QbDVision

A couple additional thoughts: There’s always tradeoffs. In the above example, the latter decision indeed achieves a faster readout. But you'll eventually need to do PD while also ensuring it's comparable to the Ph1 product & run a bridge study group. This can be expensive and potentially cause delays. Another common question is whether to build internal manufacturing capability vs. rely on CDMOs. The former may be short-term expensive, but long-term cost saving. Part of why these decisions are difficult is that you're "locked in" to the manufacturing process as described in the Module 3 of your IND. CMC is often an underlooked component for early-stage spinouts, but can make or break timelines unless it's thought ahead. Takeaway: get yourself a CMC advisor earlier than later

For biotechs developing complex therapies, management teams face some of the toughest decisions around manufacturing & CMC. For example - should you delay the Ph1 trial to first optimize the manufacturing process, or move ahead with a less efficient process for a faster readout?