3 Tips for Expediting Your Drug Development Program

3 Tips for Expediting Your Drug Development Program

By Kathrin Schalper, Ph.D., Senior Principal Consultant, Regulatory Strategy

Last week, I led an engaging discussion at BioLabs San Diego on how life science companies can streamline and expedite their development programs. The event was the second installment in Halloran’s Speaker Series, which launched last month. 

I kicked off the presentation with one of my favorite quotes: “Medicine is For People, Not for Profits” by George W. Merck. Before we dive into the intricacies of drug development, and how we can streamline and expedite the process, we must never forget our true motivation. We endure the strenuous process of drug development by clinging onto the hope that one day, it will translate into a life-altering treatment option for patients.

Now that we’ve covered the “why” behind drug development, let’s now transition to the “how.” 

As a biopharma company developing compounds for FDA approval, you have a tool box to help guide you along the process and speed up your timeline. Whether that’s a special designation such as breakthrough or fast-track, or conditional marketing authorization, it serves in your best interest to know exactly what you qualify for and when to apply as the early facetime with the FDA could help guide the development of your pipeline.

After exploring the drug development tool box and taking note of which tools to take advantage of, here are my top three tips for streamlining and expediting your drug development programs:

  1. Apply for special designation as soon as you qualify. These designations have diminishing returns. The sooner you apply, the more “bang for your buck.” Take full advantage of the status!
  2. Stack designations on top of each other. If you qualify, apply! There is no limit to the designations that you can take advantage of, so long as you qualify. As we all know, every little bit counts in the world of drug development.
  3. Utilize scientific advice provided by the FDA. Take full advantage of every meeting you are given with the FDA. Their experience is invaluable and can shape the future of your programs. 

If you need help streamlining your drug development program, contact our team here.

Are you interested in attending our next Halloran Speaker Series event? Follow along on Twitter to see when we announce our 2020 schedule.