The business of healthcare innovation /
edited by Lawton Robert Burns.
- 2nd ed.
- Cambridge, UK : Cambridge University Press, 2012.
- xxiv, 574 p. : il. ; 26 cm.
Incluye bibliografía e indices
Abbott 19, , 45, 65, 67, 108, 142, 436–437
Abele, John 388
ACO (accountable care organization) 546–547, , 554–555
affordable innovation 529
AHCA (Agency for Health Care Administration) (Florida) 95
alliances, definition of 357
Alzheimer’s 36, 48, 211
AMC (academic medical center) 175, 176
American Recovery and Reinvestment Act (2009) 244
aneurysm treatment 395–396
angel networks 351
anti-stenotic drugs 19
antisense 222–223
API (active pharmaceutical ingredient) 63, , 108–109
arthritis therapies 36
ASC (ambulatory surgery center) 549
assay development 53, 54
Bakken, Earl 388
Bayh–Dole Act (1980) 199
BCG (Boston Consulting Group) 5, 9, 149, 428, 435
Berg, Marc 472–473
beta-interferons 207–208
biogenerics 520
biologicals 34
biomarkers 83
bioproducts 33, 34
biosimilars 308–309, 314, 315–316, 354
biotechnology business/revenue models
and capital markets 349–350
data mining alliances 369–370
definitions 348–349
genomics technology platform companies 363–366
macro/micro factors affecting 353–355
motivators for change 350
proteomic technology platform companies 363–366
specialty drug development model 361
technological reintegration and healthcare value chain 361–366
technology development alliances 370–371
technology platform companies 363–375,
technology transfer alliances 371–372
performance measurement 372–375
productivity measurement 372–373
therapeutic area alliances 368–369
venture capital model 351–352
vertical integration 349–350, 355–361
biotechnology industry 38–39
Asia 285–303, , , , ,
Australia 297–298
Canada 283–285
challenges to industry 346–347
culture of flexibility in management 274
diseases tackled by 205–212
drug discovery/development 520
drug regulation in US 303–319
employment from 211
ethical issues 347
in Europe 276–283, ,
global companies 302–303
global structure of 274–303
impact on healthcare 205–212
innovation gaps 258–260
investment risk 195
managing biotechnology firms 271–274
and merger and acquisition (M&A) 157
merger and acquisition (M&A) trends in 124–130,
molecular diagnostics companies 219
monoclonal antibodies 206, 208, 212–215
and multiple sclerosis 207–208
in multiple technologies 515–516
and national healthcare cost constraints 258
and pharmaceutical companies 126–130, 204–205, 247–269, 328, 352–353
policy 303–326
product validation 251
productivity gaps 258–260
proteomics 2, 219–220
RDD (rational drug design) 20, 220–221,
rDNA (recombinant DNA) 196, 199–201, , 202
regulation 303–326
revenues 517–518
sector innovation 2
as seen by pharmaceutical companies 251
sequencing capability 218–219
and specialty pharmacy providers 173
spread of 199–201,
therapeutics sector 25, 201–205
tool companies 218
United Kingdom 278–280
biotechnology products, major issues 68–69
bioterrorism 318–319
Biotherapeutics and Bioinnovation Center (BBC) 130
BLA (biologics licensing application) 315
blockbuster drugs 119–120, 133, , 137, 258, 273, 555
Blumenthal, David 474
BMP-2 19
Booth, Bruce 246
bottom-up experimentation 8
Boyer, Herbert 196
BPR (business process reengineering) 468–469
brand switching 414
business models 5, 8, 25–26, , 69–73, 520–522
business strategies 6
CABG (coronary artery bypass graft) 12
CAM (complementary and alternative medicine) 549, 550–551
cancer metabolism 224
cancer therapies 36
capability of firms 7
capital, in-house venture capital 527
capital markets and finance 236–247, 264, 349–350, 351–352, 365, 370–371, 440–441, 518
cardiac bypass 12
care accountability 546–547
care delivery 546
COEs (centers of excellence) 549
consumer- and patient-centered care 550–551
decentralization 549–550
implications for suppliers 552–553
mixed payment sources 551–552
care and disease management IT 488–489
CDHP (consumer-directed health plan) 489–490
CDSS (computerized decision-support system) 469
Centers for Therapeutic Innovation 175
CenterWatch 150
CER (comparative effectiveness research) 96, 309, 546, 549, 553,
cGMP (current good manufacturing practice) 62, 67–68,
cGxP (current good practice) 105, 107
Chakrabarty, Ananda 198
China
biotechnology industry 293–296
cGxP (current good practice) 105
drug discovery/development 204
GlaxoSmithKline center of excellence 104
hybrid business models 104
intellectual property rights 103
merger and acquisition (M&A) entry 132
multinationals in 103–105,
National Economic Plans 106
pharmaceutical industry 46, 81
as pharmaceutical market 102–106
political system 106
research and development (R&D) 104
regulation and quality 321
TCM (traditional Chinese medicine) 102, 540
CHINs (community health information networks) 463
CHMP (Committee for Medicinal Products for Human Use) 323
Chorus translational development concept 46–47
claims management IT 483–488, ,
Clark, Richard 262
clinical decision-making 546
clinical development
challenges in 82–85
globalization of 82
clinical genetics 475
clinical needs, economics of 415–417
clinical trials
See research and development
cloud computing 457
CME (continuing medical education) credits 90
CMO (contract manufacturing organization) 121, 136, 552
CMS (Center for Medicare and Medicaid Services) 15
COGS (cost of goods sold) 63, 423–424
Cohen, Stanley 196
Coleman, Alan 310–311
collaboration management 528
collaborative model 26
combinatorial chemistry 221
Comité Économique du Médicament 49
common business model 520–522
COMP (Committee for Orphan Medicinal Products) 323
competitive forces 6
competitive scale 139–140
competitive scope 139–140
compound potency 65–66
computer-based molecular modeling 20
CON (Certificate of Need) laws 3–4, 11
concentration ratios in mergers and acquisitions (M&As) 437–439
conflicts of interest 11
consumer health ecosystem 556
consumer and patient centered care 550–551
consumerism and healthcare 543–544
convergent product 19
convergent thinking 8
convertible debt securities 243
COURAGE trial 396–397
CPOE (computerized physician order entry) 468–475, , ,
Crick, Francis 196
CRM (customer relationship management) 101
CRO (contracted research organization) 121, 136, 225, 235
cross-sector technology 19–21
crystallography 54
CSL (clinical science liaison) 99–100
CSO (contract sales organization) 121, 136
CTD (common technical document) 320
cyclical financing 237
data mining alliances 369–370
de-diversification 122, 166
de-diversifying 527
DEB (drug-eluting balloon) 19
defibrillators 389–391, 392–393, 399–400, 415, 418, 421
demonstration programs 173
DES (drug-eluting stent) 12, 19, 383, 431–432
desperation index 137
Dickey-Wicker Amendment 312
digital radiology 476
disease identification advances 542
disease and pharmaceutical pricing 47–50
disease treatment advances 542
disease trends 51
divergent thinking 8
diversification 33, 44–45, , 122, 131–132, 166, 524, 525–526, 531
DM (disease management) program 95
DMF (drug master file) 321
DNA 38, 196, 217, 221–222
donut hole 309
downstream customers 6
downstream value chains 546
Drews, Jürgen 366
drug delivery devices 533
drug development, scale effects 154–155
drug discovery 204, 220, 366, 367–368, 520
drug fallout 61,
drug insurance tier status 93–94
drug product 62–69,
drug regulation 303–326, , ,
drug substance 62–69,
drug supplies 13, 15–16
drug therapy 533
drug-coated device 33
drug-hunting 46, 165
drug/device collaboration 533
drug/device convergence 431–433
drugs, pay-for-performance 171
DTCA (direct to consumer advertising) 16, 90, 100–101, , 425–426
earnings growth and pipeline problems 136–139
EBM (evidence-based medicine) 546, 547–549
economies of scale 131, 143–145
economies of scope 131, 143–145
EDL (essential drugs list) 106
efficiency, and scale/scope 152–155
EFPIA (European Federation of Pharmaceutical Industries and Associations) 320
EHRs interoperable (electronic health records) 462, 466
electrophysiology 421
EMA (formerly EMEA, or European Agency for the Evaluation of Medicinal Products) (European Medicines Agency) 321–325,
EMR (electronic medical record) 453, 468–470, 482–483
EPI-MEDICS 477–479
epigenetics 224–225
EPO (erythropoietin) 226
ESC (embryonic stem cell) research 309–313
evidence-based care
See EBM
exit options financing 357
Factor Xa therapies 36, 73
FDA (Food and Drug Administration) regulation 9, 56, 59–60, , 62, 67–68, , 74–75, 77, 83, 85–86, 91, 99, 101, 120, 122, 257–258, 308, 314, 320, 381, 384, 441–445, 532, 535
FDA pre-market approval (PMA) 442–443
FDA risk classification system 442–443
FDAMA (Food and Drug Administration Modernization Act 1997) 16, 99
FIDDO (fully integrated drug discovery and development organization) 357
FIH (first in human) starts 119
finance 5, 236–247, 264, 349–350, 351–352, 357, 365, 370–371, 440–441
financial resources 523, 524
FIPCO (fully integrated pharmaceutical company) model 169, 225, 226–228, 236, 357, 360, 517, 520, 537
FIPNet (fully integrated pharmaceutical network) 169
first-cycle approval rates 86
Five Forces framework 6–7
510(k) clearances 445
flexibility, culture of 274
FOB (follow-on biologics) 314–316
form/fill/finish (F/F/F) sites 63–64
Fortune Global 500 firms 23
free-standing care (care delivery decentralization) 549–550
French Anderson, William 208–209
frugal innovation 529
FSS (Federal Supply Schedule) 49
fungibility of resources 523–524
G-CSF (granulocyte-colony stimulating factor) 34
Garnier, Jean-Pierre 263
GCP (good clinical practice) guidelines 326
gene expression 54
gene therapy 208–209, 222
General Electric six-sigma/lean management 16
generic biologics 314–316
generic drug companies 37–38
generic drugs 33
genetics, clinical 475
Genetics Institute 226–228
genomics 2, 215–219, 254, 347, 366, 367–368
genomics technology platform companies 363–366
germline gene therapy 313–314
Gilbert, Walter 232–233
global outsourcing 491
globalization of clinical development 82
GMP (good manufacturing practice) 62
Golub, Todd 219
government grants 243–244
GPO (group purchasing organization) 18, 133–134
GWA (genome-wide association) studies 217
Hammer, Michael 468–469, 473
Hatch-Waxman Act (1984) 16, 125, 133, 136, 314
HDL (high-density lipoprotein) 36
health communities 500–503
Health Security Act 124
health spending benefits 3–4
healthcare
affordability of 543
and consumerism 543–544
technology convergence in 531–534,
training needs 544–546
healthcare courses 1–3, 9–10,
healthcare delivery systems 544–546
healthcare hedge funds 246
healthcare innovation
demographics 540–541
environment 37
expanding scientific/technological bases 541
healthcare intermediaries 1–3
healthcare IT (information technology)
analysis of sector 27
benefits of 454–455
business models 461
care automation 455–458
care and disease management 488–489
CDHP (consumer-directed health plan) 489–490
claims management 483–488, ,
cloud computing 457
consumer demand for healthcare IT 495–496
consumer use of 494–503
in England 464–465
government spending on 462
hardware development 456
health communities 500–503
and hospital management 504
increased connectivity 542–543
innovation in 2
interoperability 462, 467–468
major players 492–494
market structure 458–461
multiple technologies 515–516
national health data access 463–468
personal health records 496–497
PHR (personal health record)
See PHR
RAND report 454–455
remote patient monitoring/management 476, 480–481
scale in US 451–453
slow progress in 453–454
smartcards 463–464
system response 455
systems integration 490–494
in US 466–468
virtual primary care 481–482
healthcare outsourcing 490–494
healthcare producers, study of 9–19
healthcare reform 307–309, 445–447
healthcare value chain 361–366, 544–545, 552
herbs 33
high science 9
high throughput screening 20
HIPAA (Health Insurance Portability and Accountability Act 1996) 466, 475, 483–485
HITECH (Health Information Technology for Economic and Clinical Health) Act 452, 454–455, 467, 474,
HMO (health maintenance organization) 93, 133–134,
horizontal integration 157–158
hospitals
chief executive training 12
healthcare supply costs 11
HSA (health savings account) 489, 551
HTAs (health technology assessments) 96
HTS (high-throughput screening) 54, , 221
human cloning 313–314
human genome mapping/decoding 80, 120
Human Genome Project 215, 365
Human Genome Sciences 254, 368–369
hybrid business models 104
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 319, 320–321
imaging 20,
in control, concept of 59, 66
in-house venture capital 527
in-licensing
See licensing
IND (investigational new drug) applications 56, 119
India
animal experiments 107
biotechnology industry 298–300
cGxP 107
drug discovery/development 204
generic pharmaceutical companies 108–109
internal market 106–107
merger and acquisition (M&A) entry 132, 142
multinationals in 107, 108
pharmaceutical industry 46, 81, 106–111
pharmaceutical production levels 108
political system 107
research and development (R&D) 110–111
industry concentration 158
inflammation therapies 36
information asymmetry 161
information-based platform technologies 20
infrastructure costs 134–136
Infuse spine cage 432
innovation 2
affordable innovation 529
ambidextrous firms 528–529
business model 5, 73–87
from generics base 45
from service company base 46
frugal innovation 529
in healthcare business 27–28
medical devices decline 409
and mergers and acquisitions (M&As) 522
negative innovation 529
open source innovation 167
organizational 8–9
pure innovation models 44–45
questions about 5–6
reverse innovation 529
and value chain 1–3
and virtual pharma models 46–47
See also research and development (R&D)
innovation challenge 5–9
innovation factors 8–9
innovation process, common themes 23–24
innovation product 5
innovative pharmaceutical pricing 86–87
institutional accountability 546–547
insurance technology 16
integrated delivery network (IDN) 11
integrative devices in mergers and acquisitions (M&As) 161–163
integrative mechanisms 524
integrative structures 8
internal co-promoting 139
investment exit options 357
IO (industrial organization) perspective 6–7, 130–131
IP (intellectual property)/patents issues 55, 103, 125, 132, 137, 198–199, 211, 287, 347, , 352, 360–361, 367–369, , 373–374, 516
IPO (initial public offering) 237, 238–239, 351, 352, 440–441
IRB (Institutional Review Board) 326
IT
See healthcare IT (information technology)
Japan
biotechnology industry 287–290
drug regulation 325–326
pharmaceutical industry 41
pharmaceutical pricing 50
stem cell research 310–311, 312
Jones, Fletcher 493
JPMA (Japan Pharmaceutical Manufacturers Association) 320
junk mail advertising 92
Kefauver Amendments (1962) 98
Köhler, George 212, 213
KOL (key opinion leader) physicians 90, 91
Koop, C. Everett 494
Lander, Eric 219
Lehman, Betsy 473
Lehman Brothers 370–371
licensing 154, 166, 167–169, 265, 315–316, 353, 356, 368–369,
Liu, Edison 372–373
local economies, technology sectors impact 21–23
long-term exploration 8
Longman, Roger 150
merger and acquisition (M&A) 5, 6, 9, 24–25, , 77, 126–129
absorption approach 164
biotechnology firms, trends in 124–130, 204–205
challenges and strategies 118
concentration ratios 437–439
consolidation 116
and converging business models 521
cost efficiencies and mergers 153–154
deal sizes 436–437
deal trends 439–440
deceleration 122
defense against acquisition 140–141
and disruptive change 145–146
diversification 166
earnings growth and pipeline problems 136–139
economies in marketing 154
economies in sales 154
execution of 159
and foreign pharmaceutical markets 141–142,
genomics companies 165
historical role of 117–118
as horizontal integration 157–158
in-licensing 154, 166, 167–169
and increased profit pressures 133–134
in industrial organization theory/research 130–132
industry concentration 158
informal networks 163
and infrastructure costs 134–136
and innovation 522
and integration 524
integrative devices 161–163
internal value chain integration 165
jumpstarting existing projects 166
mass-mergerers 138
medical devices industry 434–437,
merger activity, reasons for 170
multiple motivations 146
and new markets 132
offensive rationales 141–146
pharmaceutical firms 124–130, 132–146, 147–156, 521
post-merger cooperation 164
post-merger integration 164
preservation approach 164
proactive rationales 141–146
as productivity problem 156–159
project reductions 165–166
and research and development investment 150
Roche/Genentech relationship 227, 241, 269–270
and scale 150–152
and stock market activity 132
string of pearls strategy 164
symbiotic approach 164
McClellan, Mark 535
MacMillan, Ian 527
MAD (multiple ascending dose) study 56–57
Mallory, Steve 501
management of strategic alliances 528
managing the balancing act 528
managing knowledge 524
manufacturers
See producers
manufacturing management 62
market barriers and technology convergence 535–538
market dynamics and technology convergence 535–538
market share and scale 150–152
market structures, fragmented 521–522
marketing
across the value chain 87–88
biological targets 87
candidate selection 87
high-risk period 88
junk mail advertising 92
payer marketing organizations 94–95
pharmaceutical promotion 90–92
stakeholder complexities 88–89
mass-mergerers 138
MCO (managed care organization) 15, 172–173
me-too drugs 133
Medicaid 15, 89, 173, 411, 552
Medical Device Act (1976) 381
medical devices 26–27
atrial fibrillation 402
cardiac rhythm management sector sales 418
cardiovascular area 36, 383–384
channel efficiency 426
company operating margins 410–411
comparison with other industries 379–380
comparison with pharmaceutical industry 424–426
consumer/customer/payer separation 411–415
consumerism limitations 424–426
convergent technology 533
coronary artery bypass graft 396–397
costs 14–16, , 415–417
coverage ratio 408
decline in innovation 409
defibrillators 389–391, 392–393, 399–400, 415, 418
Department of Justice inquiry 377
in diabetes 402
direct selling 417–419
drug/device convergence 431–433
economics of clinical needs 415–417
education by sales reps 419–420
electronics 427–428
financing 440–441
firm clusters 21–22
franchises 419
growth drivers 395–400, 434
demographics 395
geographic reach 398–399
perennial products 398, 399
pricing 397
procedure penetration 396–397
recent 399–400
unmet clinical needs 395–396
growth projection rates 403–405
growth slowing consequences 405–409
corporate structural changes 407–408
segment shuffling 405–407
historical perspective 380–381
immunity to price pressures 414
industry analysis 382–391
industry consolidation 433–434
industry growth rates 391–395
industry as oligopoly 522
industry overview 376–378
industry revenues 379–380, 382–384
industry structure 384–386
information playback to manufacturer 420–421
innovation and commercialization challenges 518–519
interventional cardiology products 396–397
market size 382–384
materials sciences 428–431
mergers and acquisitions (M&As) 434–437,
misapplications/errors 380–381
neurological area 384
neuromodulation 402
neurovascular/stroke occlusion 401
orthopedic extremities 401
orthopedics sales 420
percutaneous coronary interventions 396–397, 401
physicians as customers 411, 421, 518–519
profits 423–424
research and development (R&D) 26–27, 422
robotic surgery 402
sales 421–424
target company valuation 434–435
taxation on 446
technology 426–433
US production/revenues 386–391
ventricle assist device (VAD) 401
world production/revenues 386–391
Medical Technologies Innovation Scorecard 22
Medicare 15, 89, 308, 411, 552
Medicare Modernization Act (2003) 16, 171
medicine supply 64
MEP (market exclusivity period) 136
merger activity, reasons for 170
microarrays 221–222
Milstein, Cesar 212, 213
mixed payment sources 551–552
molecular diagnostics companies 219
monoclonal antibodies 206, 208, 212–215
Moore, Gordon 456
Morgan Stanley financial report 261–262, 263
multinationals 103–105, 107, 108
multiple disciplines (silos) 8
multiple sclerosis 207–208
multiple treatment interference 147
Munos, Bernard 77
Myhrvold, Nathan 457
national economies, technology sectors impact 21–23
NCE (new chemical entity) 33–34, , 44, 55, 61,
NDAs (new drug application) 58, 59–60, , 85, 119, 314
negative innovation 529
neuroscience 36, 211
NEWbio (new biotech company) 38–39
NHE (national health expenditure) 172
NHI (National Health Insurance) (Japan) 50
NHIN (National Health Information Network) 462–463, 467–468
NICE (National Institute of Health and Clinical Excellence) (UK) 96, 121
Nicholas, Peter 388
Nicholson, David 262
NIH (National Institutes of Health) 37, 199–201, , 244, 311–312, 541
NME (new molecular entity) 24, 33, 44–45, , 77, 119, 149, 158, 260–261, 271
non-clinical development 60
NPfIT (National Programme for IT) 464–465
NRDO (no research, development only) model 225, 233–235
Nutt, Roy 493
Obama, President Barack 244, 307, 311–312, , 446, 452, 466
OCP (Office of Combination Products) 535
off-label promotion 99
on-label promotion 99
open source innovation/research 167, 169,
OPPAGA (Office of Program Policy Analysis and Government Accountability) (Florida) 95
organizational innovation perspective 8–9
organizational slack 8
Orphan Drug Act (1983) 316–318
OTC (over-the-counter) medications 33
OTC (over-the-counter) shift 426
out-licensing
See licensing
pacemakers 388
PACS (picture archiving communication and storage) 476
Pandemic and All-Hazard Preparedness Act 318–319
Parkinson, Jay 481–482
passive pharmaceuticals 20
patent cliff 98,
patents
See under intellectual property/patents
patient monitoring/management, remote 476, 480–481
Patient Protection and Affordable Care Act (2010) 307
patients, as consumers 411
payer activism 170–171
payer organizations 92–96
applications 486–490
claims management 483–488, ,
cost 93
cost-containment 172
and medical devices 411–415
payer integration 93
payer marketing organizations 94–95
payer size 92–93
structure 93
value chain alliances with pharmaceutical 174–175
PBM (pharmacy benefit management) 16, 133–134,
PBMs (pharmacy benefit managers) 89
PDL (preferred drug list) 95
period, definition of 356
Perot, H. Ross 492–494
PET (positron emission tomography) scanners 20
pharmaceutical industry 33–41
Asia 41, 46, 81
and biologics 129–130
biotechnology alliances 126–130, 204–205, 328, 352–353
biotechnology product issues 68–69
business challenges 72–73
business model 69–73
cash-flow model 70
cGMP (current good manufacturing practice) and compliance 62, 67
challenges to 111–112
comparison with medical devices industry 424–426
compound potency 65–66
conglomerate models 45
customer-focused culture 65
diversification 33, 44–45, , 122, 131–132
drug discovery 175
DTC (direct to consumer) advertising 16, 90, 100–101, , 425–426
efficiency in procurement 176–177
efficiency and scale/scope 152–155
example of 39–41
expansion into therapeutics 142–143
financing 37
forecast accuracy 65
generic drug companies 37–38
and government budgets 174
government development of 21–23
in-licensing 154, 166, 167–169
infrastructure costs 134–136
innovation
See innovation
and managed care organizations 172–173
manufacturing performance 64
mergers and acquisitions (M&As)
as productivity problem 156–159
trends in
See merger and acquisition (M&A)
in multiple technologies 515–516
OTC (over-the-counter) shift 426
outsourcing non-core functions 176–177
patent cliff 98,
process robustness 66
product markets 41–47
product safety withdrawals 137
profit structure 425–426
promotional techniques 90
quality culture 67–68
reach and frequency model 97–98
reliability of companies 64–65
revenue 517–518
revenue stream shocks 137
risk 46, 69–73
Russia 46
segments 41–47
and specialty pharmacy providers 173
system integration 64
transaction automation 176–177
value chain alliances with payers 174–175
West–East redeployment 78
See under drug; individual companies; innovation; research and development
pharmaceutical insurance coverage 49
pharmaceutical manufacturers
See pharmaceutical industry
pharmaceutical markets 35–36, 141–142
pharmaceutical pricing 47–50, , 86–87
pharmaceutical promotion 90–92
regulation 91–92, 97, 98–101
technological advances 101
pharmaceutical strategy
challenges to industry 117
drivers of 119–124
deconstruction of the pharmaceutical industry 121
decrease in research and development (R&D) productivity 119–121
diversification in business approach 122
diversification in capabilities 122–123
expansion in developing markets 123–124
synergistic combinations of businesses 123
pharmaceutical venture funds 245
pharmaceuticals 229–231
cancer trials 34–35
cost effectiveness 34–35
customer enthusiasm 48
definition 33
demand drivers 50–51
development 56–60
healthcare innovation environment 37
therapeutics 36
value of 34–35
pharmacogenomics 228
phases in research and development
See research and development
PHR (personal health record) 496–497
employer-sponsored 498–499
health communities 500–503
independent 499–500
insurer-sponsored 497–498
PhRMA (Pharmaceutical Research and Manufacturers of America) 99, 101, 320
physician organizations 96–97
Physician Payments Sunshine Act (2010) 11
physicians
access to IT 457
and CPOE (computerized physician order entry) 468–470, 472–473,
as customers 411, 421
and Kefauver Amendments (1962) 98
practice management 482–483
product control quotient 421
and research 176
shortages of 544–545, 552
PICC (peripherally inserted central catheter) 406
picks and shovels companies 365
pipeline NPV (net present value) 149–150
pipeline problems and earnings growth 136–139
PIPE (private investment in public equity) 239–241
Pirimal Life Sciences 45, 108, 142
platform technology business models 26, 228–231, 518
PoCs (proof-of-concept) declarations 119, 120, 165
Porter, Michael 6–7, 22
portfolio management and optimization 526–527
post-merger integration 164
PPACA (Patient Protection and Affordable Care Act 2010) 446
PPAR (peroxisome proliferator-activated receptor) 45–46
PPI (physician preference item) 12
PPO (preferred provider organization) 93
practice management 482–483
preregistration in research and development (R&D) 58–59
PricewaterhouseCoopers, Medical Technologies Innovation Scorecard 22
private placements 239
procedures costs 413
process of change 8
producer–provider alliances 16–17
producers 1–3, 17, 23–24,
product competition 555
product development cycles 23, 25
product innovation 5
product safety withdrawals 137
product sector margins 18–19
product sector prominence 17–18
productivity cliff 119
profitability and scale 150–152
programs of change 8
promotional techniques 90
Prospective Payment System (1983) 3
proteomic technology platform companies 363–366
proteomics 2, 219–220
providers 1–3
public sector insurance schemes 89
purchasers 1–3
pure innovation models 44–45
QALY (quality-adjusted life year) 416
Quintiles 46
research and development (R&D)
annual spending 260–261
in Asia 104, 110–111
biotechnology costs 354–355, 517–518
budgets 139
candidate selection 55
cash-flow model 70
declining productivity 121
development issues 56–60, 61, 69–73, 520
discovery stage 52, 69
dry well projects 69
economies of scale/scope in 143–145
genomics companies 165
governance 9
in-licensing 154, 166, 167–169
integrative devices in mergers and acquisitions (M&As) 161–163
intellectual property/patents 55
investigational new drug (IND) application 56
investment 5, 17, 45–46
and mergers and acquisitions (M&As) 150
per employee 21
lead generation 53–54
lead optimization 54–55
in medical device sector 26–27, 422
limited partnerships 241–243
merger and acquisition (M&A) problems 156–159
in multiple technologies 515–516
NME (new molecular entity) spending 271
non-clinical development 60
pharmaceutical/biotechnology alliances 126–130
phase I 53, 56–57, 61, 69, 176, 266, 315
phase II 53, 57, 61, 62, 69, 83–85, 87, 143–144, 149, 165, 167, 175
phase III 58, 61, 69, 83–85, 87, 91, 119, 137, 143–144, 149, 165, 167, 260, 274, 315, 364
phase IV 58, 60, 171
preclinical development 69
preregistration 58–59
productivity 125, 145
proof-of-concept studies 69
registration 59–60, 69, 85–86
research challenges 78–81
research density 148
research funding 37
risk 61–62, 69–73
Roche/Genentech relationship 135, 141, 269–270
and scale 143–145, 147–148, 148–150
and slowing growth 407, 408
spending as risk management 143–144
target identification 52
target validation 52–53
in value chain 51–62
RAC (Recombinant DNA Advisory Committee) 222
radiopharmaceutical tracers 20
RAND report 454–455
RBV (resource-based view) 7
RDD (rational drug design) 20, 220–221,
reach and frequency model 97–98
refusal to file letters 85
registration in research and development (R&D) 59–60
regulation restrictions 98–101
regulatory forces 6
related diversification 526
remote patient monitoring/management 476
revenue model and value capture 357
reverse innovation 529
RFID (radio frequency identification) 20
RHIO (regional health information organization) 462–463
rifle medicines 82
RIPCO (royalty-income [also research-intensive] pharmaceutical company) 225, 231–233, 236, 357, 517
risk participation 46
risk, and research and development (R&D) 61–62
RNAi (RNA interference) 222–223
ROI (return on investment) 143–144, 236
ROI (return on investment) calculus 553–555
royalties
See IP
SaaS (software as a service) 455
SAD (single ascending dose) study 56–57
Safe Medical Devices Act (1990) 535
sales channels 523
sales and scale 150–152
SAR (structure–activity relationship) 53–54
SBIR (Small Business Innovative Research) grants 243–244
scaffolds (protein structures) 214–215
scale 131, 143–145, 149, 150–155, , 523
scope, and efficiency 152–155
screening 53
SEC (Securities and Exchange Commission) 240
service company base, and innovation 46
SESAM-Vitale smartcard 463–464
SFDA (State Food and Drug Administration) (China) 104
SFE (sales force effectiveness) 101
SG&A (selling, general, and administrative) expenses 143
shareholder value maximization 8
Sharp, Phillip 232–233
sheep cloning 313–314
short-term efficiency 8
silos (multiple disciplines) 8
SinoFDA (Chinese Food and Drug Administration) 105
SKU (stock-keeping unit) 63
Smart House monitoring 478
SOC (standard of care) 82–83
sourcing ideas 8
specialized company proximity 22
speed to market 66
Starr, Paul 546
Steere, Bill 138
stem cell research 303–319,
stock market activity, and merger and acquisition (M&A) 132
stock price and scale 150–152
strategic alliances, management of 528
string of pearls strategy 164
STTR (Small Business Technology Transfer) 244
suppliers
care delivery implications 552–553
and downstream value chains 546
supply chain management 12
supply/demand disequilibria 64
surrogate endpoints 83
Swanson, Robert A. 196
SWORD (stock warrant offer for research and development) financing 241–243
synergies 131, 160–161
systems biology 20, 223–224, 362
Taylorism 157
TCM (traditional Chinese medicine) 102
TCT (transcatheter cardiovascular therapeutics) 416
technological imperative
in healthcare 3–5
non-appreciation of 10–11
technology convergence
across sectors 19–21, 531–538
and combination products 532–534
and differentiation 531
and diversification 531
in healthcare 531–534,
importance of 531
market barriers to 535–538
market dynamics and 535–538
and productivity 531
types of 533
and World Economic Forum (Davos) 532–534
technology development alliances 370–371,
technology platform companies 363–375,
technology platform model 26, 228–231
technology sectors, impact on economies 21–23
technology spending 3–4
technology transfer alliances 371–375, ,
technology zealots 327
therapeutic area alliances 368–369
therapeutic pharmaceutical pricing 48
therapeutically active devices 533
therapeutics 246
and biotechnology 25
Biotherapeutics and Bioinnovation Center (BBC) 130
economic importance of 36
neuroscience therapies 36
pharmaceutical industry expansion into 142–143
research and development (R&D) scale economics 149
TCT (transcatheter cardiovascular therapeutics) 416
therapies, in absence of standard of care 82–83
tool companies 218
toolbox companies 365
top-down strategy 8
total cost arguments 171
tPA (tissue plasminogen activator) 273, 307
TPS (Toyota Production System) 548
transgenic mice 213
Turner, Merv 262
Ubl, Steve 444–445
uHTS (ultra high-throughput screening) 80
United Kingdom, biotechnology industry 278–280
United States of America, pharmaceutical pricing 49
upstream supply costs 11–16,
value analysis committees 11–16,
value chain 7
alliances in 174–175
delivery product 554
disruptions to 546
and innovation 1–3
internal 24
and marketing 87–88
perspective on 7–8
positioning 357
VBP (value-based purchasing) 553,
VCs (venture capitalists) 38–39
Viehbacher, Chris 262
Vincent, James 232–233
virtual model 235
virtual pharma models, and innovation 46–47
virtual primary care 481–482
Wanless, Derek 464
Warner-Lambert 67, 137, 138, 139–140, , 154
Watson, James 109, 196–201,
Wears, Robert 472–473
Wharton School Healthcare Management courses 1–3, 9
Wilmut, Ian 313–314
Witty, Andrew 262
World Economic Forum (Davos), and technology convergence 532–534
El negocio de la innovación sanitaria y es un amplio análisis de las tendencias de negocios en el segmento de fabricación de la industria de la salud. Proporciona una visión completa e introducción a los sectores innovadores mejorando así la salud: productos farmacéuticos, biotecnología, tecnología de la plataforma, dispositivos médicos y tecnologías de la información. Para cada sector, el libro examina la base y las tendencias de la innovación científica, los modelos de negocio y de ingresos perseguidos para comercializar que la innovación, las limitaciones normativas en el que cada sector debe operar y los problemas crecientes que plantea el más pagadores activistas y consumidores. Los temas específicos incluyen la estructura del mercado y la competencia, la economía y la justificación del desarrollo de productos, precios, ventas y marketing, negociaciones de contratos con los compradores, alianzas frente a las fusiones, las estrategias de negocio y las perspectivas de crecimiento. Escrito por profesores de la Escuela Wharton y ejecutivos de la industria, el libro muestra por qué los sectores de la salud son una fuente muy importante de crecimiento de la economía de cualquier nación.
9781107024977 (hardback) 9781107607774 (pbk.)
CUIDADO MEDICO--INNOVACIONES TECNOLÓGICAS
TECNOLOGÍA MEDICA--ASPECTOS ECONÓMICOS
PREVENCIÓN EN LOS NEGOCIOS
PREVENCIÓN ECONÓMICA
BIOTECNOLOGÍA--ECONOMÍA
610.28 / B979
Incluye bibliografía e indices
Abbott 19, , 45, 65, 67, 108, 142, 436–437
Abele, John 388
ACO (accountable care organization) 546–547, , 554–555
affordable innovation 529
AHCA (Agency for Health Care Administration) (Florida) 95
alliances, definition of 357
Alzheimer’s 36, 48, 211
AMC (academic medical center) 175, 176
American Recovery and Reinvestment Act (2009) 244
aneurysm treatment 395–396
angel networks 351
anti-stenotic drugs 19
antisense 222–223
API (active pharmaceutical ingredient) 63, , 108–109
arthritis therapies 36
ASC (ambulatory surgery center) 549
assay development 53, 54
Bakken, Earl 388
Bayh–Dole Act (1980) 199
BCG (Boston Consulting Group) 5, 9, 149, 428, 435
Berg, Marc 472–473
beta-interferons 207–208
biogenerics 520
biologicals 34
biomarkers 83
bioproducts 33, 34
biosimilars 308–309, 314, 315–316, 354
biotechnology business/revenue models
and capital markets 349–350
data mining alliances 369–370
definitions 348–349
genomics technology platform companies 363–366
macro/micro factors affecting 353–355
motivators for change 350
proteomic technology platform companies 363–366
specialty drug development model 361
technological reintegration and healthcare value chain 361–366
technology development alliances 370–371
technology platform companies 363–375,
technology transfer alliances 371–372
performance measurement 372–375
productivity measurement 372–373
therapeutic area alliances 368–369
venture capital model 351–352
vertical integration 349–350, 355–361
biotechnology industry 38–39
Asia 285–303, , , , ,
Australia 297–298
Canada 283–285
challenges to industry 346–347
culture of flexibility in management 274
diseases tackled by 205–212
drug discovery/development 520
drug regulation in US 303–319
employment from 211
ethical issues 347
in Europe 276–283, ,
global companies 302–303
global structure of 274–303
impact on healthcare 205–212
innovation gaps 258–260
investment risk 195
managing biotechnology firms 271–274
and merger and acquisition (M&A) 157
merger and acquisition (M&A) trends in 124–130,
molecular diagnostics companies 219
monoclonal antibodies 206, 208, 212–215
and multiple sclerosis 207–208
in multiple technologies 515–516
and national healthcare cost constraints 258
and pharmaceutical companies 126–130, 204–205, 247–269, 328, 352–353
policy 303–326
product validation 251
productivity gaps 258–260
proteomics 2, 219–220
RDD (rational drug design) 20, 220–221,
rDNA (recombinant DNA) 196, 199–201, , 202
regulation 303–326
revenues 517–518
sector innovation 2
as seen by pharmaceutical companies 251
sequencing capability 218–219
and specialty pharmacy providers 173
spread of 199–201,
therapeutics sector 25, 201–205
tool companies 218
United Kingdom 278–280
biotechnology products, major issues 68–69
bioterrorism 318–319
Biotherapeutics and Bioinnovation Center (BBC) 130
BLA (biologics licensing application) 315
blockbuster drugs 119–120, 133, , 137, 258, 273, 555
Blumenthal, David 474
BMP-2 19
Booth, Bruce 246
bottom-up experimentation 8
Boyer, Herbert 196
BPR (business process reengineering) 468–469
brand switching 414
business models 5, 8, 25–26, , 69–73, 520–522
business strategies 6
CABG (coronary artery bypass graft) 12
CAM (complementary and alternative medicine) 549, 550–551
cancer metabolism 224
cancer therapies 36
capability of firms 7
capital, in-house venture capital 527
capital markets and finance 236–247, 264, 349–350, 351–352, 365, 370–371, 440–441, 518
cardiac bypass 12
care accountability 546–547
care delivery 546
COEs (centers of excellence) 549
consumer- and patient-centered care 550–551
decentralization 549–550
implications for suppliers 552–553
mixed payment sources 551–552
care and disease management IT 488–489
CDHP (consumer-directed health plan) 489–490
CDSS (computerized decision-support system) 469
Centers for Therapeutic Innovation 175
CenterWatch 150
CER (comparative effectiveness research) 96, 309, 546, 549, 553,
cGMP (current good manufacturing practice) 62, 67–68,
cGxP (current good practice) 105, 107
Chakrabarty, Ananda 198
China
biotechnology industry 293–296
cGxP (current good practice) 105
drug discovery/development 204
GlaxoSmithKline center of excellence 104
hybrid business models 104
intellectual property rights 103
merger and acquisition (M&A) entry 132
multinationals in 103–105,
National Economic Plans 106
pharmaceutical industry 46, 81
as pharmaceutical market 102–106
political system 106
research and development (R&D) 104
regulation and quality 321
TCM (traditional Chinese medicine) 102, 540
CHINs (community health information networks) 463
CHMP (Committee for Medicinal Products for Human Use) 323
Chorus translational development concept 46–47
claims management IT 483–488, ,
Clark, Richard 262
clinical decision-making 546
clinical development
challenges in 82–85
globalization of 82
clinical genetics 475
clinical needs, economics of 415–417
clinical trials
See research and development
cloud computing 457
CME (continuing medical education) credits 90
CMO (contract manufacturing organization) 121, 136, 552
CMS (Center for Medicare and Medicaid Services) 15
COGS (cost of goods sold) 63, 423–424
Cohen, Stanley 196
Coleman, Alan 310–311
collaboration management 528
collaborative model 26
combinatorial chemistry 221
Comité Économique du Médicament 49
common business model 520–522
COMP (Committee for Orphan Medicinal Products) 323
competitive forces 6
competitive scale 139–140
competitive scope 139–140
compound potency 65–66
computer-based molecular modeling 20
CON (Certificate of Need) laws 3–4, 11
concentration ratios in mergers and acquisitions (M&As) 437–439
conflicts of interest 11
consumer health ecosystem 556
consumer and patient centered care 550–551
consumerism and healthcare 543–544
convergent product 19
convergent thinking 8
convertible debt securities 243
COURAGE trial 396–397
CPOE (computerized physician order entry) 468–475, , ,
Crick, Francis 196
CRM (customer relationship management) 101
CRO (contracted research organization) 121, 136, 225, 235
cross-sector technology 19–21
crystallography 54
CSL (clinical science liaison) 99–100
CSO (contract sales organization) 121, 136
CTD (common technical document) 320
cyclical financing 237
data mining alliances 369–370
de-diversification 122, 166
de-diversifying 527
DEB (drug-eluting balloon) 19
defibrillators 389–391, 392–393, 399–400, 415, 418, 421
demonstration programs 173
DES (drug-eluting stent) 12, 19, 383, 431–432
desperation index 137
Dickey-Wicker Amendment 312
digital radiology 476
disease identification advances 542
disease and pharmaceutical pricing 47–50
disease treatment advances 542
disease trends 51
divergent thinking 8
diversification 33, 44–45, , 122, 131–132, 166, 524, 525–526, 531
DM (disease management) program 95
DMF (drug master file) 321
DNA 38, 196, 217, 221–222
donut hole 309
downstream customers 6
downstream value chains 546
Drews, Jürgen 366
drug delivery devices 533
drug development, scale effects 154–155
drug discovery 204, 220, 366, 367–368, 520
drug fallout 61,
drug insurance tier status 93–94
drug product 62–69,
drug regulation 303–326, , ,
drug substance 62–69,
drug supplies 13, 15–16
drug therapy 533
drug-coated device 33
drug-hunting 46, 165
drug/device collaboration 533
drug/device convergence 431–433
drugs, pay-for-performance 171
DTCA (direct to consumer advertising) 16, 90, 100–101, , 425–426
earnings growth and pipeline problems 136–139
EBM (evidence-based medicine) 546, 547–549
economies of scale 131, 143–145
economies of scope 131, 143–145
EDL (essential drugs list) 106
efficiency, and scale/scope 152–155
EFPIA (European Federation of Pharmaceutical Industries and Associations) 320
EHRs interoperable (electronic health records) 462, 466
electrophysiology 421
EMA (formerly EMEA, or European Agency for the Evaluation of Medicinal Products) (European Medicines Agency) 321–325,
EMR (electronic medical record) 453, 468–470, 482–483
EPI-MEDICS 477–479
epigenetics 224–225
EPO (erythropoietin) 226
ESC (embryonic stem cell) research 309–313
evidence-based care
See EBM
exit options financing 357
Factor Xa therapies 36, 73
FDA (Food and Drug Administration) regulation 9, 56, 59–60, , 62, 67–68, , 74–75, 77, 83, 85–86, 91, 99, 101, 120, 122, 257–258, 308, 314, 320, 381, 384, 441–445, 532, 535
FDA pre-market approval (PMA) 442–443
FDA risk classification system 442–443
FDAMA (Food and Drug Administration Modernization Act 1997) 16, 99
FIDDO (fully integrated drug discovery and development organization) 357
FIH (first in human) starts 119
finance 5, 236–247, 264, 349–350, 351–352, 357, 365, 370–371, 440–441
financial resources 523, 524
FIPCO (fully integrated pharmaceutical company) model 169, 225, 226–228, 236, 357, 360, 517, 520, 537
FIPNet (fully integrated pharmaceutical network) 169
first-cycle approval rates 86
Five Forces framework 6–7
510(k) clearances 445
flexibility, culture of 274
FOB (follow-on biologics) 314–316
form/fill/finish (F/F/F) sites 63–64
Fortune Global 500 firms 23
free-standing care (care delivery decentralization) 549–550
French Anderson, William 208–209
frugal innovation 529
FSS (Federal Supply Schedule) 49
fungibility of resources 523–524
G-CSF (granulocyte-colony stimulating factor) 34
Garnier, Jean-Pierre 263
GCP (good clinical practice) guidelines 326
gene expression 54
gene therapy 208–209, 222
General Electric six-sigma/lean management 16
generic biologics 314–316
generic drug companies 37–38
generic drugs 33
genetics, clinical 475
Genetics Institute 226–228
genomics 2, 215–219, 254, 347, 366, 367–368
genomics technology platform companies 363–366
germline gene therapy 313–314
Gilbert, Walter 232–233
global outsourcing 491
globalization of clinical development 82
GMP (good manufacturing practice) 62
Golub, Todd 219
government grants 243–244
GPO (group purchasing organization) 18, 133–134
GWA (genome-wide association) studies 217
Hammer, Michael 468–469, 473
Hatch-Waxman Act (1984) 16, 125, 133, 136, 314
HDL (high-density lipoprotein) 36
health communities 500–503
Health Security Act 124
health spending benefits 3–4
healthcare
affordability of 543
and consumerism 543–544
technology convergence in 531–534,
training needs 544–546
healthcare courses 1–3, 9–10,
healthcare delivery systems 544–546
healthcare hedge funds 246
healthcare innovation
demographics 540–541
environment 37
expanding scientific/technological bases 541
healthcare intermediaries 1–3
healthcare IT (information technology)
analysis of sector 27
benefits of 454–455
business models 461
care automation 455–458
care and disease management 488–489
CDHP (consumer-directed health plan) 489–490
claims management 483–488, ,
cloud computing 457
consumer demand for healthcare IT 495–496
consumer use of 494–503
in England 464–465
government spending on 462
hardware development 456
health communities 500–503
and hospital management 504
increased connectivity 542–543
innovation in 2
interoperability 462, 467–468
major players 492–494
market structure 458–461
multiple technologies 515–516
national health data access 463–468
personal health records 496–497
PHR (personal health record)
See PHR
RAND report 454–455
remote patient monitoring/management 476, 480–481
scale in US 451–453
slow progress in 453–454
smartcards 463–464
system response 455
systems integration 490–494
in US 466–468
virtual primary care 481–482
healthcare outsourcing 490–494
healthcare producers, study of 9–19
healthcare reform 307–309, 445–447
healthcare value chain 361–366, 544–545, 552
herbs 33
high science 9
high throughput screening 20
HIPAA (Health Insurance Portability and Accountability Act 1996) 466, 475, 483–485
HITECH (Health Information Technology for Economic and Clinical Health) Act 452, 454–455, 467, 474,
HMO (health maintenance organization) 93, 133–134,
horizontal integration 157–158
hospitals
chief executive training 12
healthcare supply costs 11
HSA (health savings account) 489, 551
HTAs (health technology assessments) 96
HTS (high-throughput screening) 54, , 221
human cloning 313–314
human genome mapping/decoding 80, 120
Human Genome Project 215, 365
Human Genome Sciences 254, 368–369
hybrid business models 104
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 319, 320–321
imaging 20,
in control, concept of 59, 66
in-house venture capital 527
in-licensing
See licensing
IND (investigational new drug) applications 56, 119
India
animal experiments 107
biotechnology industry 298–300
cGxP 107
drug discovery/development 204
generic pharmaceutical companies 108–109
internal market 106–107
merger and acquisition (M&A) entry 132, 142
multinationals in 107, 108
pharmaceutical industry 46, 81, 106–111
pharmaceutical production levels 108
political system 107
research and development (R&D) 110–111
industry concentration 158
inflammation therapies 36
information asymmetry 161
information-based platform technologies 20
infrastructure costs 134–136
Infuse spine cage 432
innovation 2
affordable innovation 529
ambidextrous firms 528–529
business model 5, 73–87
from generics base 45
from service company base 46
frugal innovation 529
in healthcare business 27–28
medical devices decline 409
and mergers and acquisitions (M&As) 522
negative innovation 529
open source innovation 167
organizational 8–9
pure innovation models 44–45
questions about 5–6
reverse innovation 529
and value chain 1–3
and virtual pharma models 46–47
See also research and development (R&D)
innovation challenge 5–9
innovation factors 8–9
innovation process, common themes 23–24
innovation product 5
innovative pharmaceutical pricing 86–87
institutional accountability 546–547
insurance technology 16
integrated delivery network (IDN) 11
integrative devices in mergers and acquisitions (M&As) 161–163
integrative mechanisms 524
integrative structures 8
internal co-promoting 139
investment exit options 357
IO (industrial organization) perspective 6–7, 130–131
IP (intellectual property)/patents issues 55, 103, 125, 132, 137, 198–199, 211, 287, 347, , 352, 360–361, 367–369, , 373–374, 516
IPO (initial public offering) 237, 238–239, 351, 352, 440–441
IRB (Institutional Review Board) 326
IT
See healthcare IT (information technology)
Japan
biotechnology industry 287–290
drug regulation 325–326
pharmaceutical industry 41
pharmaceutical pricing 50
stem cell research 310–311, 312
Jones, Fletcher 493
JPMA (Japan Pharmaceutical Manufacturers Association) 320
junk mail advertising 92
Kefauver Amendments (1962) 98
Köhler, George 212, 213
KOL (key opinion leader) physicians 90, 91
Koop, C. Everett 494
Lander, Eric 219
Lehman, Betsy 473
Lehman Brothers 370–371
licensing 154, 166, 167–169, 265, 315–316, 353, 356, 368–369,
Liu, Edison 372–373
local economies, technology sectors impact 21–23
long-term exploration 8
Longman, Roger 150
merger and acquisition (M&A) 5, 6, 9, 24–25, , 77, 126–129
absorption approach 164
biotechnology firms, trends in 124–130, 204–205
challenges and strategies 118
concentration ratios 437–439
consolidation 116
and converging business models 521
cost efficiencies and mergers 153–154
deal sizes 436–437
deal trends 439–440
deceleration 122
defense against acquisition 140–141
and disruptive change 145–146
diversification 166
earnings growth and pipeline problems 136–139
economies in marketing 154
economies in sales 154
execution of 159
and foreign pharmaceutical markets 141–142,
genomics companies 165
historical role of 117–118
as horizontal integration 157–158
in-licensing 154, 166, 167–169
and increased profit pressures 133–134
in industrial organization theory/research 130–132
industry concentration 158
informal networks 163
and infrastructure costs 134–136
and innovation 522
and integration 524
integrative devices 161–163
internal value chain integration 165
jumpstarting existing projects 166
mass-mergerers 138
medical devices industry 434–437,
merger activity, reasons for 170
multiple motivations 146
and new markets 132
offensive rationales 141–146
pharmaceutical firms 124–130, 132–146, 147–156, 521
post-merger cooperation 164
post-merger integration 164
preservation approach 164
proactive rationales 141–146
as productivity problem 156–159
project reductions 165–166
and research and development investment 150
Roche/Genentech relationship 227, 241, 269–270
and scale 150–152
and stock market activity 132
string of pearls strategy 164
symbiotic approach 164
McClellan, Mark 535
MacMillan, Ian 527
MAD (multiple ascending dose) study 56–57
Mallory, Steve 501
management of strategic alliances 528
managing the balancing act 528
managing knowledge 524
manufacturers
See producers
manufacturing management 62
market barriers and technology convergence 535–538
market dynamics and technology convergence 535–538
market share and scale 150–152
market structures, fragmented 521–522
marketing
across the value chain 87–88
biological targets 87
candidate selection 87
high-risk period 88
junk mail advertising 92
payer marketing organizations 94–95
pharmaceutical promotion 90–92
stakeholder complexities 88–89
mass-mergerers 138
MCO (managed care organization) 15, 172–173
me-too drugs 133
Medicaid 15, 89, 173, 411, 552
Medical Device Act (1976) 381
medical devices 26–27
atrial fibrillation 402
cardiac rhythm management sector sales 418
cardiovascular area 36, 383–384
channel efficiency 426
company operating margins 410–411
comparison with other industries 379–380
comparison with pharmaceutical industry 424–426
consumer/customer/payer separation 411–415
consumerism limitations 424–426
convergent technology 533
coronary artery bypass graft 396–397
costs 14–16, , 415–417
coverage ratio 408
decline in innovation 409
defibrillators 389–391, 392–393, 399–400, 415, 418
Department of Justice inquiry 377
in diabetes 402
direct selling 417–419
drug/device convergence 431–433
economics of clinical needs 415–417
education by sales reps 419–420
electronics 427–428
financing 440–441
firm clusters 21–22
franchises 419
growth drivers 395–400, 434
demographics 395
geographic reach 398–399
perennial products 398, 399
pricing 397
procedure penetration 396–397
recent 399–400
unmet clinical needs 395–396
growth projection rates 403–405
growth slowing consequences 405–409
corporate structural changes 407–408
segment shuffling 405–407
historical perspective 380–381
immunity to price pressures 414
industry analysis 382–391
industry consolidation 433–434
industry growth rates 391–395
industry as oligopoly 522
industry overview 376–378
industry revenues 379–380, 382–384
industry structure 384–386
information playback to manufacturer 420–421
innovation and commercialization challenges 518–519
interventional cardiology products 396–397
market size 382–384
materials sciences 428–431
mergers and acquisitions (M&As) 434–437,
misapplications/errors 380–381
neurological area 384
neuromodulation 402
neurovascular/stroke occlusion 401
orthopedic extremities 401
orthopedics sales 420
percutaneous coronary interventions 396–397, 401
physicians as customers 411, 421, 518–519
profits 423–424
research and development (R&D) 26–27, 422
robotic surgery 402
sales 421–424
target company valuation 434–435
taxation on 446
technology 426–433
US production/revenues 386–391
ventricle assist device (VAD) 401
world production/revenues 386–391
Medical Technologies Innovation Scorecard 22
Medicare 15, 89, 308, 411, 552
Medicare Modernization Act (2003) 16, 171
medicine supply 64
MEP (market exclusivity period) 136
merger activity, reasons for 170
microarrays 221–222
Milstein, Cesar 212, 213
mixed payment sources 551–552
molecular diagnostics companies 219
monoclonal antibodies 206, 208, 212–215
Moore, Gordon 456
Morgan Stanley financial report 261–262, 263
multinationals 103–105, 107, 108
multiple disciplines (silos) 8
multiple sclerosis 207–208
multiple treatment interference 147
Munos, Bernard 77
Myhrvold, Nathan 457
national economies, technology sectors impact 21–23
NCE (new chemical entity) 33–34, , 44, 55, 61,
NDAs (new drug application) 58, 59–60, , 85, 119, 314
negative innovation 529
neuroscience 36, 211
NEWbio (new biotech company) 38–39
NHE (national health expenditure) 172
NHI (National Health Insurance) (Japan) 50
NHIN (National Health Information Network) 462–463, 467–468
NICE (National Institute of Health and Clinical Excellence) (UK) 96, 121
Nicholas, Peter 388
Nicholson, David 262
NIH (National Institutes of Health) 37, 199–201, , 244, 311–312, 541
NME (new molecular entity) 24, 33, 44–45, , 77, 119, 149, 158, 260–261, 271
non-clinical development 60
NPfIT (National Programme for IT) 464–465
NRDO (no research, development only) model 225, 233–235
Nutt, Roy 493
Obama, President Barack 244, 307, 311–312, , 446, 452, 466
OCP (Office of Combination Products) 535
off-label promotion 99
on-label promotion 99
open source innovation/research 167, 169,
OPPAGA (Office of Program Policy Analysis and Government Accountability) (Florida) 95
organizational innovation perspective 8–9
organizational slack 8
Orphan Drug Act (1983) 316–318
OTC (over-the-counter) medications 33
OTC (over-the-counter) shift 426
out-licensing
See licensing
pacemakers 388
PACS (picture archiving communication and storage) 476
Pandemic and All-Hazard Preparedness Act 318–319
Parkinson, Jay 481–482
passive pharmaceuticals 20
patent cliff 98,
patents
See under intellectual property/patents
patient monitoring/management, remote 476, 480–481
Patient Protection and Affordable Care Act (2010) 307
patients, as consumers 411
payer activism 170–171
payer organizations 92–96
applications 486–490
claims management 483–488, ,
cost 93
cost-containment 172
and medical devices 411–415
payer integration 93
payer marketing organizations 94–95
payer size 92–93
structure 93
value chain alliances with pharmaceutical 174–175
PBM (pharmacy benefit management) 16, 133–134,
PBMs (pharmacy benefit managers) 89
PDL (preferred drug list) 95
period, definition of 356
Perot, H. Ross 492–494
PET (positron emission tomography) scanners 20
pharmaceutical industry 33–41
Asia 41, 46, 81
and biologics 129–130
biotechnology alliances 126–130, 204–205, 328, 352–353
biotechnology product issues 68–69
business challenges 72–73
business model 69–73
cash-flow model 70
cGMP (current good manufacturing practice) and compliance 62, 67
challenges to 111–112
comparison with medical devices industry 424–426
compound potency 65–66
conglomerate models 45
customer-focused culture 65
diversification 33, 44–45, , 122, 131–132
drug discovery 175
DTC (direct to consumer) advertising 16, 90, 100–101, , 425–426
efficiency in procurement 176–177
efficiency and scale/scope 152–155
example of 39–41
expansion into therapeutics 142–143
financing 37
forecast accuracy 65
generic drug companies 37–38
and government budgets 174
government development of 21–23
in-licensing 154, 166, 167–169
infrastructure costs 134–136
innovation
See innovation
and managed care organizations 172–173
manufacturing performance 64
mergers and acquisitions (M&As)
as productivity problem 156–159
trends in
See merger and acquisition (M&A)
in multiple technologies 515–516
OTC (over-the-counter) shift 426
outsourcing non-core functions 176–177
patent cliff 98,
process robustness 66
product markets 41–47
product safety withdrawals 137
profit structure 425–426
promotional techniques 90
quality culture 67–68
reach and frequency model 97–98
reliability of companies 64–65
revenue 517–518
revenue stream shocks 137
risk 46, 69–73
Russia 46
segments 41–47
and specialty pharmacy providers 173
system integration 64
transaction automation 176–177
value chain alliances with payers 174–175
West–East redeployment 78
See under drug; individual companies; innovation; research and development
pharmaceutical insurance coverage 49
pharmaceutical manufacturers
See pharmaceutical industry
pharmaceutical markets 35–36, 141–142
pharmaceutical pricing 47–50, , 86–87
pharmaceutical promotion 90–92
regulation 91–92, 97, 98–101
technological advances 101
pharmaceutical strategy
challenges to industry 117
drivers of 119–124
deconstruction of the pharmaceutical industry 121
decrease in research and development (R&D) productivity 119–121
diversification in business approach 122
diversification in capabilities 122–123
expansion in developing markets 123–124
synergistic combinations of businesses 123
pharmaceutical venture funds 245
pharmaceuticals 229–231
cancer trials 34–35
cost effectiveness 34–35
customer enthusiasm 48
definition 33
demand drivers 50–51
development 56–60
healthcare innovation environment 37
therapeutics 36
value of 34–35
pharmacogenomics 228
phases in research and development
See research and development
PHR (personal health record) 496–497
employer-sponsored 498–499
health communities 500–503
independent 499–500
insurer-sponsored 497–498
PhRMA (Pharmaceutical Research and Manufacturers of America) 99, 101, 320
physician organizations 96–97
Physician Payments Sunshine Act (2010) 11
physicians
access to IT 457
and CPOE (computerized physician order entry) 468–470, 472–473,
as customers 411, 421
and Kefauver Amendments (1962) 98
practice management 482–483
product control quotient 421
and research 176
shortages of 544–545, 552
PICC (peripherally inserted central catheter) 406
picks and shovels companies 365
pipeline NPV (net present value) 149–150
pipeline problems and earnings growth 136–139
PIPE (private investment in public equity) 239–241
Pirimal Life Sciences 45, 108, 142
platform technology business models 26, 228–231, 518
PoCs (proof-of-concept) declarations 119, 120, 165
Porter, Michael 6–7, 22
portfolio management and optimization 526–527
post-merger integration 164
PPACA (Patient Protection and Affordable Care Act 2010) 446
PPAR (peroxisome proliferator-activated receptor) 45–46
PPI (physician preference item) 12
PPO (preferred provider organization) 93
practice management 482–483
preregistration in research and development (R&D) 58–59
PricewaterhouseCoopers, Medical Technologies Innovation Scorecard 22
private placements 239
procedures costs 413
process of change 8
producer–provider alliances 16–17
producers 1–3, 17, 23–24,
product competition 555
product development cycles 23, 25
product innovation 5
product safety withdrawals 137
product sector margins 18–19
product sector prominence 17–18
productivity cliff 119
profitability and scale 150–152
programs of change 8
promotional techniques 90
Prospective Payment System (1983) 3
proteomic technology platform companies 363–366
proteomics 2, 219–220
providers 1–3
public sector insurance schemes 89
purchasers 1–3
pure innovation models 44–45
QALY (quality-adjusted life year) 416
Quintiles 46
research and development (R&D)
annual spending 260–261
in Asia 104, 110–111
biotechnology costs 354–355, 517–518
budgets 139
candidate selection 55
cash-flow model 70
declining productivity 121
development issues 56–60, 61, 69–73, 520
discovery stage 52, 69
dry well projects 69
economies of scale/scope in 143–145
genomics companies 165
governance 9
in-licensing 154, 166, 167–169
integrative devices in mergers and acquisitions (M&As) 161–163
intellectual property/patents 55
investigational new drug (IND) application 56
investment 5, 17, 45–46
and mergers and acquisitions (M&As) 150
per employee 21
lead generation 53–54
lead optimization 54–55
in medical device sector 26–27, 422
limited partnerships 241–243
merger and acquisition (M&A) problems 156–159
in multiple technologies 515–516
NME (new molecular entity) spending 271
non-clinical development 60
pharmaceutical/biotechnology alliances 126–130
phase I 53, 56–57, 61, 69, 176, 266, 315
phase II 53, 57, 61, 62, 69, 83–85, 87, 143–144, 149, 165, 167, 175
phase III 58, 61, 69, 83–85, 87, 91, 119, 137, 143–144, 149, 165, 167, 260, 274, 315, 364
phase IV 58, 60, 171
preclinical development 69
preregistration 58–59
productivity 125, 145
proof-of-concept studies 69
registration 59–60, 69, 85–86
research challenges 78–81
research density 148
research funding 37
risk 61–62, 69–73
Roche/Genentech relationship 135, 141, 269–270
and scale 143–145, 147–148, 148–150
and slowing growth 407, 408
spending as risk management 143–144
target identification 52
target validation 52–53
in value chain 51–62
RAC (Recombinant DNA Advisory Committee) 222
radiopharmaceutical tracers 20
RAND report 454–455
RBV (resource-based view) 7
RDD (rational drug design) 20, 220–221,
reach and frequency model 97–98
refusal to file letters 85
registration in research and development (R&D) 59–60
regulation restrictions 98–101
regulatory forces 6
related diversification 526
remote patient monitoring/management 476
revenue model and value capture 357
reverse innovation 529
RFID (radio frequency identification) 20
RHIO (regional health information organization) 462–463
rifle medicines 82
RIPCO (royalty-income [also research-intensive] pharmaceutical company) 225, 231–233, 236, 357, 517
risk participation 46
risk, and research and development (R&D) 61–62
RNAi (RNA interference) 222–223
ROI (return on investment) 143–144, 236
ROI (return on investment) calculus 553–555
royalties
See IP
SaaS (software as a service) 455
SAD (single ascending dose) study 56–57
Safe Medical Devices Act (1990) 535
sales channels 523
sales and scale 150–152
SAR (structure–activity relationship) 53–54
SBIR (Small Business Innovative Research) grants 243–244
scaffolds (protein structures) 214–215
scale 131, 143–145, 149, 150–155, , 523
scope, and efficiency 152–155
screening 53
SEC (Securities and Exchange Commission) 240
service company base, and innovation 46
SESAM-Vitale smartcard 463–464
SFDA (State Food and Drug Administration) (China) 104
SFE (sales force effectiveness) 101
SG&A (selling, general, and administrative) expenses 143
shareholder value maximization 8
Sharp, Phillip 232–233
sheep cloning 313–314
short-term efficiency 8
silos (multiple disciplines) 8
SinoFDA (Chinese Food and Drug Administration) 105
SKU (stock-keeping unit) 63
Smart House monitoring 478
SOC (standard of care) 82–83
sourcing ideas 8
specialized company proximity 22
speed to market 66
Starr, Paul 546
Steere, Bill 138
stem cell research 303–319,
stock market activity, and merger and acquisition (M&A) 132
stock price and scale 150–152
strategic alliances, management of 528
string of pearls strategy 164
STTR (Small Business Technology Transfer) 244
suppliers
care delivery implications 552–553
and downstream value chains 546
supply chain management 12
supply/demand disequilibria 64
surrogate endpoints 83
Swanson, Robert A. 196
SWORD (stock warrant offer for research and development) financing 241–243
synergies 131, 160–161
systems biology 20, 223–224, 362
Taylorism 157
TCM (traditional Chinese medicine) 102
TCT (transcatheter cardiovascular therapeutics) 416
technological imperative
in healthcare 3–5
non-appreciation of 10–11
technology convergence
across sectors 19–21, 531–538
and combination products 532–534
and differentiation 531
and diversification 531
in healthcare 531–534,
importance of 531
market barriers to 535–538
market dynamics and 535–538
and productivity 531
types of 533
and World Economic Forum (Davos) 532–534
technology development alliances 370–371,
technology platform companies 363–375,
technology platform model 26, 228–231
technology sectors, impact on economies 21–23
technology spending 3–4
technology transfer alliances 371–375, ,
technology zealots 327
therapeutic area alliances 368–369
therapeutic pharmaceutical pricing 48
therapeutically active devices 533
therapeutics 246
and biotechnology 25
Biotherapeutics and Bioinnovation Center (BBC) 130
economic importance of 36
neuroscience therapies 36
pharmaceutical industry expansion into 142–143
research and development (R&D) scale economics 149
TCT (transcatheter cardiovascular therapeutics) 416
therapies, in absence of standard of care 82–83
tool companies 218
toolbox companies 365
top-down strategy 8
total cost arguments 171
tPA (tissue plasminogen activator) 273, 307
TPS (Toyota Production System) 548
transgenic mice 213
Turner, Merv 262
Ubl, Steve 444–445
uHTS (ultra high-throughput screening) 80
United Kingdom, biotechnology industry 278–280
United States of America, pharmaceutical pricing 49
upstream supply costs 11–16,
value analysis committees 11–16,
value chain 7
alliances in 174–175
delivery product 554
disruptions to 546
and innovation 1–3
internal 24
and marketing 87–88
perspective on 7–8
positioning 357
VBP (value-based purchasing) 553,
VCs (venture capitalists) 38–39
Viehbacher, Chris 262
Vincent, James 232–233
virtual model 235
virtual pharma models, and innovation 46–47
virtual primary care 481–482
Wanless, Derek 464
Warner-Lambert 67, 137, 138, 139–140, , 154
Watson, James 109, 196–201,
Wears, Robert 472–473
Wharton School Healthcare Management courses 1–3, 9
Wilmut, Ian 313–314
Witty, Andrew 262
World Economic Forum (Davos), and technology convergence 532–534
El negocio de la innovación sanitaria y es un amplio análisis de las tendencias de negocios en el segmento de fabricación de la industria de la salud. Proporciona una visión completa e introducción a los sectores innovadores mejorando así la salud: productos farmacéuticos, biotecnología, tecnología de la plataforma, dispositivos médicos y tecnologías de la información. Para cada sector, el libro examina la base y las tendencias de la innovación científica, los modelos de negocio y de ingresos perseguidos para comercializar que la innovación, las limitaciones normativas en el que cada sector debe operar y los problemas crecientes que plantea el más pagadores activistas y consumidores. Los temas específicos incluyen la estructura del mercado y la competencia, la economía y la justificación del desarrollo de productos, precios, ventas y marketing, negociaciones de contratos con los compradores, alianzas frente a las fusiones, las estrategias de negocio y las perspectivas de crecimiento. Escrito por profesores de la Escuela Wharton y ejecutivos de la industria, el libro muestra por qué los sectores de la salud son una fuente muy importante de crecimiento de la economía de cualquier nación.
9781107024977 (hardback) 9781107607774 (pbk.)
CUIDADO MEDICO--INNOVACIONES TECNOLÓGICAS
TECNOLOGÍA MEDICA--ASPECTOS ECONÓMICOS
PREVENCIÓN EN LOS NEGOCIOS
PREVENCIÓN ECONÓMICA
BIOTECNOLOGÍA--ECONOMÍA
610.28 / B979
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