Question: How can biotech companies proactively engage with regulatory agencies to streamline approval processes for accelerated market access?

Answer: “Direct engagement with the Agency during formal meetings is the most surefire way to ensure hurdles and roadblocks – as seen by the Agency – are identified and articulated prior to initiating a clinical program. If a company is targeting RMAT designation, for example, share this objective with FDA during a pre-IND meeting or a Type D. Understand the precedent – FDA guidance, recent approvals, any mitigating factors – most relevant to the asset in question. Always recognize the Agency has but one goal: ensure drugs and biologics are safe and effective. It’s our duty to demonstrate such facts effectively and preemptively to ensure the asset moves through the review and approval process quickly. Although many biotechs must move quickly to survive, sacrificing sound regulatory strategy in the name of speed will rarely yield the desired result of a successful approval – accelerated or otherwise.”— Adam Runkle, MRA, ML