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.”
New Sources Changing the Meaning of Evidence?
AI Research Can Optimize Clinical/Operational Effectiveness
Has Joining ICH Accelerated Innovation in China?
Pricing Pitfalls in Prescription Drug Advertising
MID-NET Among PMDA’s First Steps Into RWE
Regulatory Science 2019: Leading or Holding Back Innovation?
23andMe: Information Empowering Patient Action
The Patient’s Most Engaging Question: Why?
EUnetHTA: Post-Launch Critical for Comparative Data
HSA Harmonizing Culture and Science in Singapore
Promoting Patient-Centric Business: MedComm in Latin America
Separate but Equal: Regulatory & Pricing Assessments in EU
Genetics Leading Modern Revolution in Cancer Care
Automation No Substitute for Scientific Leadership
R2D2 & C-17 New Landmarks in Canada’s Collaborative Pathways
Advanced Therapies Moving Upon Combination Platforms
Challenges in Generic Drug Safety & Surveillance
Interview with a DIA 2018 Patient Scholar
Novel Approaches to PV Collaboration
Advancing the Science of Study Endpoints
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