The U.S. drug development process for novel therapeutics targeting difficult-to-treat diseases takes an average of 10 to 12 years to complete. For drugs that go into development this year, that ...
A team of researchers at the University of Cambridge have designed a new approach to the preclinical drug development process using machine learning, which has the potential to speed up drug ...
AI drives decision inputs: In 2025, both big pharma and small pharma use advanced predictive modeling, digital twins, and AI-powered analytics throughout R&D and regulatory processes. This reduces ...
Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...
Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...
Partnership combines AI-powered protein manufacturing with advanced drug delivery technologies to accelerate timelines and improve therapeutic outcomes. Through this collaboration, Axio BioPharma will ...
The Costs They Are a-Rising: Commercialization Costs and the Innovation Process in Drug Development.
Khoshsokhan, Sina. The Costs They Are a-Rising: Commercialization Costs and the Innovation Process in Drug Development. Academy of Management Annual Meeting Proceedings. 2024, Vol. 2024 Issue 1, p1-6.
At AAPS PharmSci 360 2025, held from Nov. 9–12 in San Antonio, Texas, Corey Bloom, PhD, associate director, CMC (chemistry, ...
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.
As drug development enters a new era, Certara is expanding its global team of scientists and technologists to lead the shift toward AI-powered testing methods.
A researcher at UC San Diego. Photo by David Baillot via UC San Diego Jacobs School of Engineering A recent appeals court ruling in California has posed a burning question for regulators, the life ...
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