Masthead
(Source: Seminars in Oncology)
Source: Seminars in Oncology - July 31, 2016 Category: Cancer & Oncology Source Type: research
Editorial Board
(Source: Seminars in Oncology)
Source: Seminars in Oncology - July 31, 2016 Category: Cancer & Oncology Source Type: research
Table of Contents
(Source: Seminars in Oncology)
Source: Seminars in Oncology - July 31, 2016 Category: Cancer & Oncology Source Type: research
Theory and Practice of Clinical Pharmacodynamics in Oncology Drug Development
The discovery that biochemical abnormalities in signaling pathways are the cause of human malignancies led to the concept, design, and development of “targeted agents” —drugs designed and developed for specific control of the molecular defect responsible for the abnormal signaling. In cancers in which somatic mutations create abnormal dependencies upon signaling pathways for survival (e.g., “oncogene addiction” [1,2] and “network-atta cking mutations” [3]), abnormal molecular signaling provides a tumor-specific target not found (or needed) in healthy tissues, and therefore the therapeutic index of targeted th...
Source: Seminars in Oncology - July 26, 2016 Category: Cancer & Oncology Authors: Ralph E. Parchment, James H. Doroshow Source Type: research
Pharmacodynamic Endpoints as Clinical Trial Objectives to Answer Important Questions in Oncology Drug Development
Since the earliest days of oncology drug development, mechanism of action (MOA) has served as a guiding principle for: (i) selecting experimental agents with novel MOAs to advance into clinical trials, (ii) setting dose schedules of investigational agents, (iii) selecting patients who enrich early clinical trial populations with potential responders, and (iv) combining drugs with non-cross-resistant MOAs to generate new regimens. The use of pharmacodynamics (PD) during clinical drug development primarily involves the strategy and timing of using MOA knowledge to complement, but not supplant, clinical information in decisio...
Source: Seminars in Oncology - July 26, 2016 Category: Cancer & Oncology Authors: Ralph E. Parchment, James H. Doroshow Source Type: research
WITHDRAWN: Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community
Available online 16 June 2016 (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 15, 2016 Category: Cancer & Oncology Authors: Katherine V. Ferry-Galow, Yvonne A. Evrard, Ralph E. Parchment, Joseph E. Tomaszewski Source Type: research
WITHDRAWN: Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community
This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 15, 2016 Category: Cancer & Oncology Authors: Katherine V. Ferry-Galow, Yvonne A. Evrard, Ralph E. Parchment, Joseph E. Tomaszewski Source Type: research
Immuno-pharmacodynamics for evaluating mechanism of action and developing immunotherapy combinations
Immunotherapy has become a major modality of cancer treatment, with multiple new classes of immunotherapeutics recently entering the clinic and obtaining market approval from regulatory agencies. While the promise of these therapies is great, so is the number of possible combinations not only with each other but also with small molecule therapeutics. Furthermore, the observation of unusual dose-response relationships suggests a critical dependency of drug effectiveness on the dosage regimen (dose and schedule). (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Ralph E. Parchment, Andrea Regier Voth, James H. Doroshow, Jay A. Berzofsky Source Type: research
TEMPORARY REMOVAL: Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community
The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy. (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Katherine V. Ferry-Galow, Yvonne A. Evrard, Ralph E. Parchment, Joseph E. Tomaszewski Source Type: research
Immuno-pharmacodynamics for evaluating mechanism of action and developing immunotherapy combinations
Immunotherapy has become a major modality of cancer treatment, with multiple new classes of immunotherapeutics recently entering the clinic and obtaining market approval from regulatory agencies. While the promise of these therapies is great, so is the number of possible combinations not only with each other but also with small molecule therapeutics. Furthermore, the observation of unusual dose-response relationships suggests a critical dependency of drug effectiveness on the dosage regimen (dose and schedule). (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Ralph E. Parchment, Andrea Regier Voth, James H. Doroshow, Jay A. Berzofsky Source Type: research
TEMPORARY REMOVAL: Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community
The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy. (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Katherine V. Ferry-Galow, Yvonne A. Evrard, Ralph E. Parchment, Joseph E. Tomaszewski Source Type: research
Immuno-Pharmacodynamics (Immuno-PD) for Evaluating Mechanism of Action and Developing Immunotherapy Combinations
Immunotherapy has become a major modality of cancer treatment, with multiple new classes of immunotherapeutics recently entering the clinic and obtaining market approval from regulatory agencies. While the promise of these therapies is great, so is the number of possible combinations not only with each other but also with small molecule therapeutics. Furthermore, the observation of unusual dose-response relationships suggests a critical dependency of effectiveness on the dosage regimen (dose and schedule). (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Ralph E. Parchment, Andrea Regier Voth, James H. Doroshow, Jay A. Berzofsky Source Type: research
Strategic Considerations for Achieving Consistent Performance of Transferred Assays in the Research Community
One of the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) major activities is to develop robust, validated pharmacodynamic (PD) assays. These assays allow accurate information about drug effect on intended molecular targets to be obtained in preclinical and first-in-human clinical trials to inform early go/no‐go decisions for new drug development and to identify combinations of targeted agents. In the course of these efforts, DCTD has defined the progression of an assay’s lifecycle including analytical performance validation, fitness-for‐purpose, and establishment of assay companion S...
Source: Seminars in Oncology - June 14, 2016 Category: Cancer & Oncology Authors: Katherine V. Ferry-Galow, Yvonne A. Evrard, Ralph E. Parchment, Joseph E. Tomaszewski Source Type: research
Translating pharmacodynamic biomarkers from bench to bedside: analytical validation and fit-for-purpose studies to qualify multiplex immunofluorescent assays for use on clinical core biopsy specimens
Multiplex pharmacodynamic (PD) assays have the potential to increase sensitivity of biomarker-based reporting for new targeted agents, as well as revealing significantly more information about target and pathway activation than single-biomarker PD assays. Stringent methodology is required to ensure reliable and reproducible results. Common to all PD assays is the importance of reagent validation, assay and instrument calibration, and the determination of suitable response calibrators; however, multiplex assays, particularly those performed on paraffin specimens from tissue blocks, bring format-specific challenges adding a ...
Source: Seminars in Oncology - June 13, 2016 Category: Cancer & Oncology Authors: Allison Marrero, Scott Lawrence, Deborah Wilsker, Andrea Regier Voth, Robert J. Kinders Source Type: research
Promise and limits of the CellSearch platform for evaluating pharmacodynamics in circulating tumor cells
We present representative data from three clinical trials with the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib (ABT-888) suggesting that CTCs can be used to measure PD effects. (Source: Seminars in Oncology)
Source: Seminars in Oncology - June 13, 2016 Category: Cancer & Oncology Authors: Lihua Wang, Priya Balasubramanian, Alice P. Chen, Shivaani Kummar, Yvonne A. Evrard, Robert J. Kinders Source Type: research
