FREQUENTLY ASKED QUESTIONS
THE ANSWER IS YES
Do you provide free drug naming and brand name strategy advice to companies?
Do you guarantee results?
Does size matter? Why choose a small firm like yours over a large “legacy” firm?
Do you have existing skills and partners to execute global drug-naming projects?
What does your development process look like, and how are your clients involved in it?
We have never developed a drug name before. What should we be thinking about?
What day does the garbage go out?
WORKING WITH US
How would you define drug naming success?
What is your drug naming success rate, and how do you stay ahead of the regulatory rejection game?
Was your firm successful from the start, or did the number of your projects increase slowly?
What are your fees for drug naming services?
When should our company start the drug naming process?
How long does it take to get drug-naming approval?
When do companies start the USAN/INN (nonproprietary name or generic name) process?
Why should companies name their clinical trials?
THE ANSWER IS YES
Q - Do you provide free drug naming and brand name strategy advice to companies?
A - Yes, glad you asked. We are happy to talk about your situation via phone or email. Or you can go to our RESOURCES page for a wealth of articles, links, our "Ultimate Beginner's Guide To Drug Naming In the Regulated Age," and our one-of-a-kind Drug Naming Glossary. Or sign up for our Newsletter for on-going drug naming tips and news.
Q - Do you guarantee results?
A - Yes. We want you to feel comfortable talking to us, knowing that a risk-free guarantee is in place (although no one can guarantee regulatory approval). That’s because when we work with you to develop pharmaceutical names, if you are not satisfied with the work, we will carry out additional name creation based on your comments free of charge to you until names are selected and tested. We want you to look good, and a guarantee like this properly sets the stage for a good relationship. Don't you agree?
Q - Does size matter? Why choose a small firm like yours over a large “legacy” firm?
A - Yes, we believe that size matters, but we would not hold the big, impersonal size of the larger naming firms against them to win your business. (Ha-ha.) We prefer to keep things small––while still having a seat at the table––to better serve our clients.
We see a collaboration trend gaining traction, where clients are assigning the name creation part to a creative drug-naming firm like us, while delegating the heavy-lifting work, like market research, to the larger firms. This seems to benefit both naming firms and clients alike, and we are all for it.
For one client recently, we presented several hundred names over a 3-week period, and they were ready to execute earlier than expected. That’s an example of our creativity and agility, not possible at a larger agency.
Our model––which is equipped with independent expert consultants and Partners––makes us more nimble, more creative, and more entrepreneurial. (See our story "Drug Names Matter.") We do not offer a boilerplate approach, nor do we engage in hundreds of projects per year with multiple offices staffed with transactional sales people. Instead, we focus on a limited number of drug-naming projects where our extensive experience can be invested in client success. Our name is on the line (literally) with every project. With this “skin-in-the-game” approach, we work harder at delivering safe, high-quality drug naming, and we expect highly successful outcomes. Guaranteed. That makes it fun for both of us.
Q - Do you have existing skills and partners to execute global drug-naming projects?
A - Yes, absolutely. About three-quarters of our projects are global in scope. Our Work and Case Studies speak for themselves. A drug-naming project often includes brand name strategy development, name creation, prescreening, legal screening, and then evaluations for linguistics, name safety testing and physician market research. We have all these skills, plus some special ingredients, such as our unique Designed for Safety℠ naming approach. We are fortunate to have a long history with our Partner companies too, making for seamless consistency. We also pride ourselves in our ability to craft the best proposals for your goals and budgets. Take our Safe Drug Naming Challenge and find out.
BACK TO TOP
Q - What does your development process look like, and how are your clients involved in it?
A - Since we customize each project according to your needs, every project is different. But because proprietary brand name development must steer clear of medical errors and misbranding, at the core of our process is our Designed for Safety℠ naming approach, where the name design process is integrated with proprietary name safety measures to minimize risk before, during and after name creation.
We guide you through a rigorous and well-documented workflow focused on establishing safe naming strategies, credible name creation attributes, and trademark distinctiveness. We design up to a thousand names and filter hundreds through legal, linguistic, regulatory and name safety screening tools, and present the regulatory-ready name results to you. Proprietary services for strategy, name creation, legal screening, linguistic analysis, physician/patient research, name safety, and implementation are applied as necessary. Five different design process steps with multiple points of name safety screening are customized for each project, including:
STRATEGIZE---Kick-off, definition (target, marketplace, tactics, etc.), regulatory expectations review
NAME CREATION---Workshopping, name safety prototyping, brain storming, ideation
PRIORITIZE---Legal prescreening, regulatory and on-line evaluations, name rating/ranking
TEST/VALIDATE---Linguistics, name safety (POCA, simulations, FMEA), market research (HCPs, patients)
IMPLEMENT---Recommendations for name submission reports, pre-approval announcement planning, back-up plans
We believe in client involvement too, and our process is uniquely designed to not only help you select a high percentage of proposed names to move forward, but also to gain team consensus to them.
Q - We have never developed a drug name before. What should we be thinking about?
A - Download our "Ultimate Beginner's Guide To Drug Naming In the Regulated Age" for help. Otherwise, first decide when to begin naming activities (for help, see Pharma Naming, below). Once you have determined your readiness, you should be thinking about assembling an internal stakeholder team to participate in strategic naming activities whether you do it in-house or hire an outside drug-naming firm like us. The next consideration is your overall scope in terms of marketing territories, target audiences (professional and consumer), and timing related to your marketing approval submission. This will help provide some direction for your budget, e.g. a global brand name generally costs at least two times more than a regional name. Finally, you’ll need to determine what core drug naming activities can be handled in-house and what needs to be outsourced, such as legal availability analysis, linguistic evaluations, and name safety review. Also, check out Diane’s Story to see how a beginner got through drug naming successfully. Good luck!
Q - What day does the garbage go out?
A - Oops, wrong site. But we hope you are enjoying this one. And if you see any garbage here, let us know.
WORKING WITH US
Q - How would you define drug naming success?
A - We asked a client that same question recently. Her answer: “Having a safe and acceptable brand name we all like in advance of our PDUFA date.” That probably sums it up.
Q - What is your drug naming success rate, and how do you stay ahead of the regulatory rejection game?
A - As you may know, the pharma industry is dealing with a regulatory system where about 40-50% of drug names are rejected worldwide. (Although FDA reported better acceptance rates recently.) Our acceptance rate for names we help create and test for our clients is much higher. The reasons for our excellent track record, and the way we deal with global regulatory approvals, is based on our commitment to “creating names you can trust." Throughout our naming process we make use of "best practices," technical expertise and proprietary methods that consider both the safety and promotional aspects of drug naming (see our Designed for Safety℠ naming approach). Some of our effective "prescriptions" for safe naming include:
Strategy--Regulatory expectations review
Creativity/Prescreening--Naming design practices to help avoid medication errors; name safety prototyping
Testing--In-Depth name safety framework for evaluating proprietary names (POCA, Simulations, FMEA)
Regulatory submission documentation and back-up planning (brand name alternatives)
Q - Was your firm successful from the start, or did the number of projects increase slowly.
A - We opened with one client in the USA and gained a few more quickly. That got us through the first year. Today we work with many different clients worldwide. Repeat business is at about 75% because we believe relationship building leads to client success. Our vision is “drug names matter” and our mission is to help clients create safe drug names they can trust because the brand name is one of Pharma’s most impactful tools. Our idea is to incorporate highly creative resources by tapping into the superb Bay Area freelance creative talent base so client drug names will not only be "safe," but also well liked. We limit the number of project engagements in order to maintain our competitive advantages of creativity, agility, and safe names.
Q - What are your fees for drug naming services?
A - We have no pre-determined rate, nor do we have a holding company hovering over us. We've worked with clients on projects anywhere from $3,000 (USD) for consulting to $250,000 for a full global drug naming project. Big range, right? What we aim for is maximizing our value to you. What are your biggest problems? What are your desired results? If, for example, you need 3 names instead of 1, or if you have an employee naming contest planned, or if you prefer to work with us remotely instead of having interactive workshops––all of these impact our fee. More importantly to you, we usually supply prospective clients with several proposal options from which to select. Still not clear about our fees––-give us a call.
Q - When should our company start the drug naming process?
A - Today, companies start thinking about brand naming in Phase II, or at “proof of concept.” That’s because FDA accepts name candidates (up to 2) from sponsors after Phase II completion (as part of NDAs, ANDAs, and BLAs and prior to marketing application.) In Europe, EMA accepts name submissions (also up to 2) 18 months prior to submission of the MAA (Marketing Authorization Application).
From our experience, companies in the USA start naming activities about 12-18 months prior to their NDA submission.
Years ago savvy pharma companies would start naming as early as Phase I. The tactic got them free brand name impressions before marketing approval. Case-in-point: Enbrel® was "world famous" well before it was approved. At that time, it was less risky to announce brand names earlier because there was a higher name-acceptance rate than today, which hovers around 50% for global brands. Net/net: starting naming activities earlier is better than later.
Q - How long does it take to get drug naming approval?
A - It generally takes anywhere from 3-18 months, depending on several factors: your brand name development process, your key marketing territories, your trademark registration and filing process, and the proprietary name regulatory review process. In addition, sponsor companies in the USA can expect regulatory name reviews to take 180 days under an IND (Investigational New Drug), and 90 days under a NDA or BLA. Names that receive tentative approval then undergo a second evaluation 90 days before final approval of the drug or biologic (see the "train wreck scenario"). In Europe, the name review process takes 3 months.
Q - When do companies start the USAN/INN (nonproprietary or generic name) process?
IND (Investigational New Drug) application. The goal is usually to have a nonproprietary name before large-scale Phase III studies begin. It could take up to 2 years to get global nonproprietary name assignment if you are not familiar with the USAN and INN process.A - Many companies start in Phase I or in early Phase II, after obtaining an
Q - Why should companies name their clinical trials?
A - Many companies name, or “brand,” their clinical trials with catchy names in order to differentiate them from other clinical trials, to increase awareness, and to better recruit patients. See Case Studies for more detail.