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The San Diego Chapter of the Licensing Executives Society invites you to join us for our upcoming meeting on Tuesday, November 8, 2005

Business and Legal Issues in Outsourcing Agreements Points to Consider & Lessons Learned

FEATURED PANELISTS:

Laurie Axford Moderator
Gordon & Rees LLP

Sanja Ilic
Vice President, Clinical and Regulatory Affairs
Photo Thera Inc  

Sofie Qiao
Director of Business Operations
Discovery Partners International

William "Jay" Treat, Ph.D.
COO, Avid Bioservices , Inc.

Sven H. Wagner, Ph.D.
Associate Director, Business Development
deCODE chemistry & deCODE biostructures, Inc.

PROGRAM DESCRIPTION:
An increasing number of U.S.-based life science companies have been outsourcing their work to other companies to increase their own productivity, cut costs and bring to the market cheaper drugs faster.  It is projected that by 2008, about 47% of biopharmaceutical companies will outsource their production.  A consequence of this trend  includes proliferation of a number of contract research and manufacturing organizations (CROs and CMOs). According to a Frost & Sullivan report, by 2007 CRO industry revenues will total about $14.4 billion, compared to the $7.8 billion in revenues reported in 2002.  As the number of biologics in drug pipelines or coming off patent increases over the next five years, biomanufacturing faces several challenges. Panel members will discuss their first-hand experiences in dealing with issues in developing, negotiating and enforcing outsourcing agreements, including confidentiality and intellectual property considerations, commercial terms and liabilities.  

DATE:
Tuesday, November 8th

TIME:
6:00 p.m. - 6:50 p.m. Registration, Networking, Cocktails and Appetizers
6:50 p.m. - 7:00 p.m. Chapter Business
7:00 p.m. - 8:00 p.m. Panel Discussion

LOCATION:
La Jolla Marriott
Salons A & B
4240 La Jolla Village Drive
San Diego

COST AND REGISTRATION OPTIONS: Pre-Register by 12 noon on Friday, November 4, 2005
Pre-registration not only guarantees you a seat, but it also saves you $10.

REGISTRATION:
You have the option of registering online and paying either by credit card OR check

$35 Members by Friday, November 4, $45 at the door (cash or check only)
$40 Non-Members by Friday, November 4, $50 at the door (cash or check only)

If you are a member of LES, click here to register online here with your credit card;

If you are not a member of LES, click here to register online here with your credit card;

Seating is limited and will be on a first come, first served basis. Please note that we will still need to receive your check by November 4, to guarantee your registration. The address to mail your check to is:

Ross A. Epstein
LES San Diego
c/o Nath & Associates
12264 El Camino Real, Suit 400
San Diego, CA 92130

For additional information, please contact:
Ross A. Epstein, Chair
tel. (858) 792-8211
fax (858) 792-8946
e-mail: repstein@nathlaw.com

or

Kasia A. Epstein, Event Coordinator
Tel. (619) 944-1628
e-mail: Kasia-Epstein@sbcglobal.net

NOTE: This presentation will qualify for MCLE credit.

MEETING SPONSOR: Morrison & Foerster LLP
With more than one thousand lawyers in nineteen offices around the world, Morrison & Foerster offers clients comprehensive, global legal services in business and litigation. The firm is distinguished by its unsurpassed expertise in finance, life sciences, and technology, legendary litigation skills, and an unrivaled reach across the Pacific Rim, particularly in Japan and China. We have one compelling mission: to deliver success for our clients.

Participant biographies:

Laurie A. Axford, Gordon & Rees LLP – Moderator
Laurie Axford is a partner in the San Diego office of Gordon & Rees LLP, and a member of the firm’s Intellectual Property group. Her practice focuses on all phases of patent prosecution, including forming initial patent strategies for new technologies and managing complex existing portfolios. She has written and prosecuted patents covering inventions relating to organic chemistry, biochemistry, biotechnology, nanotechnology, synthetic polymers, textiles, small molecules, assay devices, business methods, and drug delivery systems. Prior to becoming an attorney, Ms. Axford had a successful career as a scientist in one of the first biotechnology companies in San Diego. She entered law school in 1989 and following her graduation in 1992, she became in-house patent counsel to a biotechnology company. She entered private practice in 1995, and most recently was a partner with Burns, Doane, Swecker & Mathis and managed their San Diego office. Ms. Axford received her J.D. from Western State University School of Law. She earned a B.S. degree in microbiology and an M.S. degree in molecular biology from San Diego State University. She is admitted to practice in California and before the U.S. Patent and Trademark Office. Recently, Ms. Axford was named by The Daily Transcript as one of “The Transcript’s Ten” Top Attorneys in San Diego. Active in the community, she is a member of a number of organizations, both legal and scientific. She is the former director of the San Diego Nucleic Acid Conference, and has served on numerous organizing committees for other scientific and legal conferences. She is also past president of the San Diego Intellectual Property Law Association

Sanja Ilic, M.D. - Photo Thera Inc -Panelist
Dr. Ilic is the Vice President of Clinical & Regulatory Affairs at PhotoThera, Inc. where she serves as the senior clinical interface and spokesperson regarding all aspects of Clinical and Regulatory Affairs for the Company. Dr. Ilic provides leadership, clinical insight, and strategic direction as the Company continues to develop and commercialize LLT systems for stroke treatment. Dr. Ilic provides clinical support, insight and guidance for the clinical/regulatory strategy, design and execution of complex clinical trials, and product portfolio management on a worldwide basis. In 1990, Dr. Ilic graduated from Medical School University of Belgrade, Magna Cum Laude. In 1993 she earned a Master of Science Degree in Human Reproduction from the University of Belgrade. Dr. Ilic is Board certified in Obstetrics and Gynecology. She also did graduate level research at Harvard School of Public Health, Northeastern University and Center for Creative Leadership Program. Dr. Ilic’s experience includes positions with Johnson & Johnson (WW Director, Clinical research Codman, a Johnson & Johnson Co.), Medtronic MiniMed (Director Clinical Research), Sansum Medical Research Institute (Senior Scientist), MAG Hospital (Medical Director). Dr Ilic authored more that 50 publications, and lectured on national as well as international conferences and venues of the highest scientific levels

Sophie Qiao, Discovery Partners - Panelist
Sofie Qiao has been Director of Business Operations at Discovery Partners International, Inc. since late 2003. Prior to that, she was Director of Business Development at Syrrx, Inc., a private structure-based drug discovery company, which has since been acquired by Takeda. Before moving to San Diego in 2002, she was a consultant with McKinsey & Company, working on strategic and operational issues in the biotech and pharmaceutical industries. Sofie received her B.A. in chemistry from Harvard University, and her Ph.D. in organic chemistry from M.I.T, and worked as a medicinal chemist at Genzyme Corporation for two years before moving to the business side by joining McKinsey. A native of Beijing, China, she moved to the U.S. in 1992.

William Jay Treat – Panelist
William Jay Treat received his Ph.D. in Agricultural and Biochemical Engineering in 1988 and his M.S. in Microbiology in 1982, both from Texas A&M University. After graduating, he joined Lipogen, a start-up biotechnology company developing liposomes for drug delivery and diagnostic products for autoimmune diseases. He moved from Manager of Fermentation and Purification, where he was responsible for the production of recombinant human proteins in E. coli, CHO and SF9, to Director of Manufacturing in 1999. He coordinated the transfer of manufacturing processes when Lipogen was sold to BioWhittaker, where he joined as Manager of Diagnostic Manufacturing in 1990.

During his 9 years with BioWhittaker, he held positions with increasing responsibility including Manager of Diagnostics Manufacturing, Technical Director of Biotechnology, Director of Cell Culture Media and Flexible Packaging Manufacturing and Senior Director of Marketing. In 1999 he joined Irvine Scientific as VP of Research & Development where he was responsible for coordinating new product development of cell culture media with biopharmaceutical and human assisted reproductive technology applications.

After leaving Irvine Scientific he worked with Peregrine management to launch Avid Bioservices in 2002 where he was responsible for Business Development. In 2004, he became Avid’s Chief Operations Officer, moving from his previous position as VP of Business Development. In 2005 he also assumed the COO responsibilities for Peregrine Pharmaceuticals. During these two years he took the company through 6 regulatory inspections including a successful PAI and is actively involved in project and contract negotiations at Avid. He is active in many professional societies and serves as a member of the Texas A&M Chemical Engineering Scientific Advisory Board.

Sven H. Wagner, Ph.D - Panelist
Sven H. Wagner, Ph.D. is Associate Director of Business Development at deCODE genetics, Inc., headquartered in Reykjavik, Iceland, a biopharmaceutical company applying its discoveries in human genetics. Dr. Wagner has responsibilities leveraging deCODE’s expertise in integrated drug discovery and development capabilities to offer innovative products and services in structural biology, drug discovery and clinical development. Dr. Wagner is leading strategic corporate development efforts for deCODE biostructures with focus on structure-based drug design and structure elucidation of trans-membrane proteins.

Prior to joining deCODE in 2005, Dr. Wagner was Director of Business Development at ChemBridge Research Laboratories, Inc. (CRL) in San Diego, a privately held drug discovery company focusing on the discovery of novel treatments for cancer and metabolic diseases and leveraging its off-shore research operations in Moscow, Russia through ChemBridge Corp. During his five years with CRL he forged key alliances to position CRL’s corporate development.

Previously, he joined in 1998 as Director of Marketing the life sciences company EMD Biosciences, San Diego, part of Merck KGaA, Darmstadt, Germany, and was leading the product commercialization for its Novabiochem business in North America.

Dr. Wagner began his career as research scientist for Peninsula Laboratories, Inc., Belmont, an early pioneer in commercializing synthetic peptides and immunology research tools. H e became in 1996 head of their German subsidiary Peninsula Laboratories, GmbH in Heidelberg, Germany, managing research and operations.

He has provided consulting services to start-up biotech companies in various licensing, research collaboration and business development capacities.

Dr. Wagner received a M.S. degree in Chemistry from the University of Leipzig, Germany, and a Ph.D., magna cum laude, in Pharmacology from the German Cancer Research Center (DKFZ) at University of Heidelberg.