Advanced therapies: The advantage of early and frequent regulatory interactions

Navigating the dynamic regulatory environment in cell and gene therapy development involves a complex and iterative process. To help support planning and development, regulators can provide guidance and substantive feedback on several key aspects of a sponsor’s proposed advanced therapy program.

Alicia Baker McDowell, DRSc, MS, EMBA, Head of Regulatory Strategy and Product Development Consulting at Fortrea, recently shared an overview of a product’s possible regulatory designations with the FDA and EMA and discussed the benefits of establishing engagement with regulators. Read her white paper to learn about:

• Assessing the available expedited programs for serious conditions and designations
• Building flexibility into clinical design
• Ensuring diversity and inclusion of under-represented populations in pivotal clinical trials
  

“Drug development sponsors need to think ahead—as early as possible—when developing an advanced therapy,” she wrote. “This involves considering a product’s possible regulatory designations, establishing engagement with regulators, creating long-term follow-up plans for a program and determining how to meet the goals of diversity planning. Throughout development, an early focus on chemistry, manufacturing and controls (CMC) also helps identify critical issues and gaps to avoid potential delays in product development.”

For more on Fortrea's experience and expertise in Regulatory Strategy Consulting, visit https://www.fortrea.com/solutions/fortrea-consulting-services/regulatory-strategy-consulting.html