Early Development and Translational/Quantitative Pharmacology Strategies in Pediatric Drug Development

On-Demand Webinar

“Traditional” approaches to pediatric development of small molecules involves gaining approval or collecting significant clinical data in adults prior to bridging to the pediatric population.

Challenges in pediatric programs, which include selection of starting doses, PK and PD sampling strategies, and study design are amplified when significant adult safety and efficacy data are not available.

This seminar described the application of early development strategies to enable development in children, in cases where limited adult data are available. Extensive use of translational science and quantitative modeling and simulation methods were key underpinnings to facilitate the successful execution of these programs.

About Our Speakers

Webinar-2speaker-Smith-RaynorPatrick Smith, PharmD: Dr. Smith has over 17 years of global drug development experience, and is currently CSO of d3 Medicine and a Research Professor at the SUNY-Buffalo School of Pharmacy with over 100 peer reviewed publications. Dr. Smith has extensive experience in all phases of drug development, with particular expertise in infectious diseases and oncology, and significant experience in modeling and simulation. As a co-founder of d3 Medicine, Dr. Smith has led many development projects for d3 Medicine clients ranging from pre-clinical development/IND strategy, design and execution of entry-into-human and proof of concept studies, design and implementation of modeling and simulation strategies, and crafting clinical pharmacology and clinical development plans. Prior to joining d3 Medicine, Dr. Smith was the administrative head of Clinical Pharmacology in the U.S. for Roche, and a member of key corporate governance committees defining disease area and portfolio strategy.

Craig Rayner, PharmD, MBA: Dr. Rayner is the CEO of d3 Medicine. He has more than 15 years of drug development experience across all therapeutic areas, but particular interest in infectious diseases and global health, and is an Adjunct Associate Professor at Monash University with over 100 peer reviewed publications, peer reviewed abstracts and book chapters. At d3 Medicine, Dr. Rayner is a drug development practitioner, and has led many drug development assignments and due diligences.  His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research.

 

“Traditional” approaches to pediatric development of small molecules involves gaining approval or collecting significant clinical data in adults prior to bridging to the pediatric population.

Challenges in pediatric programs, which include selection of starting doses, PK and PD sampling strategies, and study design are amplified when significant adult safety and efficacy data are not available.

This seminar described the application of early development strategies to enable development in children, in cases where limited adult data are available. Extensive use of translational science and quantitative modeling and simulation methods were key underpinnings to facilitate the successful execution of these programs.