New Center for Protein Therapeutics Formed by UB Pharmaceutical Scientists

BUFFALO, N.Y. -- Pharmaceutical researchers at the University at Buffalo have joined forces with scientists from several of the world's largest pharmaceutical companies to tackle fundamental research questions that need to be answered to advance development of promising protein-based drugs.

Their research will be carried out in the Center for Protein Therapeutics, which began its work July 1. The center was brought to fruition by Joseph Balthasar, Ph.D., professor of pharmaceutical sciences, and William Jusko, Ph.D., UB Distinguished Professor and chair of pharmaceutical sciences in the UB School of Pharmacy and Pharmaceutical Sciences.

In addition to conducting basic research, faculty affiliated with the center, headquartered in UB's New York State Center of Excellence in Bioinformatics and Life Sciences on the Buffalo Niagara Medical Campus, will train the scientists needed to build an intellectual infrastructure in this developing field.

Research and training also will be carried out in pharmaceutical sciences labs on UB's North (Amherst) Campus.

"This kind of research is so important," said Balthasar, "because over the next 10 years, 50 percent of the new drugs approved by the U.S. Food and Drug Administration are expected to be based on protein therapeutics."

Balthasar and Jusko brought together a consortium of scientists from Merck, Pfizer, Lilly, Roche and Genentech, who agreed to create a $1 million pot of money for research. The center was modeled after the UB Department of Pharmaceutical Sciences protein therapeutics laboratory, which is supported by a $1 million grant from Novartis.

All the companies have signed one-year contracts, with Genentech committing to three years of funding, said Balthasar. "We are very confident that companies will continue to support the center, but at this point we have not sought long-term contracts."

The center will operate under a novel cooperative arrangement. Consortium members presented the pharmaceutical sciences researchers with basic research topics that needed investigation. The researchers then submitted proposals addressing these topics to the center's management committee, which includes scientists from the university and from the pharmaceutical companies.

The consortium will fund 10 $100,000 projects the first year. The committee met June 26 at the center to decide which proposals should be selected for 2008-09.

The consortium approved projects submitted by six primary researchers from the UB Department of Pharmaceutical Sciences: Jusko, Marilyn E. Morris, Ph.D., professor; Jun Qu, Ph.D., research assistant professor; Donald E. Mager, Ph.D., assistant professor; Murali Ramanathan, Ph.D., associate professor, and Balthasar.

The projects that were approved include research into Alzheimer's and other central nervous system diseases, rheumatoid arthritis, multiple sclerosis and four investigations into monoclonal antibody activity led by Balthasar, who has gained an international reputation for his work in the field.

These principal investigators will hire, train and oversee postdoctoral fellows who will carry out the research.

Protein-based drugs present specific problems, some of which the researchers will address in this first round of funding. The drugs must be injected because the protein molecules are too large to be absorbed through the gastrointestinal track and would be destroyed by digestive acids and enzymes.

The drugs typically are unstable, can be difficult to prepare in pure form and have very specific effects, which make them highly valuable but very risky and difficult to test in humans, as the phase 1 trial of one new protein drug in 2006 made painfully clear: After experiencing no problems in rodents and non-human primates, the drug was injected into six patients, all of whom had nearly fatal reactions.

UB pharmaceutical scientists have pioneered computational models of drug disposition and effect that may be able to predict accurately the effects of such drugs in humans.

The center expects to train 10 to 13 post-doctoral scientists yearly with continued support from the pharmaceutical companies.

"In all subsequent years, we plan to use the same strategy for project selection -- project ideas will be nominated by the industry scientists, UB scientists will submit project proposals that respond to the nominated ideas and the management committee will select projects for funding," said Balthasar.

"We plan to fund projects for one year, with budgets of $100,000, which will allow a modest budget for research costs and also allow support for a post-doc for a year. With this approach we expect to continue to make significant advances in the science of protein therapeutics and, in the process, to train new researchers who will play important roles in protein-based drug discovery."

The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. The School of Pharmacy and Pharmaceutical Sciences is one of five schools that constitute UB's Academic Health Center. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.