The passion of your team with the guidance of a regulatory expert will be critical factors in getting the approvals you need for commercial success.
You have to work through the “wrong” ones to get to the “right” one. What does that make you think of? It makes me think of 2 things: 1) Relationships, and 2) Drug Development. I know, you’re thinking, “huh?”
Think about it though . . . dating . . . how many people did you date before you found your “Mr.” or “Mrs. Right?” (Those who are still looking don’t give up!) Think of all the time, emotions and money spent on the “wrong” ones! In my case . . . there was a lot of “sifting” until I found my loving hubby (Brownie points if my husband actually reads this! Better yet, if he doesn’t mention this, he’s sleeping in the shed tonight because it means he didn’t read my newsletter!). It was from those “Mr. Wrongs” that I learned what I ultimately wanted (or didn’t want!) in a life partner! I am now happily married (10 years already!) with two wonderful kids (cue cheesy love song).
The regulatory challenge of drug development
Drug development . . . as you all probably know (and experience!), there is much failure in this amazing, but challenging industry we live in! It can be frustrating and draining to spend so much time, money and even emotion on a product, to then have it fail in Clinical Trials and never make it to market (cue depressing break-up song).
“In general, it costs an average of $800 million and takes 12 to 15 years before a drug makes it from the lab bench to your medicine cabinet!”(1)
The regulatory roadmap
It’s tough to summarize activities over 11-14 years, but in short (as most of you know), the process goes like this:
—Drug discovery begins with an idea for a new disease target, often licensed from a university laboratory.
–Industry researchers start sifting through hundreds (sometimes thousands!) of compounds, looking for one that will hit the biological target.
–The lead candidate is tested in animals to look for toxic side effects and potential efficacy.
–IND Phase: clinical trials in humans. These trials eat up much of the development costs.
- Phase 1: small number (about 20-80) of healthy volunteers to assess safety
- Phase 2: medium number (about 100-300) of patients (affected by the disease the drug is indicated for) to assess efficacy, safety and pinpointing acceptable dose range
- Phase 3: large number (about 1000-3000) of patients to assess efficacy, safety and identify side effects.
And even more depressing . . . only about 1 in every 5,000 drugs in development actually make it to market.
What you need to successfully navigate the regulatory roadmap
Talk about a high failure rate (kinda like youngins dating)! YUK! There’s a ton of detail that goes into the above lengthy process. It takes a lot of brains (like yours), a lot of hard work (like mine), and a lot of hope (optimists) to get to market.
In trying to find the bright side of each of these depressing realities, which in turn will help motivate us: as you see, the cost to develop a drug is ridiculously high . . . this helps me feel a little better when I go to buy an OTC or prescription drug and my wallet is quickly emptied! And with the high failure rate, I’m very comforted in knowing how detail-oriented, diligent and CAREFUL drug companies and the FDA are when developing these products and reviewing the data. Makes me feel a little safer knowing the process isn’t rushed just to get a drug on the market.
So how do we continue on with our daily jobs knowing the painfully low success rate in our industry? In my mind, it’s all about perspective, persistence and positive thinking.
Quick Tips:
- As in dating, we have to weed through the bad ones to get to the good one! DON’T RUSH IT. There’s no turning back (well, not easily and pain-free anyway)!
- Each failed drug or failed relationship is NOT a waste of time or money. TONS of useful information is gained from these processes. Stay positive no matter the results, and be proud of the work accomplished.
- Take advantage of all the years of knowledge that’s out there (literature, colleagues), and consider similar products that have failed and/or been approved. You’ll have a head-start!
- Know your competition . . . risk of failure is that much higher when someone else is developing a similar product with the same disease indication.
- Have passion for the product you are developing . . . that helps maintain the positive attitude and “I won’t give up” mentality!
“I won’t give up, every day that passes; every lesson learned . . . we are that much closer to ‘the one’.”
Notes:
- Cost and time line estimates based on over 15 years of industry experience of McCormick LifeScience Consultants, LLC.
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