Five surprising factors that influence your road to the clinic

When setting out to start a cell or gene therapy program, many biotech and pharmaceutical companies inadvertently assume that the preclinical drug development milestones will be similar to traditional therapies. Cell and gene therapy (CGT) programs, however, are far more complex to manage and execute from regulatory, scientific and operational perspectives. Minor miscalculations with timelines or budgets can often delay Investigational New Drug application (IND) filing, posing a risk to the company's financial standing.