As a few others have mentioned, technical transfer activities are not completed until a company has fully developed the medical device/drug/combination product and its manufacturing process. This often doesn’t occur until during or after Ph3 clinical trials (and often the timeline depends on how risk averse the company is, i.e. some companies start tech transfer before Ph3 trials are completed because they are THAT confident that the product will be successful). Often, the product made for Ph1 trials is not manufactured in a sustainable way since the patient count for those trials is often low. After successful a PH1 trial read-out, a company will start developing the final product/manufacturing process for eventual technical transfer.

– Laura Wehmeyer