PRINCETON, N.J.— October 19, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the third quarter of 2021 after the market close on Tuesday, November 9th, 2021. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in … Continued
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading cause of death worldwide [1]. Antibody Drug Conjugates (ADCs) when first approved in 2000, seemed ideal in that they could deliver the cytotoxic drug (also referred to as the warhead) directly to the tumor site, resulting in reduced off-target damage … Continued
There is a lot of misinformation about whether or not the COVID-19 vaccines have “full” FDA approval or Emergency Use Authorization (EUA). The words approval and authorization are often used incorrectly; they are not interchangeable. On March 27, 2020, the Secretary of health and Human Services (HHS) issued a declaration that there is a public … Continued
Thursday, November 18th – 10:00 am ET Both the FDA and EMA have made statements that support the concept of using real world evidence (RWE) for regulatory decision-making. Historical control arms represent a way to take a safe and effective leap forward into real-world evidence. But there is much heterogeneity in the lexicon (eg. external, … Continued
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike a biotechnology or pharmaceutical enterprise, where the assets one typically works on are within that ecosystem, consulting offers the possibility of working on many different innovation pipelines. At any given time, you might be working on solving a problem for … Continued
Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2 months old. CYP3A-mediated DDI risk in pediatric patients was evaluated by physiologically-based pharmacokinetic (PBPK) modelling and informed the label. This talk will illustrate a modeling strategy for the extrapolation of DDIs from adults to children covering: Development of a patient-specific … Continued
As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA has created an Office of Digital Transformation (ODT) to support the effective review, approval, and regulation of human drugs, biological products, and medical devices. To achieve its goals, FDA is doubling down on cloud technologies and the … Continued
