Precision for Medicine has put another building block in place with its acquisition of contract research organization Agility Clinical as the company steers toward becoming what company officials term the first “precision medicine research organization.” Agility, based in Carlsbad, CA, is focused on the clinical research and development of rare disease and orphan therapies, a niche that fits well with Precision’s focus on the discovery of genomic biomarkers.
According to Chad Clark, president of Precision for Medicine, the combination of Precision’s presence on the West Coast with Precision’s presence and aggressive growth plans in the EU, will enable it to effectively conduct global studies in a disease area that practically demands it.
“Agility has historically been more focused in North America, and now we can offer a much broader footprint to support our new clients,” Clark said. “Global reach is critical for rare disease trials because there are so few patients, and now Agility has a highly skilled EU-based clinical trial staff available to help identify, enroll and support sites and patients.”
Despite the impression they give by their classifications as “rare” and “orphan” diseases, the opportunities in this area could be significant. According to Precision, about half of all new medications approved by the FDA in 2016 were orphan drugs—defined as ones that would treat conditions affecting fewer than 200,000 people in the U.S—and 73% that were approved moved through the process on an expedited path.
Agility, founded in 2012, has built the company’s expertise to address some of the fundamental differences between development and approval of rare and orphan disease treatments compared to more traditional drug development. In addition, the company has built a strong, and sophisticated bioinformatics and data management capability.
The CRO will continue to be headed by Ellen Morgan, company founder and CEO, who shares the view that combining the two companies will make a significant impact.
“We see Precision's biomarker expertise, growing global footprint, and focus on precision medicine as a perfect complement for our clients' needs,” Morgan said in a prepared statement announcing the deal. “Agility and Precision share very similar company cultures, including our goal of delivering new therapies to patients who need them most, and we see this as the right next step for our employees and our valued clients.”
The newest acquisition marks the second CRO deal completed by Precision for Medicine, as it looks to add specialized CRO expertise to its services portfolio. In April, 2016 it acquired Precision Oncology, which focuses solely on cancer research. In both instances, the company’s goal is to provide end-to-end research and development capabilities to its clients.
“Precision’s global laboratories and biomarker informatics platforms can now immediately support Agility’s studies with increased efficiency and reliability by delivering an integrated biomarker driven clinical trial under one roof,” Clark noted. “Agility’s clients are very interested in one team capable of handling all of the lab, biomarker and clinical development needs.”
Clark hints that this latest deal may not be the last for Precision in the CRO space. “Today, Precision has unmatched expertise in oncology and rare disease research, we have global laboratories focusing on patient stratification and immune-monitoring, and we have developed proprietary informatics platforms to exclusively manage any type of biomarker data,” he concluded. “We envision continuing to expand and advance these capabilities, and we will continue to identify other therapeutic areas where biomarker driven research can accelerate approvals to make novel treatments available to patients.”