Brilliant science is required to identify potential therapeutics. The skills needed for discovery, however, are very different than those required to realize a commercial drug product. Years and dollars are spent too often in futility — the funnel of successfully marketed drug products is small compared to the myriad of candidates. It’s clear that a different brilliant science (and process) is required to deliver high probabilities of success in achieving a viable drug product ready for commercialization. The US Food and Drug Administration (FDA) expects cogent rationale within submissions for what, how and why chemistries are used and that the manufacturer demonstrates clear process robustness to produce a product that meets quality standards of efficacy, stability and safety.
In this free webinar, the featured speaker will demonstrate how the Quality by Design cascade ensures this expectation is not only met but is clearly articulated in specific terms. This presentation will include an in-depth overview of all four stages of the Quality by Design process.