DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
FDA Draft Guidance on Sameness for Gene Therapy
The U.S. Food and Drug Administration (FDA) recently finalized several guidance documents ...
3 Health Tech Trends Shaping The Future Of Clinical Operations
“3 Health Tech Trends Shaping The Future Of Clinical Operations” was originally published ...
Regulations, Ripple Effects & Unintended Consequences
The Colorado Bioscience Association held their Annual Regulatory Affairs Symposium on ...
3 Key Gaps in the Proposed Drug Import Policy
In mid-December, the Trump administration made moves in favor of allowing drugs to be ...
Where is Gene Therapy Heading?
Within the next decade, I expect to see ground-breaking, innovative changes in the way ...
Working with the Right Type of Regulatory Affairs Professional
In looking back at my 3+ decades of experience with the pharmaceutical and medical device ...
ASH 2019: Themes and Trends Heading into 2020
The American Society of Hematology (ASH) Annual Meeting & Exposition is the largest ...
3 Tips for Expediting Your Drug Development Program
Last week, I led an engaging discussion at BioLabs San Diego on how life science ...
Diversity in Clinical Trials
As an industry, our primary goal is to bring safe and effective medications to the ...
Five Tips for Implementing Quality as a Culture in Your Organization
Last week, I led an engaging discussion at BioLabs San Diego on the concept of “quality ...