Scientific Accomplishments

Detailed below are scientific accomplishments in the five programmatic themes including these six top highlights:

• Dr. Blackburn has revolutionized our thinking on genome stability by recognizing that chromosome end telomeric dysfunction results in carcinogenesis. Dr. Blackburn was the recipient of the 2009 Nobel Prize in Medicine for her work on telomere function. Her work currently exploits the disruption of telomeric function as a means to inhibit proliferation in breast cancer.
• Dr. John Park and colleagues continue to move their innovative combinations of antibody targeting and nanoparticle drugs into the clinic. The anti-HER2 doxorubicin-containing immunoliposome agent, developed at UCSF, has been licensed to Merrimack Pharmaceuticals; pre-clinical development has been completed and the multicenter phase I clinical trial is accruing patients.
• The investigator initiated companion diagnostic I-SPY II TRIAL (PIs and Drs. Esserman, and Don Berry, MD Anderson; Biomarker Chair, Dr. van ‘t Veer; Imaging Chair, Dr. Hylton) is the first trial to obtain confirmation from the FDA Center for Drug Evaluation and Research that the neoadjuvant pathological Complete Remission signal can serve as endpoint for accelerated approval of oncology agents.
• Molecular signatures developed by Program investigators are integrated in the I-SPYII TRIAL process to define patient’s eligibility for randomization, and to establish qualification under CLIA rigor to allow obtaining the FDA Investigational Device Exempt status (MammaPrint-70 gene prognosis signature, Dr. van ‘t Veer; Cell line-derived predictors, among others for HER2 and PARP-inhibition targeted drugs, Dr. Gray; MYC-network dependent CDK inhibition, Dr. Goga).
• Studies from the San Francisco Mammography Registry (SFMR) led by Dr. Kerlikowske, including mammograms, demographic and risk factor information for over one million patients, have established breast density as a risk factor for invasive breast cancer; in particular after an earlier diagnosis of ductal carcinoma in situ (DCIS). In addition, Kerlikowske and co-workers confirmed, in an unparalleled large cohort of over two million screening mammography examinations of SFMR and the Breast Cancer Surveillance Consortium, that the precipitous decrease in hormone therapy use led to a significant decrease in incidence of invasive and DCIS breast cancer.
• The Applied Genomics Laboratory (Dr. van ‘t Veer) obtained a College of American Pathologists (CAP) registration number (#8008120-01) and anticipates to start clinical testing by the end of 2011, and to have completed the CLIA/CAP accreditation process early 2012 (CLIA: Clinical Laboratory Improvement Amendments ’88).