Michael Burczynski - Collegeville PA, US Andrew Dorner - Lexington MA, US Natalie Twine - Goffstown NH, US William Trepicchio - Andover MA, US Donna Slonim - North Andover MA, US Andrew Strahs - Maynard MA, US Frederick Immermann - Suffern NY, US
Assignee:
Wyeth - Madison NJ
International Classification:
C12Q 1/68 G06F 19/00
US Classification:
435006000, 702020000
Abstract:
The present invention provides methods, systems and equipment for the prognosis and treatment of renal cell carcinoma (RCC) or other solid tumors. Genes prognostic of clinical outcomes of a solid tumor can be identified according to the present invention. The expression profiles of these genes in peripheral blood mononuclear cells (PBMCs) of patients who have the solid tumor are correlated with clinical outcome of these patients. Examples of RCC prognosis genes are illustrated in Tables 2 and 3. These genes can be used as surrogate markers for predicting clinical outcome of an RCC patient of interest. These genes can also be used for the selection of a favorable treatment for an RCC patient of interest.
Methods For Prognosis And Treatment Of Solid Tumors
Michael Burczynski - Swampscott MA, US Natalie Twine - Goffstown NH, US William Trepicchio - Andover MA, US Andrew Strahs - Maynard MA, US Fred Immermann - Suffern NY, US Donna Slonim - North Andover MA, US Andrew Dorner - Lexington MA, US
International Classification:
C12Q 1/68 G01N 33/574
US Classification:
435006000, 435007230
Abstract:
Solid tumor prognosis genes, and methods, systems and equipment of using these genes for the prognosis and treatment of solid tumors. Prognosis genes for a solid tumor can be identified by the present invention. The expression profiles of these genes in peripheral blood mononuclear cells (PBMCs) are correlated with clinical outcome of the solid tumor. The prognosis genes of the present invention can be used as surrogate markers for predicting clinical outcome of a solid tumor in a patient of interest. These genes can also be used to select a treatment which has a favorable prognosis for the solid tumor of the patient of interest.
Expression Profiles Of Peripheral Blood Mononuclear Cells For Inflammatory Bowel Diseases
Michael Burczynski - Collegeville PA, US Ron Peterson - North Chelmsford MA, US Natalie Twine - Goffstown NH, US Andrew Strahs - Maynard MA, US Frederick Immermann - Suffern NY, US Ullrich Schwertschlag - Beverly Farms MA, US Monette Cotreau - Acton MA, US Andrew Dorner - Lexington MA, US
International Classification:
C12Q 1/68 C12P 19/34
US Classification:
435006000, 435091200
Abstract:
The present invention is directed to the identification of PBMC- and IBD-associated biomarkers that may be used to diagnose inflammatory bowel disease, and optionally, distinguish between PBMCs isolated from a patient with Crohn's disease and PBMCs isolated from a patient with ulcerative colitis. The present invention is further directed to methods of screening, including high throughput methods of screening, for regulatory agents capable of regulating the activity of PBMC- and IBD-associated biomarkers. Provided are compositions of PBMC- and IBD-associated biomarkers, including regulatory agents of at least one PBMC- and IBD-associated biomarker for methods of diagnosis, prognosis, therapeutic intervention and prevention of an inflammatory bowel disease, e.g., Crohn's disease and ulcerative colitis. Moreover, the present invention is also directed to methods that can be used to assess the efficacy of test compounds and therapies in the treatment inflammatory bowel disease, i.e., Crohn's disease or ulcerative colitis.
Methods For Prognosis And Treatment Of Solid Tumors
Michael Burczynski - Swampscott MA, US Natalie Twine - Goffstown NH, US William Trepicchio - Andover MA, US Andrew Strahs - Maynard MA, US Fred Immermann - Suffern NY, US Donna Slonim - North Andover MA, US Andrew Dorner - Lexington MA, US
Assignee:
Wyeth - Madison NJ
International Classification:
C12Q 1/68 C40B 40/08 C40B 40/10 G06G 7/48
US Classification:
435006000, 506017000, 506018000, 703011000
Abstract:
Solid tumor prognosis genes, and methods, systems and equipment of using these genes for the prognosis and treatment of solid tumors. Prognosis genes for a solid tumor can be identified by the present invention. The expression profiles of these genes in peripheral blood mononuclear cells (PBMCs) are correlated with clinical outcome of the solid tumor. The prognosis genes of the present invention can be used as surrogate markers for predicting clinical outcome of a solid tumor in a patient of interest. These genes can also be used to select a treatment which has a favorable prognosis for the solid tumor of the patient of interest.
Pharmacogenomic Markers For Prognosis Of Solid Tumors
Michael Edward Burczynski - Collegeville PA, US Frederick William Immermann - Suffern NY, US Andrew Louis Strahs - Maynard MA, US Natalie Constance Twine - Goffstown NH, US Donna Karen Slonim - North Andover MA, US William Liapord Trepicchio - Andover MA, US Andrew Joseph Dorner - Lexington MA, US
Assignee:
Wyeth - Madison NJ
International Classification:
C12Q 1/68
US Classification:
435 6
Abstract:
The present invention provides methods, systems and equipment for prognosis or evaluation of treatment of solid tumors. Gene markers that are prognostic of solid tumors can be identified according to the present invention. Each gene marker has altered expression patterns in PBMCs of solid tumor patients following initiation of an anti-cancer treatment, and the magnitudes of these alterations are correlated with clinical outcomes of these patients. In one embodiment, a Cox proportional hazards model is used to determine the correlations between clinical outcomes of RCC patients and gene expression changes in PBMCs of these patients during the course of a CCI-779 treatment. Non-limiting examples of genes identified by the Cox model are depicted in Tables 4A3 4B, 5 A and 5B. These genes can be used as surrogate markers for prognosis of RCC. They can also be used as pharmacogenomic indicators for the efficacy of CCI-779 or other anti-cancer drugs.
Cut-Point In Pten Protein Expression That Accurately Identifies Tumors And Is Predictive Of Drug Response To A Pan-Erbb Inhibitor
Christina Marie Coughlin - Berwyn PA, US Jay Marshall Feingold - Wynnewood PA, US Daniel Steven Johnston - Trappe PA, US Anna Berkenblit - Needham MA, US Andrew Louis Strahs - Maynard MA, US Charles Michael Zacharchuk - Westford MA, US
A cut-point in the quantitative measurement of PTEN protein expression that accurately identifies tumors with two inactivated alleles of the PTEN gene. Patients with a normalized PTEN score of PTEN null will be treated with a pan-ErbB tyrosine kinase inhibitor. A normalized PTEN protein expression score is obtained by comparing the tumor PTEN OD expression value with the non-malignant PTEN OD expression value.
Anna Berkenblit - Cambridge MA, US Christina Marie Coughlin - Berwyn PA, US Jay Marshall Feingold - Livingston NJ, US Daniel Stephen Johnston - Collegeville PA, US Andrew Louis Strahs - Maynard MA, US Charles Michael Zacharchuk - Cambridge MA, US
International Classification:
A61K 39/395 A61K 45/06 A61K 31/4709
US Classification:
4241451, 435 612, 435 614, 506 9, 514313
Abstract:
Methods for treating breast cancer, specifically cancers resistant to treatment with one or more known breast cancer treatment drugs, and related patient selection strategies for predicting patient response to drug therapy, such strategies including detecting the presence or absence in a patient of one or more of PIK3CA gene amplification, a mutation in PIK3CA, and a decrease in PTEN protein expression, and treating a patient positive for the presence of one or more of same by administering to the subject a pan-ErbB tyrosine kinase inhibitor.
- New York NY, US Christina Marie Coughlin - Berwyn PA, US Jay Marshall Feingold - Wynnewood PA, US Daniel Stephen Johnston - Trappe PA, US Andrew Louis Strahs - Maynard MA, US Charles Michael Zacharchuk - Cambridge MA, US
Methods for treating breast cancer, specifically cancers resistant to treatment with one or more known breast cancer treatment drugs, and related patient selection strategies for predicting patient response to drug therapy, such strategies including detecting the presence or absence in a patient of one or more of PIK3CA gene amplification, a mutation in PIK3CA, and a decrease in PTEN protein expression, and treating a patient positive for the presence of one or more of same by administering to the subject a pan-ErbB tyrosine kinase inhibitor.
Resumes
Vice President, Biostatistics, Statistical Programming And Data Management
Clementia Pharmaceuticals Inc.
Vice President, Biostatistics, Statistical Programming and Data Management
Alnylam Pharmaceuticals Aug 1, 2013 - May 2018
Senior Director, Head of Biometrics
Aveo Oncology Jul 2010 - Aug 2013
Senior Director, Head of Biometrics
Pfizer Aug 2002 - Jul 2010
Director
Pfizer 2002 - 2009
Director, Oncology Biostatistics
Education:
University of Chicago 1996 - 2001
Doctorates, Doctor of Philosophy, Statistics
University of Pennsylvania 1992 - 1996
Bachelors, Bachelor of Arts, Economics
Department of Sociology, Lse 1994 - 1995
Department of Sociology, Lse 1985 - 1988
Department of Sociology, Lse 1975 - 1976
Skills:
Biostatistics Oncology Clinical Development Clinical Trials Pharmaceutical Industry Drug Development Biotechnology Clinical Research Cro Regulatory Submissions Gcp Drug Discovery Fda Ctms Immunology Biopharmaceuticals Infectious Diseases Regulatory Affairs Validation Sas 21 Cfr Part 11 Biomarkers Gmp Pharmacology Medical Writing Data Management Vaccines Technology Transfer Pharmacovigilance Medical Devices Lifesciences Sop Pharmaceutics
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