New Workshop!

The convergence of policy reform, the evolution of highly targeted therapies, and innovations in regulatory and development science has created the potential for a new era in pediatric drug development. Policy reform in the US and EU has led drug developers to gain extensive pediatric drug development experience over the last two decades. In parallel, the development of pharmaceutical pipelines to include highly targeted therapies that account for genetic variability to treat or prevent disease has led to exciting progress in the development of new therapeutic targets (such as CFTR modulators for cystic fibrosis) to address rare pediatric disease.

Development of highly targeted therapies for small research populations has led to unimaginable innovation in regulatory and development science and revolutionized how treatments for the most complex diseases can be developed. Tools to facilitate the evaluation of cutting-edge therapeutic discoveries are also evolving rapidly through the efforts of regulatory agencies. Leveraging pre-existing data for modeling and simulation, inclusion of pediatric patients within adult confirmatory studies when dosing is similar between adult and pediatric populations, or utilizing molecular targeting to allow tissue agnostic development approaches are just a few examples of pragmatic solutions that can address the complexities of pediatric drug development.

The DIA Pediatric Drug Development Workshop will bring together the pediatric research community (drug developers, regulators, and academic researchers) to evaluate and discuss how such solutions can be applied to advance the development of biopharmaceutical therapies for pediatric patients.

Need approval in order to attend?

Check out our 2019 Program!