PORTLAND, Ore. — Oregon’s four research universities have recently formed a nonprofit alliance aimed at supporting their collaborative efforts and to help them develop the technologies and therapeutics that result from their research.
The Oregon Translational Research and Drug Development Institute, or OTRADI, comprises Oregon Health & Science University, Portland State University, the University of Oregon, and Oregon State University.
Cell-based assays will be a part of the new institute’s research activities, according to an official. “We are talking about high-content screening, and gathering more in vitro data before you progress to an animal model,” according to Arundeep Pradhan, director of technology and research collaborations at OHSU.
“I think that people are beginning to recognize that there is a greater value in [the] in vitro data generated by cell-based assays,” he added.
Pradhan said that OTRADI, which hopes to become operational before the end of June, is now talking to faculty at the member institutions who are doing cell-based assays but who “are not doing them in a high-content or a high-throughput manner. Trying to develop a structure around that format, from our perspective, makes sense as well,” he said.
Robert Monaghan, executive director and president of OTRADI, agreed, saying that “although cell-based analysis using the high-content screening format is relatively new to many researchers, I think it will show rapid growth within OTRADI as we put the equipment into place and we hire cell biologists. I think that will be one of the key areas for us.”
Monaghan and Pradhan spoke about OTRADI’s origins and mission at the Northwest Regional Cytometry Meeting, held here last week.
“At the base, you would have the four universities with their research and discoveries; then you have OTRADI, which takes the discovery up to preclinical development; then you would have the accelerator, by which I mean biopharma,” said Monaghan, who spoke with CBA News following the meeting.
“Although cell-based analysis using the high-content screening format is relatively new to many researchers, I think it will show rapid growth within OTRADI.”
The accelerator would raise the capital to produce the product and fund its further development, including ADME/Tox studies, and all the clinical trial work, he said.
Last December, the State of Oregon funded the OTRADI Signature Research Center for two years with $5.25 million of the state’s tobacco settlement. Monaghan said that OTRADI has not received any other state or federal money .
Since February, OTRADI has leased laboratory and administrative space at Portland State University, said Monaghan. The Institute occupies part of the floor that was previously the Oregon State Public Health Laboratory.
“This setup enables OTRADI to use existing laboratory space, thus reducing the start-up costs,” Monaghan said. The rented space is approximately 3,300 square feet. Monaghan estimated that the administrative space is 500 to 600 square feet, and that the laboratory space is approximately 2,800 square feet.
Research supported by OTRADI is currently focused on the infectious diseases that have the most significant impact globally, as determined by the World Health Organization, Monaghan said. These disease states include tuberculosis, hepatitis, malaria, and dengue hemorrhagic fever.
“Generally speaking, the large pharmaceutical companies have not expressed an interest in looking at some of these diseases because the market, while it is large globally, is very small financially, because these diseases are most prevalent in underdeveloped countries,” said Monaghan.
Pradhan said that although large pharmaceutical companies are capable of doing this research themselves, the likelihood that they will invest in early-stage research for these diseases is very small.
“Where we found that we had a competitive advantage in the infectious disease area is in these 20 diseases,” Monaghan said. OTRADI has about $85 million in infectious disease research funds that come in through its four partner universities, he said.
“Where OTRADI fit in is that this research needed an infrastructure to move it from the lab bench to the patient,” Monaghan said.
Basically, if the universities were looking for a compound, OTRADI would fulfill that need; and if they had a target and were looking to test it, OTRADI would fulfill that need, as well, he said.
Solutions to these disease states could include therapeutics; vaccines; biomarkers for early diagnosis and progression of disease, and treatment efficacy; and assays to evaluate the efficacy of treatments and vaccines, Monaghan said.
Help Wanted, Getting Started
OTRADI is currently hiring staff and assessing the instrument specifications that it will need to support the research, said Monaghan.
Key hires include a CSO, automation scientists, cell biologists, assay developers, and research associates. “We are starting off small and focused,” he said. “We are looking for the key personnel that have product-development experience. We are not looking for the ‘R’ in R&D, we are looking for the ‘D’ in R&D.”
The process of founding OTRADI started about three years ago, said Pradhan. “It was an idea that was developed by two or three key individuals, including Al Ferro,” who is the president of ID Biosciences and CEO of Artielle Therapeutics, which were both spun out of OHSU; and Dan Dorsa, who is the vice president for research at OHSU.
The original proposal was slightly different than what appears today: It was more OHSU-centric, Pradhan said. “When we started discussing this idea with other individuals in the community and at other universities, however, we realized that they had a need for, and an interest in, something like OTRADI.”
The final proposal, therefore, was inter-institutional, he said.
Monaghan said that he attended a meeting about translational medicine in St. Louis last August, and at the meeting, he kept hearing the same concerns from national research institutions, legal firms, and other life-science players. “Their frustration was, ‘How do we get research to the next stage so it is fundable, and develop that into a product?’”
There were a number of institutions at that meeting, he said, including the University of Wisconsin and the Wisconsin Alumni Research Foundation, the Emory University consortium in Atlanta, several large pharmaceutical companies, licensing attorneys and some legal representatives from Washington, and many technology-transfer people.
“I just sort of stood up, and expressed that we were trying something new in Oregon, supported by the governor and state legislature,” he said.
Monaghan said that after he spoke, people came up to him and were asking questions such as, “’How did you get public support for this? How did you get Oregon’s government and legislature to get behind this concept? Once you develop this, where does it go?’”
He said he answered that “we have a number of options — we have [the] accelerator on the backside, so we can raise capital; we can license out the products we develop; or we can spin our own company out from the university.”.
Monaghan added that the state government recognized that there was a missing piece in terms of the infrastructure for research in Oregon. He said Oregon Governor Ted Kulongoski “was a key player in moving this forward.”
Gov. Kulongoski “had confidence that we could, in fact, develop the research discoveries coming out of the four research institutions, and build another leg of the economic ladder of the state,” Monaghan said.
In 2005, Gov. Kulongoski established the Oregon Innovation Council, which is charged with formulating an economic-development package to drive forward various markets, including the biosciences.
OTRADI was the second signature research center funded by the state. The first was the Oregon Nanoscience and Microtechnologies Institute in 2003. The Oregon Innovation Council developed what is basically a competitive proposal process, and OTRADI was one of those that the OIC thought would be important to fund.
“The OIC wanted to fund OTRADI based on the needs of the industry and the desire, from the state government’s standpoint, to diversify Oregon’s economy,” Pradhan explained. That competitive proposal process took about nine to 10 months, he said.
“In terms of having others imitate or adapt the OTRADI model, the key is to demonstrate the model’s success,” Pradhan said. In biotech that success is measured in months to years.
“We are talking about five to 10 years for successful products to come out of the pipeline,” said Pradhan. Intermediate measures exist that define success, however, such as spin-off companies formed. “We have taken some of those other criteria into account.”
According to Monaghan, “Some of the other criteria include assay development, because every therapeutic approach or vaccine that is produced has to have an assay that shows that it works.”
In addition, there are a number of biomarkers that OTRADI can bring to market, Monaghan said. “So there are a number of shorter-term product-development areas that we believe we can push toward commercialization.”
Longer-term projects would include therapeutics, for example, because they have to go through preclinical development and then the three clinical trial phases, said Monaghan.