October 2017

Canadian biotech industry names top performers

Tuesday, October 17, 2017

BIOTECanada announces winners of the 2017 Gold Leaf Awards, which recognize biotechnology excellence. Launched in 2001, the Gold Leaf awards are given annually to recognize both companies and individuals who have made significant contributions to the biotech industry in Canada. The Awards’ importance to the recipients and the industry more broadly has grown significantly over the years.

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Janssen launches iSTEP, a mobile medication and data management tech platform

Tuesday, October 17, 2017

Janssen Research & Development has established the Integrated Smart Trial & Engagement Platform (iSTEP), an information technology toolset developed to automate investigational product supply and data management in clinical trials. The approach, developed by Janssen, is available for industry-use and is designed to replace the paper-based conventional processes of managing clinical supplies and tracking patient health data with a cohesive suite of digital technologies.

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Warp Drive Bio to combat multi-drug-resistant bacterial infections

Tuesday, October 17, 2017

Warp Drive Bio, a drug discovery company developing therapeutics that exploit the molecules and mechanisms of nature, has formed a strategic collaboration with Roche to discover and develop multiple novel classes of antibiotics. The serious global health threat of multi-drug-resistant bacterial infections has created an urgent need for new antibiotics with novel structures and mechanisms of action.

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Clinerion adds FHIR data model to its set of standard EMR formats

Tuesday, October 17, 2017

Clinerion announces that data integration to its Patient Recruitment System platform can now process electronic medical records made available by hospitals using the Fast Healthcare Interoperability Resources (FHIR) standard. Hospitals using FHIR may now directly exchange data with Patient Recruitment System without the need for additional implementation effort.

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ACRP advances CRC competency-based standards

Monday, October 16, 2017

The Association of Clinical Research Professionals (ACRP) has launched a new initiative to develop competency standards for clinical research coordinators (CRCs) as part of a larger effort to advance the professionalism of the clinical research workforce. The project will establish minimum standards regarding the knowledge and skill required for entry-level study coordinators and create a hierarchy of competencies focused on performance rather than longevity. Pathways needed for CRCs to advance their careers will be clearly defined and ACRP will develop tools to assess job proficiency, identify gaps and provide training.

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Site impact of new ICH/GCP guidelines

Monday, October 16, 2017

The Pulse on Site Success by Christophe Berthoux

The industry largely accepts ICH/GCP guidelines as the gold standard regarding conduct in clinical research, which was recently updated in response to the increasing use of technology as well as findings from regulatory inspections. In November 2016, the second revision to ICH Good Clinical Practices E6 R2 contained an integration of 26 new additions to serve as guidance for clinical study conduct.

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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