Why Is The Trial Master File Critical In M&A Activities?

Expected Pharmaceutical Mergers & Acquisitions (M&A) activities in 2022 

Consulting company PWC is projecting M&A investments in the pharmaceutical and life sciences industry to reach $350 - $400 billion in 2022. This is expected after 2021 saw a 52% increase in deal volume from 2020 and a 42% increase in deal value.1  

For an industry traditionally known for frequent M&A activity, new advances in cell and gene therapy and technologies such as mRNA will fuel growing interest in scientific innovations and growth. Deloitte identified failed or negative results in drug trials, the need to replenish pipelines, and the downstream effects from past megamergers and divestitures as potential catalysts for M&A activity in 2022.2  

The TMF tells a story 

This flurry of activity will burden R&D teams to conduct due diligence on M&A targets efficiently. The teams must then determine the required strategies to bring products, portfolios, and teams together and implement them successfully. The Trial Master File tells the story of a clinical trial and can offer critical insight into a product’s history. It can also provide powerful indicators to guide teams to develop and employ risk mitigation strategies.