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Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant
Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant
Faculty Scholarship
You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …
Symposium: Patent Rights And Licensing, Michael S. Baram, Ashley Stevens, Thomas Meyers, Michael J. Meurer
Symposium: Patent Rights And Licensing, Michael S. Baram, Ashley Stevens, Thomas Meyers, Michael J. Meurer
Faculty Scholarship
This panel will discuss intellectual property - the patent incentive, patentability issues, licensing, and litigation-related matters. It will be moderated by Dr. Ashley Stevens, the Director of the Office of Technology Transfer at Boston University. Ashley has multiple degrees, including a doctorate in physical chemistry from Oxford University. He has worked in the biotech industry for a number of years, mostly with startup companies and academic research organizations such as the Dana Farber Cancer Institute, where he was also Director of Technology Transfer. Ashley was instrumental in the startup and operations of firms such as Biotechnica International, and started his …