• An interview with Franco Negron

    In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more
  • Status Of AI Regulation On Drug Development

    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. read more
  • AI in Pharmacovigilance: Key Takeaways from Boehringer Ingelheim’s Recent Rollout

    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. read more
  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more