Ten years ago, Erik Mogalian had just finished one advanced degree and was embarking on another. Today, he is celebrating being part of a team that developed a brand new drug that effectively cures a serious illness.
Mogalian completed his PharmD degree in 2004 and then enrolled in Pharmaceutics and Pharmacokinetics track of the PhD program. As a graduate of both the PharmD and PhD programs at COP, Mogalian knows his training at UA COP has helped him in his role in the discovery of the new hepatitis C drug.
During his time in graduate school, Mogalian worked at Tucson Medical Center. Upon his completion of his PhD, Mogalian joined the Gilead Sciences team. From December 2007 to October 2012 he worked in the Formulation and Process Development (FPD) group, and in 2012 Mogalian joined Gilead’s Clinical Pharmacology group. While with FPD, Mogalian became part of an exploratory project researching a possible drug for the treatment of hepatitis C. The project led to the discovery of ledipasvir, a drug now approved for use in the United States, Europe, and Japan as a fixed-dose combination with sofosbuvir (ledipasvir/sofosbuvir; Harvoni®).
“I owe a specific thanks to Dr. Paul Myrdal and Dr. Sam Yalkowsky, whose training in solubility, development and characterization of physical forms, and understanding of aerosols, led to the use of enabling technologies to improve the behavior of a very insoluble (BCS class 2) compound (LDV), making it an easier drug for patients to take,” Mogalian states.
“I also owe specific thanks to Dr. Mike Mayersohn, whose teaching has become very central to my newer role as a clinical pharmacologist and has already resulted in the conduct of several Phase 1 studies also part of the ledipasvir/sofosbuvir drug label.”
Hepatitis C is a virus that results in the slow, discrete destruction of the liver. Often individuals do not know they are infected for many years and usually not until their liver has been subject to significant damage. The virus replicates rapidly with a high rate of mutation, which is why the development of vaccines has not been successful to date. Historical treatment of HCV included the use of interferon and ribavirin, a combination that was not very effective and not well tolerated. First-generation HCV protease inhibitors became a treatment option and increased cure rates when administered with interferon and ribavirin. Even more recently, sofosbuvir, the first nucleotide HCV (NS5B) inhibitor became available and increased cure rates further, and in some cases eliminated the need for interferon. The newly approved drug, Harvoni®, is a combination of ledipasvir and sofosbuvir; ledipasvir inhibits the protein (NS5A), which is critical for the replication and assembly of the hepatitis C virus. The combination of ledipasvir and sofosbuvir has resulted in very high cure rates for HCV (>90%) and is a major advancement for the safety and tolerability of patients receiving treatment.
“Both the breadth and depth of education I received at the COP served me well while playing a role in the discovery of ledipasvir and in the development of the ledipasvir/sofosbuvir,” says Mogalian.
When asked what advice he would give current and future pharmacy students, he says, “Find that niche that makes you tick and chase it. I started pharmacy school with full intensions of becoming a practicing pharmacist. During school, drug delivery and pharmacokinetics really struck a chord with me, so I am happy to have landed where I have in the area of drug development.”
Story by Justine O'Connell, communications assistant