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Organized by the mHealth Regulatory Coalition and hosted by Johns Hopkins Technology Transfer and the Johns Hopkins University Global mHealth Initiative, this half day conference discuss the recently published FDA guidance on mobile medical applications and will feature prominent speakers including regulatory attorneys, regulatory affairs specialists, quality system experts, European law attorneys, experienced mHealth executives and the FDA. Topics discussed include how to develop mobile apps that come close to the FDA line, but don’t cross over, regulatory differences between the US and EU systems, premarket clearance strategies, and the FDA application classification system.
The MMA Roadshow is organized by the mHealth Regulatory Coalition and hosted by Johns Hopkins Technology Transfer and the Johns Hopkins University Global mHealth Initiative.
University/Government Code (free): MMA#0comp (ID required to confirm)
Sponsor Code (50% discount): MMA#50discount
For help registering, contact Lisa Blackburn at firstname.lastname@example.org. For questions about the event, call 410516-5665 or email email@example.com
Robert M. Nerem (Georgia Institute of Technology) presents “Regenerative Medicine: The Hype, the Hope, and the Future” as part of a special seminar hosted by the Department of Biomedical Engineering, the Institute for NanoBioTechnology, and the Translational Tissue Engineering Center.
Abstract: Although the underlying concepts of tissue engineering and regenerative medicine go back more than 75 years, the term tissue engineering actually was only “coined” in the 1980s. This was followed by the 1990s being the “go-go” years with stem cells emerging as a technology, an industry developing, and the term regenerative medicine beginning to be used. There also was a lot of hype, and following the turn of the century the field entered what might be called the “sobering” years, with private sector activity falling significantly even though the science continued to advance. The last decade, however, has all the marks of being “back to the future.” Advances in cell-based therapies have been fueled by advances in stem cell science and technology and the discovery of what is required to reprogram somatic cells into stem cells, known as induced pluripotent stem (iPS) cells. For cellular therapies, a key question is what is the mechanism of action? For a specific therapy, is the mechanism one of cell replacement or is it a paracrine effect? If the latter, is it possible that one could introduce the appropriate biological signals without the use of cells? In this case the discussion shifts from “my cell is better than your cell” to “my biological signals are better than yours.” Whatever the case, one of the “holy grails” is the neurodegenerative diseases/disorders and the repair/regeneration of the central nervous system. Instead of the mixture of hype and hope in the past, and with an aging population providing the threat of a “tsunami” of neural disorders, regenerative medicine offers the real possibility of cures to these diseases/disorders in the future.
The 2018 Johns Hopkins Healthcare Design Competition is open to all student-led teams from around the world that have designed health-related solutions. Student teams will compete in three competition tracks: Designs of Solutions for Advanced Health Systems; Global Health/Humanitarian Design; and Healthcare Apps/Information Technology Design.
This event is sponsored by Boston Scientific and hosted by the Johns Hopkins Department of Biomedical Engineering and the Center for Bioengineering Innovation and Design.
David M. Van Wie, PhD, will present “Hypersonics: Back to the Future.”
Hypersonics is defined as flight at speeds above Mach 5—five times the local speed of sound. Currently, there is a resurgence of interest in hypersonic systems for applications such as weapons, rapid commercial transportation, and space launch. To realize these new applications, technology advancements are needed in the areas of novel thermal protection systems, high-temperature materials, advanced guidance, navigation and control, and propulsion. For more than 60 years, researchers at the Johns Hopkins University Applied Physics Laboratory have been investigating hypersonic technologies and applications, including Frederick S. Billig’s pioneering development of scramjet engine technology. Dr. Van Wie will offer a brief history of hypersonics highlighting Dr. Billig’s contributions and will discuss ongoing technology development challenges in this area.