Choosing The Right Drug Name


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Presentation November 2009 to FDA News on target audience selection, brand strategy, and drug naming.
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  • Choosing The Right Drug Name

    1. 1. Choosing the Right, World-Class Drug Name:<br />How to Increase Your Chances for FDA Approval, Get it Right the First Time, And Own Your Market from Launch<br />Brand Counsel, LLC<br />Jeff A. Gregory<br />November 12, 2009<br />11/11/2009<br />1<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    2. 2. Science, Strategy, and Soul<br /><ul><li> Molecules Matter
    3. 3. Strategy Matters More
    4. 4. Speaking the language of your target audience Matters Most</li></li></ul><li>Brand Counsel® – Branding Brilliance™<br />24 years brand naming, corporate identity, strategy – all within life science & technology<br />Began with pre-internet AT & T division<br />Consultant with Addison Whitney (Inventis)<br />Managing Director, Brand Institute<br />Managing Partner, Marconi Consulting<br />CEO, Chief Brand Strategist – Brand Counsel<br />11/11/2009<br />3<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    5. 5. Pharma, Biotech, Device<br />Amgen – Epogen, Neupogen<br />Sanofi – aventis - Ambien CR<br />Allergan – Restasis<br />Pfizer – Viagra (strategy), Celebrex, Lipitor<br />GSK – Advair, Boniva, Avandia<br />Medtronic – Biolinx, Endeavor<br />Tear Science – Lipiview, Lipiflow<br />11/11/2009<br />4<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    6. 6. Brands create value. <br />We create Branding Brilliance™.<br />11/11/2009<br />5<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    7. 7. Equal Parts Strategic & Creative<br />Brand Strategy<br />Competitive Analysis<br />Constituent Analysis<br />Product Positioning<br />Target Audience Eval.<br />Brand Valuation<br />Brand Continuum™ Process<br />Brand Creative<br />Full Scientific Review<br />Pharmacology<br />Disease Profile<br />Demo, Psycho, Enthography<br />Core Emotional Drivers<br />Brand Resonance™<br />11/11/2009<br />6<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    8. 8. The Emotion of Innovation<br />May 2007 – American Public Radio, “Marketplace”<br /> <br /> Falling in love. Losing a parent. Birthing a child. Launching innovative technology.<br /> <br />Wait, what?<br /> When it comes to the work we all do in the innovation space, hard science and analysis rule the day. Emotions? Who let them sneak into the cleanroom? What does emotion have to do with life science and technology?You might really be surprised.<br /> <br />What’s more emotional than extending life, improving the human condition, curing disease, and altering life’s code at it’s genetic core? That’s pretty emotional stuff, especially for the recipients of these innovations. It’s truly a life-or-death decision.<br /> <br />The premise is simple: science is not emotion-driven, yet people most certainly are.<br />And people embrace innovation, not beakers. When the diagnosis comes down, emotions are in play, not science, although science is often the answer to the problem.<br /> <br />The inherent dichotomy between science and marketing is nothing new. Think back to college: science majors were the truly serious students, burning the midnight oil while marketing majors slept until noon, taking long lunches, even then.<br /> <br />Scientists are doers, not talkers, while marketers yack on endlessly about ethereal concepts like ‘brand essence’ and ‘early adopters’ . Talkers, it seems, not actual doers.<br />11/11/2009<br />7<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    9. 9. In reality, there is science in branding, and branding in science. Think of all the great innovations lagging in dimly-lit labs just yearning to see the light of day with the right VC funding and a solid brand strategy. Calling something the ‘RU-D32 Demodulator’ is just not a very compelling brand, nor a memorable mnemonic device for VC’s to keep top of mind. Plus, it frankly makes you look like a nerd.<br /> <br />The molecules may change, but one thing is constant: people buy innovation, whether they are in a reimbursement environment, OTC, asking for a drug or device by name through their provider, or otherwise. The best and most successful brands in life science and technology leverage great science with great branding.<br /> <br />While the treatment of disease is primarily all science, the patient’s prospective is largely emotionally-driven. And while science takes place in controlled conditions, consumer behavior plays out in the doctor’s office, the ER, and among one’s closest loved ones.<br /> <br />A better understanding of both science and emotion communicates hard science with the hardest life battles we will ever face: when the diagnosis is in, and life’s details screech to a halt.<br /> <br />If you don’t think that emotions drive treatment, consider this: when the doctor says, “I’m sorry to inform you that you have cancer”, what’s driving the bus in that moment – logic or emotion?<br />What got me thinking about this? I spend my waking hours, along with many of my non-waking ones, creating brands in the innovation space: life science, pharma, medical device, biotech, technology. Its heady stuff, all of this regenerative medicine, minimally invasive defibrillators, cures for leukemia.<br />11/11/2009<br />8<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    10. 10. I do some of my best creative thinking at a coffee shop in Chapel Hill. A man comes there every day and struggles to hold his cup. His arms are stubby and deformed, his legs short. He’s perhaps 57 years old.<br /> <br />He was a thalidomide baby.<br /> <br />A sleeping pill with indications for treating morning sickness, thalidomide radically altered his life even while he was forming in the womb. In 1961, scientists learned than even one dose of it greatly affected the growth of fetal limbs, among a raft of other severe internal effects.<br /> <br />I’d call something like that pretty emotional.<br /> <br /> And, while I’m still getting up the nerve to talk with this gentleman, patients every hour learn the life-changing diagnoses of their own conditions. At these moments, in the sterile environs of hospitals and doctor’s offices, science is not at play when the news is given. Emotions take center stage.<br /> <br />While working on a prostate seed therapy for a major NJ pharma a number of years ago, the branding was getting bogged down in molecular structure. In a room full of PhD’s, scientists, pharmacologists, and researchers, I asked one simple question: When was the last time any of them had been on a cancer ward.<br /> <br />11/11/2009<br />9<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    11. 11. Not one scientist spoke. Does anyone else find that a bit disconcerting?<br /> <br />If you want a great brand, understand the science, but understand the patient as well:<br />how they use language and representational systems, their dreams and desires, their cognitive and deductive processes, the way they behave in medical situations.<br /> <br />Science and emotion. Strange bedfellows. But one hell of a couple.<br />11/11/2009<br />10<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    12. 12. So, what does the FDA want, exactly?<br />Your guess, frankly, is as good as mine. It’s such a secret, they won’t tell anyone. Even themselves, it seems. <br />Hope you enjoy gambling…<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />11<br />
    13. 13. They’re Really Not That Into Us…<br />CDER, CBER, DDMAC, DMEDP, PDUFA, ISMP, <br />M-O-U-S-E.<br />As specific as they’ll get: “We have no specific guidelines”. That’s helpful…<br />Do it wrong (whatever that is), and you’ll definitely know what they don’t like.<br />Working with the FDA is quite similar to being in a really bad marriage. Except it’s more expensive, impossible to leave, and can go on indefinitely…<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />12<br />
    14. 14. So, Why the Animosity?<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />13<br />
    15. 15. 11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />14<br />‘We have met the enemy, and he is us’<br /> Walt Kelly, “Pogo”, Earth Day - 1970<br />
    16. 16. 11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />15<br />Boneheaded Branding Techniques <br />for FDA Immediate Rejection<br /><ul><li>Reachingfor the Latin-American dictionary – It’s a dead language for a reason.
    17. 17. ‘Let’s allow people in the company with no clue about branding , legal, or FDA rules to guess the name, and we’ll give them an iPod!’
    18. 18. ‘ Why don’t we just sit around the conference room and throw out phrases like, ‘hey, what about this…’’
    19. 19. ‘Surely, our ad agency knows how to do this. I mean, seriously, how hard could it be?’
    20. 20. Hiring our ‘competition’….  </li></li></ul><li>TrainwreckTrademarking<br />Using veiled words, even phonetically, which promise healing, cures, or end of disease.<br />Being overly descriptive.<br />Writing checks with the brand name that your clinicals just can’t cash.<br />Trying to be cute and suggestive.<br />Being as subtle as a hammer.<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />16<br />
    21. 21. A Tale of Two Trademarks<br />‘Helicoll’, a collagen –based skin graft bonding agent<br />27 years in R & D<br />Zero outside funding<br />Offshored, problematic production (QA)<br />‘The only solution in the world!’ - Dr. S. Guna<br />Trademarked? – Nope<br />Cleared FDA naming – “<br />Viable? – that would be a no.<br />Procellera, a material with ionic charge to heal wounds<br />7 years start to finish<br />Oversubscribed in every round<br />Domestic Production<br />‘ It simply works.’ Dr. Scott Sheftel, F.A.A.D.<br />Sailed through TM’s<br />Flew through FDA naming<br />Does it work? Please stand by…<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />17<br />
    22. 22. 11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />18<br />Procellera<br />Helicoll<br /><br />
    23. 23. Landmark Drug Names <br />First Highly Descriptive Drug Name: Redux<br />(dexfenfluramine – removed by FDA Sept. 1997 – heart valve issues ~ MIT Tech Transfer Drug<br />Flonase<br />Effexor<br />Flomax<br />Levitra (think about it…)<br />Nasonex<br />Prevacid<br />Wellbutrin<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />19<br />
    24. 24. The X, Y, Z Factor<br />Why?<br />Memorable?<br />Confusing?<br />Brand Equity<br />Yet it still continues<br />When to fire your brand consultancy<br />When to not even hire them in the first place<br />11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />20<br />
    25. 25. Why Brand to Begin With? It’s No Like It’s Money in the Bank or Anything… <br /> Value of Global Brands as Measured by Interbrand <br />BrandBrand Value (Billion $)Market Cap.Brand Value as<br />% of Market Cap<br />Coca-Cola$83.8 $142.2 59%<br />Microsoft $56.7 $271.9 21%<br />IBM $43.8 $158.4 28%<br />GE$33.5 $328.0 10%<br />Ford $32.2 $57.4 58%<br />Disney $32.3 $52.6 58%<br />Intel $30.0 $144.1 21%<br />McDonald’s $26.2 $40.9 64%<br />AT & T $24.2 $102.5 24%<br /> 10 Marlboro $21.0 $112.4 19%<br />.<br />11/11/2009<br />21<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    26. 26. Why Build the Brand?<br />Brand building is not just advertising – it’s aspirational to your target audiences<br />Brand building involves innovation and internal creation exercises<br />Excellence in execution creates huge payoffs<br />Product Attributes are key to the brand<br />The brand is more than the product– emotion, self-expression, achievement<br />Connect with customers on an emotional level<br />Use sub-brands to tell a story and manage perceptions<br />It’s the one asset with the highest net return<br />11/11/2009<br />22<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    27. 27. “ A brand is the face of a business strategy” <br /> - Scott Galloway, Prophet Strategy<br />Brand: A promise. A distinguishing name and/or symbol intended to identify goods or services of a seller. When executed correctly, a huge competitive and market advantage. <br />Indicators of an Under-emphasis on Brand-Building<br />Managers can’t identify with confidence the brand associations and the strength of those associations.<br />Knowledge of levels of brand awareness is lacking. <br />There is no systematic, reliable, sensitive, and valid measure of customer satisfaction and loyalty. <br />There are no indicators of the brand tied to long-term success of the business that are used to evaluate the brand’s marketing effort.<br />No person in the firm is charged with protecting and growing the brand.<br />There is no long-term strategyfor the brand.<br />11/11/2009<br />23<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    28. 28. “Strong brands usually move beyondproduct attributes<br /> to a brand identity based upon a brand personality<br />and a relationship with customers” David Aaker, <br />Building Strong Brands, Prophet Brand Strategy<br />‘ Corporate branding is an intentional, marketing-oriented communications platform across all business units, media, and audiences. It is a planned, inclusive strategy that sets standards for all divisions…for the cumulative benefit of the corporation. It is a declaration of “who we are”, “what we believe”, and “why you should put your faith in our company”.<br />James R. Gregory, CoreBrand<br />11/11/2009<br />24<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    29. 29. 11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />25<br />Brand Counsel’s Approach to Pharma and Med Device Brand Naming<br /><ul><li> Deep Data Dive – Scientific Review, Active Ingredient(s), Scientific Drivers, Is the Science Background Key or Compelling
    30. 30. Complete and Thorough Competitive (and Alternative) Analysis
    31. 31. Constituent (360 degree) Analysis
    32. 32. Trade Press, Journal, and Industry Analyst Review
    33. 33. Competitive Drugs on the Market, and in the Pipeline
    34. 34. Product Positioning Statement Development
    35. 35. Coordination with FDA deadlines, collateral development, journal articles, trade shows and conferences,
    36. 36. Full clearance of final name CANDIDATES in legal, USPTO, Google, Madrid Protocol (if international), Web name availability
    37. 37. Qualitative Market Research to end users, docs, and procurement
    38. 38. Assistance with CMS, Insurance Reimbursement, Regulatory
    39. 39. All intellectual property, when developed, becomes client property</li></li></ul><li>STRATEGIC BRAND ANALYSIS<br />Customer AnalysisCompetitor AnalysisSelf-Analysis<br /><ul><li>Trends * Brand image/identity * Existing Brand Image
    40. 40. Motivation * Strengths, strategies * Brand heritage
    41. 41. Unmet Needs * Vulnerabilities * Strengths/capabilities
    42. 42. Segmentation * Trends, Motivations * Organizational values</li></ul> * The Soul of the Brand™<br />↓<br />BRAND IDENTITY<br />(Core, Extended, Essence) - A set of associations we aspire to create<br />Brand as ProductBrand as OrganizationBrand as PersonAs Symbol<br /><ul><li>Product Scope 1. Organization attributes 1. Personality 1. Visual
    43. 43. Product attributes 2. Innovation (ex. Genuine, Imagery
    44. 44. Quality/value 3. Consumer concern Energetic, Rugged, 2. Metaphors
    45. 45. Uses 4. Trustworthiness Personal) 3. Brand
    46. 46. Users 5. Local vs. global 2. Brand-customer Heritage
    47. 47. Country of Origin relationships</li></ul> ↓ ↓ <br />VALUE PROPOSITIONCREDIBILITY<br /><ul><li>Functional benefits Supports other brands in the family
    48. 48. Emotional benefits
    49. 49. Self-expressive benefits</li></ul> ↓<br />BRAND-CUSTOMER RELATIONSHIP – speak their language – Brand Resonance™<br /> ↓<br />BRAND IDENTITY IMPLEMENTATION SYSTEM – Brand Architecture<br />BRAND POSITIONING<br /> ↓<br /> Execution ↓<br />TRACKING – Monitoring the brand position<br />11/11/2009<br />26<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    50. 50. The VCI Alignment Model<br /><ul><li> Strategic Vision
    51. 51. Organizational Culture
    52. 52. Stakeholder Images</li></ul>11/11/2009<br />27<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    53. 53. Who is (redacted) as a Personality <br />and an Organization?<br /><ul><li> Highly Entrepreneurial
    54. 54. Truly Tailored Solutions
    55. 55. Extreme Client-Centric Focus
    56. 56. Opportunistic
    57. 57. Flexible, Adapting, Evolving Organization
    58. 58. Passionate and Engaged
    59. 59. Pragmatic
    60. 60. Intellectually Curious – always digging deeper
    61. 61. Incredible Dedication to the Client
    62. 62. Always Going the Extra Kilometers
    63. 63. Always First-Person Observation of Focus Groups
    64. 64. Daring Professionals</li></ul>11/11/2009<br />28<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    65. 65. Constituent Analysis<br />11/11/2009<br />29<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    66. 66. (redacted) Corporate Identity<br />A Global Leader in Market Research and Strategic Marketing Consulting, with a Core Competency in Life Sciences and Technology.<br />A Truly People-Driven Organization Where Rigorous Thinking and Creativity Flow Freely.<br />A Company Where Deep Data Dives and Deep Thinking Rule.<br /><ul><li>The Four C’s: Clarity of Insight</li></ul> Consulting Expertise<br /> Critical Analysis<br /> Game-Changing Recommendations<br />11/11/2009<br />30<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    67. 67. VCI Alignment Factors<br /><ul><li> Organizational Culture : A+++
    68. 68. Stakeholder Images (based on new identity of consulting): B-
    69. 69. Strategic Vision : being decided this week at partner off-site meeting </li></ul>11/11/2009<br />31<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    70. 70. (redacted) Positioning Statement<br />‘We are (redacted), a seasoned team of strategic marketing specialists with a broad range of capabilities. We are passionate and pragmatic in our work, and possess global reach. We focus on life science. Our expertise is grounded in top-notch market research and strategic execution. These elements, unique in the industry, fuel our market-driven, facts-based approach to complex marketing decisions.’<br />11/11/2009<br />32<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    71. 71. Key Differentiators<br /><ul><li> All Focus Groups are Partner-Facilitated
    72. 72. We Do Not Outsource
    73. 73. We Stay Close to the Data
    74. 74. We are Highly Experienced in Life Sciences
    75. 75. We Understand European Regulatory and Reimbursement
    76. 76. We Have a Unique Perspective on Markets
    77. 77. We are a Special Type of People
    78. 78. We Take Extreme Measures to Provide Clean, Clear Data
    79. 79. Our Quality Control is Second to None
    80. 80. We are a Melting Pot of Global Cultures
    81. 81. We Have Been on the Continent for Nine Years
    82. 82. We Have Team Members with 25 years in Healthcare, both in the US and Europe (the Hugo factor)
    83. 83. We are Truly Global
    84. 84. We Execute Market Research Projects Anywhere in the World
    85. 85. We Have a Growing Consulting Practice
    86. 86. Our Clients Come Back to Us Time and Time Again</li></ul>11/11/2009<br />33<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    87. 87. Functional Core Competencies and Deliverables<br /><ul><li>Develop Market Solutions
    88. 88. Explore Markets
    89. 89. Deliver Market Solutions
    90. 90. Maintain & Control Market Position</li></ul>11/11/2009<br />34<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />
    91. 91. 11/11/2009<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />35<br />Latest Breaking News from FDA’s Proprietary Name Pilot Program<br />( this content to be delivered live, in order to be as timely as possible)<br />
    92. 92. 11/11/2009<br />36<br />Brand Counsel, 2009 - Choosing the Right Drug Name<br />