Regulatory Strategy… Now or Later?

Have you all at one time been responsible for preparing Thanksgiving dinner? Did you “wing” it or plan ahead / strategize prior to cooking? Although I lucked out this year and went to my in-laws, I have had the “pleasure” of hosting. I can tell you that “wingin’ it” won’t work! Between the number of dishes to cook and timing everything to be ready and warm at once (biggest challenge, probably even for those who have 2 ovens!), much preparation and planning needs to occur! I remember watching my parents tag-team the kitchen every year at Thanksgiving . . . and a delicious and warm meal was always served! I know that came with good strategizing from the start!

Which “naturally” (eh-hem) leads me to our topic of Regulatory strategy; many companies implement this fairly late in the game. It’s a common belief that Regulatory comes later when the company is ready for a big submission (like their Investigational New Drug Application [IND]), but the best practice is to implement a Regulatory strategy early in the Nonclinical phase; typically years before trying to approach the FDA (or any Regulatory Agency) and enter into human clinical trials.

Getting your Regulatory strategy team in place early on in your product’s life cycle is so important. Determining the necessary nonclinical studies is critical, as every product is different and what’s required for one may not be required for another. Can you imagine spending millions of dollars on a nonclinical program and then finding out that the FDA won’t review half of the data because they felt it was irrelevant? OR . . . spending huge amounts of time and money on your nonclinical program and submitting your IND, only to find out that you left out a couple critical studies? I don’t want to be in the room when you break that news to your management team and Board of Directors!

The Nonclinical program is just one example where Regulatory strategy plays a role. The Chemistry, Manufacturing and Controls (CMC) and Clinical programs, combined with a state of the art Quality program, all require early planning and strategizing from a Regulatory perspective.

If you spend the effort and money early on to get solid programs in place, you will save a lot of time, money and stress down the road! All increasing your chances of obtaining our common goal of getting our product to market and improving the lives of patients.

As someone who genuinely enjoys Regulatory Affairs (no, I’m not feeling feverish), I think one thing that really keeps my interest is its constant evolution and change. It keeps things interesting and challenging. Companies can no longer rely on previous strategies or assumptions. They can be used as a starting point, but one must develop their own product’s customized Regulatory strategy. It’s not the black and white world everyone perceives it to be. Yes, there are regulations and guidelines to follow, but much is up for interpretation and there’s a lot of gray.

Just like when preparing Thanksgiving dinner for your 15 relatives, don’t wing it . . . strategize, devise a plan and stay organized throughout your meal or product’s lifecycle.

Toto's Tips

  • Remember to include Regulatory at the strategy table from the start.
  • Don’t rely on the Regulatory strategy of approved products . . . customize the plan for your product; that’s what the FDA will expect.