Oxana Iliach is a Senior Director of Regulatory Strategy at Certara (PA, USA), a biotech company that offers comprehensive solutions for transforming and accelerating drug development. In her spare ...

AI and machine learning are revolutionizing drug discovery, development, and lifecycle management, addressing industry ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

TUCSON, Ariz., May 8, 2025 /PRNewswire/ -- The year 2025 marks a historic milestone for Critical Path Institute ® (C-Path), as the organization celebrates 20 years of transforming the landscape of ...

U.S. pharmaceutical company Eli Lilly plans to disclose the top-line results of its phase 3 clinical trial for ‘remternutux,’ a new drug candidate being developed as a successor to its Alzheimer’s ...