RAPS

ICH plans model-informed drug development guideline in 3-4 years

The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches in drug ...
RAPS

Model-Informed Drug Development: Details on FDA Pilot Project

Details on the US Food and Drug Administration’s (FDA) plans for launching a pilot project on model-informed drug development (MIDD) began trickling out on Monday with a Federal Register notice.
Forbes

Adoption Of Model-Informed Drug Development Can Improve Pharma ROI

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...
Morningstar

Simulations Plus to Host Virtual Investor Day Highlighting Strategy for the Next Era of Model-Informed Drug Development

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced ...
FierceBiotech

Project Optimus: Transforming Dose Optimization in Oncology Drug Development

In a recent exclusive interview, Fierce Biotech’s Chris Hayden sat down with Alex MacDonald, Vice President of Model-Informed Drug Development at Allucent, to explore the impact of Project Optimus, an ...
Seeking Alpha

Certara Appoints Dr. Chris Bouton as Chief Technology Officer to Advance AI in-silico Drug Discovery and Development Platform

RADNOR, Pa., July 31, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (CERT), a global leader in model-informed drug development, today announced the appointment of Christopher Bouton, Ph.D., as Chief ...
Business Wire

Simulations Plus Convenes Industry and Regulatory Leaders to Define Responsible AI in MIDD

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that ...
Business Insider

Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib

RADNOR, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced its Simcyp ® Simulator enabled physiologically-based ...
Yahoo Finance

Simulations Plus and three pharma companies collaborate on AI-driven drug development

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EurekAlert!

Ebenbuild publishes validation study in Nature Communications Medicine demonstrating strong predictive performance of lung digital twins

Peer-reviewed study confirming strong predictive performance of patient-specific lung digital twins, validated against ...
Nasdaq

Certara Appoints Dr. Chris Bouton as Chief Technology Officer to Advance AI in-silico Drug Discovery and Development Platform

Strengthening technology innovation and leadership of the Certara AI/ML-enabled biosimulation platform used to speed time to market in drug discovery and development RADNOR, Pa., July 31, 2025 (GLOBE ...