United States

Veteran Affairs, Seven Bridges partner on Million Veteran Program

Monday, April 11, 2016

Seven Bridges, a biomedical data analysis company, has signed a Collaborative Research and Development Agreement (CRADA) with the U.S. Department of Veteran Affairs (VA) to support two key research initiatives for the VA’s Million Veteran Program (MVP). The MVP is a national, voluntary research program funded by the VA’s Office of R&D, with the goal of partnering with Veterans receiving their care from the VA Healthcare System to study how genes affect health. Seven Bridges will serve as an industrial collaborator on the MVP, supporting the development of a hybrid cloud for large-scale data analysis, and a genotype-phenotype graph analysis engine.

[Read More]

FDA’s postmarket oversight of expedited drugs found lacking

Monday, April 11, 2016

The FDA lacks reliable, readily accessible data on potential safety issues needed to meet postmarket safety responsibilities and to conduct systematic oversight of new drugs.
This was the conclusion of a recent report issued by the U.S. Government Accountability Office (GAO). The GOA found that the FDA’s Center for Drug Evaluation and Research’s (CDER) internal data evaluations have problems with completeness and accuracy. These problems prevent the timely publication of legally required postmarket studies and reports on tracked safety issues—potential safety concerns the FDA determined to be significant, and which the FDA monitors using an internal database.

[Read More]

INC Research, CISCRP collaborate on patient awareness

Wednesday, April 6, 2016

INC Research Holdings, a global phase I to IV CRO, has announced a strategic collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process. Through this collaboration, INC and CISCRP will jointly develop and implement educational initiatives designed to bring greater awareness to the importance of clinical trial participation in advancing public health.

[Read More]

Snapdragon Chemistry expands to new labs in Cambridge, MA

Tuesday, April 5, 2016

Snapdragon Chemistry has moved to new lab facilities in Cambridge, Massachusetts. Snapdragon’s corporate partner, Zaiput Flow Technologies, has also moved to the 85 Bolton Street site. This co-location will enhance the collaboration of these strategic partners and accelerate the development of advanced continuous chemical manufacturing technologies and solutions.

[Read More]

Revisiting industry partnerships with the Department of Veterans Affairs

Monday, April 4, 2016

Contract research organizations (CROs) should consider partnering with the Department of Veterans Affairs (VA) when conducting clinical trials, according to an attendee at the recent Clinical Trial Collaborations conference in Boston, Massachusetts. “The atmosphere is right for increasing the number of industry-VA collaborations,” said Dawn McKenna, executive director of the Bedford VA Research Corporation in Bedford, Massachusetts. McKenna spent years working in the pharmaceutical research and development industry as well as government and nonprofit areas before taking the helm in Bedford last year.   

[Read More]

Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

[Read More]