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