accessible thanks in part to new software such as Ap-

ple’s ARKit, which is making it faster and easier to develop applications. There are more than 2,000 AR applications avail-able today, and more coming, according to a report by the research firm Forrester Research. “Virtual reality (VR) and AR solutions are revolutionizing the way large and complex B2B products get marketed and sold – just as three-dimensional (3D) modeling precursors forever changed the way these products get designed and man-ufactured,” Forrester notes.

Early adopters in life sciences are starting to use AR to explain complex concepts and treatments. It optimizes today’s digital channels by providing an attention-grabbing new content type that allows healthcare professionals (HCPs) and patients to engage directly with 3D images. For example, one company creat-ed a 3D heart model to demonstrate how a medicine moves through the organ as part of a new treatment, producing much greater impact for the audience than a simple video. Other AR applications have mapped an individual’s body for surgery and shown the exact location of veins in a patient’s arm, helping HCPs treat pa-tients better and improve outcomes.

Regeneron is using AR to create deeper empathy and understanding of patients

suffering from vision loss. HCPs can expe-rience the blurriness, wavy lines, or black patches caused by different types of retinal disease to better appreciate the challenges patients face from this condition.

As AR continues to gain traction in the life sciences industry, it will be built into core enterprise software such as Cus-tomer Relationship Management (CRM) and content management systems – bringing an exciting digital content for-mat to life by making it widely accessible and actionable. In this demonstration – https://bit.ly/2Lw37wg – built in con-junction with Pixacore and presented in May at the 2018 Veeva Commercial Summit in Philadelphia, Veeva shows how AR baked in to Veeva CRM com-bines the virtual and physical worlds to help develop patient empathy and a bet-ter understanding of disease state. The demonstration let the audience experi-ence what it was like for a patient when his vision starts to fail from macular de-generation, an incurable disease.

Here are three of the most significant ways AR will be a game changer for mar-keting, sales, and customer service in life sciences.

AR will enhance customer engagement by creating highly engaging experi-

ences for HCPs and patients. This is cru-cial today, especially as HCPs expectation increases for digital engagement. Finding new ways to interact with them can serve

as a true differentiator and help foster more personal relationships. Using AR to spur emotional reactions such as wonder or surprise can also create a better con-nection with customers, and help ensure HCPs are fully engaged.

Specifically, AR enables life scienc-es companies to innovate how they tell and deliver their product’s value, as well as demonstrate the outcomes. These demonstrations are extremely powerful, particularly when unpack-ing complex medical concepts because customers can visualize the product in their actual environment. HCPs gain a clearer understanding of how a treat-ment works in the body, even in a par-ticularly patient’s body. The contextu-alized experience allows HCPs to more fully appreciate the treatment benefits, too, which also makes the information more memorable.

Consumer brands are already using AR to personalize the customer expe-rience. Ikea Place allows customers to place and move furniture virtually in their own homes. The 3-D furniture appear at scale, with true-to-life repre-sentations of the texture, fabric, light-ing, and shadows for a true ‘try before you buy’ experience. Similarly, AR can demonstrate exactly how marketing ma-terials might look on display in a doctor’s office, similar to how over-the-counter drug makers virtually arrange their shelf layout in-store. This simple change not only personalizes the engagement ex-perience, but it also raises the bar from personalized content to a personalized virtual experience.

Unprecedented scientific discovery has led to an increased focus on de-

veloping specialized treatments that are highly complex – both in action and, oftentimes, in delivery. With every new discovery, effectively communicating complicated breakthrough therapies or even cures becomes more challenging – particularly just with words. Videos help but are still limited.

Today, AR technology offers a multi-dimensional way to commu-nicate complex concepts for greater comprehension and retention. In fact, researchers have concluded that AR is more effective in demonstrating spatial and temporal concepts, allowing people to engage in the learning process with multiple senses and producing better results. As Benjamin Franklin said, “Tell me and I forget. Teach me and I remember. Involve me and I learn.” AR involves the viewer, in multiple ways, so he learns faster.

In healthcare, for example, AR can be used to teach medical practitioners complex medical procedures – not just in theory, but also in practice – allowing them to virtually touch and manipulate objects to see the effect or practice the procedure. AR can also provide 3D on-body visualizations of how medicines or medical devices work for both HCPs and patients. Think of the value of virtually demonstrating a unique delivery mech-anism for a new drug to HCPs early in

The new (augmented) reality in life sciences

By Joshua Slatko • josh.slatko@medadnews.com

AR/VRspecialfeature

A By Arno Sosna

Early use cases for AR in life sciences

1. Enhance personalized customer engagement

2. Improve understanding of complex treatments

inside

14 • MED AD NEWS AUGUST 2018

rescription blockbuster brands thrived as well as ever in 2017, with 131 product entries exceeding the $1 billion sales barrier during last

year according to Med Ad News � les.According to this year’s “Drugs to Watch” report

from Clarivate Analytics, a worldwide leader in providing trusted insights and analytics to accel-erate the pace of innovation, there are 12 new medicines expected to launch in 2018 that are projected to achieve annual sales of $1 billion or more by 2022. Those anticipated 12 blockbuster launch products for 2018 represent a higher total than that generated in any other year since the “Drugs to Watch” report began in 2013. The anal-ysis used the Cortellis database, which includes data gathered from diverse sources encompass-ing drug pipelines, patents, clinical trials, chemis-try, deals and company announcements.

“Despite political and regulatory uncertainties in the USA and EU markets, the annual Drugs to Watch report 2018 shows that the pace of phar-maceutical innovation continues to accelerate,” says Mukhtar Ahmed, president, Life Sciences at Clarivate Analytics. “2018 is on track to see many new potential game-changing drugs come to market, which will bene� t the lives of millions of patients around the world.” The new medicines forecast to launch in 2018 cover a wide array of therapeutic areas such as type 2 diabetes, endo-metriosis, childhood epilepsy, hemophilia, HIV, migraine, opioid addiction and shingles.

Included among the 12 anticipated blockbuster launches arriving to the marketplace during 2018 are Epidiolex, the � rst FDA-approved cannabi-diol-based drug, and Erleada, the � rst approved treatment option for men su� ering from castra-tion-resistant prostate cancer whose cancer has not yet spread.

GW Pharmaceuticals’ Epidiolex during June became the � rst-ever plant-derived cannabinoid prescription medicine to win FDA regulatory clearance. The epilepsy drug, which contains can-nabidiol, is approved to treat two rare forms of childhood epilepsy: Lennox-Gastaut and Dravet syndromes in patients age 2 or older. LGS and Dravet syndrome – which develop in childhood – are rare, severe forms of epilepsy that are notori-ously treatment-resistant.

The next-generation androgen receptor inhib-itor Erleada (apalutamide) was granted U.S. mar-keting clearance in February for the treatment of patients with non-metastatic castration-resistant prostate cancer. The approval is based on Phase 3 SPARTAN clinical trial data which demonstrated that Erleada decreased the risk of distant metasta-sis or death by 72 percent and improved median metastasis-free survival by more than two years.

While these various new medicines work their way to blockbuster status in the years to come, Humira continues to set industry sales records. Hu-mira’s combined sales between marketers AbbVie and Eisai reached nearly $19 billion during 2017. The anti-tumor necrosis factor biologic Humira (adalimumab) was launched in the United States during January 2003 and is indicated for multiple immunological disorders. For the � rst six months of 2018, AbbVie reported $9.89 billion in world-wide sales for the autoimmune biologic therapy.

The mega-blockbuster brand is expected to continue generating U.S. sales growth until 2023, at which time biosimilar sales will begin to take ef-fect in the United States when AbbVie’s strategy to fend o� rivals of the world’s No. 1 prescription drug due to various licensing deals with the likes of Sam-sung Bioepsis, Amgen and Mylan expire.

Meanwhile, Humira biosimilars are set to launch in the European Union during 2018. The biosimilars are projected to have signi� cant uptake in the European Union since they are expected to be priced 10 percent to 20 percent lower than the originator brand across the EU. According to leading data and analytics company GlobalData, this will be further facilitated by the quotas that healthcare authorities have in place for biosimilar prescription. GlobalData analysis says one of the highest quotas are from the UK’s National Health Service (NHS), which recom-mends that 90 percent of new patients and 80 percent of patients currently receiving therapy, be prescribed the lower cost biologic (or biosimi-lar) within 12 months of the launch of a biosimilar. Lakshmi Dharmarajan, PhD, GlobalData Associ-ate Director of Immunology, notes that, ‘‘Actual uptake does vary among di� erent hospitals and healthcare facilities, and could in fact be lower. On average, gastroenterologists treating ulcer-ative colitis, anticipate prescribing the biosimilar versions to around 45% of the total adalimum-ab-treated population in the 5EU* by 2021. ... We believe that Humira biosimilars may not have as fast an uptake as Remicade biosimilars in the EU, especially for gastroenterology indications.”

Humira’s loss of U.S. patent protection in 2023 is expected to fuel the largest patent cli� the phar-ma industry has ever experienced in one calendar term with $67 billion of global sales at risk that year, according to EvaluatePharma’s “World Pre-view 2018, Outlook to 2024” report. The two most impactful years to date for worldwide sales lost to patent expiration have been 2012 ($562 billion) and 2015 ($51 billion). The report’s analysis notes that, “The growing power of payers, combined with the arguably underestimated threat of bi-osimilars and the genericization of some of the industry’s biggest products, including Humira are factors that could act as a brake on growth. The report shows that $251bn of sales are at risk be-tween 2018 and 2024, teeing up a second patent cli� the industry will have to get over.”

While Humira during 2017 ranked as the top-selling medicine for the sixth consecutive cal-endar term with impressive year-over-year global growth of $2.42 billion, a new runner-up emerged last year: Revlimid (lenalidomide). The medicine generated 2017 sales for Celgene of almost $8.19 billion, nearly $10.76 billion behind front-runner

Humira’s tally for last year. Revlimid, which won initial FDA approval in December 2005, is avail-able for treating multiple myeloma, myelodys-plastic syndromes, and mantle cell lymphoma. BeiGene during July 2017 acquired Celgene’s commercial operations in China and gained an exclusive license to commercialize Celgene’s approved therapies in that country, including Revlimid. Global sales for the oral immunomod-ulatory drug exceeded Revlimid’s total during 2016 (during which the medicine ranked No. 6 globally on Med Ad News’ list) by almost $1.22 billion. EvaluatePharma has projected worldwide sales of $11.93 billion for Revlimid in 2024, which would rank the drug No. 3 globally at that time after Humira at $15.23 billion) and Merck & Co.’s anti-programmed cell death-1 (PD-1) monoclo-nal antibody Keytruda at $12.69 billion). Keytruda ranked No. 22 on this year’s Med Ad News’ Top 200 Medicines list with 2017 global sales of $3.81 bil-lion for the oncology medicine.

Celgene and Revlimid made headlines in July when the Summit, N.J.-based company joined several other pharma � rms in pledging to refrain from additional price increases for six months as the Trump administration enacts its drug-pric-ing plan. Before those several manufacturers re-versed course, the president had called out P� zer for raising drug prices in 2018. Celgene had al-ready increased the price of Revlimid by 5 percent in 2018, and the product’s worldwide sales for the company rose 21 percent to $2.45 billion during the April- June period, constituting more than 64 percent of Celgene’s overall revenue during sec-ond-quarter 2018. For the � rst six months of this year, Celgene reported that Revlimid sales totaled nearly $4.69 million, an increase of 19.6 percent on a reported basis versus the one-year-earlier

period. As of late July, company management projected Revlimid net sales for full-year 2018 to ~$9.7 billion compared to previous guidance of ~$9.5 billion.

During May, Celgene was reportedly one of several companies that the U.S. Food and Drug Administration previously identi� ed as using a safety program that some pharmaceutical man-ufacturers have leveraged to prevent generic competition.

For the second consecutive year, the TNF inhib-itor therapy Remicade was the third-highest-sell-ing prescription medicine in the world. Marketed around the globe by Johnson & Johnson, Merck and Mitsubishi Tanabe Pharma, Remicade (in-� iximab) is available as a treatment for various immune-mediated in� ammatory diseases. The branded biologic was launched in the United States in September 1998 and produced 2017 global sales of $7.76 billion between the three marketers, which was down by about $1.1 billion compared to Remicade’s 2016 global sales result. A biosimilar version of Remicade was introduced during 2016 in the United States, and additional competitors continue to enter the marketplace according to J&J. Lower 2017 sales were also at-tributed by J&J to increased discounts/rebates. The patents for the product in certain countries in Europe where Merck is the marketer expired during February 2015, and biosimilar versions have additionally been introduced in certain non-U.S. markets.

During the 2018 � rst half, J&J reported global Remicade sales of $2.71 billion, down 15.4 percent versus the January-June 2017 period. For Merck, the immunology medicine generated � rst-half 2018 sales of $324 million internationally, compared to $437 million during same-time 2017. medadnews

top 200 medicinesannualreportBlockbusters thriving despite tumultuous climateThere were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering e� ects of massive patent cli� s in 2012 and 2015.

By Andrew Humphreys • andrew.humphreys@medadnews.com

WORLDWIDE SALES AT RISK FROM PATENT EXPIRATION (2010-2024)

Worldwide Prescription Sales ($ in billions)

Year 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Total Sales at Risk 29 34 52 31 31 51 39 32 39 43 17 17 41 67 27

Expected Sales Lost 13 20 37 24 20 16 16 29 26 23 19 15 15 22 19

% Market at Risk +4% +5% +7% +4% +4% +7% +5% +4% +5% +5% +2% +2% +4% +6% +2%

Source: Evaluate, May 2018

RANK DRUG DISEASE 2018 2019 2020 2021 2022 COMPANY (HQ)

1 Hemlibra (emicizumab)*,†,|,¶,‡‡ Hemophilia A with factor VIII inhibitors 496 1,457 2,356 3,362 4,002 Roche (Switzerland)/Chugai (Japan)

2 Biktarvy (tenofovir alafenamide + emtricitabine + bictegravir)**,¶, †† HIV infection 896 2,282 3,387 4,296 3,716 Gilead (U.S.)

3 Ozempic (semaglutide)* Type 2 diabetes 260 862 1,576 2,583 3,469 Novo Nordisk (Denmark)

4 Erleada (apalutamide)¶,** Non-metastatic CRPC 25 500 1,200 1,600 2,000 Johnson & Johnson (U.S.)

5 Shingrix (Zoster vaccine recombinant, adjuvanted)§§ Shingles 242 537 879 1,202 1,368 GlaxoSmithKline (UK)

6 Patisiran§,|,¶,‡‡ Hereditary TTR amyloidosis 83 373 726 1,104 1,212 Alnylam (U.S.)/Genzyme (U.S.)

7 Epidiolex (plant-derived cannabidiol)‡|,¶,** Dravet syndrome and Lennox-Gastaut syndrome 19 266 645 936 1,191 GW Pharmaceuticals (UK)

8 Aimovig (erenumab)*,‡‡ Migraine 115 361 685 941 1,170 Amgen (U.S.)/Novartis (Switzerland)

9 Lanadelumab*,†,|,¶,‡‡ Hereditary angioedema 74 350 629 902 1,153 Shire (Ireland)

10 Elagolix ¶,**,‡‡ Endometriosis 57 268 549 896 1,152 AbbVie (U.S.)

11 Steglatro (ertugliflozin)** Type 2 diabetes 220 482 769 1,024 1,087 Pfizer (U.S.)/Merck (U.S.)

12 Sublocade (once-monthly buprenorphine)‡,¶,** Opioid dependence 121 308 439 634 1,072 Indivior (UK)

Data were obtained from the Cortellis Competitive Intelligence database, accessed March 05, 2018 (Source: Thomson Reuters I/B/E/S). Forecasts are in U.S.$ million. CRPC=castration-resistant prostate cancer. TTR=transthyretin. *=biological drug. †=Breakthrough Therapy designation. ‡=Fast Track designation. §=RNA interference. |=Orphan Drug designation. ¶=Priority Review. **=small molecule. ††=novel integrase inhibitor. ‡‡=first-in-class. §§= vaccine.

Analysis of 12 new drugs forecast to enter the market in 2018 and achieve blockbuster sales of over $1 billion by 2022

Top 12 to watch

Source: Clarivate Analytics Drugs to Watch 2018 report

P

22 • MED AD NEWS JUNE 2018

ions Health is a dedicated two-day festi-val held annually within Cannes Lions in France. Lions Health is billed as the only place in the world to experience talks from

leading pharma, healthcare, wellness, biotech and med-ical marketing practitioners. Event management says Lions Health is built to deliver the insights, ideas, tools and techniques that lead to life-changing outcomes.

The fifth annual Lions Health took place on June 18-19 along the French Riviera. The FCB Health Network was named “Healthcare Network of the Year.” This ac-colade is presented annually and honors the “healthcare network that obtains the most points” in award wins and shortlist entries across the Pharma and Health & Wellness categories at Lions Health.

Havas Lynx Manchester was the Cannes Lions’ Healthcare Agency of the Year recipient. That team also was bestowed with two Silver Lions and a Bronze Lions in Pharma.

TBWA\India was awarded the Health Grand Prix for Good at Cannes Lions Festival of Creativity for ‘Blink to Speak’, which is believed to be the first eye language guide made in India to help the paralyzed interact with-out speech. The eye language guide was created for the non-profit organization Asha Ek Hope Foundation and NeuroGen Brain and Spine Institute, after several months of research with physicians, patients and care-givers to ensure the guide would make a real difference to those people’s lives who are struggling with speech

The following passages represent perspectives on a variety of topics from some of the industry personnel who attended Lions Health 2018 ...

The Return of Big PharmaRich LevyCCOFCB Health Network Cannes Lions Pharma Jury President 2018

After five years, big phar-maceutical companies fi-nally had their coming-out party at the Cannes Lions Festival of Creativity. And for those of you not used to seeing those words - “pharmaceutical compa-nies” and “creativity” - in the same sentence, you better get used to it be-cause I think this is just the beginning of great things.

This year, 15 of the world’s top Big Pharma companies were represented on the shortlist and with gold, silver and bronze Lions. Companies like Boeh-ringer Ingelheim, Pfizer, Roche, Bayer, Takeda, Lilly and many more. This was also the year we saw numer-ous shortlisted works, and Lions being awarded to HCP branded campaigns. Yes, you’re reading that correct-ly: the work that we do every single day of the week - branded work to HCPs - was awarded many of the top awards this year.

What was different this year than from other years? What happened to allow this work to be recognized? What can we learn moving forward to 2019 and 2020?

I think there were three trends that made this year’s work stand out – and will help future entries moving forward:

1) Big Pharma work had incredible craft. If you look at this year’s Pharma shortlist, over 80% of the en-

tries were in Craft categories. If your entry didn’t have incredible craft, it didn’t even get consideration for a shortlist or a Lion. We saw great photography, cinema-tography, illustration and art direction. But in the jury room, we also saw countless touching and emotional films that made us stop and think. And none of them made the shortlist. The issue – they all looked exactly the same and had very ordinary craft. In fact, there were jury members who pointed out that most were shot in black & white. All liberally used B-roll footage to height-en the drama. Most had at least 25% of the shots in slow motion. All you needed to do was insert rare disease and engaging patient and you had yourself a Cannes entry. There was one entry I specifically remember that had an incredible insight and was well done. But it was shot so poorly, and entered by a giant pharma company, that we couldn’t get over the lack of craft. We thought the giant company should have aspired to better.

2) Integrated ideas will always stand out – if all the components are equally great. This year we saw a

lot of campaigns with components in multiple media. The problem was that very few of them were great in ev-ery medium. Just because you run a campaign in print and broadcast and in-office and social does not neces-sarily make it an integrated campaign. In the jury room, we look at each piece and they all have to be great. There was an MS campaign that I remember had an excellent social element, but the rest of the campaign was just OK. And even though the campaign was entered in 15 categories, including social, by the time we finished looking at all the entries, the rest of the campaign ac-tually hurt the social entry. The jury had decided that this campaign wasn’t good enough. Which was a shame – because one piece was really good. But that’s also an-other learning for the future. Don’t over enter a cam-paign. Remember that the same jury judges EVERY category in Lions Health. Therefore, by the time you’ve watched the same case film for the 10th, 15th, or 20th time, you’re actually tired of looking at it. Please, please, please – in the future – enter a campaign no more than 5 times. The most awarded campaigns this year were entered 3 to 5 times. Everything entered more than 10 times did not get shortlisted.

3) The new Pharma categories really helped separate pharma from non-pharma work. I don’t think we

can underestimate the effect the new categories had on the entry process. No longer were the same entries in both Pharma and Health & Wellness. We had very little debate about whether a specific entry belonged in our jury room. (With one notable exception – we actually recommended an entry move from our jury to the H&W jury. When the agency declined, we had no choice but to vote with our hearts. 12 entries – 0 shortlists.) I believe that in the future, understanding which category to en-ter your work in will be the greatest predictor of success. Spend time considering what your campaign really is all about. Is your campaign at its heart an online video? Is it a social post? Is it a broadcast campaign? All of these examples are different categories. And yet, as a jury, all are viewed differently. Where and how you enter will dictate your success or failure.

This was a transformative year in Cannes. We can fi-nally put to rest that “Big Pharma can’t win.” We can fi-

nally stop talking about how the regulations in the USA make it impossible for US agencies to win. And we can finally stop apologizing for working in healthcare adver-tising. Because as this year’s Cannes winner proved, the work that we’re doing can be both lifesaving and cre-ative. And for that, I’m very proud.

ACTIONS SPEAK LOUDER Dana PanzoneAssociate Creative DirectorFCB Health, an FCB Health Network Company

“Brands have more pow-er than they know. Every moment, no matter how dark, is an opportunity for change, light and growth.”

Of all the great quotes from the Cannes Lions Festival of Creativity, these words from Grey’s Anatomy actress Ellen Pompeo have stuck with me the most since my re-turn.

In light of such issues as data privacy breach-es and fake news hurting the credibility of market-ers, Pompeo’s views on brands needing to stand for something and take action for humanity were echoed by several other speakers at this year’s Festival. It also showed in a lot of the work.

The ALS Association’s “Project Revoice” campaign, an initiative that helps give people with ALS a chance to have their voices back, earned the Grand Prix for Good and a standing ovation at the award show.

Bodyform & Libresse’s “Blood Normal” campaign, which boldly aims to destigmatize and normalize wom-en’s periods by depicting real menstrual blood in their ads, won the Glass Lion for Change Grand Prix.

Savlon’s “Healthy Hands Chalk Sticks” campaign put children’s hand hygiene first in India with their sim-ple yet brilliant creation of chalk infused with soap-like cleansers and was awarded the Effectiveness Grand Prix.

NeuroGen Brain & Spine Institute and Asha Ek Hope’s “Blink to Speak” campaign created an entirely new language to help people with paralysis communi-cate and received the Health Grand Prix for Good.

Keep in mind, of course, that all of the aforemen-tioned campaigns won awards in other categories as well. This shows that creativity for the greater good has no boundaries—not even when it comes to pharma.

And speaking of pharma and proving that great work is possible even in a highly regulated industry, 16 of the top 20 pharmaceutical companies in the world were shortlisted this year.

Now that we’ve gained momentum, let’s keep push-ing forward.

Let’s keep fighting the good fight. Let’s act with a strong moral fiber in these unstable

times. Let’s keep making a difference in people’s lives.It’s not only a huge opportunity for us in this indus-

try, but also our responsibility and reason for doing what we do.

Lions Health 2018 Takeaways

Lions Health 2018extrafeature By Andrew Humphreys • andrew.humphreys@medadnews.com

FCB Health Network

LFCB Health

By Christiane Truelove • chris.truelove@medadnews.com

innovationspecialfeature

Focus on innovation

n seeking innovative players that could change pharma and healthcare, Med Ad News found the developer

of an app that helps people determine what illnesses are in their neighborhoods; the creator of a wearable injector that allows patients on biologics to receive these drugs outside the clinic; and a designer of a deep learning network aimed at giving pharma and healthcare companies a handle on their data.

I10

14

22

Christopher Bouton, CEO of Vyasa Analytics

DTC:A recent study of DTC advertising concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.

BIOTECH:This yearly review analyzes recent news developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers, and biobanks.

CX:Pharma marketers must listen to their customers and find ways to smooth the patient journey if they are to create effective customer experiences and create loyalty beyond the first prescription.

s the approvals of CAR-T, gene ther-apies, and the first digital therapy make

headlines across the world, the first question asked is, “How much does this cost?” The second question is, “Who is going to pay for it?” And the third question, from the payer perspective, is “Why should I pay for it?”

In the United States, a fragment-

ed healthcare delivery system, in which patients are forced to hop from insurer to insurer every few years, complicates matters. But even in Europe, where patients often stay with the same national system for a lifetime, the answers are not coming any easier.

The United States currently has two CAR-T therapies – Kymriah from Novartis and Yescarta from Kite Pharma and Gilead – and

one gene therapy, Luxturna, from Spark Therapeutics. Kymriah was approved in August 2017 for the treatment of for certain pe-diatric and young adult patients with a form of acute lymphoblas-tic leukemia. Yescarta gained approval in October 2017 for the treatment of adult patients with certain types of large B-cell lym-phoma who have not responded to or who have relapsed after at least two other kinds of treatment. And Luxturna was approved in December 2017 to treat children and adult patients with an inher-ited form of vision loss that may result in blindness.

In Europe, Glybera, for the treatment of lipoprotein lipase deficiency, was approved in July

2012. Amgen received approval of Imlygic for metastatic mel-anoma in October 2015. And Strimvelis, from GlaxoSmith-Kline, was approved in May 2016 for treating ADA-SCID, or “bub-ble boy” syndrome.

All of these therapies have fairly high costs. Kymriah’s announced price was $475,000. Yescarta is $373,000. And Luxturna is $850,000. When first announced on sale in Germany, Glybera’s price tag was close to $1 million, making it the most expensive drug in the world. Imlygic costs $65,000 for a six-month cost of treatment. And Strimvelis was an-nounced at €594,000 ($665,000) at the time of its approval.

The Magazine of Pharmaceutical Business and Marketing • medadnews.com • June 2018 • Volume 37, Number 3 • $25

continued on page 6

16 • MED AD NEWS JUNE 2018

ucked a third of the way into the May issue of the Journal of General Internal Medicine, in between articles about be-

havioral risk factors in the chronically ill and improving flu vaccine rates by using EHR portal messages, doctors across the land recently came across something they rarely encounter in a medical journal: a peer-reviewed study of direct to consum-er broadcast advertising. Opinion pieces on DTC in journals aren’t uncommon, but the authors of “Direct-to-consumer broadcast advertisements for pharmaceu-ticals: off-label promotion and adherence to FDA guidelines” went a step further by analyzing ads for regulatory compliance – every broadcast ad, in fact, that aired be-tween January 2015 and July 2016, for a total of 97 ads and 60 drug products.

Those authors didn’t seem very im-pressed. Their own conclusion: “Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber deci-sions merits further scrutiny.”

“Personally, I do not think DTC adver-tising should be legal in the United States,” says Joseph Ross, M.D., a professor of medicine and public health at the Yale School of Medicine and co-author of the DTC study article. “I have not seen good evidence that it is associated with better informed patients and caregivers. In con-trast, the studies I have seen suggest that it’s associated with higher rates of use of medications for less appropriate patients, meaning that it leads to both overdiagno-sis and overtreatment of patients.”

What did the authors mean by low qual-ity of information? In two words, quantita-tive data; they point out in the article that none of the ads they reviewed described drug risks quantitatively, and only a quar-ter described drug benefits quantitatively.

“The benefits were rarely quantified in a way that would allow a patient or caregiv-er to better understand whether they are likely to achieve a better outcome by tak-ing the medication,” Dr. Ross told Med Ad News. “For this, one would need to focus on absolute risk differences or, better yet (although it is unlikely), characterize num-ber needed to treat (i.e., 45 people need to take this medicine for one person to ben-efit). Most ads had little data on benefit. When they did, it was presented as relative risk (people on average got 20 percent bet-ter). And there was no quantitative data for safety or adverse events.”

Dr. Ross also brings up the issue of cost. “Because we rarely, if ever, see advertising for drugs available as generics, DTC adver-tising promotes use of higher cost medica-tions when cheaper, generic alternatives,

that work equally well, are available.”And then there’s off-label marketing.

According to the study authors, ads for five diabetes products “suggested non-FDA-approved – or off-label – uses, all of which were for weight loss and/or re-duction in systolic blood pressure.” As an example of what “suggested” means, they cited language from an ad for Novo Nor-disk’s Victoza – “Victoza is not approved for weight loss. In our largest study, when added to metformin, people lost on aver-age up to 6.2 pounds” – and AstraZen-eca’s Farxiga – “And although it’s not a weight loss or blood pressure drug, Farxi-ga may help you lose weight and may even lower blood pressure when used with cer-tain diabetes medicines.”

Does FDA consider statements like that to be off-label marketing? No, says Hens-ley Evans, principal at the sales and mar-keting consultancy ZS Associates.

“Off-label promotion would mean that they were suggesting that Victoza be used for weight loss in patients who have not been diagnosed with Type 2 diabetes, and it does not appear that there is any intent to do that,” Evans told Med Ad News. “Since they are pretty clearly saying in each case that the drug is not approved for weight loss, I would not call this off-la-bel promotion. Additionally, most new campaigns are pre-cleared with the FDA ahead of time, and while direction back from the FDA is not always clear in all as-pects, they are generally very specific with regard to claims.”

As to quality of information, Evans of-fers a very different perspective than the authors of the study, pointing out that they don’t offer any data showing that quantitative information makes ads easier to understand for the average consumer. “Based on my own experience and giv-en the very low overall numeracy of the U.S. population, adding quantitative data makes it more likely that consumers might be misled by the data, not less likely,” she says. “‘Low-quality’” seems to be a very subjective term.”

None of that, of course, should be tak-en to mean that pharma brand managers have perfected the art of balancing their messages, or that they can’t do better.

“I do think that the industry can constantly seek to improve the clarity and understandability of its DTC ad-vertising,” Evans told Med Ad News. “Many advertisers do make significant investments in consumer research to help structure messaging to ensure that consumers can and do understand both the benefits and the risks. The medical, regulatory and legal review processes through which DTC advertising is re-viewed internally by manufacturers is typically quite rigorous, and manufac-turers are consistently working to im-prove their processes and make their

ads effective while complying with FDA guidelines.”

But are those guidelines clear enough? One point on which the study authors and Evans agree is that FDA’s regulations on DTC are quite subjective. And in fact, the study authors take on that subjectivity in one of the key conclusions of their article: “By creating clearer, more objective re-quirements, the FDA could better regulate broadcast DTC advertising.”

Until that day comes, though, brand managers will try to stretch the bound-aries – and the JGIM study suggests that adding a bit of heft to the medical/regula-tory/legal review team may be in order.

“For many companies, a key objective is to produce and deliver high-quality, compliant promotional materials/adver-tisements, with speed to market as a key metric and success factor,” says Karl Kraft, VP, marketing operations and med/reg/legal, TGaS Advisors. “Marketers will con-tinue to push the envelope on what they can and can’t do regarding promotion, but a seasoned MRL review team will effec-tively interpret FDA guidelines to ensure their organization remains compliant. The results of this study suggest a gap in the interpretation of FDA guidelines for DTC advertising. Moving forward, organiza-tions will need to ensure the right people and processes are in place to deliver both effective and FDA compliant DTC ads.”

So the JGIM study may not be cause for brand managers to rend their gar-ments, but it should at least serve as a wake-up call.

“We live in an era of fake news,” says Jay Carter, senior VP, director of business de-velopment, AbelsonTaylor. “Fact checking is therefore essential, whether in the lay or medical press. I work on the front-line of the efforts to create effective and respon-sible DTC promotion. It’s a lot like making sausage. It can get messy.

“Reading (the) study on DTC adherence to FDA guidance in the Journal of Gen-eral Internal Medicine reminded me of the prevalence of fake news in our society. While my first inclination was to view the study as picayune, I was quickly reminded that fact-checking is essential in today’s society, and that the study is likely a sin-cere effort to shed light on how well the in-dustry adheres to FDA regs. That is surely a good thing.

“That doesn’t mean that there isn’t an agenda. In 2015 AMA officially called for a ban on DTC promotion of prescription drugs and medical devices. I strongly sus-

pect the authors of this study share this view. Just as we evaluate content from Fox News or the Washington Post, readers of studies like these need to keep the editorial agendas in mind. All in all, I’m grateful for the insights. But I’ll continue to hold my nose while making the sausage that is DTC advertising.” medadnews

Which color is it? By Joshua Slatko josh.slatko@medadnews.com

DTCspecialfeature

A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.

T

Top pharmaceutical companies by DTC ad spend

in millions

Rank Company 2017 2016

1 Pfizer $1,312 $1,413

2 Lilly $480 $396

3 AbbVie $467 $498

4 Allergan $420 $484

5 Merck $371 $389

6

7

8 D A T A PENDING

9 ( h o p i n g to receive by tomor-row)

10

Industry-wide $6,128 $6,423Source: Kantar Media

Top pharmaceutical brands by DTC TV spend

in millions

Rank Brand 2017 2016

1 Humira $341 $344

2 Lyrica $216 $221

3 Xeljanz $167 $139

4 Trulicity $145 $58

5 Eliquis $142 $174

6 Keytruda $127 N/A

7 Xarelto $120 $84

8 Taltz $116 N/A

9 Breo $103 $103

10 Cosentyx $100 $87Source: iSpot.tv

Top pharmaceutical brands by DTC ad spend

in millions

Rank Brand 2017 2016

1 Humira $429 $439

2 Lyrica $350 $392

3 Xeljanz $273 $259

4 Eliquis $227 $301

5 Keytruda $209 $67

6 Taltz $207 $82

7 Chantix $207 $157

8 Trulicity $195 $142

9 Cosentyx $174 $147

10 Entresto $159 $124Source: Kantar Media

inside

10 • MED AD NEWS JUNE 2018

ith many big deals already on the ledger this year, 2018 is on track to be a popular one in terms of M&A activity in the biotech/biopharma

world. With key drugs dealing with lower sales due to patent cliffs and increased competition, the big players in the pharma and biotech space are looking to build their pipelines with new prospects to boost growth. Also helping fuel the acquisition pace is tax reform that enables companies to pay less in corporate taxes and repatriate cash at a reduces rate.

2017 was regarded as a lackluster year on the merger and acquisition front in the pharma/biotech world by many industry analysts. “The strength exhibited by biopharma shares in 2017 is perhaps surprising when considering the fail-ure of M&A action to pick up. Widely considered a driver of investor enthusiasm, takeover activ-ity actually dimmed over the year,” according to the EP Vantage Pharma, Biotech & Medtech 2017 in review report.

“A paltry 179 deals were struck, raising just $80bn and thus making 2017 the slowest M&A year of the past five. These figures encompass global drug makers,” the analysis says. “Many blamed uncertainty over US tax reforms for holding big companies back from making bold strategic moves. Escalating valuations were an-other culprit, while the hobbling of several of the industry’s serial acquirers, namely the spe-ciality companies, cannot have helped.

Helping propel an uptick in pharma/biotech M&A transactions so far in 2018 is the imple-mentation of the new tax law, which cuts cor-porate tax rate from 35 percent to 21 percent and encourages companies to bring back huge cash held overseas at a one-time tax rate of 10 percent. As a result, big pharma and biotech companies based in the United States can more failry compete with foreign counterparts firms that operate in better tax environments.

2018 opened with a surge in prime-time transactions during January as Sanofi acquired

Ablynx and Bioverativ while Celgene landed Juno Therapeutics and Impact Biomedicines. On Jan. 22nd, Sanofi announced a deal repre-senting an equity value of $11.6 billion (on a fully diluted basis) to acquire Bioverativ Inc., a biopharmaceutical company focused on thera-pies for hemophilia and other rare blood disor-ders. The transaction, completed on March 8th, expands Sanofi’s presence in specialty care and strengthens the company’s leadership in rare diseases. The deal also provides Sanofi with a leader in the growing hemophilia market and provides a platform for expansion in other rare blood disorders.

One week after the announcement of the Bioverativ transaction, Sanofi agreed to pur-chase Ablynx at a price per share of €45 in cash for the biopharmaceutical company, represent-ing an aggregate equity value of €3.9 billion. The deal, bolsters Sanofi’s R&D strategy with Ablynx’s innovative Nanobody technology plat-form. Nanobodies are proprietary therapeutic proteins based on single-domain antibody frag-ments, which combine the advantages of con-ventional antibody drugs with some features of small-molecule drugs. The acquisition also expands the French drugmaker’s growing rare blood disorders franchise with Ablynx’s late-stage investigational caplacizumab acquired thrombotic thrombocytopenic purpura (aTTP) treatment.

On Jan. 7th, Celgene revealed the signing of a definitive agreement to buy Impact Biomed-icines, which has been developing the highly selective JAK2 kinase inhibitor fedratinib for myelofibrosis and polycythemia vera. Celgene made an up-front payment of $1.1 billion and is also responsible for $1.25 billion in contin-gent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in other therapeutic indications and sales-based mile-stones are additionally possible. A New Drug Application filing for fedratinib in myelofibrosis is planned for mid-2018.

Celgene’s busy January continued when the Summit, N.J.-based biopharma company

agreed to purchase Juno Therapeutics Inc. for $87 per share in cash (representing a total of $9 billion) net of cash and marketable securities ac-quired and Juno shares already owned by Cel-gene (9.7 percent of outstanding shares). Juno is regarded as a pioneer in the development of CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a broad, novel portfolio assessing multiple targets and cancer indications. Adding to Celgene’s lymphoma program, JCAR017 (lisocabtagene maraleucel; liso-cel) represents a potentially best-in-class CD19-directed CAR T undergoing a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). U.S. regulatory approval for JCAR017 is on track for 2019 with potential worldwide peak sales of $3 billion.

February deals inlcuded Merck’s AUD 502 million ($394 million) agreement to purchase the Australian oncolytic immunotherapies manufacturer Viralytics Ltd. to strengthen its presence in the fast-growing immuno-oncolo-gy market. The proposed acquisition of Viralyt-ics adds the investigational oncolytic immuno-therapy Cavatak, supporting Merck’s strategy to broaden its pipeline with the best scientific assets. According to Reuters, the deal came at a time of booming merger and acquisition activi-ty in the biotechnology sector, with $27.5 billion of transactions agreed in January alone as large drugmakers continue to seek promising assets to improve their pipelines.

Roche Holding AG agreed to purchase the remainder of U.S. cancer data company Flatiron Health that it di dnot already own for $1.9 billion to speed development of cancer medicines and support the Swiss biotech company’s efforts to price them based on how well they work. Roche already owned owns 12.6 percent of Flatiron, a privately held company backed by Alphabet Inc. that taps into data on individual cancer cases to help physicians chose promising approaches for their patients.

March M&A activity in March included Dan-ish drugmaker Lundbeck’s deal potentially worth $1.1 billion to purchase buy Prexton Therapeutics, a specialist in treatments for brain disorders. Prexton’s drug candidate foliglurax is undergoing Phase II testing for the treatment of Parkinson’s disease, with first data expected to be available during first-half 2019.

A big deal was announced by Novartis during April when the Swiss company entered into an agreement to acquire AveXis Inc. for $8.7 billion. The acquisiton of the U.S.-based clinical-stage gene therapy company was finalized on May

15th. AveXis’ lead product candidate, AVXS-101, has the potential to be first-ever one-time gene replacement therapy for spinal muscular atro-phy (SMA), a disease that results in early death or lifelong disability with considerable health-care costs. Granted breakthrough therapy des-ignation by the FDA, AVXS-101 is expected to be launched in the United States during 2019 and represents multi-billion dollar peak sales potential. In addition, AveXis offers a valuable gene therapy platform, with potential beyond SMA, and scalable manufacturing to accelerate potential future gene therapy programs and launches for Novartis.

The largest industry deal of the year by far occurred in May with Takeda Pharmaceutical Co. Ltd.’s proposed 45.3 billion pound ($62 bil-lion) acquistion of Shire plc, creating a global, values-based, R&D-driven biopharmaceutical leader with headquarters in Japan. The acquisi-tion represents the largest overseas purchase by a Japanese company and will vault Takeda into one of the world’s top 10 global drug manufac-turers.

The Takeda-Shire transaction unites com-plementary positions in gastroenterology and neuroscience, and provides leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines. Expected to close during the first half of 2019, Takeda shareholders will own 50 percent of the combined group.

Eli Lill and Co. announced a pair of acquisi-tions within five days of each other during May. First up was a $1.6 billion transaction reported on May 10th that strengthens Lilly’s clinical portfolio with ARMO BioSciences Inc.’s lead im-muno-oncology asset and PEGylated IL-10 pe-gilodecakin, which is being studied in multiple tumor types. ARMO BioSciences is a late-stage immuno-oncology company that has been developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors.

Lilly then expanded its oncology pipeline with the acquisition of AurKa Pharma Inc. Aur-Ka was established by TVM Capital Life Science to develop the oncology compound AK-01, an Aurora kinase A inhibitor that was originally dis-covered at Lilly. The compound represents a po-tential first-in-class asset that AurKa Pharma has been evaluating in Phase 1 studies in multiple types of solid tumors.

J&J’s Janssen Biotech Inc. announced during

bioannualreportState of the Bio IndustryThis yearly review analyzes recent news developments, trends and outlooks in the areas of biotechnology, biosimilars, bio-pharmaceuticals, biologics, biomarkers, and biobanks.

WBIG DEALS IN 2018

By Andrew Humphreys • andrew.humphreys@medadnews.com

8 Copyright © 2018 Evaluate Ltd. All rights reserved.M&A fails to pick up

M&A fails to pick up

The strength exhibited by biopharma shares in 2017 is perhaps surprising when considering the

failure of M&A action to pick up. Widely considered a driver of investor enthusiasm, takeover

activity actually dimmed over the year.

A paltry 179 deals were struck, raising just $80bn and thus making 2017 the slowest M&A year of the past five. These

figures encompass global drug makers - medtech M&A is detailed later.

Source: Evaluate® January 2018Five years of M&A – deal values and volumes

Comb

ined d

eal v

alue (

$bn) 

Deal

coun

t 

50

100

150

200

250 350

300

250

200

50

100

150

00

Combined deal value ($bn)

Deal Count 

Year2017

80.0

2016

104.4

2015

188.9

2014

219.3

2013

79.5

203

290

229226

179

Many blamed uncertainty over US tax reforms for holding big companies back from making bold strategic moves.

Escalating valuations were another culprit, while the hobbling of several of the industry’s serial acquirers, namely the

speciality companies, cannot have helped.

Whatever the reasons, the analysis below suggests that a big drop in small and mid-sized takeovers pushed transaction

volumes, and total deal values, lower.

Year <$250m $250m-$1bn $1-10bn $10-25bn $25+bn

Count Avg ($m) Count Avg ($m) Count Avg ($bn) Count Avg ($bn) Count Avg ($bn)

2017 67 69 18 620 8 2.5 1 11.9 1 30.0

2016 72 54 28 564 14 2.8 1 14.0 1 32.0

2015 134 57 32 521 26 2.9 3 16.4 1 38.7

2014 86 47 35 524 23 3.6 1 16.0 2 49.3

2013 52 86 30 479 14 3.6 1 10.4 0 -

M&A totals by valuation category* Source: Evaluate® January 2018

* Where deal values disclosed.

5 Biotech Stocks To Buy With Amazing Pipelines

1. Amgen Inc. (AMGN)

2. Seattle Genetics Inc. (SGEN)

3. Spectrum Pharmaceuticals Inc. (SPPI)

4. Gilead Sciences Inc. (GILD)

5. BioMarin Pharmaceutical Inc. (BMRN)

Source: InvestorPlace (March 27, 2018)

Top 5 Biotech Stocks for 2018

1. Celgene Corp. (CELG)

2. Gilead Sciences Inc. (GILD)

3. Exelixis Inc. (EXEL)

4. Enzo Biochem Inc.

5. AbbVie Inc. (ABBV)

Source: Investopedia (May 3, 2018)

16 • MED AD NEWS JUNE 2018

ach of us has that favorite brand. You know the one. The one that you tell all your friends about. The one that

you’ll pay more for and wait in line for hours to have. The one that delivers an ex-perience at every interaction that seems to “get you.” That brand that provides value, services, and support in ways that are un-expected and, dare I say, extraordinary.

None of that happens by accident. Con-sumer brands invest significant resources in developing and executing campaigns that create expectations for what custom-ers can experience from that brand. But then they go further. They don’t leave those experiences to chance. By listen-ing to their customers, consumer brands purposefully design experiences that meet and at times even exceed those expecta-tions by eliminating friction and reducing effort, across the customer journey, and on behalf of the customer.

That is just exactly how we in pharma marketing ought to be thinking when we consider the relationships we want to have with our customers. And listening is where those relationships will begin. Listening - in whatever way we can - yields data that, combined with behavioral insights and understanding, illuminates the truth of our customers’ experiences. It is through these truths that we may begin to consider how interactions between our brands and our customers can become more mean-ingful.

This is an extraordinary time to be a pharmaceutical marketer. We know ex-ponentially more about our customers’ wants and needs than ever before. We have tools that our predecessors never could have imagined – social media, ma-chine learning for data analysis, virtual and augmented reality, highly granular targeting capabilities, on and on. And we have products to offer that can absolute-ly transform lives – turn death sentences into chronic illnesses and chronic illnesses into mild inconveniences.

But, all that said, when was the last time that you personally had an interaction or relationship with a healthcare entity that was so extraordinary that you told your friends or family about it? Or came out on the other end feeling that your life had been made easier, not more difficult? It’s highly unlikely. In fact, according to a re-cent PwC survey, healthcare and pharma have the second and third largest gaps be-tween customer expectations and reality, coming in right behind the airline indus-try. Virgin, JetBlue, and even Southwest understood this. Each has disrupted the airline industry by carving out competi-tively differentiating spaces by launching on the principles of customer experience. Each only gets customers from point A to point B. Yet, each has created experi-ences based on a deep understanding of what customers want and desire. They’ve

created loyal customers - advocates, really - that love talking about their experiences. Jet Blue has more than two million fol-lowers and over 53,000 likes on Twitter! So if a bag of peanuts, a leather seat, and DirecTV gets you 53,000 likes, what might providing a life-saving medicine alongside purposefully designed friction busting in-teractions do? We have so much room for improvement in health care; even in-cremental improvements could make a significant difference in our customers’ lives and provide competitive advantages within categories.

Seamless, consistent, and valuable ex-periences are what customers in 2018 ex-pect, whether in health care or anywhere else. Anyone who has already experienced Amazon or Zappos or Uber doesn’t just expect a compelling product—they expect an effortless experience that enhances the product. A customer who has become used to the unitary, highly responsive ex-perience of Amazon is almost inevitably going to be disappointed with the sort of transactional, brand-focused experiences that most pharma brands are still ped-dling.

It’s not for lack of effort on our part. It’s safe to say that we all care about our customers; we appreciate the role that CX plays and understands intuitively how much it matters. We do our best to make sure that interactions between our brands and customers are meaningful. But now we can and must go beyond intuition and transactions. CX is not limited to a specific transaction, website visit or sales call. It’s about the collective experience that our customers have along the journey. Re-search shows that at least 40 percent of physician brand preference is attributable to CX factors beyond the product. Cus-tomer experience matters.

But we are still struggling uphill. We are pushing against the inertia of an industry that has spent the better part of a centu-ry being entirely brand-focused. We live in a regulatory environment that compli-cates models of care and, at times, limits engagement with our customers. And we push against our own internal frag-mentation, what the business consultants like to call “silos.” Always, we start with the best intentions and draw up custom-er journey maps and find places to touch the customer along those journeys. But inevitably, the touch points remain largely transactional—where we are talking at our customers—rather than transformational and bidirectional and, well, responsive to actual wants and needs. And the customer journey maps remain inside out – focused on the brand and when we want to en-gage – rather than outside in, focused on the wants and needs and dreams of the customer, most of which have little to do with brands. “Customer-centricity” and “customer experience” have been popular buzzwords in our industry for years now,

but how often are we still just delivering information about our brands rather than listening.

And listening is what we must do—we need to listen and take to heart what our customers are saying about the difficulties they are facing beyond the brand, and then act to create more high-value interactions that will have an exponential customer impact. We need to deliver on the promise of our products beyond mere customer ac-quisition, when we cross our fingers hop-ing that our patients will come back; we must purposefully create emotional con-nections with a human-centered, need-fo-cused, ongoing experience.

What might this look like? Consider the mental illness space. Patients suffer need-lessly not because medications don’t work but because of non-drug-related obstacles. Perhaps patients feel alone or not under-stood. Or, feeling overwhelmed and un-able to leave their home, they don’t or can’t make an appointment with their physi-cian. Or maybe they don’t even have a phy-sician and don’t know where to go to find one. Perhaps they are fortunate enough to make it into the system and get diagnosed, but then, without a support system, they fall out. In a space like this we have the extraordinary opportunity to build a cus-tomer experience with empathetic inter-actions designed to address these specific, inherent challenges and support patients in ways that go far beyond brands. For ex-ample, your brand could take advantage of technology that allows patients access to care without leaving their homes. Your brand could help patients find others just like them, mentors who can provide un-derstanding and support. Purposefully designing CX around customer needs generates measurable positive outcomes, drives revenue, and has the potential to generate a degree of loyalty from patients and healthcare providers that we just don’t see in pharma today.

Consider, too, rare diseases. Confronted with a rare disease, patients and caregiv-ers are overwhelmed. Something they’d never heard of last Thursday, a disease they might not even be able to pronounce, is now threatening their life or the life of a loved one. Information and resourc-es—even answers to the simplest ques-tions—are hard to come by. Families and customers with rare diseases have to tackle fear, uncertainty, a lack of credible information, and, sometimes, a lack of ac-cess to care; the nearest specialist might be 100 miles away. Faced with these circum-stances, many rare disease communities have developed organically, led by the pa-tients themselves – patients who lack the resources that we in pharma have at our fingertips. Of course, bringing a revolu-tionary product to the market is no small achievement on its own. But what an op-portunity to go further! We can, by listen-ing to what our patients need, want, and desire and by taking advantage of resourc-es (like data and technology) in new and useful ways. Imagine designing CX with curated resources on behalf of patients,

providing clinical trial alerts, and enabling telehealth connections with specialists at Centers of Excellence. We have the power to take rare disease patient communities so much further.

Or what about something as simple as reconsidering the roles of our sales forces? Consider this—the vast majority of sales force interactions are purely transactional and unidirectional, dropping information off about our brands with no real opportu-nity to develop meaningful relationships. How much value does that really provide for the physician or for the office staff? Does this really meet anyone’s expecta-tions of a modern customer relationship? What if we start calling sales reps “rela-tionship managers” instead, and actually make them real relationship managers? We can train reps to be relationship man-agers, seeking out the challenges that their customers face and then providing them with the tools and support necessary to overcome those challenges. Think that might improve some outcomes, and even sales? I believe it would—and it’s support-ed by evidence. A 2017 study lead by the Temkin Group found that 73 percent of companies with above average CX matu-rity had better financial performance than their competitors.

So, we need to retool at a fundamental level the entire way we think about our relationships with patients and physi-cians. “We see our customers as invited guests to a party and we are the hosts,”

Saving lives isn’t enough any more By Colleen Carter

Testing your CXWant to measure your CX IQ? Answer these questions.

• Are your customers satisfied, or are they loyal? • Who “owns” customer experience within your organization? • What expectations are your promotional efforts setting, and is your customer experience meeting those expectations, or falling short at key moments?• What percentage of your resources are committed to acquisition - getting that first script - compared to the resources committed to CX that builds loyalty and advocacy? • Are your customer journey maps “inside-out” maps that center focus on the brand and how and when YOU want to engage with your customers OR “outside-in” maps that focus on identifying the points of greatest friction for your customer?• Can everyone within your organization articulate the key characteristics of your defined customer experience?• Do silos exist within your organization that don’t allow for a seamless and consistent customer experience?• How regularly do you talk to your customers about their experience with your brand?• How are you using the data you collect about customers to optimize their experience?• What are the top five challenges your customers have when considering their needs?• How are you currently measuring customer experience?

customer/patient experiencespecialfeature

Pharma marketers must listen to their customers and find ways to smooth the patient journey if they are to create effective customer experiences and create loyalty beyond the first prescription.

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By Christiane Truelove • chris.truelove@medadnews.com

payer accessspecialfeature

Straining the systemCurrent health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.

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Volume 37, Number 2 • April 2018 • medadnews.com • $100

T H E M A G A Z I N E O F P H A R M A C E U T I C A L B U S I N E S S A N D M A R K E T I N G

HEALTHCARE COMMUNICATIONS AGENCIES

After an osteoporotic fracture, consider speaking to your patients about initiating treatment to reduce the risk of future fractures.

A SIGN DARKER THINGS MAY COME

OSTEOPOROTIC FRACTURE:In postmenopausal women,

*A review of international publications published between 1959 and 1998 on the outcomes after hip fractures in men and women older than 60 years.5

A recent fracture could lead to a downward spiral of immediate subsequent fracture, mobility loss and, potentially, death.3,4

1 in 4 patients who had a hip fracture died within 12 months.5*

23% OF ALL SUBSEQUENT FRACTURES OCCUR IN THE FIRST YEAR AFTER THE FIRST FRACTURE

2†

† A cross-sectional study with postmenopausal women aged 50 to 80 (N=4140) who completed a questionnaire on risk factors for osteoporosis, fracture history, and onset of menopause. The time that elapsed between a fi rst and subsequent clinical vertebral and nonvertebral fracture, including low-trauma and high-trauma fractures, was analyzed at various times after the fi rst fracture.2

DON’T UNDERESTIMATE THE URGENCY TO TREAT

© 2017 Radius Health, Inc. All rights reserved. 02/17. DS-Osteo-US-00085

HAVE ANY OF YOUR POSTMENOPAUSAL PATIENTS HAD AN OSTEOPOROTIC FRACTURE?

AN OSTEOPOROTIC FRACTURE IS A SENTINEL EVENT. SPEAK TO YOUR PATIENTS ABOUT THEIR HEIGHTENED RISK OF FUTURE FRACTURE1,2

HEAR FROM AN OSTEOPOROSIS EXPERTHEAR FROM AN OSTEOPOROSIS EXPERT

Dr. Nelson Watts, an endocrinologist formerly

at Emory University and the University

of Cincinnati, currently at Mercy Health—

Osteoporosis and Bone Health Services

in Cincinnati, gives his perspective

on osteoporosis at rethinkosteoporosis.com

References: 1. National Coalition for Osteoporosis and Related Bone Diseases. National Action Plan for Bone Health: Recommendations From the Summit for a National Action Plan for Bone Health. http://www.oif.org/site/DocServer/BoneHealthReport.pdf. Accessed February 15, 2017. 2. van Geel TA, van Helden S, Geusens PP, Winkens B, Dinant GJ. Clinical subsequent fractures cluster in time after fi rst fractures. Ann Rheum Dis. 2009;68(1):99-102. 3. Offi ce of the Surgeon General (US). Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: Offi ce of the Surgeon General (US); 2004. 4. Johnell O, Kanis JA, Odén A, et al. Fracture risk following an osteoporotic fracture. Osteoporos Int. 2004;15(3):175-179. 5. Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ. Mortality following hip fracture: trends and geographical variations over the last 40 years. Injury. 2008;39(10):1157-1163.

“Fingerpaint truly exemplifies what it means to give to others. Thank you for all you do to make our community a better place.”

Michael Finocchi, Shelters of Saratoga 

nyone with a teenage child might be in-clined to feel that technology drives

humans further apart, not closer together. But pharmaceutical marketers are betting on the opposite view. In the past year – and the coming one – brand managers have been and are continuing to grasp for any tool at hand that can help get them closer to the physicians and patients on the other end of their communications. Big data, programmatic targeting, analytics, artificial intelligence, virtual reality; it all sounds like computer science class at MIT, but the goal remains very much flesh and blood. Has it been working? Will it work? Is 2018 the year of the great turn? We at Med Ad News asked folks inside the industry what we thought were the key questions for the year. Here’s what they told us.

MedAdNews: What was the word of the year in pharma marketing for 2017? Why? What will the word of the year be in 2018? Why?

Melissa Barnhart, senior VP, media, CMI/Compas: 2017: Data. We are not at a loss for data, it’s about focusing on making the data meaningful and actionable.

2018: Individual. Under-standing your audience has always been of critical impor-tance, and now we have better tools than ever to reach indi-viduals with information that is valuable to them Instead of marketing to the masses, ensure you’re reaching the individuals who will have the most impact.

Jay Carter, executive VP, director of business development, Abelson-Taylor: The word of the year in pharma marketing for 2017

was definitely “APPROVED!” The number of new molecular entities approved in 2017 (46) is greater than any other year since 1996. And that’s not counting other high-profile approvals like CAR-T and gene therapy products.

That’s BIG news in an indus-try where investment in launch is critical to early-term and long-term success. It’s VERY BIG news to the agencies and promotion partners for pharma, as new product launch is a time when marketing spend is gener-ally at its highest.

The word of the year in phar-ma marketing for 2018 will be “data.” Make that BIG DATA. The growing availability of near real-time access to HIPAA com-pliant “scrubbed” EHR data, combined with the data ware-houses that are already accruing for major brands, offers Pharma the opportunity to really tailor communications to HCPs.

Let’s be clear, though: while data is the word, it’s not the solution. The solution to Phar-ma’s problem is to find import-ant relationships in physician data that companies can react to. We like to use a simple para-digm that makes this clear:

- “If I knew….” Knowing when

a newly diagnosed patient gets one of your brands, or when a physician switches one of your brands, is big news. Getting that information is a major blip on brand radar.

- “Then I could….” Informa-tion yields the opportunity to determine what reactions are in-dicated, and Pharma companies can tailor their reaction based upon the overall brand plan and ecosystem. Certainly seeing your brand used -- or abandoned -- can prompt a company to deliver promotion to address the issue. Algorithms can help you decide what action to take. For instance, we can now correlate whether activity by a clinician is driven by medical education vs. sales calls vs. other inputs like local managed care access.

- “So that….” As always, “so that” is the key – so that a com-pany can implement local action to address both opportunities and threats.

Robert Ehrlich, CEO, DTC Perspectives: Premium-pric-ing. Marketers have discovered that high priced drugs in small, targeted markets do make sense for mass media campaigns. What used to be drugs entirely focused

The Magazine of Pharmaceutical Business and Marketing • medadnews.com • February 2018 • Volume 37, Number 1 • $25

TOP 10 PIPELINES:Deal activity is rampant as big pharma gobbles up biopharmaceutical companies and next-generation technologies to overcome maturing pipelines and biosimilar threats.

VALUE:As more innovative – yet even more expensive – therapies enter the U.S. market, marketers will have to find equally new and innovative ways to prove the value of their drugs to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.

MAHF:Robert Leverte was inducted as the newest member of the MAHF.

continued on page 6

14 • MED AD NEWS FEBRUARY 2018

&A and deal-making production constitute a common theme among the 10 companies ana-lyzed in this annual report as the industry’s R&D leaders seek out

new game-changing medicines and technologies to complement and bolster their existing product arsenals. This article features a bevy of pipeline drug prospects and recently approved medicines with anticipated blockbuster potential spanning a wide range of therapeutic areas, from immu-no-oncology to rare diseases.

Criteria used to determine this year’s featured 10 companies include current pipeline projects and their sales & marketing potential, fields of therapeutic concentration, M&A and deal activity and its R&D impact, and recent approvals for new molecular entities as well as expanded indications for existing brands.

This is an exciting time for AbbVie – we are poised to launch a number of differentiat-ed products over the next 12 to 18 months

that will fuel significant growth in the coming years,” stated AbbVie Chairman and CEO Richard A. Gonzalez in late January when the company released its full-year 2017 financial results. Those words should come as sweet music to the ears of investors considering that AbbVie’s sales dynamo Humira (adalimumab) for treating inflammatory disorders established a new industry record for prescription medicines during 2017, as the com-pany reported growth of 14 percent on a reported basis to $18.45 billion for the biologic.

AbbVie’s R&D activities are concentrated on the following therapeutic areas: immunology (includ-ing rheumatology and dermatology); oncology; neuroscience (including multiple sclerosis, Par-kinson’s disease and Alzheimer’s disease); virol-ogy (HIV-1 and hepatitis); and general medicine (including cystic fibrosis, endometriosis, uterine fibroids and diabetic neuropathy).

Some of AbbVie’s new molecular entities an-ticipated to eventually enter the marketplace and generblockbuster sales on an annual basis include rovalpituzumab tesirine (Rova-T), upadacitinib, and elagolix.

The investigational antibody-drug conjugate (ADC) Rova-T targets delta-like protein 3 (DLL3), which is expressed in about 80 percent of small cell lung cancer (SCLC) patient tumors. DLL3 is prevalent on SCLC tumor cells, but not present in healthy tissue. Rova-T brings together a targeted antibody with a cytotoxic agent to deliver a sub-stance toxic to cells directly to the DLL3-express-ing cancer cells.

Rova-T is being studieD for the treatment of SCLC. An open-label, single-arm Phase 2 trial is under way to investigate Rova-T in the third-line setting in relapsed or refractory DLL3-expressing SCLC. Two randomized Phase 3 studies were initi-ated in the second-line and first-line maintenance

setting. Other clinical trials are under way in multi-ple neuroendocrine tumor types, metastatic mela-noma, and glioblastoma (GBM).

According to EvaluatePharma’s “World Preview 2017, Outlook to 2022” report, Rova-T ranked No. 4 among the top 20 most valuable R&D projects ranked by Net Present Value with an NPV of $8.49 billion as of May 2017.

AbbVie reported positive top-line results in De-cember from the Phase 3 SELECT-MONOTHERAPY study investigating upadacitinib (ABT-494) as a monotherapy treatment in patients with moder-ate-to-severe rheumatoid arthritis who did not adequately respond to treatment with methotrex-ate. Results demonstrated that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the clinical trial’s primary endpoints of ACR20 and low disease activity ver-sus continuing prior stable methotrexate therapy. The company expects data from two additional registrational studies during first-half 2018, sup-porting regulatory filings in second-half 2018.

In other upadacitinib news, AbbVie announced in January that the FDA granted Breakthrough Therapy Designation for the once-daily oral JAK1-selective inhibitor in adults with moder-ate-to-severe atopic dermatitis who are candi-dates for systemic therapy. The designation was supported by positive Phase 2b trial results. The Phase 3 clinical program for upadacitinib in atopic dermatitis is expected to startin first-half 2018.

Discovered and developed by AbbVie, the oral agent upadacitinib is engineered to selectively inhibit JAK1, which plays a significant role in the pathophysiology of immune-mediated disorders. In addition to being developed for rheumatoid arthritis and atopic dermatitis, Phase 3 studies are under way for psoriatic arthritis and Crohn’s dis-ease. Upadacitinib is also being evaluated for treat-ing ulcerative colitis and ankylosing spondylitis.

According to EvaluatePharma analysis, upadac-itinib represented the most promising anti-rheu-matic R&D asset in development during 2017.

At the American Society for Reproductive Med-icine Scientific Congress & Expo (ASRM), AbbVie – in cooperation with Neurocrine Biosciences Inc. – presented detailed results from two replicate Phase 3 extension trials. The studies are explor-ing the long-term efficacy and safety of elagolix, which is an investigational, orally administered gonadotropin-releasing hormone (GnRH) antago-nist intended for the management of endometri-osis with associated pain. In the extension studies, elagolix showed sustained reduction in average monthly menstrual pelvic pain and non-menstru-al pelvic pain in women through the 12-month treatment period. Elagolix is undergoing priority regulatory review for the management of endo-metriosis with associated pain.

Elagolix is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Product use results in readily re-versible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone

(FSH) secretion, resulting in reduced ovarian pro-duction of the ovarian sex hormones – estradiol and progesterone – while on therapy. Elagolix is being explored in diseases that are mediated by ovarian sex hormones, including uterine fibroids and endometriosis. The GnRH antagonist has been studied in more than 40 clinical trials totaling 3,000-plus subjects. The U.S. regulatory agency granted priority review for AbbVie’s New Drug Ap-plication for endometriosis during fourth-quarter 2017. Phase 3 studies of elagolix for the manage-ment of uterine fibroids are under way.

AbbVie presented top-line results in December from the IMMhance study, the fourth pivotal clin-ical trial assessing risankizumab as a treatment for patients with moderate-to-severe plaque psoria-sis. Results demonstrated that risankizumab met all co-primary and ranked secondary endpoints in the clinical trial. AbbVie intends to file its regu-latory approval applications during the first half of 2018. The investigational interleukin-23 (IL-23) inhibitor is being developed in collaboration with Boehringer Ingelheim.

The investigational compound risankizumab is designed to selectively block IL-23 by binding to its p19 subunit. The key cytokine IL-23 is involved in inflammatory processes and is believed to be linked to various immune-mediated diseases. In addition to Phase 3 studies in psoriasis, risankizum-ab is being evaluated to treat Crohn’s disease and psoriatic arthritis. Also, future studies are planned to investigate risankizumab in ulcerative colitis.

In December, clinical results were revealed by AbbVie from the Phase 3 MURANO trial of Ven-clexta/Venclyxto (venetoclax) in combination with the blockbuster anti-cancer agent Rituxan at the American Society of Hematology (ASH) Annual Meeting. The results showed that patients with re-lapsed or refractory (R/R) chronic lymphocytic leu-kemia (CLL ) achieved significantly prolonged me-dian progression-free survival (PFS) with Venclexta in combination with Rituxan versus bendamustine in combination with Rituxan. Regulatory applica-tions were recently filed for Venclexta in combina-tion with Rituxan for treating patients with R/R CLL.

The oral B-cell lymphoma-2 (BCL-2) inhibitor Venclexta/Venclyxto targets a specific protein in the body called BCL-2. For individuals with CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. Venclexta/Venclyxto tar-gets BCL-2 to help restore the process of apoptosis, through which the body allows cancer cells and normal cells to self-destruct.

Venclexta/Venclyxto is cleared for marketing in 49 nations, including the United States and in the European Union. Venclexta/Venclyxto is being de-veloped by AbbVie and Roche, and is jointly com-

mercialized by Roche and Genentech – which is a member of the Roche Group – in the United States. AbbVie markets the product outside of the United States. The companies are dedicated to BCL-2 re-search with venetoclax, which is being studied in clinical trials for several hematologic cancers.

Also at the ASH meeting, AbbVie reported new and updated Imbruvica (ibrutinib) data, including pooled analysis results of the longest follow-up data to date in Bruton’s tyrosine kinase (BTK) in-hibition for R/R mantle cell lymphoma (MCL) pa-tients treated with Imbruvica. The data demon-strated that, at three years, 45 percent of patients were able to achieve overall survival and 26 per-cent had PFS. AbbVie additionally presented new three-year follow-up data from the RESONATE-2 clinical trial (PCYC-1115/1116), which found that previously untreated CLL/SLL patients reported sustained improvements in measures of well-be-ing with Imbruvica compared to chemotherapy with chlorambucil. The blockbuster brand Imbru-vica is jointly developed and marketed with Jans-sen Biotech Inc.

The Phase 3 iNNOVATE study evaluation Imbru-vica in combination with Rituxan in patients with treatment-naïve and previously-treated Walden-ström’s macroglobulinemia (WM) successfully met its primary endpoint and showed improvement of PFS compared to Rituxan alone, according to AbbVie. The Independent Data Monitoring Com-mittee recommended that the clinical trial be unblinded based on the positive outcome from the pre-specified interim analysis data. AbbVie ex-pects to submit these data for label augmentation during 2018.

top10pipelinesannualreportTop 10 PipelinesDeal activity is rampant as big pharma gobbles up biopharma-ceutical companies and next-generation technologies to overcome maturing pipelines and biosimilar threats.

M By Andrew Humphreys • andrew.humphreys@medadnews.com

AbbVie

AbbVieBiogenCelgeneGileadIncyte

Johnson & JohnsonMerck

Novo NordiskSanofiShire

TOP 10 PIPELINES

8 J.P. Morgan Healthcare Conference | January 10, 2018 | © 2018

Risankizumab Anti-IL-23 Antibody

Upadacitinib Oral JAK1-Selective Inhibitor

Early-Stage Programs Innovative Biologics & Small-

Molecules, Novel Targets

Recently reported Phase 3 psoriasis data support high levels of complete skin clearance and strong durability

Strong results from the first three Phase 3 studies in rheumatoid arthritis support our view of potential best-in-class therapy

Anti-TNF/Steroid ADC (ABBV-3373) targeting RA, IBD and HS

Phase 2 data in Crohn’s disease demonstrate strong activity and support advancement to Phase 3

Phase 2 data in atopic dermatitis and Crohn’s disease demonstrate strong activity and support advancement to Phase 3

CD40 antagonist (ABBV-323) targeting IBD, SLE and Sjögren’s

Expect to begin a Phase 3 study in ulcerative colitis in the first half of 2018

Development also ongoing in psoriatic arthritis, ankylosing spondylitis, ulcerative colitis

JAK1i/BTKi combo (ABBV-599) targeting RA, SLE and Sjögren’s

Expect to launch in four indications by 2023, starting with PsO in 2019 Expect to launch in six indications by 2022, starting with RA in 2019

AbbVie Immunology Pipeline Differentiated Late-Stage Assets and Promising Early-Stage Programs

Upadacitinib and risankizumab expected to be significant growth drivers, with 2025 nominal sales potential of ~$6.5Bn and ~$5Bn, respectively

By Joshua Slatko • josh.slatko@medadnews.com

AGENDA 2018: THE SONG REMAINS THE SAMEThe names of the tools may be changing, but the goal for brand managers remains the same in 2018: getting as close as possible to real patients and their needs.

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hat is the price of innova-tion? What is the value of a medicine that provides therapeutic benefit but has awful side effects that

reduce quality of life? Or what is a drug’s value when it is a real innovation but its long-term benefit is an unknown and its potential overshadowed by its high list price? These are the questions that manufacturers will have to wrestle with as they usher new classes of therapies to market and find new ways of demon-strating their value to payers and patients in the United States.

The second half of 2017 saw some milestones for drug innovation. In Au-gust 2017, Novartis received approval for the first chimeric antigen receptor T-cell (CAR-T) therapy when the FDA approved Kymriah for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. And then in December 2017, Spark Ther-apeutics received approval for Luxtur-na, a novel gene therapy for a rare form of inherited vision loss.

Neither therapy is inexpensive. Kym-riah was announced at $475,000 for a treatment course. And Luxturna is priced at $850,000.

National Academies of Sciences steps inIn November 2017, the National Acade-mies of Sciences released a report, “Mak-ing Medicines Affordable: A National Imperative.” The report makes several recommendations to gain control of phar-maceutical prices in the United States.

“This is a difficult challenge. There may be trade-offs between current drug affordability and new drug availability,” the report’s writers say in the introduc-tion. “Controlling drug costs too rigidly, for instance, could potentially reduce the expected profits of drug companies, and this could alter their decisions regarding major investments to develop new drugs.

“Furthermore, the complex nature of the nation’s medical system – which includes patients, clinicians, hospitals, insurance companies, drug companies, pharmacists, pharmacy benefit man-agers, various government agencies, advocacy organizations, and many oth-ers – makes it very difficult to predict the precise effects of any specific policy changes. This is exacerbated by the fact that there is very little publicly available

information on the costs and profitability for the drug companies and various other participants in the system.”

The report recommends that the fed-eral government consolidate and apply its purchasing power to directly negoti-ate prices manufacturers and strengthen formulary design and management. The government should also improve meth-ods for assessing the value that drugs provide and also ensure that incentives to develop drugs for rare diseases are not extended to widely sold drugs.

“In addition, increased disclosure about the financial flows and profitability among the participants in the biophar-maceutical sector should be required,” the report says.

Other recommendations include en-couraging access to generic drugs, speed-ing up the review processes for generic manufacturers, and eliminating DTC ad-vertising for prescription drugs and “pro-vide more useful information to patients about the potential benefits and costs of treatments, thereby reducing inappropri-ate demand for higher priced drugs.

“Finally, insurance plans should be modified to reduce the financial burden that patients and their families currently experience when they need costly pre-scription drugs, and individual cost-shar-ing arrangements that are based on drug prices should be calculated as a fraction of the net purchase prices of drugs rather than the list prices from manufacturers. The government should also tighten qual-ifications for discount programs that have drifted from their original intent to help vulnerable populations,” the report says.

Perspectives on pricingBut the report is off in its assertion that drug prices are one of the fastest-grow-ing components of national health care, according to Dan Renick, president of Precision for Value, which provides payer insights and strategy, health economics and outcomes research, managed mar-kets marketing and promotional effec-tiveness strategies.

The Centers for Medicare reported that drug spending grew by 1.3 percent in 2016 while national health expenditures grew at 4.3 percent. Renick says this growth has actually been the rule rather than the exception for the decade.

“You have to put things into context, there was a blip of sorts when the hepatitis C drugs came out in 2014 and 2015, and drug expenditures naturally expanded

quite a bit during that two-year period,” Renick told Med Ad News. “Since then, they’ve gone back to a decade of what’s been pretty modest growth, including two years, 2010 and 2012, where there was no growth. It seems to be a pretty popular media fascination to keep point-ing at drug prices, when national health expenditures have grown far greater than prescription drug spending.”

There were also drug price increases in the late ‘80s-early ‘90s that followed the Medicare “best price” implementation, Re-nick says, and increases during the 1990s led to the high deductible health plans that slowly but surely started to take over the commercial space in benefit design.

“In Medicare Part D, we had at the time, at 2005 and 2006, [when] Mark McClellan and others built a very elegant design that was very appropriate for the drugs that were in the marketplace then, like Zocor, Nexium, and Lipitor,” Re-nick says. “There were only a very small number of oncology drugs and a handful of these highly specialized drugs for rare and orphan diseases. It largely worked, but now we’re seeing how we need to re-visit that in a major way.”

According to Peter Pitts, former asso-ciate FDA Commissioner and president and co-founder of the Center for Med-icine in the Public Interest, with poli-ticians and the media focusing on the predatory practices of Martin Shkreli for the past 18 months, the true problem has been masked. “If a drug is raised 40 percent in price over the next three years, that is true, but it’s not the whole picture, because there are significant variables that come into play,” Pitts says.

Renick and Pitts both point to the complexity of the supply chain nd the role PBMs have played in shaping drug pric-ing practices.

“The supply chain has become way too complex in the past 10 to 15 years. We end up with a net negative value because of the participation of so many parties, ranging from wholesalers to PBMs to even phar-macies in that mix,” Renick says. “I think everyone is in favor of much more trans-parency with respect to the supply chain. I think it’s very telling when the CFOs of wholesalers come out in quarterly earn-ings reports and declare that they’re go-ing to have depressed earnings as a result of a less price increase. So you’ve got a significant player who is saying very pub-licly that they depend on drugs going up in price in order for their business model to be viable. That shouldn’t be the case.

Then the public feels that there’s a co-ordinated effort to have price increases because it satisfies a lot of participants in the supply chain.”

Pitts asserts no one really pays the list price for any medication. “Before a tablet or a vial of a medicine leaves the manu-facturing plant, it goes to a PBM or tertia-ry wholesaler and it’s already been cut 40 or 50 percent because of negotiations,” he told Med Ad News. “There are always going to be anecdotal examples. But ba-sically for all intents and purposes, no patient pays the list price. Most people either pay their co-pay or they patient as-sistance. When people say ‘My drugs are too expensive,’ what they generally mean is, ‘My co-pay is too expensive.’ And that is a legitimate concern. And any type of assessment has to take into consideration is that this is a whole ecosystem. If you’re only talking about the price of the med-icine that’s listed by the company in its press release, it’s true but meaningless. Nobody pays it.”

PBMs “are a big problem because they do not have fiduciary responsibility to their clients,” Pitts says. “When you don’t have fiduciary responsibility, and these are public companies, and the No.1 job of any CEO at a public company is to in-crease their stock value. So why would you pass savings along to the consumer when you can pocket them and raise your stock price? You have the dichotomy of what is best for my stock price and what is best for healthcare in America. And those two things are right now in direct conflict with each other.”

Some of the more hotly criticized price increases have been those for insulin, and manufacturers blame PBMs. “Lilly was talking a few years ago about the price increases for their insulin, and this again came up during Alex Azar’s confirmation hearing [for HHS Secretary] the other day too,” Pitts says. “The reason why Lil-ly raised its price was because they were forced to give steeper discounts to the PBMs. So Lilly raises the price and actu-ally makes less money on the product.”

The solution, at least initially, is far greater transparency in how the pricing system works, Pitts told Med Ad News. “Now the problem with that is companies complain about PBMs, PBMs complain about pharmaceutical companies, but they are locked in this death grip and they can’t exist without each other. Pharma-ceutical companies will call me and com-plain about that they’re losing money, but when a reporter calls me and says can you

By Christiane Truelove • chris.truelove@medadnews.com

As more innovative – yet even more expensive – therapies enter the U.S. market, marketers will have to find equally new and innovative ways to prove the value of their drugs to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.

The value equationvalue of medicinesspecialfeature

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obert Leverte was hon-ored by the Medical Ad-vertising Hall of Fame as its 2018 inductee on Feb-ruary 8 at a black-tie event

at The Pierre Hotel in New York City. Leverte’s prolific career has included founding ERS – an in-house ad agency at ER Squibb – co-founding Ruvane-Le-verte advertising, serving as chairman at Bozell Jacobs Medical Group, and oper-ating as CEO of the Leverte Companies.

“Bob Leverte has been a significant part of the industry’s beginnings and growth,” says Steven Heicklen, president and founder of HeickMed Communications and former executive VP of Leverte Asso-ciates. “His accomplishments encompass the founding and building of successful organizations as well as developing ideas and practices from direct-to-patient communication to agency compensation methods to mentoring individuals in a unique way that allowed them to grow and succeed in the industry.”

Leverte started his career in health-care as a detail person for Schering Lab-oratories during 1963. He moved to the agency side of the business at Robert A. Becker, where he worked in market research before switching to working on the Eli Lilly account. Leverte found-ed ERS, an in-house ad agency for ER Squibb, and co-founded Ruvane-Le-verte Advertising with John Ruvane. As chairman and CEO of Bozell Jacobs Medical Group, he managed the ac-quisition of Ruvane-Leverte and Grey Advertising, establishing one of the first integrated medical and consum-er healthcare agencies with worldwide reach. That agency was at the forefront of the direct-to-patient movement. During 1998, he founded the Leverte Group, which was acquired by Health-Star in 2001. Leverte retired in 2006.

“Since the formation of the Medical Advertising Hall of Fame, I have wit-nessed the induction of so many indus-try ‘giants’ ... always in awe of what these leaders accomplished and how they changed this wonderful industry,” Le-verte told Med Ad News. “Never think-ing that some day I would be included among them. I am so humbled by this honor, and so proud to be included among this elite group. A special thank you to the membership of the Medical Advertising Hall of Fame for their recog-nition and support in selecting me.”

2017 inductees also honored

Due to a blizzard in the New York City area that canceled the originally sched-uled event, the 2017 Medical Advertising Hall of Fame inductees were unable to attend last year’s rescheduled affair, but they were in attendance and recognized

at the 2018 gala: Ryan Abbate, innovator and founder of Pacific Communications, and Mike Lazur, an award-winner cre-ative director Torre Lazur.

Abbate rapidly earned a reputation as a visionary and innovator. He was a leader in the use of DTC communica-tions with programs for the nicotine replacement product Nicorette. Start-ing in sales and then moving to adver-tising management at Merrell Dow, Abbate became – at 29 – the youngest department head in the Dow Chemical organization. During 1990, he joined Allergan Pharmaceuticals, where one of his responsibilities was running a small, in-house agency group. When Allergen decided to divest this operation, Abbate took it over and formed Pacific Commu-nications with 18 employees. By the time of his retirement in 2014, he had built the firm into the largest healthcare ad-vertising agency on the West Coast with 250 employees, establishing it as one of the fastest growing and most successful agencies in the business.

Lazur’s career started as an assistant art director with a consumer agency,

honing his skills on such brands as the Triumph sports car, British Leyland’s Land Rover, and Prince Matchabelli per-fumes. In 1976, Lazur was hired to work for a fledgling new healthcare agency in New Jersey, known as Thomas G. Fer-guson Associates. In 1981, Clyde Davis of Klemtner Advertising hired Lazur as senior art director to work on brands such as Pfizer, Squibb, and USV. During 1983, he received a call from Joe Torre asking him to work for his new agen-cy. After helping to build the agency, in large part with a string of new product campaigns that garnered the title The Launch Agency for the firm, he became a partner in the renamed Torre Lazur Agency. During 1996, Torre and Lazur partnered with McCann Erickson to take the agency global, and he became chief creative officer for McCann’s global healthcare activities.

About the Medical Advertising Hall of Fame

The MAHF was founded during 1996 with a mission to preserve the

history and heritage of the medical advertising profession and honor those who founded and built the in-dustry through their induction into a Hall of Fame. Since its founding, the mission of the organization has been broadened to include recogni-tion of past excellent creative work via its Heritage Advertising Awards, and creation of educational resourc-es through a Young Executive’s Pro-gram that holds multiple educational seminars throughout the year. The organization seeks support from the industry for its efforts, with a focus on the annual awards dinner held ev-ery February.

As the Medical Advertising Hall of Fame continues its third decade of service to the industry, the organi-zation is pursuing more education-al programs and expansion to cover digital communications. For more information about the MAHF, please contact Executive Director David Gideon at david@davidgideon.net or Deputy Director Anne Gideon at anne@davidgideon.net. medadnews

By Andrew Humphreys • andrew.humphreys@medadnews.com

Medical Advertising Hall of Fame 2018 Robert Leverte was inducted as the newest member of the MAHF.

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Robert Leverte

Ryan Abbate

Mike Lazur

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agenda2018specialfeature

Med Ad News: How are your organiza-tion and clients implementing and optimizing patient engagement strategies?

Dana Maiman, CEO/President, FCB Health: Patient engagement is not a one-size-fi ts-all and neither is our ap-proach to implementing and optimiz-ing strategies to support patients. Lately, we’ve been building adaptive, needs-based engagement models. The foun-dation of which is a behavioral strategic framework. The steps to this approach involve uncovering the patient insights and needs that ladder to desired be-haviors and business objectives. This leads to a unique, patient-informed en-gagement strategy. What we’ve noticed is that ... Whether the business objec-tives are focused on disease education, branded conversion, or adherence and advocacy, the engagement strategy be-comes the team’s mission for how all our tactical elements come together into a seamless, engaging experience for all stakeholders.

a. The key to successful patient en-gagement programs is to make the tac-tics relevant at the individual patient lev-el. To achieve this relevancy we use a “mass customization” approach. Our pro-cess starts with gaining insight into the patient journey and the motivators and barriers for health behavior change we aim to create. Next we analyze variations in patient demographics, attitudes, clin-ical profi les, and media and technology use, with a goal of creating a segmenta-tion strategy to maximize patient homo-geneity. Then we create the engagement plan, based on decision rules or a predic-tive engine, that delivers highly custom-ized, profi le-driven engagement tactics.

b. We simplify deployment of these tactics by using variable content tem-plates. Deployment of tactics varies in timing, messaging, language and mar-keting channel depending on each in-dividual patient’s profi le and analytics, including experimental design when ap-propriate. We are experts in preparing MLR submissions in an easy-to-under-stand format so that clients and review-ers can embrace this approach.

c. We optimize results by setting up test and control groups to identify the most successful interventions, then im-plement the proven tactics.

Sonja Foster-Storch, President, GSW-North America, part of INC Research/inVentiv Health: Our approach to opti-mizing patient engagement starts with our ability to understand the Patient Journey® and what is occurring at crit-ical moments that can impact what a person is experiencing. In order to be ef-fective, we go beyond the surface to de-velop engagements that are part of an individual’s journey and provide val-ue based on how that user wants to in-teract in that given moment. By under-standing the motivations and behaviors of the patient, we start to think how we can build engagement through custom-er experience marketing eff orts. At GSW, we utilize our predictive marketing and data science team to help us understand the most optimal solutions that will cre-ate our multi-channel marketing eff orts and how we help our clients implement patient engagements that help impact their lives and desired outcomes. Our ef-forts are monitored and optimized over time by completing our strategies to be successful through our measurement teams. This overall approach of incorpo-rating data science and measurement into the development of our engage-ment strategies ensures we are meet-ing patients’ needs of making every mo-ment matter.

Faruk Capan, CEO, Intouch Solu-tions: Think about the experience you have with your favorite store – one of mine happens to be Amazon. They have what I need; they provide excellent ser-vice with no surprises; they even predict what I will be interested in. I can re-or-der household supplies just by saying a few words to Alexa. Even their market-ing isn’t interruptive, but instead seems to suggest exactly what I am looking for when I am looking for it. I engage with Amazon repeatedly because the whole experience is positive and seamlessly connected. This is the model we’re build-ing for our clients and their customers – one that is service-oriented, integrated, predictive. The old way just won’t work. Patients expect and deserve more.

Amar Urhekar, President, McCann Health Americas: Patient engagement continues to be of critical importance for both our agency and our clients. As the market continues to evolve to value

based healthcare, with consumerism be-coming a driving force, patient engage-ment is becoming even more critical. It is not enough anymore for a patient to just be knowledgeable. Knowledge must lead to greater engagement in order to drive optimal outcomes.

We partner with our clients and ap-ply social science techniques to fully un-derstand our target patients’ motiva-tions, needs, and behaviors across the healthcare journey. This allows us to de-velop appropriate strategies and solu-tions to drive favorable change. One solution we’ve developed is our propri-etary ARULETM framework, which ensures that we design communications that are Appealing, Relevant, Usable, Learnable and Easy to act on. ARULETM is current-ly being validated up against some of the most rigorous health literacy frame-works, and is being vetted by several in-dustry experts, and our team members out of Columbia University Mailman School of Public Health. Doing this al-lows us to facilitate a more even-sid-ed dialogue between patients and HCPs that ensures that both stakeholders un-derstand what is being said, and its im-plications on health outcomes. This level playing fi eld makes it easier for doctors and patients to connect with one an-other on a human level, creating an ex-change of empathy.

Drew Desjardins, Executive VP, Chief Strategy O� ce, Dudnyk: Rather than diving into a tactical conversation, I’d like to focus on how we create relevant dia-logue to fully engage with patients. For years, Pharma has applied a very sim-ple formula in its approach to talking to patients – portray patients in market-ing materials who refl ect the aspirations of a typical patient. That’s why we see lots of patients at rooftop parties, pick-ing out vegetables at roadside produce stands, and running with their dogs along beaches – after all, who wouldn’t want that? But when it comes to rare dis-eases, it’s essential to fully understand the dreams, fears, and expectations of patients so we can communicate with them in meaningful ways.

Mapping patient journeys is not new; Pharma has been doing this for decades. But it’s not enough to just chart the buy-ing process. Sure, the transactions are important. But what really matters is how patients think based on a combina-tion of “hard wiring” and environmental factors to make decisions and, ultimate-ly, how they feel about those decisions after they’ve been made. At Dudnyk, we fi nd it incredibly valuable to overlay the HCP journey onto the patient journey to help us understand when and how in-formation is being shared, but then we push even further to understand the im-

The Magazine of Pharmaceutical Business and Marketing • medadnews.com • December 2017 • Volume 36, Number 6 • $25

NEW VENTURES:

For the tenth year, Med Ad News has chosen new Pharmaceutical Marketing Ventures to Watch that could change the way pharmaceutical products are marketed and sold.

MOBILE MARKETING:

Marketers continue to leverage the power of mobile devices, but have learned it’s not all about the apps.

POINT OF CARE:

Whether in the doctor’s offi ce, hospital or pharmacy, new care models are being established that are designed to bring fundamental change to the doctor-patient relationship.

continued on page 6

16 • MED AD NEWS DECEMBER 2017

or the tenth time this past October, Med Ad News began once again its search for the future of pharmaceutical marketing. We sought out young com-panies, spin-off s, off erings, and ven-

tures to profi le that are providing the most innova-tive and interesting products, services, or marketing opportunities to pharmaceutical companies and the healthcare community. This year’s two profi lees are both focused on targeted digital advertising, but in very diff erent ways; one is an AI/machine learning module that can be embedded in ads and respond to physicians’ questions, and the other is a “smart” mar-ketplace for buying and selling digital ad inventory. Here are Med Ad News’ newest Pharmaceutical Mar-keting Ventures to Watch.

@Point of Care is bringing static digital ads to life by adding its ad-tech tool @SK with Watson. Built with artifi cial intelligence, cognitive, and machine learn-ing technology, the tool ingests the product data/content and supports medical professionals seeking information by providing real-time, succinct answers to questions. Its innovative functionality, company executives say, off ers healthcare marketers unsur-passed levels of granular insight via analytics on their customers.

The @Point of Care team has been through several businesses over the course of thirty years, each one building to some degree on the previous ventures. All the businesses were in the medical information and data space, from educating doctors to formulary in-sights to medical news. “The most recent business, which was sold to Everyday Health, was MedPage Today – breaking medical news written on the clini-cian level,” says Robert Stern, @Point of Care’s CEO. “This business taught us a great deal about gathering just-in-time information and turning this informa-tion around in minutes. I.e., how to gather and parse data in real-time and off er new metrics not seen be-fore in the industry.”

So what was next? During the course of their work on MedPage Today, the team discovered that there was no resource for clinicians that could give them immediate, short, targeted answers to their point-of-care questions in the exam room without having to go through mounds of information and self-curate an answer. “In a ten-to-fi fteen minute patient visit, that was not going to work,” Stern says. “So, we took our knowledge from MedPage Today on how to gath-er and update clinically relevant evidence based in-formation on the fl y and present it in a crisp pointed answer useful to the clinician while the patient was in the room, a virtual consult.”

As luck would have it, IBM introduced the Watson AI/Cognitive machine learning tool and was looking

for medical applications just as the @Point of Care team was looking for an AI tool. “As we were looking to leverage our expertise to build a next generation healthcare AI platform with IBM Watson’s natural language expertise and cognitive services, we came to the partnership with deep level content and knowl-edge services,” Stern says. “To make a long story short, we entered into a partnership which is now more than four years old.”

In the meantime, @Point of Care’s in-house de-velopment team has built on and added its own pro-prietary cognitive models and tools to work with the Watson product, adding more depth and specifi c medical technology AI/and machine learning that leaders say make the combined tools best in class for clinical decision support. “There are several large players in the fi eld – Elsevier, DynaMed, UpTo-Date, Epocrates, Medscape – but none with the game changing tech we have built,” Stern says.

So @Point of Care was able to bring all this intelli-gence, artifi cial and otherwise, to bear with its Cogni-tive Decision Support platform, off ering physicians a way to access relevant content quickly at the point of care. But the next innovation – the one that earned @Point of Care this profi le – went a step further.

“So, once we built the clinical decision-making tool and could leverage our skills and experience in devel-oping an expertly trained cognitive data model, our CTO David Setiadi, Ph.D., and our commercial sales lead, Margo Ullmann, said, ‘Why can’t we lift the AI/Cognitive machine learning component and make it available as a standalone to supplement ads and make them come alive in real time, ads that can an-swer questions posed by clinicians or patients in real time?’” Stern told Med Ad News. “So, we mocked up a few demos, developed our @SK with Watson Chat Bot, and left pitch rooms fascinated and buzzing with ideas being tossed around about, how do we get this idea executed as soon as possible.”

The @SK Chat Bot is only about two months old and is already creating plenty of buzz. “As far as ad agencies and their clients go, this is a perfect, con-trollable product,” Stern says. “They provide the ap-proved content, resources, and answers and we train the @SK Chat Bot to respond with those specifi cs or refer their question(s) to appropriate channels. So, no surprises because it’s a controlled media off ering that legal and regulatory can guide.”

How does it work? Agencies develop and supply the creative and media buys, which they execute. Then, @Point of Care takes their creative and ap-proved product information and pulls it into the @SK AI/Cognitive environment, and prepares the Q&A portion to be inserted as per the agency creative and size needs. “We can also change programming on-demand, so as labeling or other info changes we can make behind the scenes additions without taking down the advertisement,” Stern says.

Although the @ASK Chat Bot itself is relatively new, the clinical decision support tool from which it emerged is very much not; according to @Point of

Care executives, it’s been used by more than 200,000 clinicians in 29 disease categories. So there’s plenty of data support - and evidence-based linkage to changes in prescriber behavior - behind the curtain.

“Our real value on the backend is insight,” Stern says. “What we can analyze on a de-identifi ed ag-gregated basis is what is the clinician is looking at in terms of answers to their questions during the patient encounter that changes their prescribing or treatment or continuation with current treatment. No one else can do that.”

And of course, it’s all highly targetable. “@sk with Watson, and the @SK Chat Bot, are totally targeta-ble, and the answers are diff erent for patients than clinicians.” Stern says. “You can slice and dice mes-saging to any segment of audience that fi ts the client criteria.”

What’s next for the @SK Chat Bot? Pretty much any space where medical knowledge is needed. “Chat Bot for sales reps and MSLs, hospitals, physician of-

new venturesspecialfeature By Joshua Slatko • josh.slatko@medadnews.com

Ad-Ventures in Marketing XFor the tenth year, Med Ad News has chosen new Pharmaceutical Marketing Ventures to Watch that could change the way pharmaceutical products are marketed and sold.

F

@Point of Care - ad-embedded @SK with Watson tool

@Point of Care’s @SK with Watson tool can be embedded into third-party ads and offers quick responses to physicians seeking information; the tool’s underlying decision support module has already been used by more than 200,000 clinicians in 29 disease categories.

By Andrew Humphreys • andrew.humphreys@medadnews.com

healthcare agency roundtable

Healthcare Agency RoundtableExecutives from 2017 Manny Award winners/fi nalists and other healthcare communications agencies participated in this Q&A forum of industry topics.

16

inside

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annualreport

18 • MED AD NEWS DECEMBER 2017

hen it comes to mobile marketing for branded pharmaceuticals, the future continues to be now. With digital mar-keting considered to be just marketing, and mobile device usage omnipresent

among consumers and HCPs, makingcampaigns that can be seen and interacted with in a mobile setting re-mains paramount. For agencies and their clients, this means optimizing old and new technologies.

Mobile’s impact has been in several areas, says Victo-ria Summers, associate principal at ZS Associates. These include insight generation and engagement. “More and more launch brands are egaging in mobile-fi rst strate-gies,” Summers says. “And they’re thinking of how they engage with patients through the mobile device.”

At one end of the spectrum are brands that reach out through mobile-enabled websites. Then there are brands that are using mobile apps as a tool for educa-tion At the other end of the spectrum are pharma-de-veloped apps that integrate into devices such as a Fit-Bit, and provide recipes and other tools for managing health, according to Summers. “We’ve done a review of all the apps available through the Android store and iTunes and there are a little over 200,000 available,” she says. “But a vast majority, more than 60 percent, are downloaded less than 5,000 times.”

Since every campaign has a digital marketing com-ponent these days, this means mobile plays an inextri-cable part.

“Generally, the funny thing about mobile is that it’s now part of the conversation even when it’s not specifi -cally intended to be part of the conversation,” says Alex Tamayo, VP, Cross Strategy, Digitas Health. “As a mat-ter of fact, we really stopped talking about mobile as a separate practice almost entirely.”

According to Dori Cappola, senior VP, Klick, for the world in general including pharma, mobile has be-come second nature. “Mobile is an extension of the human being, regardless if it’s a patient, or a profes-sional,” she says.

A few years ago, Klick was being asked to make desk-top strategies, and then clients were asking for mobile

strategies. “Now what youre really making is a brand strategy,” Cappola says. “And your brand strategy is in-clusive of all platform and all things of which a person may get information.”

These days, responsive design is used to create dig-ital assets such as websites, to make them accessible through whatever device is being used. “The way we view it now and the way that we are encouragin our cli-ents to view it, instead of talking about segments of your strategy being device based, let’s talk about it more in terms of the media,” Cappola says. “Where a plan used to say, ‘here’s where desktop is, here’s where mobile is, here’s where TV is,’ it’s now along the lines of, ‘these are maybe banners, these are maybe e-mails, this is point of care, this is EHR, and this in in-app advertising.’”

HCP, patient views of mobile

In discussions with clients about engaging with pa-tients and HCPs, Digitas Health talks about “moments of importance,” and when talking about the resources at hand, mobile almost always is part of them, in some shape or form. “Mobile is probably the most frequently used tool by HCPs simpy because that’s how they Goo-gle things, which they do all day long, because they can’t fi nd answers fast enough on their EHR,” Tamayo says. “It’s the most important second screen to them.”

Between “Dr. Google” as a consultant and the tab-lets increasingly used by pharma sales reps, mobile is pervasive, according to Tamayo. And Digitas Health’s clients are asking most often about optimizing the use of tablets.

“Tablets help reps customize a conversation,” Tamayo says. “And our clients want to know how do we bring the insights about the HCP that happen in that moment of conversation that we can pull out. HCPs have given reps a lot of feedback about what their barriers might be, what they’re interested in, and how do we capture that information and data and build really smart contact and content strategies that will last long after that meeting and tie them back into the meeting itself.”

For as long as clients have been using sales force au-

tomation and rep triggered emails, they are starting to see those tactics as the fi rst step in a very coordinated content strategy. Previously companies did not have any of that input. and largely had to guess what clients wanted to hear about a particular brand or condition, Tamayo says.

While HCPs are seeking information, on the patient side, the motivation for using mobile is diff erent. “They want to be understood,” Tamayo says. “Quite honestly, when we talk about rare conditions or chronic condi-tions, patients don’t necessarily feel the empathy that helps them deal with thir conditions. So they’re using mobile, particularly social platforms, to both express themselves and fi nd commonality with other patients. And even caregivers are fi nding commonality with other caregivers, who are struggling to provide aid to patients.”

Even though patients and physicians have diff erent needs, “at the end of the day, we like to remind our clients that physicians are people,” Cappola says. And there is really no diff erence between older and younger physicians when it comes to how comfortable they are using mobile.

Mobile devices act as a pull medium instead of a push, Cappola says, so this means interactions are more transactional and messages need to be more targeted and personalized. “A lot of times in pharma, when it comes to using things on the mobile device, we do fi nd a lot of the in-app types of placements that are specif-ically geared towards the healthcare industry, such as ePocrates, are helpful because they’re designed to off er things like placements for fair balance. Because that’s the diffi culty in mobile for pharma, saying everyting we need to in that tiny screen.”

Mobile helps pharma master social

Pharma’s embrace of mobile technology may have been initially cautious, but had an unexpected positive outcome, Tamayo says. “We used to complain a lot that pharma was late to the game, late to adopt technology, late to adopt social media platforms,” he told Med Ad News. “What turned out to be a very happy unintended consequence of that is pharma embraced social after so-cial had become primarily mobile. So we only had one learning curve, instead of two.”

The industry adjusted to FDA’s restrictions on mak-ing brand claims in social media by using mobile and

mobile marketingspecialfeature By Christiane Truelove • chris.truelove@medadnews.com

Marketers continue to leverage the power of mobile devices, but have learned it’s not all about the apps.

W

Pharma mobilizes

20 • MED AD NEWS DECEMBER 2017

oint of care interactions between patients and healthcare professionals are undergoing signifi cant changes. Whether in the

doctor’s offi ce, hospital or pharmacy, new care models are being established that are designed to bring fundamental change to the doctor-patient relationship. At a time when new drug product innovation has slowed down considerably, digital tech-nologies and behavioral shifts are seen as an effi cient and eff ective way to create patient-centric improvements. Observ-ing and understanding the macro-trends in major point of care destinations tells us a lot about the potential for improved patient outcomes.

Mike Collette, CEO of PatientPoint, and Nanette Oddo, Vice President of Phree-sia, are Co-Chairs of the Point of Care Communication Council (www.PoC3.org), an organization that advocates for the eff ective use of point of care channels to advance healthcare outcomes. “The single biggest change is how we have to redefi ne what point of care is,” Mike says. “Historically patient care has been within the four walls of a doctor’s offi ce or hospi-tal. Today, the point of care extends well beyond the four walls.”

Nanette Oddo sees another big change in what she calls the “shift of risk.” She points out that because today’s patients are more aware of medication side ef-fects, for example, point of care conver-sations have shifted from one-way com-munication from the doctor to a more give-and-take collaboration. Patients are also more educated about – and wary of – the cost of drugs, co-pays, and insur-ance coverage considerations. “Once the patient is ready for a discussion, both the patient and the doctor have to be better prepared for a richer, deeper, easier to understand exchange of information.” She emphasizes that the discussion can’t just be about a specifi c brand or treat-ment. “The question is, what can brands do to think through the entire disease state discussion?”

The doctor’s o� ce – not what it used to be

Tools and resources designed to have more productive conversations at the point of care can play a pivotal role in improving health outcomes. Research published in the American Journal of Managed Care found that the average of-fi ce visit is 87 minutes, with only 20 min-utes spent with a healthcare professional. That’s a lot of unproductive time. To make the situation even more critical, long and unproductive wait times in the doctor’s offi ce tend to aff ect those patients most in need of care. Lower-income patients, for example, are often paid by the hour and simply can’t aff ord to be away from work; these same patients are more likely to be in poor health. And older, cognitively im-

paired patients are particularly aff ected by the lack of opportunity to have a com-prehensive conversation.

Over the past several years the trend has been that patients spend more time waiting in the exam room than they do in the waiting room. Consultants fi gured out that moving patients to the exam room as quickly as possible leads the patient to be-lieve they are receiving care rather than merely wasting time. Often the reality is that the patient is simply wasting time in a “more medical” environment. But an isolated environment can also be more conducive to receiving non-personal in-formation by watching videos or reading pamphlets that are specifi c to their con-dition. When available, these informa-tional tools can increase the value of the patient’s limited time when he or she is actually talking to the doctor.

There are several game-changing trends that are designed to reduce the ineffi cien-cies of the offi ce setting. Addressing the challenges of a growing primary care phy-sician shortage, especially in rural settings, while at the same time reducing cost, telehealth technologies are changing the very concept of point of care intervention. Vidyo’s telehealth solution, for example, provides real-time video interactions to deliver in-home, ambulatory and acute care services. The adoption of telehealth solutions will accelerate as new genera-tions of patients intuitively understand the seamless interoperability of connect-ed digital devices. There is also the grow-ing trend of doctors making house calls. As people are living longer and opting to age in place, house calls keep patients out of the hospital while still allowing for a number of on-site digital interactions – e-prescribing and EHR usage, for exam-ple. Medicare and Medicaid are actively encouraging house calls as a solution for delivering better care at lower cost.

EHR technology is undergoing chang-es that can have a dramatic impact on point of care interactions. Adoption of patient portals has been slow, but the benefi ts can be enormous. “Patient por-tals will soon be much more important, as usefulness improves,” says PoC3’s Mike Collette. Although patients have been slow to adopt improved EHR of-ferings, the ability to provide patient ed-ucation or fi nancial services within the healthcare professional’s work stream is very valuable. And the benefi ts aren’t confi ned to the patient. For a medical practice, “increased patient portal adop-tion impacts business results, including higher average patient pay yield, an in-crease in patient accounts receivable and reduced accounts sent to collections,” according to Josh Gray, vice president of Athena Health’s research division.

User experience fl aws have been one obstacle to patient portal usage, but a more critical problem is the lack of trans-parency found within most patient por-tals. Relatively few healthcare systems provide solutions that actively encourage

physicians to share detailed health in-formation directly with their patients to make sequential point of care discussions more detailed and useful. One somewhat limited system, called MyChart, is found on many EHRs, representing a step in the right direction. MyChart allows patients to see lab results, appointment sched-ules, and messages from providers that include a brief review of the patient’s con-dition, a list of medications, and billing information. But what is often referred to as “clinic notes” are almost never includ-ed, denying the patient access to the pro-vider’s true assessment and analysis of the visit. In general, the argument can be made that the more information a patient sees, the higher the trust – which leads to a higher adoption rate.

Technology e� ectiveness in hospital settings

According to the CDC, hospitals repre-sent about 33% of total healthcare ex-penditures. To put that in perspective, physician and clinical expenditures rep-resent 20%, with the cost of prescription drugs representing only 10% of cost. But while hospitals represent the biggest op-portunity for improvement, technolog-ical advancement at this crucial point of care has been challenging. According to a PricewaterhouseCoopers Health Research Institute report, “in the New Health Economy, digitally enabled care is no longer a nice to-have, but rather a fundamental business imperative.” This imperative is proving to be easier said than done.

An Accenture study found that 66% of the 100 largest hospitals in the country off er mobile apps to patients, but only 2% of patients use them – even though almost 60% of patients see the need for such apps. Poor user experience and in-ept functionality are often at the root of low usage, but, even worse, only 11% of hospital-designed apps have the top three features patients want the most: access to electronic medical records; the ability to book, change or cancel ap-pointments; and the ability to make pre-scription refi ll requests. One of the most basic point of care needs would seem to be the simplest to implement: so-called “wayfi nding apps” that allow patients to navigate through hospitals. Yet adoption of these apps remains very low because of a combination of poor promotion of the product and a dismal user experience.

The eff ective integration of digital solu-tions also present a problem, especially within larger hospital systems. Technol-ogy is most eff ective when it is part of an integrated solution – and that is yet to be the case in many instances. Today’s point of care ecosystem consists of an array of high-potential medical technology that is riddled with integration barriers. A re-cent research paper published by Health-care Informatics challenges the medical community to “imagine a team of health-care providers taking full advantage of a patient’s genetic makeup, body imagery,

EHRs, wearable devices, and real-time medical research and population health data.” This vision has existed before, the study says, but “by 2030, predictive analytics and artifi cial intelligence will genuinely support this vision, bringing more accurate, timely identifi cation and management for a range of health con-cerns.” While 2030 may be a long way off , incremental changes in point of care technology – aided by cloud-based solu-tions – are underway, aimed at intercon-nectivity and increased access to both patients and providers.

Interesting trends are taking place at the pharmacy

Nanette Oddo believes that changes in the pharmacy business model will have a great impact on point of care decisions. Many patients rely on the pharmacist to dispense drug treatment information along with prescriptions. According to the CDC, one-half of Americans have a chronic condition, and one in four have multiple chronic conditions; 90% of Americans take at least one prescription medication, and two-thirds over the age of sixty-fi ve take fi ve-to-nine medica-tions. That makes pharmacies a prime candidate for point of care interventions.

But even as pharmacies are expanding their in-store clinics, there is an emerging trend to make core pharmacy off erings “a click away” for patients. Capsule Phar-macy (www.capsulecares.com) is a New York City-based “virtual pharmacy” that off ers online prescription fulfi llment and free same-day delivery, by-passing the pharmacist as a point-of-care resource. This localized approach in an urban set-ting is one thing, but Amazon – the ul-timate business disrupter for retailers of all stripes – strikes fear in the hearts of pharmacists everywhere. Mobile ap-plications such as Truveris have already made inroads by helping consumers fi nd drugs at the lowest prices, but Amazon has the tools to take the technology to a much higher level. Pharmacy giant CVS is reportedly interested in buying Aetna in order to continue its march into point of care services and blunt the looming threat posed by Amazon. CVS already acts as a pharmacy benefi ts manager (PBM) that negotiates drug prices. The CVS MinuteClinics off er walk-in services, supplemented by CVS at-home services such as infusion. Adding Aetna to the mix could push millions of Aetna clients into CVS’s pharmacies.

One thing is certain: point of care will continue to change

As Intel founder Gordon Moore famously said, change has never happened this fast before, and it will never be this slow again. Point of care is undergoing an evolution that will lead to revolutionary changes not only in how patients receive care, but where and when they receive it. Technolo-gy will be the prime driver. medadnews

point of careextrafeature

By Robert Palmer, Chief Innovation O� cer, HCB Health

Point of Care Innovation: The Evolution of Medical Interactions

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