BioE2E event, Wednesday, February 6th

Early Stage Drug Development, A Balance of Luck and Perseverance: Herceptin A Case Study

Register online at http://www.acteva.com/go/bioe2e before Monday, February 4, at 6pm to get the pre-registration price of $25.

On-site registration is $35 (cash or check only).

Location: Wilson Sonsini Goodrich Rosati, 950 Page Mill Road, Palo Alto
Time: 6:45pm networking, 7:30pm panel discussion

Herceptin almost failed to be developed because of a lack of vision by many but a few diehard scientists and cancer activists. Following the initial discovery of cellular oncogenes it took almost two decades the expertise and vision needed develop a drug targeting a cellular form of an oncogene, Her2, to create Herceptin. The 20-year timeline was influenced by the rise of new way of thinking about antibodies as therapies, a fuller understanding of the mechanism behind some types of breast cancer, and all this was accompanied by near heroic persistence by academic physician at UCLA and scientists at Genentech.
 
Additional technology had to be developed prior to treating patients as well. Following the development of monoclonal antibodies additional technologies that were required included:

• Sensitive IHC/FISH
• Protein modeling and engineering
• Humanization of antibodies
• Rapid (< 1 month) protein production methods in mammalian cells

The mantra “binding is not enough” was one take home message following the success of Herceptin but equally important the development of Herceptin carries with it a message of doggedly pursuing something when you believe it strongly. Hear the story of how one of biotech's most significant breakthrough drugs came into being despite many naysayers. The next generation of Her2 therapeutics, including HER2 vaccines, will also be summarized.

Dr. Gorman is an entrepreneur, strategist, and research scientist with experience in business and drug development aspects of biotechnology industry. She has an outstanding record of achievement in basic research and drug development in diverse areas including gene therapy, gene expression and transfer, hormone processing, cell biology, protein transport, and the humanization of antibodies and production of recombination of proteins. At Genentech, Dr. Gorman played a key role in the development of a number of marketed products including Kogenate, Activase, Hercepin, Xolair, and Raptiva. She also played a role the early stages of Avastin. Based on her work at Genentech, Cori is also recognized as a pioneer in the development of monoclonal antibody therapeutics and has co-authored 6 INDs. An experienced entrepreneur, Cori has worked in all aspects of start-up company, including raising capital, strategic planning, recruiting scientists, and developing infrastructure. Her contributions were key to enabling Valentis, a gene therapy company, to proceed to a successful IPO. Dr. Gorman has a strong publication and presentation record and is an inventor on several issued patents in the fields of gene expression and delivery and gene therapy. Dr. Gorman is also experienced in business development having closed eighteen corporate partnerships for clients over a two-year period. Early in her career Dr. Gorman was a recipient of several fellowships from the American Cancer Society, the National Cancer Institute, the European Molecular Biology Organization and NATO. She has be recognized for her teaching excellence and has been an recurring invited lecturer at the University Colorado Health Sciences educating physicians in molecular aspects of disease as well as a guest lecturer in the biotechnology program at Yale. Cori is recognized by citation index as one of the most highly cited authors in the past two decades, with over 10,000 citations.