Pharm Exec's latest annual listing of the top biopharma players paints a stable picture of performance for the usual placeholders, but change and disruption to current business models could upend positioning in the years ahead.

	With the exception of a few new bottom-end entrants, and some juggling of positions in the top half, stability remains the name of the game for those biopharmaceutical companies making up this year’s list of the industry’s top 50 global sales leaders (see tables below). Of course, the relative calm in the rankings meter doesn’t mean that stability necessarily begets profitability for all. Amid growing pricing pressures, key patent losses for some, and a slowdown in M&A activity since the middle of 2016, several mainstays on the Pharma 50 list experienced only modest revenue gains in the latest full-year figures collected, while others suffered slight declines. 

’s 17th annual listing again features data provided by biopharma market intelligence firm Evaluate Ltd. 

	Experts attribute the consistent entrenchment of familiar names in the top 10 and 20 to the simple adage of “how business gets done” in this industry-mainly big pharma following a model that continues to prioritize amassing products and innovation through internal R&D, licensing, or acquisition. Pfizer, for example, which repeated as the industry’s prescription sales leader, has maintained its hold by applying the latter two. As have companies such as Shire, which spurred by its completed merger of Baxalta in June 2016, shot up from the 30th spot to No. 22 on this year’s revenues list. And on the R&D side, Shire’s investment increased 45.5% to $1.29 billion. 

	Merck & Co., despite being ranked fourth in sales, is No. 1 in R&D spend, with a 47.6% spike in investment versus the previous year. The company’s newest rising seller, the immunotherapy Keytruda, continues to be studied across numerous tumor types, lines of therapy, and combinations. Others that didn’t climb the sales ranks but are investing solidly in R&D include Lilly (15th in sales, eighth in R&D spend) and AstraZeneca (11th in sales, seventh in R&D). 

	As far as future shifts in sales-figure positioning in the Pharma 50, Jonathan Gardner, EP Vantage News Editor, US, at Evaluate, cites two areas to watch. “The first is pricing, to the extent where payers become more assertive in areas where they have been reluctant in the past, such as oncology or orphan diseases,” Gardner tells 

. “On the latter, we’ve seen payers be surprisingly skeptical of new drugs Spinraza and Exondys 51, and there is potential for that to expand. The second issue is disease areas that have become crowded with new agents-autoimmune disorders such as psoriasis and rheumatoid arthritis-that could give payers even more leverage than they’ve had in the past on franchises such as Humira and Enbrel.”

	Gardner also notes that until the outlook on US pricing legislation, tax reform, and repeal and replace of the Affordable Care Act becomes clearer, a big rush on M&A is unlikely. “Opportunistic deals will appear, but companies with significant amounts of overseas cash will be reluctant to risk overpaying on taxes to execute major US acquisitions,” he says. “Pricing and ACA repeal/replace pose similar, if lower-level risks.”

	Which leads us to our special Pharma 50 accompanying 

 by guest authors at the executive search and talent advisory firm Russell Reynolds Associates. The authors contend that a significant disruptive event looms on the horizon for the industry, brought on by new US legislation on pricing and new definitions of value. The article points out that traditional sourcing routes for biopharma innovation-in-licensing, M&A, and R&D collaboration-have been expanded by new models of engagement with external innovators, such as open innovation models and corporate ventures. Managing the diversity and complexity of these innovations, and building a more nuanced communication with the external world, will require all those companies in our Pharma 50 to adopt new leadership approaches-and install new types of specialists and C-suite roles to guide the collective industry through the coming disruption and beyond. 

See how the top 50 biopharma revenue generators stack up ahead (click on the tables to enlarge).

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Pharm Exec's 17th annual listing of the top biopharma players paints a stable picture of performance for the usual placeholders, but change and disruption to current business models could upend positioning in the years ahead.   

Pharm Exec's Top 50 Companies 2017

Russell Reynolds Associates outlines the new leadership tactics and C-level specialty roles that Pharma 50 companies will need to steer the industry through the disruptive event on its horizon. 

	The pharma business model is still largely a traditional model characterized by a simple formula: One product. One customer. One price. The model has been viable for decades and has brought high returns to the industry. Since the 2000s, however, the stakeholder map has become more complex, as purchasing power has been shifting from physicians to payers, regulatory bodies and, to some extent, patients. We believe this shift will eventually lead to a significant event in the industry that will disrupt how companies price their products and require a different type of leadership in the industry.

	In Earth’s history, 66 million years ago, a meteoric disruption-known as the K-T event -led to the extinction of several large species. After the event, dinosaurs became extinct while more nimble and adaptive small reptiles, birds and mammals survived. Is a similar event coming for the pharma industry? We believe a P-E (pharmaco-economic) event will occur, where the US government institutes legislation requiring demonstrated product outcome and prices based on patient value. In this case, the concepts of product, customer, and price are redefined. In the post P-E event era, the industry will be governed by brand new rules, which will require pharma companies to adapt to avoid going the way of the dinosaur. The old model of single-pill solutions and lifecycle management to drive innovation will give way to more agile companies that are driving whole-patient, or “beyond-the-pill,” services and novel therapies.

	This changed business environment will also require a new set of leaders that are patient-centric driven, have greater content and scientific expertise, and can understand insights from the vast amount of real-world data generated by products in the market. In order to navigate through this upcoming disruption, we believe pharma companies are already creating new roles and seeking new types of leaders to guide the transformation and adapt to the change.

	In our proprietary research, Russell Reynolds Associates (RRA) has examined the new C-level positions (CxO) across the top-50 pharma companies for patterns and trends and developed an outlook for the near future. In this article, we offer a perspective on pharma leadership through two lenses: 

 In reaction to stricter regulatory requirements, we observe the emergence of specialist roles and their elevation to the C-level. 

 In preparation for a P-E event, we expect an emergence of new leaders, whose goal will be to guide the industry through continued disruption. 

	In our analysis, we considered the composition of executive management committees and extended senior management teams, including CEOs and their direct reports, for top-50 pharma companies. The research was conducted using publicly available information from May 2017, such as company websites, BoardEx, and LinkedIn, and was supported by RRA’s ongoing consulting to the pharma industry.

Traditional managers to C-suite specialists

	In the 1990s, the executive committees of large pharma companies started to grow in size. Geographic expansion, regulatory complexity in established and emerging markets, and diversification of market portfolio and assets in the R&D pipeline are just some factors that led to the rise of specialists in certain therapeutic areas, geographies, R&D stages, and corporate functions-all with a seat at the C-table. The organizations grew into large and complex matrix organizations. 

	Today, the average size of the senior leadership team at top-50 pharma companies is 11-12 members, and the range varies widely from four to 28. Among top-50 organizations, 58% have business unit heads in their C-family, on average two to three, and a maximum of eight. Conversely, regional heads have started to disappear from leadership’s inner circle, and today only one out of three top-50 pharma firms has regional heads at the very top (see Figure 1; click to enlarge).

	In the 2000s, with regulatory requirements becoming more stringent, a number of specialist position were elevated to the C-suite, replacing traditional managers. Specifically, we see three roles that have extended their remit significantly and have been elevated to the C-level in many pharma organizations.

Traditionally rooted in the R&D organization, the medical affairs function has evolved dramatically in recent years, driven by regulatory scrutiny and operational complexity. Today, medical affairs fulfills a strategic mandate to represent “the voice of the patient” internally vis-à-vis R&D, commercial, and other functions and to drive high value-add activities externally. In 28% of top-50 pharma companies, the Chief Medical Officer reports directly to the CEO and has a prominent external-facing role. For the purpose of this study, we analyzed the background of Chief Medical Officers in pharma C-suites in terms of education and previous professional experience. Our analysis suggests that scientific rigor and previous extensive experience in R&D, medical affairs, and/or regulatory affairs helps increase credibility, independence and authority internally as a patient advocate and externally as the primary medical representative of the company in the market (see Figure 2). Additional experience in commercial or project-related activities complements the profile of a Chief Medical Officer and sharpens his/her strategic focus.

 Recent challenges in the pharma market-sales and marketing malpractice, off-label sales, and data integrity, among others-have led to legal issues and shaped negative public opinion about pharma companies. Going forward, the pharma industry needs to (re-)position itself as a trusted partner in public health. To ensure regulatory and non-regulatory compliance and ethical behavior and find new ways to engage with prescribers, key opinion leaders, and other external stakeholders, pharma organizations are taking an integrated approach to compliance. 

	Twenty-six percent of top-50 pharma companies have elevated the Chief Ethics and Compliance Officer to a direct report to the CEO or the Board. To spot potential issues before they emerge, the Chief Ethics and Compliance Officer assesses the value chain for the possibility of behaviors that violate ethical or regulatory mandates. To set a course of right behavior from the start, the Chief Ethics and Compliance Officer also serves as a key advisor on the adoption of business models and the assessment of transformation risks. 

	A more detailed look at the profile of Chief Ethics and Compliance Officers leads to the conclusion that a solid legal background and an extensive track record in the pharma industry are prerequisites for the role. A high ratio of internal promotions from deputy General Counsel or divisional legal business partner within the same organization suggests that credibility and trust on the side of business leaders as well as internal connections are essential to get buy-in for this role (see Figure 3).

 Over the last decades, the pharma industry has grown tremendously in size and complexity and developed a highly sophisticated system to ensure that patients receive high-quality products. Most pharma companies have been undergoing the transformation process from baseline compliance and delivery on regulatory authority inspections to continuous improvement and a culture of quality, or speaking in their lingo, from quality control to quality assurance. To complete the organizational separation of quality from operations on a corporate level, 24% of companies have elevated the Chief Quality Officer to the level of direct report to the CEO. 

	A route-to-the-top analysis indicates that this is a narrow field of specialization, as the vast majority comes through internal promotions from within the pharma company’s quality function, by having their roots in quality (83%) and/or technical laboratory analysis (50%) (see Figure 4). The fact that at the very top, quality is occasionally co-located with other responsibilities, for instance, HSE (health, safety, and environment) explains the broader range of other experiences.

	The roles described have been evolving over time, but companies may decide to shift from this incremental approach to more aggressive leadership development in preparation for a P-E event. The goal is to provoke and accelerate change bold enough to help the organization adapt to the quickly changing ecosystem while recognizing that the specific type and pace of change should be calibrated to the company’s starting point regarding process and cultural maturity.

	This change will involve institutionalizing new roles across three categories: transformation leaders, ecosystem leaders, and enabling leaders. 

	The leaders in this first category are the architects, motivators, and catalysts that help pharma companies adapt and grow into organizations that can meet the challenges of a new industry landscape.

Chief Transformation Officers have a mandate to lead the organization through momentous times in a company’s history. Effective Chief Transformation Officers inspire employees and act as role models for the sort of behavior needed to encourage and embed change. To be able to orchestrate a highly complex process and deliver on results, they need the full support of the Board, the CEO, and the entire executive team. Among the companies in the top-50 pharma ranking, only two have already nominated top executives to lead the transformation-Alexion and Amgen. Given a very limited sample size, we can give only a directional profile of a Chief Transformation Officer: well-regarded senior executive with previous experience in transformational processes at larger organizations outside the pharma sector, excellent problem solving skills, and very strong interpersonal skills.

Digitization of the pharma industry has a strong impact on all functions along the value chain. To reap the benefits of digital, pharma companies must plan for, build, and operationalize their digital capabilities, often into evolving business functions. To accelerate the process, a Chief Digital Officer often acts as a catalyst with a mandate to drive digital transformation, challenge the corporate thinking on digital, and define the digital strategy across all corporate functions. The ultimate goal is, however, to evolve to a digitally integrated organization and develop a generation of digitally savvy business leaders in all functions.

 Big data has the potential to revolutionize the industry, though complexity within the regulatory environment and pharma business model are two main reasons why the large pharma companies are still lagging behind in adoption of advanced analytics. In addition to the fact that ownership of post-clinical data is not in the hands of the pharma industry, the key challenge for most companies is how to translate all the innovative ideas into something tangible and “real.” The mandate of a Chief Data Officer would be to build the governance process and lifecycle management for big data and define where the most value can be created-i.e., translate the insights from advanced analytics into commercial impact and real financial outcome. Transformation requires the Chief Data Officer to be a change agent with an understanding of relevant data sources, technology and tools, and data science as well as strong business acumen and excellent communication skills.

	While each leadership position described so far is distinct in its set of responsibilities, they require a shared set of attributes. In RRA’s proprietary analysis conducted in 2015, we distilled the core competencies of effective transformation leaders and found that the most successful leaders embody five specific characteristics (see Figure 5). 

	First, they are innovative, with a propensity to challenge traditional methods and approach matters in new ways. Second, they are disruptive, willing to take calculated risks and “buck the system” when necessary. Third, they are decisive leaders who boldly carry the torch of change. Fourth, they are socially adept leaders with the ability to understand people and easily adapt to different audiences. Fifth, transformation leaders are determined-a characteristic evident in their high level of optimism and their achievement orientation.

	We are beginning to see many roles emerging with a shared goal-to manage the relationships with the external world-we call them “ecosystem roles.” These roles help pharma companies proactively shape their own positioning in the ecosystem vis-à-vis other players, build long-lasting partnerships as well as create and effectively communicate value of pharma products and services. The end goal is improved health outcomes, faster time-to-market for products, and more efficient management of internal and external R&D processes.

	The roles that are beginning to emerge to help manage these partnerships are largely situated at the middle-management level and have a mandate to align different (and “siloed”) functions within the pharma organization to deliver consistent messages to the external world (see Figure 6). In order to break through the organizational barriers and ensure the right level of focus and investment, 30% of companies have introduced one or more ecosystem roles into their C-families, ensuring that their objectives are given high priority, top-level backing, and sufficient resources.

	To deal with different players in the healthcare ecosystem, we see several emerging archetypes of positions.

 To reflect the shift to a more patient-centric business model, pharma companies are introducing roles that take a holistic view and think through the entire patient experience. Roles like Head of Patient Journey Excellence, Head of Patient Experience, and Head of Patient Engagement are seen more in the health services space but have begun to appear in pharma as well. In 2012, UCB was the first top-50 pharma company to appoint a Chief Patient Affairs Officer, followed by Sanofi in 2014. Today, Merck & Co. is the only company among the top 50 with a Chief Patient Officer in the C-suite. The primary goal of the position is to bridge the gap between the patient community and the pharma company-and more broadly, the pharma industry.

 Being traditionally a communications function, this role has evolved over time. Today, it covers strategic communication, government relations, public policy, health policy, investor relations, and more. Among top-50 pharma companies, 25% have a more traditional communications, corporate affairs, and corporate social responsibility seat in the C-suite, and another 25% have extended the role or created an additional one for engagement with external stakeholders (external affairs, public affairs, and global government affairs are the common titles).

 Approximately 75% of the most exciting late-stage assets in the collective pharma industry pipeline comes from sources outside of the company that owns them today. The traditional sourcing routes have been in-licensing, corporate acquisition and R&D collaboration. This spectrum has been expanded by new models of engagement with external innovators such as open innovation models, corporate ventures and direct company engagements. In order to effectively manage diversity and the complexity of externally sourced innovations, companies require a more strategic and orchestrated approach. Today, 18% of top-50 pharma companies have a business development leader at their C-table. Other companies have introduced new roles; for instance, Roche has a Head of Partnering in its enlarged corporate executive team, and Abbott has a Head of Ventures in its leadership team. As external innovation and business/corporate development are increasingly becoming synonymous with each other, it is only a matter of time until we see the first Chief External Innovation Officer.

	In the pharma industry, permanent restructuring, post-acquisition reorganization, cost-cutting initiatives and similar internal disruptions can have two potentially dangerous but highly manageable byproducts: organizational fatigue and burdensome administrative complexity. Two groups of enabling leaders can address these issues, providing the high levels of ongoing support that create an organizational environment that is able to sustain sizable transformation.

We can expect new C-suite roles to be created to promote people, culture, well-being, and inclusiveness. In addition to Chief People Officers, we will see more Chief Diversity and Inclusion Officers and Chief Culture Officers at the very top of the leadership ladder-with the mission to actively shape and promote internal company culture and foster employee happiness and satisfaction. 

 To address the inevitability of larger leadership teams and more complex organizational structures, we observe the desire to consolidate and even centralize some responsibilities on a corporate level and/or vertically throughout the organization. An example of consolidation is the role of a Chief Administration Officer (6% of top-50 companies). This person assumes the administrative back-office accountability and relieves the CEO from his/her day-to-day tasks, allowing him/her to put extra time and effort toward more strategic and critical decisions. An example of centralizing the larger number of administrative responsibilities is placing one person on the senior management team in charge of global business services (6% of top-50 companies). This role is in charge of business support services and can be considered as a “span breaker,” i.e., productivity and efficiency gain for the entire global organization.

	In anticipation of a P-E event, we expect pharmaceutical companies will consider new roles-transformation, ecosystem, or enabling-as a part of their leadership teams. In order to design these roles-and set the leaders in these roles up for success-companies need to think critically and honestly about their unique needs and leadership goals, the full shape of prospective positions and where they are today in the transformation journey (see Figure 7).

	While the C-suite changes are just now beginning in pharma, other industries have already progressed in their leadership adjustment. In the consumer goods industry, for example, we have already seen a higher number and an increased diversity of new CxO roles, such as Chief Growth Officer, Chief Customer Officer and Chief Omnichannel Officer. The Chief Design Officer in automotive and the Chief Innovation Officer and Chief Customer Experience Officer in health services are examples of new specialist positions institutionalized at the highest levels of the organization. The pharma industry can learn from these examples and try to break down functional barriers and align the company.

	The key learnings from other industries are the following:

 The success of these new roles is dependent on finding someone who embraces the change and confidently leads the transformation. Identifying the best talent either internal or external to the organization, who has transformation competencies, is critical. 

Cultural collision is inevitable, so be prepared.

 As the mandate of a new leader is to challenge the status quo, some degree of conflict is predetermined. In the case of externally appointed leaders, the Board and CEO need to effectively onboard new leaders to minimize cultural conflicts while pushing for the change. 

A clear set of key performance indicators to measure success of the new roles allows leadership to further refine the role itself and its scope of responsibilities, as well as ensure an appropriate level of dedicated resources.

	Monitoring adaptations in organizational structures, both within the industry and outside, will give a clue to how imminent leaders believe this change will happen. Within the healthcare industry, emerging biotech and digital health companies will likely move faster along these future trends, and it may take time for these roles to trickle up to larger more established organizations. 

	The quickening pace of change in the industry will require a bold reimagining of top-level leadership to adjust and thrive in a new pharma environment that emphasizes demonstrated product outcomes and value to patient. The transformation approach may vary by organization, but all the companies will need to adapt to the change eventually. 

is a Consultant at Russell Reynolds Associates. He can be reached at 

is Global Knowledge Leader for Healthcare at Russell Reynolds Associates. She can be reached at 

Outlining the new leadership and C-level roles of tomorrow needed to take on the disruption event on pharma's horizon. 

Navigating Through Disruption: A Pharma 50 View

	Those were the two most common ways Bahija Jallal, executive vice president of AstraZeneca and head of MedImmune, was described by her colleagues, employees, and friends during the Healthcare Businesswomen’s Association’s Women of the Year awards last month in New York City.

	“She is smart and hard-working,” said Pascal Soriot, executive director and CEO of AstraZeneca. “Bahija is a true citizen of the world. She came to the US to change the world.”

	Jallal, who grew up in Morocco, studied in Paris, worked in Germany and then in the US, was honored as the 2017 HBA Woman of the Year during a luncheon that drew 2,200 in-person attendees and many more watching via live feed at more than a dozen viewing parties across the world. We chronicled Jallal’s career

	“Bahija is courageous and resilient,” said Soriot, before inviting Jallal to the stage. “She fights for what she believes in.”

	Soriot went on to relay examples of how Jallal did this, noting that when AstraZeneca brought MedImmune into its portfolio in 2007, the translational sciences leader was faced with harsh critics, but she never let them get the best of her.

	Many times Jallal was faced with people calling MedImmune a “money drain,” and as a result she would “put her job on the line many times,” Soriot added.

	“In my heart of hearts, I am a scientist,” Jallal told the ballroom filled with seasoned pharma executives as well as those aspiring to become the healthcare leaders of the future. “It has been an incredible journey of curiosity. Every answer leads to a new question.

	“My dream was to figure out the answers to all my questions. I always followed my heart in my career decisions. I’ve never done a development plan or chased titles.”

 for the April cover story, started when she was nine years old and her father went to a clinic in pain with a suspected kidney stone and never came home.

	She shared several tips that have helped guide her success. First, don’t be afraid to fail.

	“If you don’t fail, it means you’re not pushing innovation and science far enough,” said Jallal. “And, when you do [fail], be resilient. Dust yourself off, figure out what went wrong, and try again.”

	“We can turn science fiction into science fact,” she said.

	“Remember, amidst all the ups and downs, and highs and lows, why we come to work every day,” said Jallal. “I followed science and followed my heart. Do not apologize for being smart, or following your passion.”

	Her last bit of advice centered around what she likes to call the, “what will people think of me” syndrome.

	“All too often we get stopped in our tracks in search of perfection,” she said. “By [doing this], we hold ourselves back. We don’t have to be perfect. No one is perfect.”

	Despite all of her accomplishments, Jallal said there is a lot more work to do. She explained that science has never been better when it comes to innovation and breakthroughs. “But too many patients still suffer from cancer, diabetes, asthma, and other diseases,” she added.

	In all, more than 30 women were honored as 2017 HBA Luminaries, and more than 60 were named 2017 HBA Rising Stars.

	In addition, Joaquin Duato, worldwide chairman, pharmaceuticals, at Johnson & Johnson, received the Honorable Mentor award, and Ceci Zak, principal and COO of Batten & Co (a strategic consulting firm within the Omnicom Group) received the STAR award. 

’s Senior Editor. She can be reached at 

Columns

An honoree at HBA’s recent Women of the Year awards luncheon, Bahija Jallal’s story is one of courage and resilience.

Tips for Success from a Big Pharma Leader

The patient voice is growing louder in all aspects of the drug development and commercialization journey. Pharm Exec examines some of the current industry thinking on the evolving pharma-patient relationship. 

				Over the last decade or so, patient groups have become better organized, more professional, and, not least, more vocal. As the pharmaceutical industry and regulators have acknowledged this strengthening of influence and resources, the patient has begun to have more impact on the way pharma works, particularly in health technology assessment markets. Consequently, the move to involve patients across the drug development and commercialization process-from R&D and clinical trials to promotional campaigns-is becoming an increasingly important consideration for companies committed to pursuing transformational medical innovation. 

	There are, of course, remaining barriers to the smooth cooperation of pharma and patient groups. A pharma company is a commercial organization, bound by regulatory restrictions and the expectations of all its stakeholders. The relationships pharma companies have with patient organizations can only advance if the right balance is struck and clearly defined boundaries are established. Historically, as Steve Wooding, head of Janssen’s global commercial and market access strategy organization, points out, there have been issues resulting from the potential of both pharma and patient organizations to use their influence inappropriately. 

	“The patient voice has to come through, but there needs to be a clear separation between responsibility and accountability,” Wooding told 

. “We do need to make sure that the relationship is on an equal footing and is based around appropriate exchange of information.”

	Ipsos MORI’s head of ethnography, Victoria Guyatt, notes the operational barriers to shifting further toward patient centricity. “There’s still the thinking among pharma companies that, ‘if we talk to patients, does that mean we can’t deliver for our stakeholders?’” she says. “One of the things that pharma is getting good at is the gathering of patient insights-listening on social media, for example-but embedding and pushing these insights out to the rest of the organization, the R&D teams, is still difficult. And there’s a lot of anxiety about doing the wrong thing.” 

	For Abeona Therapeutics’ vice president for patient advocacy, Michelle Berg, “harmonizing language and terminology” is a challenge. “It can be difficult for some individuals, or families or community members to understand the drug development practice, gene therapy and clinical trials,” she says.

	Developments in digital communication have radically altered the position of patients, and there is broad consensus that the resulting empowerment has brought major improvements to the pharma-patient dialogue. From a rare disease perspective, in particular, social media and online forums have  proved to be vital tools that can engage patient communities that were hitherto almost invisible. 

	Abeona Therapeutics focuses on developing products for severe and life-threatening rare genetic diseases, such as mucopolysaccharidosis (MPS) IIIA and IIIB, a progressive neuromuscular disease with profound CNS 

involvement, which manifests in young children. Berg told 

: “I am grateful that we have such communication tools available for families, because knowing that these are such rare diseases, there are not clusters of families in a region who can find each other and share experiences. With the advent of digital communications, families and healthcare providers have the opportunity to locate and support one another.”

	A patient diagnosed with acanthamoeba keratitis, a rare amoebic infection of the cornea, told 

’s Stephen Armstrong (“Social Networking for Patients,” August 10, 2016) that when she was first diagnosed, “most of the information I could find was either inaccurate or terrifying. But I found a Facebook group, with only 38 members at the time, and the relief was enormous. I was so happy to connect with someone, to share the same emotions and experiences, the same anxiety and frustration and shock in a normal, accessible way.”

	Armstrong adds that online groups don’t just enable patients to share experiences and support each other. He points to research from the University of Toronto conducted in 2011 that found that the 620 groups on Facebook for breast cancer had purposes including fundraising (44.7%), raising awareness (38.1%), promoting products or services (9%), and exclusively offering support to patients or caregivers (7%).

	However, Armstrong also highlights the risk of social media disseminating misleading, superfluous, or incorrect information, or being used for the promotion of dangerous or unsuitable remedies. Berg adds that “communication tools are only going to be as good as the information that is perpetuated, and a problem can be that false or inaccurate information can be perpetuated quite quickly, which can have a negative impact. That’s why it’s important for organizations to have resources available and that are committed to supporting individuals and families with rare diseases, offering resources that can serve as a fact-check against any information that might not be right.” 

	Marc Princen, EVP and president, international business, Allergan, reminds us that pharma is a very regulated industry. “We are talking about decision-making where trained healthcare professionals must make the right decisions,” he says. “It shouldn’t be just a free-for-all. We need to respect the regulations. It is helpful that the technology exists and people can get better informed, but professional advice and decision-making is still needed.”

	Armstrong observes that “few physicians are currently using social media to talk to patients.” Indeed, for some patients, “the idea of any healthcare professionals taking part in patient groups is an anathema; many see them as private patient spaces where people can vent frustrations about treatment,” he says. If clinicians are to engage, they need to keep up to date. Armstrong spoke to one parent who explained that her daughter, who has type 1 diabetes, only uses the photo and picture-based platforms Instagram and Snapchat rather than Facebook or Twitter. She added she had “no idea” how clinicians could use these platforms even if they can understand them.

	Nevertheless, the pharma-patient dialogue continues to advance, and pharma is faced with re-evaluating how to incorporate the patient view in its processes, not just to facilitate a better relationship but effectively to translate innovation into the market.

	“In the old days, you had your product and you put it out there. But to bring meaningful innovation to people today, for instance, with clinical trials, we have to ask ourselves: are we designing trials that are great for the scientists but impossible for the patients?” says Wooding. “The latter will ultimately delay access and commercialization of your medicine. And what endpoints do we need? Whether a treatment shrinks a tumor, for example, is a useful endpoint from a regulatory standpoint; but it may not be enough from a patient standpoint, if they don’t feel better or their quality of life is not improved along with the medical benefit.” 

	These are the criteria, says Wooding, that payers are starting to look at, “so we have an opportunity now to build those metrics into the process in a meaningful way.”

	In many cases, symptomatic relief is more important to patients than outcome improvements in the long run. With payers in the past having valued outcome improvements higher than symptomatic improvements, it has become clear that the patient voice needs to be drawn further into the debate. As

s Jill Wechsler noted in her April column, FDA is now looking to improve communications with patients by forming an Office

 of Patient Affairs in the Office of the Commissioner. “This would provide a single, central entity to handle inquiries from the patient community, and would expand the current patient team in FDA’s Office of Health and Constituent Affairs,” she wrote. 

	From the industry side, building meaningful relationships with patient groups is less a case of responding to patient lobbying and more a case of encouraging them “to share with us what is important to them so that we can actually make those developments,” says Wooding. 

	Princen, who was formerly Takeda’s president of Europe and Canada, notes that it is about finding out “how you can institutionalize working with the patient.” He says that Takeda worked with an outside think tank, which put together criteria for inflammatory bowel disease, Crohn’s disease and ulcerative colitis. “We developed an app that included these criteria, allowing for collection of data on symptoms, triggers and aggravating factors, and provided it to patient organizations,” he says. “This type of objective criteria-setting is really useful, and it is where the patient organizations are very helpful. The next step was to work with the payers, measuring the real patient outcomes and then work out how the funding could be shared.”

	So, what does pharma look for from a patient group to facilitate an effective collaboration? Ideally, according to Wooding,  it’s the ability to connect with a large unifying group. 

	“But that isn’t always possible,” he says. “It is certainly an advantage if they have a depth of scientific knowledge. They should be informed and have a clear structure that we can interact with; they need to have the right charter in place and to be professionally operated.”

	Wooding adds that, in specialty areas, particularly in diseases with increasingly complex treatments and where the side effects need to be managed effectively, “effective partnering is easier with a better informed, better aligned patient.”

	For Berg, “it’s very important to collaborate and partner with those specific communities that we are aiming to serve, in order to step into their shoes and understand the impact of what that disease might be, not only for the individuals afflicted but, in the case of much of what we’re working on, in the pediatric population.” She believes  that understanding what’s important to the parents and caregivers is critical and, in some cases, may be more important than understanding the priorities of the children themselves. “Because with these diseases, their voices are not really able to be heard,” says Berg.

	A measure of how important patient input is perceived in the rare disease area is highlighted by results of a survey of over 3,000 US patients and caregivers across several hundred diseases and conditions, conducted this year by Rare Patient Voice. The survey found that the majority of respondents (55%) were in favor of patient advocacy groups partnering with pharma or biotechnology companies to develop drugs for medical conditions. Some of those who support partnerships stressed that they can enable drug development to take patient perspectives into account; that they are the best way to obtain funding; that they can accelerate the development of treatments; and that, ultimately, “anything that might help obtain a cure or improvement should be tried.”

	Writing on the Clinical Trials Arena website, Horizon Pharma’s Dr. Jeffrey Sherman, in an article published late last year, emphasizes that “engaging with patient groups to understand the patient voice from the beginning of research can greatly benefit overall drug development.”  Sherman outlines how, for a clinical trial evaluating a medicine for the treatment of Friedreich’s ataxia (FA), a rare neuromuscular disorder, Horizon collaborated from the outset with the patient organization Friedreich’s Ataxia Research Alliance (FARA). 

	“FARA offered crucial input on trial design to ensure that travel requirements, medicine administration and study eligibility criteria were realistic within the FA community,” he notes. “Moreover, FARA provided full access to its comprehensive patient registry, the only collection of demographic and clinical information for 2,000-plus FA patients around the world.” 

	The result was that the FA study completed enrollment in less than one year, “an unusually fast pace for a rare disease trial.”

	While Wooding acknowledges that, in terms of involving patients, “there are only so many things that you can choose to do within an R&D setting,” he points out that Janssen’s move in this direction has begun to deliver results for the company in the last couple of years. 

	“We are now starting to see patient-reported outcomes become acceptable in terms of registration and licensing and labeling,” says Wooding. “For example, for a prostate cancer medicine, we now have within the indication the fact that the drug can have an impact on pain. For most patients, that is their most relevant day-to-day symptom. Those kinds of things are working their way through into labels. The only way for a company to anticipate what’s important to patients is to have their input. With the availability of more data, to link to the 

genotype and phenotype, this will become even more of an opportunity.”

	Wooding concludes: “We have always been a patient-oriented company, highly aware that patients are waiting. We realize, however, that not only are patients waiting, they are engaging and wanting to take more control of their own destinies.” 

	It is very clear, he says, that the voice of the patient is not only going to become more influential, but will have a significant impact from a business point of view. “At Janssen, we heard it,” says Wooding. “Now we needed to do something about it. Some of that is about best practice sharing; some is about spreading the message within our organization. In other cases, it’s about trying out new approaches and seeing what works. It’s about continuing the patient dialogue-and learning from it.” 

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

With the patient voice growing louder in all aspects of the drug development and commercialization journey, Pharm Exec examines some of the current industry thinking on the evolving pharma-patient relationship.

The Quest for Meaningful Pharma-Patient Dialogue

In an executive roundtable discussion, underwritten by Zephyr Health, a panel of biopharma executives share their insights on market access and the changing dynamics in reaching physicians and healthcare professionals. 

				The challenge for market access professionals is trying to put the payer, patient, provider, and health system together in a way where they all benefit. Given the complexities of healthcare delivery, which is fragmented, and the increasing costs to patients to purchase their needed medicines, market access executives have a near impossible task. This executive roundtable was underwritten by Zephyr Health and uncovered many themes during the collegial discussion. These issues included physician access and education, patient access, the changing role of the pharmaceutical sales representative, and the role of technology.

What are the challenges to current market access, as it relates to the physician, and your sales representatives reaching those physicians?

 Access to physicians, with the consolidation occurring in systems as well as physician practices, the reps are getting squeezed out. They have less opportunity to communicate the value proposition of our medicines. And this is happening at the same time the value proposition has become more complex.

	But there is opportunity for pharmaceutical companies to improve how we communicate with physicians. Maybe through electronic health records or e-prescribing, but there is an undercurrent of communication that’s taking place that physicians and other decision-makers tap into. So we can get into the communication streams of where physicians, payers and others are consuming information.

 To your point, the massive consolidation is changing the dynamics around centralized decision-making. For some regions, there is a large amount of depth and breadth. Think about how heavily penetrated Cleveland Clinic might be in the Cleveland area. Your sales team could be having hundreds of interactions with that system in a given day, but the level of influence that those individuals are having could be very different. Not all visits and interactions and engagement activities are going to be created equal when you have a much more centralized decision-making structure.

 Exactly. That autonomous decision-making of the physician is becoming less and less. We

 need to move representatives to account managers. Because even at a “rep level,” they’re dealing with physicians who are part of systems or groups. The reps need to approach that as an account, not solely from a physician-to-physician-to-physician approach.

 That’s part of the evolution that we’ve had at AbbVie. But the Cleveland Clinic example is a great one. We recognized about four years ago that there was a consolidation of decision-making at these large health systems. At the same time, the electronic medical record became mandated by ACA. Those events made us start focusing on a relationship with the health systems, not from a promotional perspective but from a business-to-business perspective.

	We created health system executives that would dig into their needs and goals, as opposed to a product approach. It’s going from a standard-of-care approach to a population health approach. We moved the conversation to, “How do you get more patients diagnosed and ultimately treated?” It’s good for the patient, it’s good for the system and it’s good for lowering the overall cost of healthcare.

 At Takeda, we too are shifting our approach. We have focused a lot on partnering for access as a priority, and we’ve been trying to increase our capabilities to do that.

	Like AbbVie, we have focused on upscaling our account executives so they’re partnering with the healthcare systems but also forging much closer collaborations with our medical affairs associates. So now managed markets and medical are more hand-in-hand than they’ve ever been before. 

	It’s very important for evidence generation to partner with payers and work within their own system, using their data and addressing obstacles to infrastructure and data analysis. This partnership is necessary to demonstrate real-world evidence in the environment.

 Which is great because, in doing so, you’ve now aligned some of the commercial elements with health economics. I see this as a big win for patients and hold out hope that earlier communications between manufacturers and payers may lead to earlier coverage determinations, which, in turn, may improve patient access. 

 There are tools and resources that can help us take the traditional view we’ve had of the sales representative role, or the commercial team role, and really help evolve that so it’s much more in sync with 

what’s critical to the other stakeholders within the healthcare value chain.

 We released a survey that we did with about 60 leaders across 22 pharmaceutical companies in different roles-market access, sales and marketing leadership. Almost 70% said they’re all using some type of market access data on a regular basis. However, 40% said there are still opportunities and gaps in terms of better using that data to align the functions and the go-to-market approach across those functions within any given healthcare company.

 In terms of the technology perspective, what is very exciting is the data density that’s generated from smartphone devices and other connected devices, and the data from the EHR systems, that’s allowing us to drive insights on patients that would have taken us years to uncover before platforms-frankly, like Zephyr’s-that allow you to derive insights from algorithms and machine learning.

	Takeda has recently engaged Zephyr to take our data and make it more patient-insight driven so that the representatives have information that can bring higher utility to their discussions.

	We’ve been really encouraged by the data aggregation and insights we’ve been able to produce.

 You can have a portal that provides sales representatives with a lot of analytics. My prior experiences with rep portals, however, has been varied. Some reps love to mine the data unique to their customers. But many reps don’t really use the portal at all. To them, the portal is just another CRM platform that’s devoid of real-world experience. They think, “I know my physicians; I have my relationships and know what’s going on in their practice.” In my opinion, this is part of the struggle in the evolution to create this new kind of specialized business that relies on analytics.

 One thing we’re doing is based exactly on the rep struggle you described.

	Some representatives have a large number of targets or accounts with a lot of data that’s changing constantly. We are taking a more consumer-driven approach, serving up information to the field team-be it account managers or representatives-at a time when it could be more useful to them and based on change in that data or information.

	It makes their job easier because they can proactively receive information that is being pushed to them programmatically through the software and machine learning. They can then decide what to do with it or how to incorporate it. It could give them guidance in terms of key information, messaging that might be most relevant and/or prioritizing engagement with a given target or account based on something that’s changed.

 What Takeda likes about Zephyr’s platform is the potential to increase pull-through and simplify the representative’s job in the very complex ecosystem that they’re operating in now.

	Imagine, as you’re walking into a physician’s office, the system gives you a recommendation that’s saying, “You can provide this physician, with this information,” that takes a lot of the complexity out for the rep. You can use these insights to direct your non-personal promotion as well. 

 The better representatives are sophisticated enough to use data to do effective problem-solving or engage the stakeholders necessary to solve a problem. Whereas others just get mired in the ambiguity of the data because it can’t be overly specific to a given patient or physician.

 I think the biggest barrier is how to build this data infrastructure. Data is a tool, not a strategy. The way you get commercial teams to use it and not roll their eyes at it is to build data into the workflow in a way that they’re using the data but they may not even be aware that they’re using it.

: What else is top of mind in market access that affects reps and physicians downstream?

 It’s important to understand the implications of payers to patient co-pay programs as there’s not a therapy that has one single payer. You generally have a smattering of payers: 30% Medicare, 40% commercial, the remaining Medicaid, for example. And some commercially insured patients may be subsidized by a State or Federal health plan that may limit their eligibility.

	Also, think of all of the changes around Patient Assistance Programs, or PAPs. For these, it’s important to

 consider recent advisory opinions from OIG and seek guidance to develop SOPs or program rules to best navigate their requirements. Given the nuances of these rules, PAPs are not programs that a sales rep can casually discuss with their physician customers despite their best interest for their patients’ access.

 We are also starting to see a high level of push back on PBMs as part of the larger pricing dialog. Many different stakeholders are asking questions around how PBMs are encouraging high prices with a heavy focus on rebates. It will be interesting to see if this continues to gain traction, especially as PBMs continue to expand capabilities to include medical benefit drug management capabilities.

What is happening to shift companies to a more proactive market access strategy?

 Having a harmonized view at an organizational level around what the hypothesis is of that future market environment is critical for a consistent commercial approach. Not having this view creates inconsistency in the commercial evaluation process and diminishes efficiency. While the nature of prediction means it will never be 100% correct, an accurate and harmonized view of the future market access landscape has enhanced the commercialization process for many of my clients. 

 Takeda’s been moving, over the last few years, from a primary care company to a diversified company with primary care and specialty products. We recognize we need different capabilities.

	For the last 18 months, we’ve been investing to win in specialty, which means building upon our hub, creating different patient services, understanding different reimbursement dynamics and helping patients understand how to get access to our medications.

Now we’re comfortable that we’ve built those capabilities-we’ve transitioned from what’s needed in primary care to what’s needed in specialty, and focus on leading in those areas. But it is really a capability shift.

 Looking at that primary care mold another way, reps used to call on physicians by knocking on doors. I’m oversimplifying, but for a specialty drug, where the calling point might be an urban hospital setting-trying to get access or the level of complexity associated with the decision-making processes in that hospital can be daunting. Especially when it comes to deciding the patient’s care in a post-acute care setting. Will it be the physician, the discharge planner, or case management? 

 We see the challenges of cost containment, cost shifting, and consolidation at all levels across the system. That’s what’s really leading to higher rebates and a more thoughtful approach to how we’re helping that patient in the cost shift.

	From a policy perspective, Takeda has been trying to get involved in the conversation and make people think about medicines not as an expense but as an investment in a chronic care solution.

Medicine as an investment. Doesn’t that start to get into a value, outcomes or HEOR (health economics and outcomes research) discussion?

 Historically, in drug development, it used to be, “Just study it enough to get it FDA-approved.” You’d look for HEOR after the fact, which is hard to do.

	At Lundbeck, we’ve set up our drug development steering committee to include not just medical but commercial, HEOR, the cross-functional management team, in order to instill technology-based elements that can pick up nuances. So when you do get to the product approval, those nuances or potential benefits have been studied and can show a meaningful difference-one that has been studied from Day One, rather than in the sequential fashion of the past. 

 I think that becomes a base or a core competency we all have to build. Can you show not just differentiation, but an economic improvement into the standard of care? In the future, if you’re not doing that, you’re just going to be swinging and missing constantly.

 Providing that context around,“What is the value that it brings to the market and what can it ultimately mean from a commercial standpoint?” is absolutely imperative.

 We say, “What does the future look like three and five years out?” What do we have to be doing now to get there? Because, as we know, any kind of research, or clinical development, or paradigm shift with a payer, is going to take that long. That guides our principles on how we work together cross-functionally.

	We don’t even think about how are we going to commercialize a medicine that has been submitted for approval without having a completely locked strategy with our medical affairs and health economics teams. 

I think we’re getting very close to where big data analytics is going to allow us to bring payers, providers and industry together to look at a common set of data that’s very unifying around what is the patient outcome and what is the real-world evidence we can generate.

 Could you give one piece of advice for your colleagues in the industry on the topics we’ve discussed today?

 Never stop learning in the healthcare reimbursement space. Just when you think you’ve figured it out, you’re going to understand that there’s a lot that you don’t know. More than ever, every patient-based on their employer, their health plan, their benefit, the medicine that they’re taking, the geography they live in

	Once you stop asking questions and trying to innovate, it’s going to pass by you so fast; it’s moving exponentially.

 Ensure the integration of marketing, managed markets, sales, HEOR, and medical affairs. That integration is so important because healthcare is an interdependent relationship.

 It’s incumbent on every innovator to be able to effectively convey the value of their product in the context in which it’s reimbursed. Just because it fulfills an unmet need is not nearly enough. Understanding all of the elements around their product’s coverage by a payer, the necessary coding and setting of care implications leading to adequate payment for the healthcare provider is critical, especially in a buy-and-bill environment.

 Takeda has a relatively new CEO (Christophe Weber, appointed CEO in 2015). And he said pretty simply how we’re going to refocus the business and our priorities and I think it’s true. He said, “Patient, trust, reputation, business. If you put the patient at the center of everything you do, you will build trust with society.” 

Executive Roundtable: Where is Your Physician?

	What do you want to be when you grow up? That’s a question we’ve all heard at some point in our lives, usually when we are in grade school (though for some of us, we may still be wondering). When I asked my sons when they were grade-schoolers that question, the choice was fireman or dog walker. Now in high school, it’s much more nuanced, but neither has said “CEO” or definitely not say Chief Digital Officer or

 Chief External Innovation Officer. But these are the roles noted in our 

 from consultants at Russell Reynolds as up-and-coming in the pharma C-suite. In fact, there has been much talk about what future pharmaceutical executives face, and the skills they will need, in regard to industry disruption.

	Recently, Senior Editor Michelle Maskaly attended the FT US Healthcare & Life Sciences Summit and came back with the news that future pharma leaders may not only 

. If you can’t explain how you learned from failure, then you won’t be able to address the complexities of the pharma company of the future.

	We are currently in the process of accepting nominations for our annual Emerging Pharma Leaders feature, which highlights those up-and-coming individuals that show promise in taking pharma to the next level. What are the qualities that will make them the leaders of tomorrow? We encourage you to submit your nominations 

	This month also marks the annual meeting of the Drug Information Association, where industry professionals network, engage and collaborate with their colleagues. We recently spoke with Barbara Lopez Kunz, Chief Global Officer of DIA, about the current challenges in our industry. She said, “This is a time of enormous dynamism in the healthcare space. And many of the stakeholder communities have been working hard to optimize within their particular part of the ecosystem. But what we find, is that the opportunities to really make step changes sit at the system level. And that’s where DIA plays an really important role. We need to make sure that we address the right problems and think about what people we need to bring forward to make sure we get the regulators integrated with innovators and increasingly, the payers and HTAs, and, of course, the patients have a very strong voice in healthcare product development. We capture the insights that come from these discussions and turn them into action plans, which can be taken up by industry leadership and policymakers and others across the community.”

	Terese Waldron, Director, Executive MBA Programs, for Saint Joseph’s University, and 

 Editorial Advisory Board member, noted some interesting trends in its 2017 Pharmaceutical & Healthcare Marketing MBA graduating class. 

	“This year, we noticed that many of the titles include ‘leads;’ so while they have the skills, workload and responsibility of an executive, their titles don’t necessarily reflect that,” said Waldron. She believes that is because companies are more compressed than ever and the “executive” roles are fewer. “This, of course, leads to increased competition to advance in one’s career,” noted Waldron.

	In addition, also potentially based on the shrinking employee base, many of the graduates are wearing multiple hats. “We see that they are definitely taking on more duties that cover multiple roles,” said Waldron. 

	“In the next two to three years, the pharmaceutical industry is going to become even more dynamic,” she explained. “Of course, I’m a big believer in graduate education. SJU’s Pharmaceutical & Healthcare Marketing MBA helps high potentials to acquire the skills and strategic strengths necessary to tackle the issues that are coming quickly to the industry. Pharma companies need that strength. I encourage our corporate clients to continuously build their talent. Companies need to invest in their talent now, and not just at the executive level. The middle-managers, directors and leads may be the pivotal employees that need to be leveraged for the future.”

	Based on a third-party study of SJU’s graduating class, nearly 70% have further developed the skills that have already translated into career advancement; compared to 50% averages at nationwide levels. “I look at my Pharmaceutical & Healthcare Marketing MBA graduates, and I know they have the confidence and knowledge to go forward and grow their companies,” Waldron concluded.

	Whether or not members of this year’s MBA graduating class ever imagined themselves to be the next Chief Transformation Executive, or the next Emerging Pharma Leader or the next thought-leader speaker at DIA, there is one thing for sure, there is no lack of talent, expertise and passion in this industry. It is time for the talent to go forth and conquer. 

From the Editor

There's no shortage of talent, expertise and passion in the biopharma industry. It's time for that talent to shine.

Pharmaceutical Executive-06-01-2017

Pharm Exec's Top 50 Companies 2017

Navigating Through Disruption: A Pharma 50 View

Tips for Success from a Big Pharma Leader

The Quest for Meaningful Pharma-Patient Dialogue

Executive Roundtable: Where is Your Physician?

Talent That Takes You into the Future

Europe: A Long Summer of Drug Pricing Tension

Gottlieb Takes Reins at FDA, Big Issues Loom

Country Report: Taiwan

Pharmaceutical Executive, June 2017 Issue (PDF)