Regulatory Portfolio Management: From Bad To Gold

To facilitate the intricate process of product development and regulatory submissions, effective management is essential to foster a pipeline's expansion and ensure the timely execution of regulatory tasks.

A small biotechnology firm specializing in immuno-oncology found itself in a comparable situation and enlisted the services of Halloran Consulting Group (Halloran) to secure a Regulatory Program Manager. Their objective was to oversee their extensive regulatory portfolio, which comprised more than 20 programs at different stages of development, and establish swift visibility and control over all these initiatives.

Due to the company's diverse development stages, varied asset plans, multiple information silos, and high personnel turnover, a comprehensive view and oversight of all programs became essential. While the company already had a rudimentary program management system, it required an experienced regulatory program manager to establish consistent regulatory practices across the pipeline. The company also sought a clear approach to comprehending each program's history, strategy, and real-time status so that it could efficiently meet internal timelines, share information across multiple teams, and prepare for future interactions with the U.S. Food and Drug Administration (FDA).

Uncover how a multiphased approach to these challenges helped the small biotech to organize its 20+ programs allowing for efficient decision making, timely adaption to changes in strategy, and an understanding of current activities. Get all the details by accessing the case study below.