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.
Future Science & Drug Review: FDA Closing the Gap
HHS Final Rule: Good Data Shared Well Leads to Great Science
Patient Partners: Power That Rests in Us All
Technology & Data Driving Europe’s ClinOps Forward
CFDA Joins ICH, Seeks Public Comment on Further Reforms
New DIA Forum to Align Regulatory & ClinOps Expectations
Different Roots, Shared Fruits: FDA-EMA Collaboration
RWE: Bridge Between Clinical Research & Practice?
Progress in Pediatric Therapeutics Bigger Than “Smaller Dose”
Is Drug Repurposing Really As Promising As It Seems?
More Than Socially Fair or Economically Just – It’s Better Science
New China-Denmark Food & Drug Regulatory Cooperation Centre
ABPI Sees Brexit as One Game of Two Halves
Europe’s IMI Helps Drive New R&D and Access Models
Lack of Access Can Lock Patients in “Disease of Despair”
Can We “Pay for Results” to Sustain Innovation?
Uncertainty is Certain: Pandemic Vaccine Preparedness
Where and How to Bridge the EU Biotech Funding Gap
Transparency Essential to Payers’ New Role in EU
EBE Plots Path from “Flawed Underfunded Biotech System”
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