Pharmaceutics & Novel Drug Delivery Systems

The need for Novel excipients is growing due to various formulation issues related to drug solubility, patient-centric considerations, unique needs in biologics and an increase in advanced manufacturing methods such as continuous manufacturing and 3D Printing. There has historically been significant uncertainty regarding the potential regulatory implications of using novel excipients and this has severely limited innovation in drug development. Due to this uncertainty and concerns about customer uptake, excipient manufacturers have also been reluctant to develop novel excipients. However, there is some big news on the horizon which could help resolve these uncertainties. On September 7, 2021, The U.S. FDA's Center for Drug Evaluation and Research (CDER) launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. If this pilot program is successful, this program could be made permanent. This would provide a new pathway which would encourage the early development and use of novel excipients to facilitate advancing the next generation of medicines to patients and help stimulate excipient innovation in the global pharmaceutical industry. This presentation will summarize the current need for novel excipients and will outline the current FDA Pilot Program and its potential impact on drug development and innovation.