Presentation November 2009 to FDA News on target audience selection, brand strategy, and drug naming. Copyright (c) 2009 Brand Counsel, LLC All Rights Reserved jeff@brandcounselllc.com

1. Choosing the Right, World-Class Drug Name: How to Increase Your Chances for FDA Approval, Get it Right the First Time, And Own Your Market from Launch Brand Counsel, LLC Jeff A. Gregory November 12, 2009 11/11/2009 1 Brand Counsel, 2009 - Choosing the Right Drug Name

3. Strategy Matters More

5. Pharma, Biotech, Device Amgen – Epogen, Neupogen Sanofi – aventis - Ambien CR Allergan – Restasis Pfizer – Viagra (strategy), Celebrex, Lipitor GSK – Advair, Boniva, Avandia Medtronic – Biolinx, Endeavor Tear Science – Lipiview, Lipiflow 11/11/2009 4 Brand Counsel, 2009 - Choosing the Right Drug Name

6. Brands create value. We create Branding Brilliance™. 11/11/2009 5 Brand Counsel, 2009 - Choosing the Right Drug Name

7. Equal Parts Strategic & Creative Brand Strategy Competitive Analysis Constituent Analysis Product Positioning Target Audience Eval. Brand Valuation Brand Continuum™ Process Brand Creative Full Scientific Review Pharmacology Disease Profile Demo, Psycho, Enthography Core Emotional Drivers Brand Resonance™ 11/11/2009 6 Brand Counsel, 2009 - Choosing the Right Drug Name

8. The Emotion of Innovation May 2007 – American Public Radio, “Marketplace” Falling in love. Losing a parent. Birthing a child. Launching innovative technology. Wait, what? 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. 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. The premise is simple: science is not emotion-driven, yet people most certainly are. 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. 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. 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. 11/11/2009 7 Brand Counsel, 2009 - Choosing the Right Drug Name

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. 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. 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. 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. 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? 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. 11/11/2009 8 Brand Counsel, 2009 - Choosing the Right Drug Name

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. He was a thalidomide baby. 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. I’d call something like that pretty emotional. 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. 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. 11/11/2009 9 Brand Counsel, 2009 - Choosing the Right Drug Name

11. Not one scientist spoke. Does anyone else find that a bit disconcerting? If you want a great brand, understand the science, but understand the patient as well: how they use language and representational systems, their dreams and desires, their cognitive and deductive processes, the way they behave in medical situations. Science and emotion. Strange bedfellows. But one hell of a couple. 11/11/2009 10 Brand Counsel, 2009 - Choosing the Right Drug Name

12. So, what does the FDA want, exactly? Your guess, frankly, is as good as mine. It’s such a secret, they won’t tell anyone. Even themselves, it seems. Hope you enjoy gambling… 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 11

13. They’re Really Not That Into Us… CDER, CBER, DDMAC, DMEDP, PDUFA, ISMP, M-O-U-S-E. As specific as they’ll get: “We have no specific guidelines”. That’s helpful… Do it wrong (whatever that is), and you’ll definitely know what they don’t like. 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… 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 12

14. So, Why the Animosity? 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 13

15. 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 14 ‘We have met the enemy, and he is us’ Walt Kelly, “Pogo”, Earth Day - 1970

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. ‘ Why don’t we just sit around the conference room and throw out phrases like, ‘hey, what about this…’’

19. ‘Surely, our ad agency knows how to do this. I mean, seriously, how hard could it be?’

21. A Tale of Two Trademarks ‘Helicoll’, a collagen –based skin graft bonding agent 27 years in R & D Zero outside funding Offshored, problematic production (QA) ‘The only solution in the world!’ - Dr. S. Guna Trademarked? – Nope Cleared FDA naming – “ Viable? – that would be a no. Procellera, a material with ionic charge to heal wounds 7 years start to finish Oversubscribed in every round Domestic Production ‘ It simply works.’ Dr. Scott Sheftel, F.A.A.D. Sailed through TM’s Flew through FDA naming Does it work? Please stand by… 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 17

22. 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 18 Procellera Helicoll http://tinyurl.com/ygjrhr9

23. Landmark Drug Names First Highly Descriptive Drug Name: Redux (dexfenfluramine – removed by FDA Sept. 1997 – heart valve issues ~ MIT Tech Transfer Drug Flonase Effexor Flomax Levitra (think about it…) Nasonex Prevacid Wellbutrin 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 19

24. The X, Y, Z Factor Why? Memorable? Confusing? Brand Equity Yet it still continues When to fire your brand consultancy When to not even hire them in the first place 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 20

25. Why Brand to Begin With? It’s No Like It’s Money in the Bank or Anything… Value of Global Brands as Measured by Interbrand BrandBrand Value (Billion $)Market Cap.Brand Value as % of Market Cap Coca-Cola$83.8 $142.2 59% Microsoft $56.7 $271.9 21% IBM $43.8 $158.4 28% GE$33.5 $328.0 10% Ford $32.2 $57.4 58% Disney $32.3 $52.6 58% Intel $30.0 $144.1 21% McDonald’s $26.2 $40.9 64% AT & T $24.2 $102.5 24% 10 Marlboro $21.0 $112.4 19% . 11/11/2009 21 Brand Counsel, 2009 - Choosing the Right Drug Name

26. Why Build the Brand? Brand building is not just advertising – it’s aspirational to your target audiences Brand building involves innovation and internal creation exercises Excellence in execution creates huge payoffs Product Attributes are key to the brand The brand is more than the product– emotion, self-expression, achievement Connect with customers on an emotional level Use sub-brands to tell a story and manage perceptions It’s the one asset with the highest net return 11/11/2009 22 Brand Counsel, 2009 - Choosing the Right Drug Name

27. “ A brand is the face of a business strategy” - Scott Galloway, Prophet Strategy 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. Indicators of an Under-emphasis on Brand-Building Managers can’t identify with confidence the brand associations and the strength of those associations. Knowledge of levels of brand awareness is lacking. There is no systematic, reliable, sensitive, and valid measure of customer satisfaction and loyalty. 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. No person in the firm is charged with protecting and growing the brand. There is no long-term strategyfor the brand. 11/11/2009 23 Brand Counsel, 2009 - Choosing the Right Drug Name

28. “Strong brands usually move beyondproduct attributes to a brand identity based upon a brand personality and a relationship with customers” David Aaker, Building Strong Brands, Prophet Brand Strategy ‘ 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”. James R. Gregory, CoreBrand 11/11/2009 24 Brand Counsel, 2009 - Choosing the Right Drug Name

30. Complete and Thorough Competitive (and Alternative) Analysis

31. Constituent (360 degree) Analysis

32. Trade Press, Journal, and Industry Analyst Review

33. Competitive Drugs on the Market, and in the Pipeline

34. Product Positioning Statement Development

35. Coordination with FDA deadlines, collateral development, journal articles, trade shows and conferences,

36. Full clearance of final name CANDIDATES in legal, USPTO, Google, Madrid Protocol (if international), Web name availability

37. Qualitative Market Research to end users, docs, and procurement

38. Assistance with CMS, Insurance Reimbursement, Regulatory

40. Motivation * Strengths, strategies * Brand heritage

41. Unmet Needs * Vulnerabilities * Strengths/capabilities

43. Product attributes 2. Innovation (ex. Genuine, Imagery

44. Quality/value 3. Consumer concern Energetic, Rugged, 2. Metaphors

45. Uses 4. Trustworthiness Personal) 3. Brand

46. Users 5. Local vs. global 2. Brand-customer Heritage

48. Emotional benefits

49. Self-expressive benefits ↓ BRAND-CUSTOMER RELATIONSHIP – speak their language – Brand Resonance™ ↓ BRAND IDENTITY IMPLEMENTATION SYSTEM – Brand Architecture BRAND POSITIONING ↓ Execution ↓ TRACKING – Monitoring the brand position 11/11/2009 26 Brand Counsel, 2009 - Choosing the Right Drug Name

51. Organizational Culture

52. Stakeholder Images11/11/2009 27 Brand Counsel, 2009 - Choosing the Right Drug Name

54. Truly Tailored Solutions

55. Extreme Client-Centric Focus

56. Opportunistic

57. Flexible, Adapting, Evolving Organization

58. Passionate and Engaged

59. Pragmatic

60. Intellectually Curious – always digging deeper

61. Incredible Dedication to the Client

62. Always Going the Extra Kilometers

63. Always First-Person Observation of Focus Groups

64. Daring Professionals11/11/2009 28 Brand Counsel, 2009 - Choosing the Right Drug Name

65. Constituent Analysis 11/11/2009 29 Brand Counsel, 2009 - Choosing the Right Drug Name

68. Stakeholder Images (based on new identity of consulting): B-

69. Strategic Vision : being decided this week at partner off-site meeting 11/11/2009 31 Brand Counsel, 2009 - Choosing the Right Drug Name

70. (redacted) Positioning Statement ‘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.’ 11/11/2009 32 Brand Counsel, 2009 - Choosing the Right Drug Name

72. We Do Not Outsource

73. We Stay Close to the Data

74. We are Highly Experienced in Life Sciences

75. We Understand European Regulatory and Reimbursement

76. We Have a Unique Perspective on Markets

77. We are a Special Type of People

78. We Take Extreme Measures to Provide Clean, Clear Data

79. Our Quality Control is Second to None

80. We are a Melting Pot of Global Cultures

81. We Have Been on the Continent for Nine Years

82. We Have Team Members with 25 years in Healthcare, both in the US and Europe (the Hugo factor)

83. We are Truly Global

84. We Execute Market Research Projects Anywhere in the World

85. We Have a Growing Consulting Practice

86. Our Clients Come Back to Us Time and Time Again11/11/2009 33 Brand Counsel, 2009 - Choosing the Right Drug Name

88. Explore Markets

89. Deliver Market Solutions

90. Maintain & Control Market Position11/11/2009 34 Brand Counsel, 2009 - Choosing the Right Drug Name

91. 11/11/2009 Brand Counsel, 2009 - Choosing the Right Drug Name 35 Latest Breaking News from FDA’s Proprietary Name Pilot Program ( this content to be delivered live, in order to be as timely as possible)

92. 11/11/2009 36 Brand Counsel, 2009 - Choosing the Right Drug Name