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008			120410s2012 enka b 001 0 eng
020			_a9781107024977 (hardback)
020			_a9781107607774 (pbk.)
040			_aDNLM/DLC _cDLC
082	0	0	_a610.28 _223 _bB979
245	0	4	_aThe business of healthcare innovation / _cedited by Lawton Robert Burns.
250			_a2nd ed.
260			_aCambridge, UK : _bCambridge University Press, _c2012.
300			_axxiv, 574 p. : _bil. ; _c26 cm.
504			_aIncluye bibliografía e indices
505			_aAbbott 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
520			_aEl 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.
650		0	_aCUIDADO MEDICO _xINNOVACIONES TECNOLÓGICAS _9461
650		0	_aTECNOLOGÍA MEDICA _xASPECTOS ECONÓMICOS _91845
650		0	_aPREVENCIÓN EN LOS NEGOCIOS _91846
650		0	_aPREVENCIÓN ECONÓMICA _91847
650		0	_91220 _aBIOTECNOLOGÍA _xECONOMÍA
700	1		_aBurns, Lawton R. _eedit _91848
942			_2ddc _cBK
999			_c17540 _d17540