DIA: Driving Insights to Action
Science:Life Sciences
Various data sources are used to evaluate patient safety throughout the healthcare product lifecycle, but the strengths and limitations of these sources can vary widely. In their most recent research published in Therapeutic Innovation & Regulatory Science, the Safety Working Group of the Biopharmaceutical Section of the American Statistical Organization focused on statistical strategies for obtaining reliable evidence from sources of safety data. This podcast discusses these strategies with three members of the working group: Dr. Richard Zink, Director of Statistical Services at TARGET PharmaSolutions; Dr. Olga Marchenko, Head of Therapeutic Area Statistics at Bayer, and Dr. Qi Jiang, Executive Director of Global Biostatistical Science, Head of Therapeutic Areas in Oncology, Inflammation, and Nephrology at Amgen.
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?
“My Voice Needed to Be Heard”
IMEDS Collaboration Builds Upon Sentinel Surveillance
Crafting Sound Medical Affairs Professionals
Regulatory & Ethical Considerations in a Pediatric Trial
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