Law Seminars International Presents

A Comprehensive Two-Day Conference on

Biotechnology

Business and legal developments

September 27 & 28, 2007
Washington State Convention and Trade Center in Seattle, WA
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Who Should Attend

In-house and private practice attorneys, industry executives, industry representatives, consultants, government and university officials, investment bankers

Why Attend

This year's update on the key legal and business issues facing the biotech industry will cover many important topics, ranging from funding approaches, licensing and collaboration trends, M&A developments and evolving intellectual property and regulatory issues. The interplay between the biotechnology industry, government and large-scale philanthropy is also a significant and growing topic for the healthcare industry, as well as changing government regulations governing sales and marketing activities and life as a public company. The unique challenge for those of us working in biotechnology is grasping and managing the combination of intensive government regulation, the need for sophisticated intellectual property protection, and difficulty finding funding for new inventions with long product development cycles. This program will bring you up-to-date on current developments in these areas and give you the practical tools you and your company need. Here is a chance to meet with leading executives and practitioners and ask questions about your issues of greatest concern. We hope you will be able to join us. --Program Co-Chairs: Eric L. Dobmeier, Esq. and Alan C. Smith, Esq.

What You Will Learn

~ Life science incubators and other funding strategies ~ M&A developments ~ The relationship between government and industry ~ Strategies for winning regulatory approval ~ Recent patent litigation and reform proposals ~ Private sector joint research agreements ~ Product partnering and platform technology deals ~ Partnering with universities ~ Legal and regulatory risks in sales and marketing ~ Disclosure requirements for public companies

Agenda

Thursday, September 27, 2007

8:00 am Registration and Continental Breakfast
8:30 am Introduction and Overview of Day One: Finding and Partnering Issues for Biotechnology Companies in the Northwest
  Eric L. Dobmeier, Esq., Program Co-Chair, Chief Business Officer
Seattle Genetics, Inc. / Bothell, WA
  Alan C. Smith, Esq., Program Co-Chair
Orrick, Herrington & Sutcliffe LLP / Seattle, WA
8:45 am The Critical Issue of Funding: Innovative Approaches to Financing and Getting Operating Help for Early Stage Companies
  Early-stage financing: Life science incubators
  Melinda Richter, Executive Director
San Jose BioCenter / San Jose, CA
  Funding in return for rights outside the developed world
  Gerald J. Siuta, Ph.D., Business Development Consultant
Global Alliance for TB Drug Development / New City, NY
  The role of large-scale philanthropy in promoting biotech
  Erik H. Iverson, Esq., Associate General Counsel
Bill & Melinda Gates Foundation / Seattle, WA
10:30 am Break
10:45 am Maintaining Funding in the Later Stages of Development
  Stephen M. Graham, Esq.
Orrick, Herrington & Sutcliffe LLP / Seattle, WA
11:30 am Financing Alternatives for Biotech Companies: A Case Study of Seattle Genetics
  Different ways to raise money over the life of a biotech company
  Eric L. Dobmeier, Esq., Program Co-Chair
Seattle Genetics, Inc. / Bothell, WA
12:15 pm Lunch (on your own)
1:30 pm Merger and Acquisition Developments
  Legal and business perspectives on trends and developments in M&A activity for biotech companies; M&A as exit strategies
  Alan C. Smith, Esq., Program Co-Chair
Orrick, Herrington & Sutcliffe LLP / Seattle, WA
2:15 pm Trends in Private Sector Partnering: Licensing and Collaborations
  Joint research agreements; licensing
  Kevin F. Kelly, Esq.
Heller Ehrman LLP / Seattle, WA
3:00 pm Break
3:15 pm Product Partnering and Platform Technology Deals
  Shane R. Albright, Esq., Ph.D.
Cooley Godward Kronish LLP / Palo Alto, CA
4:00 pm Trends in Partnering with Universities
  University technology transfer transactions
  Fiona Wills, Ph.D., Director of TechTransfer, Invention Licensing
University of Washington / Seattle, WA
  Challenges to spinning out companies from universities, the needs of these companies, and approaches that universities and regions have used to facilitate company creation
  James A. Severson, Ph.D., Vice Provost for Intellectual Property and Technology Transfer
University of Washington / Seattle, WA
5:00 pm Reception Sponsored by Orrick, Herrington & Sutcliffe LLP

Friday, September 28, 2007

8:00 am Registration and Continental Breakfast
8:30 am Introduction and Overview of Day Two: Critical Intellectual Property and Regulatory Issues
  Eric L. Dobmeier, Esq., Program Co-Chair
Seattle Genetics, Inc. / Bothell, WA
  Alan C. Smith, Esq., Program Co-Chair
Orrick, Herrington & Sutcliffe LLP / Seattle, WA
8:45 am Taking Advantage of the Positive Aspects of the Relationship Between Government and Industry
  Regional benefits of the biotech industry; public fears and controversies; lobbying and public relations
  Jack Faris, Ph.D., President
Washington Biotechnology & Biomedical Association / Seattle, WA
  Federal government role and public policy: How is the new majority in Congress likely to change federal policies toward biotech?
  Kathleen M. Weldon, Vice President, Government Strategy
Biogen Idec / Washington, DC
9:45 am Break
10:00 am Best Current Strategies for Winning Regulatory Approval
  Clinical trials: Current issues in the U.S. and abroad
  Kirk D. Schumacher, Esq., General Counsel
Seattle Genetics, Inc. / Bothell, WA
  Current stumbling blocks for obtaining final approval from U.S. Food and Drug Administration and the most effective strategies for getting over them
  Nancy L. Buc, Esq.
Buc & Beardsley / Washington, DC
  Winning market authorization in Europe: Dealing with the European Medicines Agency (EMEA) and 27+ national regulators
  Linda R. Horton, Esq.
Hogan & Hartson LLP / Washington, DC
12:00 pm Lunch (on your own)
1:15 pm Changing Patent Rules
  Impact of major recent Supreme Court patent decisions on biotech development
  William T. Christiansen, II, Esq., Ph.D.
SEED IP / Seattle, WA
  Update on significant litigation and trends in the circuits
  Elizabeth A. Howard, Esq., Ph.D.
Orrick, Herrington & Sutcliffe LLP / Menlo Park, CA
  Patent reform proposals
  Andrew T. Serafini, Esq., Ph.D.
Woodcock Washburn LLP / Seattle, WA
3:15 pm Break
3:30 pm Regulation of Sales and Marketing Activities
  Review key legal and regulatory risks associated with the marketing and promotion of biopharmaceuticals, including fraud and abuse issues, advertising and promotion restrictions, off-label promotion, and the emerging subject of state law compliance
  A. Demarest (Demi) Allen, Esq., Associate General Counsel, Corporate Compliance
ZymoGenetics, Inc. / Seattle, WA
4:15 pm Disclosure Issues for Publicly Traded Biotechnology Companies
  A comparison of SEC and FDA requirements on what you must release and when
  Michelle Burris, Senior Vice President and Chief Financial Officer
Trubion Pharmaceuticals, Inc. / Seattle, WA
  Kate McKereghan Deeley, Esq., Senior Vice President, General Counsel
Trubion Pharmaceuticals, Inc. / Seattle, WA
5:00 pm Evaluations and Adjourn

Tuition

Regular tuition for this program is $995 with a group rate of $895 each for two or more registrants from the same firm. For government employees, we offer a special rate of $795. For students and people in their job for less than a year, our rate is $497.50. All rates include admission to all seminar sessions, food and beverages at breaks, and all course materials. Make checks payable to Law Seminars International.

Cancellation & Substitution

You may substitute another person at any time. We will refund tuition, less a $50 cancellation fee, if we receive your cancellation by 5:00 p.m. on Friday, September 21, 2007. After that time, we will credit your tuition toward attendance at another program or the purchase of a Homestudy. There is a $25 cancellation fee for Course Materials orders and $50 for Homestudy orders.

Continuing Education Credits

This program qualifies for 13.5 WA CLE credits. Upon request, we will apply for CLE credits in other states and other types of credits.

Location

The conference will be held at the Washington State Convention and Trade Center at 800 Convention Place in Seattle, WA 98101, (206) 694-5000. Discounted sleeping rooms are available at the adjacent Sheraton Seattle Hotel (1400 Sixth Avenue, Seattle, WA 98104) from $189/night. Reserve on-line at www.sheraton.com or via phone at 888-625-4988 and reference SET code 352710. Rooms are available on a first-come, first-serve basis.
More about the Location
Map & Directions

If You Cannot Attend

Our complete Homestudy Course, consisting of a VHS or DVD recording and the written course materials, is available for $1005. The written course materials alone are available for $100. We will ship your Homestudy order via UPS ground within two weeks after the seminar or the date we receive payment (whichever is later).
Order Homestudy

Faculty Bios

Eric L. Dobmeier, Program Co-Chair, is Chief Business Officer for Seattle Genetics, Inc., and oversees the company's legal, business development, marketing, corporate communications and project management functions. Previously, he was in private practice with the law firms of Venture Law Group and Heller Ehrman White & McAulliffe.

Alan C. Smith, Program Co-Chair, is Chair of the Seattle office of Orrick, Herrington & Sutcliffe LLP, and a member of the Corporate Group. He focuses on technology, life sciences, Internet and other high growth companies, with emphasis on securities offerings, mergers and acquisitions, venture capital financings, corporate formation and public company reporting and disclosure.

Shane R. Albright, Ph.D., an associate with Cooley Godward Kronish LLP, is a member of the Business Department and represents biotechnology, medical device and other life science companies in a wide range of intellectual property and technology-related transactions, including corporate partnering, licensing and sponsored research.

A. Demarest (Demi) Allen is Associate General Counsel, Corporate Compliance, for ZymoGenetics, Inc. He has counseled pharmaceutical companies extensively on legal issues relating to sales and marketing, clinical trials, drug safety surveillance and product labeling. Previously, Mr. Allen was in-house counsel for ICOS Corporation.

Nancy L. Buc, partner with Buc & Beardsley, is former General Counsel, U.S. Food and Drug Administration and a member of the Office of Technology Assessment Advisory Committee on New Developments in Biotechnology.

Michelle Burris is Senior Vice President and Chief Financial Officer for Trubion Pharmaceuticals, Inc. Previously she was with Dendreon Corporation. Prior to that, she was with Corixa Corporation, where she was responsible for the company's financial, administrative and operating functions.

William T. Christiansen II, Ph.D., is a partner with SEED IP, where he specializes in biotechnology patent matters, with emphasis on due diligence analysis, U.S. and international patent strategy and procurement, and competitive patent position analysis.

Kate McKereghan Deeley is Senior Vice President, General Counsel, at Trubion Pharmaceuticals, Inc. Previously she was the founding manager of Somerset Consulting, LLC, and before that, was with Corixa Corporation.

Jack Faris, Ph.D., is President of the Washington Biotechnology & Biomedical Association (WBBA). He previously was the Vice President of University Relations at the University of Washington and overseer of public relations and community strategy at The Bill & Melinda Gates Foundation.

Stephen M. Graham is a partner and worldwide chair of Orrick, Herrington & Sutcliffe LLP's Corporate Department. He focuses on private and public mergers and acquisitions, public offerings, private placements and general corporate matters of emerging and established high growth companies.

Linda R. Horton, a partner with Hogan & Hartson LLP, counsels clients in the pharmaceutical, medical device, animal health, food and cosmetic industries on requirements of the EU regulatory authorities, the U.S. Food and Drug Administration (FDA), and similar agencies in other countries. She previously was with the FDA.

Elizabeth A. Howard co-chairs Orrick, Herrington & Sutcliffe LLP's Life Sciences Practice and focuses on patent infringement litigation, with emphasis on the life sciences. Her practice also includes trade secret, contract and licensing disputes and client counseling, in addition to litigating in federal district courts and California state courts.

Erik H. Iverson is Associate General Counsel for the Bill & Melinda Gates Foundation, where he works primarily within the Global Health Program, focusing on the legal structure of funded programs and intellectual property issues relating to the foundation's grant-making activities. Previously Mr. Iverson was with Perkins Coie LLP.

Kevin F. Kelly, a shareholder with Heller Ehrman LLP, practices commercial law and is chair of the firm-wide Intellectual Property Transactions Practice Group. He has expertise in negotiating technology-related licenses, collaborations, strategic alliances and other related transactions.

Melinda Richter, founder and Chief Executive Officer of Prescience International, started and is Executive Director of the San Jose BioCenter, co-founded and directs the UC Berkeley Global BioExecutive Institute, and provides consultation services to other incubators.

Kirk D. Schumacher is General Counsel for Seattle Genetics, Inc., where he has participated in the negotiation and completion of multiple corporate alliances and technology collaborations. Previously, he was with Venture Law Group and Riddell Williams.

Andrew T. Serafini, Ph.D., partner with Woodcock Washburn LLP, has particular experience working with the venture capital community, emerging companies, and established companies and specializes in providing life sciences clients with strategic and comprehensive intellectual property counseling and management.

James A. Severson, Ph.D., is Vice Provost for Intellectual Property and Technology Transfer at the University of Washington. He is responsible for UW TechTransfer, the unit of the University that seeks to commercialize discoveries made from research conducted at the UW.

Gerald J. Siuta, Ph.D., is the President of Siuta Consulting, Inc., and works as a Business Development Consultant to the Global Alliance for TB Drug Development where he has negotiated agreements with international organizations and companies.

Kathleen M. Weldon is Vice President, Government Strategy for Biogen Idec and oversees all federal government relations for the company. Previously, she was a staff member of the House Ways & Means Health Subcommittee.

Fiona Wills, Ph.D., is Director of University of Washington's TechTransfer Invention Licensing group, which handles patentable inventions and research tools resulting from work across the University campus, material transfer agreements, and consults on intellectual property terms for agreements.