Law Seminars International Presents

The Second Annual Conference ~ Running the Race with

Biotechnology

Maintaining Your Lead

November 17 & 18, 2005
Hilton Torrey Pines in La Jolla, CA
Order      Download PDF Brochure

Who Should Order Homestudy

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

Why Order

Biotechnology is racing ahead with advancements in gene therapies, stem cell research, pharmaceutical drug developments, biologics and devices. To get pioneering biotechnology and pharmaceutical innovations to market, they must pass through a complex maze of intellectual property, contract, licensing, regulatory and financing issues, often interspersed with litigation and dispute management. Industry leaders and practitioners need a holistic approach to biotechnology and pharmaceutical development which takes into account all of these challenges. This two-day conference is an advanced level interactive session with national experts on leading issues of the day. It is an opportunity to meet with peers, to engage in thoughtful discussion, and to update and expand your understanding in all of these areas." ~ Kate Murashige, Esq., Ph.D. and Lynn H. Pasahow, Esq.

What You Will Learn

Emerging business and legal issues in biotechnology, including: Legal Protections, FDA Regulations, Key Licensing Alliances, Financing, Antitrust Issues, Dispute Resolution, Hot Topics in the Press

What Attendees Said

~ Nice mix of subjects. ~ Excellent ideas to relate to my practice ~ It was helpful to hear what others who practice in this area are doing. ~ Excellent list of presenters, offering perspectives from wide range of disciplines

Agenda

Thursday, November 17, 2005
8:30 am Introduction & Overview
  Kate H. Murashige, Ph.D., Esq., Program Co-Chair
 Morrison & Foerster LLP / San Diego, CA
  Lynn H. Pasahow, Esq., Program Co-Chair
 Fenwick & West LLP / Mountain View, CA
8:45 am California Proposition 71
  The $3 billion stem cell initiative
  Claire Pomeroy, MD, MBA, Vice Chancellor, Human Health Services & Dean, School of Medicine
 University of California, Davis / Sacramento, CA
9:30 am New SEC and FDA Requirements on What Information You Release and When
  The FDA's centralized procedures for notifying the SEC about potentially false or misleading public statements including disclosure of non-public information to SEC staff; tips for avoiding referrals and maximizing protection of confidential information
  Robert P. Brady, Esq.
 Hogan & Hartson LLP / Washington, DC
10:15 am Break
10:30 am Working with Public Institutions
  Current issues in university technology transfers
  Cheryl A. Fragiadakis, Department Head, Technology Transfer
 University of California / Berkeley, CA
11:15 am Intellectual Property Consequences of Changing the Regulatory Standard for Follow-On Biologics
  Differences between drugs and biologics; intellectual property consequences of the regulatory standard for follow-on products; implications for effective market protection.
  Gregory J. Glover, MD, Esq.
 Ropes & Gray / Washington, DC
12:00 pm Lunch (on your own)
1:00 pm Offshore Regulatory Trends
  The regulation of biotechnology in China
  Jie Chen, Esq.
 C/O Fenwick&West LLP / Mountain View, CA China
  The regulation of biotechnology in the European Union
  Kendra Anne Martello, Esq., Associate
 Heller Ehrman LLP / Washington, DC
2:30 pm Break
2:45 pm Litigation Update
  Now can we tell the scope of patents?
  Lynn H. Pasahow, Esq., Program Co-Chair
 Fenwick & West LLP / Mountain View, CA
  The Supreme Court's decision in Merck v. Integra Life Sciences: The scope of the safe harbor provision of the Hatch Waxman Act:
  Brian D. Coggio, Esq.
 Greenberg Traurig, LLP / New York, NY
4:15 pm After the Start-up: Financing Biotechnology Development
  Early stage
  Ralph E. Christoffersen, General Partner
 Morgenthaler Ventures / Boulder, CO
5:00 pm Reception
  Sponsored by Fenwick & West LLP and Morrison & Foerster LLP

Friday, November 18, 2005
8:30 am After the Start-up: Financing Biotechnology Development
  Later stage
  Alan C. Mendelson, Esq.
 Latham & Watkins LLP / Menlo Park, CA
9:15 am Teaming Up: Licensing and Collaborations
  Why and when to partner; finding partners; key deal issues to consider; CREATE Act
  Kevin F. Kelly, Esq.
 Heller Ehrman LLP / Seattle, WA
  Sergio Garcia, Esq.
 Fenwick & West LLP / San Francisico, CA
10:45 am Break
11:00 am Effective Mergers & Acquisitions
  Mergers and acquisitions as tools for growing a business: When M&A is the most appropriate solution; due diligence issues; FDA regulatory issues
  Scott Andrew Sher, Esq.
 Wilson Sonsini Goodrich & Rosati / Palo Alto, CA
11:45 am Antitrust Update
  Current antitrust issues in alliances, M & A, delaying the introduction of generics, interference settlements (collusive extension of patent term)
  David A. Balto, Esq.
 Robins, Kaplan, Miller & Ciresi LLP / Washington, DC
12:30 pm Lunch (on your own)
1:30 pm Clinical Trials
  Clinical trials in the US and offshore; trends and issues in the use of trial management companies
  Nancy K. Plant, Esq.
 Adkins & Plant PLLC / Bainbridge Island, WA
2:15 pm Biotechnology Patent Pools and Standards Setting
  Patent thickets in the fields of diagnostics, therapy, vaccines, or drug discovery may be resolved by carefully constructing patent pools which, in order to avoid anticompetitive behavior, need to adhere to neutrally established standards
  Jorge A. Goldstein, Esq., Ph.D.
 Sterne Kessler Goldstein & Fox P.L.L.C. / Washington, DC
3:00 pm Break
3:15 pm Patent Law Reform
  Biotechnology's perspective on patent law reform
  Nancy J. Linck, Esq., Ph.D., Deputy General Counsel, IP & Trade
 Biotechnology Industry Organization / Washington, MD
4:00 pm Patent Law Update
  Recent cases
  Kate H. Murashige, Ph.D., Esq., Program Co-Chair
 Morrison & Foerster LLP / San Diego, CA
4:45 pm Q&A
5:00 pm Adjourn

Cancellation

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

Continuing Education Credits

Law Seminars International is a State Bar of California approved MCLE provider. This program qualifies for 14 California MCLE credits and 13.75 WA CLE. Upon request, we will apply for CLE credits in other states and other types of credits.

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

Kate H. Murashige, Ph.D., Program Co-Chair, is a partner at Morrsion & Foerster LLP. Her practice focuses on the pharmaceutical and healthcare industries.She has been an invited speaker at the Human Genome Conference on patent matters and has been an advisor on gene patenting to the Office of Technology Assessment. She has spoken before Members of Congress and their staffs regarding the Human Genome Project.
Full bio and contact info for Kate H. Murashige at Morrison & Foerster LLP

Lynn H. Pasahow, Program Co-Chair, is a partner in the Litigation and Intellectual Property Groups of Fenwick & West LLP. His practice focuses on patent and other intellectual property counseling, litigation, and mediation.

David A. Balto is a partner at Robins, Kaplan, Miller & Ciresi LLP. He counsels a wide variety of companies on FDA regulation, strategic alliances, distribution issues, mergers and joint ventures. Previously Mr. Balto was Policy Director of the Bureau of Competition of the FTC and attorney advisor to Chairman Robert Pitofsky.

Robert P. Brady, partner, Hogan & Hartson LLP is the head of the Pharmaceutical/Biotechnology Practice Group. His practice focuses on product law and counsels companies, individuals, and associations on a wide range of legal and regulatory matters involving the U.S. Food and Drug Administration (FDA) and related state and federal agencies.

Jie Chen is a partner of Jun He Law Offices headquartered in Beijing, China. She specializes in foreign investment, mergers & acquisitions, banking and financing, and general corporate practice.

Ralph E. Christoffersen, general partner, Morganthaler Ventures, was most recently the president and CEO of Ribozyme Pharmaceuticals, Inc., a Morgenthaler portfolio biotechnology company whose mission is to commercialize the Nobel Prize-winning discovery of ribozymes for use as human therapeutics. He was formerly the senior vice president of research at SmithKline Beecham, vice president of discovery research at The Upjohn Company, and president of Colorado State University.

Brian D. Coggio is a shareholder of Greenberg Trauig's New York Intellectual Property Group where he acts as a trial lawyer and counselor. Although he has litigated disputes involving a myriad of technologies, his practice focuses on chemical/pharmaceutical disputes, including those centered in biotechnology.
Full bio and contact info for Brian D. Coggio at Greenberg Traurig, LLP

Cheryl A. Fragiadakis is the head of the Technology Transfer Department at the Lawrence Berkeley National Laboratory, University of California, Berkeley.

Sergio Garcia is a partner in the Corporate and Licensing Groups at Fenwick & West LLP, and serves as Co-Chair of the Life Sciences Practice Group. His practice focuses on the representation of life sciences companies in complex commercial transactions, including collaborative development and licensing agreements and strategic partnering arrangements. He also advises clients on regulatory, public disclosure and corporate compliance issues. He was formerly the vice president, Legal and general counsel for Protein Design Labs, Inc., where he was responsible for overseeing the company’s legal affairs and corporate compliance.

Gregory J. Glover, is a partner at Ropes & Gray LLP and coordinator of the Life Sciences Practice. He is a licensed physician and registered patent attorney with experience in food and drug law, intellectual property law, and technology licensing.

Jorge A. Goldstein, partner, is a Director in the Biotechnology/Chemical Group at Sterne, Kessler, Goldstein & Fox P.L.L.C. His intellectual property experience has been principally in areas such as genomics, molecular and cell biology, and recombinant DNA technology.

Kevin F. Kelly, shareholder, Heller Ehrman LLP, practices commercial law and has extensive experience in negotiating technology related licenses, strategic alliances, and other transactions. He represents numerous clients in complex commercial transactions, primarily involving biotechnology, pharmaceuticals, vaccines, and computer software and hardware.

Nancy J. Linck is presently BIO’s Deputy General Counsel, Intellectual Property and Trade. Prior to joining BIO, she was Sr. Vice President, Intellectual Property and Regulatory Affairs, at Guilford Pharmaceuticals in Baltimore. From 1994 until late 1998, Nancy served as the Solicitor of Patents and Trademarks at the U.S. Patent & Trademark Office. The Solicitor, at the time, was General Counsel for the PTO. Nancy was also a partner in the law firm, Cushman, Darby & Cushman.

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.

Alan C. Mendelson is a partner at Latham & Watkins. His practice is targeted toward the representation of emerging and public growth companies, with strong emphasis on companies in the life sciences industry.

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.

Claire Pomeroy, MD, MBA, University of California, Davis, is an expert in infectious diseases and a professor of internal medicine, microbiology and immunology. She oversees the UC Davis Health System and all of its academic, research, and clinical programs.

Scott A. Sher is a partner at Wilson Sonsini Goodrich & Rosati. He focuses on antitrust and trade regulation issues and has significant experience working with high-tech clients. He has advised clients on issues pertaining to mergers and acquisitions, joint ventures, the Robinson-Patman Act, pricing and distribution, trade association and patent pooling matters, and the Sherman Act.
Full bio and contact info for Scott Andrew Sher at Wilson Sonsini Goodrich & Rosati

Firm Links

Wilson Sonsini Goodrich & Rosati