October Issue: Our Experts' Tips for Pediatric Drug Development
This month, we celebrated Child Health Day 2024, a testament to the great strides made in pediatric medicine and clinical care worldwide. The journey toward developing better, faster, and safer medicines and cures for children is not without its challenges—small patient populations, research and regulatory complexities, and unique physiological considerations.
Certara stands at the forefront of pediatric research, helping our clients fully leverage modeling and biosimulation strategies to enhance scientific insights and understanding of new medicines. We accurately predict the safety and efficacy of treatments for pediatric patients using virtual populations.
Together with our client community, we are privileged and motivated by the opportunity to bring new treatments to children and support a healthier future for all.
Read this month's newsletter to learn about:
Need help de-risking your pediatric drug program to increase its likelihood of scientific and regulatory success? Contact us today!
RAPS SPONSORED WEBCAST
Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview
Developing oncology medications for children faces unique challenges due to ethical concerns and physiological differences. Traditional clinical trials struggle with small sample sizes and recruiting pediatric patients, slowing drug development. This webinar will address strategies to overcome these challenges and optimize pediatric oncology drug development, covering innovative methodologies, regulatory considerations, and data-driven decision-making to improve drug efficiency and patient outcomes.
Date: November 21, 2024
Time: 8 AM PT / 11 AM ET
ARTICLE
What Recent Pediatric Guidelines Mean for Drug Developers
Justin Hay, Senior Director; Amy Cheung, Senior Director of Integrated Drug Development; and Patrick Loebs, Director, at Certara, examine recent changes in pediatric guidelines and how they affect drug development projects.
BLOG
Developing Pediatric PBPK Models for Differing Ethnic Populations
This blog discusses the importance of physiologically-based pharmacokinetic (PBPK) modeling in pediatric drug development. It highlights the need for ethnically diverse pediatric PBPK models to support international clinical drug trials, focusing on recent advancements in Japanese pediatric population models.
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WHITE PAPER
Advancing Pediatric Drug Development Using Simcyp PBPK
This white paper discusses the use of Simcyp physiologically based pharmacokinetics (PBPK) technology in pediatric drug development. It highlights case studies on dose selection, neonate exposure, rare diseases, DDIs, and child-specific formulations.
CASE STUDY
Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer
This case study explains how Certara scientists helped Regeneron determine the most promising dosing regimen for Odronextamab to maximize the chances of clinical trial success in pediatric patients.
Register now to attend live Certara webinars:
October 23, 2024, Joint Advice on FDA/EMA Compliance – Aligning with Evolving EU Regulations
Where to find Certara this Fall:
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About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.
Corporate Headquarters: 4 Radnor Corporate Center, Suite 350, Radnor, PA 19087 USA