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Connecting the Dots The inclusion of healthcare as a priority on the presidential agenda has led to knock-on consequences that are being felt across the healthcare value chain in the Philippines. Universal healthcare coverage (UHC) has been cemented, which has led to a shift from branded medicines to generics, leading many players to a strategic repositioning. The most successful players have been those who focused on a strategy that was inclusive of all stakeholders and aligned with the presidential agenda of affordable and accessible healthcare.

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TheEuropeanMedicines Agency (EMA) is 20 years old this year — and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its early adolescence, the agency now must make up its mind about what it wants to be. This is not just a matter of defining its personality. It also means taking on greater responsibility obtaining the resources it will need, and asserting  its mission isuccessfully in the face of the often harsh realities of the outside world.  

The agency's own sharpened awareness of the complex conditions beyond Canary Wharf is  its programme for 2014, which identifies half a dozen new priorities. As EMA's executive director, Guido Rasi, publicly observed at the end of last year, "The environment in which we are operating is ever-changing, continuously presenting us with new challenges." 

Perhaps the biggest challenge is the agency's intention to publish clinical trial data from marketing authorization applications. This has provoked criticism from industry that the EMA is going too far, while health cacpaigners contend it is not going far enough. Resolution may take longer than anticipated. Late last year the agency deferred its decision on precisely how it would disclose rtrial data as recently as December. As recently as December. Rasi was speaking of how "we will continue to discuss our approach to achieve this goal with our stakeholders so that we finalise a policy that is carried by a broad consensus." The cautious wording recognizes how contentious the debate has become — intensified by legal action that AbbVie and InterMune are taking against the agency's current, and much more limited, data-release policy, and by conflicting demands from the European Parliament that no clinical trial data should be regarded automatically as confidential. 

The other really tough issue the agency must confront is the longstanding disconnect between marketing authorization and drug reimbursement. For industry, the resulting delays in market access are seen as a disincentive for innovation, while the expanding demands of national health technology assessment agencies hold a threat of inefficient duplication. For patient groups, the concerns focus on inequalities of treatment and lack of access. And now even regulatory agencies are recognising the intrinsic risk of wasted effort and overlap that will please no one.  

2014 will see EMA addressing "the evolving nature of our interaction with health technology assessment bodies." He sees the agency as moving towards running the processes of regulatory licensing and HTA assessments in parallel, "with the aim of accelerating and facilitating access to authorized medicines for patients". 

His officials point out that the agency has been conducteding a growing number of parallel scientific advice procedures since 2010, and the aim is to build on that experience. The agency is planning for imminent release of draft guidance on how applicants can seek simultaneous feedback from regulators and HTA bodies on their product development plans. This work will also tie into the ongoing policy reflection exercise on the design of clinical trials that would allow for the development of more targeted medicines. 

One of EMA's big battles of 2014 will be to regain public trust in an era when the credibility of all authority has been called into question.  

Hence major efforts will continue this year to boost agency transparency, and counter concerns over possible conflicts of interest. The work plan envisages publication of the agendas and minutes of EMA's committees, further increases in communication outreach, and yet more new rules about disclosure of interests to bolster the independence of dossier approved experts. The agenda of the agency's leading scientific body, the Committee on Human Medicinal Products, was published for the first time during the December 2013 meeting; minutes of the meeting will be published in January. It will then become standard practice to publish the agenda at the start of each meeting; and the minutes after their adoption the following month.  

In December, the agency's management board endorsed a number of principles for revising the policy on conflicts of interests for scientific-committee members and experts. This latest rule-change aims at getting the balance right between maintaining a pool of high-quality scientific experts and ensuring that experts are free from undue financial or other interests. The principles, which are still to be turned into detailed rules, include concepts such as timing (how long before a past interest ceases to be a bar) and differentiation (experts involved in decision-making versus experts involved only in advice). There's the need, too,  to recruit experts:  to make involvement with EMA more attractive  to scientists and physcians. 

But many NGOs believe the rules are not being made sufficiently strict. Pierre Chirac of Prescrire and the Medicines in Europe Forum says EMA should strengthen its policy to protect decision-making from undue influence. He warns against what he calls the "unconscious link" between people who have worked together or have common interests.  

Similarly, on the hot topic of access to clinical trial information, he insists that raw data should be made available to independent researchers. But he is not optimistic that EMA "will resist huge pressure from the industry". It has, he says, stopped providing Prescrire even with documents that contain no raw data. 

By contrast, Richard Bergström, director general of the European industry association, EFPIA, is more optimistic about the data access debate. He believes that industry's concerns over protecting commercially confidential material are being taken into account as EMA finalizes its policy. He is more worried about how EMA plans to link drug authorization more closely to drug reimbursement.  

Bergström is also concerned about ensuring that EMA opinions and decisions are led by top-quality science, and over the best allocation of regulatory resources in the face of tighter healthcare budgets and ever-greater workloads. The issue is complex, he suggests, since it cannot be solved merely by concentrating available talent centrally: national authorities will also have to remain adequate and credible if they are to ensure national buy-in to decisions taken at the centre.  

As if all this were not enough, the agency is determined to boost international cooperation, particularly on inspection of clinical trial sites outside the EU, and to contribute to the combat to the search for new anti-infective treatments.  

The implementation of the pharmacovigilance legislation that came into effect in July 2012 will continue to impose new workloads in 2014, as will implementation of the falsified medicines legislation. At the same time, the agency is also introducing modifications to its fee structure, and undergoing a major internal reorganisation this year, with redesigned processes and rearranged departments. And its work will be further disrupted by a physical move, relocating its 1000 staff members to new premises just down the road in London docklands, along with 500 items of loose furniture, 3000 personal crates, 5000 linear meters of filing, and 260 plants. 

If the agency plays its cards well, it could dispel the memories of those unfortunate blemishes that marred its adolescence, and look forward to resuming its evolution as a world-leading centre of regulatory excellence. If it doesn't, the agency could find itself, rather like the European Union of which it is a part, losing its way in a world changing faster than it can keep up with. 

Features

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces key policy challenges of 2014.

Will Europe's Regulatory Watchdog Come Of Age In 2014?

The managed care   model has seen huge growth in the US pharmaceutical industry, with an   estimated 85 percent of all prescription                          drugs now reimbursed through a managed care   plan. It follows that gaining access to a managed care formulary can   spell the                          difference between product plenty – and outright   penury. But a formulary win alone is no longer sufficient to guarantee   strong                          commercial returns through the full extent of   the product life cycle Something more is required. 

That something is   an effective, outward-facing "pull-through" program to increase patient   acquisition and retention to therapy,                          at each stage of the life cycle. Pull through   programs focus on targeted messaging, qualitative insights and   quantitative                          data benchmarks, all designed to help sales   leaders understand how to leverage the local market influences that   drive perceptions                          of access among healthcare providers. The goal   should be to disengage the negative influences on product uptake and   acquire                          or "pull" more patients into the brand. 

Pull through   programs are a response to a customer environment that is astoundingly   dense and increasingly interdependent.                          It's not only payers who now control the levers   on patient access to medication; there is an array of emerging   stakeholders                          and influencers that set that perception,   including Integrated Delivery Networks, Hospital formularies, Key   Opinion Leaders,                          physician and organizational technology   platforms, local standards of care, and national and regional healthcare   policies. 

"Pull-through"   can mean different things to different people. Some define pull through   as a process aimed at increasing market                          share and generating sales for a specific   product within a given time frame. Others define pull through as   broadcasting a                          formulary listing to enhance the value of   managed care contracts. Others define pull through as a bridge builder   to physicians.                          No matter how organizations define pull through,   its practical application centers on influencing physician adoption of a                          drug that leads to increased patient   acquisition, especially against competing therapies. The desirable   outcome is that: 

» Managed care, marketing, and sales executives understand how payer controls and patient affordability influence prescribing                          and dispensing at all levels of the market geography – national, regional and local. 

» Sales reps and marketing teams are able to initiate and deliver a simple yet powerful message about the positive patient                          experience, to the highest value prescribers in the market. 

As companies seek to   maximize a brand's access, the insurer/payer's own business objectives   may be compromised. If the insurer                       believes it, will he demand retribution, such as in   the form of a reduction or withdrawal of formulary status? 

Another question is   whether retribution is even possible. For example, if the pharmaceutical   provider markets the only product                       that can cure or prevent a fatal disease, the   payers' ability to set controls on patient use of this product is often   limited,                       regardless of price. In this regard, it may not be a   source of animosity among payers, as their core business model is   optimizing                       profits by calculating and incorporating the risk   (cost) of health care delivery (including all pharma products) in their                       premiums. Therefore, if the insurer has   incorporated the costs of the pharma/biotech products in the current   year's premiums,                       the insurer will likely still record a profit.   However, insurer dissatisfaction may still exist as their customers   (i.e.,                       employers, government and individuals) see   increases in premiums and cost sharing and hold insurers responsible for   it. In                       other words, there is a potential reputation hit. 

The quandary for   the insurer can be summarized by the concept of "appropriate   utilization." For the insurer, appropriate utilization                       is the primary goal of his value and service   proposition to the customer. If a pharma company can help the insurer   achieve                       this, it creates the ultimate "win-win" situation   with insurers. It means that, for a specified medical loss ratio, the   insurer                       is maximizing value to patients, meeting or   lowering the health care cost portion of their premiums as well as   keeping premiums                       affordable to customers.

To properly align   the stars for this to happen, there are several things that must occur.   If the product has good access (ideally                       on formulary with no restrictions, and where use of   competitive products is inhibited by some controls), this positions it                       as among the more "cost-effective" options for the   insurer. In this ideal situation, there will be a maximizing of market                       share along with augmented rebates for payers and   lower insurer health costs. Both parties will want to extend and grow   the                       use of this product. However, real life is so   complex that most of big pharma's marketers, medical affairs and sales   departments                       have not been able to implement the level of   "appropriate utilization" most desired by the insurer. A key disconnect   is the                       distrust between insurers and pharma based on the   notion that only a "win-loss" zero-sum game can take place between the   two                       parties, in such a competitive set of   circumstances. 

The healthcare   environment is becoming more complex, with emerging influencers in the   market all attempting to either control                       the way healthcare is practiced or drive   perceptions about products or services. This makes it harder for the   healthcare professional                       to understand who actually has control in deciding   what medicines the patient population is eligible to receive for   reimbursement                       through multiple insurance plans. In response,   companies are adopting a more customer-centric approach, through   'Go-To-Market'                       business models to help address the variability of   influences that healthcare stakeholders have on the prescription   decision-making                       process. 

Even though pharma   firms recognize that their commercial models need to change in line with   the proliferation of outside influences                       on market choices, analytic tools and insights are   only starting to emerge that will enable organizations to keep pace.   These                       early deployments reveal some misalignments in   terms of intentions and the actual outcomes obtained, such as: 

» Differences between the true level of influence of stakeholders and the resources companies allocate to them. 

» A majority of   spend and resources is still focused on providers, with far less   invested to understand the real underlying                       influences on healthcare providers and what factors   determine their ability to treat the eligible patient population for   various                       disease states. 

The obvious   conclusion? Pull through excellence makes it easier to understand the   extent and nature of payer, patient, providers,                       integrated delivery networks, and all other policy   influences at every levels of the decision chain, improving the prospect                       for brand success. 

By identifying   patient benefit designs structures, payer utilization techniques,   patient affordability thresholds, physician                       perceptions of access, and organizational standards   of care for each local market, organizations can start to craft the   most                       relevant messages for use in driving physician   adoption and productivity to capture new patients. Pull Through   Excellence                       begins with: 

» Best in class analytics to understand local markets and local perception of access. 

» Processes that   design optimal messages that can be delivered via push/pull sales and   marketing strategies and tactics to                       maximize brand performance, especially in areas   subject to competitive pressures. This can include focused opportunities   with                       'High-Value' prescriber target lists. 

» Harmonizing resource investment based on trends that drive performance in local markets. 

Key Questions To Shape Your Pull Through Strategy

Our research has identified the following as most important: 

» How is overall brand performance influenced by the decision triad of the payer, patient and practitioner? 

» To what extent is the prescribers' product selection determined at the pharmacy level?

» How does payer benefit design influence patient behavior? 

What benefit design controls do payers leverage to manage brand utilization?

» What are the key brand/switching patterns relative to the brand's competition? 

Is my brand losing or gaining patients? To which competitors?

How does the payer influence brand initiation, conversion and adherence?

» Is the cost of the medication and patients' socioeconomic status impacting the patient's ability to start and stay on the                       medication? 

How does abandonment vary by territory, payer, prescriber and patient demographics?

» What is the influence of generic utilization on my brand? 

Are certain payers, patients or practitioners more likely to start or switch to generics?

» How can tactical   selection, resource allocation and fine tuning of messages be enhanced   by understanding the impact of influencers? 

Here are a few common problems that lend themselves to resolution via a strong Pull through strategy: 

Government and commercial payers continue to exert their influence on brand performance. 

Declining brand performance for those brands not positioned well within a plan.

 Continued loss of resources to promote brands and maximize their performance. 

Brand margins will continue to decline and brand access will continue to become more expensive. 

Brand switching to generics   continues to increase as co-pay differentials impact patient decisions   on brand and generic selection. 

Continued erosion of brand utilization leads to declining brand performance. 

Patients are less compliant and persistent than they have been in the past for many brands. 

This represents lost sales opportunities for brands because of payer controls, patients unwillingness to pay, and the current                       effects of the economy. 

Pharma has difficulty quantifying the degree that plan control impacts brand utilization at all levels of geography. 

Not knowing this information hinders pharma's ability to set appropriate sales targets, and allocate appropriate resources. 

Pharma continues to face budget cuts, staff reductions, and have less resources needed to cross-link siloed data sets 

Missed opportunities created by targeting high-volume versus high value prescribers. 

Pharma has difficulty determining the 'right' pull through message to deliver to the right prescriber. 

Missed opportunity by delivering the wrong message to high-value prescribers leads to less optimal performance. 

Linking together data from different siloed databases can be costly and lead to an incomplete view of the marketplace. 

 Pharma will continue to 'miss-out' on information critical to overcoming the challenges impacting brand performance at a                       national, regional, and local level. 

: Creates ineffective and siloed strategies and tactics among the different pharma stakeholders. 

To assist the proliferating ranks of Managed Market Account Managers, which are now the most important cog in company sales                       channel strategies, we propose a five step approach to developing a Pull through excellence strategy: 

Step 1: Pull through   objectives should be centered around patient acquisition and prescriber   initiation, adoption and productivity,                       with targeted capabilities designed to set the   perception of access. 

Step 2: Pull   through excellence starts with a common definition and alignment across   key stakeholders; one internal owner                       with executive level sponsorship and a permanent   mandate to work toward ongoing success—to the end of the product cycle.

Step3: Pull through excellence requires a comprehensive understanding of capabilities, philosophy, processes, and people. 

Step 4: Build a Pull through Excellence Engagement Model around a process to identify the areas that will benefit the greatest                       from increased attention, as follows: 

» Identify most meaningful areas or brands that could benefit from pull through excellence approach. 

» Scope out a proof of concept engagement model to propose to the business leads. 

» Conduct Analysis and/or engage around proof of concept areas or targets. 

» Roll out a Pull through Execution pilot program around a designated area established through proof of concept. 

» Measure and evaluate the pilot's effectiveness. Discuss modification and or scaling. 

Step 5: Conventional wisdom about managed markets can be misleading in this increasingly complex 

. The key question to ask is: Are we looking at managed care access through the wrong lens, given the preponderance of market                       changes? 

Formulary position   and payer-approved initiatives to influence physician prescribing are   becoming more important in influencing                       and predicting prescription utilization. A   successful pull-through program can benefit both the pharmaceutical   manufacturer                       and health plan payer. By driving physician   prescribing away from more costly and more restricted drugs,   pharmaceutical company-initiated                       Pull through programs can increase market share   while lowering the overall cost of the medication to the payer, employer   and                       ultimately even the patient. 

In conclusion, Pull through excellence strategies allow managed market teams to: 

» Understand how payer controls, patient's willingness to pay, and prescriber receptivity impacts brand performance at all                       levels of geography 

» Evaluate market conditions from the bottom up. 

» Access information to favorably influence the primary drivers for their brands among physicians, payers and patients. 

» Make better decisions on targeting, resource allocation, and promotion. 

» Assess brand potential at a localized level. 

» Measure performance and improve brand success. 

Try it—it's a formula that will work, assuming the proper commitment. 

is Principal at the ConfluenceElite Group, LLC. 

is Senior Principal, Managed Market Services at IMSHeath. 

is President of the Institute of Pharmaceutical Management. They can be reached at 

A patient-centric approach to drug development delivers the benefits that actually create value.

Managed Markets: Positioning Your Product For Success with Pull Through Strategies

The pursuit of excellence in biopharmaceutical innovation in Russia has never had a sponsor—until now. Prix Galien International, a global network of Nobel laureates in medicines, established its 18th country beachhead in Moscow last year, culminating in a historic first: an October 24 awards dinner to recognize the best in new drug research as well as innovation in biotechnology and pharmaceutical products. The competition for the three awards, the logistics of which were organized with Moscow-based publisher of 

, featured nearly 40 candidates submitted by a mix of major Russian research institutions, local Russian drug companies and big Pharma multinationals with an active presence in the country.  

In another first, the event was held under the patronage of the Russian Federation's Ministry of Health. The winners were selected by an independent committee of local clinicians and scientists, most with membership links to the Russian Academy of Sciences, the equivalent to the US National Institutes of Health—as well as research expertise in key therapeutic areas like pulmonology, gastroenterology, obstetrics and endocrinology. No inducements were made and the Committee works on the basis of strict conflict of interest guidelines—a practice unusual for Russia. The Health Ministry also has representation within the group. 

The October 24 dinner attracted nearly 200 guests, and was webcast live through the Russian Internet Society for Internists, an educational and training network for primary care physicians in Russia and other countries in Eastern Europe. An estimated 8,000 members of the network dialed in. "This proved to be a novel and very useful application of social media channels, which in many ways represents the future of health communication in a country as large and demographically diverse as Russia," said Frederic Boucheseiche, General Secretary of Prix Galien Russia and the first Russian member of 

Eight candidates vied for the designation as Best Research in Russia, which was won by a team of three researchers led by Professor Alexander Sobolev of the Institute of Gene Biology at the Russian Academy of Sciences. Their work focused on applying the molecular   principles of   nanotechnology to create a novel drug delivery application known as Modular Nanotransporters [MNT]. These are tiny particles that facilitate the rapid penetration of the cell wall to deliver a drug to its therapeutic target with enhanced safety, solubility and potency, while avoiding side effects. MNTs are especially applicable in treating cancerous tumors, a leading cause of premature death in Russia. 

Nanotechnology in general is a key linchpin of Russia's efforts to build a global presence in new drug delivery platforms that can help realize the promise of personalized medicine. 

The two awards for biotech and pharmaceutical products went to Novartis Russia for its drug 

, a monoclonal antibody to block blood vessel growth in cancerous tumors, and to Eli Lilly for 

, a chemotherapy treatment with a unique mode of action that targets the toughest cancer cells deep inside a tumor.  The country managers for both companies noted that cross-national partnerships  between  researchers,  companies, and clinicians and patients help give these treatments global scale and reach. 

The second Prix Galien awards ceremony will be held in the autumn of 2014. "Recognition has to be institutionalized and sustainable if medicines innovation is to take root in the domestic Russian context," Boucheseiche told 

Column

For the first time, the spotlight shines on Russia's potential in biotechnology and pharma products

Russian Innovation: A Higher Mark

Anyone who's done battle with a bureaucracy knows that the most difficult ear to speak into is the one that's connected to a mouth with the power to say yes or no. Voices in favor of change, no matter how loud and compelling, can easily be drowned in a symphony of established structures, not to mention competing interests and conflicting policies. Advocacy of any sort can be a daunting task, but when the advocate is a patient, and the issue is his life,  then "Silence = Death," as ACT UP said during the AIDS epidemic.  

But the growing patient advocacy movement, in the US and globally, isn't just about getting access to new, potentially life-saving drugs. And the methods for improving patients' quality of life, their interaction with clinicians – and ultimately their health outcomes – aren't limited to picket line protests, underground clinical trials and public figures burnt in effigy. Access remains vitally important, but it's one among many issues kindled by patients who want to live well, in spite of illness. 

Brianna Cayo-Cotter, Change.org’s managing director of communications (Photo: Michael Secton)			

Patients with certain kinds of dementia, for example, can suffer just as badly from a wrong diagnosis as from the lack of access to therapy. Cancer patients need answers to questions specific to their own individual lives that often go unanswered. Policies that make it difficult for otherwise appropriate patients to participate in clinical trials need to be legislated. Patients spread across geographies must bridge time and space to meet in solidarity, and to push their causes past the doorstep and onto the dinner table of the decision-makers, wherever those deciders dine. 

				, an online petition platform, made a name for itself among pharma industry onlookers after a petition for Andrea Sloan, an ovarian cancer patient, sought compassionate use access to BioMarin's PARP inhibitor (BMN-673) currently in development. BioMarin declined to include Sloan in an active clinical trial, which may have been the end of the story. But then things got strange.  

Every time someone signs a petition on Change.org, an email is sent to the petition's designated target: in this case, six executives at BioMarin, including CEO Jean-Jacques Bienaime. Other supporters of Andrea Sloan emailed Bienaime directly. In an accidental "reply all" to one of these emails, Bienaime "was a little too candid in a response that he'd meant for other people on his [internal] team," explains Change.org deputy campaign director Tim Newman, who worked directly on the Andrea Sloan petition. "So we helped to link [Andrea Sloan's advocacy group] to a local news channel."  

It's not a good idea to use insulting language toward a patient dying of cancer, particularly when you're in control of access to a drug that patient believes could save her life. A media firestorm ensued. Andrea Sloan lived in Austin, Texas, and politicians as varied as Newt Gingrich, Howard Dean, Karl Rove, Ted Cruz, John Cornyn and more than 70 Texas state legislators all endorsed the Andrea Sloan campaign. That's in addition to celebrities including Kathy Bates, Jon Lovitz, Mia Farrow, Rosie O'Donnell and Rosie Perez.  

				Change.org campaigners select individual, user-generated petitions based on their potential to succeed and to make a demonstrable impact. Once selected, campaigners help petitioners identify the decision-makers capable of responding. They also coach on the wording of petitions, give pointers – a personal photo helps – and suggest potential media opportunities and social media outreach. "Sometimes we need to tell petitioners how to set up a Twitter account, and how to use social media to increase the chances of success," says Brianna Cayo-Cotter, who helps manage Change.org's campaign team, and serves as the company's managing director of communications. Andrea Sloan, however, didn't need much handholding, according to Cayo-Cotter. Sloan had her own media savvy, full-court press advocacy group called Andi's Army; Change.org just helped extend the reach.  

The BioMarin controversy came to head when Bienaime was questioned directly about Sloan during BioCentury's NewsMakers in the Biotech Industry conference in New York City last September. Change.org simultaneously issued a press release with links to the offending emails sent by Bienaime to Sloan's supporters, as well as supportive comments made by BioMarin shareholders. 

Even though FDA stood ready to approve Sloan's access to BMN-673 through compassionate use, BioMarin still refused, maintaining that it was too early to know whether the therapy would be safe or effective. Critics suggested that BioMarin feared Sloan's public use of the drug would jeopardize the regulatory approval timeline. It seemed Sloan and BioMarin had reached a stalemate.  

But then, as a result of Andi's Army and the Change.org campaign, which garnered over 200,000 thousand signatures and a growing number of celebrity endorsements and media reports, another, anonymous pharmaceutical company stepped in and gave Sloan access to its experimental PARP inhibitor. Sadly, it was too late. Sloan died on New Year's Day. 

The vibe at Change.org's headquarters in San Francisco's Pontrero Hill district is an even commixture of dressed-down mellowness and political urgency. Sunlight blooms through unobstructed windows onto hardwood floors and illuminates the office's white, industrial-style interior. Employees freely congregate around unwalled work centers and flat screens in the main office space. Philz local blend coffee is available in the kitchen, and Kentucky, Cayo-Cotter's dog (rescued roadside on a trip through the Bluegrass State) tirelessly pursues a tennis ball. Cayo-Cotter joined Change.org in 2011, after founder Ben Rattray reorganized the company's focus. 

Rattray, a Stanford graduate, launched Change.org in 2007 with a desire to "use technology on a massive scale to create positive change, not just as a way to share photos or sell coupons," says Cayo-Cotter. In the beginning, Change.org was fundamentally a blogging platform, with a fundraising capability and space for debating ideas. Bloggers on the site could start petitions around things they blogged about, and eventually Rattray decided that petitions should be open to anyone on the site.  

One of the first non-blogger petitions was started by a South African woman, a lesbian, whose close friends had been victims of "corrective rape," a practice whereby gay women are raped by men in an attempt to correct them of their lesbianism. The South African government wasn't addressing the problem, and in one week the petition had racked up nearly 150,000 signatures from people all over the world. Rattray started getting calls from the Justice Ministry in South Africa. Ministry officials agreed to set up a task force to examine the problem, and to consider hate crime legislation. Corrective rape is still prevalent in South Africa, but Rattray's experience with the campaign convinced him that online petitions could serve the public good.  

Others remain skeptical about the actual power of an online petition. Last fall, Change.org introduced a new tool aimed at further demonstrating the impact of its petitions, called Verified Decision Makers. Once a petition is created, Change.org can reach out to the decision maker and let them know about the campaign. The decision-maker is given a dedicated page and instructions on how to respond to the petition. If the decider responds directly to a petition, those comments show up on the petition page, to be shared and critiqued by other online commentators.  

"It's really interesting to see which decision makers respond, and how they respond," says Cayo-Cotter. "So far the most responsive entities have been local government officials, followed by companies, and third is the federal government in the US, which is kind of a telling state of affairs." There has been some federal participation. Rep. Paul Ryan (R-WI) and Sen. Elizabeth Warren (D-MA) are both Verified Decision Makers.  

Cayo-Cotter says pharmaceutical company decision makers "would be fantastic to have on the site...there are so many petitions around health issues." Over 10,000 health-related Change.org petitions were signed by over 18 million people, at press time. Change.org hasn't begun pitching the Verified Decision Makers tool to pharmaceutical executives yet, but "if anyone reading your article wants to sign up, we'll get them verified," says Cayo-Cotter.  

Pharma isn't known for its consumer-facing digital prowess, but companies "trying to brand themselves and show their investors and their customers that they're different, and willing to engage with patients in an interesting way...I think there's a real advantage in that," says Cayo-Cotter. Pharma is "already creating responses to policies and proposals around things that are getting raised in petitions. They're just being left out of the conversation. This is an opportunity to directly communicate with the people that care the most about a particular issue." 

				Change.org petitions can be about anything, from asking an insurance plan to cover the costs of a child's chochlear implant, to the global eradication of cancer, and everything in between – the aspirations and feasibility of the asks vary dramatically. More than one petition asks for a ban on pharma DTC advertising in the US. Any cause that can be squeezed into the format of a petition is acceptable, not just health issues, but one successful petition often begets another, sometimes exponentially.  

The number of Change.org petitions seeking compassionate use grew significantly last year. "We call it wildfire," says Cayo-Cotter. "When one person starts a petition for access to a drug, you'll start to see dozens and dozens of petitions...that ends up creating a space for there to be a real policy change, or an industry shift around an issue." Canada and the EU also have expanded access programs allowing some patients to receive experimental therapies. 

In Canada, Khizar Hayat petitioned Amgen last year on behalf of his nine-year-old son, an acute lymphoblastic leukemia patient. Hayat asked Amgen for access to blinatumomab, a phase II drug. Amgen declined, but Pfizer stepped in with inotuzumab ozogamicin, an experimental antibody-drug conjugate. In late October, Hayat wrote a "victory note" on his petition page thanking supporters and noting that his son had begun treatment. That petition only had 1,581 signatures. In his note, Hayak credited the "well-wishers and the persistent efforts of the physician who is treating my son to persuade the pharmaceutical companies [to] release the drugs on compassionate grounds." It's unclear whether the petition played a role in bringing Pfizer on board. But why not try everything?  

The important thing, for Hayat, is that his son got access to treatment. Change.org may not have been wholly or even partially responsible for that decision, but the company is pushing the issue of compassionate use back into the public eye, which could help to reignite the discussion about whether it's ethical to give patients a drug that might do them harm. The first large compassionate use program instituted by FDA was to grant AIDS patients access to AZT in 1986, on the basis of phase II data. Dying patients and politicians with a libertarian streak agree that drastic times call for drastic measures, particularly when everything else has failed. Who better than the patient himself to make that determination? But many physicians remain uncomfortable prescribing an unapproved, untested drug, even as a last resort. If the patient dies as a result, does that go against the medical vow of nonmaleficence? If a patient's odds of survival are just as similar with an experimental drug as without, what is the proper prescription? 

The largest compassionate use petition in 2013 was started by Amy Auden, wife of Nick Auden, a stage four melanoma patient. The petition, asking for access to PD-1 drug candidates from either Merck (lambrolizumab) or Bristol-Meyers Squibb (nivolumab) garnered over half a million signatures. Both companies declined, and Nick Auden, a father of three, died in November. In a note to petition signers, Amy Auden expressed "deep gratitude for those who fought with us," adding that "Nick's death beams a spotlight on a glaring need for change in compassionate access practices for life-saving drugs in late-stage investigational trials."  

				Change.org chalked up a number of victories in the healthcare space last year, and more than one insurance carrier changed its coverage policy as a result of the petitions. In Georgia, for example, Coventry Health Care changed its statewide policy to include the coverage of cochlear implants after a petition on behalf of five-year-old Carson Rubin was signed 111,825 times. In North Carolina, BlueCross BlueShield (BCBS) agreed to cover 14-year-old Morgan Gleason's life-saving intravenous immunoglobin treatment. In the victory note, Morgan's mother Amy Gleason said BCBS had pre-approved future treatments, and erased a $240,000 medical bill. 

Before Andrea Sloan died, she appeared in videos to discuss her situation, and submitted to numerous interviews. In the comment sections on industry outlets, including Ed Silverman's currently defunct Pharmalot blog, onlookers wondered why Sloan, an attractive white woman, felt that she deserved a compassionate use exception while many other patients had been turned away from clinical trials and denied access to therapy. "Anybody can use Change.org," responds Cayo-Cotter. "It's a smart thing to do if you're being denied access to drugs or medical care...it can really raise a patient's profile in a way that was impossible even three years ago."  

As to the Hippocratic question, Cayo-Cotter notes that both Sloan and Auden "didn't get access to the drug that they wanted, and they both ended up dying, so would [access] have been riskier than no access? It seems like a moot question." Before campaigning on behalf of a patient seeking compassionate use, Change.org first verifies that it's what the actual patient wants (many petitions are started by friends or family), and that a medical professional has been consulted.  

Cayo-Cotter says she hopes to engage further with organized patient advocacy groups to promote policy changes that extend beyond individuals to large groups of patients. She applauds David France's stirring documentary – How to Survive a Plague – which chronicles the AIDS epidemic and the role of HIV activist groups Act Up and TAG, and the lives they saved by pushing regulators and pharmaceutical companies to act. "I just remember watching that piece of the history of compassionate use activism and thinking, 'Wow, Change.org is becoming a digital platform where that's happening today.' And I was moved by that comparison."  

Online petitions can travel far and wide in an instant, but sometimes its takes an old fashioned trip to Washington DC, and the courage to speak up, to make a change. Not surprisingly, it was the internet that first brought Camila Strassle, currently a freshman at Stanford University, to the Cystic Fibrosis Foundation (CFF).  

"I have a brother with cystic fibrosis, so my mom and I were looking online for ways that we could get involved," says Strassle. "The CFF had a link for advocacy and through that I found out about a teen program for siblings with cystic fibrosis to actually go to Washington DC and advocate on their behalf." The reason cystic fibrosis patients can't get together to lobby on their own behalf, notes Strassle, is because they can't be in the same room together, due to the risk of cross-infection. 

For the past four years, Strassle has gone to Washington to participate in the CFF's Teen Advocacy Day; she has met with more than two-dozen members of Congress. In 2010, she helped turn a bill – the Improving Access to Clinical Trials Act, or IACT – into law. "It was a bipartisan bill that was passed and signed into law by President Obama," says Strassle. IACT address a problem with clinical trial participation. Before its passage, people who received Supplemental Security Income weren't allowed to accept research compensation, because it rendered them ineligible for public medical benefits. "With rare diseases, it's a small population, so it's hard enough already to find people to participate in trials," says Strassle. "It was slowing everything down." 

With a host of new therapies for cystic fibrosis entering or nearing the market, Strassle says one of the main initiatives currently at the CFF is promoting access to specialized 'care centers,' a network of CFF accredited centers built on a model that recognizes the unique needs of cystic fibrosis patients. "For example, specialists working in the care centers look at the pancreas, at nutrition, at all of these separate issues that effect patients with cystic fibrosis," says Strassle. "As a result, life expectancy for patients has increased over time, and the NIH has come out in support of this model."  

According to the CFF website, over 110 care centers are accredited nationwide, with more than 260 clinics where children and adults with cystic fibrosis can get care. The centers also participate in clinical research, and data from the centers is collected in the CFF's patient registry. Aside from the care centers, the CFF runs a nonprofit drug development affiliate called Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT). The CFFT partners with pharmaceutical companies and receives royalties from drug sales developed using CFFT funding, and most cystic fibrosis drugs have leveraged the basic research and clinical trial network operated by the CFF, according to the website.  

Strassle continues to advocate with the CFF on her brother's behalf, and worked as an intern with the CFF's public policy department last summer. As a freshman, Strassle is completing her general requirements, but is planning to double major in English and health policy. She'll be looking out for the health policy track next year. "I'm really looking forward to taking those classes," she says. 

In some ways, patients diagnosed with a well-understood and established disease, even a serious one, can consider themselves lucky. At least they know what they're up against, and can bring the right weapons to the fight. Imagine if something began to go wrong, but no one could tell you with any certainty what was happening. Years go by, along with the possibility of treating the disease before it gets worse. 

Susan Grant was a top financial advisor at American Express, overseeing millions of client dollars, when something happened to her brain. "I knew something was different, but I didn't know what it was," says Grant. "Of course, American Express didn't want me to tell my clients anything [about my condition], but when I sat down at a table with 100 clients to transition them to a new advisor, and I tried to tell them the doctors don't know what I have, they wouldn't accept it. They wouldn't let me dodge the question, so I just started saying, 'Something's different in my brain.'" 

Several years and six wrong diagnoses later, Grant, at 53, was diagnosed with frontotemporal dementia (FTD), a CNS disease that can strike in adults as young as 40 years old. Up to 50 percent of the dementia cases occurring before age 65 are thought to be a result of FTD, according to the Alzheimer's Association. Grant has fought her way into clinical trials, and fought back against physicians who've attempted to downplay her symptoms, or take a "wait and see" approach to medical intervention. Many physicians believe that patients with FTD, and even Alzheimer's, aren't capable of "insight," meaning they can't recognize changes to their mental state. That is true for some patients, says Grant, but in her case and in many others, patients do recognize that something has changed, even if they don't yet have a name for it. 

Because patients with FTD can face a rapid deterioration of executive function, it's critical to get the right diagnosis as early as possible. That means using the right terminology in the doctor's office, and getting a referral for a neurologist that specializes in neurodegenerative diseases. An early diagnosis helps patients better manage the disease, and seek treatment, if not yet for the root cause of the disease, than at least for the debilitating side effects. Also, a definitive diagnosis early on gives patients time to get their finances in order, and to take advantage of disability benefits, as Grant did. 

In 2007, Grant founded Planning for Hope, a grass-roots organization geared toward empowering patients with FTD. She has authored an instructive eBook for FTD sufferers, and raised $150,000 to create an hour-long documentary to promote awareness of the disease, and to change the conversation about patients and the stigmas that come with a diagnosis. The film, also called Planning for Hope, has been shown on a number of PBS affiliates, and can be watched online at 

Although there is no cure for FTD, Grant speaks highly of cognitive improvement software and the use of puzzles and word games. She still bristles at the language NIH and other organizations use to describe FTD patients. They're described in the medical literature as having "no morals" or "misbehaving in public," says Grant. "Why would anyone come forward if this is the language that's being used?"  

Even though a concrete diagnosis provides an answer to the question of what is wrong, it oftentimes leads to a host of new questions. The mission of Cancer101, a nonprofit organization based in New York City, is to empower, inform and engage cancer patients and their caregivers by helping them partner with healthcare providers to make informed, collaborative decisions. 

Advocacy organizations and individual patients are getting more involved in every facet of the healthcare system, from drug R&D, to federal and state policy all fueled by the hour-to-hour passion of living with a disease.

The Active Patient: Faces Of Change

	It's no secret the pharmaceutical industry lags way behind other sectors when it comes to leveraging social media to meet business objectives. A big reason for this has long been a lack of clear guidelines from FDA.

	This month FDA released its draft guidance on the use of "Interactive Promotional Media,"1 ending several years of speculation and finally providing the industry with substantial guidance on its use of digital media. Though this draft guidance document is currently being distributed for comment only, for the first time it sets out a clear position on tools and technologies that allow for real-time communications and interactions, which includes social media.

	In the new guidelines, FDA explains that pharma firms should identify the parts of websites that are interactive and allow for real-time communications, in addition to describing its communications within these third-party sites. On a monthly basis, marketers will also need to submit a Form FDA 2253 or Form FDA 2301 for websites that include interactive or real-time communications. To facilitate the submission process, FDA will allow multiple sites and the corresponding documents within a single form -a stark departure from its policies governing static promotional pieces.

	FDA will be accepting comments and suggestions on these draft guidelines for the next 90 days. As of July 9, FDA is mandated to release final guidance "regarding Internet promotion, including social media, of medical products regulated by FDA" as per the Food and Drug Administration Safety and Innovation Act (FDASIA) that was signed into law in 2012. This means that, as of this summer, pharma will finally have a clear and official set of guidelines from FDA regarding the medium.

Many observers feel this recent news will mean the proverbial tipping point has been reached, and pharma will finally take the plunge in social media. If so it will certainly be about time, as social media has become pervasive in our lives and, let's face it, pharma is coming more than fashionably late to this party.

	According to a recent Pew Internet study, as of September of last year, 73% of online adults use social networking sites. As of 2012, close to three-quarters of Fortune 500 companies were active on Twitter, with more than 80% of executives at these firms believing social media engagement actually led to increased sales. Across industries, an astounding 93% of marketers report they use social media for business.

	Despite years of exposure and ample case studies of success from other sectors, however, most pharma companies don't currently have much of a social media strategy and the vast majority enjoys a rudimentary presence at best. To drive home this fact, in a recent survey more than 90% of 88 executives representing big Pharma firms said "no" when asked: Does your company engage potential or current customers via social media?

	By and large, pharma companies have been extremely conservative in their approach to social media. In addition to a lack of clear FDA guidelines, many firms have kept the medium at arm's length due to compliance concerns related to Adverse Event reporting and potential off-label discussion between reps and patients taking place in a public forum.

	On the face of it, pharma is not alone in being heavily regulated. Indeed, any industry that faces regulation of its communications must ensure that its use of social media is compliant.

	In pharma there has long been an underlying and troubling belief that the absence of social media activity voids potential responsibility for user-generated content relating to adverse events. This has resulted in the industry taking a "see no evil, hear no evil" approach to social media monitoring in which it essentially ducks its head in the sand. Recent trends suggest, however, that this attitude may soon be nearing its sell-by date.

	Relative to the US, in the EU pharma companies, in collaboration with regulators, are making greater efforts to leverage social media to monitor adverse events. More specifically, the Innovative Medicines Initiative (IMI) has been created in the aim to build electronic reporting platforms and mobile apps to enable patient reporting of adverse events to regulatory authorities themselves.

	When reviewed in its entirety, it's not difficult to conclude that compliance issues alone fail to explain fully pharma's disdain for the medium. If nothing else, a significant reason for the industry's hands-off approach most likely stems from pervasive skepticism of the channel's overall benefit for an industry that generally does not usually have direct relationships with its end-customers.

	Pharma must accept the fact the relationship it enjoys with its customers doesn't take place in a vacuum. Its customers bring a high level of service expectations based on these other non-pharma interactions. And let's face it, consumers are talking about pharma companies whether they are using social media or not. And believe it or not, pharma's customers actually want pharma to play a bigger role in social media-sphere. As proof, Manhattan Research recently reported that 42% of online consumers think pharma companies should be involved in online health communities.

	Now that social media guidelines are falling into place, in coming months we can probably expect to see a growing shift in mentality across the industry as firms recalibrate their marketing strategy to include a social component. Due to heavy regulations and ever-present compliance concerns, of course, jumping on the social media bandwagon will still require a measured and deliberate approach. But it will require an approach nevertheless.

	Because promotional messaging is highly regulated by FDA, social media engagement will require a scripted and automated response from pharma to ensure communication is compliant, supported by human interaction to deal with events that fall outside of the system's parameters. For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites and set up automated systems that can route potential adverse event to proper channels with a high degree of accuracy.

	In other industries, a high proportion of all social media engagements are already automated. Some companies have even reported automating up to 80% of their social media interactions - and there is no reason why this cannot be replicated in pharma, making it possible for the industry to communicate with patients in a manner that is 100% compliant. Now, of course, 80% as a benchmark may seem arbitrarily high, but in a heavily regulated and compliance-driven industry like pharma, it may be exactly what the doctor ordered.

	Regarding the creation and approval of content, as a general trend both FDA and pharma companies are slowly becoming accustomed to the approval and use of digital media, with a movement toward modularization of content align and business rules. Social media will require a similar approach.

	Pharma companies now need to rethink how content is produced, submitted, disseminated, stored and archived. This will require building new processes for brand marketers, creative agencies, technology vendors and others stakeholders that make up the content ecosystem. At the same time, given the present dearth of social media experience in the industry, some fresh talent from outside will undoubtedly need to be added to the mix to help the industry get up to speed quickly.

	1. FDA, Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, January 2014.

is a Managing Consultant; he can be reached at 

is a Vice President, all at Capgemini Consulting Life Sciences.

Feature

For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites.

Social Media: Have We Reached The Tipping Point?

With a freshly minted brand identity bound tightly to its formidable Japanese parent, Millennium: The Takeda Oncology Company is shedding its reputation as a "one drug wonder." That drug, 

 [bortezomib] is the first FDA-approved proteasome inhibitor and the first approved 21st century treatment for multiple myeloma; with its multiple expanded indications, the blockbuster has, for many patients, turned what was once seen as a death sentence on diagnosis into something resembling a chronic disease. There are a few more spins on the cycle to come from Velcade, and Millennium now has its second marketed product, 

, for relapsed Hodgkin lymphoma. The capstone is what looks like a new drug pipeline of steady, solid performers, all centered on oncologic applications, and with roughly half of the candidates now being tested at an advanced Phase III level. A globalized organizational model, the positive R&D buzz, the scale and deeper pockets afforded by the combination with Takeda – all this suggests Millennium may finally be moving up the ranks in the cancer league play. It's a view expressed with sunny, Greek-style confidence by Millennium's new President, Anna Protopapas, in an interview last month with 

 Millennium Takeda's singular focus on oncology avoids the frequent strategic R&D repositioning that characterizes the more diversified big Pharma players. But there are risks, too, in depending on what is now seen as a crowded, highly competitive sector, where the science is challenging and pricing pressures are intense. How does Millennium maintain its therapeutic advantage in this environment? Is the overriding commitment to oncology products a hard fact for investors going forward? 

 Contributing to the fight against cancer has always been Millennium's mark of distinction. This was reaffirmed and accentuated by our merger with Takeda in 2008, where we now serve as the company's global "center of excellence" in oncology research, product development and commercialization. This commitment remains firm. In fact, we do not believe that oncology products bind us too narrowly in serving patients. Cancer is a complex condition; it affects patients in different ways. It is now accepted that cancer is a highly heterogeneous collection of diseases. Understanding these at the genetic and molecular level helps us discover new medicines.  

 Oncology is not only at the frontier of science, it is the focal point for change in the practice of medicine as well as in the way new therapies are promoted to the provider and payer communities. The business model for oncology specialists is under significant financial pressure, while proactive patient education has become essential to a successful launch strategy. What is Millennium Takeda doing to address these structural transformations in the marketplace? 

 Our response to transition in the marketplace is very simple. It is to generate the right data and evidence to support our products' value proposition to clinicians, payers and patients. The starting point is the clinical trial, which we design and position not as an end in itself but as part of a research continuum that will extend well into the Phase IV post-marketing work that oncology stakeholders are coming to regard as even more important than the data submitted to secure initial FDA authorization. In fact, the differentiating factor in success is how well this evidence relates to the real-world clinical setting after registration. We build a strong data trail designed to support additional indications, to guide physicians in deciding among choice of therapy, to demonstrate compliance with relevant treatment protocols, to establish cost-effectiveness against the current standard of care, and to set proper expectations for the patient in terms of outcomes. Our data is increasingly targeted to this latter objective, because, as more cancer therapies are introduced, the patient experience is now the dominant thread driving treatment eligibility decisions.  

With greater choice, we face an equally important obligation to help patients and their provider decide what is best for their condition. This is precisely what we did with 

 where strong trial data put us in the fortunate position as the only approved FDA treatment for myeloma with a demonstrated survival benefit in its label. We were able to leverage this evidence very quickly to ensure physicians took it into account in prescribing decisions.  

Another example is the truly compelling evidence compiled on 

 the treatment recently approved for patients with relapsed-refactory Hodgkin lymphoma. This cancer strikes young adults disproportionately and the drug is indicated for those who have exhausted other drug options – so the stakes for the eligible patient are very high. Trial data we presented with our partner, Seattle Genetics, at the December 2013 American Society of Hematology conference, yielded a median survival curve of 40.5 months – more than three years – for trial patients, most of whom, based on historical controls, typically would not be expected to do very well.  

In our view, the strength of this data leads immediately to a conversation about value – no convincing is needed. We want products that advance the discussion beyond incremental benefit; our ultimate aim is to produce a cure. I think that attitude filters back to positively influence our relationship with providers and – obviously – patients. 

Can you quantify whether good evidence increases access, particularly as the price point for new cancer treatments leads to payer "sticker shock?" 

 Access in oncology today is a complex proposition. Though it is critical, evidence alone will not move market share. There is an additional premium required in interpreting and explaining the evidence. Millennium has put significant resources into recasting our sales force to make it an informative source of case-relevant information and expertise; physicians see our reps because they need to or want to, not because they happen to have a free moment. As the accompanying table shows, every year since the launch of Velcade in 2003 we have had important new data to share around the drug's indications and clinical performance. We see this as an educational investment in market uptake. What good is a great medicine if the community lacks any awareness of its merits?  

And we have metrics to prove a return on that investment. Independent third party surveys put our reps at the top of the league in obtaining access to practicing prescribers; that access is secured through the informative, accessible data we generate around our products. Millennium actually scores better in building relationships with cancer specialists than rival pharma players with more medicines to sell and a bigger name recognition in oncology.  

 Who is behind the trend toward raising the bar on data and evidence as a condition for approval – and reimbursement – of oncology medicines? Is government driving the process or is your main concern what is happening on the private payer side? 

 The pressure to quantify value is coming from multiple fronts. Private and non-profit insurers, PBMs and managed care providers are no longer complacent, third party participants in a system where costs are simply passed on to others. Patients are bearing more of the direct cost of care, so they too expect an explicit connection between investment and outcome. As for government, its influence around the value debate is variable; in Europe, public authorities play a dominant role as the basic underwriter of health care services, while here in the US it is still an evolving player in a mixed public-private system. But we are clearly heading in the European direction.  

Millennium is prepared to work closely with any regulator or government that seeks to better understand the ways our medicines create value for the health system. This commitment extends to cooperation at the very earliest stages of the drug approval process, where we deliberately seek out the FDA and EMA, as well other agencies, for advice in the design of our trials. The biology around cancer is novel and unprecedented, so quite often our scientists are designing protocols that have not been done before. It's a matter of self-interest to do so, but nonetheless we are finding these interactions are very collaborative and constructive. The contacts were instrumental in obtaining, in October 2012, European registration and subsequently local reimbursement for 

as indicated for one type of Hodgkin's lymphoma and refractory/relapsed anaplastic large-cell lymphoma [ALCL]. It's another example where our investment in generating the right kinds of evidence really pays off.  

What professional attributes do you look for in recruiting sales staff? Does science trump marketing? 

 Experience in the oncology area is what distinguishes our sales team. A very high percentage of them have been with the company since the launch of 

10 years ago. We want to avoid a culture that looks at selling as something driven by quarterly results, where sales staff come and go too quickly to develop roots with the customer. In oncology, a strong ongoing relationship with physicians is a competitive differentiator. Consistency in these relationships is the best way to deploy our human capital. We want to retain people whose careers develop in tandem with our products.  

Millennium Takeda's new president, Anna Protopapas, explains the life choices that brought her from Cyprus to Cambridge-and a lead position in the hotly contested search to make cancer a treatable disease.

Pharmaceutical Executive-02-01-2014

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