The Roundtable: Our Thoughts About Model Based Drug Development

Author: Maria Saluta

Maria obtained her B.S., M.S., and Ph.D. in Microbiology from St. John’s University. Her Master’s thesis “The Effect of Cultrate 6300 on the Growth and Cephalosporin C Production by Paecilomyces persicnus P10-M1” focused on improving cephalosporin antibiotic production using a by-product of sugar cane refinery. Maria’s Ph.D. thesis entitled “The Occurrence of Duplicate Lysyl-tRNA Synthetase Genes in Escherichia coli and Other Procaryotes” provided a molecular taxonomic approach to examining a rare duplicate gene occurrence in bacteria and its possible role in human disease. Maria has held various research, scientist applications support and leadership commercial and marketing roles the Life Sciences and Diagnostics industries, and is currently the Sr. Product Marketing Manager for the Biosimulation portfolio at Certara.

Recent Posts

Navigating the Path for Pharmacokinetic CDISC Data Preparation

Maria Saluta

Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the […]

Read More
Topics: PK/PD Modeling & Simulation

What’s New in Phoenix 7.0!

Maria Saluta

On September 14, Dr. Nathan Teuscher presented an informative webinar focused on new features and enhancements in Phoenix® 7.0, which was released on August 10. This blog post summarizes the topics discussed during the presentation. Nathan began his presentation with an overview of new features in Phoenix 7.0 including: A new graphics engine for high […]

Read More
Topics: PK/PD Modeling & Simulation

On the Road Again: Leveraging the Power of Phoenix

Maria Saluta

Last year during our inaugural Phoenix Roadshow workshop program across the US, Europe and Asia, we gained valuable feedback and ideas from our customers on “All Things Phoenix.” Based on the success of that program, and with new updates and case studies to share with our users, we commenced our 2nd Annual Phoenix Roadshow in […]

Read More
Topics: PK/PD Modeling & Simulation

Get Ready for CDISC-SEND!

Maria Saluta

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and […]

Read More
Topics: PK/PD Modeling & Simulation
Learn More
LinkedIn