Greater Certainty in Drug Development

Generative AI (GenAI) is poised to revolutionize writing and report generation. In fact, industry studies have shown the use of GenAI can introduce efficiencies of up to 40% while providing the tools needed to provide a happier writing team. However, successful implementation of a GenAI tool within your medical or regulatory writing team doesn’t start &hellip; <a href="https://www.certara.com/webinar/where-to-start-setting-your-medical-writing-team-up-for-success-with-genai/">Continued</a>

Faced with more and more complex clinical research than ever before, regulatory writers are facing new demands. Along with eCTD structural mastery, writers must bring to their task data integration skills, consistent approaches to explanation, and a collaborative spirit.&nbsp;&nbsp; AI-powered writing software, CoAuthor™, helps your writing team to accelerate the drafting and submission of quality &hellip; <a href="https://www.certara.com/webinar/ai-powered-regulatory-writing-software-frequently-asked-questions-by-japanese-customers-japanese-webinar/">Continued</a>

Moxidectin for Women’s Health Equity Model-Informed Drug Development is increasingly impacting public health and regulatory decision-making in support of global health initiatives.&nbsp; In this webinar, we will share a recent global health case study on the use of&nbsp; pharmacokinetic (PK) and physiologically based pharmacokinetic (PBPK) modeling of moxidectin to understand the impact of drug exposure &hellip; <a href="https://www.certara.com/webinar/from-research-to-real-world-impact-a-model-informed-drug-development-midd-framework-to-support-understudied-populations/">Continued</a>

Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A defect in the Frataxin (FXN) gene causes FA. FXN is essential for the proper functioning of the mitochondria, and its deficiency leads to mitochondrial dysfunction, oxidative stress, and neuroinflammation.   Patients develop ataxia, balance issues, loss of motor skills, speech impairment, weakness, visual impairment, … Continued

The Centers for Medicare & Medicaid Services (CMS) is piloting a program that would negotiate and administer outcome-based agreements and supplemental rebates on behalf of state Medicaid agencies  The CGT Access model will initially focus on gene therapy for sickle cell disease   On December 4, 2024, CMS announced that it had successfully negotiated contracts with … Continued

What is a “cell therapy”? Nearly every recent oncology clinical conference has featured this phrase. Cell therapies, such as CAR-Ts (chimeric antigen receptor T-cells), aren’t small molecule drugs or simple biologics. They’re a whole new class of therapeutics! How does CAR-T technology work? In simple terms, it’s a method for enabling our immune system to … Continued