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  • Posted by: John Breen on Wednesday, July 16 2014 11:06 AM | Comments (0)

    FDA word cloud

    The United States Food and Drug Administration (FDA) recently released a long-awaited draft guidance document for the development and assessment of proprietary drug names for prescription and non-prescription products. Regulatory decisions can sometimes impact the pharmaceutical industry in unpredictable ways, so this guidance is a welcome addition. But will these guidelines drive the industry toward greater consistency and predictability in proprietary name reviews?   

    Here are four key takeaways from InterbrandHealth’s analysis of the draft:   

    1. The FDA is instituting a number of criteria that can be objectively measured 

    One of the key challenges in naming research is that it produces few black and white results; we’re often forced to manage many shades of grey. Within the draft guidance document, the FDA aims to present more tangible metrics—pre-screening criteria, checklists, specific categories for its POCA tool (Phonetic and Orthographic Computer Analysis)—that should, in theory, result in greater standardization in the approach to name testing and therefore greater predictability in outcomes. The FDA also has provided its latest thinking on a number of topics that have created anxiety for our industry in the past, including brand modifiers and “dual proprietary names.” While some of these topics will still be assessed on a case-by-case basis, the draft guidance offers hope of greater consistency.   

    2. POCA plays a starring role in the guidance 

    When first released, the FDA’s POCA algorithm was viewed as one of many inputs to a name safety assessment. With the new draft guidance, the FDA is placing greater emphasis on the results of a POCA search than we have experienced to date. Now, the FDA has officially grouped POCA scores into three categories and is using these categories as the basis for a final safety evaluation. This is a bit of a departure for the FDA that certainly warrants monitoring.    

    The draft guidance document places greater emphasis on name similarity versus other contributing factors to medication errors than ever before. Many of the industry’s more practical arguments for why a proprietary name candidate will not be confused with an existing marketed drug in the real world—including differences in how products are actually prescribed, dispensed and administered—may no longer be persuasive. This is particularly true of names that score higher than 70 on POCA with an existing drug name. Despite differences in product characteristics, the FDA states that these highly similar names are at risk for confusion. At InterbrandHealth, we have found POCA to be a useful tool in prioritizing potential safety conflict. However, our experience also suggests that the results can range from inconsistent to confounding. So, it will be very interesting to see if POCA can, in fact, serve as a successful filtering tool.   

    3. The FDA is looking for more rigorous prescription simulation studies 

    The best practices summarized in the draft guidance for prescription simulation studies are similar to the FDA’s 2008 PDUFA Pilot Concept Paper. The FDA is requesting that at least 20 scenarios be included in a prescription simulation study, including marketed products. While this is feasible in a market research study, it will increase survey complexity. Applicants may need to rethink existing approaches and be prepared to invest more time and money to complete this “recommended” market research. 

    As noted earlier, over-the-counter (OTC) products fall under the draft guidance document, which implies that these sponsors may need to conduct more in-depth testing, including more prescription simulations.   

    4. There is no mention of Failure Mode and Effects Analysis (FMEA) 

    Our final observation addresses not only what’s in the draft but also what’s missing. In the 2008 PDUFA Pilot Concept Paper, the FDA alluded to the importance of FMEA in a sponsor’s name safety assessment. In a significant departure from this earlier stance, FMEA is now completely omitted from the draft guidance document. While sponsors are not being asked to complete this analysis, we are curious to see whether the FDA will continue to conduct FMEA as part of its safety review for proprietary name candidates. Currently, it appears that the FDA is asking the industry to generate initial hypotheses for a review through its requested methods and then this data will be fed into the internal evaluation. InterbrandHealth envisions this could limit the voice of a sponsor in its attempt to present a rationale for proprietary name selection beyond the outcomes of the prescription simulation studies and POCA results.    

    In summary, the draft guidance offers greater clarity and the possibility of increased predictability, but it is too soon to know if the endpoints summarized in the document will “guarantee” an FDA approval of a proprietary name candidate. The removal of FMEA, while reducing subjectivity, is particularly surprising. However, it appears that through the launch of this guidance, the FDA is looking to the industry to help shape and standardize the process with a goal of creating greater certainty in outcomes, which is a positive step.   

    InterbrandHealth is currently submitting comments to the FDA regarding the draft guidance document, and we look forward to uncovering its implications as the guidance comes to life through our work.   

    John Breen is the Executive Director of Analytics for InterbrandHealth. Lillian Smith is an Analyst for InterbrandHealth.    

    For more information about the drug naming process or the FDA guidance document, connect with InterbrandHealth here.

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  • Posted by: Ramya Kartikeyan on Monday, July 7 2014 03:40 PM | Comments (0)

    Making the jump from prescription to OTC

    At the NewYorkBIO 2014 conference, multidisciplinary speakers focused on the need for a clearer path to commercialization for pipeline drugs to promote regulatory efficiency and openness. In a call out to developments made by the FDA, the keynote speech delivered by the Commissioner of the U.S. Food and Drug Administration, Dr. Margaret Hamburg, highlighted changes that have been introduced to bring new products to the market sooner, without compromising the integrity of the regulatory process as a whole.   

    An improved regulatory system runs at the heart of a changing healthcare market, which includes stratified patient populations, larger clinical trials, the growing role of biologics, and the diminishing value of the blockbuster drug model for the majority of companies. With the cost of developing most drugs reaching approximately $1bn from bench to bedside, more companies are looking for ways to extend the life of their drugs beyond their impending patent cliffs.   

    A separate panel at the NYBIO conference delved into the intricacies of shifting from prescription (Rx) status to over-the-counter (OTC) to capitalize on the brand equity built by the corporate manufacturer over years of marketing. With a potential loss of 85 percent or greater market share, drug manufacturers of select therapies will likely be able to successfully convert their Rx products into OTC products, but doing so comes with its own set of challenges. Each manufacturer is required to conduct a series of marketing assessments to ensure that the product adheres to existing guidelines on safety.   

    Due to the nature of the Rx to OTC switching process, the majority of the drugs that have successfully made the jump include drugs in categories such as migraine, high cholesterol, oral contraception, erectile dysfunction, antivirals, etc. The top 10 products in the OTC category currently generate more than $300m per year per drug, which offers a significant “cash cow” alternative for those products setting up to battle stiff generic competition. Even with a steady cash flow from OTC sales, companies are often forced to drop their prices to remain competitive and relevant within this new market dynamic. However, in light of the Affordable Care Act, industry specialists expect more and more patients to self-treat with OTC treatments before seeking the costlier option of seeing a medical professional.   

    So, should a branded drug asset compete on par with other products in the OTC market given these stakes? Can an Rx branded product cut through the “noise” and effectively capitalize on its brand equity to generate momentum in sales with a direct-to-consumer distribution channel? Pharma companies need to carefully consider these challenges and investigate if the R&D investment is worth the payoff.   

    Ramya Kartikeyan, Ph.D., is the Director of Analytics for InterbrandHealth.    

    For more information about product brand equity, connect with InterbrandHealth here.

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  • Posted by: Nicole Diamant on Monday, June 30 2014 03:35 PM | Comments (0)

    If Virgin were in the healthcare space

    From digestible colon cameras to bionic hands to 3D printed organs, the healthcare industry is exploding with scientific discovery, technological achievement, and impossible visions made possible. And yet, when we look at the majority of the creative work done for the healthcare sector, it rarely captures the sense of excitement that often accompanies these cutting-edge developments. The way the industry communicates and represents itself visually is often safe, cliché, or just tries too hard to win us over. Are opportunities being missed?  

    “Cool” may not be the first word that comes to mind when most people think of healthcare, but, in such an innovative field, cool things do, in fact, happen. Maybe it’s time for the sector’s creative work to reflect that.     

    At the inaugural Lions Health festival at Cannes, InterbrandHealth’s Executive Creative Director, R. John Fidelino, explored this cognitive dissonance in his talk “Chasing Cool in Healthcare.” In his provocative presentation, R. John tackled the concept of cool, the current language of healthcare, and how communications and creative professionals can shift their thinking and elevate the groundbreaking work being done in this field.     

    Should healthcare be cool? If so, how can we push the boundaries to more effectively communicate with consumers in this increasingly patient-centric world? The inherent nature of something deemed cool is the effortlessness of it. Cool things, people, and places inspire us and make us want to be associated with them. When we think about healthcare, we need to ask ourselves, are we achieving this same thing with our brands? Do we strive to hit the three qualities that characterize cool: meaningful, authentic, and immersive?    

    And is cool even appropriate for healthcare? It may be that we are uncomfortable with “cool” in healthcare—it may trivialize the seriousness of disease and sickness. While the category does demand a high level of respect, we do it a disservice by not recognizing and promoting innovative work and exciting breakthroughs. Are we diving deep enough and helping people understand all aspects of our category? 

    Great consumer brands craft relationships with people—through websites, apps, social media, in-store experiences, and more. In healthcare, are we creating that same 360-degree experience? We need to start thinking about how words and images create full and complete worlds for consumers. That is what makes a great brand. What if Virgin ran a hospital? What if Apple sold pharmaceuticals? What if Nike made medical devices? Consumer brands are already dabbling in the healthcare space. Imagining the future of healthcare and the types of brands that may eventually play in this space can be inspiring and eye-opening.

    Healthcare enriches life, even saves life. What could be cooler than that? We need to stop being bashful about the category. We need to recognize all the great things happening in our industry, celebrate them, and help people appreciate the wonders of this rapidly evolving field. When we acknowledge how amazing our category really is, we won’t have to chase cool—we’ll naturally embrace it. And others will too.     

    Here are a few questions to help us assess our brands' cool factor:   

    • Are we crafting brands that are authentic, meaningful, and immersive?
    • Are we creating 360-degree experiences for consumers?
    • Are we properly communicating the awesomeness of our category?
    • Are we thinking outside of healthcare and appropriately adopting the best practices of great consumer brands?  

    Nicole Diamant is the Marketing Manager for InterbrandHealth. You can follow her on Twitter: @NicoleDiamant

    For more information on the Chasing Cool presentation, please contact InterbrandHealth. A video clip can be seen here.   

     


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  • Posted by: Nicole Diamant on Monday, June 2 2014 10:40 AM | Comments (0)

    iPharma conference speaker

    Day One of iPharma closes with a look at what lies ahead for the future of digital marketing in pharmaceuticals

    In the wake of some of the biggest pharma deals of the year, industry marketers gathered to discuss their digital strategies at iPharma 2014. Like its sister sector, healthcare, pharmaceuticals has been slower to adopt new media and technology than consumer goods, but industry leaders now recognize the significant impact online activities have on their brands’ reputations. Despite regulatory challenges, the presentations all focused on positive—and possible—shifts communicators can make to better serve patients and physicians. Here are some guiding questions based on the speakers’ presentations you can use to focus your marketing and strengthen your brand.  

    1. Are you interacting with your patients online?

    As consumers ourselves, we know the power of online interaction and how it drives customer behavior. Digital health is no different. One study showed that 95 million Americans use smartphones for health info, a 27 percent increase from last year. Patients also spend nearly 52 hours per year reading health information online. This is a great opportunity for communications professionals to write blogs or scientific articles to help patients find the information they are looking for or give them tools to interact with condition-specific communities. Being active online also gives you a chance to respond quickly to negative feedback, which, according to Time Inc.’s VP of Digital, resonates 150 times more than positive comments.   

    2. Are you using data to target your marketing efforts? 

    Whether it’s studying your customers’ online behaviors or tapping into predictive analytics, big data is a key way to stretch your marketing dollar. Technology now even allows you to pinpoint the smartphone users near a particular doctor’s office. 95 percent of patients complete an internet search immediately before or after visiting their doctor. Imagine sharing important information with them about their condition or symptoms right when they are looking for it.   

    3. Are you communicating clearly with your team about your brand? 

    Great brand strategies resonate through all levels of an organization, from research and development to human resources. Your employees are the face of your brand and the primary people who interact with your customers and shape their brand experience. If internal communication about your brand is not clear, open, and honest, employees will fill in the silence with their own perceptions.   

    4. Is the customer at the heart of your marketing plan? 

    To often, brands misstep by placing themselves at the center of a strategic marketing plan. They ask, “What information do we want to give?” rather than ”What information do our consumers want to hear?”  When you have a valuable product that aids someone with a disease, condition, or illness, the product may just be one channel of assistance. Are you considering other ways your expertise and reach can help your customers? Are your actions driven by a desire to improve their lives and provide value? Do consumers see value in your brand beyond a product?  

    5. Are your communications authentic? 

    Storytelling has become a key component of marketing and branding in recent years. Some of this is a result of the 78 percent of internet users who watch or download videos online. Videos that go viral often tug at our heartstrings but only resonate when the storytelling is original or authentic. You cannot manufacture great stories. But in pharma, there is an advantage. Any brand with products and services that impact human health has touched lives. And those who have been touched have great stories to share. What’s more, these stories will automatically be relevant to others who are dealing with similar conditions or challenges.    

    6. Are you building programs for short-term results or lasting impact?

    Because everything is changing so rapidly in the pharma space, marketing KPIs are often skewed for quick, c-suite-approved results: “likes,” on Facebook, “retweets,” etc. These results are not insignificant, but they aren’t necessarily indicators of longevity. Activities that foster a genuine relationship with consumers, that emphasize service and connection more than selling, will keep a brand strong, despite changes in the marketplace.   

    7. Are you listening? 

    To your patients? To your physicians? To your employees?  What are your customers looking for? Seek to assuage anxiety by providing answers, comfort, or community via content marketing, videos, and website development. Katharine Patterson, Global Communications Manager for GE Healthcare, closed her presentation with a simple but powerful directive, “Be a human first. Then a marketer.” 

    Nicole Diamant is the Marketing Manager for InterbrandHealth.   

    Curious about using brand strategies to boost your digital efforts? Connect with InterbrandHealth here.

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  • Posted by: Suzanne Martinez on Wednesday, May 14 2014 12:52 PM | Comments (0)

    name word cloud

    What’s in a name? When you work in branding, the answer is everything. A branded name is an essential element of identity. It’s usually the first thing that customers see or notice and, typically, it’s how they remember a company or product. It’s the start of their brand experience and is crucial for cultivating trust and loyalty. Traditionally, healthcare has focused its brand names around functional features and not attempted to reach audiences on an emotional level. Interbrand research shows that this is a missed opportunity; brand can affect the bottom line and drive profit, premium, and preference. So, why is the critical process of naming so challenging in healthcare?

    1) Trademark development is a key issue for new brands in the healthcare space. As with consumer brands, a name must have legal viability. When we begin the naming process, most clients start by telling us what they would like the brand to communicate. Our team then constructs hundreds of names that convey that idea either through specific combinations of letters, metaphors, or stylistic attributes. As trademarks continue to proliferate, it is harder to find white space around a specific letter string/communication (especially if it is inspired by a functional feature that isn’t spectacularly innovative or groundbreaking).

    2) Equally difficult is acquiring a website domain. Securing a .com for your brand, essential in today’s increasingly digital world, can be incredibly challenging. As the digital arena expands, so does global reach. 

    3) It’s essential to test the linguistics of any brand name against different global markets to ensure what you are saying in one language doesn't mean something bad, off-putting, or irrelevant in another language. 

    4) Even after passing these tests, names go up against a tough audience: internal stakeholders. Many people involved in evaluating and decision making around a new brand name are not familiar with the challenges a potential trademark must overcome and do not understand how valuable a viable name candidate truly is. Typically, they have strong, subjective, and sometimes emotional, opinions about what their brand should communicate and are surprised when they don’t see it articulated as expected in a name.

    5) Unlike most consumer industries, the healthcare industry faces an additional, distinct set of challenges when it comes to brand name development. If the name is for a drug, implant, and, occasionally, a medical device product, regulatory authorities must approve it. Not only are there different regulatory authorities in different markets—making global branding particularly challenging—but each has an individual set of criteria to evaluate and approve the name. Regulatory authorities look at many aspects of a potential brand name, with their main concern focusing around safety.

    Remember the last time you got a prescription at the doctor’s office? Could you read the written prescription from your physician? Regulators require that healthcare names not sound like or look like another product name to minimize confusion and pharmacist or physician error. That’s why names for the same condition, such as depression, are as varied as Prozac, Zoloft, and Wellbutrin. Additionally, the name cannot directly communicate a health and wellness claim or non-functional benefit.  So we can hint at attributes—pro- active-prozac, loft-lift-zoloft—but not be overt about benefits; no one will ever really be able to brand an antidepressant called “happy pills,” even if we use the term colloquially.

    6) Once a name passes the trademark tests and surpassed regulatory hurdles (if necessary), the brand name still has obstacles ahead. Healthcare marketers need a name that speaks to a variety of audiences, whether it is a product name or corporate name. Communication pieces need to interact very differently with patients versus physicians versus insurance companies. Something you would say in the consumer world that is inherently understood as positive may be interpreted as negative in the context of healthcare. Take Jet Blue, for example. This is a great name that immediately communicates speed (monosyllabic), action (jet), and safety/serenity (blue skies). However if the word "blue" were used for a medical product, it may communicate depression, coldness, or even death (think: code blue).

    When considering how difficult it is to brand an entity within the healthcare category, it makes sense that our industry has traditionally focused its names on functionality. This has resulted in a lot of scientific healthcare brands that don't tap into the emotions of their customers. When brands are unable to build a relationship with customers beyond a functional feature, they may not experience long-term success. A brand’s longevity requires a connection that goes beyond how something works–tapping into emotions and creating a relationship with end-users. This opportunity is huge and exciting, but it must be approached using industry expertise and category insights in order to build a meaningful connection with customers that stands the test of time.   

    Suzanne Martinez is a Senior Consultant, Verbal, at InterbrandHealth.

    Connect with InterbrandHealth, the only full-service global branding consultancy with an exclusive focus on healthcare.

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