The SAGE Handbook of Healthcare (Sage Handbooks)

Cover page......Page 1
Title Page......Page 3
ISBN 1847870481......Page 4
Contents (with page links)......Page 5
Technology and Healthcare......Page 9
The Market and Healthcare Technology......Page 10
NOTES......Page 11
PHARMACOECONOMICS......Page 12
PHARMACOGENOMICS......Page 13
THERAPEUTICS: CASE STUDIES Oncology......Page 14
Cardiovascular and Other Therapies......Page 15
DIAGNOSTICS......Page 16
I Pharmacoeconomics......Page 17
OVERVIEW......Page 19
KEY CHANGES IN 2007......Page 21
EMPLOYER-SPONSORED HEALTH PLANS......Page 23
DUAL-ELIGIBLE BENEFICIARIES......Page 26
SPECIAL NEEDS PLANS......Page 27
HealthSpring: A Regional Player Goes National......Page 29
DISEASE MANAGEMENT......Page 30
MEDICARE MEDICAL SAVINGS ACCOUNTS......Page 32
OUTLOOK AND IMPLICATIONS......Page 33
INTRODUCTION......Page 36
Medicare......Page 38
Office-Based Treatment......Page 40
Physician Reimbursement......Page 41
Patients’ Out-of-Pocket Payments......Page 44
Hospital Outpatient Treatment......Page 45
Hospital Inpatient Treatment......Page 47
Self-Administered Drugs (Medicare Part D)......Page 49
PRIVATE SECTOR Physician Reimbursement......Page 50
Distribution Controls......Page 51
Cost Sharing......Page 52
OFF-LABEL PRESCRIBING......Page 53
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 55
REFERENCES......Page 56
UNITED STATES......Page 57
Outpatient Prospective Payment System......Page 58
Medicaid......Page 60
FRANCE......Page 61
GERMANY......Page 65
UNITED KINGDOM......Page 68
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 70
OVERVIEW......Page 73
Antidepressants......Page 74
Antipsychotics......Page 77
Anticonvulsants......Page 78
Perils of Off-Label Marketing......Page 79
Medicare......Page 81
Private Insurers......Page 83
GERMANY......Page 84
UNITED KINGDOM......Page 86
JAPAN......Page 87
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 89
REFERENCES......Page 90
INTERNATIONAL PRICE COMPARISONS FOR NEUROLOGY DRUGS Overview......Page 91
Dementia Therapies......Page 94
Parkinson’s Disease Therapies......Page 95
Multiple Sclerosis Therapies......Page 97
Antiepileptic Agents......Page 98
Reformulations and “Me-too” Drugs......Page 99
REIMBURSEMENT ENVIRONMENT United States General Environment......Page 100
Private Insurance......Page 101
Medicare......Page 102
Patient Assistance Programs – An Important Source of Drug Funding......Page 103
Medicaid......Page 104
Dementia Therapies......Page 107
Parkinson’s Disease Therapies......Page 109
Multiple Sclerosis Therapies......Page 110
France General Environment......Page 111
Multiple Sclerosis Therapies......Page 112
Germany General Environment......Page 113
Dementia Therapies......Page 116
Multiple Sclerosis Therapies......Page 117
Dementia Therapies......Page 118
Dementia Therapies......Page 119
United Kingdom General Environment......Page 120
Dementia Therapies......Page 121
Parkinson’s Disease Therapies......Page 122
Multiple Sclerosis Therapies......Page 123
Antiepileptic Agents......Page 124
Multiple Sclerosis Therapies......Page 125
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 126
Generic Neurology Drugs – An Increasingly Competitive Market......Page 127
REFERENCE......Page 130
PARAGRAPH IV CHALLENGES: AN OVERVIEW......Page 131
THE CURRENT LANDSCAPE FOR AUTHORIZED GENERICS......Page 132
STRATEGIES FOR DEALING WITH EXCLUSIVE GENERICS Consolidation and Integration of Brand and Generic Activities......Page 133
Discounting and Price Negotiations......Page 134
Generic Erosion with 180-Day Exclusivity: One Brand, One Generic......Page 135
Generalizable Rates of Erosion for Brands......Page 136
IMPLICATIONS FOR AUTHORIZED GENERICS Generic Erosion and the Authorized Generic Strategy......Page 137
The Three Competitive Scenarios: Example 1......Page 138
The Three Competitive Scenarios: Example 2......Page 139
Authorized Generics: Not the Only Option......Page 140
OVERVIEW......Page 142
ORGANIZATION AND FUNDING OF THE CANADIAN HEALTHCARE SYSTEM......Page 143
PRICING OF PRESCRIPTION MEDICINES......Page 144
Excessive Price Guidelines for Existing and New Medicines......Page 145
Recent Price Increases in Patented Medicines......Page 146
Proposed Changes to the Patented Medicines Regulations......Page 147
Review of the Guidelines with Respect to Price Increases......Page 148
National Pharmaceuticals Strategy and Catastrophic Drug Coverage......Page 149
Provincial and Federal Government Reimbursement......Page 150
Common Drug Review......Page 151
Impact of Price Increases on Provincial Drug Plans......Page 152
Quebec’s Pharmaceutical Policy......Page 153
Hospital Formularies......Page 154
CROSS-BORDER TRADE OF PRESCRIPTION DRUGS TO THE UNITED STATES......Page 155
OUTLOOK FOR THE CANADIAN PHARMACEUTICAL MARKET......Page 156
REFERENCE......Page 157
OVERVIEW......Page 158
US PATENT LAW......Page 159
EUROPEAN PATENT LAW......Page 160
European Patent Explained......Page 161
Community Patent Stalls......Page 162
Disclosure......Page 163
Oppositions and Reexamination......Page 164
Right to Exclude and Compulsory Licenses......Page 165
Oyster Patent Broadens Scope......Page 166
Amgen v. Chugai Pharmaceutical......Page 167
European Stance......Page 168
Contrasting Laws for Generic Drugs Hatch-Waxman Act......Page 169
European Laws......Page 170
European Biotechnology Directive......Page 171
Medical-Use Patents......Page 172
OUTLOOK......Page 173
OVERVIEW National Procedures......Page 175
Centralized Procedure......Page 176
Mutual Recognition Procedure......Page 177
EMEA AUDIT SURVEY......Page 178
Centralized Procedure......Page 179
Mutual Recognition Procedure......Page 180
Data Protection and Generics Competition......Page 181
Review Times......Page 182
Unsuccessful Applications......Page 183
Terms and Conditions of Marketing Authorizations......Page 184
Mutual Recognition Procedure and Decentralized Procedure......Page 185
Generics......Page 186
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 187
GERMANY......Page 189
SPAIN......Page 192
ITALY......Page 195
FRANCE......Page 196
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 199
ORGANIZATION AND FUNDING OF THE UK HEALTHCARE SYSTEM......Page 201
PHARMACEUTICAL PRICES IN THE UNITED KINGDOM......Page 202
Admission to Reimbursement Application......Page 203
Supply-Side Restrictions......Page 204
Profit Control......Page 205
Primary Care Budgets and Cost Consciousness......Page 207
Influence of the National Institute for Clinical Excellence......Page 209
Focus on Clinical Priority Areas......Page 210
Parallel Imports......Page 211
REIMBURSEMENT OF HOSPITAL MEDICINES General Features......Page 213
Demand-side Restrictions......Page 214
SALES AND PRESCRIBING TRENDS Market Overview......Page 215
Leading Drug Classes......Page 222
Leading Molecules......Page 225
OUTLOOK FOR THE UK PHARMACEU-TICAL MARKET......Page 228
REFERENCE......Page 230
ORGANIZATION AND FUNDING OF THE ITALIAN HEALTHCARE SYSTEM......Page 231
PHARMACEUTICAL PRICES IN ITALY......Page 232
Creation of a New Medicines Agency......Page 233
REIMBURSEMENT OF OUTPATIENT MEDICINES Prontuario Farmaceutico Nazionale (National Formulary)......Page 235
Price Control......Page 236
Prescribing Restrictions......Page 237
Promoting Greater Use of Generics......Page 238
REIMBURSEMENT OF HOSPITAL MEDICINES......Page 239
SALES AND PRESCRIBING TRENDS Market Overview......Page 240
Leading Drug Categories, Classes, and Compounds......Page 242
OUTLOOK FOR THE ITALIAN PHARMACEUTICAL MARKET......Page 245
ORGANIZATION AND FUNDING OF THE SPANISH HEALTHCARE SYSTEM......Page 248
PHARMACEUTICAL PRICES IN SPAIN......Page 249
REIMBURSEMENT OF OUTPATIENT MEDICINES......Page 250
Reference Pricing......Page 251
Sales Tax......Page 253
Prior Authorization......Page 254
The Spanish Market for Multisource Pharmaceuticals: A Complex Picture......Page 255
REIMBURSEMENT OF HOSPITAL MEDICINES......Page 256
SALES AND PRESCRIBING TRENDS......Page 257
OUTLOOK FOR THE SPANISH PHARMACEUTICAL MARKET......Page 261
INTRODUCTION......Page 262
The Role of Statins in the Management of Dyslipidemia......Page 263
The Statin Market in Germany......Page 264
ORGANIZATION AND FUNDING OF THE GERMAN HEALTHCARE SYSTEM......Page 265
PHARMACEUTICAL PRICING AND REIMBURSEMENT Pricing......Page 267
Reimbursement......Page 268
REFERENCE PRICING Overview......Page 269
Reference Prices of Statins......Page 271
General Industry Response to Reference Pricing of Statins......Page 273
Open Letters to Decision-Making Bodies......Page 274
Patient Assistance Program......Page 275
Reaction to Pfizer’s Stance......Page 276
Market Impact......Page 277
Generics Substitution......Page 279
Indicative Prescribing Amounts......Page 281
OUTLOOK AND IMPLICATIONS Outlook in Germany Government Plans for Stricter Cost Containment......Page 282
Continued Pressure to Reduce Spending on Statins......Page 283
Implications for Key Stakeholders German Government......Page 284
Health Insurance Funds......Page 285
Pharmaceutical Industry......Page 286
France......Page 288
Spain......Page 291
United Kingdom......Page 293
Parallel Trade......Page 294
Conclusion......Page 295
GLOSSARY, IMPACT OF GERMAN REFERENCE PRICING ON STATINS Glossary of Abbreviations and Foreign-Language Terms Used in This Report......Page 296
UNAVAILABILITY OF GOLD-STANDARD THERAPIES......Page 298
OFF-LABEL USE OF ONCOLOGY DRUGS......Page 301
LACK OF MEDICAL ONCOLOGISTS......Page 302
Initiatives to Raise Oncology Standards......Page 303
ECONOMIC ISSUES......Page 304
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 306
Pharmaceutical Pricing and Reimbursement......Page 307
Prospective Payment......Page 310
Pharmacy Decision Making......Page 311
Cost Sharing......Page 313
Off-label Prescribing......Page 317
GERMANY......Page 318
Prospective Payment......Page 319
Disease Management......Page 320
Cost Sharing......Page 321
Off-label Prescribing......Page 322
Prospective Payment......Page 324
Financial Constraints......Page 325
Access to Innovative Therapies......Page 326
Pharmaceutical Pricing and Reimbursement......Page 327
National Institute for Health and Clinical Excellence......Page 328
Review of Variations in the Use of NICE-approved Cancer Drugs......Page 329
Patient Action Against Lack of Access to Certain Drugs......Page 336
JAPAN......Page 337
Pharmaceutical Pricing and Reimbursement......Page 338
Prospective Payment......Page 339
Unavailability of Gold-standard Therapies......Page 340
OUTLOOK AND IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY......Page 342
OVERVIEW OF CHINA’S HEALTHCARE SYSTEM......Page 346
OVERVIEW OF PHARMACEUTICAL PRICING AND REIMBURSEMENT IN CHINA Current Pharmaceutical Pricing Regulations in China......Page 348
Comparison of Pharmaceutical Prices per Pill in China versus G7 Prices per Pill......Page 349
Drug Class Price Comparisons from Exmanufacturer to Retail Level in China......Page 351
National Essential Drug List......Page 354
Urban Health Insurance......Page 355
Rural Health Insurance......Page 357
Pricing......Page 358
Reimbursement......Page 359
INTRODUCTION......Page 361
POC’s Customers......Page 362
THE TECHNOLOGY TRAJECTORY......Page 363
REGULATORY ISSUES......Page 364
MANAGED CARE......Page 365
DEVELOPMENT AND PROTECTION......Page 366
THERANOSTICS......Page 368
SALES AND MARKETING......Page 369
The Revenue Potential Model: Applying POC Diagnostics to Sexually Transmitted Diseases......Page 370
REVIEWING INFLUENCES ON THE POC MARKET......Page 371
REFERENCE......Page 372
II Pharmacogenomics......Page 373
THE EARLY PROMISE OF GENOMICS......Page 375
GENOMICS PALES COMPARED WITH BIOTECH......Page 376
GENOMICS-DERIVED CLINICAL PIPELINES......Page 378
Celera Genomics......Page 381
deCode Genetics......Page 382
ExonHit......Page 384
Human Genome Sciences and GlaxoSmithKline......Page 385
ZymoGenetics......Page 386
Opportunities......Page 387
Threats......Page 388
Millennium Pharmaceuticals......Page 389
HGS-CoGenesys......Page 390
Incyte Pharmaceuticals......Page 391
Personalized Medicine......Page 392
Targeted Therapy in Breast Cancer......Page 393
Genomics-derived Therapeutics......Page 394
REFERENCES......Page 395
PHARMACOGENOMICS DEFINED......Page 396
Drug Efficacy......Page 397
Gefitinib and Erlotinib......Page 398
Drug Metabolism......Page 399
Pharmacogenomics’ Impact on Clinical Trial Costs......Page 400
Case History: deCODE Genetics’ Use of Pharmacogenomics in Heart Attack Trials......Page 401
Pharmacogenomics’ Impact on Drug Revenues and Markets......Page 402
Pharmacogenomics’ Impact on the Blockbuster Model of Drug Development......Page 403
Pharmacogenomics’ Impact on Other Commercial Strategies......Page 404
Case Study: Treatment of Ten Hypothetical Patients with and without Pharmacogenomic Testing......Page 406
RECENT PHARMACOGENOMIC DEALS AND ALLIANCES......Page 408
United States......Page 410
Japan......Page 411
Pricing and Reimbursement......Page 412
REFERENCES......Page 413
CELL THERAPY’S POTENTIAL......Page 414
Central Nervous System Disorders......Page 415
Cancer......Page 417
Chronic Liver Disease......Page 418
DESIGNING A CELL THERAPY......Page 419
Cell Therapy Business Models......Page 420
Device Driven......Page 421
Multitechnology......Page 422
Determining Market Strategy......Page 423
The Partnering Vacuum......Page 424
OUTLOOK FOR THE CELL THERAPY MARKET Market Expansion Factors......Page 425
Future Partnerships......Page 426
MOMENTUM IS STEADILY BUILDING......Page 428
MARKETS......Page 429
Nanoformulations and Drug Delivery......Page 430
In Vivo Imaging......Page 434
Nanomaterials in Medical Devices......Page 435
Launch of the Nanotech Stock Index......Page 436
Venture Capital Environment......Page 437
A CHALLENGING PATENT CLIMATE......Page 440
Mergers and Acquisitions......Page 442
SAFETY, NANOTOXICOLOGY, AND BIOETHICAL ISSUES......Page 443
REFERENCE......Page 445
INTRODUCTION......Page 446
THE VALUE OF PROTEOMICS IN DEFINING NEW DIAGNOSTIC AND THERAPEUTIC PROTEINS......Page 447
Separation......Page 448
Two-dimensional Polyacrylamide Gel Electrophoresis......Page 449
Identification of Proteins/Peptides Mass Spectroscopy......Page 450
The Plasma Proteome Project......Page 452
Use of SELDI-MS for Pattern Diagnostic Markers......Page 453
PROTEOMICS BUSINESSES......Page 455
GeneProt......Page 456
Assay Companies Correlogic Systems......Page 457
Predictive Diagnostics......Page 458
Tools Companies......Page 459
Europroteome......Page 460
OUTLOOK FOR CLINICAL DIAGNOSTICS......Page 461
REFERENCES......Page 462
III Therapeutics......Page 463
IMPROVING CANCER THERAPIES: GOING BEYOND SURVIVAL......Page 465
BIOMARKERS DEFINED......Page 466
Tumor Marker Assays......Page 467
Surrogate End Points in Clinical Trials......Page 468
Trastuzumab (Genentech’s Herceptin)......Page 469
Imatinib Mesylate (Novartis’s Gleevec/Glivec)......Page 470
Gefitinib (AstraZeneca’s Iressa)......Page 471
REGULATORY RESPONSE......Page 473
THE FUTURE OF ONCOLOGY CLINICAL DEVELOPMENT......Page 474
REFERENCES......Page 476
INTRODUCTION......Page 477
Monoclonal Antibodies......Page 478
Rituxan......Page 479
Avastin......Page 480
Targeted Cytotoxins and Radiological Agents......Page 481
Panitumumab......Page 482
Galiximab......Page 484
Mapatumumab......Page 485
HERCEPTIN: A MODEL FOR EXPANDING AN AGENT’S REACH......Page 486
REIMBURSEMENT CONCERNS WITH ANTICANCER BIOLOGICS......Page 488
OUTLOOK......Page 490
REFERENCES......Page 491
CANCER VACCINES MAY FULFILL AN UNMET NEED An Underserved Market......Page 492
PREVENTIVE CANCER VACCINE LAUNCHES HPV Prevention: A Multibillion-dollar Opportunity......Page 494
Gardasil and Cervarix: Competitive Positioning......Page 495
Prostate Cancer Dendreon’s Provenge......Page 496
Cell Genesys’s GVAX......Page 497
Therion Biologics’ PanVac-VF......Page 498
Other Vaccines Oncophage for Renal Carcinoma......Page 499
Regulatory Obstacles......Page 500
EMERGING APPROACHES TO CANCER VACCINE DEVELOPMENT......Page 501
Multitarget Design Enhancements......Page 502
MARKET OUTLOOK FOR CANCER VACCINES......Page 503
REFERENCE......Page 505
OVERVIEW OF ANGIOGENESIS......Page 506
POTENTIAL THERAPEUTIC INDICATIONS......Page 508
Cancer......Page 509
CURRENT THERAPIES Bevacizumab (Avastin)......Page 511
Pegaptanib (Macugen)......Page 512
Thalidomide......Page 513
AE-941 (Neovastat)......Page 514
A6......Page 517
BAY-43-9006 (Sorafenib)......Page 518
Panzem Capsule/NCD (2-Methoxyestradiol)......Page 519
Ranibizumab (Lucentis)......Page 520
Vatalanib......Page 521
CP-547,632......Page 522
MARKET OUTLOOK......Page 523
REFERENCE......Page 524
INTRODUCTION......Page 525
Role of Apoptosis in Disease......Page 526
The Apoptotic Pathways......Page 527
Intrinsic Pathway......Page 528
Extrinsic Pathway......Page 529
Bcl-2 Inhibitors......Page 530
Genta’s Genasense......Page 531
Avi Biopharma’s XIAP NeuGene Antisense Compound......Page 532
Human Genome Sciences/GlaxoSmithKline’s HGS-ETR1......Page 533
Other Intrinsic Pathway Drug Discovery Methods......Page 534
Challenges to Caspase Inhibitor Development Nonapoptotic Programmed Cell Death......Page 535
OUTLOOK......Page 537
REFERENCES......Page 538
OVERVIEW OF CHRONIC LYMPHOCYTIC LEUKEMIA Disease Characteristics Etiology and Pathophysiology......Page 540
Staging and Survival......Page 541
CURRENT TREATMENT OPTIONS FOR CHRONIC LYMPHOCYTIC LEUKEMIA......Page 542
Stem Cell Transplantation: A Potential Cure for CLL?......Page 544
Second-line Therapies......Page 545
Third-line Therapies......Page 546
Rituximab......Page 547
Other Monoclonal Antibodies......Page 550
Antisense Oligonucleotides......Page 551
REFERENCES......Page 552
SOCIETAL AND PHARMACOTHERAPY TRENDS IN ADDICTION......Page 554
Abused Drugs......Page 555
Alcohol......Page 556
Abused Drugs......Page 558
Smoking......Page 559
Alcohol......Page 560
Other Drugs under Evaluation for Treating Alcohol Dependence......Page 561
Xenova’s TA-CD......Page 562
Smoking......Page 564
Pfizer’s Varenicline......Page 565
Alcohol/Drug Dependence Pharmacotherapy Markets......Page 566
REFERENCE......Page 567
THE NEED FOR NEW ANTIREJECTION DRUGS......Page 568
CAUSES OF TRANSPLANT REJECTION......Page 569
CURRENT THERAPIES......Page 570
Next-generation Immunosuppressants......Page 571
The Newest Immunosuppressants: mTOR Therapies......Page 573
Costimulatory Blockers......Page 574
Mixed Chimerism......Page 575
Agents That Induce Peripheral Tolerance......Page 576
Combination Therapies......Page 577
Novartis’s FTY-720......Page 578
Bristol-Myers Squibb’s LEA-29Y......Page 579
THE FUTURE OF ANTIREJECTION THERAPY......Page 580
REFERENCES......Page 581
INTRODUCTION......Page 582
Difficulties Build for Boston Scientific’s Taxus......Page 583
Taxus versus Cypher: Study Results......Page 584
Medtronic Launches Endeavor Stent......Page 585
NitroMed’s BiDil (Isosorbide Dinitrate/Hydralazine) Launched for African-Americans......Page 586
Pfizer’s Revatio (Sildenafil) Receives Initial Marketing Authorization......Page 587
Encysive Pharmaceuticals’ Thelin (Sitaxsentan) Completes Marketing Authorization Application......Page 588
Label Expanded for Solvay Pharmaceuticals/CV Therapeutics’ Aceon (Perindopril Erbumine)......Page 589
Troubles Abound for Scios’s Natrecor (Nesiritide)......Page 590
ASCOT Study Results Could Help Boost Sales of Some Drugs......Page 591
REFERENCES......Page 592
OVERVIEW OF HYPERTENSION Definition of Hypertension......Page 593
Prevalence......Page 594
Current Therapies......Page 595
Unmet Needs in the Treatment of Hypertension......Page 597
The Development of Renin Inhibitors......Page 598
Speedel/Novartis’s Aliskiren......Page 599
The Potential for Renin Inhibitors in Other Diseases......Page 601
OUTLOOK FOR RENIN INHIBITORS......Page 602
REFERENCES......Page 603
INTRODUCTION......Page 605
VLA-4 AS A THERAPEUTIC TARGET......Page 606
Natalizumab......Page 607
683699/T-0047......Page 608
The Future of VLA-4 Antagonists in MS......Page 609
CROHN’S DISEASE......Page 610
ASTHMA......Page 611
THE REGULATORY PROCESS: INCREASED SCRUTINY WILL LEAD TO CHANGE......Page 612
REFERENCES......Page 615
OVERVIEW OF INSULIN THERAPY Mechanism of Action......Page 616
Short-acting Insulins......Page 617
Type 2 Diabetes......Page 618
THE INSULIN MARKET......Page 619
Development History......Page 620
Clinical Trials......Page 621
Eli Lilly and Alkermes’ AIR Inhaled Insulin System......Page 622
Novo Nordisk and Aradigm’s AERx-iDMS System......Page 623
THE OUTLOOK FOR INHALED INSULINS......Page 624
REFERENCES......Page 625
INTRODUCTION: PROMISING RESULTS IN THE RECENT PROACTIVE STUDY......Page 626
TYPE 2 DIABETES: DISEASE BACKGROUND AND PREVALENCE Pathophysiology and Risk Factors......Page 627
Type 2 Diabetes and Cardiovascular Disease......Page 628
Sulfonylureas......Page 629
Biguanides......Page 631
Glucagon-like Peptide-1 Analogues......Page 632
Amylin Analogues......Page 633
The Role of PPAR in Cardiovascular Disease......Page 634
PROactive Study Design......Page 635
PROactive Study Results......Page 636
OUTLOOK......Page 637
REFERENCES......Page 639
IV Diagnostics......Page 641
OVERVIEW OF DIAGNOSTICS AND PHARMACEUTICAL COMARKETING EFFORTS......Page 643
Cultural Differences between Pharmaceutical and Diagnostics Companies......Page 644
BARRIERS TO COMARKETING: SEPARATING FACT FROM FICTION......Page 645
Myth #1: Many Diagnostic Competitors Are Good for Therapy......Page 646
Myth #2: Diagnostic Intellectual Property Cannot Be Defended......Page 647
Myth #3: No Diagnostic Is Worth Spending $50 Million at Launch......Page 648
Hypothesis 1: Early Proactive Involvement Is Essential......Page 649
Hypothesis 2: Unifying Copromotion Brand Objectives......Page 651
Scenario 1......Page 652
Hypothesis 3: Funding the Plan......Page 653
CONCLUSION: INTEGRATION OF DIAGNOSTICS AND THERAPEUTICS......Page 655
REFERENCES......Page 656
REASONS FOR CALCULATING THE RETURN ON INVESTMENT......Page 657
ESTIMATES OF RETURN......Page 659
USING CASE-BASED REASONING TO CALCULATE THE RETURN ON INVESTMENT......Page 660
Presenting Patients......Page 661
Patient Compliance with Therapy......Page 662
Hypothesis 1: A Related Diagnostic Will Accelerate the Uptake of a Novel Drug in Clinical Areas Where Diagnosis Is Difficult......Page 663
Hypothesis 2. A Related Monitoring Test Will Improve Patient Compliance with a Drug That Requires Long-term Use......Page 664
EVALUATING A DIAGNOSTIC PARTNERSHIP......Page 666
REFERENCES......Page 667
INTRODUCTION......Page 668
PATHOPHYSIOLOGY OF ALZHEIMER’S DISEASE......Page 669
VALUE OF A BIOMARKER FOR ALZHEIMER’S DISEASE......Page 670
Sensitivity and Specificity......Page 671
Limitations of Genetic Markers......Page 673
EMERGING IMAGING AGENTS FOR DIAGNOSIS OF ALZHEIMER’S DISEASE......Page 675
FDDNP......Page 676
GE Healthcare......Page 677
Genetic Marker Alliances......Page 679
Merck/Celera Diagnostics......Page 680
MARKET IMPLICATIONS......Page 681
OUTLOOK......Page 684
CMS REIMBURSES COST OF PET FOR EARLY DETECTION OF AD......Page 685
REFERENCES......Page 686
THE DAWN OF TRANSLATIONAL MEDICINE......Page 687
RECENT FDA INITIATIVES......Page 689
Research Biomarkers......Page 690
Alzheimer’s Disease Research......Page 691
Pharmacogenetic Biomarkers......Page 692
Lessons to Be Learned from the COX-2 Inhibitor Rofecoxib (Merck’s Vioxx)......Page 693
Lessons to Be Learned from Gefitinib (AstraZeneca’s Iressa)......Page 694
The FDA’s Position on Pharmacogenomic Data......Page 695
Genomic Biomarkers in the Clinic......Page 696
THERANOSTICS/COMPANION DIAGNOSTICS......Page 697
Clinical Data’s Depression Drug Test......Page 698
POTENTIAL IMPACT OF BIOMARKER USE......Page 699
REFERENCES......Page 701
IMPROVED DIAGNOSTICS AS IMPORTANT AS IMPROVED THERAPIES TO OPTIMIZING CANCER TREATMENT......Page 702
BIOMARKER DISCOVERY GAINS SUPPORT......Page 703
Classical Modes of Detection in Biofluids......Page 704
SELECT BIOMARKERS WITH POTENTIAL MULTIPLE CANCER APPLICATIONS......Page 705
Telomerase......Page 706
Prostate Cancer PSA......Page 707
Other Potential Biomarkers for Prostate Cancer......Page 708
Cervical Dysplasia and Cancer......Page 709
CA 15-3......Page 710
Ovarian Cancer......Page 711
POTENTIAL OF BIOMARKERS HAS YET TO BE REALIZED......Page 713
REFERENCES......Page 714
Advantages......Page 716
Disadvantages......Page 717
BIOTERRORISM......Page 718
Anthrax......Page 719
ENDOCRINE CONDITIONS......Page 720
Ovulation......Page 721
Diabetes......Page 722
Drugs of Abuse......Page 723
PREDICTIVE MEDICINE......Page 724
Aeron Biotechnology......Page 725
LifePoint......Page 726
OraSure Technologies......Page 727
Saliva Diagnostic Systems......Page 728
MARKET TRENDS......Page 729
Index (with page links)......Page 731