This sponsored supplement  was produced by Focus Reports.  

"2014 represents an exciting time for healthcare in Chile with the implementation of a new national drug law; ensuring the creation of a system that makes access to medications easier and more transparent for patients and, moreover, assures a sufficient supply all over Chile," explains Helia Molina, a doctor specializing in pediatrics and nephrology and Chile's Minister of Health since March 2014. The 'Ley de Farmacos,' or Drugs Law, was passed by Chile's former government in January 2014; its implementation now rests with the new administration.  

Cover Art by Ignacio Gana. Ignaciogana@gmail.com			

"The new government of Chile has made a commitment to improving the health of the population," Molina explains, "and the Ministry of Health will expand the list of chronic diseases included in the Regime of Explicit Health Guarantees (AUGE) plan, which ensures government-funded coverage for patients regardless of age, class, and ability to pay." 

This should contribute to boost a market that is already expected to grow 8.2 percent between 2012 and 2017 according IMS Health. In 2012, the Chilean pharmaceutical market was worth a total of USD 2 billion, according to the latest available data from IMS.  

The new government plans to introduce further legislation to improve healthcare in Chile. In her paper entitled '50 Commitments for the First 100 Days of Government,' President-elect Michelle Bachelet builds the basis of her plan for better health services for the nation, committing to invest significantly in the construction of new hospitals, increase the number of specialists to combat long waiting lists in the public sector and provide patients with better access to free drugs. 

As it currently stands, Chile's universal healthcare plan covers 80 percent of the population. The remaining 20 percent are entitled to pick their coverage from a number of private insurance companies known as ISAPRES. 80 percent of people in Chile should have access to free drugs under FONASA, the public health insurance system; however, the reality is that there are often shortages at hospitals, and as a result people turn to private pharmacies to fill their prescriptions out-of-pocket. As a result, despite FONASA, out-of-pocket expenditures in Chile are some of the highest in the OECD: A total 4.6 percent of the average Chilean family's budget is spent on healthcare, compared to the OECD average of 2.86 percent.  

Ricardo Fabrega, director of the Public Health Institute			

There is positive news on some fronts however: after years of infamously tense relations between MNCs and the government, both parties finally seem to have found a platform for dialogue. "As an industry, we have an active dialogue with the ministry regarding the expansion of access to innovative medicines, but the discussion is still young and we still have a lot to do," explains Erich Viertel, country manager at Janssen Chile. "Finding the best path to lead Chile toward economic development has been an ongoing task of Chilean governments and leaders over the last century. And if the country is able to sustain its current momentum, at the end of this decade it will probably become the first fully developed country in Latin America." 

The Chamber of the Pharmaceutical Industry in Chile (CIF), which represents the international innovators, will carefully monitor the implementation of the new healthcare law, which requires prescriptions to mention the name of the chemical compound. While this is seen as positive for the customer, who will now have access to cheaper alternative products and also their personal brand preference, for, innovators there is still a major concern about bioequivalence.  

Jean Jacques Duhart, executive vice president, CIF			

In Chile, as in other Latin American countries, similares have high market penetration: generic drugs that do not have proven bioequivalence. "If the law would allow physicians to prescribe any generic drug including non-bioequivalents, all efforts made by previous governments would be for nothing," says Jean Jacques Duhart, executive vice president of CIF. "A large portion of products on the Chilean market cannot demonstrate quality, safety and efficacy through bioequivalence studies. Similares are neither generics nor originals and have not demonstrated their quality, efficacy and safety as recommended by the World Trade Organization."  

He also warns: "This is not merely a concern in terms of health and risk for patients but it also introduces an important market distortion—different actors are competing with different standards."  

Erich Viertel, country manager, Janssen			

Chile is aiming to achieve complete bioequivalence of generics by the end of 2014. Chile's Public Health Institute is leading the bioequivalence testing, aimed at regulating differences between generic and bioequivalent drugs. The recently appointed director of the Public Health Institute, Ricardo Fabrega, echoes the need for drastic change and stresses that: "laboratories that produce generics will have to understand that they must comply with bioequivalence studies; otherwise we will take them out of the market."  

Carlos Cicogna, managing director, MSD			

The request for bioequivalence could be a game changer. Companies producing similares could be forced out of the market, or to drastically change their practices. According to Carlos Cicogna, managing director of MSD Chile, it could also drive investments from MNCs in the country: currently, MNCs are responsible for more than half of the bioequivalent generics on the market. "The environment is getting more attractive for innovators such as MSD: with the new regulations we will see an equal playing field; fair conditions are being implemented. And as a result there is an increasing interest from the industry to increase investment in the country." 

Cicogna, who has been in Chile since 2009, has already witnessed drastic change in the market: "There have been two major developments in the past five years: the implementation of the new drug law and the shift in landscape: the top players on the Chilean pharmaceutical market used to be local players, but today the key players are multinationals."  

Elmer Torres Cortes, general manager, ASILFA			

Another proposal currently being discussed in parliament is the complete overhaul of ANAMED, the national regulatory agency for medicines in order to bring it in line with other regulatory bodies around the world. Elmer Torres Cortes, general manager of ASILFA (the association representing generics companies in Chile) explains, ANAMED is currently part of Chile's Public Health Institute, but should be separated in order for it to stand as an independent regulator of medicines. The current plan being discussed for ANAMED is for it to reach level four of the Pan American Health Organization (PAHO) assessment table, at which point it can be designated a reference authority for medicines. "ANAMED should be autonomous, independent and capable of monitoring the local and international industry. We believe this is fundamental for the pharmaceutical industry in Chile," Cortes adds.  

With the goal of making Chile a hub for innovation, the Chilean Ministry of Economy and CORFO, the Chilean Economic Development Agency, announced last year that four multinational companies would invest in new research and development centers. From the pharmaceutical sector, Pfizer will invest in a precision medical center studying new genome-based diagnostic technologies for cancer. The aim is to enhance Pfizer's precision medicine approach to help understand the underlying biology of disease and identify patients likely to benefit from new drugs.  

For the project, Pfizer partnered with the government to develop technology and research: CORFO has contributed USD 7 million out of a total investment of USD 21 million. "Our expectation is that with the initial support of the government, this will be the first of a series of programs that Pfizer will develop in Chile," explains CORFO's executive vice president Eduardo Bitran. "With this subsidy, which we consider seed money, we expect Pfizer to change its view of the country and continue to develop applied research in Chile. As a country we are sending a signal with the aim that other pharmaceutical companies will follow suit."  

This strategy seems to be paying off: "The feedback from the industry has been extremely positive and as a result we have received many inquiries about the center," says Ricardo Avila, medical director at Pfizer Chile. "It seems that there is an increasing interest to increase investment in the country." Pfizer's country manager in Chile, Carlos Murillo, feels responsibility to turn this project into a success in the coming years and believes that Pfizer has paved the way for Chile to position itself as a biotech hub for Latin America. "I expect the ecosystem to start flourishing soon," he asserts. "This country is for our company an example of how we can work in partnership with the government."  

Carlos Murillo, country manager, Pfizer			

Over the past decade, as clinical research activities have been growing steadily within Latin America, Chile has worked hard to become a regional leader for conducting clinical trials. Due to its qualified human capital base and favourable government environment, the country has competitive advantages for developing such a cluster. Currently, Chile lead the per capita rate of clinical trials in Latin America (0.34 per 10 000 inhabitants, threefold of that of Brazil or Mexico).  

Roche has a long history of conducting Clinical trials in Chile. Currently the company has 19 on-going trials in 10 different disease stages and is eager to conduct more in the future. According to Ciro Caravaggio, general manager of Roche conducting clinical trials in Chile can be expensive, the process can be slow, and requires significant approval hurdles. "Furthermore, many don't see the value the trials can bring to a hospital or a patient. For a major oncology hospital, clinical research is an integral part of care and not an afterthought; it is critical! So many patients are at the end of their treatment and want new hope."  

Eduardo Bitran, executive vice president, CORFO			

Historically the clinical trial environment has been seen as a matter for international companies but the CIF is working hard to turn around this situation. "We are working on involving more local partners in clinical trials and research and development. It is our ambition to establish Chile as a leader for clinical trials and research in medicines", CIF executive vice president, Jean Jaques Duhart said.  

Pharma M&As are back with a vengeance. Latin America, which is predicted to grow two to three times faster than developing markets in the years to come, has been a prime target. Chile has not been spared in this recent activity, with several acquisitions in recent months.  

The dealmaking in Chile started in December 2013 when Grünenthal Group, an international research-based pharmaceutical company headquartered in Aachen, Germany, completed the acquisition of Andrómaco Laboratories for an undisclosed sum. Andrómaco is a leading Chilean pharmaceutical company with over 70 years in the market that specializes in prescription drugs, but also has a wide range of high technology products, generics and OTC. Grünenthal accepted the public tender offer with respect to the acquisition of all issued and outstanding shares of Andrómaco.  

João Simões, head of integration at Grünenthal Chile, explains that the acquisition has been a major step in the company's growth strategy and has almost doubled its revenues up to USD 450 million in Latin America. In the words of Grünenthal Group's CEO, Eric-Paul Pâques: "With Empresas Andrómaco, we acquire the best regional company to complement our own business and our therapeutic areas in the Andean countries and Central America." In Chile, it propelled Grünenthal into the market's top four companies.  

In May 2014, Alliance Boots, a British pharmacy-led health and beauty group, signed an agreement to acquire Farmacias Ahumada (FASA) Group. FASA is a publically-listed pharmaceutical specialist in Latin America comprising of two retailers: Farmacias Benavides, based in Mexico and Farmacias Ahumada, based in Chile. Together the retailers operate over 1,400 stores, with combined revenues of around USD 1.4 billion: the third largest retail pharmacy chain in Mexico with around 1,000 stores, and one of the three largest retail pharmacy chains in Chile with around 400 stores.  

The latest move in a series of multi-billion dollar deals came in May with year, with the acquisition of CFR Pharmaceuticals by Abbott Laboratories. The largest maker of heart stents and adult nutritional beverages joined the wave of mergers and acquisitions with a USD 2.9 billion agreement to acquire Chile's biggest drugmaker. Santiago-based CFR sells a range of products for women's health, heart and respiratory diseases in 15 markets across Latin America. The deal will more than double its branded generic drug business in Latin America and establish the company among the top 10 pharmaceutical companies in the region.  

Edgardo DÃ­az Navarrete, director, CENABAST			

Articles

Special Sponsored Section

2014 kicks off a defining period for healthcare in Chile as a new national drug law is implemented, with the hopes of creating a system that makes access to medicines easier and more transparent for patients.

Country Report: Chile

It's difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the recession is over, this outpouring of recommendations and recipes is hardly surprising. Hope springs eternal in the human breast. 

The trend is reflected in the medicines sector, with a plethora of manifestos and strategy proposals from industry, regulators, and campaigning organizations. One of the most grandiose is the self-styled "groundbreaking vision towards a life sciences strategy for Europe," launched in high summer by the European Federation of Pharmaceutical Industries and Associations.  

This "landmark paper" claims to provide steps towards "an integrated strategy" for the sector in Europe. "With Europe now emerging from the crisis, there is an opportunity to improve health prospects of citizens, while promoting economic growth. As new European leaders and policymakers across the political spectrum begin work to improve Europe's future, EFPIA calls for greater political collaboration," the industry association specifies. 

It is reasonable to expect that new European leaders and policymakers will begin work to improve Europe's future. But given the notorious absence of political collaboration in European health affairs, it is imprudent to assume that all that work will improve the situation for the drug industry. Given the fundamental nature of the challenges that Europe is facing, what emerges may actually be worse than the current imperfect context for medicines. EFPIA and other industry advocates of radical change run the risk of jumping out of the frying pan only to find themselves in the fire. 

The essence of the EFPIA call to arms is a plea for "a new generation of partnerships and collaborative solutions to address the EU's growing health and competitiveness challenges." It urges changes in perception, more "thinking outside the box," better understanding of future demands and of the value of investment, and the "need to address the system as a whole" in order to create sustainable systems. Of course the central refrain of the vision is "ensuring that the pharmaceutical and life sciences industries—jewels in Europe's economy—continue to thrive." Consequently, much of the content is devoted to the need for the industry to be "highly competitive" and for "innovation-led growth." The merits of the industry—in terms of those familiar claims relating to products, jobs, exports, or research commitment—occupy much of this manifesto. 

So, too, does the catalogue of the economic problems the industry faces. EFPIA warns against "making it difficult to obtain innovative medicines, increasing user charges, or delisting services from the benefits catalogue." It complains about the distortion that international reference pricing creates in the European market for medicines—going so far as to call for an urgent review of "the practical operation of the free movement of goods principle in medicines." It blames "the current patchwork of valuation and assessment criteria across Europe" for being "arbitrary and politicized," and "leading to wasteful and costly duplication of effort." And it cautions that "arbitrary financial policies" are inhibiting investment in research. 

All this is fair enough. It is the role of a powerful sector association to extol the merits of the sector it represents, and argue the case for it to receive favorable treatment. But there are other voices clamoring to be heard, and other tendencies shaking the ground. The presumption that in all the prospective changes, "medicines have a key role to play," is one that the industry will naturally make. It is not, however, universally shared—and some of the alternative thinking comes from sources which are also powerful. 

Not least among those voices is the European Union itself. Its years of ruminations about how to make health systems sustainable have still to lead to definite conclusions, but the trend is evident in the interim decisions it is now reaching. In early July, the EU Council gave legal force to a long series of recommendations that include telling Austria "to reinforce preventive healthcare, for which public spending is below EU average," Croatia that control over public expenditure on healthcare "is not achieved," and France that pharmaceutical spending is one area where "efficiency could be further improved." By contrast, Finland's "stronger focus on prevention" is "credible and relevant." 

At a summit in April to discuss chronic disease, Tonio Borg, European commissioner for health, was unambiguous in urging greater emphasis on prevention rather than treatment: "Only a tiny fraction is spent on prevention," he said, asking "Does this proportion make sense, when many of the most prevalent chronic diseases are largely preventable?" And the EU health council in June championed health promotion and disease prevention as "key factors for better health," and recognized "the importance of investing in health promotion and disease prevention in improving the health of the population."  

There is a form of selective myopia in the vision of the EFPIA strategy. Its president, Christopher Viehbacher, who is also CEO of Sanofi, said as he outlined the strategy: "Only a significant improvement in health outcomes, supported by increased innovation, can keep healthcare expenditure under control." This is not strictly speaking true. It presupposes that the long-hallowed approach to healthcare expenditure remains intact: that is, seeking better and better medicines to treat more and more illnesses.  

That presumption is at the very least questionable, and at worst, may be rendered invalid by a seismic shift in European health strategy that could profoundly modify the resource-allocation between treatment and prevention. If the allocation of resources was inverted (it is customarily estimated that less than 5% of current healthcare spending is devoted to prevention, with the rest devoted to treatment), it might also be possible to keep healthcare expenditure under control and improve health outcomes without the contribution from increased innovation that Viehbacher and EFPIA appear to be counting on. EFPIA quotes European Commission estimates that, without new approaches, average healthcare spending could rise from 7% to 9% of GDP by 2060, placing a strain on national finances. The conclusion EFPIA draws, that "halting and reversing the progression of chronic diseases is the best investment that health systems can make," may be correct—but it may also be true that the objective might be achieved by prevention rather than by treatment.  

Against this background, EFPIA may not win the backing it expects for its priorities of "removal of inequalities to better patient benefits," support for "systems to speed access to medicines," or "the building of a thriving innovative life sciences sector." If the outcome of all this radical re-thinking and new partnerships is that much greater priority is given to prevention, EFPIA's ambitions for a "new European life sciences strategy that will benefit patients and society as a whole" may prove to be of no benefit whatever to the drug industry.  

On the contrary, budgets for treatment might be subject to cuts much sharper than those that industry currently complains of, and the trends in spending might move resources irreversibly from treatment to prevention. Industry optimists would do well to remember the somber conclusion of that famous couplet about hope springing eternal in the human breast. It concludes tartly: "Man never is, but always to be, blest." 

Column

Industry's grand vision for reshaping the life sciences in Europe may ultimately prove to be a lost cause.

EFPIA's 'Integrated Strategy' in Europe: Out of the Frying Pan, Into the Fire?

This year's class of 15 young executives is deeply of the moment, with assignments that include advancing therapies against hepatitis C, building new cell-based platforms in regenerative medicine, creating new businesses beyond a protected home base, restructuring the supply chain to accommodate a new generation of complex biologics, and transforming raw data into "news I can use" analytics. The emotional viscera that binds all is a commitment to the patient. Despite those legions of lawyers, accountants, bankers, and regulators—none of whom made the list this year—pharma remains at heart a people business.  

, Global Strategic Lead, Fertility, Ferring Pharmaceuticals 

, Global Franchise Head, Hemophilia, Baxter Healthcare 

, Senior Director and Platform Leader, Cell Therapy, Janssen Research & Development 

, Executive Director of Product Strategy and Alliance Management, Achillion Pharmaceuticals 			

, Director, Marketing Innovation, Research and Commercial Analytics, Eli Lilly & Co. 

, Chief Medical Information and Innovation Officer, Merck & Co. 

, Vice President, Global Brand Development, Eli Lilly & Co. 

, Vice President, Product Strategy Lead—Neuroscience, Shire Pharmaceuticals 

, VP Oncology Business Unit Head, GlaxoSmithKline 	

, Founder and Chairman of the Board, R-Pharm 	

, VP, US commercial operations. Gilead Sciences  

, VP, formulation development, Vertex Pharmaceuticals 

, Head of Global Business Development Office and Strategy, Takeda Pharmaceuticals 

Joerg Ahlgrimm, VP of Operations, Baxter BioScience

By the middle of 2015, global healthcare giant Baxter International Inc. is expected to officially split off its BioScience business, establishing the unit as an independent, innovation-focused biotechnology company. The new organization, which will maintain its industry-leading role in developing and manufacturing plasma-based proteins to treat hemophilia and other rare bleeding disorders, plans to support as many as 20 product launches in the next few years. Helming the operational component of these pursuits will be Joerg Ahlgrimm, the division's current vice president of operations and global supply chain. Ahlgrimm was appointed to the post in late 2013, when the BioScience unit combined its global operations structure and network under one leader. As the defining stage in the division's evolution nears, Ahlgrimm is developing an aggressive strategy to ensure that operations and supply chain management is optimized to support BioScience's future growth.  

Amid Baxter's business transformation and the completion of final steps in separating its BioScience and Medical Products businesses, one could certainly assume Ahlgrimm's focus is on the big picture these days. After all, as head of operations, his organization supports more than $5.5 billion in sales and more than $2 billion in value of production. Ahlgrimm's belief is that operations, which he calls the "backbone" of a premiere biotech company, will be an important enabler for the new BioScience company in the years ahead. It seems clear that Ahlgrimm—who has held a number of leadership positions at Baxter since 2001—is intent on viewing the looming spinoff and all the accompanying expectations as his opportunity to apply the day-to-day management skills that have gotten him this far—on the precipice of leading the operations of a new global biopharmaceutical company.  Ahlgrimm's forward-minded and collaborative leadership style has served as a driving force of change at Baxter, his colleagues contend.  

"Don't preach water and drink wine," says Ahlgrimm, whose operations arm encompasses more than 10,000 employees across facilities  in the US, Europe, and in Singapore. "You have to demonstrate the expectations you have from the organization through your own behaviors."  

For Ahlgrimm, that philosophy adheres to the mantra: "never become complacent. Something can always be made better." He is quick to acknowledge that he had to learn that mindset himself early in his career. Ahlgrimm's first experience in the pharmaceutical industry was through an internship while enrolled at Ernst-Abbe-Fachhochschule Jena, an applied sciences university in Jena, Germany. He eventually joined Baxter in 2001 as supervisor of packaging scheduling in Vienna, Austria. Three years later, Ahlgrimm was promoted to director of supply chain for Baxter BioScience before being named vice president of global supply chain in 2008. 

"At the beginning of my career, I was convinced that to play to my strengths was much more important than to consider my weaknesses," says Ahlgrimm, 41. "I received good constructive feedback in some of our talent review processes around my personal behaviors. This taught me to be much more open to feedback."  

Ahlgrimm credits those experiences for adjusting his leadership style for the better. Ahlgrimm became a better listener and instead of focusing more on all the things he already did well, he took a hard look at opportunities for improvement.  

"One big learning over time was this whole notion of building networks, establishing mentoring relationships, gaining feedback, and continuously working on becoming a better you," says Ahlgrimm. 

Following that process has translated to tangible success for Ahlgrimm. During his career at Baxter, he has helped identify ways in which the company can expand its global supply chain to accommodate new products and growing global demand, while allowing enough flexibility to be a leader in local markets. In today's cost-constrained market, Ahlgrimm has been integral in finding ways to gain consistency and efficiency across Baxter's manufacturing facilities. In 2012, his team successfully negotiated and implemented a manufacturing services partnership with Sanquin Blood Supply Foundation, which provides Baxter up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-derived treatments. The agreement not only helped meet a supply need for Baxter in a relatively short timeframe, but it also prevented the need to build another facility in the short-term.  

Ahlgrimm's hope is that such efforts will help raise the bar in developing effective therapies for some of the most complex conditions in the world. Along with targeting hemophilia and other chronic bleeding disorders, Baxter produces plasma-based therapies to treat immune deficiencies, alpha 1-antitrypsin deficiency, and burns and shock. The company is also developing programs in new priority focus areas, including niche areas of oncology and biosimilars.  

"The products we produce support patients who rely on them every day to manage very challenging, chronic, and often rare conditions," says Ahlgrimm. "For every patient who needs them today, we have an obligation to make sure they have uninterrupted access to our quality products. My day-to-day job is also one of my biggest challenges—just making sure that our patient community gets a reliable supply.  And in the long term, we are challenged to find ways for more people to get these valuable treatments. There are so many people in the world with rare diseases who don't receive any treatment, or who are not even diagnosed, even though a treatment or help for their condition is available. Our goal is to make sure that those people are being helped, too." 

Ahlgrimm believes the limited treatment reach for patients with rare disorders is a combination of lack of awareness and funding or health economic issues in certain regions. Baxter's goal of 20 product launches in the next few years, the company hopes, will make a difference for patients around the world—provided respective clinical trial programs are successful.   

"From the operations point of view, we're getting involved very early in these projects," says Ahlgrimm. "The commercial success of these launches, especially in a biopharmaceutical company, is very much dependent on how strong operations is able to keep up with demand, set up the large-scale manufacturing process to execute those launches from a day-to-day management point of view, and then successfully deliver these new treatments to patients." 

Though certainly ambitious, Baxter feels the 20-product goal is an achievable plan, Ahlgrimm says. He believes, from an operations standpoint, that the recent restructuring of the BioScience business has helped establish the organizational foundation to enable successful product launches over the next few years. In fostering internal alignment around these efforts, Ahlgrimm is inspiring BioScience colleagues about the importance of the operations strategy through global internal town hall meetings, recorded video messages, and presentations. He notes that industry trends continue to reflect a shift from drugmakers being very much internally focused to now tapping more heavily into external networks to support the many diverse aspects of their business. This has resulted in increased activity around industry consolidation, asset transfers, and spinoffs, Ahlgrimm acknowledges. He points to the importance of companies "sharpening their profile" by removing silos in supply chain manufacturing, purchasing, R&D, and other specialty areas—and integrating them into a more end-to-end-focused organization.  

"When you look at the microeconomic environment, the ability of an organization to change faster than the market conditions and the competition will determine success going forward," says Ahlgrimm. "Demonstrating change, being a change agent yourself, and then helping your organization to go through change and accept change as a normal part of how you run your business is, in my eyes, critical for our future success."   

Jenise Doutsas, Global Strategic Lead, Fertility, Ferring Pharmaceuticals

In the late 1990s, Jenise Doutsas, a psychology major with a master's degree in occupational therapy, was working at a hospital in Detroit when she found she was about to be laid off, a result of institutional changes at the hospital stemming from the Clinton Administration's tranche of healthcare reforms. So she set about thinking about what she else could do that was "both healthcare-related and fulfilling." At the hospital she would see pharmaceutical reps coming and going and thought, "I could do that."  

She applied to Organon Pharmaceuticals for a sales job. Organon noted her lack of a traditional sales background but Doutsas convinced them she had been "selling" every day: selling to patients the importance of doing their exercises, selling to physicians the need for an occupational therapy consult before a patient was discharged. She got the job. 

From there her upward trajectory has been steady and swift. Organon promoted her to district manager and she moved from Detroit to Virginia, where, aligned by territory rather than therapeutic area, she was given responsibility for managing the reps for women's health, pain, and anesthesiology. She then headed for Chicago, managing the fertility business for 12 states "at a much bigger scale, geography, and dollar volume." But as she took on this role, Organon announced they were going public; "literally two days later," says Doutsas, "they were acquired by Schering-Plough." 

But her rise continued apace; at Schering she became an executive district sales manager for the company's fertility products. Two years later, another merger meant another paymaster, Merck & Co., where she moved up to associate director of global marketing, working with the

Doutsas is proud of how she not only survived but thrived during those major company upheavals. "I think what they taught me is that there really isn't anything constant," she says. "You wonder if you're going to like working for a new organization, but you have to be agile. If you believe in yourself and what you're working toward, you can make it through the transitions." 

It helped, she says, that she had outstanding colleagues. "Organon had a family feel and at Merck I was surrounded by really talented people, such as Arpa Garay (executive director and US market leader, diabetes, at Merck), who is by far the best leader I've worked with. She taught me that strategy is really about picking one or two things you want to do and doing them big. She challenged me to think differently and push myself into areas where I might initially be uncomfortable." 

Doutsas also had very clear ideas about her goals and aspirations and has not been afraid to communicate them—"If you're not your own biggest advocate, you might find yourself stuck where you don't want to be," she explains. But perhaps her biggest strength has been her flexibility, her willingness to face up to hard choices and those major upheavals. "I've taken risks and made big moves," says Doutsas. "To do that demonstrates commitment and the ability to adapt to new environments." 

She is currently demonstrating that ability again. As 

 went to press, Doutsas was in the midst of embarking on the biggest change of her life and career so far, leaving Merck —and the United States—to move to Europe to become global strategic lead for fertility at Ferring Pharmaceuticals, a Swiss-based, mid-size biopharmaceutical company. 

Fertility is a therapeutic area she already knows well, of course, but, as she explains, "with a big move like this you have to do something you can leverage, something you can contribute straight away." For Doutsas, the key draw is the opportunity to experience a global marketing position outside the US.  

Features

This year's class of 15 young executives is deeply of the moment, with wide-ranging therapeutic, business, and operational expertise-all binded by an underlying commitment to the patient.

Emerging Pharma Leaders 2014

The Internet and interactive social media provide an efficient, low-cost way to send messages fast to millions of people—and to targeted patient populations. But pharma companies have been slow to take advantage of these methods, largely because of FDA rules that control what manufacturers can state about their products. FDA has been rolling out new guidelines for using interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any easier.  

FDA's Office of Prescription Drug Promotion (OPDP) provides some useful advice in its new advisories, which were discussed further in an OPDP webinar July 10 (slides available at 

). Overall, the agency sticks to its rules requiring ads and promotional messages to be accurate, not misleading, balanced, and limited to approved uses. Because it's very hard to get full risk information into a 140-character tweet or search engine listing, such communiqués may not fit FDA's regulatory scheme for drugs and medical products, according to a draft guidance on using the Internet and social media platforms with character space limitations (published June 16, 2014 at 

). There's no leeway to use icons to indicate that all drugs are risky, as proposed by industry; without equal presentation of risks and benefits in a character-limited message, OPDP advises marketers to "reconsider using that platform," especially for products with complex indications or serious risks.  

A second draft guidance gives marketers some leeway to correct misinformation on drugs and medical devices posted on the Internet by independent third-parties. Corrections of "user-generated content" (UGC) have to be truthful and not misleading, apply only to messages outside company control, and should not be used as "a springboard to engage in promotional messaging," explained attorney Jeffrey Wasserstein on the FDA Law Blog (

, June 17, 2014). Marketers should address only the specific misinformation cited, but are not expected to continually monitor the site and track further comments.  

Marketers don't have to inform FDA of every corrective posting, but should keep a record of such communications. That advice builds on another FDA guidance published in January 2014 that aimed to simplify how marketers should inform OPDP of Internet postings. FDA acknowledges that presubmission is not practical for continued participation in social networks and online forums; after initially submitting information on a website, OPDP permits companies to send in a monthly list of its postings, while keeping records of postings on file.   

But in trying to define which communications are a marketer's responsibility and thus should be submitted, this earlier guidance raised a lot of objections from industry. Marketers complained that the guidance makes them responsible for too broad a range of Internet postings and question whether tweets and "likes" constitute advertising or labeling—or really fall under "free speech" that lies outside FDA rules. 

A final guidance is slated to address FDA's concerns about using links to other Internet sites that discuss drug risks and benefits. FDA has warned against connecting to off-label information, and that a "one-click" process for linking to full risk and benefit information does not satisfy its requirements for fair balance and full disclosure.  

FDA also includes on its list of social media guidances a document published in December 2011 on how industry can respond to "unsolicited requests" for off-label information—both online and in public meetings. OPDP advised marketers to provide answers to such questions privately and off-line, an approach that remains in effect despite loud objections that it's impractical and confusing.  

These social media guidances reflect FDA's continuing struggle to reconcile drug advertising regulation with changing information technology. The agency held a hearing on FDA & the Internet back in October 1996 to explore appropriate pharma use of websites and chat rooms. The discussion addressed strategies for correcting erroneous product information posted on the Internet, manufacturer use of links to other websites, and impact of rules set by the Federal Trade Commission and international agencies—all issues that were not resolved and remain controversial today.  

Meanwhile, FDA ramped up citations for noncompliant Internet messages, culminating in 14 violation notices in 2009 to companies sponsoring search engine ads that lacked full risk information. Other letters held companies accountable for statements from third-party websites and blogs. Marketer objections prompted another FDA public hearing in November 2009, where dozens of industry representatives and IT vendors demanded changes in FDA rules to better fit the digital age. The agency's response was to propose new research on how consumers respond to risk information presented on various websites. So Congress added a provision to the FDA Safety & Innovation Act of 2012 (FDASIA) requiring the agency to address social media communications by July 2014.  

Even with the new advisories, pharma companies may continue to lag far behind other industries in utilizing the Internet to communicate important information to the public. Drugmakers have been using social media primarily for corporate operations—announcing financial reports, hiring employees, recruiting clinical trial investigators and participants, and disease awareness. There is disagreement over how effective the Internet is for detecting adverse drug events. And it's not clear how pharma can utilize opportunities to implement "multi-channel" marketing to support new product launches and to reach targeted patient populations.  

The irony of the social media marketing debate is that patients increasingly turn to the Internet to search for health information, identify possible treatments, and confirm diagnoses. FDA, itself, is a heavy user of social media to announce new approvals, broadcast safety warnings, and raise policy issues.  

FDA's insistence that marketers convey only truthful and balanced information on products also ignores developments that permit outside parties on all sides to weigh in on company claims and present alternative positions. Increased transparency in research results and treatment recommendations, readily available through Internet websites and social media, speaks to the need for new regulatory approaches by FDA and much greater enforcement "discretion." 

Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world. Our Washington Correspondent Jill Wechsler reports.

Social Media Struggles Continue

—our eighth, comprising an honor class of nearly 200 recipients to date—is more than just a way to recognize young executives who've made a difference in their organizations. Each list also serves as a window on work in an industry that, perhaps more than any other, relies on human capital as the coinage of success. Because our nominees are selected on the basis of a track record in directing teams, we can identify current trend lines around leadership behaviors: in a distracted world, fixing clear goals, with messages that motivate; keeping people on point and accountable for results; taking on reasonable risks while accommodating failure; and avoiding those process regimens that plague large institutions through a commitment to diversity—in culture, ideas, and talent. 

The following is a capsule summary of insights about our changing industry gleaned from the 15 emerging leader profiles compiled by the 

 This year's list features two young CEOs from Russia and Portugal whose companies are venturing beyond their protected domestic base to test big-time opportunities in the US, Europe, and Japan.  Antonio Portela, CEO of Portugal's Bial, capped years of effort in securing an FDA marketing license in November 2013 for the epileptic drug 

—the first new medicine developed in Portugal for sale in the US. R-Pharm CEO Aleksey Repik is transforming Russia's second-largest domestic drug company into a global player linked to a network of partnerships with the cream of big Pharma, all while making his company top of the league within Russia as the sole local producer able to meet global standards for GMP. Both companies are family owned, a familiar model for successful businesses in the emerging market countries, and one that insulates them from the short-term investor pressures associated with being publicly held. Interestingly, many of today's big Pharma players started out the same way—give or take a century.  

 Job assignments and career growth are tracking to a much more global trajectory, with many of our leaders remarking how they have benefited from postings outside their cultural comfort zones. Europeans are obtaining high-profile assignments managing US businesses, while one of our American leaders became a change agent in transforming his company's approach to market analytics in Japan. Overall, the immigrant experience continues to enrich the managerial talent pool in the US.  Legislators in Washington, take note. 

Supply chain manufacturing—from pumpkin to the gilded coach.

 As three of our leaders can attest, operations management is no longer a technical backwater but a front line strategic capability that has the undivided attention of the "c-suite." There will be no profits from tomorrow's individually targeted biologics if process technologies fail to keep pace with the complexities of reproducing them in a scalable, cost-efficient manner, for safe use by patients worldwide. 

 While big data has been touted as the solution to the industry's evidentiary challenges, there is a growing awareness that numbers alone do not create the interpretive knowledge required to guide decisions. A prized asset for managers these days is the ability to draw insights, establish context, and simplify the complex, which means that data is best applied as a tool toward that larger end, where the necessary judgments must be made by people relying on learned experience and—yes—intuition. It follows that none of our leaders wish to be known as "quants," but emphasize those softer people skills that allow managers to adapt and stay ahead of the curve imposed by today's unruly markets. As one leader says, "always start with the end in mind."  And data can only take you part of the way. 

 As the recording of the human genome allows more precise targeting of drugs to address specific conditions, all diseases are becoming rare diseases, with dozens of specialty biologics to treat them now emerging from industry labs. For our leaders in commercial development, the best therapeutic opportunities are now found in this space. This is despite the fact they all cut their management teeth on traditional small-molecule products for chronic, big population conditions applied in primary care settings with a high level of generic penetration. The transition to specialty drugs imposes a significant learning curve on all marketers, and this generation of leaders is first to experience it. 

Silo thinking—the albatross that still wanders.

 Organizational structure, office politics, culture barriers, and the inbreeding created by functionalized expertise remains the key obstacle to turning strategy into results. The will to change has to be matched with real incentives, says our group. 

From the Editor

Pharm Exec's 2014 roster of emerging pharma leaders serves as a window on work in an industry that relies on human capital as the coinage of success, writes William Looney.

Pharmaceutical Executive-08-01-2014

Country Report: Chile

EFPIA's 'Integrated Strategy' in Europe: Out of the Frying Pan, Into the Fire?

Emerging Pharma Leaders 2014

Social Media Struggles Continue

A Window on the Industry: The Emerging Pharma Leaders 2014