Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of improvement in tumor response rates showed only 10 percent of these therapies...
Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.1 In the past, most studies conducted in APAC countries were later studies, but there has recently been an uptick in the number of phase 1 trials. This bustling activity, in combination with...
The Asia-Pacific (APAC) region now ranks first in the world for total number of active oncology clinical trials, with China alone accounting for more than half of those studies.1 To take advantage of the potential benefits of conducting clinical research in APAC countries, sponsors need to understand the nuances of designing and operationalizing studies in...
When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...
Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...