DIA: Driving Insights to Action
Science:Life Sciences
In 2016, a young boy was accepted as a patient in a clinical trial designed to develop a cure for DMD. A few months later, Nicholas Bullers and his family delivered to the FDA Pediatric Committee and Pediatric Ethics Subcommittee a presentation about the anguish that Nicholas faced in this trial. The Bullers family shared this journey in the DIA Global Annual Meeting session “Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial,” and in the following interview conducted after that session. Watch the video of this podcast interview.
Advancing the Science of Study Endpoints
Analyzing Innovation’s Progress in Gottlieb Era
Comparing Generic Safety Profile with Branded Cousin
Defining Unmet Need Critical to Determining Value
Triple-A RWE: Adequate Data, Appropriate Designs, Actionable Evidence
US REMS Requirements for NDAs and BLAs
Epoietin Biosimilars: Qualitative Study of Patients' Views
Disparities Between FDA/EMA Review Processes
DIA Japan's Focus in Fall 2018
FDA Leadership on Future Biologics and EMA/FDA Cooperation
Global Perspectives on Patient Engagement
DIA Board Chair Discusses DIA Now and Digital Tomorrow
Integrating Genetic Medicine into Clinical Care
Regulatory Landscape of Drug-Device Combination Products
Value-Based Assessment & Contracting: What Needs to Be Done?
Block Chain, AI, Internet of Things: Future of PharmaTech?
IMEDS Collaboration Builds Upon Sentinel Surveillance
Crafting Sound Medical Affairs Professionals
Statistical Strategies for Using Sources of Safety Data
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