Insights & Publications
White papers, case studies, and expert commentary on the issues shaping pharmaceutical and biotech development today.
Featured Publication
The FDA's accelerated approval pathway has undergone significant reform following the Omnibus legislation. This white paper examines the new confirmatory trial requirements, withdrawal procedures, and what they mean for oncology and rare disease sponsors.
Topics Covered
A mid-size oncology company received a CRL citing CMC deficiencies and clinical data gaps. We detail the 14-month remediation strategy that led to a successful NDA approval.
Adaptive designs offer significant efficiency gains in rare disease development, but require careful upfront planning. We explore the key design considerations and agency expectations.
Payer engagement can no longer wait until post-approval. This paper outlines a proactive HEOR strategy framework that integrates outcomes research into clinical development planning.
When a clinical-stage biotech needed to choose between three pipeline assets with limited runway, we applied a structured go/no-go framework that aligned science, regulatory risk, and commercial potential.
Recent FDA warning letters and enforcement actions related to REMS non-compliance offer important lessons for sponsors. We analyze the patterns and outline best practices for program maintenance.
FDA has issued multiple guidance documents on the use of RWE to support regulatory decisions. This paper synthesizes the current landscape and provides a practical framework for sponsors.
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