Law Seminars International Presents

Washington Biotechnology & Biomedical Association

The 6th Annual Comprehensive Conference on

Biotechnology

It's a Jungle Out There!

September 29 & 30, 2005
Westin Seattle Hotel in Seattle, WA
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Who Should Order Homestudy

Attorneys, industry executives, industry representatives, consultants, government and university officials

Why Order

We're going exploring for this year's Biotechnology Conference in Seattle. And just as biodiversity is a key characteristic of jungles, we'll look at a diverse array of legal and industry "flora and fauna" in the course of our program. We've assembled a great team of expert guides to walk us through not only the basic issues for biotech companies and their counsel (getting started, working with universities, getting funding, strategic partnering, the intricacies of biotech patents, etc.), but also to take us down some forking paths and up some rocky cliff faces to explore exotic topics like foreign clinical trials and regulatory approvals, immigration, and global treaty-making. Along the way, we're sure to see some dangerous features and creatures like antitrust, mass torts, and anti-kickback laws. We hope even the more seasoned "travelers" among us will stumble across something new and thought-provoking in our two-day trek. Join us if you dare! ~ Program Co-Chairs: Joanna Lin Black and Roger M. Tolbert

What You Will Learn

- Case Law Update - Proposed Legislative Changes - SEC & FDA Requirements - The Mutual Recognition Procedure - Antitrust Update - The Life Science Discovery Fund - Clinical Trials - Financing - M&A as Exit Strategies - Biotech Deal Making - Mass Tort Litigation - Patent Updates - NIH New Ethics Guidelines

Agenda

Thursday, September 29, 2005
8:30 am Introduction: It's a Jungle Out There
  An explorers' guide to the challenges of biotech
  Joanna Lin Black, Esq., VP, General Counsel
 Xcyte Therapies, Inc. / Seattle, WA
  Roger M. Tolbert, Esq., Program Co-Chair
 Orrick, Herrington & Sutcliffe LLP / Seattle, WA
8:45 am Forming the Party: Taking a Professor Along
  Working with universities; new ethics rules in Washington's public sector
  Catherine Innes, Director of Policy & Strategic Initiatives
 University of Washington TechTransfer / Seattle, WA
  The National Institutes of Health's new ethics guidelines
  Holli Beckerman-Jaffe, Esq., Director, NIH Ethics Office
 National Institutes of Health / Bethesda, MD
  Impact of tightened immigration and visa rules on the life sciences industry
  Kevin Lederman, Esq.
 Law Offices of Cowan & Miller / Seattle, WA
10:15 am Break (Rest, But Don't Gulp Your Water)
10:30 am Packing Up and Starting Out
  Early stage financing: life science incubators
  Carl Weissman, CEO
 Accelerator Corporation / Seattle, WA
11:00 am Finding Enough to Eat Along the Trail
  The climate for later-stage venture capital and initial public offerings
  Eric Bell, Senior Associate
 Vulcan Capital / Seattle, WA
11:30 am Help from the Local Authorities
  The Life Science Discovery Fund
  Marc Baldwin, Executive Policy Advisor
 Washington State Office of Financial Management / Olympia, WA
12:00 pm Lunch (On Your Own: "Eat What You Kill")
1:15 pm Teaming Up: Licensing and Collaborations
  Legal issues and trends in joint research agreements and licensing; CREATE Act
  Kevin F. Kelly, Esq.
 Heller Ehrman LLP / Seattle, WA
  Managing the human dynamics of biotech deal making
  Eric L. Dobmeier, Esq., Sr. Vice President, Corporate Development and General Counsel
 Seattle Genetics, Inc. / Bothell, WA
2:30 pm Go On Without Me (and Take My Pack and Water)
  Mergers & acquisitions as exit strategies
  Alan C. Smith, Esq.
 Orrick, Herrington & Sutcliffe LLP / Seattle, WA
3:15 pm Take a Breather (Time to Phone Home?)
3:30 pm Playing Fair: Antitrust Update
  Antitrust update; deals between branded pharma and generics
  David A. Balto, Esq.
 Robins, Kaplan, Miller & Ciresi LLP / Washington, DC
4:15 pm Jungle Lore (Part 1): Changing Patent Rules
  Patent reform proposals
  Nagendra Setty, Esq.
 Jones Day / Atlanta, GA
5:00 pm Camping for the Night (Adjourn Until Tomorrow)

Friday, September 30, 2005
8:15 am Reveille; Wake up and smell the coffee
8:30 am Pause for Reflection: What are We Doing Out Here, Anyhow?
  Regional benefits of the biotech industry; public fears and controversies; lobbying and public relations
  Jack Faris, President
 WBBA / Seattle, WA
9:00 am Draining the Swamp: New International Public Health Laws
  Rule of law in the global arena; WHO treaty making process
  Bruce J. Plotkin, Esq.
 Attorney and Legal Consultant, International Health & Trade Law / Seattle, WA
9:30 am Sending Reports Back Home
  Disclosures by publicly held biotech companies; a comparison of SEC and FDA requirements on what you must release, and when
  Joanna Lin Black, Esq., Program Co-Chair
 Kirkland, WA
10:15 am Break
10:30 am Sending Out Scouting Parties: Clinical Trials
  Overview of clinical trials in the US
  Nancy K. Plant, Esq.
 Adkins & Plant PLLC / Bainbridge Island, WA
  Special considerations for foreign clinical trials
  Oren Cohen, MD, Chief Medical and Scientific Officer
 Quintiles Transnational Corp. / Durham, NC
11:45 am Lunch (On Your Own Again: Please Do Not Fight Over the Remaining Supplies)
1:00 pm Storming the Citadel: The Battle for Regulatory Approval
  U.S. Food and Drug Administration update
  Nancy L. Buc, Esq.
 Buc & Beardsley Lawyers / Washington, DC
  Overview of the Mutual Recognition Procedure and other EU regulatory matters
  Kendra Anne Martello, Esq., Associate
 Heller Ehrman LLP / Washington, DC
2:30 pm Stepping Around the Quicksand
  Mass tort litigation, kickbacks, public distrust and other pharmaceutical falls and cliff-hangers; how to avoid them, or else to cope with them
  Kathleen Patterson, Esq.
 Orrick, Herrington & Sutcliffe LLP / San Francisco, CA
3:15 pm Break (Hang in There!)
3:30 pm Jungle Lore (Part II): More Patent Rules to Live and Die By
  Attorney opinion practice after Knorr-Bremse
  Paul T. Meiklejohn, Esq.
 Dorsey & Whitney LLP / Seattle, WA
  Written description/enablement update; Merck v. Integra
  William T. Christiansen, II, Esq., PhD.
 Seed Intellectual Property Law Group PLLC / Seattle, WA
4:45 pm End of the Trail: Wrapping Up; Questions

Cancellation

There is a $25 cancellation fee for Course Materials orders and $50 for Homestudy orders

Continuing Education Credits

Law Seminars International automatically obtains CLE credit approval for the state in which a seminar is held. On request, we will apply for CLE credits in other states and other types of credits. Current credits status: WA CLE 13 | Call about others

Cost

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

Joanna Lin Black, Program Co-Chair, is former VP and General Counsel at Xcyte Therapies, Inc. She has extensive experience representing numerous biotechnology and high tech companies in corporate governance matters, financings, M&A transactions and licensing and intellectual property issues.

Roger M. Tolbert, Program Co-Chair, leads the intellectual property contracting and licensing practice in Orrick, Herrington & Sutcliffe LLP's Pacific Northwest office. A partner in the firm, he represents clients from the biotechnology, pharmaceutical and e-commerce industries. Mr. Tolbert is listed in "The Best Lawyers in America" and by Seattle Magazine as one of Seattle’s Top Lawyers.

Marc Baldwin is the Washington State Office of Financial Management's Executive Policy Advisor for economic development issues. He was the lead policy staff person on life science and technology transfer issues during the last legislative session.

David A. Balto, partner, Robins, Kaplan, Miller & Ciresi LLP, has practiced antitrust law for over 20 years in government and private practice. He counsels a wide variety of companies on FDA regulation, strategic alliances, distribution issues, mergers and joint ventures.

Holli Beckerman-Jaffe is the Director of the National Institutes of Health (NIH) Ethics Office. Prior to assuming this position, Ms. Jaffe served as Ethics Counsel to the NIH. In 2002, she completed a detail to The White House as an Ethics Advisor in the Office of the Counsel to the President.

Eric Bell, Vulcan Capital, focuses on life sciences venture investments. Prior to Vulcan, he headed the business development out-licensing efforts for cancer vaccines and innate, immuno-modulators for Corixa Corporation.

Nancy L. Buc, partner, Buc & Beardsley Lawyers, Washington, D.C., 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.

William T. (Bill) Christiansen, Esq., PhD., partner, Seed Intellectual Property Law Group PLLC, specializes in biotechnology patent matters, with emphasis on U.S. and international patent procurement and strategic management of patent portfolios.

Oren Cohen, MD, Chief Medical and Scientific Officer, Quintiles Transnational Corporation, serves as lead medical expert and represents the company's positions on many government policy issues. Previously, he held several positions of increasing responsibility at the National Institute of Allergy and Infectious Diseases (NIAID). He is the author or co-author of more than 50 articles in textbooks and peer-reviewed medical journals, and he received several awards for his contributions to the work of NIAID and NIH.

Eric L. Dobmeier, Sr., VP, Corporate Devlopment and General Counsel, Seattle Genetics, Inc., has led negotiation and completion of multiple corporate alliances that have generated more than $45 million. He has also participated in raising over $100 million in equity financing for Seattle Genetics.

Jack Faris, recently appointed president of the Washington Biotechnology & Biomedical Association (WBBA), is the former VP of university relations at the University of Washington and overseer of public relations and community strategy at The Bill & Melinda Gates Foundation.

Catherine Innes, Director, Policy and Strategic Initiatives for UW TechTransfer at the University of Washington, develops outreach and educational programs and publications on intellectual property laws and University of Washington policies and practices related to technology commercialization.

Kevin F. Kelly, shareholder, practices commercial law and is a member of Heller Ehrman LLP's National Life Sciences Practice Group.

Kevin Lederman, partner, Law Offices of Cowan & Miller, has practiced exclusively in the field of immigration law for 13 years. He is currently listed in "The Best Lawyers in America" and has been selected as one of Washington State's "Super Lawyers".

Kendra Anne Martello, Heller Ehrman LLP, focuses on FDA regulatory, compliance, and enforcement issues pertaining to: pharmaceuticals (prescription and OTC), medical devices, biotechnology, dietary supplements, and foods. She also regularly counsels clients on Drug Enforcement Administration and Federal Trade Commission regulation and oversight of drug manufacturers and distributors, as well as on consumer product regulation and enforcement matters before the Consumer Product Safety Commission.

Paul T. Meiklejohn, partner, Dorsey & Whitney LLP Intellectual Property litigation group, focuses his practice on all aspects of IP Litigation. He is Adjunct Professor at the University of Washington on Patent Infringement Litigation.
Full bio and contact info for Paul T. Meiklejohn at Dorsey & Whitney LLP

Kathleen Patterson, partner, Orrick, Herrington & Sutcliffe LLP, focuses her practice on the defense of pharmaceutical, medical device, and biologic manufacturers in complex product liability litigation.

Nancy K. Plant, managing member, Adkins & Plant PLLC, has served as in-house counsel at three pharmaceutical companies: Burroughs Wellcome Co., the Du Pont Merck Pharmaceutical Company, and most recently, Immunex Corporation. At Immunex, Nancy provided legal advice on sales and marketing activities, clinical trials and clinical trial agreements, and a variety of commercial transactions.

Bruce J. Plotkin's practice focuses on international health and trade law and policy. Since 1998, he has been the legal consultant to the World Health Organization on the revision of the WHO International Health Regulations, the new global legal rules to prevent disease transmission in international trade, travel and transport.

Nagendra (Nick) Setty, partner, Jones Day, focuses his practice on all aspects of intellectual property counseling and litigation, including patent, trade secret, trademark and copyright matters, with particular emphasis on complex patent litigation.

Alan C. Smith, Orrick, Herrington & Sutcliffe LLP, Seattle Office chair, focuses his practice on technology, life sciences, Internet and other high growth companies, with an emphasis on securities offerings, M&A, VC financings, corporate formation and public company reporting and disclosure.

Carl Weissman, Venture Partner at MPM Capital, is President and CEO of Accelerator Corporation, an MPM led effort, in affiliation with Dr. Leroy Hood's Institute for Systems Biology (ISB).