Biologics, Steriles fill-finish and clinical supply

In 2017, a record 16 out of 46, or 35%, of the new molecular entities (NMEs) approved by the U.S. Food and Drug Administration were precision medicines. Over the last four years, precision medicines have averaged one out of four NMEs. There also has been a sharp increase in drugs receiving an orphan designation. With the dramatic rise in the targeted therapies that are in development, many of which are biologics, yesterday's development capabilities do not necessarily fit the needs of today's molecules. Many companies find themselves racing furiously to get these precious and expensive molecules to clinic as quickly as possible. Speed, small batch sizes, material losses, and economics are all major concerns for companies attempting to accelerate their molecule through early development. Thermo Fisher Scientific has unique capabilities that have helped many companies overcome these challenges and to get their molecules to clinic quickly.