Post-approval Pharmacovigilance: Support Along the Entire Lifecycle of Your Drug

Patient safety doesn’t end with regulatory approval. In many ways, approval is just the beginning.    Pharmacovigilance activities conducted after regulatory approval are every bit as important as those conducted during clinical trials. Sponsors know this, but many are nevertheless unprepared for just how much work is involved.   A smaller emerging biopharmaceutical company faces […]

The Challenge of Overreporting: A Fresh Perspective from the FDA

In a recent WCG webinar, Steven Beales, Senior Vice President, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, Robert Temple, the Deputy Director of CDER, and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy. They discussed overreporting SUSARs and the impact on patient safety. This whitepaper is based largely, but […]

A Successful DMC Requires a Productive, Early Organizational Meeting

By Matt Downs, MPH, Statistical Scientist, WCG Statistics Collaborative For a DMC, that first organizational meeting sets the stage for the DMC’s future data reviews. It should occur prior to recruitment and have a robust agenda.   I like to use the analogy of a boat in a port. Before you set sail, you want […]

CNS Trial Failure Rates High As Need for New Drugs Grows

The failure rate of CNS drugs in Phase 2 and 3 clinical trials is approximately 85%, second only to oncology. Because of the blood-brain barrier, the development of drugs for CNS indications presents particular challenges, as compounds need to be lipophilic in order to pass through that barrier. Over the past decade many larger pharmaceutical […]

Big Challenges for Small Sponsors: Competition in Oncology Research

INTRODUCTION: Trial growth has dramatically outpaced site capacity since 2015, at the same time the number of new investigators participating in clinical trials has decreased by 48%. Those are just two reasons sponsors miss 80% of critical clinical trial milestones, and for smaller biopharma sponsors one missed milestone alone can create significant issues for a […]

A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule

In this webinar, Robert Temple, the Deputy Director of CDER and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy will join us to discuss how chronic over-reporting of SUSARs to investigators and ethics committees has risen to a critical level in affecting patient safety and what to do about it. 10 years ago, […]

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