The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers. It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs. As such, this Draft Guidance supports the Qualification of Drug Development Tools section (507) of the 21st Century Cures Act enacted on December 13, 2016 and provides the framework for developing the data set (evidence) supporting designation of a biomarker as qualified for a particular context of use (COU). Within this context of use, the qualified biomarker, “…can be relied on to have a specific interpretation and application in drug development and regulatory review…” While biomarkers measured by medical devices are outside the scope of the Draft Guidance, the Agency broadens the practical scope beyond qualified biomarkers to include the evidence needed to support the use of biomarkers in INDs, NDAs and BLAs:
“Many principles discussed in this guidance could also be appropriate when considering the evidence scientifically sufficient to support the use of a biomarker in an individual drug development program (e.g., investigational new drug application, new drug application, or biologics license application submissions).” Continue reading
Series Introduction: View all articles in this series.
Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Abuse Potential, we are sharing how we design and setup accurate and valid nonclinical GLP abuse liability study types required by regulatory agencies: self-administration, drug discrimination and physical dependency.
Below is a short summary of the full-length article (available for download) that explores how to design a drug discrimination study with in-house data samples from Covance. Continue reading
Our ongoing “Meet Me in 5” series covers 5 people, topics or questions to illustrate how Covance nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.
In this article, we spoke with Honggang Bi, PhD, Corporate Vice President and General Manager at Covance China. He shared his career development and discussed the recent milestone of reaching 1,000 employees in Covance China. Continue reading
Most people in our industry are familiar with the “Leaky
Funnel” analogy that describes the model where we approach a large number of
patients for inclusion in a study, but they leak out of the pipe at every
juncture. The loss of patients through planning, screening and execution of the
study is not only costly, but it can also significantly delay or even prevent the
successful execution of an otherwise valid study.