For drug developers ready to progress a molecule to the pivotal clinical trial stage, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) is a significant milestone. Drug developers approach this task with a wide range...
While much of the world continues to cancel events and defer projects in light of the COVID-19 pandemic, drug development often doesn't have the luxury of going on hold. Preclinical drug testing and the submissions that follow can't afford potential delays, which...
The recently updated guidelines on assessing drug-drug interactions will likely improve experimental outcomes, reduce costs and streamline development timelines. The U.S. FDA updated its guidelines for in vitro drug interaction assessment to help drug developers...
Between travel limits and social distancing, in-person visits at testing sites for drug and medical device development are currently not an option. Qualifying testing sites is a standard industry practice, but the resulting restrictions of COVID-19 present new...
The novel coronavirus (COVID-19) pandemic has thrown many standard procedures out the window, including how companies approach the logistics of shipping biological samples to China. To prevent the introduction and spread of infectious disease, Chinese Customs...
The unforeseen and drastic effects the COVID-19 pandemic has had on the industry have led to unanticipated challenges, including stricter international shipping regulations, travel restrictions, local lockdowns and more. However, industry leaders are still here to...
As our partners’ research and development programs begin to ramp up, so does the need for additional resources. At WuXi AppTec, we remain committed to ensuring the availability and integrity of the research models used on our customers’ vital development programs is...
As your partner we are taking all the necessary steps to make sure your drug development continues without any disruptions in the process. Moving your molecule forward during COVID-19 doesn’t need to be stressful or difficult. We continue to learn and have found...
Meeting drug development timelines are highly important and the building blocks of success for drug development companies. Frequently, financing tranches are connected to the achievement of milestones, and potential strategic partners may be evaluating multiple...