Shimasaki Craig D. The Business of Bioscience: What goes into making a Biotechnology Product
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Index 267
physician, 106
customer satisfaction, 99
definition, 96
five-step process
market channel selection, 108–109
potential market size determination, 107
product’s value proposition
articulation, 108
target market segment, 107–108
validation and refining, 109
market development milestones, 115
Marketing Concept, 98–99
misconceptions
personal digital assistant (PDA), 96
technology, 96–97
molecular genetic test, breast cancer risk
assessment
market channel, 112
potential market size determination, 110
target market segment, 110–111
validation and refining, 112
value proposition, 111
nasal spray vaccine, influenza virus
market channel, 114
potential market size determination,
112–113
target market segment, 113
validation and refining, 114
value proposition, 113–114
product, understanding and appreciation,
99–100
Production Concept, 98
Sales Concept, 98
Marketing tools
branding, 103
market research and assessment
market size and opportunity, 104–105
primary and secondary market
research, 104
positioning, 102
segmentation
behavior and usage, 101–102
demography, 101
geographic location, 100–101
targeting, 102
Material transfer agreement (MTA), 201
Molecular testing business models, 46–47
N
Nanogen, 58
New Drug Application (NDA)
clinical trials, 213
marketing approval, 214
Noncompete agreement, 64
Nonexclusive/coexclusive licenses, 40–41
Nonprofit foundation partnership, 141–142
Non Qualified Options (NQOs), 62
Nuclear Regulatory Commission (NRC), 207
O
Oklahoma Center for Advancement of Science
and Technology (OCAST), 5
P
Patent
claims, 34
novelty and nonobviousness, 33
patent attorney, 33, 34
property right, 32
types
international, 35–36
provisional, 35
traditional/regular (nonprovisional),
34–35
utility, 34
Patent Cooperation Treaty (PCT), 35
Pharmaceutical companies
drug development, 200
marketing approval, 200
Pre-seed capital, 147–148
Private Placement Memorandum, 133
Product development pathway
assistance
preclincial therapeutic and biologic
drug development, 90
SBIR, commercialization, 91
winning competitive grants, 90–91
biotechnology R&D, 74
business and organizational development
path, 91–92
categories, types, 75–76
market development path, 91–92
milestones, 88–89
obstacles, 75
value creation, 73–74
Product development stages
analytics and tools
basic and translational research stage,
84–85
clinical validation stage, 86–87
marketing and growth stage, 87
proof-of-concept stage, 85
prototype development, 85–86
regulatory review stage, 87
scale-up and manufacturing stage, 87
268 Index
Product development stages (cont.)
treatments
basic and translational research stage,
76–77
clinical testing stage, 80–83
development stage goal, 78
lead/process optimization stage, 78–79
marketing and growth stage, 84
preclinical testing stage, 79–80
regulatory review stage, 83
scale-up and manufacturing stage,
83–84
Professional Employer Organization (PEO), 183
Q
Quitting, biotech entrepreneur
employee assistance, 237
entrepreneur leaving company, 237
honesty and transparency, 236–237
market approach, 234
responsibilities, 236
time sequence to
external indicators, 234–235
internal indicators, 235–236
R
Raising money
angel investors, 132–133
annual burn rate, 119
clinical laboratory services, 124–125
diagnostic tests cost estimates, 123–124
financing windows, 119
friends and family, 130
industry corporate partnership, 142
institutional debt financing, 142–143
investor conference meetings, 118
Investor’s Golden Rule, 120
medical device estimates, 124
nonprofit foundation partnerships,
141–142
peer-reviewed grant funding system,
130–131
personal money, 129
potential investors, 118
private placements/offerings, 133
Senior Secured Convertible Debenture, 119
start-up company
academic scientist/physician, 125–126
business person (nonscientist/
nonphysician), 126–127
comparative time, 126
founder effects, 125
industry scientist/physician, 126
spin-off group, industry, 127
state and local financing program support,
131–132
strength, 118
therapeutic estimates, 123
two pitfalls, 121
valuation, company, 120
venture capital industry, 134–135
corporate attorney, 138
dark side, 138
due diligence, 140
face-to-face meetings, 139
funding chasm, 140–141
limited partners, 134, 138
longest investment horizon, 136
partnership, 135
silicon valley, 134
term sheet, 139–140
Return on investment, 143–144, 166
Risk manager
business strengths and weakness assess-
ment, 50
risk assessment and management, 49
risk factors, 49–50
S
Scientific Advisory Board (SAB)
Clinical Advisory Board and, 69–70
compensation, 69
functions, 68
meetings, 69
stock options, 69
technology inventors, 68
virtual company, 70
Securities and Exchange Commission
(SEC), 132
Senior Secured Convertible Debenture, 119
Small business administration (SBA), 233
Small Business Innovative Research (SBIR)
program, 130
Start-up capital. See Pre-seed capital
Strategic alliances
mutual benefit, 199
pharmaceutical companies, 198
Strategic Technology Transfer Research
(STTR) programs, 130
T
Term sheet, 139–140
Thomson VentureXpert, 122
Trademarks, 37
Index 269
V
Venture capital industry
corporate attorney, 138
dark side, 138
due diligence, 140
face-to-face meetings, 139
funding chasm, 140–141
limited partners, 134, 138
longest investment
horizon, 136
partnership, 135
silicon valley, 134
term sheet, 139–140
Venture Capital Investment, 135