5 pediatric drug development tips to learn this quarter

The evolution of the pediatric regulatory environment has increased the demand to develop a common scientific-based approach that is acceptable to global regulatory authorities. It is crucial to create a thoughtful plan to support efficient pediatric drug discovery and development to ensure safe and effective medicines for children.

Typical challenges encountered in a pediatric program include:

• Enrollment challenges due to small populations and multiple sponsors targeting the same population
• Burden of research procedures
• Limitation in use of placebo and lack of active comparators
• Physiological differences across the entire pediatric population
• Bridging of knowledge from adults to pediatrics

Here are our top blogs, webinars, and videos to help set your pediatric program up for success!

INFOGRAPHIC:

Hot Topics in Pediatric Drug Development. In 2021, Certara hosted the inaugural New Horizons in Pediatric Drug Development symposium to bring together pediatric thought leaders and innovators to share new developments in the field and to collaborate on ideas to advance pediatric drug development. Here’s what we learned. Learn more.

BLOG:

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline. Three essential themes dictate the concepts in the recent guideline. Read more.

PODCAST:

Accelerating Pediatric Drug Development: Regulatory and Industry Perspectives. In this episode?of Becker’s Hospital Review, we are joined by Patrick Smith, PharmD, President, Integrated Drug Development, Certara and Lynne Yao, MD, Director, Division of Pediatric and Maternal Health, US FDA. They give us an overview of the pediatric drug development landscape, model-informed drug development, share best practices, and more. Listen here.

WHITEPAPER:

Advancing Pediatric Drug Development and Regulatory Acceptance Using Simcyp PBPK: from Birth to Young Adult.?Read case studies ranging from?dose selection and neonate exposure to DDI for pediatrics and developing child-specific formulations. Read more.

ON-DEMAND WEBINAR:

This webinar discusses a recently developed online patient engagement portal to enable patients to provide direct feedback on PLS. We also focus on the pediatric PLS space, with consideration given to the cognitive development and unique needs and perceptions of children and young people. Watch here.

Where is Certara this month?????

Conferences

• September 19-21,?PHUSE CSS
• September 20-22,?Fierce Medical Affairs Strategic Summit West
• September 25-27,?ACCP Annual Meeting
• October 11-14,?AMCP Nexus 2022
• October 16-19,?2022 AAPS Pharmsci 360
• October 18-19,?BioIT Europe 2022
• October 18-20,?Gene Therapy Immunogenicity 2022
• October 18-28,?Fierce Digital Pharma East
• October 27-28,?New Horizons in Pediatric Drug Development Symposium 2022
• October 30 - November 02,?2022 ACoP13

Webinars

• September 20,?Navigating the Biotech Funding Crunch: How to Achieve Your Next Value Inflection, in partnership with Nasdaq and AAPS
• September 22,?A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development, in partnership with RAPS
• September 27,?Learn how to leverage the power of cloud computing to streamline your workflow!
• September 28,?eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation
• September 29,?What's new in GlobalSubmit 22.9.1
• October 11,?Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA), in partnership with Fierce Pharma

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About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Corporate Headquarters: 100 Overlook Center, Suite 101, Princeton, NJ 08540 USA