DIA: Driving Insights to Action
Science:Life Sciences
In 2018, the US FDA approved a record high number–59–of new, novel drugs. “We are at a point now where there is so much innovation in this space and the regulatory aspects are catching up, so we now have three approved gene therapy products in the US and over seven to eight hundred INDs for cell and gene therapy filed with FDA,” explains Dr. Adora Ndu, Executive Director of Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical, and Regulatory Science Co-Editor for DIA Global Forum. “With each interaction with each product that’s filed and with each product that’s approved, the regulatory experience is broadened.”
Relevance Will Put Europe on Investment Fast Track
Risk Inherent in Benefits of Drug/Device Products?
EU Business and Data Needs Converge Through Telematics
RIM Accelerating Efficiencies in Regulatory Pathways
Translating Clinical Trials into Clinical Benefit
More Tools & Data Sources: More Insights for RBM?
Landmark AMA to Rely on Regulatory Reliance
Healthy Population Key to Economic Success
Defining Rational Medicine and Research at DIA Japan 2019
How Do You Put Your Disease on the Agenda?
Participatory Medicine Changing Information Exchange
New Ethics and Consent Guidelines Pillars for Safety in India
Real World Data Expanding into Label Expansion
Educating Persons Critical in Personalized Medicine
FDA Payer Communication Guidance Steps Toward Sustainability
Genetic Engineering Transforming Research Ethics
Only Big Trust Propels Big Data into Big Discoveries
Empowering Today’s Patients to Help Tomorrow’s
Imaging Data Plus AI “One of the Best Combinations”
Clinical Trial Diversity Begins (and Ends) with Patients First
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