Emerging Issues in Biotechnology Law
Why Attend?
This advanced course of study, comprising 14.5 hours of instruction, provides guidance on the hottest issues in biotechnology and related legal developments, including:
Collaborations with academia
Business alliances
Working with the federal government/Department of Defense
Clinical trials
Intellectual property
Agricultural biotechnology
Third-wave-industrial biotechnology
FDA response to emerging technologies
International issues
The ABA Science & Technology Section Biotechnology Law Committee's BIOTECHNOLOGY LAW PRIMER, just published earlier this year, is available at a special discounted price of $151.95 to couse registrants.
Planning Chairs
Raymond H. Drymalski, Bell, Boyd, & Lloyd, LLP, Chicago (also on Planning Committee)
Erika Lietzan, Covington & Burling LLP, Washington, D.C.; Chair, Biotechnology Committee, ABA Section of Science & Technology Law; co-editor, Biotechnology and the Law (also on Planning Committee)
Michael Traynor, Cooley Godward Kronish LLP, San Francisco; President, American Law Institute ((also on Planning Committee)
Faculty
Kenneth S. Abramowitz, Managing General Partner, NGN Capital, New York
Sheldon Bradshaw, Chief Counsel, U.S. Food and Drug Administration, Washington, D.C.
Kathleen A. Denis, Ph.D., Associate Vice President for Technology Transfer, The Rockefeller University, New York
Kenneth J. Dow, Assistant Patent Counsel, Johnson & Johnson, and Vice President, Patent Law, Centocor Inc., Malvern, Pennsylvania
Brent Erickson, Executive Vice President, Industrial and Environmental Section, Biotechnology Industry Organization (BIO), Washington, D.C
Eileen Smith Ewing, Kirkpatrick & Lockhart Preston Gates Ellis LLP, Washington, D.C.; co-editor, Biotechnology and the Law (also on Planning Committee)
Stephen M. Goodman, Pryor Cashman LLP, New York (Planning Committee only)
Henry T. Greely, Deane F. and Kate Edelman Johnson Professor of Law, Stanford Law School, Stanford, California
Judith A. Hasko, Latham & Watkins LLP, Menlo Park, California
Gail H. Javitt, Law and Policy Director, Genetics and Public Policy Center, Washington, D.C.; Research Scientist, Berman Institute of Bioethics, Johns Hopkins University
Janet M. McNicholas, Ph.D., Bell, Boyd & Lloyd LLP, Chicago
Robert B. Nicholas, McDermott Will & Emery LLP, Washington, D.C.; chapter author, Biotechnology and the Law
Mary K. Pendergast, President, Pendergast Consulting, Washington, D.C.
Marya A. Postner, Ph.D., Cooley Godward Kronish LLP, Palo Alto, California
Frank M. Rapoport, McKenna Long & Aldridge LLP, Philadelphia
Wolfgang Rehmann, Taylor Wessing, Munich, Germany
Grail Walsh Sipes, Covington & Burling LLP, Washington, D.C.
Dr. Kari Stefansson, M.D., President and CEO, deCODE genetics, Reykjavik, Iceland
Jay T. Taylor, McDermott Will & Emery LLP, Washington, D.C.
Erich E. Veitenheimer, Ph.D., Cooley Godward Kronish LLP, Washington, D.C.
Timothy M. Westmoreland, Visiting Professor, Georgetown University Law Center, Washington, D.C.
Jay Winchester, Senior Counsel, U.S. Army Medical Research and Materiel Command, Fort Detrick, Maryland
ALI-ABA Staff: Thomas M. Hennessey, Assistant Director, Office of Courses of Study
Biotechnology and the Law, a comprehensive text on the subject just published by the Biotechnology Law Committee of the ABA Section of Science & Technology Law, is available to course registrants through the ABA web store at the special discounted price of $151.95 (plus $17.95 shipping and handling). To order, go to http://www.abanet.org/abastore/productpage/5450044 and enter source code PAB6EALI upon checkout.
Program Schedule
THURSDAY, SEPTEMBER 6, 2007
7:30 a.m. Registration and Continental Breakfast
8:30 a.m. Keynote Speaker: Dr. Stefansson
9:30 a.m. Collaborations with Academia — Dr. Denis and Ms. Hasko
Ramifications of the increasing role of industry in funding translational research at academic and research institutions; structuring material transfer agreements between academic or research institutions and industry (including transfers and licenses of cell lines); the impact of MedImmune v. Genentech on licensing practices by academic institutions
10:30 a.m. Networking Break
10:45 a.m. Corporate Partnerships — Dr. Postner
Developments in drug discovery and development alliances, including the increasing leverage of biotechs vis-a-vis Big Pharma and Big Biotech and the impact on deal terms; co-development and co-promotion rights; impact of the larger partner’s equity investment; change in control issues
12:00 noon Lunch Break
1:15 p.m. Working with the Government and Department of Defense — Messrs. Rapoport and Winchester
Developments in government contracting for biodefense and pandemic flu countermeasures: Understanding HHS advanced purchase contracting under Project BioShield and BARDA legislation; negotiating IP, technology transfer, and march-in rights; compulsory licensing post-DOHA; Orphan Drug Act tax credits and exclusivity; indemnification, the animal rule, and the National Interagency Biodefense Campus
2:15 p.m. Keynote Speaker: Mr. Abramowitz
Opportunities and challenges in worldwide healthcare venture capital: Raising money, investing, growing portfolio companies, and exiting
3:15 p.m. Networking Break
3:30 p.m. Clinical Trials — Professor Greely and Ms. Sipes
The changing regulatory and ethical landscape for biotechnology innovators, including the impact of the Te Genero trial on permission to begin (and design of) Phase I trials as well as patient enrollment, informed consent, and insurance issues; treatment INDs and the impact of Abigail Alliance; FDA’s evolving approach to use of surrogate endpoints and portions of the Critical Path initiative (e.g., phase 0 trials); increased collaboration between the FDA and the SEC in monitoring disclosure of clinical trials results by publicly traded companies
5:00 p.m. Adjournment for the Day
FRIDAY, SEPTEMBER 7, 2007
7:30 a.m. Continental Breakfast
8:00 a.m. Keynote Speaker: Mr. Bradshaw
9:00 a.m. Intellectual Property — Ms. Johnson and Dr. McNicholas
Prosecution of and enforcement of patents covering biotechnology products (e.g., whether patents provide sufficient protection for biotechnology products – versus trade secret protection or data exclusivity in relation to product approval); the Bolar amendment and the impact of Merck v. Integra and other issues for biotechnology companies; follow-on biologics; patent reform legislation.
10:15 a.m. Networking Break
10:30 a.m. Agricultural Biotechnology — Messrs. Nicholas and Taylor
Update on the U.S. regulation of agricultural research and products, including animal drugs and biological products, transgenic and cloned animals, food and feed plants and crops, plant based vaccines and pharmaceuticals; emerging issues, including biosecurity (ecoterrorsim), trade barriers, and food safety
11:45 a.m. Lunch Break
1:00 p.m. Capitol Hill Update 2007 — Professor Westmoreland
Legislative and agency developments affecting the biotechnology industry, including pediatric exclusivity reauthorization, PDUFA reauthorization, patent reform, follow-on biologics legislation, and drug safety reform
2:00 p.m. Third Wave Panel of Biotechnology — Mr. Erickson and Ms. Ewing
The “third wave” in biotech innovation: the legal issues, public policy hurdles, and business opportunities facing companies that use biotechnology and genetically modified micro-organisms in creating renewable fuel sources, especially cellulosic ethanol and biorefining; the development of biotech enzymes that improve everything from detergents to food additives; the current and projected market growth of this emerging new sector
3:00 p.m. Networking Break
3:15 p.m. The FDA Response to Emerging Technologies —
Mss. Javitt and Pendergast
The FDA’s response to emerging technologies – its jurisdiction in the first instance, and to the extent it does have authority, whether it has adequate flexibility and is using that flexibility appropriately; combination products; pharmacogenomics; cloning; gene therapy; regulation of "human cells, tissues or cellular or tissue-based products" (HCT/Ps)
4:15 p.m. International Issues — Mr. Rehmann and Dr. Veitenheimer
The impact of globalization on life-cycle planning; international clinical trial issues; nature and evolution of less protective IP regimes; DOHA and compulsory licensing; parallel trade; counterfeiting; European issues, including the proposed new EC advanced therapies regulation (gene and cell medicines, tissue engineered products); challenges to orphan drug exclusivity (e.g., assessing sameness); the US/EU dispute at the WHO regarding genetically modified food
5:30 p.m. Adjournment
Total 60-minute hours of instruction: 14.5. Note: The discussions include at least one full hour on ethics and professional responsibility issues, accepted as such by most, but not all, MCLE jurisdictions.
Suggested Prerequisite: Limited experience in legal practice in subject matter or completion of Basic CLE Course in subject matter
Educational Objective: Acquisition of knowledge and skills to develop proficiency as a practitioner; maintenance of professional competence as a practitioner; provision of information on recent legal developments
Level of Instruction: Advanced
