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.
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 ...
TMCnet

Simulations Plus Expands Global Access to Model-Informed Drug Development Training Through Its 2026 Spring School

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of ...
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 ...
TMCnet

Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of ...
Seeking Alpha

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

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

Certara Enters Definitive Agreement for the Sale of its Regulatory and Medical Writing Business to Veristat

Transaction sharpens focus on Model-Informed Drug Development (MIDD) and Clinical Intelligence Updated 2026 guidance to be provided upon ...
Nasdaq

Certara Appoints Dr. Adrian McKemey as President of Drug Development Solutions

RADNOR, Pa., March 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of Adrian McKemey, Ph.D. as President ...

Certara to sell regulatory and medical writing business for up to $135M

Certara (CERT) stock jumps as the company agrees to sell its regulatory & medical writing unit for up to $135M, boosting AI ...
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 ...
Bloomberg L.P.

Artificial intelligence’s fit in drug development, life sciences

This analysis is by Bloomberg Intelligence Industry Analyst Andrew Galler and Senior Associate Analyst Jack Maltby. It appeared first on the Bloomberg Terminal. Life sciences is among the most ...