Developing A New Biologic Drug: Regulatory Challenges And Considerations

By Parrish Galliher and Brian Hubbard

Regulatory challenges and considerations when bringing a new biologic to market

The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market, there are many regulatory milestones and hurdles. As in other aspects of drug development, up-front planning can prevent headaches down the road. One of the key decisions is knowing when your team is short on regulatory experience and expertise, and when to call on a consultant or hire an expert to fill the gap. Your regulatory investigator can also be an excellent resource, who can share valuable knowledge and advice. Meet with them early, and cultivate a good relationship.

Phase I clinical trials are first-in-human trials on healthy subjects to determine drug safety. As you complete pre-clinical trials and plan to move to clinical Phase 1 trials, you must plan for compliance with a strict level of regulatory requirements as part of these efforts.