More than 40 percent of potential new drugs fail in preclinical trials, says Bryan Berger, and another 30 to 40 percent are disqualified during the first phase of clinical testing.
Berger, a P.C. Rossin assistant professor of chemical and biomolecular engineering, says one reason for the low success rate is that many drugs are too insoluble to be absorbed in sufficient quantities by the body. Another stumbling block is the difficulty in “scaling up,” or producing large quantities of a substance that is easily made in tiny quantities in the laboratory.
He says the pharmaceutical industry loses millions of dollars a year to drug failures but has struggled to find a cost-effective and biocompatible fix for drug insolubility.
Berger is proposing a three-part solution to the problem. He believes he can boost drug solubility with a protein called hydrophobin that is found in mushrooms and other fungi. The hydrophobin would act as a surfactant by reducing surface tension between liquids and solids.
By controlling hydrophobin’s pH, Berger believes he can target the delivery of a drug to diseased sites in the body. And by genetically reengineering the bacteria E. coli, he hopes to produce a drug in commercially viable quantities.
Berger recently received a five-year CAREER Award from the National Science Foundation for a project titled “Scalable Synthesis of Designed Biosurfactants to Enhance Drug Bioavailability.”
In his CAREER project, Berger is working with Particle Sciences of Bethlehem, Pa., a contract development and manufacturing organization that offers drug formulation services to pharmaceutical companies.
“We plan to work with ibuprofen, also known as naproxen, as a first test case. Naproxen is notoriously water-insoluble. We will try to formulate the drug with a different surfactant and progress from there to try to formulate anti-cancer drugs.”
Berger also won recognition for the project in 2013, when he received a National Innovation Award at the TechConnect World Conference and Expo in Washington, D.C. The event brings together hundreds of innovators and technology business developers and funders.
Read the full story at the Lehigh University News Center.
-Kurt Pfitzer is a writer with Lehigh University Media Relations.