The challenge for pharma in adapting multichannel marketing strategies for the global stage, while trying to refine messages and communicate a brand identity to multiple local audiences

	In today’s fast-evolving digital world, a pharma company faces plenty of challenges in maximizing the value and impact of its multichannel marketing strategy. The formidable rise of the digital-savvy, empowered patient, for example, has disrupted the hierarchies of the industry-physician-patient communication dynamic; the growing complexity of safety requirements, increasing drug recalls, and the push for greater transparency has led to more wastage of marketing assets when they fail to clear compliance hurdles; and with many pharma companies spending about 40% more on marketing than on research (according to market activation company Tag), spiraling costs are an ongoing concern-Tag reports seeing marketing-content wastage of up to 30%.

	In adapting multichannel marketing strategies for the global stage, while trying to refine messages for multiple local markets, the industry encounters further obstacles. Not only are domestic concerns much amplified-a company with a global marketing spend of $2 billion stands to lose tens of millions a year just on content wastage, for example-but the task of navigating a wealth of varying cultural sensitivities, codes of conduct, and national laws also comes into play.

	Understanding how to communicate a brand identity and new products successfully at both a global and local level is a complex process. As Tag observed last year, “Most companies can’t justify the time and resources needed to conduct grass-roots-level research every time a brand wants to launch a product in a new country.” But defining a global strategy and refining it to local audiences is vital to a company’s success, Tag went on, “not only for [its] customers … but also for the supply chain that will support it.”

	While “think global, act local” has long been established as a marketing mantra for multinational companies, ironically, it can be harder to achieve in this era of faster worldwide communication. “The media is more complex than it used to be,” Tag’s managing director for client services, Kevin Spicer, told 

. “The use of data to drive marketing is more complex. And those things vary by market, so today you’ve got to be supersmart about the ecosystem, the digital channels, and the technology in each market.”

	Spicer believes, however, that “it is absolutely possible to strike the right balance between global consistency and local tailoring.” The companies that are doing this well are those that understand the need for strategic-level partners, according to Spicer. “They tend to have established partnerships that allow them to face the challenges around global consistency, economies of scale, and suitability for a particular market or culture across creative media and production,” he says. “While there’s a necessary focus on products and research, these companies understand that they’ve got to think about the customer first and plan their marketing activity around the customer’s mindset and their channel use.”

	One firm that has been striking the right balance between the global and local voice is Danish drugmaker Lundbeck. Lundbeck’s digital strategy has moved toward using one platform for all its channels. As the company’s head of global digital platforms and analytics, Vicky Lalumiere, outlined last year, “This is essential for us at global HQ and [for] our affiliates… When we think of either reps or websites or social media, it all comes down to one platform and one way of driving our content.”

	This isn’t just a matter of a technical platform but of “having a coherent and overarching communications strategy within our culture and among our affiliates,” Lundbeck’s vice president of global customer engagement, Danilo Pagano, told 

. “What we do on a daily basis is to try to establish-at a local level in Europe, in Asia, and the Americas-a solid and robust content strategy around disease awareness, 

around Lundbeck’s focus on improved brain health in patients, and on improved medical knowledge around brain health.”

	Previously, Lundbeck’s global marketing strategy was more fragmented, says Pagano. “Every affiliate was in charge of its local strategy, without any global tools.” So, two years ago the company moved to a common platform, a common digital space, “where we can place our content and where affiliates can pick and choose the content they want to use-in line with local regulations and restrictions- and then translate, adapt, and publish that content,” he explains. “From a technical perspective, it is a big digital repository; from a communications strategy perspective, it is about having one single voice, for example, when it comes to fighting the stigma around depression or providing more information on how to deal with a schizophrenic patient.”

	While a coherent communications policy and truly collaborative working culture are crucial factors in the successful rollout of a multichannel marketing strategy, the underpinning technology has, not surprisingly, been growing in importance. The companies at the “mature end” of the global-multichannel-marketing curve are ones that are “aware of the need to invest in digital and technology,” observes Spicer. Their partnerships and internal marketing functions will be working well, but they also understand the need for a technology engine underneath, “whether that’s asset management systems, workflow systems, or audience management to allow them to connect through data,” he says.

	Mirroring its ubiquity elsewhere in the industry, artificial intelligence (AI) is making its presence felt in this arena. “We’re seeing AI starting to understand how to interpret an instruction from a user to find assets that could be relevant for a brief,” says Spicer. “One subset of the very big area of AI case-use is in content production. There are pieces of software that allow you to press a button and seconds later you’ve got 150 adapts, so the role of armies of people creating adaptations of master artwork is becoming less and less. This can lead to savings in cost and weeks of work potentially.”

	Lundbeck is venturing into AI with the use of chatbots. The chatbot on Lundbeck’s online psychiatry and neurology resource center, Progress in Mind, offers “a new way to interact with healthcare professionals (HCPs),” explains Pagano. “HCPs can interact with it as if they’re having a natural conversation.”

	The chatbot can provide them with information such as the latest study on depression or news from the latest Schizophrenia International Research Society (SIRS) conference, for example. “As it is powered by machine learning technology, the chatbot ‘learns by doing,’ so its ability to interact in a natural way with customers improves with every conversation,” he says.

	For some of Lundbeck’s patients themselves, Pagano adds, AI can have advantages over human interaction. “Schizophrenic patients can be paranoid, and they can actually feel more comfortable dealing with a machine than a human,” he says. We’ll see far more human-to-machine interaction in the brain health space in the future, Pagano believes. Already, in China, where there is a major shortfall of general practitioners, AI is being used via “remote consultations” to drive patients to specialists.

	Becoming more sophisticated in translating its multichannel strategies between global and local regions has seen pharma broaden its understanding of cultural sensitivities in markets around the world. Regional differences in the way HCPs consume and engage with messages remain a major consideration in developing a global strategy. As Tag noted in its blog last year, there is still “huge variation in uptake and attitudes among physicians in different parts of the world,” for example.

	The blog pointed to IQVIA data from March 2017, which found that “94% of Japan’s specialist physicians felt their preferred amount of digital communication was being achieved,” whereas this figure was just 50% in the US and 17% in the UK. It added: “In Italy and Germany, all doctors surveyed were dissatisfied, saying they wanted more digital activity, and a faster move away from the traditional modes of communication.”

	For Spicer, however, success can depend more on the client than the region, and on where the client is on the maturity curve. “It depends on how open and ready they are, on how much technology they’ve already got in place, rather than it being about the market.” China, however, is “an outlier for us,” he says. “Where a lot

 of other global strategic partners are Western-run, China has its own ecosystem.” It can be a challenging place to execute a multichannel marketing strategy. There can be a cultural disconnect between how a multinational company works and the need to have presence and ability in China. Says Spicer, “Does the global company really understand the Chinese digital ecosystem and all the different social platforms and technologies there? How does it grapple with heavy regulation? How does it deal with needs and local relationships at a government level?”

	Pagano agrees that China presents a unique challenge, but he says the country “is a source of inspiration for us because it is moving into the digital realm so fast.”

	While Lundbeck is establishing a common content strategy, how that content is best delivered varies slightly across different regions; different social media channels are favored locally. In China, Lundbeck uses the WeChat platform to engage and promote disease awareness among customers; the company is also experimenting with and piloting projects where information is delivered through other digital channels, such as QR Codes, which are widely used in China. Elsewhere, in Brazil for example, WhatsApp is a preferred mode of communication. In South Korea, it is KakaoTalk. In Italy and Spain, it’s Facebook.

	While, for Pagano, “social media offers the best way to raise disease awareness and fight social stigma”-Lundbeck, accordingly, spends “a massive amount of time designing and building content that is digestible on social media”-it is important not to lose sight of some of the more traditional channels that can still be 

effective. Says Spicer: “I think the demise of television was somewhat overexaggerated, as was the demise of print. Both are doing pretty well, frankly. Conventional media can still do a lot that digital cannot; it’s about keeping that balance, retaining what works and finding new solutions.”

	Ultimately, it comes down to a company’s structure and culture and “how far people are able and willing to collaborate,” adds Spicer. “It’s not just the work around setting up the technology. It’s the people and processes around the systems that you need to get right. You need to retrain and reshape the culture around the solution.”

’s European and Online Editor. He can be reached at 

	1. “Global vs local: how to navigate tough challenges in pharma marketing,” 

	2. “Lundbeck’s digital strategy and how they manage global and local content,” 

Articles

Features

Exploring the challenge for pharma in adapting multichannel marketing strategies for the global stage, while trying to refine messages and communicate a brand identity to multiple local audiences.

The Multichannel Reach: Balancing the Local and Global Voice

Examining the key learnings from BCG’s 2019 benchmark study-and the capabilities uncovered that will be critical to future performance

	Since 2013, The Boston Consulting Group (BCG) Market Access Roundtable has been conducting a comprehensive benchmark of market access-related activities every three years. In 2019, we conducted our third benchmark, which covered the “traditional” market access (MA) activities, e.g., pricing, health economics  and outcomes research (HEOR), and also activities that interface with other functions, namely health policy and real-world evidence (RWE).

	The 2019 benchmark is based on quantitative data from the 14 participating companies and 100-plus interviews conducted with market access, public policy, and RWE leaders from across global, regional, and nine local markets: US, EU5, China, Brazil, and Japan. In addition, we ran a structured survey with over 40 questions and synthesized the response of about 400 participants. The detailed results, containing 40-plus analyses, are documented in five chapters: Key insights, Organization, Resourcing, Governance, and Capabilities, and shared with the participating companies.

	In this report, we highlight key observations from the 2019 benchmark, which includes 10 industry-level insights; deep dives on five hot topics identified, and 10 capabilities that were seen to be critical for the future success of the market access function.

	The BCG Market Access Roundtable is a forum that brings together senior market access leaders and serves as a platform for interactive discussion on industry-level topics. Roundtable members collectively select topics that are relevant but not handled in other forums, and which can have either near- or long-term relevance.

	Members work in smaller working groups on specific topics to develop thought pieces, relevant frameworks, or policy-related publications, which are collectively ratified by the Roundtable on a biannual basis.

 Access function across organizations seem to be in a state of flux, with most companies in the benchmark having changed their leadership in the last three years.

 Many companies are “experimenting” with alternate models for market access (e.g., BU structures, Agile), based on the approaches the rest of the organization is taking.

 Overall anchoring of market access functions is still typically between commercial and R&D teams, with some shifting in between the two.

 2019 shows fluctuations in resourcing across global, regional, and top markets, in contrast to the general overall growth trend observed in 2016.

 Role of global vs. regional vs. local is still largely unresolved, with all possible models still in play, and logic deeply embedded in overall organizational anchoring.

 Role of health policy (separate from public policy) has increased across most organizations, with many splitting it explicitly from public policy and in some cases integrating it within the access function.

 Multiple models co-exist for organizing the RWE function (centralized group, center of excellence [CoE], or decentralized setup), with no clear preferences and continuing shifts.

 Importance of integrated evidence planning (IEP) is driving for greater collaboration of medical affairs and access functions and of global and local, with its associated growing pains (e.g., anchoring, local support, funding).

New technologies (e.g., cell and gene therapies), how to compete in a “data-rich world,” and “new ways of working” were identified as three trends that would further impact the role of access as a function.

“Understanding of stakeholders that impact MA,” “Effective coordination and decision-support within [and beyond] MA functions,” and “Ability to optimize strategic pricing objectives” were the top-ranked capabilities.

	In distilling the various interviews and survey results, we found that a key priority that cuts across all leadership (market access, public policy, and RWE) groups we talked to was sourcing, developing, and retaining market access talent and capabilities.

	The BCG Market Access Roundtable had already identified talent and capability development as a key priority in its first benchmark in 2013 and, based on that work, had developed a comprehensive framework on market access competencies.

	Subsequently, we also pioneered the set-up of an executive training course in collaboration with the London School of Economics (currently in its third year of delivery). Given the fact that this has been highlighted again as a key priority and recognizing that a lot has changed in the last decade, the BCG Market Access Roundtable has launched a new working group to tackle the topic and will provide recommendations by the end of 2020.

	Aside from highlighting the need to improve the collaboration across these three sub-functions, six other priorities that fall in the cross-over between the functions were also highlighted (see Figure 1).

	For our benchmark, we focus on seven key MA activities, five of which are typically within the core of MAs functions, such as pricing, health technology assessment (HTA), HEOR, and health policy, and the two closely-related activities of public policy and government affairs (PPGA) and RWE.

	Comparing how the seven MA activities are anchored across the different companies, we identified five key trends that are worth noting.

		Traditional activities: pricing, HTA, and HEOR are primarily anchored in commercial, while PPGA is primarily anchored in corporate affairs.

		Many of the benchmark companies have started to split out HEOR functions and, in many of these cases, they are moved to R&D and located/combined with RWE group.

		Many companies have started to split out health policy as a specific sub-function from public policy and moved it in with other traditional MA activities.

		For RWE, while primarily anchored in the R&D/medical group in most companies, we are seeing a growing trend to split it and have some capacity/capability also in commercial.

		Most global MA heads sit at CEO-2 level, often reporting into a head of marketing/strategy/chief commercial officer.

	We do not observe a dominant organizational design for traditional MA activities (e.g. pricing, HEOR), and activities at interface with other functions, namely health policy and RWE. Having said that, we found it helpful to look at two dimensions along which companies have made trade-off choices:

1. Degree of centralization vs de-centralization.

 There is a large spread in the level of centralization vs. decentralization (~1.26x above and below the average), driven by the overall context of the company (e.g., portfolio mix, commercial structures, strategic focus). However, there are two general trends we can observe: a) there is overall tendency to reduce regional/global resourcing in favor of local; and b) increasing resources in China.

2. Functional set-up vs. anchoring by therapeutic areas (TA)

 There is an even higher variation along this dimension, driven by distinct choices made by each company to address its specific current challenges. Interviewed MA leaders also made it clear that there was a general expectation that more changes are to come as strategic focus and portfolio/TA mix evolves. In addition, we found that while there is a large spread in how functional resources are deployed (~1.44x above and below the average), there was a slight overall shift in the functional focus-with increased resources in customer-facing activities, in particular those that are local, and gaining efficiency in backend activities like HE/HTA modeling.

Deep Dive 4: Resourcing (global/regional/local)

	In the 2016 benchmark, virtually all companies increased their resourcing across the board. In 2019, the picture is more nuanced, with some companies continuing to increase their resources (either started later or from a lower base) while others are optimizing existing resources through differentiated deployment. For example, the regional layer is losing favor at about a third of companies. Others are exploring “agile or “new ways of working,” allowing for greater flexibility of resource deployment, which generally also result in fewer regional alignment roles.

	As in the other years, we also looked at the overall resourcing of the MA function across global, regional, and local deployment and found two distinct scaling factors at play:

, expressed by the number of mid-to-late-stage products a company currently has in their pipeline. As MA activity tends to be most pronounced in the lead up to and at launch, the number of mid-to-late-stage products in the pipeline seem to be a good indicator for the MA resource need.

, expressed by the sales of their current products. The value generated from currently marketed products enables companies to hire MA resources, and larger companies by sales can afford to staff greater teams.

	The scaling by launch needs and sales also allows to control for the differences in TA focus, portfolio, size, and other factors. The close alignment to the regression outlines the validity of the two scaling factors.

Deep Dive 5: Integrated evidence planning

	As has been noted in the previous benchmark and continued discussions at the BCG Market Access Roundtable, IEP has emerged as a key joint process to align evidence-generation activities across MA, medical, development, RWE, and regulatory early and encompassing the product life cycle.

	Integrating the evidence-generation activities ensures the right evidence package is built for a product accounting for all stakeholders in the most effective/efficient way. This requires driving alignment on aspects of target product profile and trial design between functions to ensure the right choices are made across functions vs. within a function only.

	Most organizations have deployed one form or another of IEP, although they are at differing levels of integration, sophistication, and maturity. At earlier stages of integration, companies still develop functional evidence-generation plans bottom-up, and bring those plans together into an “integrated” plan later. While this is a good starting basis, it does not allow for the most efficient use of resources. In addition, we notice that involvement of countries (timing and number) varies across the companies  and is less systematic in terms of the involvement of smaller yet progressive countries (see Figure 2).

10 top capabilities to ensure future success

	Close to 400 MA colleagues from global and regional markets and the nine largest countries outlined what they perceive to be the key capabilities for future success. Ten capabilities stood out, covering traditional aspects of MA such as health policy, evidence generation and synthesis, and pricing, as well as broader themes such as organizational effectiveness (see Figure 3).

	Looking across the top 10 capabilities, two themes emerge as key: evidence generation and synthesis, and collaboration/co-creation.

	More than half of the capabilities relate to collaborating and co-creating with internal and external stakeholders. As MA is becoming even more of a cross-functional endeavor, more MA objectives can only be achieved through support and collaboration from other functions. Consequently, the ability to steer the whole organization toward achieving MA goals becomes more complex. Hence, more capabilities in this regard are required.

	With access becoming the front and center issue for pharma companies, “access” is part of the agenda of multiple different functions, and the role of the MA function is evolving rapidly.

	With the increased importance comes a greater need to more closely collaborate with other functions, and drive the larger organization toward achieving the company’s access objectives. At the same time, other functions are building their access focus and capabilities. Hence, access activities are no longer limited to the MA function only, and while the reach of access is increasing, the remit of the MA activity is blurring.

	The MA function within companies will need to refine its focus and rethink the way it interacts with internal and external counterparts and stakeholders.

Columns

Examining the key learnings from BCG’s 2019 benchmark study-and the capabilities uncovered that will be critical to future performance.

Market Access: From Being to Becoming

	We’ve seen the signs. Cambridge Analytica. Facebook. Even Ring-recently, the app and service that customers use to manage and control the Ring camera is sending personal data around in a seemingly public, not monitored or customer-acknowledged use of data.

 The bumpy ride of data in the consumer world has not gone unnoticed in pharma. Where this conservative industry may have the one-up on everyone else, is

 exactly that conservatism. A penchant for compliance, an almost religious aversion to anything that might go afoul of FDA guidance and regulation (at least in drug submissions), and a need to follow SOPs at any and all levels-may actually help pharma, not hurt it.

	Consumer concerns around data privacy were highlighted in a recent report

, which found that approximately 97% of consumers are somewhat or very concerned about protecting their data, but the majority don’t have the time or prowess to educate themselves. A further 91% want state or federal government to adopt strict regulations to protect their data; 43% of consumers would provide detailed data about themselves to a brand for a discount, and another 32% would for an exclusive benefit; and 72% said they would more likely read consumer-facing legal and policy agreements if they were shorter, and 61% would if they were more straightforward.

	As I sat in a session on a Clinical Data Innovation at SCOPE (Summit for Clinical Operations Executives, held in February), it was clear that the executive leader from a large pharma presenting takes data to heart and he believes that any data breach that is publicized in the mainstream media has definitely hit the conscious of, at the very least, clinical trial participants. He suggested that maybe it is causing them to be more anxious about signing over their data in a clinical trial. They may ask themselves, what happens to my data? Who has access? As this executive said, “The concern may be unfounded, but it’s there.”

	Further, there is an inherent trade-off between innovation and risk. The speaker said, “analytics could turn into the ‘wild west,’ where we risk doing things with data that we shouldn’t.” And not just at the clinical trial level; he views all data as an enterprise issue and one that pharmaceutical leaders should be honestly assessing.

	Companies should be preparing for greater GDPR impacts as the global data regulation landscape is “incongruent” and “difficult” to manage. In essence, GDPR is more strict than HIPAA. For additional thoughts on establishing a global data privacy policy or standard, or about using de-identified data, listen to this 

 from Privacy Analytics. The Q&A includes insights from the experts on GDPR and standardization.

	Also in the big picture is the concept of individual data ownership. There is a lot of talk about data ownership and people being compensated for the use of their data “and we should think about that,” suggested the expert speaker.

	To combat the possibility of a wild west analytics climate, he suggested that before anyone gets involved in data analysis for secondary purposes that it should be deemed appropriate and vetted by the right professionals at your organization.

	And finally, the idea that any one functional area owns the data collected for its purposes is not valid. As the speaker stressed, “Enterprise owns the data. And technology that is put in place should structure the use of that data.”

articles that discuss data, privacy, and security in pharma:

, two heads of compliance discuss the challenges in keeping pharma data safe and secure.

 examines the myriad sources of patient data and its uses, as well as constructing mechanisms to ensure patient privacy.

 explores the question of data ownership and how pharma can build trust with patients in regard to that data.

	In the meantime, taking a long-term, proactive, enterprise view of your company’s data may be the best way to keep your organization and reputation safe.

https://arstechnica.com/tech-policy/2020/01/amazons-ring-app-shares-loads-of-your-personal-info-report-finds/

https://www.prweb.com/releases/new_study_by_tealium_reveals_half_of_consumers_dont_feel_well_informed_about_how_businesses_use_their_data/prweb16735237.htm

From the Editor

Amid concerns over a potential 'wild west' climate for data analytics in pharma, taking a long-term, proactive, and enterprise view of your company’s data may be the best way to keep your organization and reputation safe. 

Consider Data Before It’s a Problem

How to capitalize on the rise of omnichannel marketing by taking those added channels-now enhanced by online avenues such as social media and mobile devices-and targeting the modern customer in a coordinated manner

	The explosion of online technology over the last decade has created tremendous opportunity for pharma to market to healthcare professionals (HCPs) and customers. At the same time, the field has become inundated with so many new tools that it’s sometimes difficult to understand how to implement them successfully. The complexity isn’t just in the addition of new channels, but in today’s connected world, the integration of those channels is where the emphasis now lies, and omnichannel marketing is leading the way.

	What began as multichannel marketing-targeting customers through multiple pathways such as TV ads, in-person visits, direct mail, and in-store ads-has evolved into omnichannel marketing. The advantage of omnichannel is taking those different channels, now enhanced by a variety of online avenues such as social media and mobile devices-and using them in a coordinated manner. Omnichannel addresses the modern customers’ seamless movement through all types of media in everyday life. It is about using integration and customer experience over a more traditional siloed marketing approach to attain the greatest reach and richest results.

	“I think we are moving away from a multichannel concept- where a marketer has to master push-message deployment into standard channels such as mail, newsletter, and the web-to a real omnichannel concept,” says Tim Fischer, director, head of channel evolution and operations at Merck KGaA. “Marketing executives need to ensure omnipresence of content relevant to their customers in all available channels so that customers can ‘pull’ content from their preferred channels and not the other way around.”

	This importance will only grow as digital channels continue to expand. According to We Are Social and Hootsuite’s Digital 2020 reports, 4.5 billion people around the world use the internet, up 7% since January 

2019. The average internet user spends six hours and 43 minutes online each day, which translates to 40% of their waking life. One-third of that time is spent on social media (see 

). GlobalWebIndex indicates that mobile use makes up half of all internet use. And a quick search on Google Trends confirms the term “omnichannel” has been outpacing “multichannel,” on average, in popularity over the past year.

	Pharma’s engagement with customers has also changed over the last decade due to the increase of online digital media and the interconnectivity of the physical and digital worlds, with the help of the Internet of things, voice assistants, chatbots, and similar technology.

	“HCPs are not only using websites or smartphone apps to inform themselves, but they and their patients are getting used to more integrated digital solutions from diagnosis, to treatment, to interaction with HCPs and other stakeholders,” says Fischer. “As such, the ecosystem of apps, devices, digital media, and traditional contact points has become complex through the rise of AI-enabled services, machine learning, and the use of chatbots and voice assistants.”

	“If we look at Gartner’s recent list of key strategic technology trends for 2020, such as hyperautomation, multi-experience, and cloud computing, the marketing executives of tomorrow need to be masters in managing customer experience rather than channels, and experts on how to change business processes and see efficiency gains as well as understand technology to best use it in their omnichannel presence,” says Fischer.

	It’s not enough to jump on the bandwagon of a new technology, such as AI, virtual reality, Snapchat, or TikTok, just because it’s the hot new thing. Companies need to focus on cutting through the noise to discern what is really worth the investment.

	“I have somebody on my team who works on new technology and innovation, but he’s also aligned to the brands as well,” says Paul Dixey, multichannel lead at Novartis UK. “This particular person looks at what’s coming in from global or what agencies are suggesting, and is tied to the business to say, ‘Well, how does that actually fit in with our business? How does that actually deliver a better experience to customers and to patients, and that has a longer time scale?’”

	Once the new technology is fully understood and becomes relevant, then it can be integrated into a greater marketing plan.

	While staying innovative and relevant is important, there are some basic marketing tools that should not be forgotten.

	“I still think there is good value in doing a proper website that people can easily find and navigate, and having an email platform that doesn’t get blocked by filters,” says Dixey. “They should be essentially just your entry ticket. What really is the game changer is putting great content into those channels. Otherwise, these channels are just empty vessels. That’s where I think pharma still struggles-with putting the right content in there.”

	Another traditional marketing tactic that should not be overlooked is face-to-face interaction, from simple office visits to conferences. “I think the medical scientific liaisons, account management, group meetings, conferences are all still important,” says Dixey. “I just think we need to look at them in a different way.”

	Adding a digital layer to those experiences can enhance their effectiveness. For example, Stefania Alvino, digital and multichannel manager at Daiichi Sankyo Italy, says that roundtables or mini networking events could be run better if they were linked to a social community.

	“The role of a sales rep or medical liaison will change from a mere visit to someone who masters digital media to communicate more richly with peers,” says Fischer. “The actual physical engagement will become less important vs. other digitally enhanced forms of contact. This is already changing customer relationship management (CRM) in the industry right now.”

	Before companies try to reach the customer, it’s important to look at who they’re trying to reach. Discerning customers’ goals and challenges can be helpful in creating a marketing mix. Offering content that they’re interested in and that the company is interested in putting in front of them is the sweet spot, says Dixey.

	“We are still not enough campaign-driven and do not think enough from our customers’ communication need point,” says Fischer. “I think our industry is still in a product-push rather than information-pull mode. If we understand what stakeholders are looking for online or offline, and can bring them together in relevant CRM systems, we are much better at orchestrating channels. Creating the right data hub model, the right CRM infrastructure, using the right platforms, and connecting this to the channel ecosystem is the key element.”

	One of the main advantages of a pull medium, such as a website tagged with relevant key words, is that the audience self-selects its information, which can create a higher relevance in the audience. Simple digital metrics such as click-throughs and downloads reinforce that relevance by allowing a company to see how consumers use their information. Based on those details, companies can quickly adjust their message if needed.

	“You have to be constantly looking at this, fine-tuning your approach, rather than spending ages producing a great big box of content and then putting all of your money in one channel and then not doing anything until you’ve got the next budget round,” says Dixey.

	Though online and offline channels each have their benefits, they are most effective when overlapped. “Look at inbound call centers,” says Fischer. “Artificial intelligence algorithms paired with voice assistants or chatbots are a great example of how you can reduce the cost per touch point, enable a faster and better customer experience, and combine this with multiple digital outlets such as a kiosk system, your website, and your business card to make your service available 24/7.”

As customers move effortlessly across old and new media, the distinction between channels is certainly blurring. And to be successful, companies should look to omnichannel marketing’s separate-but-whole approach centered around a positive user experience, experts believe.

	“The right solution for a good strategy is a channel mix made of online and offline touch points that can work together if they share the same message, customized for each channel but integrated between them,” says Alvino. “Field force should be in the middle like an orchestra director, choosing the right channel [such as social media, email, or in-person visit] for the right customer.”

’s Senior Editor. She can be reached at 

How to capitalize on the rise of omnichannel engagement in pharma and pursue myriad modes of message delivery in today’s digital world.

Multichannel Marketing: Integrating Omnichannel

	General disappointment over the slow pace of expanded market access to less costly biotech therapies has generated renewed efforts by FDA and other federal agencies to clarify policies and remove roadblocks to increased competition in the field. FDA has issued new guidance to support biosimilar development and approval, while also teaming up with the Federal Trade Commission (FTC) to counter negative messages

 from brands regarding biosimilar safety and effectiveness. While useful, these initiatives fail to alter the patent and exclusivity policies that create the main impediment to broader biosimilar uptake.

	The 10th anniversary this month of enactment of the Biologics Price Competition and Innovation Act (BPCI) is focusing attention on the gains made since 2010 and main challenges ahead. FDA and sponsors are preparing to file and evaluate applications for follow-on versions of insulins as they now become eligible for licensing as biosimilar or interchangeable therapies. FDA held a public meeting in May 2019 to gain input on a streamlined approach to evaluating insulin follow-ons, particularly for combination products.

	A positive sign is that the pace of FDA approvals of biosimilars has picked up in recent months, with more than 25 approved products as of early February and more than a dozen competitors on the market. In addition, the World Health Organization has begun to prequalify biosimilars of “essential medicines” approved in Europe and the US, making these treatments for serious conditions more available in less developed countries.

	The FDA-FTC initiative takes aim at “misinformation” campaigns backed by brands to discourage prescribing and demand for biosimilars. In a joint statement, the two agencies outlined how they will work together to promote competitive markets for biological products to help Americans gain access to affordable medicines.

 Biological products “contribute significantly to drug costs,” noted FDA Commissioner Stephen Hahn, while FTC chairman Joseph Simons similarly observed that delays in making biosimilars available deprives patients of “lower prices and increased innovation.”

	One specific goal for the two agencies is to help biosimilar makers gain ready access to samples of reference products needed to develop and test follow-ons-a difficulty that also has plagued the broader generic drug industry. FTC, furthermore, plans to take a close look at patent settlement agreements involving biologics and biosimilars to detect any antitrust violations.

	This could involve brand rebate policies that discourage payers from providing financially attractive formulary placement and coverage of biosimilar products. A joint public workshop on March 9 discussed these collaborative efforts to advance biotech competition more fully.

	In addition, FDA and FTC pledge to take “appropriate action” against false or misleading communications about biosimilars. Leading biosimilar makers Pfizer and Novartis have filed complaints with FDA about brand “scare tactics” that imply reduced safety and efficacy for biosimilars, and that patients may respond differently even to an approved follow-on.

	FDA clarifies its policies for assuring that promotional messages by both brands and competitors are truthful, non-misleading, and balanced, as with all drug advertising, in draft guidance on promotional labeling and advertising for reference biologics and biosimilars issued in early February. The agency instructs brands to avoid implying in promotional materials that a reference product is safer or more effective than an approved biosimilar, or that the follow-on is “not highly similar” to the reference product, even if the competitor drug is not licensed for all indications.

	The guidance emphasizes that a biosimilar product is not required to be identical to the brand to be licensed, but just that it be “highly similar” and without “clinically meaningful differences” in terms of safety, purity, and potency.

	Another FDA guidance sets out a regulatory process for providing speedy reviews of biosimilars or interchangeable products when manufacturers seek to update an application to add indications to the label. As noted earlier, patent and exclusivity terms may prevent a newly licensed biosimilar from including all 

indications of a reference product on the label, often for pediatric or orphan disease treatment.

	But once those limitations expire, the follow-on manufacturer can file a supplemental application with data supporting the expanded indications.

	The draft guidance clarifies how data and labeling should be presented in such cases and how the manufacturer may submit supplements to add previously omitted conditions of use.

 FDA says it will review such supplements within six months, much faster than the usual 10-month timeframe set for supplements to biologics license applications (BLAs).

	With politicians on both sides of the aisle touting the importance of biosimilars for bolstering consumer access to less costly medicines, FDA is expected to continue to offer policy updates designed to facilitate product development. The hope is that curbs on anti-biosimilar rhetoric and more new follow-ons coming to market with discounts near 25% off reference prices will offset the obstacles presented by patents and exclusivity policies to biosimilar marketing.

’s Washington Correspondent. She can be reached at 

https://www.fda.gov/news-events/press-announcements/fda-and-ftc-announce-new-efforts-further-deter-anti-competitive-business-practices-support

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/promotional-labeling-and-advertising-considerations-prescription-biological-reference-and-biosimilar

Initiatives aim to limit the gamesmanship that can inhibit prescribing of follow-on biologics.

Feds Target Biosimilar Anticompetitive Practices

	Growth in plasma-derived medicinal products is good news for drug developers and for patients-but it is generating a bitter turf war in Europe over how to source the starting material: human blood.

	Over the last decade, the use of plasma-derived medicinal products (PDMPs) has widened steadily, with the global market more than doubling to surpass $20 billion by 2016. Demand has leapt further ahead more recently, both with increasingly sophisticated usage of existing products, and with the emergence of new products and new indications. Most strikingly, the use of immunoglobulin has expanded dramatically from treating primary immune deficiency to other conditions, including multifocal motor neuropathy. New specialty plasma proteins have emerged, such as C1 esterase inhibitor for the treatment of hereditary angioedema, and strong surges in use are being seen for and prothrombin complex concentrate as well as alpha-1 antitrypsin. PDMPs are also now finding further uses in secondary immunodeficiency following new cancer treatments.

	The challenges in supplying the plasma required to sustain this evolution are sending shockwaves through what has for years been a tranquil and traditional corner of the healthcare scene in Europe. Here, in contrast to the US and other regions of the world, blood donors have volunteered their services with altruistic regularity in 1,400 blood establishments handling 20 million blood donations every year. And donors receive no compensation in many countries other than a cup of tea and a biscuit. The predominantly charitable or state organizations that collected blood, primarily for transfusion, also offer some supply of what is known as “recovered” plasma, for therapeutic uses, and also, to a lesser extent, for fractionation into the starting materials for PDMPs. But the advances in science, technology and clinical care-and the resulting demand for plasma-derived medicines-have rendered that model inadequate.

	Commercial operators have increasingly set up their own networks specifically for obtaining what is known as “source” plasma for PDMPs. And that is where the differences of approach are now generating real conflicts-between public and private interests, between voluntary and compensated donation, and ultimately between the relative weight to be given to the interests of patients and the interests of collection organizations.

	No one disputes the need for more plasma. The European Medicines Agency (EMA) guideline on PDMPs notes how “improvements in protein purification and molecular separation technology have made available a wide variety of products, with medical applications covering a large field, and the therapeutic value of these is unquestioned,” but that “the quantity of plasma for fractionation is limited by the number of donors.” The European Commission, which is trying to steer a middle course between the warring factions, notes that the current legislation is “limited in provisions that help achieve sufficiency,” and that “while the number of private plasma collection centers in the EU has increased in recent years, this is far from sufficient to keep up with increasing demand for plasma derived medicines.” Figures from The Marketing Research Bureau, a consultancy, show that just to meet European demand for polyvalent immunoglobulin, nearly four million liters of plasma had to be imported from the US in 2017 to complement Europe’s own resources of nine million liters. For 2025, the consultancy estimates that this gap will rise to nearly six million liters-more than a third of the total requirement of 15 million liters.

	But identifying a problem and agreeing to a solution are two very different challenges-and more particularly in the perennially complex world of European policy formation. The Commission is in the throes of revising its blood-products legislation, and both sides in the debate are ramping up their rhetoric to gain as much as possible from the outcome. The legal intricacies are too arcane to merit detailed attention here- suffice it to offer a couple of examples by way of illustration: PDMPs are covered by the basic 20-year-old EU rules on pharmaceuticals, and so too is any “plasma that is prepared by a method involving an industrial process;” they are also covered by the 15-year-old blood directive; and as if that were not enough, PDMP standards are set in a series of monographs from the European Pharmacopoeia-a separate authority under the aegis of the (also separate) Council of Europe. In addition, EU member states are allowed to apply their own more stringent requirements for PDMPs. Italy, France, and Spain choose to limit their collections of blood and plasma exclusively to domestic clinical needs.

	As the quest for higher volumes of plasma intensifies, the traditional blood donor centers say they want to see the law changed in a way that will give them greater protection against disruption from commercial interests.

	The European Blood Alliance (EBA), an association of non-profit blood establishments, is determined to defend its “voluntary and non-remunerated donation” model, and claims that a Council of Europe agreement- the Oviedo Convention-supports its rejection of financial gain from the human body and its parts. At present, private-sector collection and donor payment is not allowed in many EU countries. In a thinly coded message, EBA says “excellence in blood products supply chain cannot be characterized merely by high productivity and quality,” and it appeals over the heads of everyone else for decisions that will “contribute to a well-functioning professional healthcare system”-in other words, preservation of something like the status quo. It  recommends giving the Council of Europe’s currently non-binding guidelines a mandatory effect throughout the EU.

	Another public-sector based group, the International Plasma Fractionation Association, is similarly urging “a preference for and commitment to the ‘gift model’ of blood and plasma donation without remuneration” and the non-profit model. There are risks, it says, in a market-related supply system-not least an “erosion and/or fragmentation of a community-based donor population.” The answer to insufficient collection is, it says, for governments to boost the public-sector system.

	But the Plasma Protein Therapeutics Association (PPTA), which brings together private-sector manufacturers, as well as collectors of source plasma used for fractionation, sees major inefficiencies in the current arrangements. In addition to manufacturers of plasma-based products, PPTA’s EU members comprise an alliance of 14 organizations that collect around three million liters of plasma at 97 centers in Germany, Austria, Czech Republic, and Hungary-a good achievement, but not enough, it acknowledges. Top of its wish-list is 

EU action to promote a network of dedicated centers for collecting plasma specifically for PDMP manufacture in all EU countries. At present, the infrastructure is so patchy-with big gaps in access to the plasmapheresis equipment that permits higher volumes of source plasma collection-that the goal of European self-sufficiency will remain elusive, PPTA says. The group also wants the ban on payment in many EU countries to be lifted too. It points out that plasmapheresis is a more burdensome and longer process (up to 90 minutes per session) than the 15-minute process for a standard whole-blood donation-and that therefore it should at least be possible for some compensation for those donors.

	The accent in PPTA arguments is principally on patient needs: without plasma, many valuable treatments cannot be made available to them. In contrast, the public-sector arguments tend to focus on protecting the donor. But these are, in some ways, proxy arguments: at bottom, opening the door to payment and to private-sector collection is seen as threatening a fatal blow to the public sector’s voluntary state-run model; while the private sector perceives an attempt by the public sector to manipulate the review of European legislation in a way that would tie the industry’s hands with red tape in the guise of safety rules.

	The outcome will affect more than the interests of a handful of vested interests, because therapy for many conditions for many patients is reliant on adequate supplies of plasma-and at a time of increasing turbulence in international trade, and globalization of health threats, Europe’s patients may find themselves more than ever dependent on European-sourced plasma.

Reflector is Pharmaceutical Executive’s correspondent in Brussels

The collection of source plasma for new therapies igniting debate.

Blood Feud Divides Europe Over Plasma Shortfalls

	Almost 4.5 billion people across the globe were active internet users as of January, according to Statista, a German online portal for statistics. That equals around 59% of the world’s population. Physicians and healthcare professionals (HCPs), having adapted their approaches to social media, are wielding them as powerful tools in interacting with the pharma industry. Whether it be crowdsourcing other professional opinions for a case or connecting with patients through real testimonials, the use of social media allows for messages to have the opportunity to be seen on a global stage.

	“No matter the channel, building connections through authentic patient stories remains the single-most effective trigger for healthy behaviors and improved outcomes,” says Brenda Snow, founder and CEO of Snow Companies, a patient engagement agency. “We’re making sure our biopharma clients engage on social in a meaningful and regulatory-compliant way.” According to her company’s digital tracker, of more than 125 pharmaceutical brands on Facebook, 54% feature real patients in some way. Biopharma marketers hope to evoke emotion through patient stories that include meaningful and useful information to the viewer or reader that ultimately ends up as an endorsement for their product.

	But these types of patient engagements face challenges in credibility and functionality. “Taking the plunge into social media alone won’t make your brand stand out,” says Phil Storer, senior vice president for digital at Snow Companies. HCPs, experts point out, want the patient to feel connected to the subject of the story and draw parallels to their own conditions. A recent Nielsen study found that digital influencers are the most trusted form of advertising. There is a growing need for influencer programs that routinely abide by regulatory and medical 

guidelines. However, patient testimonials can partly fulfill that role in the online pharma space.

	Another channel drawing interest form HCPs when it comes to social media is the expanded possibilities for outsourcing. Designated platforms and applications, such as Figure 1, for example, which has been called the “Instagram for doctors,” enable physicians to display their cases in front of colleagues around the world in seconds, whereas, traditionally, they could only access those peers readily available to them. “We’re a global platform, with 2.8 million HCPs registered,” says Joanna Moshman, director of business development for Figure 1, based in Toronto, Ontario. “We have thousands of physicians, but our network also includes the entire spectrum of healthcare: nurses, medical students, physician assistants, and about 33% of our community is physician-track.”

	Figure 1 has worked with 25 pharma clients of varying size over the past few years, with close to 100,000 cases uploaded by HCPs so far. Features within the application allow for patients to feel secure with their physicians using their cases for reference, with consent forms and data-blocking faculties.

	AI-powered chatbot technologies present more of a challenge when it comes to online engagement between patients, HCPs, and pharma. Though these processing systems can generate and mimic a human response and create a more intimate conversation for the user, they aren’t necessarily intuitive. By typing something into a chat window on a website, the attitude or emotional state of whom a user is speaking to can be lost, experts say. That can impact the patient engagement and emotional connection that is trying to be created through other social media approaches. Users can also find themselves typing the same question over and over, trying to solicit a response that their predictive analytics does not recognize. Though there is industry excitement surrounding AI and chatbot technologies, there remain several complex details to iron out.

’s Assistant Editor. She can be reached at

A look at the ongoing barriers and opportunities in building connections between HCPs, patients, and pharma through social media.

Social Media’s Influence in Messaging Mix

: Pharm Exec talks with AstraZeneca’s Habib Bennaceur about the key transitions in his career and his current role as global vice president, diabetes (orals), in positioning AZ’s Farxiga as a drug with the potential to impact the lives of both patients with and without type 2 diabetes

	Habib Bennaceur trained as a medical doctor at the University of Algiers in the 1990s, but his first role in pharma was as a sales representative for Pfizer Algeria in 2002. Soon afterwards, he became a product physician for cardiovascular (CV) and neurology, and in 2006 was appointed Pfizer Algeria’s CV product manager. The following year, Bennaceur joined AstraZeneca (AZ) France as medical project manager. At AZ, he has taken on 

roles with increasing responsibility, for example, as regional medical director in Maghreb, where Bennaceur led a medical department reorganization and headed up a team covering Algeria, Morocco, and Tunisia. He was appointed president of AstraZeneca Algeria in 2013 and North West Africa president in 2014, in both roles spearheading a campaign to build collaborations with health authorities in the Maghreb region through R&D initiatives, patient support programs, and international projects.

	A change of focus saw Bennaceur move to the UK in 2017 as AstraZeneca’s global vice president, Brilinta, the company’s blood thinner, before taking his current role leading the commercialization of Farxiga. An SGLT2 inhibitor originally developed for the treatment of type-2 diabetes (T2D), Farxiga (Forxiga in Europe) is now also being positioned to treat heart failure and chronic kidney disease (CKD) both in patients with and without T2D. 

 sat down with Bennaceur to talk about how he has navigated his career transitions from medical to commercial and “local” to global, and how Farxiga will be featuring strongly in his future activities.

Having trained as a medical doctor, your first role in pharma was as a sales rep. At AstraZeneca, you would make a more decisive move from a medical to a commercial role. How did you find making that transition?

 The opportunity to put patients first and follow the science is the reason I joined pharma as a physician. It is fantastic that AstraZeneca valued my prior experiences, giving me the opportunities to develop from a medical role to a commercial one, which is quite unique. It was a smooth transition for me. AZ is committed to putting patients first and basing all its decisions on science. All the functions are working toward the same vision, the same goal, so it seemed a completely natural move.

What would you say were your key achievements working for AstraZeneca in the Northwest Africa region?

You cannot achieve anything externally unless you have the best people working for your company. So, a top priority for me was making sure capabilities were upgraded and brought up to international standards, and, not least, position AZ as an attractive place to work in the area. It was also about reinforcing relationships with scientific societies and, especially, the healthcare authorities to position AZ as a true partner in improving healthcare and patient health management in the region.

	What I’m particularly proud of is the oncology strategy I was able to implement in Northwest Africa. In collaboration with the local authorities, we were able to shape the healthcare system and environment to have the greatest impact on the lives of people living with cancer. In Algeria, for example, we aligned our strategy and

 action plan with the Ministry of Health’s national Cancer Plan. We really worked hand in hand with the healthcare authorities and with academia to improve the management of cancer in Algeria. First, we put an emphasis on clinical research in oncology to provide Algerian patients whose alternatives were limited with innovative molecules. We did this by forging partnerships with state-of-the-art research institutes, such as the Gustave Roussy Institute. We implemented lung cancer diagnosis platforms-the first ones in Algeria-and we raised women’s awareness of the necessity to screen for breast cancer. We also created a home care network dedicated to patients at the terminal stage.

What are your priorities now as AstraZeneca’s global vice president, diabetes (orals)?

 I have the privilege of working cross-functionally with talented colleagues around the world, setting and implementing the strategies that will have the greatest impact on the millions of people living with diabetes and intersecting diseases, such as heart failure and chronic kidney disease.

	My primary focus is developing commercial strategy, but I work in collaboration with global colleagues in R&D, medical, and in-country teams to then translate strategy into action. Ultimately, my goal is to continue to build our innovative diabetes portfolio, making sure we put in place the right strategy to benefit patients both today and for 

	Farxiga is playing a most exciting role in this, because we have consistently had new indications and new data for the drug. It was initially approved by multiple regulatory agencies to be used in the treatment of T2D. However, a few months ago (October 2019), FDA also approved it to reduce the risk of hospitalization for heart failure in adults with T2D and established cardiovascular disease (CVD) or multiple CV risk factors. The approval was based on results from the DECLARE-TIMI 58 CV outcomes trial. So, where Farxiga was a drug specifically for diabetes patients, we are now positioning it as a treatment to improve the management and the lifestyle of patients with and without T2D who are suffering from heart failure with reduced ejection fraction (HFrEF), based on the landmark Phase III DAPA-HF trial. And this year, the CVD-REAL study highlighted the potential of SGLT2 inhibitors such as Farxiga to prevent chronic kidney disease progression in patients with and without T2D and to treat the cardio-renal complications often faced by people living with T2D.

	This presents a huge opportunity for us and for patients with heart failure or CKD with or without T2D. We are talking about millions of patients and, currently, a high death rate. What we at AZ have to do, as well as doing this right, is make sure that the scientific community and the healthcare professionals clearly understand that Farxiga is not only a T2D drug, but can also change the life of patients without that disease.

What for you has been the key learning in moving from a regional perspective to a global focus?

	Bennaceur: What was challenging was the need to develop a dual mindset, focusing on the short term and the long term at the same time. As a country president, your long-term perspective is very different from that of a global role; it’s more like three to four years. When you come to a global position, you need to make sure that you are doing everything right in the short and medium term, but you also need to be looking seriously at the challenges you will be facing in 10–15 years’ time. I think adopting that mindset was the biggest stretch in moving from country manager to a global role, but at the same time it is very exciting.

AstraZeneca’s Habib Bennaceur talks about the key transitions in his career-from local to global-and his current role in positioning AZ’s Farxiga as a drug with the potential to impact the lives of both patients with and without type 2 diabetes.


Pharmaceutical Executive-03-01-2020

The Multichannel Reach: Balancing the Local and Global Voice

Market Access: From Being to Becoming

Consider Data Before It’s a Problem

Multichannel Marketing: Integrating Omnichannel

Feds Target Biosimilar Anticompetitive Practices

Blood Feud Divides Europe Over Plasma Shortfalls

Social Media’s Influence in Messaging Mix

Habib Bennaceur: Following the Science

A Bad Deal with Data?

Pharmaceutical Executive, March 2020 Issue (PDF)

Country Report: United Arab Emirates