One of the biggest nonprofit biomedical research outfits in the world is getting a new translational medicine research arm, aimed at speeding the conversion of basic research insights into novel medicines. Yesterday, officials at the Scripps Research Institute announced that it will merge with the California Institute for Biomedical Research (Calibr), which was launched in 2012 as a nonprofit version of a drug development company. Both Scripps and Calibr are headquartered in San Diego, California, and led by Scripps chemist Peter Schultz.
In an interview yesterday, Schultz said that he hopes the merger will not only speed the development of new medicines, but that proceeds from any commercial successes will be fed back into the institute’s coffers to bolster future research. “We will generate significant revenues, which will be reinvested in the entire enterprise,” Schultz says. If true, that could be a major boon for Scripps, which has been running in the red for years, as it has struggled to replace declining grant money from the U.S. National Institutes of Health. Over the next 2 years, Schultz says Calibr expects to launch clinical trials on eight different medicines, three of which should be ready to go either later this year or in the first quarter of 2017.
The new merger isn’t the first to attempt to marry basic biomedical research with efforts to promote commercialization. Universities and medical schools around the world have established translational research arms in recent years hoping to cash in on basic research discoveries. But such efforts often stumble, Schultz says, because the culture of basic research, which focuses on insights from individual investigators, is often at odds with translational efforts, which require highly integrated teamwork. “We aren’t building from scratch; rather we are integrating the strengths of two proven nonprofit research organizations,” he says.
Scripps and Calibr have previously had an alliance. Schultz says their formal merger should help reduce overhead and make it even easier to develop new medicines. He adds that the combined institute will appoint a board of senior investigators to continually evaluate and prioritize proposals for drug development projects. Calibr scientists will then use their suite of high-tech robotic equipment to screen novel compounds, evaluate their toxicity and safety in animals, and prepare any compounds for human clinical trials.
That’s different from the way most drugs are developed coming out of universities and other research nonprofits, Schultz notes. Typically, basic researchers work to gain novel insights into health and disease, discovering, for example, a novel cell receptor that might serve as a target for a new drug. They then might launch a startup company to pursue new drugs, raising money from outside investors. The startup will then carry out additional preclinical work to come up with an actual drug candidate. If successful, the startup may then partner with a large pharmaceutical company to run clinical trials to evaluate the potential medicines in patients.
But there are multiple problems with this approach, Schultz says. First off, startup companies typically don’t have the expertise or infrastructure to quickly do the full suite of safety and efficacy testing that must occur prior to setting up human drug trials. In addition, the intellectual property returns to the institution on startup deals often aren’t lucrative. Institutes can strike much better deals if they hold onto the intellectual property throughout the preclinical development stage so they can ensure investors that their compound has already passed numerous hurdles. “The idea now is to remove that complexity and move to human trials. You really accelerate the process and increase the validation to a clinical stage.” By doing so, he says, “you’ve moved the whole project up the value creation chain.” If successful, any proceeds can be fed back into early stage research. “It becomes self-recurring and self-sustaining,” Schultz says.
Jeff Kelly, a chemist and chair of the Department of Molecular and Experimental Medicine at Scripps, says he is also hoping the new merger will help him and his colleagues see results from their basic research. “I want my work to have an impact on the lives of people suffering from life-threatening diseases, and the [Scripps] integration with Calibr provides an important mechanism for moving molecules faster and further along the research and development continuum.”