Dctd Programs and Initiatives (2013-2017) Biometric Research Program 46
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DIVISION OF CANCER TREATMENT AND DIAGNOSIS PROGRAMS AND INITIATIVES (2013-2017) U.S. Department of Health & Human Services | National Institutes of Health NATIONAL CANCER INSTITUTE DIVISION OF CANCER TREATMENT AND DIAGNOSIS PROGRAMS AND INITIATIVES (2013-2017) U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH TABLE OF CONTENTS ACRONYMS VIII LIST OF TABLES XIII LIST OF FIGURES XIV PREFACE XVI OVERVIEW 1 MAJOR INITIATIVES SUPPORTING THE CANCER COMMUNITY 4 Current Research Emphasis 5 Future Research Emphasis 5 Mechanisms of Cancer Drug Resistance and Sensitivity 5 Development of Improved Patient-Derived Models to Enhance Early Phase Clinical Trials 5 Development of Cancer Immunotherapy Biomarkers 5 New Cancer Immunotherapy Model Systems 5 Understanding the Microenvironment of Pancreatic Cancer to Enhance Immunotherapeutic Options 5 Current Programs and Initiatives 6 NCI’s Precision Medicine Trials 6 Precision Medicine Initiative (PMI) – Oncology Supplements 11 NCI National Clinical Trials Network (NCTN) 12 NCI Experimental Therapeutics Clinical Trials Network (ETCTN) 18 Specialized Programs of Research Excellence (SPORE) 23 NCI Experimental Therapeutics (NExT) Program 24 NCI Patient-Derived Models Repository (PDMR) Program 31 Pharmacodynamic Assay Development and Implementation Section (PADIS) 32 The Cancer Imaging Archive (TCIA) 35 Innovative Molecular Analysis Technologies (IMAT) 37 The Cancer Immunotherapy Trials Network (CITN) 38 Childhood Cancer Survivor Study (CCSS) 38 NCI Developmental Therapeutics Clinic (DTC) 39 NCI Program for Natural Products Discovery (NPNPD) 41 NCI Formulary 42 Exploring the Horizon 42 NCI Exceptional Responders Initiative 43 Provocative Question Initiative 44 Recalcitrant Cancer Research Act of 2012 44 NCI R21 Program: Translational and Clinical Exploratory Research 45 II DCTD PROGRAMS AND INITIATIVES (2013-2017) BIOMETRIC RESEARCH PROGRAM 46 Overview 47 Structure and Function 47 Biostatistics Branch 47 Computational and Systems Biology Branch 50 Future Directions 51 CANCER DIAGNOSIS PROGRAM 52 Overview 53 Structure and Function 56 Biorepositories and Biospecimen Research Branch 57 Diagnostic Biomarkers and Technology Branch 58 Diagnostics Evaluation Branch 58 The Pathology Investigation and Resources Branch 59 CDP Grants Overview 60 Assistance to the Cancer Community 61 Molecular Characterization Laboratory (MoCha) 61 Program for the Assessment of Clinical Cancer Tests (PACCT) 61 Strategic Partnerships to Evaluate Cancer Signatures (SPECS) 62 Biomarker Evaluation in NCI Cancer Therapy Trials 63 REMARK and the EORTC-NCI Cancer Molecular Markers Collaborations 63 Clinical Assay Standardization 64 Biospecimen Access for the Cancer Research Community 65 NIH Genotype Tissue Expression (GTEx) Program 66 Biospecimen Research Network (BRN) 67 Tools and Guidance for Biobanking 67 Pathology Evaluation of Tissue Specimens for Research 68 Future Directions 69 Biomarker Support for Immunotherapy 69 Preclinical and Clinical Molecular Characterization for Developmental Therapeutics 69 Circulating Tumor Nucleic Acids 70 Bioethics and Science in Biobanking 70 DIVISION OF CANCER TREATMENT AND DIAGNOSIS III CANCER IMAGING PROGRAM 72 Overview 73 Structure and Function 76 Molecular Imaging Branch 77 Clinical Trials Branch 77 Image-Guided Intervention Branch 77 Imaging Technology Development Branch 78 Nanodelivery Systems and Devices Branch 78 CIP Grants Overview 78 Assistance to the Cancer Community 79 Specialized Initiatives 79 Imaging Informatics 81 In Vivo Cellular and Molecular Imaging Centers 81 Molecular Imaging Clinic 82 Synthesis of Agents 83 Molecular Imaging Radiopharmaceutical Resources 84 Clinical Trials 84 Quantitative Imaging Network (QIN) for the Measurement of Therapy Response 91 Ongoing Strategies in Imaging – National Strategic Plans, Initiatives, & Roadmaps 94 Specialized Workshops 96 Future Directions 97 CANCER THERAPY EVALUATION PROGRAM 98 Overview 99 Structure and Function 99 Investigational Drug Branch 100 Clinical Investigations Branch 101 Clinical Grants and Contracts Branch 101 Regulatory Affairs Branch 102 Pharmaceutical Management Branch 103 Clinical Trials Monitoring Branch 103 Clinical Trials Operations and Informatics Branch 104 CTEP Grants Overview 104 IV DCTD PROGRAMS AND INITIATIVES (2013-2017) Assistance to the Cancer Community 104 CTEP-Sponsored Phase 2 Trials Leading to Pivotal Trials 104 Fostering Career Development of Junior Clinical Investigators 105 Clinical Trials Program 105 Future Directions 124 DEVELOPMENTAL THERAPEUTICS PROGRAM 126 Overview 127 Structure and Function 127 Office of the Associate Director 127 Preclinical Therapeutics Grants Branch 128 Molecular Pharmacology Branch 128 Biological Testing Branch 129 Drug Synthesis and Chemistry Branch 131 Natural Products Branch 131 Biological Resources Branch 131 Toxicology and Pharmacology Branch 132 Pharmaceutical Resources Branch 132 Information Technology Branch 132 DTP Grants Overview 132 Assistance to the Cancer Research Community 134 NCI-60 Cell Line Screen 134 In vivo Model Development and Testing 134 Tumors, Cells, Cell Lines, and Mice 134 Collection and Distribution of Synthetic Compounds 134 Acquisition of Small-Molecule Oncology Agents 135 Laboratory of Synthetic Chemistry 136 Natural Products Repository 136 cGMP Manufacturing and Formulation 138 Investigative Toxicology Laboratory 139 The Biopharmaceutical Development Program 140 BRB Preclinical Repository 143 IT Enhancements Facilitating Interactions with the Research Community 144 Future Directions 145 DIVISION OF CANCER TREATMENT AND DIAGNOSIS V RADIATION RESEARCH PROGRAM 146 Overview 147 Structure and Function 147 Radiotherapy Development Branch 149 Clinical Radiation Oncology Branch 149 Molecular Radiation Therapeutics 150 RRP Grants Overview 151 Assistance to the Cancer Research Community 152 Imaging and Radiation Oncology Core (IROC) 152 Radiobiology Bioterrorism Research and Training Group 153 Workshop on Utilizing the Biological Consequences of Radiation Therapy in the Development of New Treatment Approaches 153 Future Directions 154 TRANSLATIONAL RESEARCH PROGRAM 156 Overview 157 TRP Mission 157 TRP Grants Overview 158 Organized SPORE Workshops 159 Brain SPORE Workshops (2013-2017) 159 Gastrointestinal (GI) and Pancreas workshops (2013-2017) 159 Skin SPORE Workshops (2013-2017) 160 Lung Cancer SPORE Workshops (2013-2017) 160 Prostate and Genitourinary (GU) SPORE Workshops (2103-2014) 161 Leukemia Inter-SPORE Meeting (2014) 162 Head and Neck Cancer SPORE Workshop (2014) 162 Hematologic Malignancies SPORE Workshop (2015) 162 Translational Research in Ovarian and Gynecologic Cancers Workshop (2016) 162 Translational Science in Prostate Cancer Workshop (2016) 162 Head and Neck/Thyroid Cancer SPORE Workshop (2017) 163 Future Directions 163 VI DCTD PROGRAMS AND INITIATIVES (2013-2017) OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE 164 Overview 165 Mission 165 OCCAM Grants Overview 166 Assistance to the Scientific Community 167 Herbal Mixture Program Project Grant 167 NCI Best Case Series Program 167 Patient Education Resource 167 Conferences 168 Training 170 Research Resources 170 Collaborations 170 Future Directions 172 2017 DCTD STAFF ROSTER 174 Office of the Division Director 175 Biometric Research Program 177 Cancer Diagnosis Program 178 Cancer Imaging Program 179 Cancer Therapy Evaluation Program 181 Developmental Therapeutics Program 184 Radiation Research Program 187 Translational Research Program 188 Office of Cancer Complementary and Alternative Medicine 189 DCTD STAFF PUBLICATIONS 190 2013 191 2014 196 2015 203 2016 210 2017 216 DIVISION OF CANCER TREATMENT AND DIAGNOSIS VII ACRONYMS AACR – American Association for Cancer Research BRD – Biospecimen Research Database AAPM – American Association for Physicists in Medicine BRISQ – Biospecimen Reporting for Improved ABTC – Adult Brain Tumor Consortium Study Quality ACG – Agreement Coordination Group BRMs – biological response modifiers ACR – American College of Radiology BRN – Biospecimen Research Network ACRIN – American College of Radiology BRP – Biometric Research Program Imaging Network BTB – Biological Testing Branch ACT – NCTN Accrual Core Team ADCC – antibody directed cellular cytotoxicity caAERS – cancer adverse event reporting system ADME – absorption, distribution, metabolism, CADP – Clinical Assay Development Program and excretion caDSR – NCI Cancer Data Standards Registry and ADTTP – Advanced Development Therapeutics Repository Training Program caHUB – NCI Cancer Human Biobank AERS – Adverse Event Reporting System CALGB – Cancer and Leukemia Group B AFRRI – The Department of Defense Armed Forces CAM – complementary and alternative medicine Radiobiology and Research Institute CAP – Corrective Action Plan AHRQ – Agency for Healthcare Research and Quality CBC – Chemical Biology Consortium ALCHEMIST – Adjuvant Lung Cancer Enrichment CBCTR – NCI Cooperative Breast Cancer Tissue Resource Marker Identification and Sequencing Trial CBIIT – NCI Center for Biomedical Informatics and ALL – acute lymphoblastic leukemia Information Technology allo HCT – allogenic hematopoietic cell transplantation CCCT – NCI Director’s Coordinating Center for AML – acute myeloid leukemia Clinical Trials APEC – Asia Pacific Economical Collaboration CCOP – Community Clinical Oncology Program ARRA – American Recovery and Reinvestment Act CCR – Center for Cancer Research of 2009 CCSS – Childhood Cancer Survivor Study ASCO – American Society of Clinical Oncology CCTG – Canadian Cancer