On the New Paths

A number of product trends continue to develop. Ongoing advances in understanding the relationship between protein structure and function continues to facilitate the development of engineered biopharmaceuticals. Alternative engineering methods, such as PEGylation and alteration of a protein’s glycocomponent, continue to come to the fore. Intensive efforts to develop non-parenteral biopharmaceutical drug delivery systems may also finally be beginning to pay off. Although final safety studies remain to be completed, Exubera (an inhalable insulin developed by Inhale Therapeutics, Pfizer and Aventis) now stands a very good chance of being approved for general medical use. Generic and nucleic acid-based biopharmaceutical products are also likely to become a reality within thenext few years.

Patent protection for a range of early biopharmaceutical blockbusters (including erythropoietin, human growth hormone and a -interferon) is now coming to/ is at an end, and the generic biopharmaceutical industry is now gearing up. No gene therapy-based product has yet gained regulatory approval. Progress however continues, even if it appears as ‘two steps forward, one step back’. The recent French severe combined immunodeficiency (SCID) trial results illustrates this perfectly. Using a retroviral based delivery protocol, the French managed to correct SCID in a number of children.Although successful, the ensuing development of a leukaemia-like condition in at least two trial participants has put celebrations (and retroviral based trials in many world regions) on hold. Potentially the greatest impact upon the sector’s future, however, rests with genomics, proteomics and related technologies. Without doubt these technologies will not only identify many new drug targets, but will also reveal many biopharmaceutical lead compounds. It’s a good time to be a pharmaceutical biotechnologist!

-Dr. Gary Walsh-