Experts agree that CROs will be more connected in 2016, however limitations – and hesitatations – still surround remote based monitoring.
Cancer drug discovery gets a boost from canSAR, large 3D database
The addition of 3D enhancements to the world’s biggest database for cancer research and drug discovery should be a huge boost to researchers looking for more effective ways to develop new cancer treatments.
The top 5 life science developments to look for in 2016
These are exciting times for the life sciences sector as it builds on its understanding of disease at the cellular and genetic level to usher in new and differentiated therapies into the market…The top 5 scientific developments to be tracked in 2016 are…
- Immuno-oncology
- 3d bioprinting and stem cell therapy
- biomarkers and companion diagnostics
- genomic sequencing
- biosimilars
The new EU clinical trials regulation: what you need to know before 2016
New Draft Guidance on best practices for IND communications between sponsors, FDA
Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. (Regulatory Focus, Regulatory Affairs Professionals Society)
FDA authorizes first human study to use in vivo genome editing application
The US Food and Drug Administration (FDA) broke new ground last week when it authorized the world’s first human clinical trial for an in vivo genome editing application. The investigational new drug (IND) application approval for California-based Sangamo, which is the first and only company to put a gene editing therapy into clinical trials, allows the company to begin conducting in 2016 a Phase 1/2 open-label, dose-escalation study in up to nine male adults with severe hemophilia B. (Regulatory Focus, Regulatory Affairs Professionals Society)
National leaders in precision medicine speak at SDCRN meeting
Advancing Precision Medicine: Genomics, Metabolomics, and Clinical Trials By Dr. Roberta Alexander San Diego, CA. October 12, 2015 The San Diego Clinical Research Network (SDCRN) organized another great event on October 12. It was held in the Alexandria Building of BIOCOM in the Torrey Mesa area. The building and the Read more
Africa’s pharm industry booming, but dire shortage of clinical research specialists
Why does Africa need more pharmaceutical professionals? Africa’s pharmaceutical industry is one of the world’s fastest growing…Despite the boom, the continent’s pharmaceutical industry faces several challenges that will stifle its growth. Africa has a dire shortage of specialists to conduct clinical research and develop novel medicines to tackle diseases on the continent. (World Economic Forum. Published in collaboration with Quartz Africa)
Vermont’s “Phytoscience Institute” wants to make Vermont the home of cannabis R&D
Think tank wants to make Vermont the home of cannabis R&D. In 1996, California became the first state to legalize medical marijuana. Eleven years ago, Vermont followed suit. But doctors still know surprisingly little about the pharmacology of cannabis. And a Vermont-based think tank is hoping to transform the industry by applying new scientific rigor to an old drug. (VPR. Vermont’s NPR News Source)
NY State awards $17 million to 26 medical institutions to train new clinical researchers
$17.2 million awarded to 26 NY medical institutions. Gov. Andrew Cuomo says $17.2 million in state awards is going to 26 academic medical institutions to train new clinical researchers doing cutting-edge biomedical research. (The Washington Times)
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