DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
Quality Governance and Evolution of Quality Management Review
Quality governance can be defined as an overarching framework that provides assurance of ...
Preparing Now for FDA START Program for Rare Disease Drug Developers
On September 29, 2023, the U.S. Food and Drug Administration (FDA) took action to help ...
Small Biotech and Pharma Dilemma – Three Steps to Remain Competitive on a Budget
While attending the annual SCOPE summit this year, listening to sessions and walking the ...
Pulling the Thread on FDA’s Master Protocol Draft Guidance
The U.S. Food and Drug Administration’s (FDA) draft guidance, Master Protocols for Drug ...
5 Broad Implications for Project Optimus: Future of Oncology Trials
Oncology drug development is different from most drug development programs in other ...
Reconsidering the 3+3 Dose Escalation in Oncology Studies
Many product developers are propelled by the goal of delivering life-saving treatments as ...
Trial Rescue: Leadership Approach Propels Clinical Development
Situation
Why The FDA Modernization Act 2.0 is The Challenge Our Industry Needs
Shawn Roach, one of Halloran’s Regulatory Chemistry, Manufacturing, and Controls (CMC) ...
Navigating the Patient Clinical Trial Training Matrix
Content in collaboration with ScienceMedia Authors: Malachi Bierstein, Chief Commercial ...
The Value of Artificial Intelligence to Support Inspection Readiness
A Health Authority (HA) inspection of a clinical trial can occur at any time, and ...