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Biotechnology and the Law: A Primer, Part One (Audio CD Package) |
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The ABA Section of Science and Technology Law's Biotechnology Committee has produced a primer to help lawyers and their clients find their way through the daunting legal maze that confronts biotechnology companies.
The editors and authors of the recently released book Biotechnology and the Law have distilled the book's 950 pages and 21 chapters into a fast- paced overview of key legal issues that affect a biotech company through its complex life cycle.
This two-part program serves as a crash course introduction to legal regimes that general counsel or business attorneys might not encounter representing companies in other industries, such as FDA law and regulations, the Bayh-Dole Act, and other regulatory constraints. The program will help intellectual property lawyers, litigators, and employment attorneys appreciate the unique legal landscape confronting biotech companies. All participants will gain a greater ability to spot issues for their biotech clients.
Part One
In the first session, the panel will start with the fundamentals of corporate structure and other issues in starting up a biotech company. They will cover dos and don'ts of acquiring the key ingredients namely, intellectual property, staff, and financing. The first session concludes with a discussion of research, development and commercial collaborations.
Part Two
In the second session, the panel provides an overview of the regulatory approval process, explaining how a scientific discovery becomes an approved pharmaceutical or biologic product. Patent counsel sketch out how patent prosecution and litigation unfold and impact the success or failure of a biotech company. Finally, the panel discusses which missteps can lead to litigation and strategies to help minimize and manage these risks. Although primarily focused on U.S. legal issues, the panelists will touch on select aspects of E.U. and other foreign laws that can dramatically affect a biotech company's prospects for success.
Order Part 2 here >>>
This package contains 2 audio CDs and printed course materials.
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Buy the book that this program is based on: Biotechnology and the Law
Hugh Wellons, Eileen Smith Ewing, Robert Copple, William Wofford, and Erika King Lietzan are the editors of this legal resource to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application.
A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
This book contains over 20 chapters by more than 20 leading experts in specialties such as patents, company formation, finance, federal regulation of research through funding, FDA regulation of biomedical research, approval of products for human use, privacy issues, litigation issues and more.
Buy the book here >>>
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