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Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland
20814-1145

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com


Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Books

    Dr. Spilker's latest book: "Guide to Drug Development: A Comprehensive Review and Assessment" is currently available from Lippincott, Williams and Wilkins in Philadelphia (copyright 2009). Go to www.LWW.com or call 1-800777-2295 or 1-215-521-8300. Copies may be obtained free for a 30 day trial.

    Contents

    About the Author xi
    Preface xiii
    Acknowledgments xv
    Abbreviations xvii

    SECTION 1 - Introduction and Overview of a Company and the Industry

    1 Introduction to Drug Development --- 3
    2 Pharmaceutical Industry: Definitions --- 8
    3 The Big Picture --- 15
    4 Standards: Types, Uses, and Issues --- 34
    5 Pharma-think, Academic-think, and
    Government-think --- 45
    6 Pharma Sense versus Common Sense --- 55

    SECTION 2 - Basic Principles, Strategies, and Approaches

    7 Overview of Factors Affecting Drug Discovery --- 61
    8 The Drug Discovery Process --- 68
    9 Golden Rules of Drug Discovery --- 97
    10 The Drug Development Process --- 104
    11 Golden Rules of Drug Development --- 114
    12 Biotechnology --- 119
    13 Extrapolating Animal Safety and Efficacy Data to Humans --- 132
    14 Evaluating and Interpreting Data --- 143
    15 Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches --- 151
    16 A New Paradigm of Drug Development --- 167
    17 Future Environments for Drug Discovery and Development --- 172

    SECTION 3 - Corporate Organization and Management Issues

    18 Models of International Operations --- 183
    19 Organization at the Corporate Level --- 191
    20 Corporate Management --- 202
    21 Reducing Pharmaceutical Risk --- 225
    22 Enhancing Communication --- 231
    23 Personnel and Staffing Issues --- 246
    24 Competitive Intelligence --- 261
    25 Conflicts of Interest and Bias --- 266
    26 Crisis Management --- 280
    27 Mergers, Joint Ventures, and Alliances --- 287
    28 Pharmacopolitics --- 298
    29 Institutional Memory --- 308
    30 Differences among Pharmaceutical Companies --- 315

    SECTION 4 - External Corporate Relationships and Interactions

    31 Interactions and Relationships between Academicians and Industry --- 331
    32 Investigator-sponsored Research Proposals Submitted to Industry --- 341
    33 Technology Transfer from Academia to Industry --- 345
    34 Interactions between Pharmaceutical Companies --- 349
    35 Interactions with Trade Associations --- 354
    36 Interactions with Legislators and Government Agencies --- 359
    37 Interactions and Relationships with Healthcare Professionals --- 370
    38 Interactions with Patients and the Public --- 374
    39 Patient Package Inserts --- 384
    40 Interactions and Relationships with the Media --- 391

    SECTION 5 - Research and Development Organization, Management, and Assessments

    41 Organizing Research and Development --- 401
    42 Managing Research and Development and Avoiding Tangents --- 410
    43 Personnel Issues in Drug Discovery and Development --- 429
    44 Myths about the Pharmaceutical Industry and Drug Development --- 436
    45 Fads and Fashions in Drug Development --- 441
    46 The Many Facets of Reality: Approaches to Issues and Problems --- 446
    47 International Organization and Management --- 451
    48 Project Management: Balancing Line Function and Matrix Approaches --- 460
    49 Choosing the Number and Types of Drugs to Develop --- 475
    50 Choosing Standards for Developing Drugs --- 480
    51 Creating and Using Benchmarks --- 489
    52 Evaluating a Portfolio of Investigational Drug Projects 496
    53 Compassionate Use Programs --- 529
    54 Virtual Drug Development --- 533
    55 Developing and Marketing Orphan Drugs for Rare Diseases --- 544
    56 Productivity and Project Success --- 553
    57 Overview of Safety and Risk Management --- 569
    58 Developing Standard Operating Procedures --- 578

    SECTION 6 - Clinical Activities and Issues

    59 Introduction to Clinical Trials --- 589
    60 Creating a Clinical Strategy and Development Plan for a New Drug or Indication --- 603
    61 Designing and Implementing a Clinical Trial --- 615
    62 Questions to Ask about a Clinical Trial Protocol --- 640
    63 Dose-response Relationships in Clinical Trials --- 644
    64 Collecting and Interpreting Life Events Data in Clinical Trials --- 655
    65 Quality of Life and Pharmacoeconomics in Clinical Trials --- 662
    66 Overview of Phase 4 and Postapproval Clinical Activities --- 677
    67 Phase 4 Trials and Postapproval Pharmacovigilance Methodologies --- 685
    68 Feasibility of Multinational Trials --- 693
    69 Groups that Influence Protocol Design --- 707
    70 Monitoring and Auditing a Clinical Trial --- 712
    71 Electronic Data Collection and E-clinical Trials --- 721
    72 Principles of Patient Recruitment and Retention --- 733
    73 Surrogate Endpoints and Biomarkers --- 737
    74 Contract Research Organizations and Outsourcing Strategies --- 746
    75 Conducting Clinical Trials Efficiently and Rapidly --- 756
    76 Clinical Significance --- 765
    77 Incorporating Benefit-to-risk Determinations in Drug Development --- 771
    78 Interactions between Clinicians and Statisticians for Analysis and Interpretation of Clinical Data --- 780
    79 The Concept of Normalcy --- 787
    80 Recruiting and Training Clinical Investigators --- 797
    81 Human Subject Protection and Ethical Issues in Clinical Trials --- 807
    82 Improving the Standards of Clinical Trial Publications .819
    83 Registries and Directories of Clinical Trials, plus Disclosure of Their Results and Archiving Their Data --- 823
    84 Clinical Trials Come of Age --- 832

    SECTION 7 - Regulatory Affairs Activities and Issues

    85 Introduction to Regulatory Affairs --- 841
    86 Negotiating and Interacting with Regulatory Agencies --- 859
    87 Learning Which Regulatory Guidances and Standards May Be Modified --- 867
    88 Preparing for and Holding Meetings with Regulatory Agencies --- 873
    89 Food and Drug Administration Advisory Committee Meetings --- 884
    90 Regulatory Applications for Marketing Approval and Global Interactions with Regulators --- 891
    91 Regulatory Strategies in Real-life Product Development --- 902

    SECTION 8 - Marketing Activities, Issues, and Interactions with Medical Affairs

    92 Overview of Marketing Activities and Issues --- 911
    93 Corporate Issues Regarding the Medical–Marketing Interface --- 946
    94 Organizational and Staffing Issues Regarding the Medical–Marketing Interface --- 954
    95 Marketing Needs, Wants, and Issues in Developing Drugs --- 963
    96 Joint Medical and Marketing Activities --- 972
    97 Switching Prescription Drugs to Over-the-counter Status --- 986
    98 Costs and Pricing --- 993
    99 Providing Product Information to Healthcare Professionals --- 1007

    SECTION 9 - Functional Activities and Issues

    100 Information Management --- 1021
    101 Selected Statistical Issues --- 1038
    102 Data Management --- 1049
    103 Toxicology Activities and Issues --- 1058
    104 Animal Testing and Animal Welfare --- 1065
    105 Pharmacokinetics --- 1072
    106 Licensing Activities and Issues --- 1077
    107 Technical Development Activities and Issues --- 1102
    108 Production Activities and Issues --- 1119
    109 Patent Activities and Issues --- 1144
    110 Legal Activities and Issues --- 1159
    111 Financial Activities and Issues --- 1172

    SECTION 10 - Overview of Current and Future Development

    112 Poor Development and Corporate Practices: Threats to a Pharmaceutical Organization --- 1191
    113 Keys for Pharmaceutical and Development Success --- 1201
    114 Computer Simulations and Modeling --- 1214
    115 The Future of Drug Discovery and Development --- 1221

    SECTION 11 - Case Studies in Clinical Development, Regulatory Affairs, and the Management of Drug Development

    116 Clinical Case Studies --- 1231
    117 Regulatory Affairs Case Studies --- 1237
    118 Management of Drug Development Case Studies -- 1244

    Index 1251


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