By Daniel Kavanagh, PhD, Senior Scientific Advisor, Gene Therapy
The field of gene therapy is exploding. Investment in the global gene therapy market is expected to grow at an annual rate of 30%.1 By the end of 2020, there were 1,100 biopharma developers in the cell and gene therapy space, compared to 100 in 2019. Of the 1,200 cell and gene therapy trials ongoing in 2020, 152 had reached Phase 3.
This growing market presents a multitude of challenges for sponsors, CROs, institutions and their sites that they must consider when running these trials. To meet these challenges, all stakeholders need to understand the important roles of not only the IRB, but also the IBC—Institutional Biosafety Committee—in facilitating a safe and effective study.
In this article, we share the four biggest takeaways for drug developers in this booming space.