Reena Philip

发表

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models

Kevin C. Dorff, Aaron M. Smalter, Stephen C. Harris, 2010, Nature Biotechnology.

Distinguishing lung tumours from normal lung based on a small set of genes.

W. Xiao, J. Jen, Ping Yang, 2007, Lung cancer.

FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Jiang Liu, Jielin Sun, Reena Philip, 2021, Clinical Cancer Research.

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Reena Philip, K. Goldberg, R. Pazdur, 2020, Clinical Cancer Research.

FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Jiang Liu, Reena Philip, R. Pazdur, 2020, Clinical Cancer Research.

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Liang Zhao, Hui Zhang, Richard Pazdur, 2015, Clinical Cancer Research.

Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective.

Reena Philip, Janaki Veeraraghavan, You Li, 2020, Methods in molecular biology.

Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.

Christopher R Kinsinger, Mehdi Mesri, Henry Rodriguez, 2010, Clinical chemistry.

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2020, Clinical Cancer Research.

State of the Science and Future Directions for Liquid Biopsies in Drug Development.

Reena Philip, G. Kelloff, P. M. Williams, 2020, The oncologist.

FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1

Jiang Liu, Reena Philip, K. Goldberg, 2020, Clinical Cancer Research.

Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non–Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors

G. Rosner, A. Chaudhuri, G. Pennello, 2022, JCO precision oncology.

FDA perspectives on pharmacogenetic testing

Reena Philip, M. Robinowitz, S. Gutman, 2005, Expert review of molecular diagnostics.

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease

A. Schetter, Reena Philip, R. Pazdur, 2018, Clinical Cancer Research.

Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases

P. Febbo, R. Grossman, H. Tseng, 2020, Clinical pharmacology and therapeutics.

Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, US Food and Drug Administration Public Workshop-Workshop Proceedings.

Reena Philip, E. Litwack, G. Blumenthal, 2019, JCO precision oncology.

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations

Reena Philip, K. Goldberg, P. Keegan, 2018, The oncologist.

U.S. FDA Drug Approvals for Breast Cancer - A Decade in Review.

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals

Reena Philip, Y. Hu, Donna Roscoe, 2015, Expert review of molecular diagnostics.

Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit.

J. Taube, M. Oberley, R. Herbst, 2022, JCO precision oncology.

FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden–High Solid Tumors

Reena Philip, L. Fashoyin-Aje, Martha Donoghue, 2021, Clinical Cancer Research.

Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development

J. Fuscoe, T. Han, Z. Tezak, 2012, BMC Genomics.

Regulatory implications of ctDNA in immuno-oncology for solid tumors

Reena Philip, R. Pazdur, Shenghui Tang, 2023, Journal for ImmunoTherapy of Cancer.

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation–Associated Advanced Ovarian Cancer

S. J. Schrieber, Chao Liu, Richard Pazdur, 2017, Clinical Cancer Research.

FDA Approval Summary: Olaparib monotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2020, The oncologist.

Neoadjuvant Breast Cancer Trials: Translational Research in Drug Development

Reena Philip, L. Amiri-Kordestani, P. Cortazar, 2015, Current Breast Cancer Reports.

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

Anuradha Ramamoorthy, Richard Pazdur, Kaushalkumar Dave, 2018, Clinical Cancer Research.

FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation

Reena Philip, Martha Donoghue, K. Goldberg, 2017, The oncologist.

US FDA perspective on challenges in co-developing in vitro companion diagnostics and targeted cancer therapeutics.

Reena Philip, M. Chan, Lea Carrington, 2011, Bioanalysis.

Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.

Christopher R Kinsinger, Mehdi Mesri, Henry Rodriguez, 2010, Clinical chemistry.

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Jiang Liu, Reena Philip, K. Goldberg, 2021, Clinical Cancer Research.

FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Jiang Liu, Reena Philip, Martha Donoghue, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Richard Pazdur, Reena Philip, Reena Philip, 2016, Clinical Cancer Research.

U.S. FDA Drug Approvals for Gynecological Malignancies - A Decade in Review.

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Amivantamab for the Treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.

Jiang Liu, Jielin Sun, Reena Philip, 2023, Clinical cancer research : an official journal of the American Association for Cancer Research.

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models

Todd H. Stokes, Kevin C. Dorff, Aaron M. Smalter, 2010, Nature Biotechnology.