Shimasaki Biotechnology Entrepreneurship

Starting, Managing, and Leading Biotech Companies
1. Auflage 2014
ISBN: 978-0-12-404747-1
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 488 Seiten

As an authoritative guide to biotechnology enterprise and entrepreneurship,ÿBiotechnology Entrepreneurship and Managementÿsupports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity,ÿBiotechnology Entrepreneurship and Managementÿprovides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

Autoren/Hrsg.

Shimasaki, Mba

Inhaltsverzeichnis

1;Front Cover;1
2;Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies;4
3;Copyright;5
4;Dedication;6
5;Contents;8
6;Preface;14
7;Foreword;16
8;Acknowledgements;18
9;Contributors;20
10;Section I Biotechnology Entrepreneurship;22
10.1;Chapter 1 - Unleashing the Promise of Biotechnology to Help Heal, Fuel, and Feed the World;24
10.1.1;HEALTH BIOTECHNOLOGY: HELPING TO SAVE AND EXTEND LIVES;24
10.1.2;FOOD AND AGRICULTURAL BIOTECHNOLOGY: HELPING TO FEED THE WORLD;27
10.1.3;INDUSTRIAL AND ENVIRONMENTAL BIOTECHNOLOGY: A BETTER WAY TO MAKE THINGS;29
10.1.4;THE PUBLIC POLICY ENVIRONMENT FOR BIOTECH INNOVATION;32
10.1.5;REFERENCES;33
10.2;Chapter 2 - A Biotechnology Entrepreneur’s Story: Advice to Future Entrepreneurs;36
10.2.1;PATH TO ENTREPRENEURSHIP;36
10.2.2;RISKS OF JOINING A BIOTECHNOLOGY COMPANY;37
10.2.3;GENZYME IN THE EARLY DAYS;37
10.2.4;THE IMPORTANCE OF UNDERSTANDING BUSINESS AND FINANCE;38
10.2.5;RAISING CAPITAL;38
10.2.6;MANAGING THE UNCERTAINTY OF BIOTECHNOLOGY;39
10.2.7;CORE VALUES;39
10.2.8;INTEGRATING THE SCIENCE AND BUSINESS;39
10.2.9;THE VALUE OF A BUSINESS BACKGROUND AND EXPERIENCE;40
10.2.10;DRIVEN FROM WITHIN;40
10.2.11;IN TOUCH WITH EVENTS OUTSIDE THE COMPANY;41
10.2.12;GOOD FORTUNE AND SUCCESS;41
10.2.13;CLOSING ADVICE;41
10.2.14;REFERENCE;41
10.3;Chapter 3 - The Biotechnology Industry: An Engine of Innovation;42
10.3.1;THE BIRTH OF AN INDUSTRY;43
10.3.2;THE INDUSTRY TAKES ROOT;45
10.3.3;THE INDUSTRY TODAY;46
10.3.4;THE CHALLENGE OF DRUG DEVELOPMENT;46
10.3.5;FALLING R&D PRODUCTIVITY;47
10.3.6;THE CONSISTENT CHALLENGE;48
10.3.7;HOWDY PARTNER;49
10.3.8;THE END OF THE BLOCKBUSTER ERA;50
10.3.9;THE TIMES THEY ARE A CHANGING;51
10.3.10;MAPPING THE HUMAN GENOME;51
10.3.11;AN EVOLVING VISION;52
10.3.12;CHANGING ECONOMICS;53
10.3.13;A GREATER PROMISE;54
10.3.14;INVESTING IN INNOVATION;55
10.3.15;PARTNERSHIPS OF CONVENIENCE;55
10.3.16;PROMOTING TECHNOLOGY TRANSFER;56
10.3.17;NOT JUST ABOUT DRUGS;57
10.3.18;EVERYTHING OLD IS NEW AGAIN;58
10.3.19;THE CHALLENGE OF SCALE;58
10.3.20;IMPROVING YIELDS;59
10.3.21;THE CHALLENGE TODAY;59
10.3.22;THE MOMENT IS NOW;61
10.3.23;VALUE IS TRANSIENT;62
10.3.24;VALUE IS GEOGRAPHIC DEPENDENT;63
10.3.25;VALUE TO PAYERS IS NOT A CONSTANT;63
10.3.26;VALUE IS NOT A FUNCTION OF SALES AND EARNINGS;63
10.3.27;THE CHALLENGE FOR LIFE SCIENCES COMPANIES;64
10.4;Chapter 4 - What is Biotechnology Entrepreneurship?;66
10.4.1;THE SIGNIFICANCE OF THE BIOTECHNOLOGY ENTREPRENEUR;66
10.4.2;THE INTEGRATION OF TWO DISTINCTLY DIFFERENT DISCIPLINES;66
10.4.3;BIOTECHNOLOGY ENTREPRENEURSHIP VERSUS GENERAL ENTREPRENEURSHIP;67
10.4.4;ENTREPRENEURSHIP AND INTRAPRENEURSHIP;68
10.4.5;THE BIOTECHNOLOGY ENTREPRENEUR, MANAGER, OR LEADER;68
10.4.6;ESSENTIAL BIOTECHNOLOGY ENTREPRENEURIAL CHARACTERISTICS;69
10.4.7;FOUR BACKGROUNDS OF BIOTECHNOLOGY ENTREPRENEURS;72
10.4.8;BEING THE ENTREPRENEUR FOR A SEASON;73
10.4.9;DRIVING FORCES BEHIND A BIOTECH ENTREPRENEUR’S DECISIONS;74
10.4.10;LEARNING FROM “FAILURE”;76
10.4.11;SUMMARY;76
10.4.12;REFERENCES;77
10.5;Chapter 5 - Five Essential Elements for Growing Biotechnology Clusters;78
10.5.1;BIOTECHNOLOGY CLUSTERS ARE ACTIVELY DEVELOPING WORLD-WIDE;79
10.5.2;WHAT IS A BIOTECHNOLOGY CLUSTER;80
10.5.3;WHAT ARE THE BENEFITS OF A BIOTECHNOLOGY CLUSTER?;80
10.5.4;THE FIVE ESSENTIAL ELEMENTS NECESSARY TO GROWING A BIOTECHNOLOGY CLUSTER;82
10.5.5;“GROWING” BIOTECHNOLOGY CLUSTERS;83
10.5.6;FIVE ESSENTIAL ELEMENTS TO GROWING A BIOTECHNOLOGY CLUSTER IN A REGION;83
10.5.7;IMPORTANT CONSIDERATIONS;90
10.5.8;OTHER ENHANCERS OF BIOTECHNOLOGY CLUSTER DEVELOPMENT;90
10.5.9;MAINTENANCE FACTORS VS. DRIVERS;91
10.5.10;INHIBITORS OF BIOTECHNOLOGY CLUSTER GROWTH;91
10.5.11;THE ROLE OF GOVERNMENT IN DEVELOPING BIOTECHNOLOGY CLUSTERS;91
10.5.12;WHERE TO START?;92
10.5.13;SUMMARY;93
10.5.14;REFERENCES;93
11;Section II - The Human Capital;94
11.1;Chapter 6 - Characteristics of Successful Biotechnology Leaders;96
11.1.1;SUCCESS AND FAILURE;97
11.1.2;REQUIREMENTS FOR ACHIEVING SUCCESS: ORGANIZATIONAL;97
11.1.3;SIX FACTORS FOR SUCCESS;99
11.1.4;CONCLUSION;102
11.1.5;REFERENCES;102
11.2;Chapter 7 - Building, Managing, and Motivating Great Teams;104
11.2.1;ENTREPRENEURIAL PROCESS FUNDAMENTALS RELATED TO TEAMS;105
11.2.2;SUMMARY OF “LESSONS LEARNED” (THE EXPERIENTIAL PERSPECTIVE);108
11.2.3;KEY QUESTIONS TO ASK WHEN BUILDING THE TEAM—THE ACADEMIC PERSPECTIVE;110
11.2.4;AN APPROACH TO UNDERSTAND FACTORS THAT MOTIVATE TEAMS;114
11.2.5;SUMMARY AND CONCLUSIONS;116
11.2.6;AN ABRIDGED OVERVIEW OF TEAM PERFORMANCE LITERATURE;116
11.2.7;ACKNOWLEDGEMENT;118
11.2.8;REFERENCES;118
11.3;Chapter 8 - Building Human Relationship Networks;120
11.3.1;PURPOSEFUL NETWORKING IS A WAY TO EXPAND LIMITED RESOURCES;120
11.3.2;HUMAN NETWORKS LEAD TO MENTORING;124
11.3.3;BOARDS OF ADVISORS AND DIRECTORS CAN HELP ACCELERATE COMPANY SUCCESS;126
11.3.4;PERSONAL TRAITS AND CHARACTERISTICS;129
11.3.5;CONCLUSION;129
12;Section III - The Technology;132
12.1;Chapter 9 - Understanding Biotechnology Product Sectors;134
12.1.1;BIOTECHNOLOGY PRODUCT AND TECHNOLOGY SECTORS;134
12.1.2;PRODUCT DEVELOPMENT COSTS VARY BY SECTOR;135
12.1.3;PRODUCT DEVELOPMENT T.IMEFRAME VARIES FOR BIOTECHNOLOGY SECTORS;137
12.1.4;CREATING VALUE;138
12.1.5;OVERVIEW OF PRODUCT SECTORS;138
12.1.6;SUMMARY;158
12.1.7;REFERENCES;159
12.2;Chapter 10 - Technology Opportunities: Evaluating the Idea;160
12.2.1;SOURCES OF BIOTECHOLOGY PRODUCT IDEAS;160
12.2.2;RESEARCH TO COMMERCIALIZATION CHASM;161
12.2.3;EXPERIMENTAL PATHS: BASIC RESEARCH VERSUS TRANSLATIONAL RESEARCH;162
12.2.4;TECHNOLOGY IS A SOLUTION SEEKING A PROBLEM TO SOLVE;162
12.2.5;HOW TO DETERMINE IF A PRODUCT CONCEPT IS WORTH PURSUING AS A COMPANY;163
12.2.6;EVALUATE THE UNDERLYING SCIENCE AND THE TECHNOLOGY TEAM;164
12.2.7;EVALUATING THE PRODUCT’S PERCEIVED MARKET POTENTIAL;166
12.2.8;THE PEOPLE FACTOR;168
12.2.9;WHAT TO DO NEXT?;169
12.2.10;SUMMARY;169
12.2.11;REFERENCE;169
12.3;Chapter 11 - Commercialization of Bioagricultural Products;170
12.3.1;WHAT IS AGRICULTURAL BIOTECHNOLOGY?;170
12.3.2;THE AG BIOTECH COMMERCIALIZATION PROCESS;173
12.3.3;THERE IS A PATH!;175
12.3.4;WHAT’S BEEN ACHIEVED SO FAR;176
12.3.5;HERBICIDE-TOLERANCE AND INSECT-RESISTANCE TRAITS;177
12.3.6;HOW THE LANDSCAPE CHANGED;178
12.3.7;PATENTLY IMPORTANT TRENDS;179
12.3.8;LESSONS LEARNED AND OPPORTUNITIES FOR A NEW ENTREPRENEUR;179
12.3.9;REFERENCES;181
12.4;Chapter 12 - Understanding Biotechnology Business Models and Managing Risk;182
12.4.1;WHAT IS A BUSINESS MODEL?;182
12.4.2;THE VIRTUAL COMPANY BUSINESS MODEL (A TEMPORARY START-UP MODEL);183
12.4.3;BUSINESS MODEL EXAMPLES;184
12.4.4;THERAPEUTICS AND BIOLOGICS COMPANIES;184
12.4.5;DIAGNOSTIC AND RESEARCH TOOLS COMPANIES;187
12.4.6;ALL BUSINESS MODELS HAVE TRANSFERABLE COMPONENT PARTS OR SEGMENTS;189
12.4.7;HOW DO YOU DETERMINE THE BEST BUSINESS MODEL FOR A TECHNOLOGY;190
12.4.8;ENTREPRENEURIAL LEADERS ARE RISK MANAGERS;190
12.4.9;BIOTECHNOLOGY COMPANY EVALUATION TOOL;191
12.4.10;SUMMARY;194
12.4.11;REFERENCES;195
13;Section IV - The Emerging-Stage Biotechnology Company;196
13.1;Chapter 13 - Company Formation, Ownership Structure, and Securities Issues;198
13.1.1;ENTITY FORMATION;198
13.1.2;OWNERSHIP STRUCTURE;201
13.1.3;FUNDRASING;203
13.1.4;SUMMARY;205
13.2;Chapter 14 - Licensing the Technology: Biotechnology Commercialization Strategies Using University and Federal Labs;206
13.2.1;THE FEDERAL GOVERNMENT’S INVESTMENT IN BASIC BIOMEDICAL RESEARCH;206
13.2.2;TRANSLATION OF ACADEMIC RESEARCH TO PRODUCTS FOR THE PUBLIC GOOD;206
13.2.3;ACCESSING ACADEMIC TECHNOLOGIES AND COLLABORATIONS;207
13.2.4;TECHNOLOGY TRANSFER OFFICE SET-UP AND LICENSING FROM UNIVERSITIES AND FEDERAL LABORATORIES;210
13.2.5;ADVANTAGES FOR A BIOTECH START-UP TO WORK WITH THE NIH AND UNIVERSITIES;217
13.2.6;NEW AND INNOVATIVE PROGRAMS AS WE MOVE TOWARDS “V2.0” OF TECHNOLOGY TRANSFER;221
13.2.7;IMPACT OF TECHNOLOGY TRANSFER;223
13.2.8;REFERENCES;226
13.3;Chapter 15 - Intellectual Property Protection Strategies for Biotechnology Innovations;228
13.3.1;THE INTELLECTUAL PROPERTY TOOLBOX [1];228
13.3.2;PATENTS;228
13.3.3;CONTRACTS RELATING TO INTELLECTUAL PROPERTY;235
13.3.4;JOINT RESEARCH PROJECTS;236
13.3.5;COPYRIGHTS;236
13.3.6;TRADEMARKS;236
13.3.7;PHARMACEUTICAL PATENTS AND MARKET EXCLUSIVITY;238
13.3.8;REGULATORY APPROVALS FOR BIOLOGICS AND BIOSIMILARS;240
13.3.9;DIAGNOSTICS AND PERSONALIZED MEDICINE;241
13.3.10;CORPORATE IP MANAGEMENT;243
13.3.11;PATENT STRATEGIES AND PRODUCT LIFECYCLE MANAGEMENT;244
13.3.12;SOME RESOURCES;245
13.3.13;REFERENCES;245
14;Section V - Biotechnology Market Development;248
14.1;Chapter 16 - Biotechnology Products and Their Customers: Developing a Successful Market Strategy;250
14.1.1;IDENTIFY THE PATIENT;250
14.1.2;IDENTIFY THE PHYSICIAN OR HEALTHCARE PROVIDER;251
14.1.3;IDENTIFY THE PAYERS;251
14.1.4;DEVELOP A MARKETING STRATEGY FOR YOUR FUTURE PRODUCT;251
14.1.5;WHAT IS MARKETING?;252
14.1.6;ADVANCEMENT OF THE MARKETING CONCEPT;254
14.1.7;MARKET RESEARCH AND ASSESSMENT TOOLS;255
14.1.8;OTHER MARKET TOOLS AND CONCEPTS;258
14.1.9;STARTING TO DEVELOP A MARKET STRATEGY;259
14.1.10;IDENTIFY YOUR MARKET DEVELOPMENT MILESTONES;262
14.1.11;BIOTECHNOLOGY PRODUCT ADOPTION CURVE;262
14.1.12;SUMMARY;262
14.2;Chapter 17 - Biotechnology Product Coverage, Coding, and Reimbursement Strategies;264
14.2.1;THE ANALYTICAL FRAMEWORK FOR NEW TECHNOLOGIES;266
14.2.2;DEFINING THE TERMS OF COVERAGE;266
14.2.3;POSITIONING THE PRODUCT FOR FAVORABLE REIMBURSEMENT;269
14.2.4;HEALTH TECHNOLOGY ASSESSMENT (HTA);270
14.2.5;PRICING;270
14.2.6;REIMBURSEMENT MECHANISMS;271
14.2.7;EUROPEAN PRICING AND REIMBURSEMENT SUMMARY;275
14.2.8;REFERENCES;275
14.3;Chapter 18 - Getting the Word Out: Using Public Relations Strategies to Support Biotechnology Business Goals;278
14.3.1;WHAT IS PUBLIC RELATIONS AND HOW CAN IT SUPPORT YOUR BUSINESS OBJECTIVES?;278
14.3.2;GET READY: WHAT’S YOUR STORY?;279
14.3.3;GET SET: CREATING YOUR COMMUNICATIONS TOOLS;280
14.3.4;DESIGNING AND IMPLEMENTING A STRATEGIC COMMUNICATIONS PROGRAM;281
14.3.5;NEWS RELEASES;281
14.3.6;MEDIA RELATIONS—WHY IT STILL MATTERS;282
14.3.7;WORKING WITH REPORTERS AND EDITORS;283
14.3.8;BUILDING VISIBILITY WHEN YOU DON’T HAVE NEWS;284
14.3.9;CASE STUDY—STRATEGIC USE OF PR TO SUPPORT BOTH FINANCING AND PARTNERING;284
14.3.10;WHAT ABOUT DIGITAL AND SOCIAL MEDIA?;285
14.3.11;SUMMARY;286
14.3.12;ADDITIONAL RESOURCES;286
15;Section VI - The Financial Capital;288
15.1;Chapter 19 - Sources of Capital and Investor Motivations;290
15.1.1;UNDERSTANDING INVESTOR CRITERIA AND LIMITATIONS;290
15.1.2;UNDERSTANDING INVESTORS’ EXPECTATIONS FOR RETURN ON INVESTMENT;291
15.1.3;UNDERSTAND WHAT COMES WITH INVESTED MONEY: MOTIVATIONS AND INTERESTS;291
15.1.4;WHAT ARE THE CAPITAL SOURCES AVAILABLE TO BIOTECHNOLOGY COMPANIES?;292
15.1.5;DETERMINING THE VALUE OF DEVELOPMENT-STAGE BIOTECHNOLOGY COMPANIES;298
15.1.6;FINANCING STAGES FOR A BIOTECHNOLOGY COMPANY;300
15.1.7;WHAT IS AN “EXIT” STRATEGY?;303
15.1.8;HOW MUCH MONEY IS RAISED AT EACH FUNDING STAGE?;304
15.1.9;HOW MUCH OF THE COMPANY IS GIVEN UP IN EACH ROUND?;304
15.1.10;SUMMARY;305
15.1.11;REFERENCES;305
15.2;Chapter 20 - Securing Angel Capital and Understanding How Angel Networks Operate;306
15.2.1;WHAT IS AN ANGEL INVESTOR?;306
15.2.2;TYPICAL BACKGROUND OF ANGEL INVESTORS;306
15.2.3;HOW MUCH DOES A TYPICAL ANGEL INVESTOR INVEST?;306
15.2.4;ANGEL INVESTOR MOTIVATIONS;306
15.2.5;LOCATING ANGEL NETWORKS;308
15.2.6;THINGS TO KNOW WHEN PRESENTING TO ANGEL INVESTORS;309
15.2.7;UNDERSTANDING ANGEL NETWORKS AND HOW THEY ARE FORMED;309
15.2.8;ANGEL EXPECTATIONS;311
15.2.9;REFERENCES;312
15.3;Chapter 21 - Understanding and Securing Venture Capital;314
15.3.1;WHAT IS VENTURE CAPITAL?;314
15.3.2;CAPITAL IS A COMMODITY, WHEREAS EXPERIENCED INVESTING PARTNERS ARE NOT;315
15.3.3;VENTURE CAPITAL PARTNERS ARE TIME CONSTRAINED;316
15.3.4;HOW CAN AN ENTREPRENEUR IMPROVE THEIR CHANCES OF SECURING VENTURE CAPITAL?;317
15.3.5;HOW AND WHEN TO APPROACH A VENTURE CAPITAL FIRM;318
15.3.6;RAISING CAPITAL FOR BIOTECHNOLOGY COMPANIES;319
15.3.7;EXPERIENCED AND SEASONED MANAGEMENT TEAM WITH PASSION;320
15.3.8;DO NOT OVERVALUE YOUR COMPANY AT ANY FUNDING STAGE;320
15.3.9;THE PRESENTATION TO VC PARTNERS;321
15.3.10;NEXT STEPS IN THE INVESTMENT COMMITMENT PROCESS;322
15.3.11;SUMMARY;323
15.3.12;REFERENCES;323
15.4;Chapter 22 - Your Business Plan and Presentation: Articulating Your Journey to Commercialization;324
15.4.1;PITCHING TO INVESTORS AND PARTNERS;324
15.4.2;THE BUSINESS PLANNING PROCESS;325
15.4.3;THE CONTENTS OF THE BUSINESS PLAN;326
15.4.4;PRESENTING THE WRITTEN BUSINESS PLAN;331
15.4.5;ORALLY COMMUNICATING YOUR BUSINESS PLAN;332
15.4.6;CONCLUSION;333
16;Section VII - Biotechnology Product Development;334
16.1;Chapter 23 - Therapeutic Drug Development and Human Clinical Trials;336
16.1.1;SMALL MOLECULE DRUGS;336
16.1.2;LARGE MOLECULE DRUGS;344
16.1.3;CLINICAL TRANSITION STUDIES—INVESTIGATIONAL NEW DRUG APPROVAL;346
16.1.4;CLINICAL TRIALS;347
16.1.5;SUMMARY;351
16.1.6;REFERENCES;351
16.2;Chapter 24 - Development and Commercialization of In Vitro Diagnostics: Applications for Companion Diagnostics;352
16.2.1;BRINGING IVD PRODUCTS TO MARKET;353
16.2.2;SUCCESSFUL ADOPTION OF IVDS;355
16.2.3;REIMBURSEMENT OF IVD PRODUCTS;356
16.2.4;APPLICATION OF AN IVD AS A COMPANION DIAGNOSTIC;356
16.2.5;FORGING DIAGNOSTIC AND THERAPEUTIC PARTNERSHIPS FOR COMPANION DIAGNOSTIC APPLICATIONS;357
16.2.6;INTEGRATING AN IVD INTO THE DRUG DEVELOPMENT PATHWAY AS A COMPANION DIAGNOSTIC;358
16.2.7;CHALLENGES TO THE DEVELOPMENT AND COMMERCIALIZATION OF CDX PRODUCTS;359
16.2.8;FUTURE APPLICATIONS FOR IVD PRODUCTS;360
16.2.9;SUMMARY;361
16.2.10;References;361
16.3;Chapter 25 - Regulatory Approval and Compliances for Biotechnology Products;362
16.3.1;HISTORY OF THE FDA;363
16.3.2;REGULATIONS RELATED TO BIOMEDICAL PRODUCT DEVELOPMENT;365
16.3.3;CURRENT REGULATORY PATHWAYS;365
16.3.4;TRANSLATIONAL DEVELOPMENT;366
16.3.5;HUMAN CLINICAL TESTING PHASES;368
16.3.6;BIOLOGICS LICENSE APPLICATION (BLA);369
16.3.7;SUMMARY;369
16.3.8;REFERENCES;370
16.4;Chapter 26 - The Biomanufacturing of Biotechnology Products;372
16.4.1;THE HISTORY OF BIOTECHNOLOGY AND BIOMANUFACTURING;372
16.4.2;A TYPICAL BIOMANUFACTURING PROCESS;374
16.4.3;BIOSIMILARS;377
16.4.4;DISCOVERY;378
16.4.5;PROCESS DEVELOPMENT;378
16.4.6;CLINICAL MANUFACTURING;379
16.4.7;CLINICAL TRIALS;380
16.4.8;GOOD MANUFACTURING PRACTICES;381
16.4.9;FACILITY REQUIREMENTS;382
16.4.10;THE BIOMANUFACTURING TEAM—THEIR TYPICAL ROLES AND RESPONSIBILITIES IN A BIOLOGICS MANUFACTURING FACILITY;384
16.4.11;MATERIAL MANAGEMENT;387
16.4.12;BIOLOGICS DRUG SUBSTANCE MANUFACTURING;387
16.4.13;MANUFACTURING SUPPORT FUNCTIONS;400
16.4.14;CONTRACT (CMO) VERSUS IN-HOUSE MANUFACTURING;404
16.4.15;SUMMARY;406
17;Section VIII - The Later-Stage Biotechnology Company;408
17.1;Chapter 27 - Company Growth Stages and the Value of Corporate Culture;410
17.1.1;CORPORATE DEVELOPMENT AND TRANSITION STAGES;410
17.1.2;THE START-UP PHASE;411
17.1.3;THE DEVELOPMENT PHASE;412
17.1.4;DECLINE PHASE;414
17.1.5;THE CEO’S ROLE IN THE TRANSITION OF LIFE STAGES;415
17.1.6;MANAGEMENT SKILL SETS;415
17.1.7;CORPORATE CULTURE AND CORE VALUES IN A BIOTECHNOLOGY COMPANY;415
17.1.8;GUIDANCE FOR HIRING TEAM MEMBERS;419
17.1.9;RECOGNIZING WHEN TO LET SOME PEOPLE GO;420
17.1.10;SUMMARY;421
17.1.11;REFERENCES;421
17.2;Chapter 28 - Biotechnology Business Development: The Art of the Deal;422
17.2.1;BACKGROUND OF BIOTECHNOLOGY LICENSING AND PARTNERING DEALS;423
17.2.2;WHAT IS A BUSINESS DEVELOPMENT “DEAL?”;423
17.2.3;STARTING THE PROCESS;425
17.2.4;THE DEAL REQUIRES A PLAN;428
17.2.5;CLOSING THE DEAL;432
17.2.6;A SUMMARY OF THE DEAL DANCE;433
17.2.7;REFERENCES;435
17.3;Chapter 29 - Biotech-Pharma Collaboration—A Strategic Tool: Case Study of Centocor;436
17.3.1;THE BIRTH OF CENTOCOR;436
17.3.2;THE COLLABORATIVE JOURNEY BEGINS;437
17.3.3;FINANCE: “GRAB AS MANY COOKIES AS YOU CAN”;439
17.3.4;EXPANDING ITS MARKET POTENTIAL;439
17.3.5;THERAPEUTICS;440
17.3.6;CENTOCOR GOES IT ALONE;441
17.3.7;“CENTOCORPSE”: CENTOCOR IN CRISIS;442
17.3.8;COLLABORATION—A MEANS OF RESCUE;442
17.3.9;CENTOCOR BECOMES PROFITABLE;443
17.3.10;CONCLUSION;444
17.3.11;ACKNOWLEDGEMENTS;444
17.3.12;REFERENCES;444
17.4;Chapter 30 - Ethical Considerations for Biotechnology Entrepreneurs;448
17.4.1;THE NATURE OF ETHICAL REASONING;448
17.4.2;KEY ISSUES AND PRACTICAL MATTERS FOR BIOTECHNOLOGY ENTREPRENEURS;450
17.4.3;CASE STUDIES;452
17.4.4;REFERENCES;454
17.5;Chapter 31 - Career Opportunities in the Life Sciences Industry;456
17.5.1;AN OVERVIEW OF THE MANY DIFFERENT VOCATIONAL AREAS IN THE LIFE SCIENCES INDUSTRY;456
17.5.2;MAKING A CAREER TRANSITION;462
17.5.3;FINDING A JOB IN THE LIFE SCIENCES INDUSTRY;463
17.5.4;NETWORKING;464
17.5.5;INTERVIEWING;464
17.5.6;CAREERS IN THE LIFE SCIENCES INDUSTRY: JOB SECURITY AND VOLATILITY;464
17.5.7;FINAL COMMENTS AND CONCLUSIONS;464
17.5.8;RESOURCES;464
17.6;Chapter 32 - Summary;466
17.6.1;BIOTECHNOLOGY ENTREPRENEURSHIP;466
17.6.2;BIOTECHNOLOGY SECTORS AND PRODUCT DIVERSITY;467
17.6.3;GROWING BIOTECHNOLOGY CLUSTERS;467
17.6.4;TECHNOLOGY OPPORTUNITIES;468
17.6.5;INTELLECTUAL PROPERTY PROTECTION STRATEGIES;468
17.6.6;COMPANY BUSINESS MODELS;469
17.6.7;THE VIRTUAL COMPANY;469
17.6.8;DEVELOPMENT OF A COMPANY CULTURE WITH CORE VALUES;469
17.6.9;SOURCES OF CAPITAL FOR PRODUCT DEVELOPMENT;470
17.6.10;COMPANY GROWTH STAGES;471
17.6.11;BIOLOGICS MANUFACTURING;471
17.6.12;REGULATORY APPROVAL FOR BIOTECHNOLOGY PRODUCTS;471
17.6.13;BIOTECHNOLOGY PRODUCTS HAVE THREE CUSTOMERS;472
17.6.14;BUSINESS DEVELOPMENT AND PARTNERING;472
17.6.15;PUBLIC RELATIONS FOR BIOTECHNOLOGY COMPANIES;472
17.6.16;ETHICS IN BIOTECHNOLOGY;472
17.6.17;CAREER OPPORTUNITIES IN THE LIFE SCIENCES INDUSTRY;473
17.6.18;CONCLUSIONS;473
18;Index;474

Leseproben

Chapter 1

Unleashing the Promise of Biotechnology to Help Heal, Fuel, and Feed the World

James C.Greenwood     President and CEO, Biotechnology Industry Organization (BIO), Washington, D.C.

Abstract

The biotechnology industry is helping to heal, fuel, and feed the world and create significant societal and economic value. Health biotechnology is transforming the practice of medicine by providing new and better ways to detect, treat, and prevent disease at the molecular level. Biotech crops are increasing yields to improve food security and also bring significant environmental, economic and nutritional benefits (http://www.isaaa.org/resources/publications/pocketk/27/default.asp). Animal biotechnology helps increase and improve livestock production. Industrial biotechnology is transforming the methods of manufacturing many old products and makes new products possible. Biorefineries are producing renewable fuels, renewable chemicals, and other products that are key components of an emerging biobased economy. These technologies which include tissue engineering, stacked traits in bioengineered plants, and synthetic biology will enable even more transformative products in the future. The biotechnology industry grew under an environment of favorable public policy which was vital for supporting the early development of the biotechnology industry. Therefore, maintaining favorable policies is a critical element for continued expansion of its products and success for future biotechnology entrepreneurs.

Keywords

biotechnology industrypublic policyhealth biotechnologybiomedicinespersonalized medicineagricultural biotechnologyplant biotechnologyanimal biotechnologyindustrial biotechnologybiofuelsrenewable chemicalsbioplasticsbiorefineriesbiobased economy

Biotechnology is a significant part of our lives, often in ways we may not realize. Biotechnology has enabled the creation of breakthrough products and technologies to combat disease, protect the environment, feed the hungry, produce fuels, and make other useful products. We can see biotechnology at work each day in our homes, workplaces, and everywhere in between. Biotechnology enables and improves the production of the food we eat, the clothes we wear, the consumer products we use, and the medicines we take.

Humans have used some form of biotechnology since the dawn of civilization. The biotech products of today might seem like miracles to our ancestors, but they are developed on a foundation of hard-won scientific knowledge discovered by countless generations of researchers and visionaries. As a biotech entrepreneur or investor, you will build on this foundation and be part of the most transformative industry of the twenty-first century. Your work will help save lives and improve the quality of life for potentially billions of people around the world.

The modern biotechnology industry emerged in the 1970s, based largely on a new recombinant DNA technique published in 1973 by Stanley Cohen of Stanford University and Herbert Boyer of the University of California. Recombinant DNA and subsequent discoveries have enhanced and accelerated our ability to develop practical biotechnology products to help us live longer and healthier lives, have a more abundant and sustainable food supply, use cleaner and more efficient processes for industrial manufacturing [1].and reduce our greenhouse gas footprint. As of 2013, biotechnology is a more than $83 billion global industry. In 2012, the U.S. government released a National Bioeconomy Blueprint noting that bioscience industries are “a large and rapidly growing segment of the world economy that provides substantial public benefit.” Nations around the world make large investments in the bioscience industry because they want the benefits of biotech innovation along with the good jobs and economic development that biotech brings. The men and women of the biotechnology industry help heal, fuel, and feed the world. They also create immense economic value. This chapter will discuss a few of the many accomplishments of the biotechnology industry and some of the astounding breakthroughs on the horizon—new advances which you may play an important role in developing. It will also focus on the role that good public policy must play in supporting the biotechnology industry.

Health Biotechnology: Helping to Save and Extend Lives

Biotechnology product developments are transforming the practice of medicine and providing new and better ways to detect, treat, and prevent disease. These products provide targeted treatments to minimize health risks and side-effects for individual patients. Biotechnology tools and techniques open new research avenues for discovering how healthy bodies work and what goes wrong when problems arise.

The first biotech drug for human use, human insulin produced by genetically modified bacteria, was approved by the U.S. Food and Drug Administration (FDA) in 1982. Today, the recombinant DNA technology that made production of human insulin and many other biologic medicines possible has been joined in the biotech tool kit by monoclonal antibodies, cellular therapy, gene therapy, RNA interference, stem cells, regenerative medicine, tissue engineering, new vaccine approaches, and other innovative technologies. (see Figure 1.1).

In the past decade, there have been approximately 300 new prescription medicines approved for use by the FDA [2]. There are more than 900 new biotech medicines in development for conditions including diabetes, blood disorders, Alzheimer’s disease, autoimmune disorders, and many more. Biotechnology has revolutionized healthcare in many ways. Yet much more remains to be done in humanity’s age-old battle against disease. Worldwide, more than 17 million people die each year from cardiovascular disease [3]. More than seven million lives are lost to cancer [4]. More than a billion people, most of them in the developing world, are affected by deadly malaria, tuberculosis and sleeping sickness [5]. Approximately 300 million people suffer from one of the more than 7000 known rare diseases [6].

FIGURE 1.1DNA is the genetic code for life

The promise of biotech is to reduce suffering and extend lives by developing better ways to detect, treat, and prevent diseases at a genetic or molecular level. This will give us all a better chance to enjoy longer, healthier, and more productive lives. Let’s look at some of the ways biotech has made a difference and where we might find the next lifesaving breakthrough.

Saving Lives with Vaccines

Vaccines and immunizations represent the greatest successes of biotechnology in sheer number of lives saved. Most people in the developed world take it for granted that their child will not die struggling for breath inside an iron lung due to paralysis from polio. We have little worry that our kids will be permanently scarred from the ravages of smallpox or die from complications of measles or from whooping cough. Diseases that inspired fear and ended untold millions of lives for most of human history are now nearly forgotten. Vaccines make this peace of mind possible.

By the beginning of the twentieth century, vaccines existed for rabies, diphtheria, typhoid fever, and the plague. By the 1990s, smallpox and polio had been eradicated or nearly eradicated worldwide, preventing millions of deaths. Worldwide, 2.5 million child deaths are prevented each year by immunization. In this past decade alone, the biopharmaceutical industry has added to our arsenal new vaccines for shingles, pneumonia, human papilloma virus (which causes a common form of cervical cancer), and rotavirus (an infection fatal to many infants). Vaccine companies are now working to develop preventive vaccines against dangerous hospital infections such as group B streptococcus (GBS) or Staphylococcus aureus; vaccines for neglected diseases such as dengue, malaria, and tuberculosis; and new pediatric vaccines. Research and investment in therapeutic vaccines has opened up new possibilities for treating hepatitis, many cancers, Alzheimer’s, diabetes, and other conditions. Immunology and vaccine development continue to be a promising and vital field of health biotechnology (Figure 1.2).

Surviving Cancer Like Never Before

Biotechnology is helping us make substantial progress in the fight against cancer. For more and more patients, a cancer diagnosis is no longer the death sentence it once was. Due to new, more effective treatments and other medical advances, survival rates have increased significantly for many types of cancer. For example, childhood leukemia is now cured in 80 percent of cases, testicular cancer in more than 90 percent of cases, and Hodgkin’s lymphoma in more than 90 percent of cases. Cancer nevertheless remains the third leading cause of worldwide deaths each year, with global rates expected to double by 2020 and triple by 2030, resulting in 17 million cancer deaths that year.

Biotechnology is helping us better understand the molecular and genetic basis of cancer. We can now develop targeted treatments that use gene-based tests to match patients with optimal drugs and drug...