Successfully Managing The Transition From Research To Development

Transitioning a drug candidate from research to development is a critical phase that requires meticulous planning, regulatory alignment, and expert execution. A thorough understanding of FDA requirements is essential, and addressing regulatory expectations through a robust Integrated Development Plan (IDP) ensures alignment across preclinical, clinical, and manufacturing domains. Common preclinical challenges include selecting appropriate animal models, adapting study designs based on FDA feedback, and avoiding assumptions that lead to delays or clinical holds. Engaging the FDA early, especially through pre-IND meetings, is vital to clarify regulatory expectations and refine development strategies. Missteps, such as underestimating the importance of FDA feedback or skipping pre-IND interactions, can derail progress.

The shift to development also demands organizational changes. Key success factors include aligning teams on IND-enabling work, engaging subject matter experts (SMEs), and maintaining a strategic focus on meeting FDA requirements. By proactively addressing regulatory, technical, and operational elements, companies can facilitate a smoother transition, advancing their drug candidates efficiently toward clinical trials and eventual market approval.