Smoother Regulatory Process for China
September 8th 2016One year ago, the China Food and Drug Administration (CDFA) was pushed to accelerate its activities to promote new or updated regulations and guidelines. Since then the results have been smoother processes for innovative drug development in China.
GERD Treatment: Where We Went Wrong
September 6th 2016Patients of gastroesophageal reflux disease (GERD) that have been frequently diagnosed, or misdiagnosed, have been dissatisfied with the available treatment. To resolve this issue, industry players must define meaningful endpoints for future trials, incorporate patient reported outcomes, and apply biomarkers.
Discussion on TransCelerate’s QMS Initiative
September 6th 2016TransCelerates work on their clinical trial Quality Management Systems (QMS) initiative began about one year ago. This article summarizes findings from a recent DIA publication about the initiative and evaluates potential issues during QMS framework implementation.
What Could Brexit Mean in Practice for Pharma?
September 6th 2016Following the UK’s decision to leave the European Union, the result has been uncertainty and speculation as pharma attempts to understand its implications. How this change will effect the pharma and life sciences industry as well as the European community remains to be seen.
Stepping Up Cancer Treatment Targeting
September 2nd 2016Cancer therapy has seen progress - not groundbreaking, but improving thanks to the scientific and technological tools at our disposal. This fall offers industry events and trial evaluations that aim to continue this progressive trend toward a breakthrough.
Standardized Metrics for Better Risk Management: The Right Data at the Right Time
August 31st 2016Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance.