Five Surprising Factors That Influence Your Road To The Clinic

When embarking on a cell or gene therapy (CGT) program, many biotech and pharmaceutical companies mistakenly assume that preclinical drug development milestones will mirror those of traditional therapies. However, CGT programs are inherently more complex to manage and execute, with significant regulatory, scientific, and operational considerations. Even small errors in budgeting or timeline estimates can cause delays in Investigational New Drug (IND) applications, which can jeopardize a company’s financial stability.

At the same time, the demand for CGT is rapidly increasing, with the industry raising a record $23.1 billion in 2021. This high demand, coupled with the need for advanced scientific expertise and sophisticated logistics, has led to capacity constraints among service providers.

To successfully navigate the path to IND approval, it is crucial for CGT programs to be supported by a robust strategic and regulatory plan, with well-defined timelines and budgets established at the outset. In this article, we examine the factors that impact CGT timelines during the preclinical phase and offer actionable strategies to help ensure timely and cost-effective IND filing.