Drug Naming Wish List 2015
The lead executive charged with naming a new pipeline drug today has one of most uncertain jobs in all of biopharma. Faced with multiple hurdles which become steeper with each passing year––trademark availability, linguistic and cultural appropriateness across continents, and name safety/regulatory acceptance––high anxiety seems the norm. Successful naming demands big doses of art (creativity and linguistics) and science (regulatory know-how and market research), with a smidgen of luck (timing) thrown in.
2014 marked the highest level of FDA (Food & Drug Administration) new drug approvals since 1996, and EMA (European Medicines Agency) also reported higher levels of new drug approvals. At the same time, we witnessed the biggest remodeling of drug naming guidances in decades. Given all this disruption, see if these five items should be on your drug naming wish list to help things go a little smoother in 2015.
1. Start Naming Earlier.
Gone are the days when brand naming activities started in Phase I, and brand names like Enbrel became “famous” well before marketing authorization. The rule of thumb seems to be to begin brand naming when proof of concept is determined, or at the end of Phase II trials (as per the FDA’s advice). However, with the new more complex naming guidances and overcrowded legal registers, the clarion call is “earlier is better than later.”
2. Adhere to Regulatory “Best Practices” to Counter Drug Naming Uncertainty.
No doubt that for many drug-naming teams, the biggest wish for 2015 is to have confidence that regulatory authorities will approve their preferred name. But there’s no such utopia in drug naming––up to half of all drug names are rejected. (Although the numbers are improving.) Sticking to the new regulatory guidances, and doing things the right way will at least provide a higher level of confidence for the team. And having confidence will reduce the feeling of uncertainty.
3. Treat Naming As An Investment.
The value of building equity in your brand far exceeds the cost of creating a new drug name. Your brand name is your friend. Use it as a sound bite for communicating your unique science, your competitive difference, your whatever. Imagine your CEO in front of investors at this week’s JPMorgan Healthcare Conference saying, “Our new CodeName101 product does ___,” versus “Perjeta performed far above ___ .” Better stated: What is the cost of not creating a drug name?
4. Brand Your Clinical Trials.
Branding clinical trials, and more specifically creating names or trademarks to replace number-coded designations, is growing. No wonder. Research shows that promoting a clinical trial name instead of a code name increases enrollment, enhances citation rates, and even increases methodological quality of the clinical trial.
5. Be Enterprising.
Biopharma executives are passionate about their scientific discoveries. But their scientific dreams cannot advance to commercial reality unless they take a go-ahead approach to drug naming. How better to appeal to investors, to attract potential partners, and to communicate with the entire healthcare community?
Best wishes for success in 2015. What are your thoughts? Let us know here.