Stuart Levy

Fluidity Versus Certainty in Early Small Molecule CMC Development
Friday, June 19, 2020
The transition of a drug from optimized medicinal chemistry lead to candidate nomination and development through clinical proof of concept has been referred to as the “Valley of Death.”1-3 It is the most consequential, high-... read more
The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and ...
Tuesday, February 25, 2020
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to develop and supply a drug’s dosage form holistically. While there are certainly distinctions between the activities contributing to... read more
Form Selection in API Development and Manufacturing, In the Context of “Phase-Appropriateness”
Thursday, March 21, 2019
The form of an active pharmaceutical ingredient (API) can be defined as both the chemical and physical state in which it is isolated and supplied for the development and manufacturing of drug product. Because the nature of ... read more

Articles by Stuart Levy