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eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored in the dose decision making process. Thus, cancer patients often struggle to tolerate their medication long-term, requiring dose modifications including dose … Continued

https://www.certara.com/on-demand-webinar/echalk-talk-how-oncology-drug-developers-can-prepare-for-fdas-project-optimus/

U.S. FDA Licenses Certara’s Immunogenicity Simulator

Affirms the advancements of innovative biosimulation technology and its growing impact in R&D PRINCETON, N.J.— February 23, 2022 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has licensed Certara’s Immunogenicity (IG) Simulator to research and evaluate immunogenicity in protein-based therapeutics. Certara’s IG Simulator … Continued

https://www.certara.com/pressrelease/u-s-fda-licenses-certaras-immunogenicity-simulator/

Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 8th Consecutive Year

Asserts Certara’s leadership in advancing the development and approval of new drugs for patients PRINCETON, N.J.— February 15, 2022 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received … Continued

https://www.certara.com/pressrelease/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-8th-consecutive-year/

FDA Project Optimus

How prepared are you for Project Optimus? From dosing and study design to regulatory strategy and submission, we’ve got you covered. With the launch of Project Optimus, the FDA is reforming the dose optimization and dose selection paradigm in oncology drug development. With deep experience in model-informed oncology drug development, dosing and regulatory strategy and … Continued

https://www.certara.com/project-optimus/

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) which will develop new expectations for cancer drug makers to evaluate the efficacy of a wider range of doses in development and to shift from using maximum tolerated dose (MTD) approaches to establish the dose for pivotal … Continued

https://www.certara.com/blog/what-is-the-fdas-project-optimus-how-will-it-affect-oncology-drug-development/

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued

https://www.certara.com/on-demand-webinar/what-oncology-drug-developers-should-expect-from-the-fdas-project-optimus/

Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices PRINCETON, N.J.— December 21, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 … Continued

https://www.certara.com/pressrelease/certara-announces-fda-renewal-and-expansion-of-certaras-biosimulation-software-for-reviewing-regulatory-submissions/

Pinnacle 21 Awarded FDA Contract for 5 Years for Software and Services

Pinnacle 21 Enterprise software expedites regulatory review of all study submission data Princeton, N.J., October 28, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has awarded a five-year contract with Pinnacle 21 for ongoing software and related services support for the agency’s DataFit … Continued

https://www.certara.com/pressrelease/pinnacle-21-awarded-fda-contract-for-5-years-for-software-and-services/

FDA’s Digital Transformation: The Future of Technology and How to Prepare

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

https://www.certara.com/on-demand-webinar/fdas-digital-transformation-the-future-of-technology-and-how-to-prepare/
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