The business of healthcare innovation / edited by Lawton Robert Burns.

Colaborador(es): Burns, Lawton R [edit]Tipo de material: TextoTextoEditor: Cambridge, UK : Cambridge University Press, 2012Edición: 2nd edDescripción: xxiv, 574 p. : il. ; 26 cmISBN: 9781107024977 (hardback); 9781107607774 (pbk.)Tema(s): CUIDADO MEDICO -- INNOVACIONES TECNOLÓGICAS | TECNOLOGÍA MEDICA -- ASPECTOS ECONÓMICOS | PREVENCIÓN EN LOS NEGOCIOS | PREVENCIÓN ECONÓMICA | BIOTECNOLOGÍA -- ECONOMÍAClasificación CDD: 610.28
Contenidos:
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
Resumen: 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.
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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.

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