DIA: Driving Insights to Action
Science:Life Sciences
2020 marks the tenth anniversary of the FDA’s Biosimilars Price Competition & Innovation Act, which created a regulatory approval pathway in the US for biosimilars designed to increase access to safe, effective and cost-effective biological treatment options for patients. “I have absolute confidence in these products as a scientist and seeing them work clinically, but we've got to make it work commercially,” explains Gillian Woollett (Avalere Health) in this interview with Anna Rose Welch (Chief Editor, Biosimilar Development, Life Science Connect). “I always say biosimilars offer savings–but be careful with that statement. That means somebody is not receiving the money they were previously receiving, and they don't want to forego that money.” Anna Rose will moderate the Short Course on Current Biosimilars Policy at DIA’s 2020 Biosimilars Conference.
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?
“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
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