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Pharmaceutical Executive Digital Edition - April 2012

In the rarified world of consulting for Big Pharma, the 

 of thought leadership is a word riot-of PowerPoint slides and the runaway sentence, punctuated by the occasional semi-colon.  Several years ago, professional services firm Ernst & Young (E&Y) took a close look at its annual "state of the industry" survey and went for a breakthrough, deciding to brand the research around a simple forward-facing word with staying power: 

. The decision not only helped E&Y corner the market for change in an industry that had lost its footing; it forged a new metaphor for leadership in human capital.  

 HBA Woman of the Year: When Opportunity Knocks			

 is fundamentally a narrative about the commercial renewal that comes from embracing diversity, and there is no better standing symbol for that message than the 

 series creator, Global Pharmaceutical Sector Leader Carolyn Buck-Luce. A strong communicator, sought-after speaker, meticulous planner with an eye on the 10-year refresh button, and rooted by family, Buck-Luce also does double duty as the biopharma community's night watch. And like others who work the late shift against drift and status quo thinking, she is often first to see the light. "Carolyn has been singular in prodding this industry to embrace an uncertain future as an opportunity," says HBA colleague and 2003 Woman of the Year Catherine Sohn. "An outsider with an insider's mastery of detail, her message to the men who run Big Pharma has been direct and consistent: The marketplace for medicine is changing, so adapt or perish."  

In both her personal life and career, Buck-Luce displays a high tolerance for the calculated risk.  "If you are open to it, risk is not a hazard, but synonymous with growth. And women who don't take risks tend never to rise above the circumstances that convention and attitudes place them in," Buck-Luce explained to 

Colleagues say that one of Carolyn's core beliefs is never playing it safe, a view reinforced by her four children. Son Jake, 27, was asked by his mother during a break from Reed College about the impact her long work hours had had on him. "I posed it to him deliberately, as a researcher rather than a parent. He thought for a moment and replied, 'I have a little voice that speaks to me, particularly when I'm scared, that says go ahead, take a risk. Good things happen when you do.' And he said, 'Mom, that's your voice.' That comment not only washed away a lot of misplaced guilt; it also made me realize that a willingness to keep stretching the limits of your range is fundamental for women to succeed at work and at home, because learning and mentoring have no fixed venue." 

There is also intolerance for the artificial divides and barriers that narrow women's range of experience. Just as she has fought in 

 to expose the "silo-based thinking" that drags down Big Pharma's innovative potential, Buck-Luce refuses to separate life into those neat little categories called work, community, and family. "I have only one job in life—to make a difference. I see my life as a journey to be a good leader, whether it's inspiring a team at Ernst & Young, building strategic plans for the organizations I support; or being that little voice for my kids." Stepdaughter Nina Church relays how Buck-Luce showed her ways to balance professional success with a larger social objective. "She helped me transition from an analyst position at American Express to the Nike Foundation, where I now apply my business expertise to help adolescent girls overcome the cycle of poverty." 

If life begins as an empty vessel, Buck-Luce's was full to the brim early on. It was her mother who provided spiritual and intellectual replenishment. Entering the University of Chicago at 16, Minna Buck went on to become one of two female graduates in her class at the University's Law School—the other was Patsy Mink, a fixture of 1960s politics and family friend who served for decades as U.S. Representative from the state of Hawaii. In Carolyn's childhood home in upstate New York's Onondaga County, her mother taught her a job was not just a way for an individual to make a living—it could also change lives. "My mother seemed to be managing every one of President Johnson's Great Society programs in the county. She was a strong advocate for the war on poverty, and eventually became a family court judge, where she observed firsthand the role women play in keeping the social infrastructure intact."   

Buck-Luce strikes a familiar refrain for all HBA winners in referencing what shaped her professional success. "It was first my mother's example, but in both my parents I was nurtured by the message that a woman could do anything. My father was older than my mother but he was a big promoter of my mother, sister, and me—never did I doubt that father saw us as able to do great things." 

Buck-Luce also had the advantage of coming of age in the 1960s, a time of political and social upheaval. Her parents were avid Democrats and encouraged dinnertime conversations on how the world could be changed through politics. "I recall my mother pulling me out of a sweet 16 party with friends so I might see the riots at the 1968 DNC convention in Chicago."   

Given her parent's expansive views, Buck-Luce decided early to look beyond her own neighborhood, find a cause, make an impact—and become a world leader. What punched her first ticket on that journey was the discovery of a talent for languages. As a 15-year-old exchange student in Mexico, she learned Spanish. Her heart was then set on acceptance at Georgetown University's School of Language and Linguistics; the application fell short but entry did come a year later, as a transfer from Ohio State with straight A's.  That in turn led to course work in business and the achievement of fluency in Russian. "It was the height of the Cold War, yet commerce was sprouting between the capitalists and communists—I thought, what better way to "spread détente" than to insert myself in the growing area of East West trade?" 

Like most young people mapping their first moves into the workplace, Buck-Luce searched for a role model. She became fixated on David Rockefeller, CEO of Chase Manhattan Bank, who made Chase the most global of U.S. banks, with a strong base in East West trade. "I decided I was going to join him at Chase and grow their business in Russia." After a frenzy of calls and tapped connections, Buck-Luce was able to arrange a day of interviews at Chase headquarters in New York.   

In preparing for the interviews, it did not occur to her that dress might be a priority. "Never having spoken to a banker in my life, I borrowed a black and red suede maxi-skirt that had snaps all the way up the front and combined it with a pair of knee-high lace up boots and a rather tight 'come hither' looking black blouse. Well, the conversations went fine but I got more than a once over, especially by all the female secretaries." Sadly, the candidate did not get the job—Buck-Luce was crushed. "Why hadn't I opted for the gray suit and frilly collar?  It was a mystery to me that it could have mattered so much." 

From this, Buck-Luce derived a valuable lesson—opportunity can come from failure, which she prefers to describe as the bounce you get coming back from the bottom. "Every organization has a unique culture and understanding that culture is vital to job success. Yes, you need to have the requisite IQ smarts and the emotional intelligence to relate to others, but what's also important is the OQ—organizational quotient of intelligence, which I call the capacity to anticipate and adapt to how that organization breathes, thinks, and feels. Realizing that I had flunked the OQ test because of my style of dress was an incredible learning experience for me."  

The rejection also strengthened the young linguist's resolve to contribute to East West détente, even though there were few other options at the time. Through good luck she found one such opportunity when the U.S. Information Agency went looking for Russian speakers willing to spend several years on a good will exchange in the Soviet Union to tout the advantages of the model American home. Buck-Luce received special status as a foreign service officer and toured with the model home to sections of the country normally off-limits to foreigners. "Tens of thousands of ordinary Russians came to see the home. I was stationed in the living room, where I was very popular due to the fact that I had a stereo and played the Beatles White Album full blast."   

From this, Buck-Luce gained an insight on how to connect with people at a human level. "During an era where the Cold War propaganda was intense, I had to stand in that fake living room and make people believe and trust in me, as a person who could spark a connection across language, custom, and politics. I realized that what you say is less important than how you say it. Before cross-cultural awareness was touted as a leadership trait and a source of competitive advantage for companies able to tap diversity in the marketplace, I understood it as that desire of all people to understand and be understood." 

A sweet irony from her time in the Soviet planned-paradise is a commitment to making long-term goals for each of the three pillars of her life—family, work, and community. "I am a believer in the 10-year plan, which is based not on my current capabilities, but what I hope to learn, the critical experiences I hope to have, and the people I'd like to meet and impact over that period of time."  

Buck-Luce's 10-year plan after Russia was one in which she sought to build business credentials as a complement to her linguistic skills. She began the trek with an MBA at Columbia Business School followed by—at last—a successful appointment in banking, with Citibank. Buck-Luce spent her 10 years there, but not in the region she had hoped: Citibank downgraded its East West trading business right after Buck-Luce had joined with the expectation of being posted in Vienna. Instead, she spent her time at bank HQ in New York, learning about corporate lending and helping to build the leveraged buyout business. Midstream, she attracted the attention of senior bank leaders and was asked to take a year "off the line" to drive recruiting for the next class of MBAs. "Many people thought I was crazy to go into HR, but I thought it would be a great way to learn how to represent the institution as a spokesperson. It didn't feel risky at all—just strategic," she recalls. 

The assignment introduced Buck-Luce to an issue—workforce diversity—that became a career interest and priority that continues to this day. "It provided my first exposure to the talent planning field and made me aware of the hurdles that women with the same educational credentials as men faced in navigating the fast track. Even in the early 1980s, it was clear the work force was changing into a denser fabric of color, ethnicity, and gender. Citibank had to reflect that in the faces it presents to the world." 

"My time at Citi under a transformational CEO, Walter Wriston, also taught me how technology changes everything. Wriston invested in a satellite so that we had global e-mail in the early 1980s; he put the very first ATM in the Park Avenue HQ. He said, it's not the money but information about money that will make our money." Buck Luce told 

 that much of her assessment of the pharma industry is based on what she learned in financial services. "Drugs today are an information business," she says flatly.   

Work on leveraged buyouts led her from collegial Citibank to the testosterone-fueled world of investment banking, where she did a brief stint at First Boston. Juggling a surfeit of deals, she confronted some tantalizing choices: to stay with First Boston, accept an offer to join Wasserstein and Perella's new boutique investment firm, or agree to a standing offer from Canadian billionaire Robert Campeau, who was impressed by her prowess financing a buyout for the Allied and Federated department store chains. 

Buck-Luce took yet another risk and went with Campeau. "Talk about leveraged—at one point I was managing so much debt our interest payments surpassed $1 million a day. We made a lot of promises to the bankers and after awhile I realized the strategy we had was not working. Bob disagreed and we parted company." 

The next step was to establish her own firm, as a broker dealer in the man's world of Wall Street. It was a high-wire act, recruiting staff, trying to drum up business and impress scores of "type A" personalities. At the same time, family pressures—including a difficult divorce—were creating a struggle among dual loyalties: "Do I nourish my fledgling business or nurture my permanent family?" 

Buck-Luce chose the latter. "There was never a doubt my children were the priority." Divorce was followed by a controversial remarriage to the Reverend Forrest Church, senior presiding minister at the Upper East Side Unitarian church that was the root of Buck-Luce's intense spiritual life. Through the marriage, Buck-Luce inherited two older stepchildren—a son and a daughter—in addition to two boys of her own. It was apparent that balancing career and family meant that Buck-Luce would need to pursue a different line of work, where she could exert more control over her time and reestablish intimacy within a family unit that had suddenly doubled in size.  

The solution was an invitation in 1991 to join Ernst & Young, as a partner with a simple assignment: build new businesses and develop people. This included the start-up of a national corporate finance unit; launch of a new Center for Strategic Transactions; building an e-commerce business; and coordinating strategic alliance work as E&Y Strategic Investments Officer. "In 2000, E&Y embarked on new strategy to have a large percentage of the firm's future growth come from non-audit work for clients whom we also did not serve as auditors."  

The fact that few Big Pharma firms had audit relationships with E&Y was a gap waiting to be filled, so 10 years ago Buck-Luce volunteered to establish a profitable consulting footprint with Big Pharma, becoming senior Partner responsible for the global Pharmaceutical sector. Buck-Luce said, "I knew little about pharma—but from my background as a banker, I knew how to 'read' industries and to take their components apart. It's a bit like learning languages, too. And it turned out to be a valuable asset that opened doors for me in the 'C-suite,' because a major priority of pharma during the past decade has been to expand awareness of how things are done in other industries." Buck-Luce adds that her cross-industry background helped bring insights to her work as global coordinating partner for E&Y's relationship with Pfizer, the biggest of Big Pharma. 

 series has proved to be a binding glue. "In 

, we were first to make the case for behavioral change—today, product success means providing a service that delivers value to many stakeholders beyond the traditional physician.  The future of Big Pharma depends on it being a convener of communities, with the ultimate goal of improving health outcomes." 

Yet it is in her role as a change agent within the firm where Buck-Luce feels she has made the most lasting contribution. When Buck-Luce joined E&Y, only four percent of the firm's partners were women. "One of the first things I did at E&Y was to participate in a team to draft a strategic vision to the year 2000. Demographics was a topic we looked at. It was striking that we had so few female partners even though more than half of workers coming into the firm at the time were women. We had a serious aspiration gap in the making, and yet I noticed anytime the topic of 'diversity and inclusion' came up among the partners the answer was always the same: 'it's implicit in everything we do.' That, to me, was the very problem." 

Buck-Luce recalls one brave male partner who, after hearing that refrain yet again at a meeting in Chicago, asked colleagues to scan the room and relay back what they saw. There was a stony silence, but the point was made—a commitment to diversity isn't enough. You must be explicit about it being essential to winning in the market. After the meeting, then-chairman Phil Laskaway asked Buck-Luce to "speak her mind" on the topic at the annual partner's meeting, which she agreed to do—on condition that her recommendations not be subject to review. 

Those recommendations led to the creation of a Chairman's Diversity Task Force, which Buck-Luce joined as one of four founding members; today, women and minorities account for nearly a quarter of the partnership total. "I am proud of that record and I am proud to be a partner at E&Y. Our strategy is simple: if we have the best people doing quality work, the result is we will have the best clients. In pharma, I tell my CEO clients it is all about innovation. If you devote your energy to discovery, development and life cycle management of the most innovative 

 then you will have the most innovative products." 

Buck-Luce has spread that passion, devoting a large block of her time at E&Y to building a Professional Women's Network while focusing her external engagement around diversity and talent issues. She recently was chair of the New York Women's Foundation, which provides grants to community-based organizations to improve economic justice for underserved women and girls. As a thought leader on diversity issues, she has had a long relationship with the New York-based Center for Talent Innovation, producing jointly with founding economist Sylvia Ann Hewlett several groundbreaking, peer-reviewed studies on the glass ceiling. "Carolyn has worked with us on some truly inspirational studies that, for example, identify why women are overrepresented in the entry ranks of scientific research but tend to fall off the ladder on the way up. We also exposed as a myth the explanation that women do not get ahead because they 'opt out' to have kids. Harvard Business Review has published this work and helped build the Center's influence in the field of corporate talent management—Carolyn is an amazing leader because she opens many doors," Hewlett told 

Buck-Luce will soon reach the mandatory partner retirement age of 60 and leaves E&Y in December. True to form, she has her next 10-year plan in motion. Simply put, Buck Luce sees her future as an "organizational shaman," where she will apply her experience to the challenge of helping leaders tap the courage necessary to think differently and create companies of sustainable value. Service on corporate boards in the healthcare sector are a particular interest, not only because healthcare is unique—as Buck Luce says, where else can profit and success be married so directly to a service that does good for society?—but also frankly because the corporate board is the last bastion of male power. "It's the final glass ceiling, and without more women at that level, corporate cultures won't change." 

Teaching is another priority. A true pleasure over the past few years has been teaching a course at the Columbia School of Public and International Affairs (SIPA) on "Women in Power." Part management, part politics, and part psychology, but always interactive, the course is one of SIPA's most popular.    

Then there is the new role as HBA Woman of the Year. Buck-Luce wants to make HBA more global, because grooming future women leaders will depend on gaining experience in markets 

 U.S.  "I am interested in a training curriculum on what it takes to be a global leader in pharma," Buck-Luce says. Part of that will involve getting more senior women—in all areas of healthcare, as well as outside—active in advising HBA members. 

Features

Throughout her life, HBA Woman of the Year Carolyn Buck-Luce has made progress by recognizing that when one door closes, another one opens.

HBA Woman of the Year 2012

As an American, asking a Scottish academic or biopharma industry executive about the health implications of an independent Scotland will get you quiet smiles that are difficult to interpret. The Scottish themselves (not to mention the English) seem a bit surprised about the rise of the Scottish National Party (SNP) led by First Minister of Scotland Alex Salmond, who, in January, announced that the Scottish Government would hold a referendum vote on Scottish independence in the fall of 2014. Whether or not the government has the power to declare independence is up for debate, and a public consultation period is currently ongoing, with plans to introduce the referendum bill to the Scottish Parliament in early 2013. The precise wording of the referendum question (or questions)-to be answered yay or nay-is still being determined.  

But Scotland already has an independent education system, legal system, and health system (NHS Scotland), the latter a single-payer that provides health services to the Scottish public for free at the point of access. And the Scots are way ahead of many other nations (including the U.S.) with respect to electronic record keeping. "Scotland has excelled at collecting data and tissue for years, which means we have outcomes data without additional studies," says Rhian Touyz, director of the Institute of Cardiovascular & Medical Sciences at the University of Glasgow. "For every patient admitted to a hospital in Scotland since the 1970s, we get their data." Pharmaceutical companies looking to conduct clinical trials are given access to a fully phenotyped population of over 5.1 million. 

Indeed, clinical research is a source of national pride in Scotland; last November, the Edinburgh BioQuarter cut the ribbon on a £60 million ($95 million) Centre for Regenerative Medicine, heralded as a leading institute for the study of stem cells. Generation Scotland, a large-scale collaboration between the Scottish university medical schools, biomedical research institutes, and NHS Scotland, aims to create more effective treatments based on genetic knowledge. Its banner project—the Scottish Family Health Study—involves an "intensively phenotyped, family-based cohort with which to study the genetic basis of common complex diseases and response to treatment." The program has already enrolled its target 25,000 family members.  

Despite world-class strength in early stage clinical research, and a country-wide EHR network—made possible at least in part by the absence of multiple and competing healthcare providers—Scotland has some of the steepest health inequities by socio-economic status in all of Europe, as well as a disturbingly high incidence of cardiovascular disease and percentage of cigarette smokers. These are expensive problems, and so the question becomes: What, if anything, in terms of resources, would be lost or jeopardized if Scotland decides to go it alone in 2014? 

Making that determination is about as difficult as reading the faces of the individuals to which the question was posed. Most responses were circumspect. Andrew Henderson, manager of life sciences at Scottish Development International (a joint venture between the Scottish Government and industrial policy and commerce groups), and founder and director of the Scottish Stem Cell Network, declined to comment on "political issues" given his role as part of a government agency. Sandosh Padmanabhan, an academic at the University of Glasgow who is working on a British Heart Foundation fellowship, was a little more forthcoming: "The SNP could present problems." For example, the British Heart Foundation is a charity—a British charity—and "the Medical Research Council's (MRC) remit [decreed by Royal Charter] is to improve cardiovascular health 

," he says. This could result in a loss of funds for these crucial health intermediary organziations. Scotland, in fact, has been more successful in securing MRC funds than any other part of the UK; Scotland represents only 8.5% of the total UK population, but received over $1 billion in funding—or 11.5% of MRC's total investment—in 2009.   

The 2014 vote is Scotland's "most important decision in 300 years," Alex Salmond wrote in a paper explaining the referendum. "Our politics should be judged on the health of our people, the welfare of young and old, and the strength of our economy." Quoting poet Robert Burns in a speech on independence in Edinburgh last month, Prime Minister David Cameron urged all citizens to "see ourselves as others see us,"—that is to say, united. If the people of Scotland opt instead for disunion, will the country be able to use its small size and interconnectedness to its advantage in an increasingly competitive global marketplace? 

Columns

What does a Scottish vote for independence mean for Big Pharma investment and healthcare funding and delivery in the UK?

Scotland, Independence, and Pharma

The rise of the emerging markets as an opportunity for Big Pharma cannot be measured solely by growth and revenue statistics. These new players in the global economy are also having a profound impact on how the industry innovates, as the source for new ideas ranging from how to market medicines to underserved consumers to the application of traditional knowledge that brings down drug development costs. Seeding the thought leadership base is a new class of activist scientists, many of whom advocate an equally activist national industrial policy and, in contrast to their counterparts in the West, enjoy close ties to government. 

An exemplar of this influential sect is India's Dr. R. A. Mashelkar, a scientist, management expert, and IP specialist who has chaired no less than 12 policy commissions for the government and is currently President of the Global Research Alliance, a network of some 60,000 scientists from publicly-financed research institutions in Asia, Europe, and North America. Mashelkar has spoken out forcefully in India—at some risk to his reputation—to promote recognition and enforcement of IP rights. More recently, he has become a proponent of new business models designed to deliver medicines profitably, but cheaply, to low income consumers—on the premise that if this market is approached as a distinct community, even the poorest have significant disposable income to spend on health. Finally, despite his government ties, Mashelkar is also widely known in the business community, serving on the boards of Tata Motors, Reliance Industries, and Piramal Life Sciences, as well as Microsoft's global science advisory board. Last month, Mashelkar sat down with 

 to discuss the life sciences business—with the compass pointed south. 

PE: You advocate a shift in business strategy for emerging markets, from the exclusive pursuit of "value for money" to an approach that incorporates "value for many."  How does management avoid losing focus in moving from satisfying a distinct and familiar customer base to a larger, more diverse set of consumers, with varying preferences?

The challenge is twofold: first, to create a strategy to serve the market you wish to address and then to adapt the larger process of management to make a successful transition from the "journey of the mind"—the plan on paper—to the real world of the marketplace. For example, companies often start their strategy review by asking: "Given our cost structure, which segments of a market can we serve?" Instead, companies must ask: "Given that we need to cater to the unserved, what should our cost structure be?" Project teams have to change their ways. They have to work within self-imposed boundaries that stem from a deep understanding of consumers. That will lead to a novel, "outside in" view of how to be innovative in addressing the needs of the unserved. The language inside the organizations should change, too. The thought process should start with an understanding of consumers as people and individuals rather than an undifferentiated mass; likewise, your suppliers are better seen as partners, not just vendors; most important, we must regard every employee as an innovator, the in-house safety net that helps organizations keep pace with disruptive change.  

In building a new business model for the unserved, the question to be asked is "What if we change the way we operate to reduce costs and focus on return on capital employed, not just on operating margins? If we reduce prices enough and make our products available to many more people, won't there be explosive growth as they quickly find uses for and buy our offerings?" This is precisely the outcome from the effort by India's Tata Motors to create a new car to cater to the aspirations of an emerging class of lower-income workers. In marketing the Tata Nano, the company soon realized it was dealing with a customer who had never used a car before—and had never gone to a showroom. In fact, the showroom had to come to the customer! Building consumer confidence in the Tata Nano meant raising the warranty guarantees from 18 months to four years, a world record for a car. Financing car loans to customers who were not salaried, or did not have bank accounts, was a challenge that led, in turn, to some innovative financing methods. 

Reaching millions of new customers with a low-priced product means keeping an eye on production and distribution costs to such an extent that the addition of a single dollar to overhead might endanger the profitability of the enterprise. Such cost pressures require extreme innovation in building rapport with the customer. ChootuKool, an ultra-low-cost refrigerator retailing at $69, was created by the Indian manufacturer Godrej-Boyce to appeal to largely rural households earning an average $5 per day—a market consisting of over 100 million people in India. To build support for the brand, the company enlisted local villagers to help market the refrigerator by guaranteeing a commission of $3 for every unit sold.

PE: Can a 'value for many,' low-cost model be productively applied in the healthcare and drug development business?

Healthcare has to be segregated from drug development, which has its own intricacies. For poor people with few resources, affordable healthcare is not an option but a necessity. The four billion people with incomes of less than $2 per day can spend only a few of those dollars on health care each year. But there is a brighter side to this picture, because ultra-low-cost products and services are now being made available routinely in countries like India, where the combination of scarcity of resources and the public desire for better health has become a driving force behind innovation—not only in new medical technologies, but in the processes and services that enable delivery to rural communities and other hard-to-access populations.

Take vaccines as an example. When Shantha Biotech India entered the recombinant DNA vaccine business, the cost per dose of vaccine was around $18. Through process improvements and locally appropriate technologies, the cost was brought down to 40 cents.  This was noted by the international community, and for a time, Shantha Biotech was meeting 40 percent of UNICEF demand for the vaccine.   

When it comes to therapeutics, cheap generics produced in India have created 'value for many.'  A year of anti-retroviral drugs for the treatment of HIV/AIDS used to cost $10,000.  India's own Cipla found a way to offer these ARVs in generic form, for $350. Competition helped push the price down even further, to $100–$150, thus creating value for many more.   

All these innovations are technology innovations. However, workflow innovations in India have led to dramatic cost efficiencies in the delivery of health related services. For example, Aravind Eye Care does cataract surgery for $30–$300 per patient, compared to $3,000 per patient for surgery in the U.S. The company treats 300,000 patients per year, and 40 percent of these get their treatment for free. A very clever use of workflow innovation based on a McDonald's assembly line approach has helped Aravind achieve this. Similarly, Narayana Hrudayalaya, another India-based health provider, is able to do heart surgery for an average cost of $2,000, compared to $ 20,000 in the U.S.  

The health sector also benefits from lower costs at the base. The Emergency Management and Research Institute (EMRI) in India is a leader in emergency medical services. It spent only 50 cents per person treated to build the infrastructure to supply this emergency care, compared to the $100 per person cost for the same service network in the U.S. The expense per ambulance is less than $15 versus $600 to $800 in the U.S.  

The payoff from 'value for many' innovation is not limited to resource-poor settings. A non-profit company, Diagnostics for All, has a unique printing technology that lowers the cost of many diagnostic tests, from simple blood draws to complex assays of liver function. The technology is a game-changer and can be used in every environment, including the extreme conditions of dust and humidity often found in the rural tropics. The big multinationals are entering this game as well. Siemens India unit is developing an ultra-low-cost x-ray machine and is looking at other breakthroughs with cost profiles that will bring the technology within the reach of millions of lower income patients—and carry the potential for sales leadership in Europe and the U.S., where cost is an increasing factor in health purchasing decisions.

PE: What about a low cost 'value for many' approach to drug development?

We need to remember what Sir Francis Bacon once said: "When you want to achieve results that have not been achieved before, it is unwise to think that they can be achieved by using methods that have been used before." 'Value for many' implies creating therapeutics at not a few dollars a tablet, but a few cents a tablet. Improvements to current methods of drug development will produce only a modest return in lowering costs. Realizing significant drops in cost requires a radically different approach. Just as an illustration, let me cite two examples here. 

First, traditional or alternative medicine can offer accessible and affordable healthcare, especially for preventive medicine and chronic pathophysiological states. It can also serve as a rich knowledge resource for new drugs. One promising approach is traditional knowledge-inspired reverse pharmacology, which comprises a rigorous scientific approach to use documented clinical experiences as well as qualitative patient experiences and observations for developing target candidates or formulations, through robust pre clinical and clinical research. In this process, safety remains the most important starting point and efficacy becomes a matter of validation. 

Second is Open Source Drug Discovery (OSDD), which has the potential of providing a new, inexpensive way of discovering drugs by creative collaboration of scientists from around the world. The OSDD initiative launched by the Council of Scientific & Industrial Research of India has leveraged the distributive power of the Internet to tap hitherto-untapped human potential towards drug discovery. In less than three years, the OSDD community now comprises more than 4,500 scientists from over 130 countries. OSDD has integrated the in silico, or computer-based, approaches with actual laboratory experiments, with researchers sharing data in the open portal and receiving feedback from an open, collaborative community.  

PE: What is your view on the potential for "frugal science" in biopharmaceuticals?

 magazine, George Whitesides of Harvard University discussed the promise of cost-conscious science.  He said, "Western medicine does many things well, but it is not affordable in, or very useful to, most poor populations. What then should be the technology base for affordable health care? Answering that question requires the development of science that is conscious of cost from the beginning—a frugal healthcare that might, perhaps, be more related to public health than to end-of-life, high-tech medicine."  I fully agree.  

PE: Much of your career has been spent leading groups with a policy mandate to connect the regulatory responsibilities of government with the entrepreneurial instincts of private enterprise. What lessons can you provide in overcoming the historical divide between the public and private sectors? Is it possible for a country to prosper and innovate absent the firm hand of government? Are there good examples of productive partnerships between business and government to promote an innovation agenda?  

I have had the privilege of chairing several high-powered national committees in India, which have dealt with complex policy issues. The assignments included the overhaul of the Indian drug regulatory system; finding solutions to the problem of spurious drugs; developing strategies on fast-tracking the recombinant pharma sector; promoting R&D and innovation in the Indian pharmaceutical industry; and examining the compatibility of excluding certain categories of innovative medical technologies from patentability under the WTO Agreement on Trade Related Intellectual Property Rights (TRIPS), where India is a signatory.    

What are the lessons that I have learned from all this? First, drawing a distinction between the public good and private enterprise remains a contentious issue, especially in leading emerging markets like India, where 800 million people still earn less than $2 per day. One has to find innovative and creative solutions to create a balance between the aspirations of the private sector to make profits and the aspirations of all people to have access to health care at an affordable cost. The debate often gets politicized into a perceived conflict between "intellectual property rights" versus the "rights of the poor."  I have always sought to find ways by which both sets of rights are protected. It is not an easy role to play; many times, emotions run high, and the "evidence-based analysis" that is sought does not take center stage. My task has always been to ensure that evidence—the facts—is not lost sight of in working toward a resolution.  

There are a number of good examples of productive partnerships between business and government in promoting a broad innovation agenda. One of the programs I was personally responsible for was the New Millennium India Technological Leadership Initiative, launched in 2000. In this program, we established government-funded partnerships between the public and private sector to tackle some of the "grand challenges" that India would confront in the new century. When I left as Director-General of the Council on Scientific and Industrial Research (CSIR), there were more than 100 private-sector companies and 200-plus public institutions working together. Our list of achievements was long, and included the sponsorship of a new drug for treating psoriasis, developed at a fraction of the cost in the western world; it is now at the pivotal Phase III trial phase, and was done by using the reverse-pharmacology approach. Likewise, we produced an entirely new drug for treating tuberculosis—the first since commercialization of rifamypicin in 1963—as well as a world-class Bioinformatics software called Biosuite. Both are at the same high standard as Western science but much less costly to develop and sell.  

PE: You have also played a direct role in executing science and technology policy, particularly in India. Why does the scientific community tend to perform below potential in influencing the public policy agenda to create the stimulus that science and technology provides to national development?

I agree that the scientific community often misses the opportunity to influence public policy.  Science has to be judged on the basis of relevance, as well as excellence. The public does not so much care for the conventional measurable outputs with which scientists judge science, such as the number of scientific research papers, but they do care about practical outcomes like the new jobs that are created. I believe scientists, with some notable exceptions, have not been sensitive to these realities. 

Communication is a critical skill for any scientist. I always tried to tell the political leadership the impact of science in a language that they understood. I remember once explaining to the Prime Minister of India how the creation of superior varieties of menthol mint by the Central Institute of Medicinal and Aromatic Plants at CSIR had helped India displace China as global leader in this sector, creating in turn thousands of new jobs in just a couple of years. In other words, a competitive advantage fosters national development, and helps a politician get re-elected. This emphasis on the practical elements behind the science helped CSIR increase its budget by almost a factor of three in real terms over the 10 years I led it. And the 12 high-powered "Mashelkar Committees" I chaired were reflective of the importance the government started giving to the scientists' viewpoint in policy making. 

PE: What has been the most engaging and successful assignment in your career to date, both in India and in the larger international community?  

I can cite three engagements that have been the most rewarding. The first was my role as Director of the National Chemical Laboratory during 1989-95. When I took over in 1989 (two years before India opened up and liberalized its trade economy), reverse engineering and copying was the norm in the chemicals business. What I did was convert the National Chemical Laboratory to an International Chemical Laboratory. For the first time, we committed to export Indian knowledge to the giant multinational companies, building in turn a new spirit of confidence in the national laboratory system. Our rallying cry was "yes, we can" and the guiding principle behind our work was "it's not the size of the budget but the value of the idea that matters." From a syndrome of "publish or perish," NCL moved to a new paradigm: "patent, publish, and prosper." It was a politically risky proposition at the time because Multinational was an unwelcome word, widely associated with colonialism and exploitation. Nevertheless, NCL forged bold partnerships with leading foreign firms like GE, Du Pont, and Ciba-Geigy. Holding hands with these global leaders meant that NCL had to run at their pace, and NCL did that—and more. Our success in showing that India could innovate and compete at their level had a catalytic influence in the subsequent turnaround of the Indian science and technology sectors into a fully globalized competitor.

My second most challenging assignment was the position as Director General of CSIR, the world's largest chain of publicly funded R&D institutions, with 40 laboratories and over 20,000 employees here in India. When I took over, there was serious doubt about the viability of spending public funds on a network like this. And there was scant coordination of effort:  40 laboratories moved in silos of their own making. What we did was to build "Team CSIR."  When I ended my tenure after 11 years, the transformation of CSIR was being touted as one of the top 10 achievements of Indian science and technology system in the 20th century. The CSIR transformation is today a textbook case of managing radical change for business school students across the globe. It was cited as a model for institutional transformation by the World Bank. 

Finally, my current service as the President of the Global Research Alliance is equally challenging. It requires leading 60,000 scientists from nine chains of institutions around a common objective. Our members include the leading research institutions from South Africa (CSIR) to the US (Battelle Institute), Malaysia (SIRIM), and Germany (the Fraunhofer Institute). The Alliance today has become a major knowledge partner in emerging reverse innovation economies like Vietnam.   

PE: How important are Intellectual Property rights for a country like India in terms of promoting its innovation potential and competitiveness?

A nation's ability to convert knowledge into wealth and social good through the process of innovation will determine its future. In this context, issues of the generation, valuation, protection, and exploitation of intellectual property (IP) are going to be critically important for India. 

Exponential growth of scientific knowledge; increasing demands for new forms of IP protection as well as access to IP-related information; the dominance of the new knowledge economy over the old brick-and-mortar economy; and complexities linked to IP in traditional knowledge, community knowledge, and animate objects will all pose a challenge in setting a new IP agenda relevant to the 21st century. India should no longer see IP as a self-contained technical domain, but rather as an effective policy instrument that is relevant to resolving India's socioeconomic, technological, and political challenges. The development of the competence to manage IP rights and leverage that influence is critical if India is to continue to grow in global competitiveness.   

PE: Do we need more innovation in the global system of intellectual property rights? If so, what are the most important elements of reform? How do we ensure that the system continues to provide economic and social benefits to all? 

The TRIPS Agreement has important provisions for fair play in technology transfer from which the developing world should benefit. The more affluent signatories—including the U.S. and the EU countries—simply need to follow them.  

Article 7 of the Agreement states, "The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and ecnomic welfare, and to a balance of rights and obligations." Furthermore, Article 8.2 states, "appropriate measures, provided they are consistent with the provisions of the Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology." 

Facilitating the access of the "have not" countries to technologies required by them constitutes one of the key elements in accelerating the pace of their economic and social development. Such access is generally the result of licenses and technology transfer agreements. The fact of the matter is that the prospective technology-seekers in developing countries face serious difficulties in securing this transfer. In fact, there are concrete examples to show that technology transfers to the third world have not taken place when they were needed most. The 1990 Montreal Protocol on Substances that Deplete the Ozone Layer ran into conflicts over commitments to ensure fair and favorable access for developing countries to chlorofluorocarbon (CFC) substitutes protected by IP rights. The 1992 Convention on Biological Diversity aims to ensure fair and equitable use of genetic resources partly through technology cooperation, but its technological provisions have received little attention. The TRIPS Agreement itself calls for technology transfer to the least developed countries, yet that provision has scarcely been translated into action.  

The transfer and dissemination needs of the developing countries have to be seen from the point of view of the capacity of those in need of accessing the technologies, particularly where the cost of technology may be prohibitive due to economies of scale and other reasons. In such cases, in order to implement the related provisions of the TRIPS Agreement, commercially viable mechanisms will have to be found.  

PE: What excites you about the promise of India as a key emerging economy of tomorrow? Where do you see your country in the year 2020?

If India's real GDP continues to grow at more than 8 percent annually, it will become a true middle-income country by 2020. And if it steps up that growth rate by one to two percent, it will emerge within a generation into the ranks of the truly affluent. The promise is there to become the second biggest economy after the U.S., surpassing China. But there are several "ifs" in this scenario—these include, among others, the pace of India's reforms.

In terms of our positioning among the emerging economies, we need to understand what a strong player India can be in attaining a leadership position in providing `value for many' products and services. 

In fact, 'value for many' products and services will no longer be motivated by concerns about fulfilling the obligation of corporate social responsibility. To the contrary, 'value for many' should be seen as a business opportunity with the potential to spawn new industries able to generate significant employment and profits for India. Most of the growth in consumer spending is expected to come from people in emerging markets, who have a much lower spending capacity than traditional middle-class consumers in developed countries. The fastest-growing consumer class in the emerging markets of Asia consists of people spending just $2 to $4 a day, according to the Asian Development Bank. This market can be served only by innovations around the 'value for many' concept. 

Indian companies are well positioned to take advantage of this opportunity. They have direct access to the world's second-largest emerging market, in which a huge low-income group is poised to enter the middle class. By 2030, the share of the total population in the emerging middle class, those earning $4 to $20 a day, will triple, to 49 percent, or 725 million people—exceeding for the first time the number of those earning under $4 a day. An explosion of consumer demand, spread across a range of low- and middle-income segments, will allow Indian businesses to experiment with different scaling strategies, making the cost of pursuing value for many business models much lower for firms in India than for competitors in other emerging markets. 

PE: What do you anticipate as the next steps in your work—are there new areas of interest that you wish to influence in your remaining years?

Suddenly the vocabulary of innovation is a global one—and it is changing around the world. Terms like "frugal science," "reverse innovation," "nonovation," "indovation," and "Gandhian innovation" are emerging. I described "Gandhian Engineering" as getting "more from less for more and more people, not just for more and more profit." This new paradigm has popularly been called, in an abridged form, multi-level marketing (MLM). Essentially, what MLM means is not just doing well (making profits) or doing good (the social good) but doing well and doing good (social business). The idea of MLM has caught on. The World Economic Forum annual meeting in Delhi in November 2010 had a half a day session on MLM, and I was pleased to see the CEOs of some multinational companies speaking in support of MLM.  

What I intend to do for the remainder of my career is to champion MLM, spread the message of 'value for many,' make "inclusive innovation" a key element of national innovation systems, and generate more funding for it. I was very happy when the Indian government recently announced that it was creating a new Indian Inclusive Innovation Fund, whose resources may grow to $1 billion in the next few years. 

India's most prominent scientist, Dr R.A. Mashelkar, President of the Global Research Alliance, on delivering medicines profitably but cheaply to low income countries.

Emerging Markets: Setting a New Agenda

There's a great thirst for information on pharma operations, including drug manufacturing problems likely to dry up vital medical supplies, findings from clinical research studies, and company payments to doctors for multiple activities. The rising clamor for more "transparency" in industry operations creates considerable challenges—and costs. 

To deal with still-prevalent shortages of critical drugs, Congress is poised to make manufacturers expand reports to FDA about short supply situations and to establish a new track-and-trace monitoring system. At a hearing before the House Energy and Commerce Health subcommittee last month, legislators urged FDA and industry to devise a "robust pedigree system" that would track drugs through the supply chain. Continued shortages, along with the rise in counterfeit drugs such as the cancer therapy Avastin (see sidebar), have kept drug supply chain issues on the front page. 

Manufacturers, distributors, and pharmacists told legislators that they have finally agreed on an efficient, affordable national serialization and tracking system dubbed RxTEC, which could replace the current "patchwork" of proliferating state pedigree laws. But Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said that FDA wants tracking down to the drug-unit level because lot traceability can "only partially" identify the distribution path of contaminated or counterfeit products. As a first step, FDA has established a drug serialization system and continues to work on standards for product authentication and tracking, activities that Congress is likely to authorize through pending user fee renewal legislation.  

Meanwhile, FDA is demonstrating it can be very flexible in addressing shortages of necessary therapies. Commissioner Margaret Hamburg announced in February that FDA remedied a serious shortage of the cancer drug Doxil by authorizing Caraco Pharmaceutical Laboratories to temporarily import a replacement drug, Lipodox, produced overseas by India's Sun Pharma. FDA officials emphasized that import of this unapproved foreign drug will be a temporary, limited arrangement and was authorized only after the agency evaluated the quality and safety of the Sun product.  

FDA also resolved a critical shortage of methotrexate by expediting approval of a manufacturing supplement from APP Pharmaceuticals and release of thousands of vials produced by Hospira, Inc. FDA said it also is working with Mylan and Novartis' Sandoz Pharmaceuticals to boost their production of preservative-free methotrexate, which is needed to treat children diagnosed with acute lymphoblastic leukemia.  

Yet, Hamburg noted in a February speech to the annual meeting of the Generic Pharmaceutical Association (GPhA) that many drug shortages are related to quality compliance issues. On almost the same day that APP announced expanded methotrexate production, FDA issued a warning letter citing the firm for serious manufacturing violations, primarily related to heparin production. And Hospira was able to ship some 65,000 vials of methotrexate in February because it had invested hundreds of millions of dollars in plant remediation efforts to resolve earlier manufacturing problems. Companies making medically necessary drugs "must invest in their manufacturing facilities," Hamburg advised the generics makers, noting that visible shortages involving generic drugs could lead the public "to equate generics with quality concerns."  

Demands for transparency also apply increasingly to clinical trial activities and results, thanks to new laws and regulations that expand trial registration requirements and the disclosure of research findings. However, evidence that much research information remains unknown raises questions about how well sponsors comply with research disclosure policies.  

The good news is that sponsors of FDA-regulated clinical studies are doing a better job in registering trials on the 

 website, as required by the FDA Amendments Act of 2007 (FDAAA). This has created a massive database at the National Institutes of Health (NIH), with information on some 100,000 studies.  

What seem to be missing are required reports summarizing the results of registered trials. FDAAA gives sponsors 12 months following study completion to provide results, and preapproval studies don't have to be posted for up to three years to protect proprietary information. However, an analysis published last December (2011) in the journal 

 by researchers at the University of British Columbia found that only 12 percent of completed trials issue results within a year. And just 14 percent of post-marketing studies meet the one-year submission timeframe, despite the importance of timely information on drugs already used by patients.  

in January (2012) found that only 22 percent of registered trials subject to mandatory reporting in 2009 made results available within a year of study completion. Interestingly enough, pharma companies do better in posting study results than investigators funded by NIH, but no one gets high marks. The analysts urge stricter enforcement of reporting requirements to improve research transparency: NIH should withhold grants to slow responders, and FDA should levy $10,000-a-day fines. House Democrats agree and sought explanations for disclosure delays from commissioner Hamburg and NIH director Francis Collins.  

Despite these problems, transparency advocates want to extend disclosure to include data from clinical trials for products that FDA fails to approve. While all investigational studies have to register on 

, summary results are required only for research that supports medical products that eventually reach the market. But many scientists believe that much useful information can be obtained from failed studies, and it could help sponsors and investigators avoid repeating unsuccessful research.   

On another front, pharmaceutical, biotech, and medical device companies soon will have to report all payments to doctors for inclusion in a new public database. The main thrust of this "Sunshine" policy, which was included in the Affordable Care Act of 2010, is to disclose all industry "transfers of value"—fees, grants, free meals—that could influence medical practice and prescribing. Fees to physicians and teaching hospitals for research activities also are included, a requirement that medical societies fear will make payments for bona fide research activities look like big handouts from pharma.  

Because the Centers for Medicare and Medicaid Services (CMS) issued its proposed rule for implementing Sunshine in December 2011—months past the original due date—the agency is postponing initial data collection from pharma until after it finalizes the policy. No one knows, though, when that will occur or how the data filing process will be carried out.  

Meanwhile, industry and provider groups met the mid-February deadline for filing comments, which reflect concerns about how payment data will be posted and reviewed. Many commenters seek broader contextual information on the CMS website describing the nature of relationships and interactions between manufacturers, physicians, and teaching hospitals. There's also interest in dropping reports for accredited and certified continuing medical education, which often is funded by grants from marketers that have no say on physicians serving on the programs.  

The research-related reporting provisions came under fire from medical societies and research organizations, many asking CMS to drop this provision altogether. The American Thoracic Society, for example, said that public reporting of research payments implies that "research is somehow an inappropriate activity for physicians." Congress included reporting on research, the pulmonologists note, to prevent industry from "hiding" payments under the guise of research, but not to taint investigators. The Association of Clinical Research Organizations (ACRO) similarly proposed cancelling reports on payments from manufacturers for legitimate research activities "as there is no evidence that such payments bias prescribing or other practice behavior." 

A specific problem is that the proposed reporting system will lead to double counting of payments for R&D services. This will occur, as Pfizer explains in its comments, because a $10,000 payment to a teaching hospital serving as a clinical study site also would be reported as a $10,000 "indirect research payment" to the associated principal investigator. To prevent such errors, the Association of American Medical Colleges (AAMC) suggests that industry should report research-related payments only to the institution involved, and not to individual physicians connected to a hospital.  

ACRO predicts that public reporting of legitimate research activities could cut the number of physicians participating in trials by one-fourth. Without many of the proposed changes, says ACRO, data related to research will be "incomplete at best, terribly inaccurate at worst." 

's Washington correspondent. She can be reached at 

Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.

Shortages and Sunshine

The campaigns chosen as Ad Stars this year include a diverse mix of clients, health conditions, and media channels. During the selection process, 

perused awareness campaigns, direct-to-consumer and professional marketing, iPad applications designed specifically for sales reps, and campaigns that help recruit for clinical trials. Each of the campaigns were selected not only for their strength in relation to a particular therapeutic area, which is crucial, but also because something different in the creative caught our eye; not an easy task given the number of ads we're able to more or less ignore each day.  

For many of these campaigns, the diseases they target represent distinctly different patient audiences—from elderly folks who need next-gen flu vaccines, to women suffering from tough-to-discuss vaginal dryness, to isolating and frightening conditions such as depression and schizophrenia. It's not the whiz and bang alone that makes for good medical advertising; it's the underlying knowledge of a disease, and what it means to have one, that leads to successful communication .

Marketers, including this year's Stars, always attempt to cater to their target audience—be it gastroenterologists or dermatologists—but rote market research alone doesn't provide enough paint for the portrait. Patients and doctors aren't all alike, but individual sentiment often reflects a common problem; understanding those problems from the perspective of the audience members leads to creative that's more persuasive, because it's more informed. 

This idea of incorporating the patient perspective—into not only ads but in the healthcare delivery system as a whole—is not a new one, but it's a healthy movement that's growing. Increasingly, how patients feel about and react to their own health conditions is becoming a vital part of their diagnosis and treatment. In fact, Columbia University now has a graduate program centered around this idea, which they're referring to as narrative medicine: "Narrative Medicine fortifies clinical practice with the narrative competence to recognize, absorb, metabolize, interpret, and be moved by the stories of illness," reads Columbia's Narrative Medicine program website. "Through narrative training, the program in Narrative Medicine helps doctors, nurses, social workers, and therapists to improve the effectiveness of care by developing the capacity for attention, reflection, representation, and affiliation with patients and colleagues."

It seems only natural, then, to see this holistic, dynamic mindset spread into marketing as well. As healthcare providers are "moved by the stories of illness," so, too, are we moved by the advertising that captures those stories. (Whiz and bang usually doesn't hurt, either.)

There is no cure for schizophrenia, a disease that makes patients feel as if their mind, their families, and their lives are fragmented—much as the man pictured in the Latuda "Fragments" campaign created by AbelsonTaylor. The campaign, aimed at psychiatrists, shows "Joe," a schizophrenia patient who is left fragmented by his disease. 

"Schizophrenia is a devastating disease and can tear patients apart," says Melissa Bauer Smith, Account Supervisor from AbelsonTaylor. The ad aims to show that "with Latuda, although no cure, the patient may experience symptom improvement—enough so that he can potentially begin the process of reintegrating into his family and society."  This idea of reintegration and of family comes through in the "after" image of the ad as well. It's important to note that Joe is not shown to be completely cured or whole again, but that he is noticeably improved, happier, and has his mother by his side. 

About 1 percent of the adult U.S. population is affected with schizophrenia, says Jonathan Davila, Associate Creative Director/Copy. "Profound symptoms such as scrambled thoughts, severe paranoia, and auditory and visual hallucinations leave patients frequently unable to lead independent lives" or to maintain effective relationships with friends and family. But with Latuda, Joe is able to feel more like himself again, and his relationship with his mother here is strong. "Family members and caregivers play a crucial role in the treatment process," he explains. 

The creative process, according to AbelsonTaylor, was aiming for five qualities: "relevant, distinctive, quick, emotional, and campaignable."  The hundreds of initial ideas that are tossed around get narrowed down to just a few, and in this case, nine concepts were shown to the client, Sunovion Pharmaceuticals. Five of those nine were brought into initial testing. "From there we did three rounds of qualitative testing with U.S. psychiatrists and each time, 'Fragments' rose to the top," says Verna Semenik, Associate Creative Director/Art. 

The Fragments campaign ran in psychiatry journals and also consisted of a professional website, convention exhibits, and interactive sales aids for pharma reps. And by all accounts, it's been a success: "According to follow-up market research, the image of Joe and his mother is highly recognizable, and psychiatrists have commented on its ability to portray the devastating nature of the illness," says Bauer. 

Abottle of wine shatters with explosive passion, and with it, some stigmas and misconceptions about chronic pancreatitis (CP) are destroyed as well. The striking imagery in the "Shattering Perceptions" awareness campaign from Palio gets its target audience—gastroenterologists—to look at a disease they think they know well in a new light. 

Among gastroenterologist, says Tiffany Ryan, VP, account services at Palio, "there was a pretty prevailing myth based on their med school training and on their own experience that all CP patients were alcoholics. But our data showed that only one-third of CP diagnoses were actually linked to alcohol, and so the objective was to increase the diagnosis and treatment of CP by dispelling the common misperceptions that were serving as barriers" to proper diagnosis and care. 

The image the creative team at Palio chose was intentionally dramatic. They could have gone with a glass of wine knocked on its side, perhaps, but the wow factor that draws the eye to the ad just would not have been the same. "We really wanted this to be dramatic, to get attention, and to dispel the myth," says Ken Messinger, Palio's SVP and creative director. "In fact, we had created a lot of different concepts that went into testing, but in the end it was the sheer stopping power of this image that was so critical to making sure the message was communicated." 

In addition to the expected creative team for such a campaign, Palio actually has two MDs on staff that that worked with them throughout the creative process, to help them "better understand the physician mindset," says Ryan. "Especially on a disease awareness campaign, I think that the cross-functional collaboration and understanding the science and clinical studies—as well as the current physician perceptions—is really key to generating a strong creative idea that can move the needle with physicians." 

"Essentially, the goal is to shatter the misperception that most CP patients are alcoholics who did this to themselves," says Ryan. 

And according to Messinger, it's working. "It's captured a lot of attention from physicians," he says. "Just hearing feedback anecdotally from sales reps, it seems like it's opening up physicians' eyes to the fact that what they've learned about CP patients all this time is not necessarily what's really happening."

Concentric Pharmaceuticals had a challenging task when creating an ad campaign for LEO Pharmaceuticals' Taclonex, used to treat psoriasis. The campaign, aimed at dermatologists, needed to convey that Taclonex is unique—it's a topical that acts as a "combination" product, whereas most other treatments on the market are dual treatments that require alternating between a steroid and a vitamin D product. Because switching back and forth between the two traditional treatments, as most patients do, comes with a heap of side effects each time a patient goes on or off one of the two drugs, and because of the complexity of the treatment regimen, Taclonex has the potential to improve medication adherence by eliminating perceived barriers such as certain side effects and having to remember to switch on and off different medications. 

But, according to Michael Sanzen, founder, co-CEO, and executive creative director at Concentric, the selling power of the dual-action treatment alone is just not enough. "Earlier campaigns had really focused heavily on the value of it being a combination," he says. "But what we learned over the years is that dermatologists are very, very conscious of their patients' level of satisfaction. Walking through the clinical story of the two-in-one wasn't really enough to convince them that this topical experience was going to be much better than their previous topical experiences." 

With that in mind, the image of the woman unzipping her affected skin and expressing contentment at the clearer skin underneath was chosen. The words in the ad—strength and simplicity—were selected to represent the brand, and are reflective of the ad itself. One clear image and two straightforward words, rather than several lines of copy, project the message that simple is better. "We sort of stepped back and said, 'Let's just put on the page exactly what we're trying to get across here, that we can deliver this powerful clearance in one product, once a day,'" says Sanzen. "And we were surprised how well, in our opinion, that simple copy married with the image, even without pushing it to be conceptually linked. There's something about the elegance of that image that shows that combination of power and simplicity." 

The creative team at Praxis created a campaign to raise awareness of  Venus Study, a clinical trial that was recruiting women suffering from vaginal dryness. Because the clinical trial is ongoing, the client (a pharma company) who commissioned the campaign is still hush-hush, but the campaign material is anything but—it aims to get people talking. 

The campaign consisted of brochures and posters at clinical trial recruiting sites, letters for physicians to send to patients who might qualify as trial participants, and laminated pocket cards for doctors to keep with them. But the bold image of the nail polish bottles with not-so-subtle labels such as "love hurts" and "burn baby burn" is the true conversation-starter amongst women. "At some point in our lives we've all, as women, painted our nails," says Liz Maimone, senior copywriter. "And that's very important, because makeup and beauty are things that make a woman feel confident, and these women are feeling very vulnerable—they're not feeling very feminine." 

To settle on just the right image that would evoke that sense of femininity and also familiarity among women who suffer from vaginal dryness, Praxis went above and beyond the traditional focus group approach. Maimone says, "We want to know: What are people talking about right now? Not what are they saying in a focus group, but what are they saying to their friends, and to other moms or other grandmas or other women?" So Praxis did its research by using search engines and typing in the same terms that patients suffering from the condition would type in, visiting blogs and chat rooms, and reading what the commentors on online news stories were saying. "People like to talk; you just have to be listening." 

Due in large part to the creativity of the campaign and its ability to catch the target audience's attention, the client surpassed its goal of enrolling 690 women in the clinical trial, ending up with 722 instead, and was able, according to Tricia Barrett, Praxis' VP, operations, to "close things down a month early." And as she reminds us, "In the world of clinical research—where on average, it costs around $50,000 a day to conduct a clinical trial—being able to save time is the name of the game." 

Abilify picked up an indication as an "add-on" treatment for depression in 2007—the drug is also approved for bipolar disorder and schizophrenia—and that got Digitas Health thinking about what it means to be depressed. "Winston Churchill famously called depression his 'black dog,'" say Jacqueline Nolan and Graham Mills, co-executive creative directors at Digitas Health, in a co-authored email. "This intrigued us and so...we started asking people to do a drawing that described their depression." The result was a wide variety of visual metaphors: a ball and chain, a robe, a hole in the ground, and an umbrella that rains on the depressed person. 

It would be difficult to film a umbrella raining on someone, and even harder to make the umbrella "alive," in the way that it is in the newest Abilify spots, which use animation to make the inanimate metaphors real characters; they stalk their victims. The campaign launched in the first quarter of 2011, and is ongoing, a testament to the ads' effectiveness. Animation is rare in pharma advertising; although Deutsch used animated spots a few years ago for the depression drug Zoloft, those Don Hertzfeldt-inspired spots were less compelling, and featured a blob-like humanoid, without a depression-personified character. The hand-drawn Abilify ads stand out through a combination of the story/characters, and the quality of the illustration/animation, created through a partnership with Th1ng, in London. Sylvain Chomet, producer of 

But why are these animated spots so compelling? "Using animation makes it much easier for people to project themselves into the film," say Nolan and Mills. "There can be a downside to using real people...if they don't look like you, it's harder to identify with them." In other words, the single-line rendering of a cartoon character is an abstraction that lends itself to audience subjectivity. And then there's depression, that sad-eyed bathrobe with its agoraphobic implications. "We wanted to be able to show the daily struggle people have with their depression, however it's manifested," say Nolan and Mills.

Chronic Obstructive Pulmonary Disease, or COPD, is one of the most common types of lung disease, and it's a serious burden for patients. Shortness of breath, and pain associated with deep breathing can give the impression of a heavy weight on the patient's chest, but that isn't the only downside. Smoking is a leading cause of COPD, and many patients are made to feel that they deserve the condition; blame often comes along with treatment.  

Prior to DraftFCB Healthcare's Spiriva campaign, which features images of an elephant sitting variously on patients' chests, a different agency attempted to flip the Surgeon General's warning, associating treatment with positives, but patients still picked up the sense of guilt. However, the DraftFCB elephant campaign (which was shot using a real elephant—Rosie, who also starred in the 2011 film 

) suggests that COPD is a separate entity, albeit a large one.  This way, patients can think about improving their condition without any of the nagging blame associated with smoking.  

The elephant-on-your-chest theme carries into digital territories, including 

, but DraftFCB Healthcare didn't create those assets. The agency does have the professional account, soon to be launched, but the creative is under wraps. In one television spot, the elephant in the room (COPD) first sits on a man's chest, then stalks him as he speaks to the camera and shoots billiards. By keeping the elephant in the frame as he lines up a shot on the table, DraftFCB wisely conveys the message that while Spiriva won't eradicate COPD, it can make it less of a burden. 

By now, the flu vaccine is a standard commodity in the eyes of most physicians. Handed a new flu vaccine intended specifically for the elderly —populations 65 years and older—Saatchi & Saatchi Healthcare Innovations were presented with the somewhat tricky task of convincing physicians that elderly patients need something different from the standard. 

The image in the journal ads depicts a senior female peering into a mirror, and seeing her younger self: "Fluzone High-Dose vaccine – Because her immune system isn't 30 anymore..." reads the tagline. Also prominent is a message declaring that the vaccine is covered under Medicare Part B. "The visual helps bring to light the medical necessity for Fluzone High Dose within the 65-plus population, to help break through that idea that 'all flu shots are created equal,' and drive uptake for the brand," says the Saatchi creative team via email. The look that the female senior is giving to her gorgeous, 30-year-old self in the mirror seems to acknowledge the inevitable deterioration associated with age. But at the same time, there's a renewed confidence in the elder woman's profile; her arched eyebrows and half-smile insinuate a received confidence from younger form, and an acceptance of the aging process. 

The campaign began last summer, and will run through 2012. Publicis Healthcare Communications has facilitated partnerships with Optimedia and Digitas Health, for digital and media executions. In addition to journal ads, the campaign also includes brochures and informational sheets to leave with physicians.  

"The biggest challenge has been educating healthcare professionals on immunology in the elderly, and how it relates to influenza vaccination," says the Saatchi team. "We had to carefully balance the need for Fluzone High-Dose, within the 65-plus population, without creating distrust in the standard influenza vaccine, which could hurt overall immunization rates." 

This year's Ad Stars embrace creativity through the eyes of the patients. Ben Comer and Jennifer Ringler report.

Pharm Exec Ad Stars 2012

All over the world, many patients with serious illnesses can't get access to the medicines they need. The available therapies haven't worked and there are no available clinical trials, or a new drug isn't accessible where they live. For these patients, access to a drug outside of the traditional channels may represent a life-saving treatment option. How can industry help? 

Since 1987, FDA-sanctioned "expanded access programs" have enabled patients, under specific circumstances, to access drugs or biologics still in development. Similar regulations exist broadly outside the U.S. but the nomenclature describing these programs differs widely. In an effort to bring much-needed clarity to all of this terminology, we use "Managed Access Programs" as an umbrella term that encompasses a variety of regulatory approaches enabling access to medicines that::  

» May never be approved, but still have medicinal value for a very small population (such as orphan drugs) 

» Are approved in one country, but not another 

» Have been discontinued in a particular market 

» Are an alternative to a drug discontinued globally 

Regardless of the nomenclature used, access enabled by these programs can offer significant benefits to patients and their healthcare providers; they're often the only remaining option.  

Patient access to medicines across the lifecycle from Phase I testing through to discontinuation follows a typical pattern (Figure 1-A). The number of patients gaining access grows as the trial process moves forward and continues to increase following first (1-B) and subsequent launches (1-C). 

Actual patient demand for medicines that address an unmet medical need (1-D) often exceeds the level of access that is typically delivered. The gap between actual patient access and the total demand for access reflects the fact that not all patients who may benefit from the drug are able to gain access via traditional routes. 

Figure 2 illustrates the delay in access that patients in Europe typically experience even after a drug has been approved. Each year, the European Federation of Pharmaceutical Industries and Associations publishes the Patients W.A.I.T. Indicator, which stands for Patients Waiting to Access Innovative Medicines. The data represent all medicines available in 2010 that were approved by the EMA during the years 2007 to 2009.   

For those new medicines that doctors can prescribe under national healthcare provisions, the average time elapsing between the date of European Medicines Agency (EMA) market authorization and the "accessibility" date (i.e. date of completion of pricing/reimbursement procedures, represented by the green bars in Figure 2) in 11 European countries varied from 88 to 392 days, not considering Germany and the UK. The orange bars represent the percentage of medicines available commercially in these countries with a valid EMA marketing authorization during the previous three years. This ranged between 39 percent for Portugal to 86 percent for Greece. Even with a centralized marketing authorization, the delay to access can still be significant depending on in which European country a patient lives. These delays are even more profound in other territories.   

Managed Access Programs can be used to bridge these gaps, in a fully compliant manner. Such programs can be implemented on a patient-by-patient basis, or for a group or cohort of patients, and are effective at helping companies address patient demand for medicines around the world.   

FDA's expanded access program (EAP) rules were amended in 2009 to ensure "broad and equitable access to investigational drugs for treatment." Regulations include specific criteria for authorization, submission requirements, and safeguards to protect patients and the clinical trial process. The regulations also define the different types of mechanisms that are available, including individual access under a single-patient IND (investigational new drug; or Emergency IND); access for small to intermediate groups of patients; and for larger groups via a Treatment IND or Treatment Protocol.  

A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to an investigational drug. Provisions are also in place to obtain medicines on an emergency-use basis, allowing patient treatment prior to the completion of the requirements for a single-patient IND. 

The FDA established specific criteria for when this type of IND may be appropriate. One example is when the drug is not being developed because the disease is so rare, which impedes a company's ability to recruit patients for clinical trials. FDA may also ask the company to consolidate a significant number of single-patient INDs for the same use under an intermediate-size patient population IND. Treatment INDs and treatment protocols provide access to investigational drugs for large numbers of patients who would not otherwise qualify for clinical trials.   

Outside the U.S., these access methods are known by a variety of names, including, for example, "named patient programs" (NPPs—in which physicians can request access to drugs on behalf of individual or "named" patients), "compassionate use," and "temporary authorization for use."   

Regulations differ widely among countries due to differences in national medical practices, resources available, product funding, hospital structures, and national insurance systems. These programs also allow access, in specific circumstances, to drugs that are approved in other countries but not yet approved in a patient's home country. Additionally, when there is a small patient population spread across a large number of countries (as with a rare disease), a company may be able to offer access to their drug before seeking approval and commercial launch in dozens of geographies that would not otherwise have been feasible.   

The thirty countries comprising the European Union (EU)—which fall under the jurisdiction of the EMA—each have their own nationalized regulations regarding access to unlicensed medications for individual patients and patient groups. For example: 

» In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees use and approval of unlicensed medicines. Permission is obtained prospectively, and use is permitted based on a physician's clinical judgment that an individual patient has an unmet medical need and has no suitable alternatives available.  

» In France, the French regulatory agency (AFSSAPS) is primarily concerned with the science supporting a request that a patient with a particular indication be allowed access to a drug not approved in France. Additionally, access may be permitted for single patients (Temporary Authorizations for Use; ATU nominative) or groups of patients (ATU cohort) and permission is obtained prospectively. 

» In Ireland, the Irish Medicines Board requires tight control on distribution of unlicensed medicines with assurances that the drugs will not be released beyond the intended patients named in NPP requests. Retrospective notification must be completed within two days of use. 

» In Germany, Federal Institute for Drugs and Medical Devices (BfArM) oversees access to unlicensed medicines. Historically, the primary mechanism has been via single-patient access. However, in 2010 new legislation was put in place for group access.           

Countries outside the U.S. and Europe also offer these programs. Canada's "Special Access Program" provides access to non-marketed drugs to practitioners treating patients with serious or life-threatening illnesses when conventional therapies have failed, are unsuitable, or are unavailable. Similarly, in Australia, patients can access experimental drugs via the "Special Access Scheme." In Japan, government-sanctioned "Named Patient Access" allows access to drugs with an expectation that the drug be approved in the exporting country.    

In all of these scenarios, managed access programs provide a route to obtain innovative drugs prior to approval or launch. To support the needs of these patients, companies should proactively consider offering pre-approval or pre-launch access as part of their drug development plan in therapeutic areas with critical or unmet patient needs. 

 is Vice President, New Product and Market Development, at Idis. He can be reached at 

 is Manger, Regulatory Information and Intelligence, at Idis. She can be reached at 

Benefit from industry updates and case studies related to this article at the 

5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs, July 19-20, 2012, Philadelphia, PA

While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.

Providing Access Now

Mergers and acquisitions have been prevalent in the pharmaceutical industry as companies seek to grow and fill pipeline gaps. In our business as compliance and quality advisors to the industry, we are seeing an upswing in carve-outs, where a parent company spins off a subsidiary or drug. More carve-outs reflect investors' desire for proven products with less regulatory risk and investment needs than with developing new drugs. For sellers, carve-outs esentially offer the opportunity to bring in cash from non-strategic assets. 

Whether it's M&A activity or a carve-out, there are a number of regulatory and technical issues routinely left on the back burner until the deal is closed and the transition begins. A common scenario involves the new buyer acquiring an established international drug product with expectations of ongoing revenue streams, oftentimes without conducting thorough regulatory and technical due diligence. After the deal closes, the buyer's regulatory team learns that they need to re-register the facility, conduct drug listing activities, and make mandatory product labeling changes. Some countries can require a complete re-approval process. These activities take time and money, and often the buyer's regulatory team lacks the bandwidth to handle these simultaneous tasks. As a result, revenues are delayed, budgets are exceeded, and the deal loses its luster. 

We argue that the better path is to fully quantify the post-deal regulatory/technical activities and their associated costs as part of the due diligence process. This requires deep involvement from subject matter experts or experienced technical consultants in the early stages of the deal. When both buyer and seller have a full understanding of the scope and costs, these aspects can be factored into the deal price or negotiated into the transition services agreements (TSAs). Additionally, a solid understanding of this subject may provide capitalization, escrow, or other financial advantages. 

Common Pitfalls – Regulatory Re-registrations

Too often in M&A or product-linked carve-outs, executives overlook the complexities of disentangling operations and the effort required for regulatory re-registration and labeling changes.

Pharmaceutical Executive-04-01-2012