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FDA awards new grants to support developing & assessing complex generic drugs

Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) of complex generic drugs PRINCETON, N.J.— February 7, 2023. Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded work with the University of Florida and the University of Rhode … Continued

https://www.certara.com/announcement/fda-awards-new-grants-to-support-developing-assessing-complex-generic-drugs/

New FDA Requirement to Support Labeling on DDIs in the Pediatric Population

The effects of drug-drug interactions (DDIs) could differ in the pediatric population compared to adults. The resulting changes in exposure of the victim drug, because of a DDI, at a metabolism and/or transport level could be larger or smaller, depending on the relative contribution of the affected enzyme/transporter to the disposition of the drug in … Continued

https://www.certara.com/blog/new-fda-requirement-to-support-labeling-on-ddis-in-the-pediatric-population/

Simultaneous FDA & EMA Submissions for Drug Approvals 

Is there a better way? The question always breeds critical thinking and often leads to new solutions. In this discussion, it can entirely rewrite the approach to, and relieve many of, the common pitfalls experienced during…

https://www.certara.com/article/achieving-simultaneous-new-drug-documentsubmission-for-the-fda-and-ema/

3 Takeaways from the FDA Oligo Guidance You Need to Know

In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects regarding development of oligonucleotide therapies. Whilst the guidance still leaves a few open questions, it provides drug developers with a starting point and acknowledges that … Continued

https://www.certara.com/blog/3-takeaways-from-fda-oligo-guidance/

Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs

The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022) provided the most in-depth view to date into the FDA’s thinking regarding the Oncology Center of Excellence (OCE) led Project Optimus and the shifting paradigm of dose optimization in oncology. Below are a few key take-aways from this meeting: Project … Continued

https://www.certara.com/blog/fda-asco-workshop-oncology-drugs-dose-optimization/

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

2022 is shaping up to be the “year of the guidance” as the FDA has just released a new guidance on using circulating tumor DNA in early clinical drug development. In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics. Despite many important advances in oncology drug … Continued

https://www.certara.com/blog/why-fdas-new-guidance-on-circulating-tumor-dna-is-critical-for-oncology-early-clinical-drug-development/

Project Optimus: How to engage with the FDA to advance your program

Join us for this SPECIAL SESSION taking place during DIA Global 2022. This is a cocktail reception with presentation and Q&A hosted by Julie Bullock, PharmD & ex FDA and Demetrius Carter at the Hyatt Regency McCormick Place. Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine … Continued

https://www.certara.com/conference/dia-optimus/

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

The new Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC), Guidance for Industry, was issued by the US Food and Drug Administration (FDA) in February 2022. ADCs are targeted therapies that are designed to deliver cytotoxic payloads to cancer cells. The cytotoxic payload is attached to a monoclonal antibody (that is designed for binding to the … Continued

https://www.certara.com/blog/reflections-on-the-new-fda-clinical-pharmacology-guidance-for-antibody-drug-conjugates/

What is FDA Project Optimus and How Will it Impact Oncology Drug Development?

In partnership with RAPS this webinar provided an overview of FDA’s Project Optimus and its potential impacts on oncology drug development. The historical 3×3 Phase 1 study design to establish a Maximum Tolerated Dose (MTD) was developed for cytotoxic agents (eg, platins). Now, most new agents are immunotherapies and other biologics for which a more … Continued

https://www.certara.com/on-demand-webinar/what-is-fdas-project-optimus-and-how-will-it-impact-oncology-drug-development/

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/
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