Much like the literal moonshots now back on the launch calendar, first in human studies are defined by the tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon.
When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients.
In conversation with Pharmaceutical Outsourcing, Claudia Lehman, Head of Global Pharmacovigilance Operations at Boehringer Ingelheim and Lucinda Smith, ArisGlobal’s Chief Safety Product Officer, reflect on some of the lessons learned from Boehringer’s deployment of AI to date in targeted use cases, starting with adverse event case intake and processing.
In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory expectations. Yet one factor often determines long-term success more than any other: the strength of the data generated in the earliest phases of cell line development.
This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months.
The newest generation of small-molecule therapies bring containment needs well beyond those of conventional HPAPIs. What does this mean for the pharma lexicon – and the pharma landscape?
Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI.
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats.
Veristat’s new CEO, Kim McLean Boericke, is one step closer to changing the tide in representing the small fraction of companies led by women and is now the only female with the highest job among the top-8 clinical research organizations (CROs).
As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance.
In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development.
In this interview we spoke to Brian Morrissey, General Manager of Gaelic Laboratories, about the strategy behind their acquisition of Athlone Laboratories, and its impact.
In an interview with Pharmaceutical Outsourcing, ArisGlobal’s Jason Bryant discusses the premise of AI’s next high-profile incarnation, the technology’s potential in late-stage pharma R&D operations, emerging early use cases, and some of the guardrails that need to be in place to ensure trusted, impactful use.
AI is already reshaping the clinical trials industry and that transformation looks set to continue over the next five years. New technologies will enable the development of more personalized medicines, empower more responsive trial designs and improve informed decision making by unlocking new data insights.
As drug development grows more complex and timelines compress, sponsors require CDMO relationships built on integration, flexibility, and shared accountability