Amy Barton Pai, Pharm.D., BCPS, FASN, FCCP, Associate Professor in the Department of Pharmacy Practice at Albany College of Pharmacy and Health Sciences, has been awarded a one-year research grant totaling $499,999 by the National Institutes of Health in cooperation with the Food and Drug Administration.
Dr. Barton Pai will collaborate on the grant with ACPHS Associate Professor Dr. Amit Pai, as well as Drs. Dan Meyer and Brian Bales from GE Global Research in Niskayuna, NY.
The human body needs iron. Iron is essential for making the proteins hemoglobin and myoglobin. Hemoglobin is found in red blood cells and myoglobin is found in muscles. They help carry and store oxygen in the body.
Iron is also part of many other proteins and enzymes in the body. However, since excessive iron can cause toxicity, it is tightly regulated by the body.
Iron is often delivered intravenously (“IV iron”) to treat anemia in special populations such as patients on long-term dialysis or those who undergo gastric bypass surgery.
When delivered through an IV, iron is packaged in a carbohydrate shell so that is can be properly processed by the liver and remain non-toxic to the body. But if an excessive amount of “free iron” leaks out of the shell, it can cause oxidative stress, cell damage, and lead to potential long-term health complications.
Generic versions of IV iron products (also called biosimilars) are currently being developed, but a method to predict the rate at which these products will release free iron compared to their brand name counterparts does not yet exist.
This grant will support development of a model that will help better predict free iron release from generic IV iron products through improved equivalence testing between generics and brand name compounds.
Quote by Dr. Barton Pai, ACPHS
“The process for developing IV iron generics does not guarantee these products will exhibit the same characteristics as the parent compounds. With more patients receiving IV iron, it is critical that we have a good equivalence model in place for evaluating these products before they reach the market. Right now, this is uncharted territory.”
Quote by Dr. Dan Meyer, GE Global Research
“GE Global Research has a decade-long development program for iron-based agents, and is pleased to be in position to bring to bear this capability and knowhow for the characterization of anemia therapeutics. For its part of the grant activity, GE will conduct the chemical characterization of various anemia agent formulations, develop relevant biochemical assays and execute the data collection studies that will underpin the derivation of a new equivalence model, ultimately supporting FDA evaluation of generic IV iron products.”
The project described above is supported by the National Institutes of Health and the Food and Drug Administration under Award Number 1U01 FD004889-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or FDA.
About Albany College of Pharmacy and Health Sciences
Founded in 1881, Albany College of Pharmacy and Health Sciences is a private, independent institution committed to graduating the best health care minds in the world. In addition to its doctor of pharmacy program, ACPHS offers six bachelor’s programs and five graduate programs in the health sciences. The College’s main campus is located in Albany, New York; its satellite campus is in Colchester, Vermont. For more information, please visit www.acphs.edu.
About GE Global Research
GE Global Research is the hub of technology development for all of GE's businesses. Our scientists and engineers redefine what’s possible, drive growth for our businesses, and find answers to some of the world’s toughest problems. We innovate 24 hours a day, with sites in Niskayuna, New York; San Ramon, California; Bangalore, India; Shanghai, China; Munich, Germany; and Rio de Janeiro, Brazil.Visit GE Global Research on the web at www.ge.com/research. Connect with our technologists at http://edisonsdesk.com and http://twitter.com/geresearch.