For the last several years, a rebounding global economy combined with a growing demand for advanced therapeutics has resulted in robust pipelines and the highest FDA approval rates seen in decades. As a result of heighted R&D activity, we are seeing more rapid commercialization of innovative drugs for patients. Congress has also recently introduced a new bill called the 21st Century Cures Act designed to further speed up approvals and remove red tape. Medical devices are following a similar suit.
The FDA expects organizations to have full visibility and control over their processes - with shared responsibility for contract manufacturing.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
The economic downturn in 2008, which began with the bursting of an 8 trillion dollar housing bubble, had a substantial impact on the job market. In 2008 and 2009, the U.S. labor market lost 8.4 million jobs, or 6.1% of all payroll employment, producing by far the largest labor contraction of any recession since the Great Depression.
Several informatics systems are now available on cloud-based platforms, and moving to the cloud does offer a more streamlined path to system upgrade and maintenance. Managed services providers (MSPs) have stepped in to provide a management layer between the enterprise and the public cloud in ways that allow laboratories to gain all the benefits of cloud-based applications without having to deal with the complexities of cloud integration, data migration, and system customization and management.
One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.
Analysts have estimated the failure rate of commercial laboratory information management systems (LIMS) to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.
The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.
Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced it has commenced dosing of patients in ASPIRO, a Phase 1/2 clinical trial of AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM)