University at Buffalo - The State University of New York

Published: September 6, 2007

By MARY COCHRANE
Contributing Editor

The School of Pharmacy and Pharmaceutical Sciences (SOPPS) has received a major investment that will allow it to enlarge its research program in protein therapeutics, the most rapidly expanding class of treatments for diabetes, cancer and other diseases.

The Swiss pharmaceuticals giant Novartis, along with its generics division Sandoz, together have provided $1 million for research and fellowships, which SOPPS will use to expand its laboratory for protein therapeutics and to support the work of postdoctoral scholars and graduate students on site. The grant also enables the school to provide seed money for several UB faculty research projects in the field.

Dean Wayne K. Anderson noted that the Novartis grant opens the door for UB to begin building on its plan to become the first university worldwide with an interdisciplinary program that applies pharmaceutical sciences—particularly in the areas of pharmacokinetics and pharmacodynamics (PK/PD)—to the development of protein drugs.

"This new effort is a strong testament to a quality program and innovative faculty. At the leading edge of new science, this represents an exciting development for our school and the university in the collaborative, interdisciplinary New York State Center of Excellence in Bioinformatics and Life Sciences," Anderson said.

Donald R. Stanski, global head of modeling and simulation at Novartis, identified the opportunity to combine the modeling needs of the rich biological development pipelines at Novartis for innovative medicines and at the Sandoz generics division for the development of follow-on biological drugs with the academic expertise at UB.

"This collaboration will create new approaches to using the pharmacokinetics and pharmacodynamics of biological products for the development of new medicines," Stanski said.

Ajaz Hussain, global head of biopharmaceutical development at Sandoz, enthusiastically supports this collaboration because it will "greatly contribute to development of novel methods for understanding mechanisms of actions and for establishing comparability of biosimilar products."

Novartis is the only pharmaceuticals company going beyond the traditional research and development of new medicines. The Basel-based company has leadership positions in generic pharmaceuticals through Sandoz, along with leading positions in human vaccines, animal health products and OTC medicines.

The laboratory for protein therapeutics will be the first step in the UB pharmacy school's plans to establish a Center for Protein Therapeutics devoted to advancing research and improving the understanding, formulation, analysis, development and testing of protein drugs, the most rapidly expanding class of drug treatments for many cardiovascular, renal, gastrointestinal, rheumatologic and neurological conditions and diseases.

William J. Jusko, UB Distinguished Professor and chair of the Department of Pharmaceutical Sciences, said the idea for the center came from his colleague, Joseph P. Balthasar, associate professor of pharmaceutical sciences, during meetings of SOPPS faculty to identify strategic strengths in their school as part of the UB 2020 strategic planning process.

"Joe proposed this idea about protein therapeutics, pointing out that besides himself, we have several other faculty with related interests and activities in protein therapeutics," Jusko said. "These include Sathy Balu-Iyer, associate professor, in protein formulation, and Robert M. Straubinger, professor, in bioanalysis and proteomics. The great advantage is the fact that the biotechnology industry is still a rapidly growing arena and we feel that we have great capabilities to forward this area."

Balthasar indicated that as he and other faculty in the Department of Pharmaceutical Sciences discussed plans for the center, Novartis contacted him to discuss the need for advanced studies in protein therapeutics. By coincidence, Novartis had reached the same conclusions as the department faculty: There is substantial need for the training of scientists in the application of pharmaceutical sciences to protein therapeutics, and the UB department is ideally suited to such a crucial undertaking.

"There isn't anything like this anywhere, a center devoted to furthering the application of pharmaceutical sciences to protein drugs. To have a main focus in PK/PD of proteins is unique," Balthasar said. "UB is arguably one of the only places that can have a center of this type because of the university's long-standing reputation in the areas of PK/PD and largely because of people like Bill Jusko, who is the leader in these areas in the world."

The UB program in protein therapeutics is expanding at a time when this area of research is in critical need of more accurate testing and analysis of its products, Balthasar added.

"As more protein drugs are developed, we are finding that these agents are very complex. They are much more difficult to work with than the traditional, what we call small-molecule drugs. Because of the intricate properties of these protein drugs, many of the effects that are observed in the clinic have not been predicted based on prior work done in vitro or in animal studies. There have been recent instances where there have been catastrophic side effects on first-in-human dosing of these agents," he said.

"It is likely that if there was more time spent in trying to understand the pharmacokinetics and pharmacodynamics of these therapies that better predictions could be made about safe doses in first-in-man studies, the first clinical investigations of a new drug entity."

Jusko added that there is a "lack of basic understanding of the myriad properties of therapeutic proteins. Dr. Balthasar has great expertise in unraveling these kinds of complexities. The pharmaceutical companies realize that they need to support training of more people with capabilities of evolving and elucidating the pharmaceutical properties of biotech products."

Additionally, this important field of research will encompass the interests of many faculty members in other areas of the university, Balthasar said. "Outside of our department, there are many scientists in the Buffalo Niagara research community with interests in protein therapeutics," Balthasar said. "We plan to invite our colleagues from medicine, chemistry, biology and bioengineering to participate in scholarly collaboration through the center, as well as professionals from Hauptman-Woodward Medical Research Institute and Roswell Park Cancer Institute."

Much of the research will take place in the Center of Excellence, which is providing some space and equipment. The Novartis funding provides three years of support for two postdoctoral and three graduate students. In addition, the UB-Novartis Advisory Committee has selected three projects from department faculty, each of which will receive approximately $100,000 in funding from the grant for fiscal year 2007-08.

"It's going to be a great thing for the department," Balthasar said. "The center will help to seed research, which will enable our faculty to be more competitive in obtaining additional research funding. We expect that our trainees will expand this research area here at UB, and also at other academic institutions and in the pharmaceutical industry."