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Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King Jan 2000

Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …


Symposium: Patent Rights And Licensing, Michael S. Baram, Ashley Stevens, Thomas Meyers, Michael J. Meurer Jan 2000

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 …


Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant Jan 2000

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 …