Regulatory Considerations for Co-Development Activities for a Therapeutic and an In Vitro or Companion Diagnostic within a Pharmaceutical or Biotech Company

Abstract

The regulatory and research landscape for therapeutics is continually evolving globally. These changes are influenced by factors such as requirements by the regulatory agencies and health authorities, or strategic positioning of the product in the marketplace. Challenges also arise from the necessity to develop a therapeutic product in conjunction with an assay. The therapeutic company finds itself in unfamiliar territory and might not fully appreciate unforeseen challenges that could delay and even potentially derail a development program. Choosing the right partner to develop the assay and strategic choices regarding the source of regulatory expertise can be the difference between failure and success. This article provides considerations for regulatory professionals working within pharmaceutical or biotech companies that are actively pursuing In Vitro or companion diagnostics to accompany the products in their therapeutic portfolio.