A Well-Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

A Well Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

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.

Regulatory Strategy is Essential

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.

Considerations Regarding the Need for a Global Regulatory Strategy Program

  1. Have the target clinical indication and anticipated labeling claims for your product been outlined as part of a preliminary target product profile?
  2. Does your current program include consideration of anticipated future approval requirements, e.g., endpoints, comparators, effect sizes, statistical criteria, based on current approval precedents and ongoing competing clinical programs?
  3. Does your program include consideration of a changing regulatory environment, including implementation of new legislation, guidances, or review requirements?
  4. Does your program proactively identify challenges or issues that may delay clinical development and also define innovative solutions/approaches to circumvent these challenges?
  5. Does your program leverage newly accepted development tools to reduce clinical development time and expense and also proactively plan to maximize acceptance of foreign data to access global markets?
  6. Does you program currently identify key opportunities to engage global regulatory authorities and specify key data requirements to support these interactions?
  7. Does your program proactively eliminate development risk and uncertainty, while maximizing the potential for commercial success?

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.