Elisabeth Pena Villarroel
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Choosing a brand name is the most defining moment in a pharmaceutical product’s life. Name That Brand September 2006 Apharmaceutical product’s brand name is more than a series of letters that identify a chemical compound or biological agent used to treat a specific condition. The brand name evokes a feeling, in some cases hope and in others a promise of relief or improved health. Arriving at this one word that stands for so much is not an easy task. Pharmaceutical marketers work long and hard to come up with the perfect name that conveys their drug’s message and purpose. Even then there’s no guarantee it will go to market with the name selected since the name has to be approved by the Food and Drug Administration (FDA) and other global regulatory agencies. Choosing a Name The branding process usually begins in Phase II of clinical development, although some companies start even earlier. And according to Anthony Johndrow, managing director of Straightline, companies can’t start too early to begin to think about branding. “Seldom do branding experts get involved early enough in the drug-development process,” he says. “Until people start thinking about what it is going to take to create awareness and differentiation for a potential new therapy, the project is just a code name or number. Companies lose out on the potential benefits that could be derived from the physicians involved in the trial, who can become advocates for the product brand down the road. It is extremely important to create a memorable association with a brand at this point; a brand name can anchor the experience.” Creating a brand name usually falls under the purview of the marketing team, but, the clinical team can play an important part in the naming process, as these are the individuals who are most intimate with the unique qualities and specificities of the compound. “Clinical team members can and should be successfully tapped by branding companies and marketers,” says Kris Larsen, managing director, U.S., at Interbrand Wood Healthcare. “Individuals in the clinical track can provide the vocabulary related to the unique methods of action or chemical principles of the product, which then can be creatively leveraged into powerful, differentiating messages.” At Otsuka America Pharmaceutical Inc., Terry Prime, VP of marketing, says the clinical team is involved at the earliest stage of branding during the name-generation process. “The branding process usually begins about three years before the expected product launch,” she says. “Our primary goal is to develop a brand that is distinctive and memorable, and during this process some great ideas come from clinical. As we progress through the legal reviews and vet the name country by country, brand names tend to drop out. It’s important to start with a lengthy list of distinctive names.” Most companies begin branding work at some point just before or during Phase II, however, the challenge with developing a name at this stage is the potential loss of any brand equity as well as the expense of rebranding if the preferred brand name isn’t approved by the FDA. “Companies need to try to identify brand name options that are distinct from other currently marketed products to help minimize the potential for mix-ups and medical dispensing errors,” says David Stern, executive VP of metabolic endocrinology at Serono. “But it is a roll of the dice because we don’t know what other similar sounding names may be approved in the timeframe between the start of our Phase III trials and when we go to the FDA for review.” According to Schering-Plough’s Executive Director of Global Advertising and Marketing, Don Lowy, once the company embarks on branding the compound, the name creation process begins with brainstorming and help from outside experts. “Outside consultants are very helpful in this process,” he says. “They have an expertise in finding the right names. They also help us with the first round of trademark searches to make sure we are not setting our sights on a name that already has an existing trademark.” Vince Parry, president of branding consultancy Y Brand, advises that it is important first to develop a branding strategy to guide name development, rather than choose a name that might end up not advancing — or worse — interfering with the eventual chosen strategy. “A best practice is to first understand the idea that the brand will own,” he says. “Companies need to ask three different questions. First, what are the functional aspects of the brand? Then, what are the practical problems that the brand is able to solve? Finally, what are the hopes that the brand is going to engender, or what are the fears that it is going to take away?” Creating a branding strategy from the answers to those three questions and testing a range of potential names in the functional, practical, and emotional areas, Mr. Parry says, elicits brand names that register and relate to customers in a way that reinforces the central idea about the brand that will be reflected in promotion, education, and advertising. In addition to working with branding agencies, Ms. Prime’s group also employs a couple of approaches to name generation. “One is to identify potential brand characters early, based on our clinical protocol; four or five potential brand characters really help the creative process, and we start to generate potential options from that point,” she says. “A second approach is to get the company involved. We’ve given employees the opportunity to submit names. We recognize those contributions that make it through the first round of legal searches. This has been very helpful and gives the organization ownership in the process.” According to Mr. Parry, in the initial phase of brand naming between 200 and 400 names should be developed to pass through the various screening processes. “For every 100 names developed, one viable name emerges,” he says. “So to provide two to four options for submission to regulatory bodies around the world, a company should begin with a list of 200 to 400 to ensure that a viable set of options survive. Smart companies always have backup names; a company should have a minimum of two names. It becomes very expensive to research the trademarks of these names, so there is balance between investing in viable choices and owning three or four names at the time of submission.” Adam Woodrow, assistant VP and global brand manager for Wyeth Pharmaceuticals, describes the research behind creating a list of brand names as a comprehensive focus on two distinct goals: meeting the FDA and EMEA requirements on name suitability and creating a name that is memorable and sounds and feels correct for the type of drug that is being developed. (See related box on this page.) In addition to internal brainstorming and working with branding companies and agencies, Wyeth marketing executives do extensive market research, which is conducted with various audiences, which include pharmacists and physicians and possibly the target audience for the product. “If we were to brand a specialized drug, for instance one for hemophilia, we would focus on input from hospital and community pharmacists because they dispense the product, as well as hemophilia center directors,” Mr. Woodrow says. “To evaluate if the brand name sounds right and feels right, we would work with consumers through some of the patient groups.” Making it Official Once sponsors have crafted the brand names that best represent their products, the names must be approved for use. Pharmaceutical manufacturers may submit proposed proprietary names to the FDA at any point during drug development prior to or with the submission of a marketing application. The FDA’s brand-name review focuses on two primary areas: safety and promotion. The safety review is conducted primarily by the Division of Medication Errors and Technical Support (DMETS) and the promotional review is conducted by the Division of Drug Marketing, Advertising, and Communication (DDMAC). The DMETS’ review is multifaceted. Proposed proprietary names are subject to a multidisciplinary expert panel review; handwriting and verbal analyses; a computer-assisted phonographic and orthographic assessment; a labeling and packaging analysis; and an overall risk evaluation. With a rejection rate of about 35%, sponsors need to be prepared with back-up brand names (see box on page 32). According to the FDA, rejection can be avoided if sponsors are aware of, and seek to avoid, the problems that have occurred with certain naming conventions in the past. According to one regulatory authority, the FDA typically recommends against the use of brand names that are likely to be confused with other established names; contain error-prone elements, such as confusing modifiers; or suggest a false or misleading claim. The agency also recommends that sponsors test proposed brand names with practicing healthcare professionals and consumers before FDA submission. According to Jerry Phillips, R.Ph., president of Drug Safety Institute, and the former director of the Division of Medication Errors and Technical Support at the FDA, who has extensive experience with the agency’s patient-safety initiatives, the FDA’s review of brand names is one of the most aggressive among the worldwide authorities. “The FDA has a multifaceted review process that is quite extensive; the agency does its own prescription simulation studies,” he says. “The agency places the proposed proprietary brand name into simulated prescription studies using outpatient and inpatient prescriptions and writes those orders and records them verbally. A group of volunteers at the FDA, comprised of pharmacists, physicians, and nurses, interprets those prescriptions. The FDA is the only regulatory body that does that type of internal safety testing. The agency also has a sophisticated computer tool that it uses to evaluate sound-alike and look-alike characteristics of the name, and then it does a safety analysis of those names.” In addition to choosing a memorable name that is safe and not misleading, companies can benefit from providing the results of their research to the FDA with their name submission. “Submitting data in support of the name is a best practice recommendation of our company, because it shows the FDA that the manufacturer has done its due diligence in making sure that the name can be safely used,” Mr. Phillips says. “In addition, the research data that are supplied to the FDA often are more persuasive than its own data and this will help support the potential names from a safety perspective. In the end, submitting the data in a proactive manner will help get the name approved.” Preventing confusion in the marketplace is one of the primary goals of the FDA’s review of brand names, and in the case of Serono’s recombinant growth hormone [somatropin (rDNA origin) for injection], the regulatory agency allowed the company three brand identities based on the drug’s three distinct indications and patient populations. Within Serono’s metabolic group, somatropin (rDNA origin) for injection was approved for three distinct indications in three different markets: adult and pediatric growth hormone deficiency, branded as Saizen; HIV-associated wasting, branded as Serostim; and short bowel syndrome, branded as Zorbtive. “We worked very collaboratively with the FDA, because we wanted to have specific brand names for each different indication,” Mr. Stern says. “We were in close discussions with the FDA to have separate brands because the dosing and presentations of the product are different in each indication, even though they are all somatropin. We didn’t want there to be confusion in the marketplace, which is why the FDA agreed to allow three specific brands based on three individual markets.” The name of the brand isn’t all the regulators will scrutinize during the process. According to V. Brewster Jones, chairman and CEO of Lathian, the logo design also is examined to make sure that it doesn’t imply efficacy, safety, or mechanism of action. “Regulators may view the logo as an advertisement, which may require appropriate balance every time the logo is used, which can limit marketing communications and certainly drive up cost,” he says. “The regulatory environment is a challenge in terms of creativity. The FDA is trying to avoid any confusion with the branding, which would lead to inappropriate prescribing. The agency’s role is direct with regard to examining names and indirect in terms of the grey areas, such as what companies can do with branding, what that brand implies, and its positioning.” Going Global In addition to having the brand name pass muster with regulators at the FDA, marketers need to be aware of how a brand name will be received in the global market. “In my experience, regulators play a significant role, but there are other factors that are equally challenging with global branding,” Mr. Lowy says. “We operate, to borrow from author Tom Friedman’s concept, in a flat world where we seek to build global brand equities. Beyond finding a distinctive name that has a low risk of confusion with existing brands, we seek to find brand names that are approvable in as many global countries as possible. That’s always a challenge.” Ms. Prime says while the FDA plays a significant role in the selection of a name submitted for approval as part of the new drug application, potential brand names are developed with a global strategy in mind from the beginning. “Since Otsuka generally develops global brand names, market research is conducted with physicians and pharmacists in several countries to ensure there is no confusion with existing brands,” she says. Almost all of the experts interviewed for this article cited the infamous branding blunder of the Chevy Nova, which flopped in Latin American markets because the translation of Nova in Spanish is “no go.” This example highlights the importance of making sure a brand name works in different countries and languages. “Medical conferences in the United States and in Europe attract physicians from around the world, and in these instances it is much stronger to have a brand name that is global, that way there are unified messages around the world imparting symmetry and understanding,” Mr. Stern says. “Ideally, Serono prefers to have global brand names because we sell our products in more than 90 countries, and with the world getting smaller it is very important to have global brand names.” Mr. Woodrow describes the quest for a single, global brand name as the largest challenge in the branding process, especially because of the explosion of pharmaceutical brands launched during the past decade. “It is very difficult to get a single global trade name today because there are so many companies that trademarked names, some of which are in use, some that are not,” he says. “To find a relatively short and snappy trade name today is quite difficult because of the sheer volume of drugs launched over the past few years.” Mr. Woodrow provides Wyeth’s IV antibiotic Tygacil as an example of a global brand that has done exceptionally well; the product has been approved in 38 countries, with 11 additional approvals expected this year, all under one single brand name, Tygacil. “One of the reasons this brand has been so successful is because we tested proposed name candidates in our global local markets from medical, commercial, and legal perspectives,” he says. “We have linguists who first evaluate the names. Then before making the big corporate decision to put down a trade name, we always ensure that every market where we intend on launching the drug has an opportunity to review the name options and come back with any comments.” In the case of Tygacil, Mr. Woodrow’s team narrowed the list of names to about 50 candidates. Once that list was developed it was sent to 42 different countries representing 42 different languages within the global organization to test for any translation issues, negative connotations, and how the names sounded in the local languages. This process eliminated a number of names. The next step for Wyeth was to conduct market research on how memorable the remaining names were. “We had three or four very good candidates, and Tygacil is the one that best fit the profile of the IV injectable antibiotic product,” he says. “The brand name had very good memorability scores and came through 100% clean in the research. It was never confused from a prescriber or dispenser perspective, which satisfied the FDA.” Mr. Woodrow stresses that after safety is taken into account, marketers cannot overlook the emotive elements of naming a global brand. “When we do research we are looking for a name that looks and feels right for the type of product we are trying to launch; it is an emotional concept,” he says. “Tygacil sounds like an IV injectable antibiotic to me and it sounds that way to infectious disease consultants. For example, the -cil reminds people of other antibiotics.” The Brand: More Important Than Ever Despite the current marketing trend toward unbranded and disease-awareness advertising, the brand is more important than ever, experts agree. “The brand identity must be present in any disease-awareness initiative, if not in name, then at the very least in feel,” Mr. Parry says. “Branding is not just about how things look; it is about the experience as a whole, how the brand makes people feel. So any disease-awareness initiative should be based on the branding strategy and relate in some way to the product that is underwriting the disease-awareness issue.” “Branding is more than just a trade name, it is everything that is used to promote around that trade name, such as the colors and logos used,” Mr. Woodrow says. “Even in the areas of disease-awareness promotion and nonbranded advertising, brand names are more and more important, because ultimately the last thing a patient sees and uses is a drug with a name. And word of mouth is as important as anything else, so having the appropriate trade name for a particular product is still important today for building customer loyalty.” Disease-awareness advertisements and other patient-centric communications form a category of promotion that can be very important for a brand, according to Mr. Phillips. “As a disease or condition is identified and patients start asking about medications within that category, a brand identity becomes important in the particular disease,” he says. “The bottom line is to have the brand prescribed for a particular disease.” Mr. Jones believes that disease-awareness campaigns and unbranded advertising do not pose a threat to the brand, especially in light of other market pressures that are having an impact. “The biggest threat to a pharmaceutical brand in the marketplace today is patent expiration, not unbranded communications, which tend to lift all boats,” Mr. Jones says. “In the categories where unbranded product campaigns lead to market expansion everybody benefits. But make no mistake, pharmaceutical companies working on unbranded advertising have a brand-conversion plan in place.” Mr. Larsen agrees that the brand is more important than ever, as too are the risks of losing the brand identity among the competition in today’s marketplace. “Early on companies must establish a brand strategy; develop and communicate the brand name; and begin building brand awareness before launch to maximize the time they have to recoup their investment while providing a springboard into the launch phase,” he says. PharmaVOICE welcomes comments about this article. E-mail us at email@example.com. The FDA rejects submitted brand names about 35% of the time. Don Lowy Schering-Plough There is no substitute for consumer research and lots of it. Understanding the target audience is the foundation of strong branding. Terry Prime Otsuka America Pharmaceutical Brand names are very important, especially at the launch of the product. Branding elements are critical to establishing an image with customers that is consistent with the product profile. Anthony Johndrow Straightline Because the FDA requires product names to be different from existing products, it is difficult for companies to create a franchise or family of products that are clearly linked to one another. Sound Bites from the Experts PharmaVOICE asked industry marketing experts how credibility and trust can be built through a corporate brand. Ed Capparucci is VP, Director of Client Services, at Adair-Greene Healthcare Communications, an Atlanta-based healthcare agency, which offers a full range of promotion and advertising services for pharmaceutical, biotech, and device manufacturers nationwide. For more information, visit aghealthcare.com. “As good marketers know, well-built brands are built on trust. By creating strong brand identities, corporations such as Target, Starbucks, Google, and Intel, for example, have become the standards by which all others are measured. The brand names of these companies elicit positive emotional feelings their customers want to be associated with. By adding an emotional component to their customers’ mindsets, well-branded corporations build assets that can’t be developed through general promotion alone. A great example in our industry is Johnson & Johnson, which has strongly associated the feeling of trust with its line of products.” Jay Carter is Senior VP, Director of Client Services, at AbelsonTaylor Inc., Chicago, an independent healthcare advertising agency. For more information, visit abelson-taylor.com. “Making a brand credible and trustworthy always takes time and real interaction between the customer and brand. The two key ways that physicians and patients learn about corporate brands are by interacting with the company’s portfolio of brands and by communicating with their representatives. Obviously, if both of these assets are top quality, the resulting perception of the corporation’s brand will also be high. Over the years, we’ve had the privilege of working side-by-side with clients who have understood the value of such interactions, invested in facilitating such interactions, and reaped substantial rewards from their efforts.” Dennis Crowley is President of Brand Engineers LLC, Iselin, N.J., which focuses exclusively on developing and validating highly focused and differentiated positioning for new or existing pharmaceutical and biotechnology brands. For more information, visit brandengineers.com. “Credibility and trust are founded, of course, on a portfolio of outstanding products. But they also result from a company’s history of integrity, reliability, and transparency — emotional components of a company’s brand that are supported by experience. Not surprisingly, our research shows that when companies provide a superior level of trust, doctors react more positively to their products and are more likely to prescribe them, precisely because of their faith in the company’s name and reputation. Two examples of companies that have created such reputations are Johnson & Johnson — which made the Tylenol scare a textbook example of crisis management — and Genentech — whose new treatments have defined a new direction in healthcare. By offering high-quality products and services, unmatched scientific knowledge, and corporate brands that deliver superior patient care, individual companies will not only enhance their own reputations, but also improve the image of the industry at large.” Fabio Gratton is Chief Innovation Officer at Ignite Health, Irvine, Calif., a healthcare advertising agency with a strong patient-centric focus, and which uses the latest technologies to help marketers expand their reach and accessibility to those living with chronic diseases and the people who care for them. For more information, visit ignitehealth.com. “With the explosion of e-patient communications, marketers are fearful of losing control of their messages. Yet this medium gives them the ability to spread accurate, meaningful, helpful information to their patients and to the community at large. In fact, by listening to what their customers are saying, companies can monitor and supervise the dialogues taking place — not to influence them, but to take responsible actions, such as providing additional information about their products, suggesting links to other sites that will help educate and inform and to make sure that any adverse events are recognized and reported. Such transparency will go a long way toward improving the credibility of not only individual marketers but of the industry in general.” Lorraine Pastore is President of Brand Pharm, New York, a full-service healthcare advertising agency, and a Publicis Healthcare Communications Group company. For more information, visit brandpharmusa.com. “Credibility and trust can be built for a brand through vision, being clear on what the corporation stands for and what it does; leadership, communicating that vision to internal and external constituents; communication, establishing the behaviors and activities that support that vision, clearly conveying to staff what is expected of them, what they can expect from the company, and to customers what they can expect of the corporation; reliability, doing what is said will be done management-to-staff, corporation-to-client over and over and over again; and responsiveness, being open-minded to what works and what doesn’t, and actively acknowledge and build upon both.” Bonnie RiShell is CEO of ROI2, Vienna, Va., which provides market intelligence solutions to the pharmaceutical and health industries and the agencies that support those industries. For more information, visit roi2.com. “Credibility for a corporate brand is built on a foundation of strong product brands that are recognized and trusted by all touchpoints in the decision-making chain, including key opinion leaders, physicians, institutions, and patients. Strong product brands reinforce corporate branding and messaging and reach people both within and outside the corporation: medical science liaisons, thought leaders and influencers, advocates, patients, and the community at large. ” Kristen Spensieri is from Chandler Chicco Companies, New York, a full-service healthcare public-relations firm specializing in global and country-specific corporate campaigns. For more information, visit ccapr.com. “To build trust through the corporate brand, pharmaceutical companies need to appeal to the needs of stakeholders who are beyond their own self-interest. Issues that the public cares about include: corporate transparency, improved access for those with the greatest need, prevention of chronic illness, and basic solutions for everyday living. Because pharmaceutical companies are constantly impacted by the ever-shifting political, regulatory, economic, public health, and popular culture landscapes, those that do not brand themselves for the long term are taking huge, unnecessary risks.” John Spetrino is Chief Creative Officer at Flashpoint Medica, New York, which specializes in traditional core competencies, such as full-service brand development and promotion, as well as new specialty areas in the pharmaceutical marketing communications arena. For more information, visit flashpointmedica.com. “The building blocks of any successful brand start with a single-minded clarity of purpose. It is paramount that the company and its customers understand what it stands for now and for the long run. Companies need to be open and transparent with their aspirations and deliver on their promises time and again. It is critical to stay connected with customers through flawless performance and make each experience a positive reinforcement. While much is spent on developing a company mission, a timeless principle applies — brands that are successful do not disappoint. ” Jerry Phillips Drug Safety Institute A lot of time and money is spent to come up with the best brand name from a marketing and safety perspective. With a FDA rejection rate of 35%, companies should have back-up names ready to go so they don’t get caught at approval time without a proprietary name. That would be the worst-case scenario for a pharma company. David Stern Serono Naming a brand can be challenging, but it is really about how well the company understands FDA expectations and conducts in-depth brand selection research. In the initial phase, between 200 and 400 names should be developed to pass through the screening processes. The FDA’s Rhymes and Reasons for Name Rejection The FDA rejects submitted brand names about 35% of the time. Rejections can occur for a number of reasons, including: The name of the drug might be considered promotional or “fanciful” because it contains false and/or misleading claims embedded in the name, such as superiority claims, claims for different or expanded indications, or claims for efficacy or safety not supported by data. The name of the drug might be similar in appearance, spelling, and/or pronunciation to another brand or established name. The name uses a modifier that could cause confusion, for example, the modifier might be mistaken for a standard medical abbreviation; imply a claim, for example, XL (excellent?, better than other products?); be misinterpreted as a dosing schedule (for example, QD or BID); or be misleading. A modifier might also have been appropriate when it was originally approved but has since become confusing in the context of subsequent modifications to labeling claims and/or the dosage and administration section. The name might not only be similar to another brand or established name in appearance and sound but also have overlapping product characteristics that increase the risk of confusion, such as overlapping dose, strength, dosing interval, storage environment, prescribing, and patient populations. Source: Food and Drug Administration, Rockville, Md. For more information, visit fda.gov. The Name Review Process Since October 1999, the Office of PostMarketing Drug Risk Assessment (OPDRA) has reviewed about 400 proposed proprietary names for drug products. Proprietary names undergo a multifactorial review designed to improve consistency and minimize risk with sound-alike and look-alike names. The process includes: Expert panel review. An expert panel meets weekly to exchange opinions on the safety of a new proprietary name. The panel comprises OPDRA medication error prevention staff and representatives from the Division of Drug Marketing & Advertising Communications (DDMAC), who rely on their clinical, regulatory, and professional experiences to decide on the acceptability of a proprietary name. Handwriting and verbal analyses. These are conducted within the FDA to determine the degree of confusion in visual appearance or pronunciation between the proposed proprietary name and names of other U.S. drugs. FDA health professionals (nurses, pharmacists, and physicians) are requested to interpret both written inpatient and outpatient prescriptions and verbal orders in an attempt to simulate the prescription ordering process. Computer-assisted analysis. Currently, OPDRA uses existing FDA databases to identify potential sound-alike and/or look-alike proprietary names. In the future, OPDRA plans to use validated computer software that will improve the ability to detect similarities in spelling and sound among proprietary names. Labeling and packaging analysis. OPDRA provides a safety assessment of the container labels, carton and package insert labeling, and proposed packaging of each product to identify areas of potential improvement. Overall risk evaluation. This final phase of the name review process weighs the results of each phase of the review, as well as additional risk factors, such as overlapping strengths, dosage forms, dosing recommendations, indications for use, storage, labeling, and packaging, and important lessons learned from the agency’s postmarketing experience. Source: Food and Drug Administration, Rockville, Md. For more information, visit fda.gov. Kris Larsen Interbrand Wood Healthcare Regulators’ intentions are in the best interest of patients and society for safety reasons and to prevent prescription errors. Adam Woodrow Wyeth Pharmaceuticals Some of the biggest challenges for determining a brand name are other brands with similar names in different markets; companies that are not willing to release names they have stored in databases; and old products that sound or look like a trade name that is in the works. A multifactorial review improves consistency and minimizes risk with sound-alike and look-alike names. V. Brewster Jones Lathian Systems The FDA is trying to avoid confusion in branding that would lead to inappropriate prescribing, which creates a challenge for marketers in terms of creative limits. Vince Parry Y Brand Everyone in a pharmaceutical company is a brand manager, whether he or she knows it or not, and the clinical team is an essential part of the branding process. These individuals love getting involved, and they often know more than anyone else in the company about a brand’s potential at the naming stage. Avoid using modifiers, such as XL, QD or BID, which could be misleading.