21 April 2021 - Article
Managed and directed litigation, including oversight of junior litigation team, on behalf of a Fortune 500 client related to enforcement of its medical device portfolio, resulting in a successful settlement prior to trial.
Assisted a medical imaging company in the preparation and filing of a 510(k) application for a radiological imaging device, resulting in FDA approval.Developed a strategy and presentation related to Hatch-Waxman patent term extension for a pharmaceutical company in negotiations with a potential partner.
Has rendered freedom to operate opinions involving pharmaceuticals and medical devices, resulting in successful product launches.
Coordinated and negotiated with the FDA on behalf of client related to recall of pharmaceutical product without any further administrative action against client.
Assisted pharmaceutical company in successfully negotiating clinical trial agreements related to international clinical trials.
Represented a pharmaceutical company in litigation involving False Claims Act counts, resulting in successful dismissal of matter on all counts.
Assisted numerous multi-national food companies in compliance with the Food Modernization Act and its related foreign verification requirements.
Developed an extensive patent portfolio for a laboratory robotics company acquired by a leading multi-national diagnostic company.
Represented a member country in a CERN Research Consortium in an inter agency arbitration proceeding resulting in a successful outcome.
United States District Court for the District of Massachusetts
U.S. Patent and Trademark Office
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Greater Boston Chamber of Commerce Life Sciences Alliance
Boston Patent Law Association
Boston Bar Association
“State Laws Governing Clinical Trial Regulatory Compliance Interactive Web Seminar,” Barnett International, April, 2021
“CMC Patent Opportunities,” Global Regulatory Affairs CMC; Chemistry, Manufacturing & Controls Conference, Philadelphia, PA, October 2019
“Patent Basics for the CMC Professional,” Global Regulatory Affairs CMC; Chemistry, Manufacturing & Controls Conference, Philadelphia, PA, October 2016
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FDA Social Media Guidance Panel, October 2014
“Food & Drug Administration (FDA) Overview,” Speaker, Chilean Entrepreneurial Summit, October 2014
“FDA Food Labeling," Presenter, Québec New Exporters Trade Mission, July 2014