RealFeedApp Biotech company revises its early assumptions
While early CDMO engagement accelerates timelines, premature commitment without aligned clinical and nonclinical strategies leads to costly rework. Separate planning of workstreams often causes CMC decisions to precede necessary evidence.
- Field
- business and funding
- What they did
- The authors explain that early engagement with a contract development and manufacturing organization (CDMO) is necessary to advance clinical, nonclinical, and regulatory activities in parallel.
- Why it matters
- However, starting early and committing early are different; making CMC decisions before having the necessary evidence can lead to rework that costs both time and money.
#cdmo#clinical trial#biotech#manufacturing#regulatory
