October 7, 2019
The White House is vetting oncologist Stephen Hahn as a possible nominee for FDA commissioner, although there has been no official announcement.
Hahn, currently the chief medical executive at the MD Anderson Cancer Center, reportedly met with the president early in September and is now being vetted prior to his name being sent to the Senate for approval.
Hahn has served as a professor, researcher, clinician and administrative head, as well as continuing to practice as a radiation oncologist.
The current acting commissioner, Ned Sharpless, who health organizations and former agency chiefs have praised as an outstanding candidate for the permanent position, must step down by Nov. 1 (CenterWatch Weekly, Sept. 8, 2019).
Cincinnati Children’s to Coordinate Rare Diseases Research Network
Cincinnati Children’s Medical Center will be the new home of the Rare Diseases Clinical Research Network (RDCRN), thanks to a $28 million grant from the National Institute of Translational Sciences, which is part of NIH.
The hospital will lead studies involving thousands of scientists across the U.S. and 22 other nations, analyzing big data about rare diseases and generating data to spur clinical trials of new medicines.
23andMe Partners with TrialSpark for Recruitment
The gene testing company 23andMe has moved into clinical trial recruitment, establishing a partnership with TrialSpark to match customers with nearby trial sites based on their disease and demographic.
23andMe will identify potential research participants from its 10 million customers and refer them to TrialSpark, a technology infrastructure company that provides support services and staff to community physicians who want to open their own study sites. The goal is to provide trial opportunities to patients who can’t travel to large research sites.
The partnership is soliciting proposals from clinical researchers and will select up to three studies to work with first.
Veeva Provides Free Trial Management Solution
Veeva Systems is offering sites a cloud-based trial management platform at no cost.
SiteVault eases sites’ administrative burden by handling such processes as electronic signatures, remote monitoring, certified copy workflows and reporting. Veeva will provide sites with unlimited user access and technical support from the company.
The free platform will launch in December, but Veeva is accepting requests from sites in advance.
The fully customizable version, SiteVault Enterprise, currently is available and in use by multiple research organizations.
Firma Improves Training for Trial Home Care
Firma Clinical Research is working to incorporate the real-life experience of patients into training materials for trial personnel who provide in-home services.
Working with the Myositis Association, the CRO is surveying patients to learn more about their needs and attitudes and will use that information to improve home healthcare training for its trial nurses and investigators.
Forty percent of trials Firma currently supports require medical professionals to administer a drug in the patient’s home, and patient demand for in-home trial services is increasing, the company says.
Firma also is looking at implementing the program in other therapeutic areas.
QPS Expands Globally
QPS has opened new research facilities in the Netherlands, India and China.
The new Dutch clinical research site will be located at the Medical Center Leeuwarden and will focus initially on early-stage research on Alzheimer’s and Parkinson’s diseases. A second clinical research facility in Hyderabad, India, will conduct phase 1 through phase 3 studies.
QPS’s new bioanalytical operation in Suzhou, China, will focus on mass spectrometry.
The CRO also announced a three-fold expansion of its translational medicine division at the company’s U.S. headquarters in February.