Assistant Professor and Head of PharmE3D Labs The University of Texas at Austin Austin, Texas
3D printing is a layer-by-layer process capable of producing three-dimensional drug products and/or medical devices from digital designs. Embracing innovation, the FDA’s recent approval for a 3D-printed drug product and more than 125 medical devices opened a new door for pharmaceutical technology to design and manufacture drug products. This presentation will provide an overview on how this revolutionary concept of design and manufacture of medicines continues to evolve in drug development and patient centric digital healthcare. The key focus of this discussion will be given towards the motivation of this technology with respect to pharmaceutical drug development, compounding, and personalized medicine. The regulatory discussion will address the current regulatory space for mass manufacturing of pharmaceutical products using 3D printing technology. This includes the key regulatory challenges for the upcoming paradigm shift of on demand manufacturing at the point of care manufacturing.
Describe the motivation driving the paradigm shift of on-demand manufacturing of personalized medicine
Describe the Current Regulatory Environment for Mass Production Using 3DP Technology
Summarize upcoming regulatory challenges of the 21st century point of care manufacturing and its impact on health care structure