In purchasing Beckman Coulter Genomics' Morrisville, NC, facility, research services firm ILS has garnered a number of capabilities that will enable it to establish a presence in pharmacogenomics and personalized medicine.
The group, renamed ILS Genomics following the acquisition, "had been involved with pharmacogenomics [projects] in a lot of very compelling arenas, and we are re-engaging on those," Sam Tetlow, chief business officer for ILS and general manager for the new genomics division, told PGx Reporter. "We're just out of the gate, however. And we have not secured many of those projects. Some we have."
ILS announced in late June that it had acquired the facility, which previously operated as a subsidiary of Clinical Data under the name Cogenics prior to its sale to Beckman Coulter Genomics in 2009. ILS gains approximately 20 employees with the facility and could potentially retain pharmacogenomics and molecular biology services agreements with two dozen top pharma and biotech companies.
The 37,000 square foot facility is compliant with Good Laboratory Practice and Good Manufacturing Practice standards. The facility houses a laboratory that is currently compliant with standards under the Clinical Laboratory Improvement Amendments and will be CLIA certified in the near future.
ILS Genomics will provide genotyping, gene expression analysis, and biologics product safety testing services. The subsidiary will perform genotyping and gene expression profiling services using platforms from Affymetrix, Illumina, Sequenom, Agilent, and Applied Biosystems, and has sequencing capabilities on the Sanger platform.
Tetlow couldn't discuss in detail many of the PGx efforts in which ILS Genomics could be involved. However, he noted that the facility has already secured certified service provider status with Affymetrix, which enabled it to work on verifying a panel "that continues to get traction globally for Affymetrix."
Although Tetlow could not name the specific panel, publicly available documents show that Beckman Coulter Genomics offered a 3,000-SNP pain research panel based on the Affymetrix MegAllele platform. Algynomics, a company specializing in personalized pain medications and diagnostics, began co-developing the panel with Clinical Data in 2006 (PGx Reporter 10/18/2006) and announced in 2009 that it is was working with Beckman Coulter Genomics to conduct genotyping studies with the array.
ILS provides research support to federal and commercial clients in the areas of investigative toxicology, genetic toxicology, molecular biology, histopathology, and environmental and information science services. The purchase of the Morrisville facility and subsequent creation of ILS Genomics gives the firm a stronger presence in the genomics services industry.
"ILS did have a genetic toxicology group, but that was really focused on in vitro areas where we'd do cellular models for predicting human response," Tetlow said. "That was working with pharma, but really more focused on the chemical industry and the National Toxicology Program. So, ILS Genomics is really an additive capability that we really did not have previously."
In addition to ILS' work doing safety lot testing for biologics, the company has research efforts with pharmas focused on Phase II/III drug development. It is currently focused on being "a service provider … [and] catering to the pharma company to inform patient selection and do retrospective studies, maybe submitting to [the US Food and Drug Administration's] Voluntary Exploratory Data Submissions [program] and doing diagnostic kit validation," Tetlow said.
ILS plans to combine its new genomics tools with its existing in vivo toxicology capabilities to perform animal studies that test drug developers' gene-drug relationship hypotheses before going into human studies. "There is some reticence among large pharma to jump into pharmacogenomics," Tetlow reflected. "But they have to do chronic studies in animals. If you had the genomic endpoints on the animal study, compared to the traditional pathology endpoints on that animal study, you would be able to inform what should happen in the human patient clinical trial to a much greater degree."
With the creation of ILS Genomics, the company has also begun to have discussions with pharma companies that are looking for a diagnostics partner. "We're not in the diagnostics kit business," Tetlow noted. "But we are talking to drug companies who are interested in the drug, and we're interested in the gene set or the marker that can be used as a diagnostics application."
If these biomarker validation efforts with pharma result in a commercializable test kit, Tetlow noted that ILS would likely license out the biomarker knowhow to a kit provider, but didn't rule out the possibility that ILS could commercialize a test itself. "We really see ourselves as a team that can do clinical validation," he said. "That applies to providing both pharmacogenomics [services] for drug developers or providing that support for a diagnostic kit [developer]."
According to Tetlow, ILS is in discussions with some drug firms who are looking for ILS to handle diagnostics kit development. However, such arrangements would require financial support from pharmas for the development of the test. Tetlow indicated with in this type of scenario, ILS would bring in consultants with regulatory expertise to steer the diagnostic kit through the FDA.
ILS Genomics plans to provide genomic services to drug developers advancing treatments for non-small cell lung cancer, breast cancer, colorectal cancer, leukemia, and multiple myeloma. Outside of oncology, the subsidiary will also focus on diabetes, pain indications, and neurodegenerative disorders.