Principal Scientist Bristol-Myers Squibb Company New Brunswick, New Jersey
Externalization of early phase work within the Pharmaceutical industry is becoming more common place. Commonly it is the manufacture of a few steps within a synthesis, analytical testing for specialty methods, or stability studies. Oligonucleotides and siRNA appear to be the exception to the rule. Many companies, large and small, externalize the complete program development. This is due to expertise and specialized equipment that it takes to manufacture, characterize and release these larger (non-biologic) molecules. Oligonucleotides (the single strands for siRNA) are in a unique position, as they are excluded from many of the ICH guidelines (but held to others), which complicates the regulatory pathway. This talk will focus upon the challenges of externalizing the API manufacture and release testing for this class of molecule whilst gaining alignment to bend the internal processes set up for the release and filing of a small molecule.
Upon completion, the participant will be able to understand the challenges of externalizing an Oligonucleotide or siRNA program.