choosing the right drug name

04/07/2023 Brand Counsel, 2009 - Choosing the Right Drug Name

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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, LLCJeff A. Gregory

November 12, 2009

Science, Strategy, and Soul

• Molecules Matter• Strategy Matters More

• Speaking the language of your target audience Matters Most


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Brand Counsel® – Branding Brilliance™

• 24 years brand naming, corporate identity, strategy – all within life science & technology

• Began with pre-internet AT & T division• Consultant with Addison Whitney (Inventis)• Managing Director, Brand Institute• Managing Partner, Marconi Consulting• CEO, Chief Brand Strategist – Brand Counsel


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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


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Brands create value. We create Branding Brilliance™.


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Equal Parts Strategic & Creative

Brand StrategyCompetitive AnalysisConstituent AnalysisProduct PositioningTarget Audience Eval.Brand ValuationBrand Continuum™

Process

Brand CreativeFull Scientific ReviewPharmacologyDisease ProfileDemo, Psycho,

EnthographyCore Emotional DriversBrand Resonance™


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The Emotion of InnovationMay 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.


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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.


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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.


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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.


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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…


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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…


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So, Why the Animosity?


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‘We have met the enemy, and he is us’

Walt Kelly, “Pogo”, Earth Day - 1970


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Boneheaded Branding Techniques for FDA Immediate Rejection

• Reaching for the Latin-American dictionary – It’s a dead language for a reason.• ‘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!’• ‘ Why don’t we just sit around the conference room and throw out phrases like, ‘hey, what about this…’’• ‘Surely, our ad agency knows how to do this. I mean, seriously, how hard could it be?’• Hiring our ‘competition’….


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Trainwreck Trademarking

• Using veiled words, even phonetically, which promise healing, cures, or end of disease.

• Being overly descriptive.• Writing checks with the brand name that your

clinicals just can’t cash.• Trying to be cute and suggestive.• Being as subtle as a hammer.


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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…


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Procellera

Helicoll

http://tinyurl.com/ygjrhr9

http://procellera.com/

http://encoll.com/


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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


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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


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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

Brand Brand Value (Billion $) Market Cap. Brand Value as% of Market Cap

1 Coca-Cola $83.8 $142.2 59%

2 Microsoft $56.7 $271.9 21%

3 IBM $43.8 $158.4 28%

4 GE $33.5 $328.0 10%

5 Ford $32.2 $57.4 58%

6 Disney $32.3 $52.6 58%

7 Intel $30.0 $144.1 21%

8 McDonald’s $26.2 $40.9 64%

9 AT & T $24.2 $102.5 24%

10 Marlboro $21.0 $112.4 19%.


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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


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“ 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 strategy for the brand.


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“Strong brands usually move beyond product 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


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Brand Counsel’s Approach to Pharma and Med Device Brand Naming

• Deep Data Dive – Scientific Review, Active Ingredient(s), Scientific Drivers, Is the Science Background Key or Compelling• Complete and Thorough Competitive (and Alternative) Analysis• Constituent (360 degree) Analysis• Trade Press, Journal, and Industry Analyst Review• Competitive Drugs on the Market, and in the Pipeline• Product Positioning Statement Development• Coordination with FDA deadlines, collateral development, journal articles, trade shows and conferences, • Full clearance of final name CANDIDATES in legal, USPTO, Google, Madrid Protocol (if international), Web name availability• Qualitative Market Research to end users, docs, and procurement• Assistance with CMS, Insurance Reimbursement, Regulatory • All intellectual property, when developed, becomes client property


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STRATEGIC BRAND ANALYSIS

Customer Analysis Competitor Analysis Self-Analysis•Trends * Brand image/identity * Existing Brand Image•Motivation * Strengths, strategies * Brand heritage•Unmet Needs * Vulnerabilities * Strengths/capabilities•Segmentation * Trends, Motivations * Organizational values

* The Soul of the Brand™↓BRAND IDENTITY(Core, Extended, Essence) - A set of associations we aspire to create

Brand as Product Brand as Organization Brand as Person As Symbol•Product Scope 1. Organization attributes 1. Personality 1. Visual•Product attributes 2. Innovation (ex. Genuine, Imagery•Quality/value 3. Consumer concern Energetic, Rugged, 2. Metaphors•Uses 4. Trustworthiness Personal) 3. Brand •Users 5. Local vs. global 2. Brand-customer Heritage•Country of Origin relationships

↓ ↓

VALUE PROPOSITION CREDIBILITY•Functional benefits Supports other brands in the family•Emotional benefits•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


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The VCI Alignment Model

Strategic Vision

Organizational Culture

Stakeholder Images


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Who is (redacted) as a Personality and an Organization?

• Highly Entrepreneurial• Truly Tailored Solutions• Extreme Client-Centric Focus• Opportunistic• Flexible, Adapting, Evolving Organization• Passionate and Engaged• Pragmatic• Intellectually Curious – always digging deeper• Incredible Dedication to the Client• Always Going the Extra Kilometers• Always First-Person Observation of Focus Groups• Daring Professionals


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Constituent Analysis

(redacted)


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(redacted) Corporate Identity

A Global Leader in Market Research and Strategic Marketing Consulting, with a Core Competency in Life Sciences and Technology.

A Truly People-Driven Organization Where Rigorous Thinking and Creativity Flow Freely.

A Company Where Deep Data Dives and Deep Thinking Rule.

•The Four C’s: Clarity of Insight Consulting Expertise Critical Analysis Game-Changing Recommendations


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VCI Alignment Factors

Organizational Culture : A+++

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

Strategic Vision : being decided this week at partner off-site meeting


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(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.’


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Key Differentiators

All Focus Groups are Partner-Facilitated We Do Not Outsource We Stay Close to the Data We are Highly Experienced in Life Sciences We Understand European Regulatory and Reimbursement We Have a Unique Perspective on Markets We are a Special Type of People We Take Extreme Measures to Provide Clean, Clear Data Our Quality Control is Second to None We are a Melting Pot of Global Cultures We Have Been on the Continent for Nine Years We Have Team Members with 25 years in Healthcare, both

in the US and Europe (the Hugo factor) We are Truly Global We Execute Market Research Projects Anywhere in the World We Have a Growing Consulting Practice Our Clients Come Back to Us Time and Time Again


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Functional Core Competencies and Deliverables

• Develop Market Solutions

• Explore Markets

• Deliver Market Solutions

• Maintain & Control Market Position


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Latest Breaking News from FDA’s Proprietary Name Pilot Program

( this content to be delivered live, in order to be as timely as possible)


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choosing the right drug name

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