The level of investment required and inherent risks in development of today's new and advanced biopharmaceutical products are greater than ever posed in the history of the industry. Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development. Additionally, new clinical development tools and regulatory principles, e.g., enrichment strategies, adaptive trial designs, breakthrough designation, are emerging that enable more efficient clinical development, as well as, more expedited approval pathways for new therapeutic approaches to disease management.
A regulatory-science driven regulatory strategy is essential as part of today's biopharmaceutical product early development planning. A well-prepared regulatory strategy will align the proposed clinical development plan with business objectives, and preemptively identify challenges, as well as, proposed alternative/innovative approaches to new product development which leverage new standards for evidence generation supporting continuing development and global market authorization. A regulatory strategy helps to define key issues/challenges to proactively discuss with regulatory authorities and also defines key program milestones that are often considered business catalysts driving investor interest and financing. Most importantly, a timely, well-prepared and well-maintained regulatory strategy, with proactive and collaborative interaction with regulatory authorities, is often a differentiating factor for industry leaders bringing commercially successful and innovative products to market in today's competitive marketplace.
Regulatory strategy is a major component of successful biopharmaceutical product development. Covance Global Regulatory Affairs prepares and maintains regulatory-science driven and product-specific global regulatory strategies for many product types, e.g., drugs, biologics, drug-device combinations, vaccines, gene-therapies, cell-therapies, across a range of therapeutic areas and full regulatory strategy support for product development initiatives.
Did you like this article and want to learn more? Check out this article from Clinical Leader on How to Develop a Successful Regulatory Strategy.