Affiliations
- Boston Patent Law Association
- Boston Bar Association
- Massachusetts Bar Association
- Massachusetts Pharmaceutical Association
Representative Engagements
- 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.
- Prepared appeals brief and appeared before United States Patent Office Board of Appeals.
- Negotiated consulting agreement with leading pharmaceutical expert on behalf of pharmaceutical client resulting in significant savings to the client.
- Assisted pharmaceutical company in successfully negotiating clinical trial agreements related to international clinical trials.
Presentations
- New And Improved 505(b)(2) — Facilitating Approval for Enhanced Drug Delivery, 11th Annual Drug Delivery Technologies & Deal-Making Conference (September 25-27, 2006)
- India and China: New Waves and Undertows, Strategic Research Institute’s 10th Anniversary Pharmaceutical of Discovery Chemistry, Advanced Intermediates & API’s Conference
- The Litigation Landscape in Clinical Trials: Plaintiff and Defense Theories and Federal and State Requirements, Managing Legal Risks in Conducting and Promoting Clinical Trials Conference (February 27-28, 2006)
- State-By-State Clinical Trial Requirements, Washington Source Expert Telebriefing (October, 2005)
- Implications of Merck v. Integra, William Fry Life Sciences Breakfast Briefing on Recent Legal Developments in the Pharmaceutical Sector, Dublin, Ireland (October 11, 2005)
- State Regulations of Clinical Trials, BioPharm International webcast
- Advertising Promotion of Medical Devices, Suffolk University
- FDA Regulation of Functional & Wellness Beverage, WorldNutra Fifth International Conference and Exhibition on Nutraceuticals and Functional Foods, San Francisco, CA (November 2004)
- Current Issues in Liability for the Pharmacist, Northeastern School of Pharmacy Continuing Education Series
- Emerging Issues of Liability and COBRA Compliance, Maine State Pharmaceutical Association’s annual meeting