index [] 21st century nanotechnology research and development act of 2003 1178 35 usc 101 103–104...
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Index
21st Century Nanotechnology Research and Development Act of 2003 1178
35 USC §101 103–10435 USC 271(e) 73, 75510(k) Premarket Notification
65–66
Aβ-derived diffusible ligands (ADDL) 1258Abbreviated New Drug
Application (ANDA) 413, 455, 1291, 1313
Abelcet 361, 424Abraxane 359, 422academia 126–127, 134,
277, 368, 414–415, 442, 453, 997–1000, 1002, 1009, 1291, 1293, 1299, 1301–1302, 1306–1307, 1309–1311, 1313, 1315, 1338–1340
academia-industry partnerships 997
Academic Drug Discovery Consortium (ADDC) 1291, 1310
Adagen 361, 424Adcetris 364, 427adeno-associated viral (AAV)
gene therapy 1239Administrative Procedures Act
(APA) 1180
adsorption 339, 374, 454, 583, 592, 633, 749–750, 752–753, 762, 812, 816–817, 889, 915, 1336
adsorption distribution, metabolism and excretion (ADME) 339, 374, 419, 454, 574, 580, 1229, 1336
aerosol generation 621African Medicines Regulatory
Harmonization initiative (AMRH) 97
African Society for Laboratory Medicine (ASLM) 97–98
age-related macular degeneration (AMD) 360, 363, 423, 426, 1022, 1245
agglomeration 309, 572, 579–580, 585, 593, 602, 622, 873, 877, 879, 882, 884, 887–888, 890
aggressive strategy 45, 49–50agreement 123–133air exposure 621air–liquid interface (ALI) 634Alimta 366allergy 583, 845, 851–853, 855alternative fee arrangement 119alveolus 776Alzheimer’s disease 934, 947,
949, 1016, 1021, 1253, 1258, 1323, 1387
AmBisome (AmBi) 359, 422, 1255
1418 Index
America Invents Act (AIA) 3, 6, 12–13, 43, 56, 119, 173, 1175, 1181
American Cancer Society 280, 1351
American Chemistry Council (ACC) 673
American Intellectual Property Law Association (AIPLA) 115–116
American Society for Nanomedicine (ASNM) 1192, 1213, 1253–1254, 1261
amorphous silica nanoparticles (SiNPs) 750–751, 943
Amphotec 345, 362, 425, 851, 1226
amyloid-β (Aβ) 1258amyotrophic lateral sclerosis
(ALS) 1253, 1258, 1260anaphylactoid reactions 845anaphylatoxins 845, 849,
855–856, 858–861, 863ancien régime 545–547,
558–560ancillary medicinal substances
485–486, 492–496André Nel 1191–1192anemia 363–364, 426–427,
1163antibacterial 589–590, 699,
705, 721, 883, 1179, 1193, 1197
antibodies 91, 346, 358, 413, 420–421, 851, 854, 859, 908, 933, 1022, 1255–1256, 1258, 1260, 1292, 1298, 1312, 1352, 1354, 1358, 1365–1367, 1373
anticancer nanomedicine 1081, 1083
antimicrobial 387, 509, 515–517, 520, 522, 589–590, 905, 911, 914, 1108, 1180, 1197, 1201, 1294
antimicrobial pesticide 515antiretroviral therapy (ART)
1191, 1198–1202, 1205, 1207, 1209, 1212–1213, 1253, 1256
apoptosis 581, 772, 880, 903, 906, 908–909, 911–913, 915–917, 920–921, 944, 949, 1247, 1363
appropriate controls 719, 888, 1309
aptamers 358, 421, 772, 1245, 1247, 1298, 1358, 1366, 1373
area under the curve (AUC) 1223, 1226
artificial intelligence 961, 992, 1061, 1152–1153
asbestos 386, 553, 572, 580–581, 663, 880, 885, 1132
Asian Harmonization Working Party (AHWP) 96–97
assay in vitro 719, 920 in vivo 719ASSURED 88 astrocytes 582, 931, 934,
940–942, 944, 947, 1019astrocytoma 939–940, 942atom relay switch 961, 972AU-NEPAD Agency regulatory
harmonization programme 97
autoimmunity 1281, 1283Avinza 365, 428axiology 1057, 1065, 1129
1419Index
Basel Convention 665basic science 550, 1002, 1292,
1299, 1301–1303, 1305, 1307, 1318
Bawa Biotech LLC 339, 405, 413, 437, 661, 1192, 1223, 1254, 1291
Bayh-Dole Act 3, 5, 123, 129, 134–135, 141, 150–152, 413, 440, 1292
beachhead applications 223bench-to-bedside 1001, 1006,
1292, 1324Benjamin Franklin 126best practices 98, 178, 405–406,
702, 1008, 1332–1333, 1413, 1415
binding affinities 745, 752–754bioavailability 308, 310, 339,
344, 350, 453, 572, 609, 690, 1035, 1085, 1150, 1202, 1208, 1214, 1223, 1225, 1229, 1246, 1362, 1373
biobarriers 1347, 1355, 1357–1358, 1360
biocompatibility 310, 374, 418–419, 438, 454, 589–591, 602, 764, 809–810, 875, 879, 882, 884, 903, 907, 1019, 1241, 1336, 1381, 1391
biodistribution 339, 374–375, 438, 452–456, 602, 770, 878, 886, 890, 903, 915, 1032, 1163–1165, 1194, 1197, 1206, 1228, 1256, 1336, 1392
bioequivalence 413, 431, 441, 444, 452, 1322
bioequivalent 64, 339, 341, 350, 453, 455, 1335
bioethics 1057, 1060, 1070, 1150, 1270, 1413
bioimaging 905, 920, 997, 1001–1002, 1253
bioinformatics 997, 1001–1002, 1033, 1035, 1353
biological barriers 348, 450, 746, 1081, 1084, 1125, 1228, 1359
biological products 63–64, 75, 369, 431, 433, 471–474, 476, 478, 481, 1149
biological sciences 1091, 1095, 1312
Biologics License Applications (BLAs) 1292
biomarkers 234, 273, 275, 278, 283, 285, 287–292, 569, 571, 584–585, 598, 817, 997, 1001–1002, 1007–1008, 1035, 1108, 1166, 1192–1193, 1223, 1228, 1283, 1347, 1362–1363, 1366, 1368–1370, 1377, 1386, 1389, 1392, 1394
bionanoethics 1057, 1059–1060biopersistence 873, 880–881,
886biopharmaceuticals 1034, 1081,
1084bioscience startups 261, 263biosimilars 413, 431, 452blood–brain barrier (BBB) 324,
403, 582, 932–935, 947, 1017, 1084–1085, 1104, 1253, 1255–1257, 1261, 1283
BRCA1 103, 106–109BRCA2 103, 106–109bulk counterpart 339, 350, 596,
661, 1104
1420 Index
Bundesinstitute für Risikobewertung (BfR) 669, 689, 691, 697–699, 701
bureaucratic rules 547Bureau of Industry and Security
(BIS) 161–162business development 182,
211, 231, 261, 265, 1006, 1296, 1391
business incubation 261, 263business models 216, 223,
1001, 1008, 1313, 1376
C activation-related pseudoallergy (CARPA) 845–846, 850–853, 855–863
C-reactive protein (CRP) 848, 853–854, 863
California Department of Toxic Substances Control 537
cancer 4, 106, 229, 234–235, 273–292, 342, 359, 366–367, 386, 401–402, 408, 418, 422, 429–430, 443–444, 447–450, 552, 574, 591, 699, 766, 772–773, 778, 823–824, 857–858, 863, 877–878, 881, 902, 905–906, 909–910, 914, 919, 922, 981, 983–984, 1004–1005, 1022, 1037, 1046, 1081, 1083–1084, 1123, 1133, 1191, 1193, 1195–1197, 1206, 1208, 1239, 1247, 1255–1256, 1323, 1349–1352, 1356–1357, 1359–1360, 1362–1366, 1369–1371, 1375–1376,
1378, 1385–1389, 1391, 1393–1394, 1414
capsule lipooligosaccharide 845, 857
carbohydrate 441, 1163–1169carbon nanotubes (CNTs) 115,
206, 229–230, 232, 239, 244, 251, 310, 345, 358, 386, 419, 421, 440, 499, 506, 521, 535, 538, 572, 592, 646, 662, 779, 850, 854, 915, 966–967, 1018, 1020–1021, 1081–1082, 1096, 1107, 1125, 1176, 1197, 1294, 1298, 1359, 1361
cardiopulmonary system 845cataract 1245caveolin 577, 760, 769cDNA 103, 106–107, 109,
734–735cell adhesion 755, 809, 812–814,
907, 1247, 1363cell culture 579, 719, 722–725,
728–731, 735–736, 738, 768, 773, 781, 883, 890–891, 941, 1168, 1284
cell-material interactions 809cell membrane 577, 584, 748,
755, 761, 764–767, 772, 789, 916, 981, 1228, 1355
cellular function 719, 778, 1256, 1376
cellular toxicity 745, 1168cellular uptake 418, 453,
570–571, 576, 579, 592, 602, 634, 637, 745, 769, 773, 873, 1256
Center for Biologics Evaluation and Research (CBER) 339, 368, 471, 1292, 1316
1421Index
Center for Drug Evaluation and Research (CDER) 436, 471, 474, 1314
Center for Environmental Implications of Nanotechnology (CEIN) 403, 406, 1193
Centers for Disease Control and Prevention (CDC) 339, 344
Centers for Medicare and Medicaid Services (CMS) 1164
central and peripheral nervous system 931
cerium oxide nanoparticles 901, 1256
cetyl-ammonium bromide (CTAB) 762, 882
chemical nanocomputers 961, 974
chemical vapor diffusion (CVD) 809–810
chemotherapeutics 447, 450, 1347, 1352, 1366
chemotherapy 276, 285, 359, 422, 444, 447, 449, 817, 1046, 1200, 1206, 1350, 1357, 1360, 1388
Chinese hamster ovary cells 919chitosan 499, 601–602, 836,
1240, 1245–1247, 1259, 1283
chromallocyte 961, 981chronic kidney disease (CKD)
360, 363–364, 367, 423, 426–427, 430, 442, 1163–1166, 1168
Cimzia 364, 427citizen involvement 683, 696claims 7–8, 10, 13, 18–22, 26,
31, 47–48, 65, 67, 103–104, 108–110, 117, 143, 147,
151, 158, 178, 180–181, 330, 372, 437, 489, 517, 522–524, 526, 550, 666–667, 697, 907, 909–910, 998, 1073, 1085, 1094, 1118, 1125, 1130, 1154, 1176, 1180, 1182, 1293, 1295
Class 65, 437, 1183–1184class III medical device 61, 65clathrin-mediated endocytosis
(CME) 577, 756, 758, 762–763, 774
Clinical and Translational Science Award (CTSA) 1001–1002, 1006
clinical benefit/risk 485, 493–495
clinical management 87clinical presentation 86clinical translation 1007, 1195,
1207, 1226, 1254, 1347, 1360, 1378, 1391–1392
clinical trials 131, 188, 267, 275, 278, 280, 284–285, 343, 358, 405, 418–421, 443, 453, 823, 837, 1001, 1008, 1039–1040, 1049, 1108, 1228, 1240, 1245, 1254, 1292, 1298, 1301, 1303, 1305–1306, 1308, 1313, 1315, 1317, 1333, 1356–1357, 1383–1384, 1386, 1388–1389, 1396
clottocytes 961, 978–979, 1021cognitive enhancement
1013–1014, 1018, 1020–1021, 1024
collaborative strategy 45, 51colloidal stability 873, 879,
882–884, 1195colloid science 1193, 1223,
1226–1227
1422 Index
combination products 109, 339, 368, 373, 471–472, 476–478, 480–481, 485–487, 489, 496, 1381–1382
COMECE 1141, 1150–1151, 1154, 1156
commercial implication 74, 348commercialization 1, 47, 52, 55,
85–86, 88, 90, 92–94, 96, 98, 116, 144, 155, 163, 167, 177, 187, 209, 223, 232, 234, 263, 268, 309, 312, 339–340, 343, 367–368, 372, 376, 413, 430, 437–438, 440, 453, 500, 520, 526, 535, 551, 559, 1038, 1117, 1175–1176, 1192, 1223, 1225, 1254, 1269, 1273, 1291, 1293, 1296, 1299, 1302, 1306–1307, 1311, 1317, 1319, 1321, 1323–1329, 1332, 1335, 1339, 1391, 1397, 1414
commercialization strategy 187communication 193, 202, 305,
323, 331–332, 607, 683, 685–686, 690, 694–697, 702–709, 711–712, 1018, 1032, 1036, 1091, 1095, 1123, 1128, 1269–1270, 1329, 1333
companion diagnostics 273, 276, 279, 1008
companion treatments 273comparative effectiveness
research 997, 1001complement 845–846complementary delivery
platforms 1194compliance 350, 442, 499,
503–504, 508, 515, 517,
525–526, 1198, 1213, 1246, 1309, 1383
complimentary disciplines 1223, 1228
comprehensive goal management 261
comprehensive tumor profiling 273, 281
concerned stakeholders 1269, 1271
Confidential Disclosure Agreement (CDA) 123, 125, 129–130
confidential business information (CBI) 557
confidential information 44, 56, 123, 125–126, 146
confidentiality 14, 34, 130, 141, 146, 149, 169, 672, 1040
Congress 1175, 1178, 1181constructivism 1057consumer perception 1101Consumer Product Safety
Commission (CPSC) 1177consumer products 154, 340,
622, 720, 883, 1031, 1101, 1107, 1179, 1282, 1285, 1295
contact lenses 1044, 1245–1246contagion 1117, 1131–1132,
1134control banding 323, 331, 569,
594, 607–610, 612controlled drug release 1083,
1347controlled manipulation 339,
347–348, 661, 1177Cooperative Research and
Development Agreement (CRADA) 123, 130
Copaxone 361, 424, 851copper nanoparticles 901
1423Index
copyright 3, 5–6, 29–32, 35, 43, 358–359, 367, 421–422, 430, 438, 455
corporate liability 385–386corporate sustainability
strategies 659–660cosmetics 189, 204, 209, 212,
312, 324, 328–330, 340–342, 353–354, 368, 374, 385, 387, 390–391, 395, 454, 661, 683, 690, 698, 705, 721, 781, 901, 912, 917, 922, 932–933, 1103, 1105, 1179, 1185, 1335–1336, 1379
cross-licensing 46, 156, 175–176cross-reference art collection
subclasses 1183crowd-sourced analysis 1292,
1308‘‘cryptic’’ peptide epitopes 749curcumin 1245Curosurf 365, 428current Good Manufacturing
Practices (cGMPs) 471, 478, 481, 1383
current Good Manufacturing Production (cGMP) 1292
customer service 261, 265cyberimmortality 1141,
1147–1149, 1156cytokine 577, 582–583,
722–723, 904–905, 908, 910–912
cytotoxicity 579–581, 584, 587–589, 592, 600–601, 720, 722, 730–731, 754–755, 762, 766, 768, 773, 775, 781, 811, 880, 883, 887, 901, 905–906, 908, 910–914, 916, 921, 931, 934, 937, 940–945,
948–949, 1101, 1104–1105, 1168
damnatio memoriae 1117, 1131DaunoXome 360, 423, 851DDT 547–549defensive strategy 45, 47–50deliberation 697, 700, 1057,
1068–1071dendrimers 592, 854, 1191,
1201dendritic cells 103, 289, 413,
499, 777, 779–780, 783, 831, 835, 908–909, 911–912, 1031, 1208
Department of Commerce (DOC) 1177
Department of Defense (DOD) 153, 193, 262, 1177, 1398
Department of Energy (DOE) 1177
Department of Health and Human Services (DHHS) 1177
Department of Homeland Security (DHS) 1177
DepoCyt 345, 1226Deutsche
Forschungsgemeinschaft (DFG) 201, 746, 1121
developing world 85–86, 88–89, 91, 94–96, 98
device 471–474, 476–478, 481 computation-capable 970, 972,
974diagnosis 4, 86, 89, 277,
290–291, 416, 473, 488, 874, 881, 914, 962, 983–984, 987, 991, 1033, 1038, 1041, 1066, 1081,
1424 Index
1091, 1102, 1120, 1125, 1133, 1143–1144, 1196, 1224, 1259–1260, 1304, 1360, 1362–1366, 1368, 1385, 1389, 1392
diagnostic research and development 85
diagnostics 4, 62, 90–91, 93–98, 246, 273, 275–276, 279, 292, 416, 418, 590, 594, 873–875, 961–962, 984–985, 1005, 1008–1009, 1031, 1035–1036, 1038, 1041, 1048, 1117, 1119, 1122, 1125, 1151, 1154, 1191–1193, 1196, 1227, 1230, 1255, 1299, 1305, 1324, 1339, 1347, 1361, 1363, 1365, 1377, 1379, 1387
diagnostic testing 85, 97, 291Dialysis Outcomes Practice
Patterns study 1164diffraction limit 961, 991Digital Versatile Disc (DVD) 51Diprivan 359, 422disclosure 8, 11–16, 18, 33–34,
56–57, 125, 141, 146, 149, 160, 169, 173–174, 179, 340, 503, 595, 706, 1181
dissolution 350, 589–590, 750, 877, 883, 888, 903, 906–907, 1207, 1318
distribution 31, 143, 304, 306, 309, 311–312, 339, 358, 374, 419, 421, 433, 435, 438, 441–442, 444–445, 452, 454, 518, 559, 572, 574–575, 578, 598, 623, 630, 632–633, 640–641, 644–645, 652, 669, 720, 730, 738, 745, 764,
768–769, 771–772, 774–775, 778, 784–785, 880, 906, 911, 935, 1033, 1046, 1195, 1202, 1205, 1227–1229, 1260, 1300, 1336, 1360, 1363, 1385
division of labor 303–304DNA computing 961dopamine 936, 944, 1015,
1017, 1240, 1259dorsal root ganglion neurons
931dose-effect relationship
621–623, 633–634, 650sola dosis facit venenum 1284double hit theory 859–860Down’s syndrome 961Doxil 357, 359, 401–402, 413,
422, 443–446, 451–452, 851, 853–854, 858–862, 1255, 1296, 1355
drug 471–474, 477, 480 anticancer 402, 1017, 1351,
1373drug delivery 4, 263, 308,
345, 350, 357–358, 386, 389, 408, 414, 418, 421, 437, 443, 447, 450, 456, 485–486, 491, 582, 586, 721, 746, 775, 783, 789, 873–874, 879, 882, 890, 905–906, 910, 932, 1032, 1036–1037, 1041–1042, 1085, 1094, 1102, 1107–1108, 1117, 1122, 1125, 1143–1144, 1150, 1155, 1195–1196, 1201, 1223, 1226, 1229–1230, 1241–1242, 1245–1247, 1281, 1285, 1292–1293, 1296, 1298–1299, 1332, 1334, 1355–1357,
1425Index
1374–1375, 1388–1390, 1393, 1398
ophthalmic 1245–1247drug delivery devices 485, 873,
1036drug delivery systems 386, 389,
443, 456, 783, 1037, 1281, 1374, 1388
drug development 262, 274, 279, 414, 437, 455, 1009, 1016, 1240, 1282, 1306, 1310, 1314–1315, 1317–1318, 1347–1348, 1377, 1388
drug discovery 1144, 1291, 1306, 1310–1311, 1315, 1317, 1319
drug–polymer conjugates 1223drug targeting 1203, 1253, 1258,
1373dual-color confocal fluorescence
microscopy 766due diligence 141, 146–147, 151,
158, 176, 524dynamic light scattering (DLS)
251, 445, 719, 723
economic drivers 1347economic impact 267, 303,
553ecotoxicity 1125–1127effective surface area 719electronic nanocomputer 961Elestrin 362, 425Eligard 366eligibility 10, 103, 106–107, 289,
1386embodiment 21, 84, 1141, 1149,
1367–1368Emend 359, 422
emerging technologies 340, 353, 355, 370, 437, 686, 696, 1031, 1044, 1148, 1155, 1184, 1292, 1334, 1337, 1348–1349, 1354, 1376, 1388
employer’s liability 323–324, 326
enabling technologies 188, 1082endocytosis 577, 602, 745, 756,
758–760, 762–763, 765, 769, 771, 774–775, 910, 945, 1228, 1257
endoscopy 961, 991endosome 576, 602, 759, 766,
775endothelial cell 723, 909, 1084engineered nanomaterials 116,
521, 569, 576, 600–601, 603, 605–609, 611, 647, 923, 1193, 1196, 1285
engineered nanoparticles 188, 372, 571, 575, 621–624, 632, 1101–1102, 1104–1106, 1108–1109, 1282
enhanced damages 80enhanced permeability and
retention (EPR) 339, 345, 443, 1083, 1091, 1094–1095, 1356
enhancement 1031, 1042, 1045, 1049, 1059, 1151, 1270, 1275
entrepreneurship 261, 701environmental considerations
1101environmental health 251, 253,
516, 659–660, 665, 669, 672, 933, 1048, 1101, 1105–1106, 1108, 1122, 1286
1426 Index
environmental health and safety (EHS) 251, 253, 499–502, 504, 506, 508, 516, 545–547, 550–551, 553, 1048, 1105, 1122, 1132–1133
environmental health risks 659–660
environmental liability 323, 325environmental protection 389,
392, 556, 659, 667–668, 670, 1142
Environmental Protection Agency (EPA) 154, 504–505, 507, 509, 515–518, 520–526, 537–538, 550, 557–558, 931, 1179–1180, 1283
environmental toxicity 659, 901, 1106
Epaxal 345, 362, 425, 1201, 1226
Esther H. Chang 1192, 1254Estrasorb 360, 423ethics 385, 401, 408, 1006,
1031, 1039–1040, 1045–1049, 1057–1058, 1060–1062, 1065–1066, 1069–1070, 1072–1073, 1101, 1127, 1141, 1143, 1154, 1157, 1192, 1254, 1269, 1333, 1414
EU framework 385, 389European Group on Ethics
in Science and New Technologies 1038–1039
European Medicines Agency (EMA) 407, 495–496, 1002
European Strategy Forum on Research Infrastructure (ESFRI) 1003
European Technology Platform in Nanomedicine (ETPN) Report 1084
European Translational Research Infrastructure & Knowledge Management Services (eTRIKS) 1002
European Union (EU) 252, 367, 385, 387, 389, 391, 404, 430, 442, 485–486, 488, 490, 492, 494, 496, 554, 596, 666, 703, 1150
experiential marketing 223, 236, 240–241
experimental use exception 73–75
Export Administration Regulations (EAR) 161
export control laws 141, 159, 161
exposure 515, 519–520, 526exposure biomarkers 569exposure-dose relationship 621,
646exposure pathway 631exposure rates 873extrinsic properties 1223
Facalin XR 365, 428FDA regulation 413, 437, 1335FDA’s Center for Drug
Evaluation and Research (CDER) 434, 436, 1292, 1316
FD&C Act 61, 65, 67, 473, 476Federal Contracts 123Federal Food, Drug, and Cosmetic
Act 369, 455, 471, 473, 1314
1427Index
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 516–519, 522–525, 549, 551
Feraheme 364, 427Ferrlecit 363, 426, 442first-to-file 12, 14, 56first-to-invent 12, 14, 56fixed fee arrangements 118flotillin 760fluorescence correlation
spectroscopy (FCS) 723–725, 727, 729, 752–753
follicular 781–785, 787follow-on biologics 413food-storage 515–518, 522–523four-factor test 150, 159freedom of choice 683–685, 687,
699freedom-to-operate 1292, 1327,
1340FRET 823, 826–828, 830, 832,
837
gastrointestinal tract 585, 746, 769, 1228
Gendicine 1239gene 10, 103, 105, 107, 262,
275–277, 279, 285, 292, 496, 584, 589, 722, 734, 739, 763, 773, 817, 823–825, 829, 837, 880, 916, 932–933, 938, 943, 981, 1001, 1048, 1239–1242, 1254, 1260, 1360, 1364–1366, 1369, 1378, 1386, 1395
gene delivery 589, 763, 823, 829, 837, 1240–1242, 1254
generic technology 187, 189, 206, 209, 213, 235
gene therapy 262, 496, 817, 823–824, 932–933, 981, 1239–1240, 1395
genetic biomarker 273genetically modified organisms
(GMO) 393, 550, 1126genotoxicity 573, 581, 585, 587,
778–779, 887, 901, 904, 917–919, 921–922, 1281, 1283
German International Co-operation (EAC-GIZ) 97
glaucoma 1245–1246Global Harmonization Task
Force (GHTF) 96glomerulus 961, 987Glybera 1239glycol 358, 361, 367, 421, 424,
430, 447, 580, 601, 769, 774, 815, 817, 823–824, 837, 854, 863, 875, 1246, 1298, 1355
gold nanoparticles 345, 402, 419, 447, 449, 761–762, 901, 983, 1105, 1296, 1359, 1366
golem 1141, 1151–1155Good Institutional Practice (GIP)
1292, 1309Good Manufacturing Production
(GMP) 438governance 252, 339, 348, 351,
368, 545–547, 552–554, 556, 558, 560, 1004, 1037, 1048, 1269–1270, 1332, 1339, 1380
government’s march-in rights 141, 152–153
graphene 115, 535–539, 1081–1082, 1294, 1329
1428 Index
Green Chemistry Initiative 537green science 659grey goo 664
Hall–Petch effect 1225Hamiltonian path 961, 974Hatch–Waxman Act 61, 64, 1292healthcare 232, 283, 288–289,
291–292, 340–341, 998, 1001, 1006–1009, 1031, 1035, 1037–1038, 1047–1048, 1059–1061, 1067, 1086, 1095, 1195, 1199, 1269–1270, 1272–1273, 1293, 1297, 1304, 1313, 1335, 1415–1416
health concerns 91, 390, 1101HEK293 cells 811HeLa cells 762, 768, 773hemostasis 961, 979hepatitis A 362, 425, 1201hepatocytes 720, 722, 739,
883, 890, 1022high-aspect ratio nanoparticles
(HARN) 779hippocampus 935–936, 940,
1015histamine 855hit discovery 1291, 1310HIV 85–86, 89, 359, 422,
823–824, 854, 1191–1192, 1194, 1196–1200, 1202–1206, 1208–1210, 1212–1214, 1253, 1257, 1368
HIV/AIDS 1191–1192, 1194, 1196–1198, 1200, 1202–1206, 1208–1210, 1212–1214
Howard E. Gendelman 1191, 1253
human enhancement 701, 1042, 1049, 1059, 1151, 1270, 1275
human serum albumin (HSA) 751–753
hydroxyapatite 402, 810, 815hyperlens 961, 990–991hypersensitivity reactions 364,
427, 845, 914hypothermia 1022, 1253
ICRP 637–638immune complement 901, 914immune system 283, 286,
289, 577, 581–584, 846, 901–904, 907, 909, 911, 913–915, 922, 1086, 1212, 1260
immunogenicity 289, 413, 452, 849, 1202, 1241, 1257, 1362
immunoglobulin 583, 755, 853, 1085
immunotherapy 273, 275, 278, 284–286, 288–289, 824, 1202
immunotoxicity 374, 454, 538, 569, 904, 1336
infectious diseases 85–86, 94, 96, 1355, 1368
Infectious Diseases Research Institute (IDRI) 94
inflammation 574, 581, 583, 585, 590, 664, 720, 778–779, 785, 880, 903–904, 907, 909, 911, 914–915, 932, 1019, 1104, 1163, 1168, 1260, 1283
1429Index
inflammatory reactions 663influenza 362, 367, 425, 430,
1201, 1368informatics 276, 417, 1007,
1033–1034information deficit model 695informed dialog 683infrastructure investment 261,
264infringement 23, 27–28, 31–32,
48, 63, 73–74, 76–81, 84, 103, 105, 116, 131, 143, 148, 150, 156, 158, 176, 358, 421, 1328
innovation 3, 5, 23, 29, 34–35, 63, 92, 156, 159, 163, 187–189, 199–200, 206, 209, 211, 214–218, 225, 236–237, 241, 250–251, 269, 375, 414, 455–457, 520, 550, 555, 559, 664, 668, 676, 712, 998, 1004, 1009, 1034, 1047, 1175–1176, 1184, 1270, 1306, 1310, 1313, 1326, 1328, 1351, 1362, 1376, 1413–1415
innovation crossover 1413, 1415
Innovative Medicines Initiative (IMI) 1002
Innovative New Diagnostics (FIND) 94
instrumental values 1057, 1066–1067, 1072
insurance market 323, 325–326, 331–332
insurer 282, 323intellectual property (IP) 3–7,
9, 11, 13–15, 17, 19–21, 23, 25, 27, 29, 31–35, 43–57, 61–62, 68, 92, 119, 123, 125, 131–132, 141–146,
148–152, 154–156, 159–161, 163, 167–176, 178, 180–183, 193, 195–196, 198, 206, 210, 215–217, 229–230, 232, 234, 238, 248, 264, 348, 553, 998, 1006, 1048, 1061, 1118, 1181, 1230, 1274, 1291, 1307, 1311, 1327, 1339, 1416
intellectual property portfolio 43intellectual property strategy 29,
49, 57, 167, 176, 181, 183, 1291, 1311
intercellular penetration 781interdisciplinary 202, 660, 711,
1000, 1006, 1091, 1096, 1211, 1223–1225, 1229–1230, 1261, 1285, 1304, 1326, 1333, 1413–1414
interdisciplinary approaches 1413
internal corporate venturing 187International Center for
Technology Assessment (CTA) 1179
international harmonization 375, 455, 481
International Organization for Standardization (ISO) 339, 344, 375, 455, 501–503, 646, 709, 1329, 1337
intracellular trafficking 745intracellular transport 823, 825,
827, 837intracortical recording device
1013intraocular implants 1245–1246intraocular pressure 1245–1246intravenous iron 431,
1163–1166, 1168–1169intrinsic properties 1223
1430 Index
intrinsic values 1057, 1066–1067, 1071
invalidity 77, 80, 103Invega Sustenna 366, 429invention 7–8, 11–23, 33, 44,
55–56, 61, 63–64, 78, 84, 104, 107, 133, 141, 143–145, 147–152, 156, 160, 171, 173–176, 178–180, 228–229, 232, 234, 413, 439, 1102, 1181–1182
inventors 7, 15–18, 21, 23, 47, 108, 134, 141, 144–145, 151, 155, 174, 177, 180, 233, 343, 993, 1329
inventory 526, 1031Investigational Device Exemption
131Investigational New Drug
Application (INDA) 131, 1291
investment 45, 52, 57, 90–91, 124, 172–174, 176, 180, 188, 194, 197, 199, 208, 214, 217, 242, 246, 248–250, 261, 264, 267, 313, 1002, 1006, 1008, 1085, 1119, 1282, 1299, 1314, 1340, 1413–1414
investor groups 261–263IP acquisition 43, 45IP portfolio strategies 43, 45–47,
49, 51, 53iron deposition 1168iron oxide 357, 367, 375,
402, 430, 874, 877, 879, 882–883, 901, 906–909, 916–917, 922, 1163, 1253, 1256, 1260, 1359, 1363, 1373
iron oxide nanoparticles 375, 402, 877, 901
irreproducible preclinical research 1292, 1307
isolated DNA 103, 105, 107, 109Japanese encephalitis (JE) 91Jonsson Comprehensive Cancer
Center 403Journal of Interdisciplinary
Nanomedicine (JOIN) 1223, 1230
jurisdiction 6–7, 25, 160, 162, 369, 433, 1383
Kadcyla 366Kaposi’s sarcoma 359–360, 402,
422–423, 1355–1356kinesin 961, 963kinetics 408, 452, 761–762, 789,
823, 825, 829, 833, 886, 1207, 1358–1359, 1373
Krystexxa (Puricase) 364, 427
L-DNR 360, 423lab-on-a-chip 1036, 1364labile plasma iron (LPI) 1166laboratory testing 85labor markets 303, 305laches defense 73, 81lactate dehydrogenase (LDH)
725, 730–731, 738–739, 914, 937–939, 942, 944–946
Langerhans cell 788laser scanning microscopy
(LSM) 773, 780, 782, 828latanoprost acid 1245–1246latent virus targeting 1191Latin America IVD Alliance 97laypeople 326–331, 686,
1431Index
688–689, 695–697, 702, 710–711
lead discovery programs 1291, 1310
lead optimization 1291, 1310Leahy-Smith America Invents Act
(AIA) 56, 1181lectin 847–848, 863legal 1175–1177, 1180–1182,
1184legal regulations 683–684, 690legislation 64, 150, 252, 371,
385, 387–391, 395, 490, 596, 666, 684, 1175, 1178, 1306
Leroy Hood 1363leukotriene 845, 855, 863liability 73–74, 142, 154–155,
164, 224, 323–326, 375, 385–386, 455, 499–501, 503–504, 508, 515, 518, 523–526, 660, 668–669, 671, 675, 1378
license 48, 51, 56, 79, 83–84, 123, 131–134, 142–149, 151–154, 156–157, 159, 161–164, 178, 264, 267–268, 659, 672, 1291–1292, 1306, 1311, 1314–1315
license agreements 131, 133, 142, 161, 163, 1291, 1311
licensee 79, 83–84, 132–134, 141, 144, 146–149, 152–155, 157–158, 160–161, 1315
licensing 5, 46–47, 51–53, 63, 75, 83–84, 132–133, 141–143, 145–147, 149, 155–156, 159–164, 171, 175–176, 181, 195, 198,
216–217, 264, 440, 1118, 1229, 1314, 1328
licensor 79, 84, 131–132, 141, 146–149, 152–153, 155, 157–158, 160–162
life cycle analysis 569life cycle assessment (LCA) 324,
557, 1031life scientists 1223, 1225lipoplexes 1239, 1241liposomes 357, 359–363, 365,
367, 375, 401–402, 406, 422–426, 428, 430, 441, 443–445, 845, 853–854, 856–859, 861, 1081, 1083, 1085, 1193–1194, 1201, 1223, 1226, 1245–1246, 1296, 1356–1357, 1359–1360, 1362, 1373
litigation 10, 19, 46–48, 51–53, 74, 80, 103, 115–119, 148, 156, 367, 430, 440, 501, 525–526, 1182, 1225, 1291, 1311, 1329
local exhaust ventilation 569, 603
Lombardi Comprehensive Cancer Center 1192, 1254
low-density lipoprotein (LDL) 360, 367, 423, 430, 758
macropinocytosis 577–578, 760–763, 829
Macugen 360, 423mad cow disease 560Madey v. Duke University 73–74Magic Nano 668, 706, 1132magnetic 402, 817, 879, 906,
1432 Index
908, 916, 922, 932, 935, 939, 1022, 1033, 1107, 1164, 1226, 1240–1241, 1253, 1256, 1258–1259, 1360, 1373–1374
magnetic resonance imaging (MRI) 817, 879, 906, 908, 1164, 1253, 1256–1257, 1260, 1360–1362, 1392
Magnevist 851, 1361malaria 85, 94–95, 97, 548Mann–Whitney U test 327MAP kinases 916market determination 223market lifespan 303, 306, 311market opportunity 273Marqibo 363, 426mask work 75mass media 691, 706, 1118,
1120, 1130materials chemistry 1223, 1227material transfer agreement
(MTA) 123, 127–130, 141, 149
material values 1057, 1067, 1072
Mauro Ferrari 407, 1347, 1391, 1393, 1395, 1398
Mayo Collaborative Services 106measurement techniques 621,
623, 638–639, 641, 644, 647, 650–651
mechanical nanocomputer 961, 969, 972–974
MEDDEV 485–486, 489–490, 494–495
media coverage 91, 683, 1118–1119
medical device expert group 485medical devices 45, 61–68, 75,
96, 147, 194–195, 197, 210, 212, 214, 308, 340, 349,
389, 407, 433, 485–490, 493–494, 496, 883, 1032, 1036, 1046–1047, 1379, 1381, 1391, 1396
medical devices directive 485medical ethics 401, 1057, 1060medicinal products 290, 414,
420, 442, 485–487, 490–491, 494, 496
medicinal products directive 485Megace 363, 426Megace ES 362, 425meningoencephalitis 91mesenchymal stem cells 814,
1372metabolism and excretion 339,
574metal and metal oxide
nanoparticles 1191, 1197metallic nanoparticles 901,
1082, 1294metal oxide nanomaterials
901–902, 904, 906, 908, 910, 912, 914, 916, 918, 920, 922
microbivore 961, 980–981, 1024
microcrystalline diamond 809–810, 812, 817
microglia 938, 944–945, 1259microparticles 1245–1246,
1259–1260, 1373microtubule 908, 917, 963Minoxidil 787molecular diagnostics 273–274,
276, 278, 280, 282, 284, 286, 288, 290, 292, 1035
molecular planetary gear 961, 969
molecular shuttle switch 961, 971
1433Index
monetary valuation 63monoclonal antibodies (mABs)
413, 420, 1022, 1354monocyte-derived dendritic cells
(MDDC) 773, 780monocyte-derived macrophages
(MDM) 773, 780, 1209monocytic cells 905Monsanto 558, 671, 1313moral experience 1057, 1062,
1065mucoadhesive polymers 1245,
1247mucociliary activity 775multifunctional products 303,
308multiple sclerosis 361, 367, 424,
430, 1253, 1258multivalence 339, 351Myocet 345, 360, 423, 851,
1226Myriad decision 103Myriad Genetics 104, 106
nanates 1057, 1060, 1063, 1067nanites 1057, 1060, 1063, 1067nano cerium dioxide 569nano-enabled products (NEPs)
251, 545–546, 553, 570nano gold 569, 589nano silica 569, 580, 591, 601nano-sized delivery systems
1239, 1241nano titanium dioxide 569nano zinc oxide 569nanobioethics 1057, 1059–1062nanobiotechnology 339, 344,
385–386, 389–395, 1035, 1058–1060, 1070, 1332
nanobots 4, 552, 961, 963, 976, 1123, 1141, 1153–1156
nanocarriers 375, 1022, 1084, 1191, 1193–1196, 1204–1205, 1282
nanocarrier systems 1223, 1228nanocrystals 115, 365, 402, 406,
428, 1132nanocharacter 346–347, 1292,
1332nanocomputer 961, 970, 973,
976nanocomputing 961, 969–970,
976nanocrystalline diamond
809–813, 815–817nanodevice 1022–1024, 1044,
1094nanodrug 339–340, 343–344,
347, 357–358, 367, 402, 421, 430, 438, 443, 1225, 1291, 1293, 1296–1298, 1332–1333, 1337
nanoethics 1042, 1057–1058, 1060, 1141, 1269, 1275
nanofabrication 1037, 1367, 1392
nanofluidics 1347, 1364, 1368nanofoods 385, 390–392nanoformulations 339, 343,
346, 372, 1084, 1202, 1204–1207, 1245–1247, 1255, 1261, 1281–1282, 1284, 1334
nanogear 961nanogovernance 339–343, 353,
376, 1291, 1384nanomaterial 108–109, 154,
206, 251–252, 324, 326–327, 339, 343–344, 346–347, 367, 371–372, 375, 418, 430, 435,
1434 Index
455, 486, 502, 516, 539, 569–572, 574, 580–581, 583, 592–593, 595–600, 602, 606–611, 621, 624, 646–649, 651, 663, 665, 667, 670, 675, 761–763, 769–770, 873, 877, 879, 881, 883, 885, 887–888, 903, 905, 909, 912–913, 915, 1083, 1185, 1193–1195, 1197, 1284–1285, 1291, 1293–1294, 1300, 1302, 1332–1333, 1337
nanomaterial classifications 621
nanomaterial handling 569nanomaterial morphology 873nanomaterial re-engineering
569nanomaterials 323–331,
385–390, 393–394, 515, 521, 545–547, 550, 557–558, 873, 879, 901–902, 907, 909–913, 916, 920, 923, 1175, 1179–1180, 1184–1185
nanomedical industry 5nanomedicine 3–6, 8, 11, 16,
20, 24, 29, 32, 35, 61–62, 273, 289, 339, 342–344, 346–347, 356–357, 368, 372–376, 401–402, 404–406, 408, 413–420, 433, 437–440, 448–449, 451, 453–456, 845, 862, 1013, 1017–1018, 1021, 1031–1034, 1036–1049, 1091–1093, 1095–1097, 1141, 1143–1144, 1148, 1150–1151, 1153–1154, 1156, 1191–1198,
1200–1202, 1204–1208, 1210–1214, 1223–1230, 1269–1275, 1281–1282, 1284–1285, 1291, 1293, 1296–1297, 1299–1302, 1304, 1327, 1329, 1332–1333, 1335–1339, 1347–1348, 1353–1357, 1375–1376, 1379–1384, 1391–1394, 1397, 1413–1416
nanomotors 961, 963–969nanonephrology 961nanoneural interface 961,
988–989nanoneuromedicine 1253–1258,
1260–1261nanoparticle 193–195,
197–199, 213, 289–290, 339, 345, 350, 367, 389, 392, 418–419, 430, 438, 442, 447–451, 569, 572, 576, 578, 583, 593–594, 599, 611, 621–622, 627, 634, 637, 639–640, 642, 646, 648–649, 661, 669, 720, 745, 749–750, 762–764, 769, 849, 878, 905, 945, 983, 1019, 1064, 1083, 1085, 1091, 1094, 1104–1105, 1107–1108, 1125–1126, 1132, 1165, 1193, 1226–1227, 1239, 1241, 1247, 1256–1257, 1284, 1333–1334, 1347, 1356, 1359, 1362–1363, 1373, 1379, 1383, 1393
nanoparticle bioactivity 569nanoparticle distribution 745nanoparticle release 621, 627nanoparticle toxicity 339, 350,
637, 1104
1435Index
nanoparticles 339, 341, 345–347, 351, 357–358, 367, 371–372, 375, 401–402, 405, 408, 535–536, 719–720, 722, 724, 726, 728, 730, 732, 734, 736, 738, 823–826, 828, 830, 832, 834, 836–837, 901, 904–906, 909–912, 914–915, 917–922, 931–949, 1013, 1017, 1019, 1022, 1031, 1033, 1038–1040, 1045, 1163–1166, 1168, 1175, 1179, 1185, 1191, 1193–1194, 1196–1197, 1201–1204, 1245–1247, 1253–1254, 1256–1258, 1260, 1291, 1294–1296, 1298, 1300, 1335–1336
nanopatent land grabs 1292, 1329
nanopharmaceuticals 339, 344–345, 367, 413, 415–416, 430, 437, 440, 453, 455–456, 582, 1013, 1015, 1024, 1081, 1084–1085, 1119, 1131, 1281–1283, 1291, 1296, 1332, 1337
nanopharmaceutics 1239, 1242, 1284
nanopotential 330, 1295nanoprecipitates 1223, 1226nanoproducts 339, 341–343,
348–352, 357, 368–373, 404, 438, 456, 1120, 1271, 1291, 1301, 1335, 1383–1384
nanorobot 961–962, 969, 977, 980–981, 1059
nanorobotics 4, 963
nanosafety 569–570, 592–593, 597, 611, 1281
nanoscale 108, 142, 159, 224, 339, 343–352, 356, 358–367, 370–373, 375, 385–386, 388–389, 395, 401–403, 405, 414–416, 421–430, 434–435, 454–456, 499–508, 515–516, 519, 521–523, 537–539, 552–553, 557, 576, 610, 624, 640, 647, 660–662, 673, 689, 720, 746, 845, 873–874, 877, 916, 962–963, 965–966, 969–972, 974–976, 989–992, 1021, 1058, 1102, 1104, 1107, 1123, 1150, 1176–1177, 1179, 1193, 1195, 1203, 1224, 1226, 1271–1272, 1283, 1285, 1291–1294, 1296–1298, 1300, 1302–1304, 1306, 1308, 1310, 1312, 1314, 1316, 1318, 1320–1322, 1324, 1326, 1328, 1330, 1332–1334, 1336–1340, 1355–1356, 1364, 1366–1368, 1370, 1374–1376, 1380
nanoscale devices 401, 1123, 1272
Nanoscale Materials Stewardship Program (NMSP) 557
nanoscale titanium dioxide 689, 1291, 1294
nanoscale titanium dioxide carrier 1291
nanoshells 339, 345, 589, 1022nanosilver 387, 499, 504–505,
509, 515–517, 519–523,
1436 Index
526, 569, 572, 575, 589–590, 601, 604, 912, 1122
nanosimilars 375, 413, 431, 440, 451–452
nanotech 103–104, 108, 116, 168–169, 172, 176, 187–188, 206, 210–211, 213, 215–218, 224, 227–228, 233, 238, 240, 248–249, 261, 263, 331, 341–342, 348, 351, 357, 370, 372, 375, 435, 437–440, 501, 526, 546, 597, 607, 666, 977, 1082, 1121, 1141, 1143–1147, 1149–1150, 1154, 1156–1157, 1180, 1183–1185, 1275, 1295, 1297, 1335
nanotechnologist 576, 1094nanotechnology 3–6, 11, 20, 23,
43, 54, 57, 61–65, 67–68, 73–79, 81, 103–104, 106, 108–110, 115–118, 123, 126, 133, 135, 141–142, 144–164, 168, 171, 176, 178, 181, 187–188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208–210, 212–218, 223–254, 261, 303–313, 323–332, 339, 341–357, 370, 374–375, 385–395, 403–406, 408, 413–418, 433–439, 447, 449–450, 454–456, 499–504, 506–508, 515–522, 524, 526, 535–536, 545–547, 550–554, 557–560, 569–570, 572, 594, 597,
602, 609–612, 621–622, 624, 634, 637, 659–674, 676, 683–684, 686–694, 696–702, 704–706, 708–712, 746, 809, 850, 873, 901–902, 961–962, 973, 976–977, 983, 987, 992–994, 1031–1038, 1040–1049, 1057–1061, 1066, 1070, 1072, 1081–1083, 1092–1096, 1101–1109, 1118–1123, 1125, 1128, 1130–1134, 1141–1157, 1175–1185, 1192–1197, 1200–1202, 1205, 1224–1226, 1239, 1242, 1254, 1258–1259, 1269–1270, 1281, 1283, 1285, 1291, 1294–1296, 1329, 1332–1334, 1336–1337, 1347–1350, 1352, 1354–1356, 1358, 1360, 1362, 1364, 1366, 1368–1370, 1372–1376, 1378–1384, 1386–1392, 1394–1396, 1398–1399
nanotechnology awareness 323Nanotechnology Characterization
Laboratory (NCL) 405–406, 413, 418–419, 450, 1382
nanotechnology commercialization 187, 209
nanotechnology risk management 659
nanotherapeutics 339–340, 343–344, 347, 357, 376, 405, 415, 873, 1081–1083, 1131, 1195–1197, 1227, 1257–1258, 1281, 1285,
1437Index
1291, 1297, 1332–1333, 1335, 1390
nanotoxicity 846, 1064, 1253, 1282, 1284
nanotoxicology 248, 401, 403, 521, 569–572, 633, 719, 722, 745–747, 873–874, 876, 884–885, 891, 1281–1285
nanotube-based nanomotor 961, 966
nanotubes 115, 157, 190–191, 206, 211, 215, 229–230, 232, 239, 244, 251, 310–311, 345, 358, 386, 419, 421, 440, 499, 505–506, 521, 535, 538, 572, 592, 602, 646, 662–663, 779, 850, 854, 879, 915, 966–967, 1018, 1020–1021, 1081–1082, 1096, 1107, 1125, 1176, 1179, 1197, 1294, 1298, 1359, 1361, 1374
nanovectors 578, 581–582, 1347, 1357–1359, 1361, 1391
nanovesicles 401, 403nanowire-based nanomotor 961nanowires 115, 345, 591, 967,
1107, 1123, 1366–1367NASDAQ 261–262, 1397National Aeronautics and Space
Administration (NASA) 246, 1177, 1394, 1398
National Center for Advancing Translational Sciences (NCATS) 1002, 1292, 1339
National Industrial Chemicals Notification and Assessment Scheme 666
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 94
National Institute for Occupational Safety and Health (NIOSH) 339, 344, 504, 597, 599, 606, 609, 611, 647, 1294
National Institutes of Health (NIH) 123–124, 129, 133, 999–1002, 1210, 1292, 1304, 1309, 1382, 1414
National Nanotechnology Coordinating Office (NNCO) 545, 551
National Nanotechnology Initiative (NNI) 343–347, 351, 357, 417, 437–438, 504, 519, 545–546, 551, 661, 1175–1178, 1226, 1332
National Science Foundation (NSF) 153, 201, 306, 1142, 1177, 1270, 1295
near real-time monitoring 621neglected infectious diseases 94nephron 592, 961, 987–988Neulasta 361, 424neural cell growth promotion
1013, 1015, 1024neural electrodes 1013, 1015,
1017–1018, 1024neural lipofuscin 1013, 1015,
1021, 1024neural prosthetics 1013, 1021neuroblastoma 811, 939–940,
942neurodegenerative disorders
1253, 1258neurons 760, 778, 931,
935–936, 939–942, 944–947, 988–989, 1015,
1438 Index
1017–1018, 1020–1021, 1258–1260
neurotoxicity 582, 947, 1281New Chemical Entity (NCE) 11,
339, 372, 455, 1291, 1313–1315
New Drug Application (NDA) 131, 339, 349, 413, 455, 1291
New Molecular Entity (NME) 1291, 1312, 1314–1315
NIH Research Tools Policy 129nitrogen mustard 1350–1351nomenclature 142, 343–344,
372, 374, 416, 438–439, 454, 515, 517, 521, 526, 720, 1184, 1223–1224, 1292, 1300, 1329, 1332–1334, 1337
non-biological complex drugs (NBCDs) 339, 375, 413, 420, 431–432, 440–442, 453
noncompete provisions 141, 149nondisclosure agreements 14,
141nonobviousness 3, 8, 12, 16–18nonstatutory requirements 8nonviral gene therapy 1239novelty 3, 8, 12–18, 32, 149, 160,
224, 669, 1130nucleic acid-based nanomotor
961, 965
obligation 5, 34, 132, 144–145, 149, 153, 434, 436, 1057, 1061–1062, 1065, 1069, 1182
occupation 303occupational health and safety
569–570, 572, 574, 576,
578, 580, 582, 584, 586, 588, 590, 592, 594, 596, 598, 600, 602, 604, 606, 608, 610, 612, 667, 707
ocular nanotherapy 1245Office of Combination Products
(OCP) 472, 479–481Olympic sprinter 1031, 1044omics technologies 1035–1036Omontys 364, 427Oncaspar 345, 362, 425Oncomouse technology 132Ontak 363, 426ophthalmic drug delivery
1245–1247ophthalmic inserts 1245–1246optical coherence tomography
(OCT) 782optomechanical energy
conversion 961, 964oral delivery 1081, 1203, 1228Organization for Economic
Cooperation and Development (OECD) 344, 404
osteoblast 811–812, 815outmessaging 961, 981ownership interest 141,
144–145oxidative stress 350, 573,
579, 581–582, 584–586, 663, 720, 778–779, 879, 886, 903, 906–908, 911, 915–917, 919–920, 923, 936, 944–946, 949, 1163, 1166, 1168–1169, 1260, 1283–1284
pan-assay interference compounds (PAINS) 1311
Parkinson’s disease 936, 940,
1439Index
948–949, 1018, 1021, 1084, 1240, 1253, 1258
particle dynamics 745particle-particle collision
frequency 884particle size 345, 438, 441, 450,
452, 506, 572, 576, 585, 600, 602, 604–605, 623, 634, 640–642, 645, 666, 719–721, 730, 750–751, 761–762, 777, 877, 879, 909, 1104, 1226, 1256, 1333
partnerships 94, 142–143, 159, 211, 214, 252, 262–264, 267, 673, 997, 999, 1211, 1269, 1313, 1414
patent 3–23, 25, 28–29, 32, 34–35, 43–50, 53–56, 61–68, 73–81, 83–84, 103–110, 115–119, 123, 125, 132–135, 141–145, 147–153, 155–162, 167–171, 173–182, 190–191, 193, 206, 209, 215, 229–230, 267, 312, 339, 343–344, 351, 367, 372–373, 405, 413, 430, 437–440, 444, 456, 661, 977, 998, 1037, 1118, 1175, 1181–1185, 1192, 1223–1225, 1254, 1291–1295, 1299, 1301, 1306–1307, 1311–1314, 1317,1326–1329, 1331–1334, 1338–1340, 1379, 1386, 1391, 1398
Patent and Trademark Office (PTO) 105, 108–109, 119, 167, 171, 339, 344, 357, 372, 413, 437–440, 1291, 1328–1329
patent classification 413
patent clearance 43Patent Cooperation Treaty (PCT)
43, 54–55, 57, 181–182patent domination 49patentee 23, 73, 76–81, 83patent infringement liability
73–74patent laws 3, 5–6, 10, 15,
18–20, 23, 29, 74, 81, 132, 141, 148, 150, 159–160, 173, 177, 413, 439, 1181, 1329, 1333
patent litigation 74, 80, 115–119, 1182, 1329
patent offices 373, 1223–1225, 1292–1293
patent prosecution 178, 1223, 1225, 1340
patent prospectors 437, 1329patent protection 10, 16, 34,
44, 50, 76, 110, 148–150, 160–162, 169–170, 173–176, 179, 372, 437, 440, 1181, 1183, 1291, 1313, 1327
patent term extension 61, 64patent thickets 3–4, 23, 43, 49,
115, 175–176, 413, 438, 440, 1329, 1334
pathogenicity 880–881, 885pathogens 311, 582, 746, 756,
769, 980patient advocate 1347, 1349,
1398patient-centered medicine 1001patient choice 1117patient-reported outcomes 997,
1001pattern recognition receptors
(PRRs) 860–861Paul Erhlich 1355peer-review 1223, 1285
1440 Index
PEGASYS 361, 424PEGINTRON 362, 425PEGylated gold nanoparticles
449, 762PEGylated liposomal doxorubicin
443peptide from transactivator
protein (TAT) of HIV-1 823perception 204, 216, 324,
327, 569, 683, 685–688, 690–691, 695–696, 703–704, 706, 1031, 1063–1065, 1070, 1101, 1106, 1108, 1117, 1123, 1200, 1301, 1324
permanent injunction 73, 77–78, 150, 158
personalized medicine 273–274, 292, 408, 451, 984, 1001, 1008, 1032, 1035–1038, 1048, 1347, 1349, 1354, 1362–1363, 1369, 1372, 1375–1378, 1384, 1386–1387, 1389–1390
personalized treatments 273personal protective equipment
538, 569, 599, 603PET 1253, 1255, 1362phagocytes 878, 961, 980, 1356phagocytic cells 849, 909phagocytosis 442, 577, 755–756,
777, 810, 907, 910, 938, 961, 980
pharma 340, 344, 405, 413, 420, 438, 451, 949, 999–1000, 1101, 1121, 1201, 1271, 1281, 1284, 1291–1292, 1299, 1301–1302, 1306, 1310–1314, 1327, 1348, 1397
pharmaceutical attributes 1081, 1084, 1086
pharmaceutical scientists 1223, 1225, 1296
pharmacodynamics (PD) 413, 1193, 1208–1210, 1255, 1285, 1322
pharmacokinetic performance 1223, 1229
pharmacokinetics 413, 453, 849, 887, 1007, 1163–1165, 1167, 1193, 1226, 1229, 1241, 1255–1256, 1285, 1322, 1362
phase IV post-market surveillance 1292
photothermal ablation 874physical sciences 1091, 1093,
1096, 1296physical scientists 1092–1094,
1096, 1223, 1225physicochemical 371, 374,
402, 404, 419–420, 433, 441–442, 444–445, 451–452, 454, 456, 570–572, 593, 595, 633–634, 720, 723, 770, 783, 789, 825, 827, 845, 873, 875, 877, 879, 886, 888–890, 892, 901, 1040, 1165, 1167, 1193, 1205, 1241, 1336
physiological effects 746, 1165physiologically based
pharmacokinetic (PBPK) modeling 374, 454, 1223, 1229, 1285, 1292, 1336
placebo 285, 846, 861, 1323plasmonic nanobubbles 961, 983platelet activating factor 845platelet poor plasma (PPP) 816platform technology 187, 198,
200, 210, 215, 228, 232, 290
1441Index
PMN 499–500, 505–507policy 1031, 1045–1047political decisions 683–685polylactic-co-glycolic acid 1224polycaprolactone (PCL) 1224polyethylene glycol (PEG) 358,
367, 421, 430, 447, 580, 601, 769, 774, 815, 817, 823–824, 875, 1298, 1355
polyethylenimine (PEI) 823–824polylactic-co-glycolic acid (PLGA)
1224polymeric nanoparticles 1081,
1085, 1201polyplexes 823–825, 827–832,
835–837positron emission tomography
(PET) 1001, 1253, 1255, 1362
postapproval marketing 90postblockbuster world 413, 437,
439postmarketing safety reporting
(PSR) 478post-market regulations 471precautionary principle 385,
392–396, 665precautionary risk management
323, 332precision medicine 1293, 1347preclinical research 1292,
1301–1302, 1307, 1312, 1340
preclinical testing 290predictive biomarker 273preliminary injunction 73, 76–77premanufacture 499–500premanufacture notification
(PMN) 499–500, 506–507premarket approval (PMA) 61,
64–67, 339, 349, 356, 372, 1383
premarket notification 61, 65–66premarket review 341–342, 374,
454, 471, 1180, 1335–1336President’s Emergency Program
for AIDS Relief (PEPFAR) 97
President’s Malaria Initiative (PMI) 97
primary mode of action (PMOA) 339, 369–370, 407, 471, 474, 476–477, 1382
Prince Charles 1101–1104, 1106, 1108
prior art 3, 12–14, 16–17, 19, 56, 117, 439, 1181–1183, 1185
priority products 537proboscis 961, 981–982process innovation 187–188,
199, 206–207, 215product 499–501, 503–504,
508–509product development 73–74,
77, 79, 81, 191–192, 200, 202, 209–210, 213–216, 223–226, 228, 234, 239–243, 245–250, 252–253, 355, 401, 416–417, 437, 477, 684, 1085, 1210–1211, 1254, 1283, 1296, 1318, 1324, 1328, 1383
product efficiency 303product of nature 104, 106–107productivity 303–304, 546, 594,
676, 1008, 1125, 1312, 1385–1386
product liability 323, 325–326, 375, 455, 503–504, 669, 675
product orientation 209–210, 223, 228, 232, 252
prognostic biomarker 273Program for Appropriate
1442 Index
Technology in Health (PATH) 94
proinflammatory factors 907, 910
Project on Emerging Nanotechnologies (PEN) 306, 324, 1031, 1038, 1042
Prometheus Laboratories 106ProSavin 1239–1240protein adhesion 809, 816protein corona 576, 578–579,
583, 745, 748–754, 889–891, 903, 915–916
protein–material interactions 809
proteomics 408, 1001, 1031, 1034–1035, 1348, 1364, 1369, 1386, 1393–1394
Public Communication of Science and Technology 1117
public confidence 368, 385, 391, 440
public debate 685, 697, 1269–1270
public engagement 554, 683, 1031, 1128, 1134
public health 85, 90–91, 94–95, 98, 133, 153, 155, 328–329, 342, 352–353, 375, 389, 457, 476, 537, 1314, 1413, 1415
public opinion 251, 394, 520, 594, 666, 690, 1269, 1273
public perception 686, 691, 1031, 1106, 1117, 1123
public safety 385, 387, 391public supervision 1151public understanding of science
1117
publish-or-perish 1292, 1311, 1326
qualification 303, 307, 1008quality assurance 85, 1384,
1395–1396quality control 250–251, 253,
438, 445, 1291, 1300, 1332quantitative structure–activity
relationships (QSAR) 1281, 1285
quantum computing 662quantum dots 358, 421, 569,
591–592, 600, 823, 827, 829–835, 881, 1082, 1104–1105, 1132, 1225–1226, 1258, 1294, 1298, 1366
quantum nanocomputers 961, 975–976
qubits 961, 975quercitrin 1245
radical innovation 187, 189, 209Raj Bawa 339, 358–359, 367,
405, 413, 421–422, 430, 437–438, 455, 661, 1101, 1192, 1223, 1254, 1291, 1298, 1303, 1316, 1321, 1325, 1337, 1340
Rapamune 359, 422Ray Kurzweil 552, 992–993,
1145, 1148REACH 252, 385, 387–390, 395,
554, 558, 596, 666reactive nitrogen species (RNS)
938–939, 945
1443Index
reactive oxygen species 572, 778, 811, 879, 905, 912, 915, 936, 939, 1163, 1197, 1256, 1259
reactivity 339, 348, 572, 586, 601, 633, 661, 720, 882, 901, 905, 915, 1015, 1101, 1224, 1226, 1311
reexamination proceedings 115refined molecular relay 961,
971–972regenerative medicine 813,
1144, 1150, 1347, 1374–1375, 1390, 1394–1395
regulation 339–343, 349, 351, 353–357, 368–371, 373–375, 401, 403–404, 407, 413, 416, 433, 435, 437, 440, 451, 454–455, 535–537, 539, 545, 555, 558–560, 1042, 1270–1271, 1274, 1291, 1303, 1334–1336, 1379–1380
regulatory 1175–1177, 1180, 1184
regulatory challenges 142, 451, 1177, 1347
regulatory concerns 1101regulatory governance 339, 351,
1332regulatory guidance 341, 371,
1165, 1292, 1334–1335, 1337–1338
regulatory harmonization 97, 1337
regulatory requirements 349, 434, 456, 471, 485, 526
regulatory standards 85, 88, 355relevant exposure cellular uptake
873religious critique 1143
Renagel 360, 423renal tubule 961, 987Rensselaer Polytechnic Institute
339, 405, 413, 437, 661, 1101, 1192, 1223, 1254, 1291
Renvela 364, 427Request for Designation (RFD)
471, 476, 480research and development (R&D)
46, 52, 73–81, 85, 92–93, 98, 133–134, 141, 153–154, 178, 180, 192, 198–202, 211, 213, 216, 241, 248, 251, 261, 263, 305–306, 312–313, 324, 342–344, 348, 373, 375, 415, 457, 504, 551, 594, 998–999, 1002–1009, 1037–1038, 1082–1083, 1120, 1176–1177, 1270, 1285, 1291, 1295–1296, 1299, 1310–1311, 1314, 1317–1318, 1324, 1385–1386, 1394
respirocytes 961, 977–978, 1021reticuloendothelial system 441,
882, 1163, 1165, 1207, 1228, 1258
return on investment (ROI) 45–46, 52–53, 91, 1301, 1340
reverse engineering 148–149Richard Feynman 62, 975–976,
1101risk 323, 328–332, 499–501,
503, 507, 509risk assessment 252, 385, 389,
391–392, 394, 487, 495, 501, 507, 509, 569, 571, 584–585, 594–596, 598, 605, 608, 610, 633–634,
1444 Index
685, 689–690, 694–695, 703, 705, 707, 711, 719–720, 862, 1269, 1377, 1381
risk awareness 683, 685, 703risk-benefit considerations 683risk communication 323,
331–332, 683, 685–686, 690, 694–697, 703–709, 711–712, 1269
risk management 216, 323, 332, 353, 507, 557, 569, 583, 596, 600, 604, 607–610, 659, 671, 683, 690–691, 696, 703–704, 1269, 1383
risk mitigation 223risk perception 683, 685–688,
690, 695–696, 704, 706risk potential 1101Ritalin LA 365, 428RNA interference (RNAi) 1245,
1247rod logic 961, 969, 973rotaxane 961, 964route of administration 369,
1242Royal Commission of
Environmental Pollution 386
Royal Society, The 1103royalty streams 261RT-PCR 719, 739safe harbor 64, 75, 508, 524safe harbor provisions 64Safer Consumer Product
Regulations 537safety 351–352, 354–355,
375, 385, 392, 436, 441, 453, 455, 494, 499, 569, 698–699, 701, 707, 770, 1048–1049, 1176, 1178, 1203, 1227, 1240
safety and efficacy 246, 343, 374, 452–454, 487, 495–496, 1008, 1205, 1292, 1319, 1323, 1336, 1415
safety-by-design 569–571, 584, 594
Sanger method 961, 985sarcoplasmic reticulum calcium
ATPase (SERCA2a) gene therapy 1240
scale-up 206, 209, 215, 224, 231, 250, 416, 594, 598, 1207, 1226–1227, 1291
Schwann cells 931, 939, 941, 945–946
sciatic nerve 961science business 187scientific hyperbole 1117scientific integrity 1292scientific misconduct 1292, 1307self-assembled polymers 1223,
1226Semiconductor Chip Protection
Act 75Seventh Framework Programme
for Research and Technological Development (FP7) 1003
severability clause 141, 162sexually transmitted infection
(STI) 86, 1202Si-Shen Feng 1223silica nanoparticles 506, 750,
766, 768, 901, 935, 937, 943–945, 947–948, 1194
silicon dioxide nanoparticles 668–669, 931–936, 939–942, 944–949
silver nanoparticles 385, 387, 901, 911, 920, 1291, 1294
single-photon-emission computed tomography (SPECT) 1362
1445Index
singularity theory 961Singularity University 1148SK-H-SH cells 941small magnetite antiretroviral
therapy 1253, 1256Smalley, Curl, and Kroto 1354SNUR 499, 505–506social impact 1101, 1103, 1378social license 659, 672social reinforcement 683socio-economic development
303solar cells 194, 198–199, 310,
536, 662Somatuline Depot 366, 429Somavert 361, 424specification 8, 18–22, 240, 251,
494–495, 502spiral product development 213,
223, 228, 239, 242, 245, 248–250, 253
spiritual values 1057, 1067, 1072
stakeholder engagement 683standard technological ethics
1141, 1143statutory requirements 3, 8, 179stealth properties 882strategic intellectual property
management 43–44, 46, 48, 50, 52, 54, 56
stratum corneum 586, 588, 748, 783–784
subcellular localization 745, 766, 909
subject matter 3, 7–11, 24, 29, 62–63, 104, 106, 160–161, 177, 182, 1181
subjective perception 685, 710substitution controls 569success-based fee arrangement
118
superparamagnetic iron oxide (SPIO) 367, 430, 1253, 1256–1258, 1260
Supreme Court 9, 17, 75, 103–104, 106–110, 158
surface area-to-volume ratio 339, 350, 1102
surface charge 374, 454, 572, 576, 622, 763, 770, 783, 824, 853–854, 878, 885, 909, 1228, 1241, 1257, 1336, 1380
surface chemistry 572, 762, 774, 818, 873, 877, 1105, 1205, 1370
surface functionalization 622, 745, 760, 762, 769, 809, 1084
surface modification 109, 569, 576, 587, 589, 600, 602, 913, 922, 1019, 1360
surface properties 350, 441, 451, 624, 754, 774, 809, 875, 878, 880, 882, 890, 902, 915, 1226, 1359
surface protein A 845, 857surface structure 435, 624, 785,
873, 877Surfaxin 365, 428Survanta 365, 428sustainability 331–332, 554,
659–660, 668, 670, 674, 1015
syndromic approach 87synthetic chemistry 1223, 1226
T helper (Th) cells 908tachyphylaxis 851–852,
858–859talent pipeline 261, 264
1446 Index
target discovery 90, 437, 1291, 1310, 1312, 1314
targeted drugs 273–276, 278, 281–282, 1361
targeted immunotherapy 273, 283, 285, 287, 289
targeted therapies 276, 280–281, 290, 1081
Tatiana Bronich 1191–1192, 1201, 1211
Taxol 359, 363, 422, 426, 450, 851
technological revolution 305–306, 548
technology-market matching 187
technology transfer 53, 123–124, 135, 223, 261, 265, 417, 1293, 1296
Technology Transfer Offices (TTOs) 1292, 1303, 1340
technology versus biology 1091terminology 344, 351, 433, 456,
502, 1131, 1177, 1292, 1296, 1300, 1329, 1332
testing criteria 85, 341, 349, 1335
testing protocols 375, 404, 454, 719, 1337
theranostics 401, 407, 456, 873–874, 961, 982–983, 1144, 1253, 1255–1256, 1293
therapeutic monitoring 1081, 1253
therapeutics 274, 276, 344, 357, 368, 416, 420, 431, 437, 440, 449, 455, 659, 873–875, 902, 976, 984, 1009, 1035–1036, 1081–1083, 1091, 1119, 1154, 1204, 1206, 1247, 1258, 1284, 1305–1306, 1313, 1332, 1339,
1351–1352, 1358, 1360–1361, 1377, 1388
thromboxane 845tissue penetration 745, 1197,
1200titanium dioxide 342, 500, 506,
569, 572, 585, 592, 662, 689, 699, 772, 782, 879, 901, 1291, 1294
titanium nanowire 1013, 1017tort 499, 501, 504, 508, 668Tower of Babel, The 1091–1092,
1094, 1096toxicity 659–660, 663, 665, 667,
671, 675, 901–908, 910, 912–916, 918–922, 1125, 1291, 1294, 1300, 1321, 1335, 1361–1362, 1380, 1383
toxicity assessment 873, 876, 885
toxicity in neural cells 931, 937toxic mechanisms 569, 584toxicokinetics 569, 707, 1283toxicology 374, 386, 402–403,
405, 454, 515–516, 526, 570–571, 593, 597, 651, 669, 779, 809, 877, 885–886, 888, 1207, 1230, 1254, 1282–1284, 1336
toxic potential 569, 591, 611, 764, 780, 1285
Toxic Substances Control Act (TSCA) 500, 504–505, 535, 537–539, 558
trademark 3, 6, 23–29, 31–32, 43–44, 171–172, 179, 1005
trademarks 5, 24–25, 27, 29, 35, 132, 167–168, 172
trade secret 3, 6, 22, 32–34, 43, 141, 149–150, 169–171, 179, 182
trade secrets 5, 32–35, 44–45, 56, 149–150, 161, 167–168,
1447Index
170, 1292, 1311training 10, 16, 88–89, 265, 312,
436, 439, 605, 611, 999–1000, 1005, 1008, 1016, 1091, 1096, 1299, 1309, 1324, 1339, 1392–1394, 1397
Transcendent Man 961, 994transfection 589, 773, 823, 825,
827, 833, 836, 1240–1241, 1256
transferrin 441–442, 753, 758, 772, 774, 824, 933, 1169
transhumanism 1141, 1146–1149, 1154, 1156, 1275
transhumanist 1147, 1149–1151, 1156
translation 55, 177, 225, 281, 373, 417, 1001, 1004, 1006–1007, 1096, 1107–1108, 1118, 1169, 1194–1195, 1207, 1223, 1225–1227, 1254, 1291, 1293, 1299–1301, 1303, 1305–1307, 1321, 1324, 1327, 1329, 1331, 1333–1334, 1338–1340, 1347, 1349, 1360, 1378, 1391–1392, 1413
translational 418, 997–1006, 1008, 1081–1082, 1166, 1211, 1223, 1271, 1291–1292, 1294, 1296, 1298–1302, 1304–1308, 1310, 1312, 1314, 1316, 1318, 1320, 1322, 1324, 1326–1328, 1330, 1332–1336, 1338–1340, 1370, 1393–1394, 1398
translational medicine 997–1000, 1002, 1004, 1006, 1008, 1223, 1292, 1299, 1304–1305, 1312,
1338–1339translational science
1000–1001, 1292, 1305TriCor 359, 422Triglide 360, 423TSCA Chemical Substance
Inventory 535, 537Tufts Center for the Study of
Drug Development of Clinical Trial 1292
tumor necrosis factor-α (TNF-α) 447–449, 774, 905–908, 910, 936, 945
U87 cells 937, 940, 942UBI Index 261–262ubiquitin proteasome systems
943ultrananocrystalline diamond
809–810, 815–817unemployment 303–305, 313UNESCO 1058, 1061unintended consequences 1176,
1275United States Department of
Agriculture (USDA) 264, 548–550, 1177
United States Food and Drug Administration (FDA) 61, 64–65, 74–75, 131, 154, 246–247, 274–275, 278–279, 289–290, 292, 339–376, 391, 401, 403–405, 407–408, 413, 418, 422, 425, 430–431, 433–438, 441–445, 450–452, 454–455, 471–473, 475–478, 480–481, 504, 507, 521–522, 701, 851, 1031, 1040, 1047, 1163, 1175, 1180, 1184, 1192, 1198,
1448 Index
1223–1224, 1229, 1239–1240, 1254, 1291–1292, 1294, 1296, 1301, 1306, 1314–1317, 1334–1337, 1348–1349, 1355, 1366, 1379–1384, 1386–1387, 1396
United States Government 123–124, 130
United States Patent and Trademark Office (USPTO) 25–26, 54, 103, 119, 167, 171–172, 339, 413, 437–438, 1181–1183, 1291
United States Patent Law 3United States Pharmacopeia
471, 473United States Pharmacopeial
Convention 441unknown side effects 154unpacking 823, 825–833, 835,
837unreasonable 65, 81, 499–500,
503, 539, 550utility 3, 8, 11, 18, 23, 84, 90,
93, 103, 179–182, 251, 278–279, 283, 373, 439, 557, 934, 1008, 1096, 1182, 1225, 1366, 1378
vaccine 273, 283, 285–287, 289–290, 362, 425, 473, 582, 914, 1193, 1196, 1202, 1242
Valley of Death 202, 223–227, 233, 243, 248, 250, 418, 1291, 1299, 1317–1319, 1321, 1323–1325, 1339
valuation 53, 63, 167, 173, 176, 247–250
value chain 192, 207, 211, 214, 216, 303
Venofer 364, 427venture capital 198, 217, 245,
249–250, 261, 265, 570, 1002, 1294, 1415
vesicles 577, 749, 756, 759, 768–769, 771, 774–775, 846, 853, 874, 910, 1223, 1226, 1296
viability assays 719–720viral reservoirs 1191, 1200,
1203, 1205, 1207, 1213, 1255
virosomes 1201Visudyne 363, 426, 851vital values 1057Vmax 1223, 1226wave interference 961West Nile Virus 85whole-genome diagnostics 961,
984willing licensor-willing
licensee 79win-win outcomes 659workplace controls 569–570,
583, 599–600, 605, 610–612
workplace exposure 598, 607–608, 621, 649
workplace monitoring 599World Health Organization
(WHO) 87–88, 93–95, 97, 1066, 1291, 1294, 1340
Xerox 50, 675
Zanaflex 365, 428zeta potential 763, 1223, 1226zinc oxide nanoparticles 901
“The distinguished editors have secured contributions from the leading experts in nanomedicine law, business, regulation and policy. This handbook represents possibly the most comprehensive and advanced collections of materials on these critical topics. An invaluable standard resource.”
Gregory N. Mandel, JDPeter J. Liacouras Professor of Law and Associate Dean
Temple University Beasley School of Law, USA
“This is an outstanding volume for those looking to become familiar with nanotechnology research and its translation from the bench to market. Way ahead of the competition, a standard reference on any shelf.”
Shaker A. Mousa, PhD, MBAVice Provost and Professor of Pharmacology, Albany College of Pharmacy, USA
“The editors have gathered the distilled experience of leaders addressing the most salient issues confronted in R&D and translation. Knowledge is power, particularly in nanotechnology translation, and this handbook is an essential guide that illustrates and clarifies our way to commercial success.”
Gregory Lanza, MD, PhDProfessor of Medicine and Oliver M. Langenberg Distinguished Professor
Washington University Medical School, USA
“The title of the handbook reflects its broad-ranging contents. The intellectual property chapters alone are worthy of their own handbook. Dr. Bawa and his coeditors should be congratulated for gathering the important writings on nanotech law, business and commercialization.”
Richard J. Apley, JDChief Patent Officer, Litman Law Offices/Becker & Poliakoff, USA
“It is clear that this handbook will serve the interdisciplinary community involved in nanomedicine, pharma and biotech in a highly comprehensive way. It not only covers basic and clinical aspects but the often missing, yet critically important, topics of safety, risk, regulation, IP and licensing. The section titled ‘Perspectives and Editorials’ is superb.”
Yechezkel (Chezy) Barenholz, PhDProfessor Emeritus of Biochemistry and Daniel Miller Professor of Cancer Research
Hebrew University-Hadassah Medical School, Israel
This handbook examines the entire “product life cycle,” from the creation of nanomedical products to their final market introduction. While focusing on critical issues relevant to nanoproduct development and translational activities, it tackles topics such as regulatory science, patent law, FDA law, ethics, personalized medicine, risk analysis, toxicology, nano‐characterization and commercialization activities. A separate section provides fascinating perspectives and editorials from leading experts in this complex interdisciplinary field.
About the Series EditorDr. Raj Bawa is president of Bawa Biotech LLC, a biotech/pharma consultancy and patent law firm based in Ashburn, VA, USA, that he founded in 2002. He is an entrepreneur, professor, researcher, inventor and registered patent agent licensed to practice before the U.S. Patent & Trademark Office. Trained as a biochemist and microbiologist, he is currently an adjunct professor at Rensselaer Polytechnic Institute in Troy, NY, and a scientific advisor to Teva Pharmaceutical Industries, Israel.
edited by
Pan Stanford Series on Nanomedicine Vol. 2
Raj BawaGerald F. AudetteBrian E. Reese
Baw
aA
udetteR
eese
Handbook of
Clinical Nanom
edicine
Vol. 2Pan Stanford Series on Nanomedicine Vol. 2
Handbook of
Clinical NanomedicineLaw, Business, Regulation, Safety,and Risk
ISBN 978-981-4669-22-1V487