DIA: Driving Insights to Action
Science:Life Sciences
FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for assuring the safety and efficacy of biological products including vaccines, allergenic products, blood and blood products, and cellular tissue and gene therapies. “This area of advanced therapy medicinal products (ATMPs) is just an incredibly exciting one to be working in right now,” explains Center Director Dr. Peter Marks. “We have our work cut out for us here, but to me it's wonderful work to have to do because it shows how fast the science is advancing, how fast hopefully the technology will advance, to bring these medical benefits to patients.”
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
Statistical Strategies for Using Sources of Safety Data
Regulatory & Ethical Considerations in a Pediatric Trial
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