ABSTRACT
Key words: dilevalol; optical resolution; chiral synthesis; outsourcing; process plant; regulatory
The turbulent nature of New Chemical Entity (NCE) development is widely recognized. Only 1 in 10 or so new entities identified for development will reach the market place1. Pharmacological, Toxicological and Clinical findings can halt development at any time. The rate of progression of a new entity can be greatly changed by toxicology issues, by metabolic findings, formulation difficulties, the availability of bulk supplies, readouts from both clinical studies and the FDA, changing market conditions and so on. In short, priorities are constantly shifting. The process of NCE development also runs so fast that, from a Chemical Development standpoint, conflicts between keeping the IND synthesis vs. improving or changing to a better synthesis provide endless challenge and, frequently, much frustration. In an NCE development respect, Chemical Development organizations mostly act in a service role, providing high quality NCE’s for toxicology, clinical, pharmaceutical development and analytical programs in a timely manner. Beyond the service role, Chemical Development’s contribution to the identification and development of a commercial process is generally crucial. In this area, involvement with Manufacturing organizations is essential — indeed the most successful Chemical Development organizations have a close link with Manufacturing.
