Law and Policy

Working to raise awareness of legal and regulatory issues that will impact the biotechnology sector.

Leadership

CO-CHAIRS
Maria Buckley, Nutter, McClennen & Fish, LLP
Nick Littlefield, Foley Hoag LLP
Patrick Waller, Wolf, Greenfield, & Sacks, P.C.

Mission

To raise awareness of legal and regulatory issues that will impact the biotechnology sector, and to provide a forum for lawyers and others at MBC member companies and firms to network and share expertise in areas of common interest, including healthcare law, intellectual property law, employment law and regulatory affairs. United States Senator Edward M. Kennedy aptly refers to the 21st century as the "Life Sciences Century." Full integration of biotechnology in clinical research and healthcare policy will generate a multitude of discussion points on the transformation of scientific innovation into better health solutions. The Committee will keep your finger on the pulse of what's on the horizon.

Action Plan

The Law and Policy Committee strives to hold frequent educational meetings on timely and meaningful topics for member companies and firms, such as Medicare coverage and reimbursement policy. The Committee looks to partner and host programs in conjunction with other MBC committees, as appropriate.

Topics

TOPICS
Some potential topics to be discussed this year include:
  • Follow on Biologics
  • Cooperative Research and rDevelopment Agreements (CRADAs) and Intellectual Property Law
  • Biotech Tax Credits
  • Clinical Trial Disclosure
  • FDA's Critical Path Initiative
  • Clinical Trial Advisors in relation to the Stark Law
  • Patent reform
  • Drug Importation

Meetings

Date Event
5/29/08 "Drug & Device Law Update - Key Developments in Recent Case Law"
6/26/08 Injury Issues in Clinical Research

Past Presentations

Date Presentation
5/29/08 Drug & Device Law Update - Key Developments in Recent Case Law- Allen
5/29/08 Drug & Device Law Update - Key Developments in Recent Case Law- Xixis
5/29/08 Drug & Device Law Update - Key Developments in Recent Case Law- Foster
3/27/08 Emerging Issues in Data Security and Overview of New Massachusetts Data Security Law- Szabo, Schafer, Crow, Holley & Howe
1/29/08 The Great Debate: Congress and the Campaign to Change U.S. Patent Law
11/30/07 Implications of FDAAA for Biotechnology Companies- Kabir
11/30/07 Implications of FDAAA for Biotechnology Companies- Larson
11/30/07 Implications of FDAAA for Biotechnology Companies- Jones

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