Value creation in the pharmaceutical industry: the critical path to innovation
Gespeichert in:
| Weitere Verfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Weinheim
Wiley-VCH
2016
|
| Schlagworte: | |
| Online-Zugang: | http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-33913-6/ Inhaltsverzeichnis |
| Beschreibung: | XXII, 485 Seiten Diagramme, Illustrationen 24.4 cm x 17 cm |
| ISBN: | 3527339132 9783527339136 9783527693405 |
Internformat
MARC
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| 245 | 1 | 0 | |a Value creation in the pharmaceutical industry |b the critical path to innovation |c edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann |
| 264 | 1 | |a Weinheim |b Wiley-VCH |c 2016 | |
| 300 | |a XXII, 485 Seiten |b Diagramme, Illustrationen |c 24.4 cm x 17 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
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| 653 | |a Biotechnologie i. d. Biowissenschaften | ||
| 653 | |a Biotechnology | ||
| 653 | |a Biowissenschaften | ||
| 653 | |a Business & Management | ||
| 653 | |a Chemie | ||
| 653 | |a Chemistry | ||
| 653 | |a Creativity & Innovation Management | ||
| 653 | |a Innovations- u. Kreativitätsmanagement | ||
| 653 | |a Life Sciences | ||
| 653 | |a Pharmaceutical & Medicinal Chemistry | ||
| 653 | |a Pharmazeutische u. Medizinische Chemie | ||
| 653 | |a Wirtschaft u. Management | ||
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| 700 | 1 | |a Schuhmacher, Alexander |d 1972- |0 (DE-588)123348625 |4 edt | |
| 700 | 1 | |a Hinder, Markus |4 edt | |
| 700 | 1 | |a Gassmann, Oliver |4 edt | |
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| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe, PDF |z 978-3-527-69343-6 |
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Datensatz im Suchindex
| _version_ | 1804175922770739200 |
|---|---|
| adam_text | CONTENTS
LIST OF CONTRIBUTORS XVII
FOREWORD XXI
1 INTRODUCTION TO THE BOOK 1
ALEXANDER SCHUHMACHER, OLIVER GASSMANN, AND MARKUS HINDER
REFERENCE 8
2 GLOBAL EPIDEMIOLOGICAL DEVELOPMENTS 11
STEPHAN LUTHER AND PETER SCHMITZ
2.1 INTRODUCTION 11
2.2 MODEL OF EPIDEMIOLOGICAL TRANSITION 12
2.3 GLOBAL BURDEN OF DISEASES 15
2.3.1 TRENDS IN THE DISTRIBUTION OF DISEASE BURDEN 16
2.4 INFECTIOUS DISEASES 20
2.4.1 (RE-)EMERGING INFECTIOUS DISEASES 23
2.4.2 NEGLECTED TROPICAL DISEASES 26
2.5 NONCOMMUNICABLE DISEASES 29
2.6 ANTIMICROBIAL RESISTANCE 32
2.7 DYNAMICS 35
REFERENCES 38
3 THE VALUE OF PHARMACEUTICAL INNOVATION: CONCEPTS AND
ASSESSMENT 45
SAM SALEK AND PAUL KAMUDONI
3.1 INTRODUCTION 45
3.2 CONCEPTS AND DEFINITIONS OF VALUE 46
3.3 STAKEHOLDER*S PERSPECTIVES ON VALUE 47
3.3.1 DRUG REGULATORY AGENCIES 47
3.3.2 HEALTH TECHNOLOGY ASSESSMENT 47
3.3.3 PATIENTS 49
3.3.4 PRESCRIBERS/CLINICIANS 49
3.4 RECENT DEVELOPMENTS INFLUENCING THE DEFINITION AND ASSESSMENT OF
VALUE 50
3.5
3.6
3.7
4
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6
6.1
6.2
6.3
6.4
6.4.1
6.4.2
RECOMMENDATIONS: IMPLICATIONS FOR R&D 51
DISCUSSION 52
CONCLUSION 56
REFERENCES 57
A REVIEW OF THE PHARMACEUTICAL R&D EFFICIENCY: COSTS, TIMELINES, AND
PROBABILITIES 61
ALEXANDER SCHUHMACHER, OLIVER GASSMANN, AND MARKUS HINDER
INTRODUCTION 61
THE HISTORICAL PERSPECTIVE 62
THE R&D PHASE MODEL 63
THE LOW R&D SUCCESS RATES 63
THE LONG R&D TIME INTERVALS 67
THE HIGH COST OF PHARMACEUTICAL R&D 71
THE REDUCED R&D EFFICIENCY 73
CAN AN INCREASE IN R&D VALUE COMPENSATE THE REDUCED R&D
EFFICIENCY? 76
REFERENCES 78
FINANCING PHARMACEUTICAL INNOVATION 81
SVIATASLAU SIVAGRAKAU
INTRODUCTION 81
MEASURING INNOVATION: CATEGORIES OF NEW DRUGS 84
PRODUCTIVITY OF PHARMACEUTICAL INDUSTRY THROUGHOUT
TIME 86
MEASURING THE COST OF DEVELOPING NEW MEDICINES 87
FUNDING DRUG DEVELOPMENT: A GLOBAL ENDEAVOR 91
PUBLIC AND PRIVATE FUNDS: COMPLEMENTARY FINANCE FOR DRUG
DEVELOPMENT 95
HOW COMMERCIAL DRUG DEVELOPMENT PROJECTS ARE FINANCED TODAY:
BIG FIRMS, SMALL FIRMS, AND THEIR COOPERATION 97
PUBLIC HEALTH ECONOMICS AND FINANCING PHARMACEUTICAL
INNOVATION 99
CONCLUSION 101
ACKNOWLEDGMENT 102
REFERENCES 102
CHALLENGES AND OPTIONS FOR DRUG DISCOVERY 107
WERNER KRAMER
INTRODUCTION 107
PARADIGM SHIFTS OF R&D ORGANIZATIONS 108
PRODUCTIVITY OF DRUG DISCOVERY 109
IS THERE AN INNOVATION GAP IN BIOMEDICAL RESEARCH? I L L
TO GO FOR FIRST IN CLASS OR BEST IN CLASS 112
HOW WE DEFINE MEDICAL INNOVATION? 112
6.5
6.5.1
6.5.1.1
6.5.1.2
6.6
6
.
6.1
6
.
6.2
6
.
6
.
2.1
6
.
6
.
2.2
6.6.2.5
6.6.2.4
66.2.5
7
7.1
7.2
7.3
7.4
7.4.1
7.4.2
7.4.3
7.4.4
7.4.5
7.4.6
7.5
7.6
8
8.1
8.2
8
.
2.1
8
.
2.2
WHY DID DRUG CANDIDATES FAIL? 113
WHY IS THE DROPOUT RATE SO HIGH IN EARLY CLINICAL
DEVELOPMENT? 115
DRUG BEHAVIOR
IN VIVO: ROLE OF TRANSPORT PROTEINS 115
HYPES AND LACK OF SCIENTIFIC THOROUGHNESS 116
IMPLICATIONS FROM THE LESSONS LEARNT FOR FUTURE DRUG DISCOVERY
RESEARCH
123
ORGANIZATION OF DRUG DISCOVERY AND DEVELOPMENT 123
ELUCIDATION OF THE PHYSIOLOGICAL VALIDITY OF A TARGET FOR THE HUMAN
DISEASE
125
EXTENSIVE INQUIRY OF (ALL) PUBLISHED DATA OF A TARGET OR
PATHWAY 125
INTEGRATIVE KNOWLEDGE MANAGEMENT 127
DEMONSTRATION OF THE INVOLVEMENT OF A TARGET IN HUMAN
DISEASE 128
A STRINGENT AND COMPREHENSIVE TEST SEQUENCE 132
TRANSLATIONAL CLINICAL TRIALS 135
ACKNOWLEDGMENT 136
REFERENCES 136
TRANSLATIONAL MEDICINE: ENABLING THE PROOF OF CONCEPTS 141
GEZIM LAHU AND JOHN DARBYSHIRE
INTRODUCTION 141
TRANSLATIONAL MEDICINE AND ITS ROLE/VALUE IN EARLY
DEVELOPMENT 143
KNOWLEDGE GENERATION 144
TYPES OF DATA, EXPERIMENTS, AND TOOLS NEEDED TO MOVE FROM BASIC
RESEARCH TO EARLY CLINICAL DEVELOPMENT 144
DOSE SELECTION 145
ANIMAL MODELS 146
FRACTION OF NOAEL AND EFFICACIOUS DOSE 149
ALLOMETRIC SCALING AND PBPK 150
PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS PBPK 151
PHARMACOKINETIC AND PHARMACODYNAMIC MODELING 151
FIM (DOSE ESCALATION AND MTD) 153
PROOF OF CONCEPT (POC) 154
SUMMARY 156
REFERENCES 157
PREDINICAL SAFETY AND RISK ASSESSMENT 161
PAUL GERMANN AND ROB CALDWELL
INTRODUCTION 161
TEST SYSTEMS 161
IN SILICO ANALYSIS 161
IN VITRO EXPERIMENTS 162
8.3
8.3.1
8.4
8.5
8.5.1
8.5.2
8.5.3
8.5.4
8.5.5
8.5.6
8.6
8.7
8.8
8.9
8.10
8.11
8.12
8.13
9
9.1
9.2
9.2.1
9.2.2
9.2.3
9.2.4
9.2.5
9.3
9.4
9.5
CASE STUDY: HERG ASSAY 163
IN VIVO EXPERIMENTS 164
THE PRECLINICAL PACKAGE DURING THE DEVELOPMENT OF AN
NME 165
FACTORS INFLUENCING THE PRECLINICAL DATA SET 166
TIMING AND COSTS 167
INTENDED CLINICAL APPLICATION ROUTE 167
TREATMENT DURATION AND TREATMENT FREQUENCY 167
CLINICAL INDICATION 167
ONGOING CHANGES OF THE REGULATORY LANDSCAPE 168
NEW DRUG FORMATS 168
TRANSLATION INTO HUMANS: THE THERAPEUTIC WINDOW 169
INFLUENCE OF INTENDED THERAPEUTIC USE ON THE RISK ASSESSMENT
(RA) 169
DEEP DIVE CASE STUDY: SAFETY ASSESSMENT OF BIOLOGICAL DRUG
FORMATS 170
NBE CASE STUDY 1 175
NBE CASE STUDY 2 175
CARCINOGENICITY RISK ASSESSMENT FOR MARKETED DRUGS 176
TREATMENT DURATION 178
CONCLUSION - THE ART OF PRECLINICAL SAFETY: SUMMARIZING THE
CONCEPT OF HAZARD IDENTIFICATION AND DESCRIPTION, RISK ASSESSMENT,
AND RISK MANAGEMENT 179
ACKNOWLEDGMENT 179
DISCLOSURES 180
REFERENCES 180
DEVELOPING COMMERCIAL SOLUTIONS FOR THERAPEUTIC
PROTEINS 183
GALINA HESSE
INTRODUCTION 183
DEVELOPING COMMERCIAL SOLUTIONS FOR THERAPEUTIC PROTEINS 184
DEFINING A TARGET PRODUCT PROFILE 184
DEVELOPING FORMULATIONS FOR THERAPEUTIC PROTEINS 186
TESTING FORMULATIONS FOR THERAPEUTIC PROTEINS 188
DEVELOPMENT OF PRIMARY CONTAINERS 188
DEVELOPMENT OF APPLICATION SYSTEMS 190
QUALITY BY DESIGN 192
EXAMPLES FOR INNOVATIONS IN MANUFACTURE OF STERILE PHARMACEUTICAL
PRODUCTS 194
SUMMARY 197
LIST OF FDA/ICH GUIDANCES REFERENCED 198
DISCLAIMER 199
REFERENCES 199
10 THE EVOLUTION OF CLINICAL DEVELOPMENT: FROM TECHNICAL SUCCESS TO
CLINICAL VALUE CREATION 203
MARKUS HINDER AND ALEXANDER SCHUHMACHER
10.1 INTRODUCTION 203
10.2 CD: CHANGES AND CHALLENGES 204
10.2.1 CLINICAL ENDPOINTS: FROM SYMPTOM-ORIENTED ENDPOINTS TO HARD AND
PREDEFINED ENDPOINTS 204
10.2.2 DETERMINATION AND QUANTIFICATION OF RISKS 205
10.2.3 ASSESSMENT OF MEDICAL PROGRESS IN CONTEXT OF AVAILABLE
THERAPEUTIC
OPTIONS 206
10.2.3.1 EBM 206
10.2.3.2 HEALTH ECONOMICS, PHARMACOECONOMICS, AND THE FOURTH
HURDLE 207
10.2.3.3 RESULTS OF THESE CHANGES AND CHALLENGES 208
10.3 TECHNICAL SUCCESS AND CLINICAL VALUE CREATION IN CD IN THE
FUTURE 208
10.3.1 ESTABLISHED AND NOVEL APPROACHES TO DETERMINE THE
DOSE - EXPOSURE - RESPONSE RELATIONSHIP 210
10.3.2 COMPARATORS 212
10.3.3 PATIENT STRATIFICATION TO INCREASE TREATMENT RESPONSE AND BENEFIT
AND REDUCE RISK 212
10.3.4 NEW OPERATIONAL TOOLS TO SUCCEED IN TRIALS WITH INCREASED
COMPLEXITY, SPECIAL POPULATIONS, OR LARGE SIZE 213
10.3.5 COLLABORATION AND OUTSOURCING AS TOOLS TO WORK IN NETWORKS 214
10.3.6 COLLABORATION ACROSS SECTORS AND INDUSTRIES TO BOOST THE NEXT
WAVE
OF INNOVATION 215
DISCLAIMER 218
REFERENCES 218
11 TRANSLATIONAL DEVELOPMENT 225
NIGEL MCCRACKEN
11.1 INTRODUCTION 225
11.1.1 LEGACY 226
11.2 TRANSLATIONAL DEVELOPMENT 227
11.2.1 TP 228
11.2.2 TRANSLATIONAL TOOLKIT 229
11.3 DOSE OPTIMIZATION 230
11.3.1 PHYSICOCHEMICAL PROPERTIES 231
11.3.2 TARGET AFFINITY AND SELECTIVITY 231
11.3.3 CLEARANCE 231
11.3.4 PREDICTION OF HUMAN DOSE 232
11.4 PHARMACOGENOMICS 233
11.4.1 PATIENT SEGMENTATION 233
11.4.2 DISEASE SEGMENTATION 234
11.4.3 UTILITY 237
11.5 BIOMARKER DEVELOPMENT 238
11.5.1 BIOMARKER ACTIVITIES 239
11.5.2 ASSESSING THE OPPORTUNITY 239
11.6 SYSTEMS PHARMACOLOGY 240
11.7 RATIONAL DRUG DEVELOPMENT 241
11.8 CONCLUDING REMARKS 242
REFERENCES 242
12 FORTY YEARS OF INNOVATION IN BIOPHARMACEUTICALS - WILL THE NEXT
40 YEARS BE AS REVOLUTIONARY? 245
MATHIAS SCHMIDT, SANJAY PATEL, PETTER VEIBY, QIANG LIU, AND MICHAEL
BUCKLEY
12.1 INTRODUCTION 245
12.1.1 THE VALUE PROPOSITION OF BIOLOGIES 246
12.1.1.1 THE PATIENT PERSPECTIVE 246
12.1.1.2 THE PHARMACEUTICAL INDUSTRY S PERSPECTIVE 248
12.1.2 BIOSIMILARS: A BLESSING OR A THREAT TO INNOVATION? 250
12.1.3 FURTHER INNOVATION IN BIOLOGIES - INCREMENTAL OR
REVOLUTIONARY? 252
12.2 THE EVOLUTION OF BIOLOGIES MANUFACTURING 252
12.2.1 INTRODUCTION 252
12.2.2 CHO CELLS: THE INDUSTRY WORKHORSE 253
12.2.3 PROTEIN PRODUCTION STRATEGIES 253
12.2.4 THE IMPACT OF INCREASING TITERS ON MANUFACTURING FACILITIES 255
12.2.5 PROTEIN PURIFICATION PLATFORMS 256
12.2.6 CONCLUSION: WHAT WILL THE NEXT 40 YEARS OF INNOVATION BRING? 258
12.3 THE EVOLUTION OF ALTERNATIVE SCAFFOLDS 259
12.3.1 NOVEL SMALL PROTEIN SCAFFOLDS 260
12.3.2 SINGLE-CHAIN FRAGMENT VARIABLES AND DIABODIES 260
12.3.3 SINGLE-DOMAIN ANTIBODIES 261
12.3.4 NONANTIBODY SCAFFOLDS 261
12.3.5 BISPECIFIC SINGLE-CHAIN FRAGMENT VARIABLES AND DIABODIES 263
12.3.6 OTHER BISPECIFIC ANTIBODY FORMATS 264
12.4 ANTIBODY-DRUG CONJUGATES 265
12.5 THE NEXT WAVE OF BIOLOGIES 270
12.5.1 ORALLY AVAILABLE BIOLOGIES 271
12.5.2 BIOLOGIES THAT ENTER THE CYTOPLASM 271
12.5.3 BIOLOGIES THAT PASS THE BLOOD - BRAIN BARRIER 272
12.5.4 TRANSLATIONAL MEDICINE AS DRIVER OF INNOVATION 272
DISCLAIMER 273
REFERENCES 273
13 VACCINES: WHERE INERTIA, INNOVATION, AND REVOLUTION CREATE VALUE,
SIMULTANEOUSLY AND QUIETLY 277
PIERRE A. MORGON AND HANNAH NAWI
13.1 INTRODUCTION 277
13.2
13.2.1
13.2.2
13.2.3
13.2.4
13.3
13.4
13.4.1
13.4.2
13.4.2.1
13.4.2.2
13.4.2.3
13.4.2.4
13.5
13.5.1
13.5.2
13.5.3
13.5.4
13.5.5
13.6
13.6.1
14
14.1
14.2
14.3
14.4
14.5
14.6
14.7
14.8
THE WORLD OF VACCINES 278
WHAT ARE VACCINES? 278
CURRENT VACCINES ARE MAINLY PROPHYLACTIC: CURATIVE VACCINES ARE
EMERGING 278
DRIVERS TO IMMUNIZE: INDIVIDUAL AND COLLECTIVE 280
THE PIVOTAL ROLE OF RECOMMENDATIONS 280
THE VACCINE MARKET: SUBSTANTIAL, FAST GROWING, WITH INTENSE AND
CONCENTRATED COMPETITION 281
THE VACCINE INDUSTRY: DOMINATION OF THE HEAVYWEIGHTS, FOR
NOW... 282
BARRIERS TO ENTRY: FROM R&D RISK TO CAPITAL INTENSIVENESS 290
FIVE FORCES ANALYSIS: COMPETITIVE INTENSIVENESS AND DOWNSTREAM
HURDLES 291
ACCEPTABILITY 291
ACCESSIBILITY 292
AVAILABILITY 293
AFFORDABILITY 293
NEW VACCINE DEVELOPMENTS: STRATEGIC TRENDS AND WHY INNOVATION IS
NEEDED ALL ALONG THE VALUE CHAIN 295
WHERE IS INNOVATION NEEDED? R&D 296
WHERE IS INNOVATION NEEDED? MANUFACTURING AND PRODUCT
IMPROVEMENT 301
WHERE IS INNOVATION NEEDED? ACCEPTABILITY 301
WHERE IS INNOVATION NEEDED? ACCESSIBILITY, BOTH AS A FUNCTION OF
SUPPLY (AVAILABILITY) AND LOGISTICS 302
AFFORDABILITY AND SUSTAINABILITY 303
WHERE WILL INNOVATION COME FROM? STRATEGY AND PLAYERS 304
TAKE-HOME MESSAGES 305
REFERENCES 306
THE PATIENT-CENTRIC PHARMA COMPANY: EVOLUTION, REBOOT, OR
REVOLUTION? 309
PIERRE A. MORGON
INTRODUCTION 309
HEALTH, ALWAYS... 310
THE MISSION OF THE HEALTHCARE INDUSTRY 310
MEGATRENDS AFFECTING THE STRATEGIC SCORECARD OF THE HEALTHCARE
INDUSTRY 312
FOCUS ON THE SOCIETAL TRENDS AND THEIR CONSEQUENCES FOR THE
MANAGEMENT OF HEALTHCARE INNOVATION
314
THE DNA OF THE HEALTHCARE INDUSTRY: R&D AND THE MANAGEMENT OF
INNOVATION 316
SOCIETAL EXPECTATIONS FOR PERSONALIZED MEDICINE 318
NEW PLAYERS CONTRIBUTING TO INFORMATION MANAGEMENT TO
SUBSTANTIATE VALUE PROPOSITIONS FOR NOVEL THERAPIES 319
14.9 THE ROLE OF THE KEY STAKEHOLDERS IN SHAPING A NEW REGULATORY
FRAMEWORK 323
14.10 THE CONSEQUENCES FOR THE HEALTHCARE INDUSTRY IN TERMS OF
GOVERNANCE AND CAPABILITIES 325
14.11 THE SUSTAINABLE PATH FORWARD FOR THE HEALTHCARE INDUSTRY 329
14.11.1 TAKE-HOME MESSAGES 331
REFERENCES 332
15 THE PHARMACEUTICAL INDUSTRY IS OPENING ITS R&D BOUNDARIES 335
ALEXANDER SCHUHMACHER AND ULRICH A. K. BETZ
15.1 INTRODUCTION 335
15.2 OPEN INNOVATION VERSUS CLOSED INNOVATION 336
15.3 BUSINESS MODELS IN AN OPEN INNOVATION FRAMEWORK 341
15.4 OPEN INNOVATION PROCESSES 342
15.5 CAPABILITIES AND ATTITUDES ENABLING OPEN INNOVATION 344
15.6 OPEN INNOVATION IN THE PHARMACEUTICAL INDUSTRY 345
15.6.1 THE MORE TRADITIONAL ELEMENTS OF OPEN INNOVATION 345
15.6.1.1 TARGET SCOUTING 345
15.6.1.2 RESEARCH COLLABORATIONS 346
15.6.1.3 DRUG LICENSING 346
15.6.1.4 OUTSOURCING 348
15.6.1.5 JOINTVENTURES 349
15.6.2 THE NEWER CONCEPTS OF OPEN INNOVATION 349
15.6.2.1 NEW FRONTIER SCIENCE 350
15.6.2.2 DRUG DISCOVERY ALLIANCES 350
15.6.2.3 PRIVATE-PUBLIC PARTNERSHIPS 351
15.6.2.4 INNOVATION INCUBATOR 351
15.6.2.5 VIRTUAL R&D 352
15.6.2.6 CROWDSOURCING 353
15.6.2.7 OPEN SOURCE INNOVATION 355
15.6.2.8 INNOVATION CAMPS 355
15.6.2.9 FLUCTUATING OPEN TEAMS 356
15.7 NEW BUSINESS MODELS IN VIEW OF THE POTENTIAL OF OPEN
INNOVATION 356
15.7.1 GENERAL TRENDS IN THE PHARMACEUTICAL INDUSTRY 356
15.8 OUTLOOK 358
REFERENCES 359
16 OUT-LICENSING IN PHARMACEUTICAL RESEARCH AND DEVELOPMENT 363
OLIVER GASSMANN, CAROL A. KRECH, MARTIN A. BADER, AND GERRIT REEPMEYER
16.1 INTRODUCTION 363
16.2 PERFORMANCE-BASED R&D COLLABORATIONS ON THE RISE 364
16.3 THE IMPACT OF COLLABORATIONS ON THE VALUE CHAIN 365
16.4 GENERATING VALUE FROM PIPELINE ASSETS BY OUT-LICENSING 367
16.5 PHARMACEUTICAL COMPANIES* RESISTANCE TOWARD OUT-LICENSING 372
16.6 MANAGING OUT-LICENSING AT NOVARTIS: A CASE STUDY 372
16.6.1 OUT-LICENSING AS A 10-STEP PROCESS 373
16.6.2 OUT-LICENSING CONTRACT DESIGN 375
16.6.3 STRUCTURE OF THE OUT-LICENSING COLLABORATION WITH SPEEDEL 375
16.7 FUTURE DIRECTIONS AND TRENDS 377
REFERENCES 378
17 TRENDS AND INNOVATIONS IN PHARMACEUTICAL R&D OUTSOURCING 383
ANTAL K. HAJOS
17.1 INTRODUCTION 383
17.2 DRIVERS TO THE USE OF OUTSOURCING 383
17.2.1 OVERVIEW ON THE CRO MARKET 383
17.2.2 CORE VERSUS NONCORE ACTIVITIES 387
17.3 GENESIS OF OUTSOURCING IN THE TWENTIETH CENTURY: FROM COMMODITY
TO CONTRIBUTION 388
17.3.1 OUTSOURCING PORTFOLIO AND THE MOVE TO FULL-SERVICE PROVISION 388
17.3.2 GLOBALIZATION AND THE EMERGING MARKET HYPE 389
17.3.3 PROCUREMENT TAKES OVER THE OUTSOURCING FUNCTION 391
17.4 CURRENT AND FUTURE TRENDS IN OUTSOURCING: FROM CONTRIBUTION TO
INNOVATION 392
17.4.1 HOW HAS OUTSOURCING ITSELF INNOVATED AND WHAT ARE THE FUTURE
TRENDS? 392
17.4.2 HOW DOES AND WILL OUTSOURCING CONTRIBUTE TO INNOVATION? 394
17.5 DISCUSSION AND CONCLUSION 395
REFERENCES 398
18 NEW INNOVATION MODELS IN PHARMACEUTICAL R&D 401
ALEXANDER SCHUHMACHER, OLIVER GASSMANN, AND MARKUS HINDER
18.1 INTRODUCTION 401
18.2 SOME ATTEMPTS THAT WERE RECOMMENDED IN THE PAST 402
18.3 THE INCREASING PIPELINE SIZE 403
18.4 THE REDUCTION OF R&D INVESTMENTS 404
18.5 THE OPENING OF THE R&D PROCESSES 407
18.6 THE CHALLENGE WITH THE RETURN ON INVESTMENT 411
18.7 CHANGING THE R&D PROCESSES IS NOT ENOUGH 412
18.8 WHAT IS THE BEST R&D MODEL? 413
REFERENCES 414
19 THE INFLUENCE OF LEADERSHIP PARADIGMS AND STYLES ON PHARMACEUTICAL
INNOVATION 416
AUBYN HOWARD
19.1 INTRODUCTION 417
19.2 WHAT IS YOUR CONCEPT OR MODEL OF GOOD LEADERSHIP? 419
19.3 APPROACHES TO LEADERSHIP MODELING AND PROFILING 420
19.3.1 PERSONALITY TYPES 421
19.3.2 BEHAVIORAL PREFERENCES 421
19.3.3 DEVELOPMENTAL STAGES 421
19.3.4 COMPETENCY FRAMEWORKS 421
19.4 THE DEVELOPMENTAL APPROACH TO LEADERSHIP PARADIGMS AND
STYLES 422
19.5 INNER AND OUTER LEADERSHIP 424
19.6 DYNAMICS OF HOW LEADERSHIP PARADIGMS EVOLVE 425
19.6.1 MAGIC - ANIMISTIC 426
19.6.2 IMPULSIVE - EGOCENTRIC 427
19.6.3 CONFORMIST - ABSOLUTIST 428
19.6.4 ACHIEVEMENT - MULTIPLISTIC 429
19.6.5 PLURALISTIC - RELATIVISTIC 430
19.6.6 EVOLUTIONARY - SYSTEMIC 432
19.7 LEADERSHIP AT DIFFERENT LEVELS WITHIN PHARMA 433
19.8 OPTIMIZING INNOVATION IN DIFFERENT ORGANIZATIONAL MODELS AND
CULTURES 437
19.9 HOW DO WE SUPPORT THE DEVELOPMENT OF EVOLUTIONARY
LEADERS? 439
19.10 WHAT DOES IT MEAN TO OPERATE FROM THE EVOLUTIONARY
PARADIGM? 440
19.11 LEADERSHIP AND PERSONAL MASTERY 441
19.12 BUILDING AN EVOLUTIONARY BRIDGE TO RELEASE INNOVATION 442
19.13 CONCLUSIONS 445
REFERENCES 446
20
THE ROLE OF MODERN PORTFOLIO MANAGEMENT IN PHARMA
INNOVATION 449
JOACHIM M. GREUEL AND AXEL WIEST
20.1 INTRODUCTION 449
20.2 CHALLENGES IN R&D AND THE ORIGIN OF PHARMACEUTICAL PORTFOLIO
MANAGEMENT 450
20.3 GOALS AND METRICS OF PORTFOLIO MANAGEMENT 451
20.4 PORTFOLIO MANAGEMENT AS ENABLER OF INNOVATION 456
20.5 MODERN PORTFOLIO MANAGEMENT INTEGRATES IN-HOUSE R&D, BUSINESS
DEVELOPMENT, AND M&A 457
REFERENCES 458
21 PATENT MANAGEMENT THROUGHOUT THE INNOVATION LIFE CYCLE 461
MARTIN A. BADER AND OLIVER GASSMANN
21.1 INTRODUCTION 461
21.2 THE CHANGING ROLE OF PATENTS: FROM LEGAL TO STRATEGIC 462
21.3 THE PATENT LIFE CYCLE MANAGEMENT MODEL 467
21.3.1 EXPLORATION 468
21.3.2 GENERATION 469
21.3.3 PROTECTION 469
21.3.4 OPTIMIZATION 470
21.3.5 DECLINE 470
21.4 EXAMPLE: MANAGING IP RIGHTS AT BAYER 471
21.5 CONCLUDING REMARKS 472
REFERENCES 473
INDEX 475
|
| any_adam_object | 1 |
| author2 | Schuhmacher, Alexander 1972- Hinder, Markus Gassmann, Oliver |
| author2_role | edt edt edt |
| author2_variant | a s as m h mh o g og |
| author_GND | (DE-588)123348625 |
| author_facet | Schuhmacher, Alexander 1972- Hinder, Markus Gassmann, Oliver |
| building | Verbundindex |
| bvnumber | BV043363273 |
| classification_rvk | QR 525 |
| ctrlnum | (OCoLC)956510125 (DE-599)DNB1079291016 |
| dewey-full | 540 |
| dewey-hundreds | 500 - Natural sciences and mathematics |
| dewey-ones | 540 - Chemistry and allied sciences |
| dewey-raw | 540 |
| dewey-search | 540 |
| dewey-sort | 3540 |
| dewey-tens | 540 - Chemistry and allied sciences |
| discipline | Chemie / Pharmazie Wirtschaftswissenschaften |
| format | Book |
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| id | DE-604.BV043363273 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T07:23:59Z |
| institution | BVB |
| institution_GND | (DE-588)16179388-5 |
| isbn | 3527339132 9783527339136 9783527693405 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-028782430 |
| oclc_num | 956510125 |
| open_access_boolean | |
| owner | DE-1049 DE-703 |
| owner_facet | DE-1049 DE-703 |
| physical | XXII, 485 Seiten Diagramme, Illustrationen 24.4 cm x 17 cm |
| publishDate | 2016 |
| publishDateSearch | 2016 |
| publishDateSort | 2016 |
| publisher | Wiley-VCH |
| record_format | marc |
| spelling | Value creation in the pharmaceutical industry the critical path to innovation edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann Weinheim Wiley-VCH 2016 XXII, 485 Seiten Diagramme, Illustrationen 24.4 cm x 17 cm txt rdacontent n rdamedia nc rdacarrier Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf Innovationsmanagement (DE-588)4161817-8 gnd rswk-swf Biotechnologie i. d. Biowissenschaften Biotechnology Biowissenschaften Business & Management Chemie Chemistry Creativity & Innovation Management Innovations- u. Kreativitätsmanagement Life Sciences Pharmaceutical & Medicinal Chemistry Pharmazeutische u. Medizinische Chemie Wirtschaft u. Management Pharmazeutische Industrie (DE-588)4045696-1 s Innovationsmanagement (DE-588)4161817-8 s DE-604 Schuhmacher, Alexander 1972- (DE-588)123348625 edt Hinder, Markus edt Gassmann, Oliver edt Wiley-VCH (DE-588)16179388-5 pbl Erscheint auch als Online-Ausgabe, EPUB 978-3-527-69341-2 Erscheint auch als Online-Ausgabe, MOBI 978-3-527-69342-9 Erscheint auch als Online-Ausgabe, PDF 978-3-527-69343-6 http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-33913-6/ Verlag DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028782430&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Value creation in the pharmaceutical industry the critical path to innovation Pharmazeutische Industrie (DE-588)4045696-1 gnd Innovationsmanagement (DE-588)4161817-8 gnd |
| subject_GND | (DE-588)4045696-1 (DE-588)4161817-8 |
| title | Value creation in the pharmaceutical industry the critical path to innovation |
| title_auth | Value creation in the pharmaceutical industry the critical path to innovation |
| title_exact_search | Value creation in the pharmaceutical industry the critical path to innovation |
| title_full | Value creation in the pharmaceutical industry the critical path to innovation edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann |
| title_fullStr | Value creation in the pharmaceutical industry the critical path to innovation edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann |
| title_full_unstemmed | Value creation in the pharmaceutical industry the critical path to innovation edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann |
| title_short | Value creation in the pharmaceutical industry |
| title_sort | value creation in the pharmaceutical industry the critical path to innovation |
| title_sub | the critical path to innovation |
| topic | Pharmazeutische Industrie (DE-588)4045696-1 gnd Innovationsmanagement (DE-588)4161817-8 gnd |
| topic_facet | Pharmazeutische Industrie Innovationsmanagement |
| url | http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-33913-6/ http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028782430&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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