Dr Denise Croker
General Manager, Synthesis & Solid State Pharmaceutical Centre (SSPC), Bernal Institute, University of Limerick, Ireland
How we discover, manufacture and take medicines is an ever evolving industry, accelerated by advances in technology and biological and materials understanding. Blockbuster drugs, once the backbone of successful pharmaceutical companies, are on the decline as drug products become more tailored and patient populations decline. “Personalised medicines” has become a buzz word to reflect the future of patient specific drug prescriptions, potentially for a patient population of 1. Medicinal molecules are becoming larger and more complex resulting in different processing requirements and soaring health costs. Stem cell therapies have emerged with the potential to offer a renewable source of replacement cells and tissues to treat major degenerative diseases. Accompanying these advances on the drug material side have been advances in processing routes for making pharmaceutical products. The industry has witnessed a shift from batch to continuous processing, most recently demonstrated by the first Food & Drug Authority (FDA) approval of a drug product manufactured continuously (Orkambi®, Vertex). Demands to produce medicines local to their region of distribution have put pressure on footprint, mobility and flexibility of the manufacturing process. Process sustainability and environmental considerations remain key considerations. As a highly regulated environment, the pharmaceutical sector can find it difficult to implement change quickly and correctly requires vigilance in all process modification. This lecture is an effort to capture the current state of the art in the pharmaceutical sector, and provide a dialogue on the anticipated opportunities and challenges facing the sector in the future.