Law Seminars International Presents: With support from BayBio Presents a Comprehensive Two-Day Conference on

Biotechnology 2007
Key legal and business developments

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(For this past program, we offer two options for purchase: a Homestudy (DVD and written materials) or written materials alone.)

January 29 & 30, 2007
Grand Hyatt Union Square Hotel in San Francisco, CA

Who Should Order This Homestudy

Attorneys - in-house and private practitioners, industry executives, industry representatives, consultants, government and university officials, investment bankers

Why Order

This year's update on the key legal and business issues facing the biotech industry will cover many important topics. There are state legislation and research programs layering on top of the federal ones, and stem cell research continues to be a vital and controversial topic. New developments in the area of the generic follow-on products are increasingly becoming factors for innovator companies.

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 each of 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 to ask questions about your issues of greatest concern. We hope you will be able to join us.

~ Program Co-Chairs: Robert V. Gunderson, Esq. and Lynn H. Pasahow, Esq.

What You Will Learn

What Attendees Said

Agenda

Monday, January 29, 2007

8:00 am

Registration & Continental Breakfast

 
8:30 am

Biotechnology in 2007: Day One - Update on Policy, Regulation and Litigation

Robert V. Gunderson, Jr., Esq., Program Co-Chair
Gunderson Dettmer LLP / Menlo Park, CA

Lynn H. Pasahow, Esq., Program Co-Chair
Fenwick & West LLP / Mountain View, CA

 
8:45 am

New Developments and the Realities of Dealing with the FDA in Today's Regulatory Environment

Bruce F. Mackler, Ph. D., Esq., Founder
Life Sciences Management Group, Inc. / Potomac, MD

 
9:30 am

New California Legislative Initiatives: From IP to Healthcare

Matthew M. Gardner, President
BayBio / San Francisco, CA

 
10:00 am

The State of Stem Cell Research

Where are we? Can you patent natural processes? What are the right limits for infringement for clinical trials and research leading to clinical trials? What is prior art? After litigation, what will happen with funds?

Kenneth S. Taymor, Esq.
MBV Law LLP / San Francisco, CA

 
10:30 am

Break

 
10:45 am

Is a Thriving Generic Biotechnology Industry Just Around the Corner?

Aaron F. Barkoff, Ph.D., Esq.
McDonnell Boehnen Hulbert & Berghoff LLP / Chicago, IL

 
11:30 am

Commercialization of University Technology

Rationale for academic technology transfer; the cultural divide; characteristics of university technologies and matching them to your needs

Alan S. Paau, Ph.D., Assistant Vice Chancellor
Cornell University / Ithaca, NY

 
12:15 pm

Lunch (on your own)

 
1:30 pm

Recent Federal Circuit, and Supreme Court Cases Affecting Biotech Companies

Plavix; eBay; Metabolite; Phillips; Merck; Apotex; MedImmune

William T. Christiansen, II, Ph.D.,Esq.
Seed Intellectual Property Law Group PLLC / Seattle, WA

 
2:15 pm

Biotech Patent Prosecution Update

Patent and Trademark Office: Changes to continuation practice and impact on portfolio management

Kate H. Murashige, Ph.D., Esq.
Morrison & Foerster LLP / San Diego, CA

 
3:00 pm

Break

 
3:15 pm

New Patent Issues Surrounding Therapeutic Antibodies

Filing patent claims to an antibody upon identification of the antigen; obtaining generic, subgeneric or specific protection; assertng a patent against competitors; lining up third-party patents

Jorge A. Goldstein, Ph.D., Esq.
Sterne, Kessler, Goldstein & Fox P.L.L.C. / Washington, DC

 
4:00 pm

Biotech Litigation: Tips and Strategies

Lynn H. Pasahow, Esq., Program Co-Chair
Fenwick & West LLP / Mountain View, CA

Gerald P. Dodson, Esq.
Morrison & Foerster LLP / Palo Alto, CA

Karen I. Boyd, Esq.
Fish & Richardson PC / Redwood City, CA

 
5:30 pm

Reception for Faculty and Attendees Sponsored by Fenwick & West LLP and Gunderson Dettmer LLP

 

Tuesday, January 30, 2007

8:00 am

Registration & Continental Breakfast

 
8:30 am

Biotechnology in 2007: Day Two - Business and Financing

Robert V. Gunderson, Jr., Esq., Program Co-Chair
Gunderson Dettmer LLP / Menlo Park, CA

Lynn H. Pasahow, Esq., Program Co-Chair
Fenwick & West LLP / Mountain View, CA

 
8:45 am

Financing the Early Stage Company

Alternatives for equity investment; non-dilutive financing; building an early partnering business; keeping the "ultimate investors" in mind during early financing

Robert V. Gunderson, Jr., Esq., Program Co-Chair
Gunderson Dettmer LLP / Menlo Park, CA

Peter D. Staple, CEO
BioSeek Inc. / Burlingame, CA

 
9:45 am

Strategies for Late Stage Financing

Stephen M. Graham, Esq.
Orrick, Herrington & Sutcliffe LLP / Seattle, WA

 
10:30 am

Break

 
10:45 am

Understanding the Venture Capital Climate for Biotechs Today: What Are VC's Looking For?

Karen A. Dempsey, Esq.
Heller Ehrman LLP / San Francisco, CA

Donald J. Elmer, Managing General Partner
Pacific Horizon Ventures / Seattle, WA

 
12:00 pm

Lunch (on your own)

 
1:15 pm

Corporate Partnering and M&A Transactions

Due diligence; product life-cycle management, drafting and negotiating transaction documents

Seth C. Silber, Esq.
Wilson Sonsini Goodrich & Rosati / Washington, DC

William Newell, Esq., President
Aerovance, Inc. / Berkeley, CA

John Howard Clowes, Esq.
DLA Piper Rudnick Gray Cary LLP / Palo Alto, CA

 
2:45 pm

Break

 
3:00 pm

Comprehensive IP Strategies: Understanding the Ins and Outs of Your IP

Structuring claims or protections to show value; due diligence; filings; a look at the gotcha's so you don't get tripped up

Robert P. Blackburn, Esq., Founder & Principal
DNAlex / Berkeley, CA

 
3:45 pm

A Checklist for Licensing Joint Ventures and Collaborative Arrangements

New licensing deals that can be very lucrative; pitfalls, advanced strategies; collaboration transactions between smaller companies and big companies; how to combine licensing and other techniques

Robert L. Jones, Esq.
Cooley Godward LLP / Palo Alto, CA

 
4:30 pm

Outsourcing Issues in Biotechnology

Outsourcing as a method to keep costs down and reduce the need for capital; pros and cons; regulatory responsibilities; control over substances; data and privacy including transborder data flow; employment and IP issues; allocation of liabilities

John Lynn, Esq.
Kirkland & Ellis LLP / San Francisco, CA

Karen Spindler, Esq.
Kirkland & Ellis LLP / San Francisco, CA

 
5:15 pm

Evaluations & 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 14.25 California MCLE credits. 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

Robert V. Gunderson, Jr., Program Co-Chair, founding partner, Gunderson Dettmer LLP, is nationally recognized as a leading authority in the areas of venture capital fund formation, the financing of life science and technology emerging growth companies, strategic alliances and initial public offerings. He is a member of Forbes' "Midas List",, one of The Best Lawyers in America, and is recognized by The American Lawyer, as one of the most influential lawyers in venture capital and emerging growth company fields.

Lynn H. Pasahow, Program Co-Chair, partner and chair of the Litigation Group of Fenwick & West LLP, focuses his practice on complex litigation, principally of patent and other intellectual property suits in the software, Internet and biotech industries. He is listed in Best Lawyers in America, is a director of BayBio and led the team establishing the validity of biotech-pioneer Cetus' patents on its Nobel prize winning polymerase chain reaction invention.

Aaron F. Barkoff, McDonnell Boehnen Hulbert & Berghoff LLP, concentrates on patent litigation, with emphasis on pharmaceutical and biotechnology patent cases. Dr. Barkoff authors a weblog, Orange Book Blog covering issues that involve both patent law and FDA law.
Full bio and contact info for Aaron F. Barkoff at McDonnell Boehnan Hulbert & Berghoff LLP

Robert P. Blackburn, founder and principal, DNAlex, was previously vice president and Chief Patent Counsel of Chiron Corporation. He was named by the American Lawyer as one of the top forty-five in-house counsel under the age of forty-five.

Karen I. Boyd, principal, Fish & Richardson PC, specializes in patent litigation, with emphasis in biotechnological, pharmaceutical and medical device inventions. She lectures, writes and was a law clerk to The Hon. Paul R. Michel on the U.S. Court of Apeals for the Federal Circuit, Washington, D.C.

William T. (Bill) Christiansen, 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.

John Howard Clowes, partner at DLA Piper Rudnick Gray Cary LLP, focuses on venture finance, mergers and acquisitions, representation of public companies, and corporate collaborations. He co-chairs DLA Piper's Emerging Growth and Venture Capital practice, and was named a Northern California Super Lawyer.

Karen A. Dempsey, shareholder in the Venture Law Group of Heller Ehrman LLP, focuses her practice on corporate representation of private and public emerging growth companies, venture capital firms and investment banks and advises public companies on Sarbanes-Oxley.

Gerald P. Dodson, partner at Morrison & Foerster LLP, was lead trial counsel for The Regents of the University of California on landmark patent litigation against Genentech resulting in one of the largest settlements in the history of patent law and the largest ever in the biotechnology field. He is listed in Chambers Global, The World's Leading Lawyers 2001-2006.

Donald J. Elmer, founder and managing general partner of Pacific Horizon Ventures, that specializes in early-stage bioscience growth equity opportunities, is currently chairman of Illumigen Biosciences, Koronis Pharmaceuticals, and is a board member of Novocell and the Washington Biotechnology and Biomedical Association.

Matthew M. Gardner, president of BayBio, represents the company in industry bodies and roundtables including the Biotechnology Industry Organization, the Council of State BioScience Associations, the Global Bioscience Partnership, other coalitions and business development groups.

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.

Stephen M. Graham, partner, is worldwide chair of Orrick, Herrington & Sutcliffe LLP's 300+ attorney Corporate Department. He focuses in private and public mergers and acquisitions, public offerings, private placements, and general corporate matters of emerging and established high growth companies.

Robert L. Jones, partner at Cooley Godward LLP, represents technology companies in the life sciences industries and chaired its Life Sciences practice. He is a frequent speaker on corporate partnering transactions.

Bruce F. Mackler, founder, Life Sciences Management Group, Inc. and former shareholder in Heller Ehrman White and McAuliffe, LLP Inc. As legal/regulatory counsel, he has assisted in obtaining device, drug, biologic, cosmetic and food product registrations, resolving regulatory/legal compliance issues and product liability exposures.

Kate H. Murashige, partner at Morrsion & Foerster LLP, focuses her practice on pharmaceutical and healthcare industries. She has been an advisor on gene patenting to the Office of Technology Assessment, has spoken before Members of Congress regarding the Human Genome Project and the Human Genome Conference on patent matters.

William Newell, President, Aerovance, Inc., has held key senior management positions in pharmaceutical companies, with his experience in partnering transactions, M&A transactions, equity and debt financing, alliance management and commercial activities.

Alan S. Paau is Assistant Vice Chancellor, University of California, San Diego, with a Ph.D. in Biological Sciences. He holds eight U.S. patents and has contributed thirty peer-reviewed research articles to scientific journals and by invitation six reviews/chapters to technical books.

Scott C. Silber is Of Counsel in the firm's antitrust and trade regulation practice, where he focuses on antitrust litigation and counseling. He previously worked at the Federal Trade Commission most recently as antitrust advisor to Commissioner Jon Leibowitz and in the Bureau of Competition as an assistant to the Bureau Director.

Peter D. Staple is CEO of BioSeek, Inc., a leader in applying integrated human biology systems for developing new therapeutics, and was previously Chief Administrative Officer and General Counsel of ALZA Corporation.

Kenneth S. Taymor, partner, MBV Law LLP, assists private companies in the life sciences, in their start-up, organizational, operational and financial needs. Previously, he was city of San Francisco's chief legal advisor in business, real estate and financial matters.

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