Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Publication Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…CertaraJune 19, 2025
From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara On-Demand Webinar From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara Discover the Real-World Impact of Model-Based Meta-Analysis. Hear from experts, see case studies to advance…CertaraJune 18, 2025
Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer Publication Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…CertaraJune 8, 2025
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…CertaraMarch 20, 2025
Gene Therapy: A Transformative Shift in Rare Disease Treatment Video Gene Therapy: A Transformative Shift in Rare Disease Treatment After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…CertaraFebruary 26, 2025
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…CertaraFebruary 6, 2025
2025 cell and gene challenges: Scalability, supply chain and manufacturing Press Coverage 2025 cell and gene challenges: Scalability, supply chain and manufacturing Explore insights on 2025 challenges in cell and gene therapy, including commercial viability, with expert…CertaraFebruary 3, 2025
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…CertaraJanuary 10, 2025
Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA Poster Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA CertaraDecember 11, 2024
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Poster Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma CertaraNovember 22, 2024