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Staying Ahead of the Legal and Regulatory Curve

May 16, 2011
GavelProviding legal counsel within the biotech industry comes with a unique set of challenges.  Legal professionals must consistently stay on top of the latest policy and regulatory changes within the industry. From patent issues to new laws on licensing to regulations for new innovations, the BIO International Convention (June 27-30) will feature the latest updates, insights and networking opportunities—plus educational sessions where you can earn up to eight CLE credit hours—to help fast-track your career. Sit in on any number of BIO Program presentations by leading law firms and earn CLE credits.

You also can connect with other legal professionals and leaders in a variety of events during the Convention: the Tuesday Keynote Luncheon with Tony Blair, the BIO Golf Outing, the Opening Reception at the Newseum, the Licensing Professionals Meetup, and much more.
Below is an overview of related breakout sessions:

Monday, June 27, 3:45 pm – 5:00 pm

A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars

This session will educate attendees on the requirements of a new biosimilar patent litigation pathway.

Tuesday, June 28, 8:30 am – 9:45 am

The Myriad Case and the Patentability of Isolated DNA Molecules
This panel will discuss high-profile patent cases and address recent developments in the Myriad case and BIO’s leadership role as an amicus.

Tuesday, June 28, 10:00 am – 11:30 am

Navigating the New Law on Licensing Biosimilars
This session will explain how the regulatory pathway operates and the legal issues in development and marketing biologics and review how scientific challenges affect regulators and the companies seeking approval for biosimilars.

Tuesday, June 28, 3:45 pm – 5:00 pm

Talking about Your Product in the New Age: Social Media and the Internet

This session will address the current regulatory standards and policies related to dissemination of information through the Internet and social media activities to avoid potential liability.

Wednesday, June 29, 2:00 pm – 3:30 pm

Collaborative R&D from the Perspective of Large Multinationals, Universities and Start-ups

Panelists will teach participants how to approach technology owners and attract sponsors for research and licensing revenues. The session will also address key aspects of collaboration and licensing agreements.

Thursday, June 30, 8:30 am – 9:45 am

Innovative Collaborations: Deal Structures for Nonprofit/For-Profit Collaborations

This session will highlight successful industry collaborations with nonprofits and present structures and terms to avoid in the interest of a successful collaboration.

Thursday, June 30, 10:00 am – 11:30 am
Regulatory Issues for Tissue Engineered Products

FDA staff will address current FDA thinking on the regulation of tissue engineered products, including good manufacturing practices.An industry representative will identify current industry concerns.

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