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.”
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
Califf: Digitization Will Return Humanity to Medicine
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