Institutions Partner On Research
GRAND RAPIDS — Six West Michigan institutions involved in the life sciences recently came together to form a nonprofit called ClinXus, an alliance that will market the institutions’ expertise and cutting-edge clinical research capabilities to pharmaceutical companies, biotech firms and institutions such as the National Institutes of Health that want to run clinical trials on new medicines, devices and diagnostics.
If, for instance, Pfizer wanted to do a research study in Grand Rapids, ClinXus would present the opportunity to member organizations and one or more of them would submit a proposal to Pfizer and then maintain responsibility for the study, explained Matt Dugener, executive director of GVSU’s West Michigan Science & Technology Initiative and ClinXus board president.
Dugener said that research assignments potentially could come from all over the world. One of the primary benefits of ClinXus, he added, will be in providing physicians and patients access to cutting edge research that’s going on in the medical field. Initially, partners in the ClinXus alliance will concentrate on clinical work in the areas of oncology, cardiovascular, inflammatory, neurological, metabolic, endocrine and ophthalmology.
Partners in the initiative are Grand Valley Internal Medicine Specialists,
ClinXus will serve as the group’s marketing and business development arm, promoting the combined talent pool and emerging technologies of the six partners.
“What we each bring to the table is different elements of innovation within our core strengths,” said Dean Knuth, president and CEO of Jasper Clinical Research and Development. “It’s a lot faster and a whole lot better for the
ClinXus will be housed in the
Craig Webb, Ph.D., a principal investigator at the Van Andel Research Institute and vice president of the ClinXus board, said the partner institutions could do early clinical studies in oncology or cardiovascular disease or neurological sciences like schizophrenia. Within his area of expertise, for instance, in the new realm of molecular medicine, researchers are looking for biomarker signatures that indicate whether or not a drug will work and predict what patient population will respond to treatment. During a clinical trial, researchers also look for early response markers to get an early readout of success or failure, he explained.
“We clearly have some unique assets, including some heavy-duty bioinformatics computer applications, as well as patients and physicians, and we have a molecular diagnostic lab, so there are some assets we have that few people have.”
What’s also important is the way the partner organizations can coordinate clinical trials and make them efficient and cost effective, Webb added. He said the partnership will give area patients access to cutting edge clinical trials, the best drugs, the best technology and the best means to predict whether or not they should receive a particular drug.
ClinXus partners embrace the concept of innovative clinical research, which was recently given a boost by new Food and Drug Administration guidelines. The guidelines are part of the agency’s Critical Path Initiative, which was designed to accelerate the approval of innovative diagnostics, drugs and other therapeutics to prevent and treat diseases. Under the new rules, drug makers can conduct “adaptive” clinical trials, which allow researchers to change details of a study midway through it based on interim analyses of data. The adaptive design is said to improve efficiency of trials, potentially leading to reductions in overall sample size, shorter project duration, improved quality of results and reduced costs.
“Clearly, this is good timing on our behalf,” Webb said. “More than ever, collaborative scientific, regulatory and clinical expertise requires close coordination at the earliest stages, using supportive systems and infrastructure to reach the critical test of safety and efficacy in patients.” He said the group’s organizational model will further develop that strategy and notch up clinical research activity in this community to the level of leading national organizations.
All the partner institutions generally do some of their own research, but are really focusing on the new innovative clinical research defined by the FDA Critical Path Initiative, Dugener added.
“There’s a pipeline forming already, because there are not many places in the United States that are doing clinical research according to that new initiative,” he said.
Knuth said clinical trial services are in demand all over the world, but demand is changing in terms of the type of services clients want. In Phase I a drug or treatment is tested for the first time on a small group of people, and in Phases II and III on larger groups of people. Phase IV trials occur after a drug is on the market. Though traditional Phase I trials are still in demand, there’s growing demand in the market for more complex trials done earlier, Knuth said. Enter the Phase Zero clinical trial, which Knuth said helps researchers sharpen the focus and get better data in subsequent trial phases.
“Phase Zero is where you take a target — such as one the Van Andel Research Institute might have discovered — but you still don’t know what it does in humans,” Knuth explained. “You can study that target in humans without having to wait for a new drug to come along; you can do it with a non-drug study or with a drug that’s been on the market for years. It’s about understanding how the patient and how the target in a patient is going to respond. The world vision we’re headed for is the right drug, at the right dose, at the right time for each patient.”