Cerrado Gold Inc is a precious metals mining and exploration company building a portfolio of assets in South America. The company owns the Minera Don Nicolas Project, located in Santa Cruz, Argentina. It is also focused on exploration at its Monte do Carmo gold Project in Tocantins State, Brazil.
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- Nearly 90% of drug candidates fail in human trials due to efficacy or toxicity gaps, driving adoption of New Approach Methodologies (NAMs) including humanized mouse models, organ-on-a-chip, and AI. - Human liver-on-a-chip models achieved over 87% sensitivity and 100% specificity in predicting drug-induced liver injury, outperforming traditional animal safety screens. - AI algorithms can now screen billions of compounds in two days, but experts caution that computational speed does not guarantee clinical efficacy, citing Exscientia's failed AI-designed candidate. - The AI-accelerated nonclinical drug testing market is valued at USD 1,090.7 million in 2026 and projected to reach USD 4,489.9 million by 2036 at a 15.2% CAGR.
- Veristat announced four strategic leadership appointments to strengthen its biostatistics, drug development advisory, and human resources capabilities. - Dr. Zhaohui Su and Dr. Gil Fine join the Strategic Drug Development Advisory team, bringing decades of biostatistical expertise from IQVIA, McKesson, Syntex, and Sumitomo Dainippon Pharma Oncology. - Scott Tarrant was named Executive Vice President to lead the Strategic Drug Development consultancy globally, while Clint Wolfe joins as Chief Human Resources Officer. - The hires build on Veristat's 30-year foundation in biostatistics and its recent acquisition of Certara's medical writing and regulatory submission business.
- Altasciences and Certara announced a strategic partnership to integrate model-informed drug development capabilities into early-phase development programs. - The collaboration aims to address the significant failure rate in drug development, where fewer than half of preclinical candidates successfully reach first-in-human trials. - The partnership combines Altasciences' Acceleration Platform with Certara's biosimulation technology to enable earlier proof of mechanism establishment and more informed go/no-go decisions. - The integrated approach is positioned to support FDA's advancing guidance on adaptive, data-driven drug development methodologies.
- Certara has partnered with NVIDIA to integrate the BioNeMo Agent Toolkit into its AI-driven drug discovery and development platform. - The collaboration combines Certara's biosimulation software and regulatory expertise with NVIDIA's AI agents to computationally simulate human biology. - AI agents will function autonomously alongside biosimulation models, aiming to accelerate insight generation across the drug development continuum. - The partnership represents a convergence of computational modeling and artificial intelligence that could transform how new medicines are discovered and developed.
- Certara has entered a definitive agreement to sell its Regulatory and Medical Writing business to Veristat for up to $135 million, with the transaction expected to close in Q2 2026. - The divestiture allows Certara to sharpen its focus on Model-Informed Drug Development (MIDD) and Clinical Intelligence solutions, emphasizing AI-integrated modeling and simulation. - The sold business generated $50 million in revenue and $17 million in adjusted EBITDA in 2025, employing approximately 220 staff members. - Certara plans to deploy the proceeds to accelerate investment in its integrated MIDD platform and drive long-term value for customers, patients, and shareholders.
- Over 7,000 rare diseases affect an estimated 30 million people in the US alone, yet these conditions have long been underfunded and under-researched, leaving patients with limited therapeutic options. - Virtual trials utilizing digital twin technology are emerging as a breakthrough approach in rare disease research and drug development. - Piet van der Graaf, Senior VP at Certara, discusses how predictive simulation, data-driven modeling, and AI are being tailored to advance rare disease drug development. - Certara's work in digital twins represents a convergence of computational modeling and clinical research aimed at addressing the significant unmet needs in rare diseases.
- Certara's Simcyp Simulator enabled physiologically-based pharmacokinetic modeling predictions that were accepted by the U.S. FDA in lieu of clinical studies to support asciminib's new drug application. - The PBPK modeling replaced at least ten dedicated clinical pharmacology studies for asciminib, a first-in-class allosteric inhibitor targeting the BCR::ABL1 myristoyl pocket for chronic myeloid leukemia treatment. - This regulatory acceptance demonstrates the growing impact of model-informed drug development approaches, with the modeling work spanning over a decade to optimize dosing regimens and drug interaction profiles. - The virtual biological system predictions accurately characterized asciminib pharmacokinetics across diverse patient populations and clinical scenarios, supporting regulatory approval for an important new CML therapy.
- The FDA issued draft guidance on December 2 outlining specific product types where six-month non-human primate toxicity testing can be eliminated or reduced, marking significant regulatory progress for New Approach Methodologies (NAMs). - A multi-stakeholder Validation and Qualification Network with dozens of partners including FDA, European Commission, and major pharmaceutical companies like Sanofi and GSK held meetings in July to advance NAMs development. - Industry experts emphasize that NAMs are not ready for complete animal model replacement, as the tools, validation criteria, and regulatory frameworks are still being developed and refined. - The shift toward NAMs requires coordinated collaboration across stakeholders, early regulatory engagement, and investment in high-quality biological materials and AI-driven predictive models to achieve widespread adoption.
- Certara's Simcyp Simulator has become the first and only PBPK modeling platform to receive formal qualification from the European Medicines Agency for regulatory submissions across the EU. - The qualification allows sponsors to use Simcyp simulations to assess drug-drug interaction risk in regulatory submissions without re-establishing the platform's credibility for specified scenarios. - The qualification covers three contexts of use spanning six CYP enzymes and two inhibition mechanisms, potentially reducing the number of required clinical DDI studies. - This milestone represents a significant advancement in model-informed drug development as regulators increasingly prioritize biosimulation approaches to accelerate drug development.
- Certara has appointed Dr. Christopher Bouton, founder of Vyasa Analytics, as Chief Technology Officer to lead development of an AI-powered model-informed drug development platform. - Dr. Bouton will spearhead technology strategy for integrating generative AI and biosimulation technology to accelerate drug discovery and development timelines. - The appointment strengthens Certara's position in the competitive biosimulation market, building on Bouton's track record of developing AI solutions including CoAuthor™ for regulatory writing. - Certara's next-generation platform aims to increase efficiency in discovering novel therapeutics by combining scientific expertise with advanced AI approaches.
