February 26, 2018
The National Human Genome Research Institute has begun to refocus its research and funding strategies with new emphasis on the development of precision medicines, exploring the basis for certain diseases and supporting the industry’s education in data science. The main federal institute behind the Human Genome Project, NHGRI plans to prioritize its efforts in emerging areas, such as the use of genomic information in patient care and drug development, and plans to gather input from the industry and the public over the next two years. The NHGRI’s strategic plan is expected to be finalized in October 2020, which commemorates the Human Genome Project’s 30th anniversary. The institute expects to prioritize emerging areas that are not well-defined, that will benefit from significant investments and are not specific to particular diseases. Well-established areas, such as cancer and microbial genomics, are expected to be deemphasized during the upcoming process, the institute said.
ClinEdge and BTC Network Acquire GuideStar Research
Clin-X, the parent company of ClinEdge and BTC Network, has acquired GuideStar Research, to build a new research site services category dedicated to streamlining operations at the institutional level. ClinX plans to support GuideStar by broadening product lines, according to Al Peters, president of BTC Network and ClinEdge VP. Best practices from ClinEdge, BTC Network and now GuideStar Research will be incorporated across the organization’s global network of sites and through all of its service offerings, the company said.
Charles River Enters Agreement to Acquire MPI for $800 Million
Charles River Laboratories entered into an agreement to acquire MPI Research for approximately $800 million. MPI, a non-clinical contract research organization, provides testing services to biopharmaceutical and medical device companies worldwide. The acquisition aligns with Charles River’s strategy to expand its biotechnology client base, the company said, adding MPI’s work in ototoxicity and abuse liability, and expand Charles River’s existing capabilities in general toxicology and specialty toxicology, including ophthalmology, juvenile toxicity, molecular biology and surgery, as well as medical device testing. The transaction is expected to close in the second quarter of 2018.
ACRP Partners with Singapore Clinical Research Institute to Train CRCs
The Association of Clinical Research Professionals is partnering with the Singapore Clinical Research Institute to train clinical research coordinators employed in the Singapore healthcare system. Under the agreement, ACRP’s CRC Boot Camp will form part of the SCRI Academy Clinical Research Coordinator Level 1 training program.
Pharmatech and TransMed to Combine Enrollment and Precision Medicine Screening Programs
Pharmatech and TransMed Systems announced a partnership to combine Pharmatech’s site startup enrollment system with TransMed’s precision medicine platform and automated screening solutions to improve trial feasibility and research patient pre-identification using real-world data. The strategic alliance looks to employ a repository of longitudinal patient data housed within healthcare technology systems encompassing electronic medical records, laboratory information, practice management, molecular diagnostics, pathology reports and other data sources, the companies said. The data will be aggregated for hundreds of oncology practices across the combined networks of care sites.
Sponsors Voice Concern over Draft Guidance Closing Orphan Drug Study Loophole
An FDA draft guidance that proposes to close what the agency sees as a “loophole” allowing drugmakers to bypass pediatric clinical trial requirements would impact product development if it becomes final, according to some drug developers and patient advocacy groups. Issued in December, the draft guidance said the agency no longer intends to grant orphan drug designations in pediatric subpopulations of common diseases, due to the way subpopulation designations and the Pediatric Research Equity Act’s orphan drug exemption work together. The agency said their interplay creates an “unintended loophole” where a sponsor can exempt itself from conducting the pediatric studies required by PREA. Aevi Genomic Medicine commented that “the proposed remedy is likely to impede and delay development of important new medicines for children” because without the orphan drug designation, developing novel drugs and biologics for children is more difficult and “in many cases, practically impossible.” The National Organization for Rare Disorders said the guidance did not provide sufficient evidence of the perceived loophole, and asked the agency for “further evidence of the exploitation of this loophole, including how many therapies that received a pediatric subpopulation orphan designation did not complete additional pediatric testing, but were also exempt from PREA.”