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Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary below highlights the elements most relevant to clinical evidence generation and Joint Clinical Assessment (JCA) planning. This reform represents the most...
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Mergers and acquisitions (M&As) are a defining feature of today’s biopharmaceutical landscape. As companies merge pipelines, teams, and strategies, clinical development programs often undergo significant transitions. Yet during these shifts, one of the...
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Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear: hematology is entering a phase of rapid diversification. Across late-breaking abstracts, plenary sessions, and maturing follow-up data, ASH 2025 reflected...
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Learn how our regulatory affairs team was able to work with a sponsor to build a complete, FDA-compliant IND from scratch. Our collaborative efforts led to successful IND submission and initiation of clinical trials with confidence, preventing potential...
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When our sponsor acquired an investigational asset from an international company, they faced a critical regulatory challenge: Could clinical data from foreign trials not conducted under a U.S. IND be included in their New Drug Application? The foreign...
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In a recent Trailblazers interview, Cindy Henderson, Chief Strategy Officer at Veristat, shared her inspiring career journey from the mailroom to the executive team. Her story is packed with insights for anyone working in clinical research—from clinical...
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In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and shifting review priorities have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At...
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Complex therapeutic development requires deep integration across clinical, regulatory, statistical, and operational functions. Whether optimizing dose, navigating regulatory pathways, or accelerating timelines, early and sustained collaboration is...
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Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...
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The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...