실리콘밸리에서 바이오벤처 창업하기

CraigD.Shimasaki

저자CraigD.Shimasaki.Dr.Shimasakihasover25yearsofpracticalexperienceinthebiotechindustryandasaserialentrepreneurco-foundedthreebiotechcompanies.Withinthesecompanieshehasheldavarietyofpositions,includingDirectorofProjectPlanning,ExecutiveVPofResearch,VPofOperations,ChiefOperatingOfficer,andCEO.Hehasraisedmultipleroundsofcapital,bothprivateandpublicandhasbeeninvolvedinalmosteveryfacetofabiotechstart-up.Heisintimatelyfamiliarwiththechallengesofproductdevelopment,andledinternationalclinicaltestingandregulatoryapprovalprocessesformultipleproductsthroughtheFDA.Heisaninventorofnumerouspatentsforbothdiagnosticandtherapeuticapplications.Hispassionisfortheestablishmentandgrowthofbiotechcompaniesfocusedondevelopinglife-savingproductsthatsignificantlyimpactthehealthandwellbeingofothers.Hehaswrittenthisbooktoprovideinsightintotheinnerworkingsofbiotechproductdevelopmentandthepracticeofstartingandbuildingabiotechbusiness.Hisdesiresistosharehisexperiencesinthedynamicbusinessofbiosciencetohelpothersgainwisdomsotheycanbettermanagetherisksassociatedinbuildingabiotechcompany.Dr.ShimasakireceivedhisB.S.inBiochemistryfromtheUniversityofCaliforniaatDavisandhisPh.D.inMolecularBiologyandBiotechnologyfromtheUniversityofTulsaandhisM.B.A.fromNorthwesternUniversity’sKelloggSchoolofBusiness.

1장.서론·31
1.바이오테크산업은아직신생아단계이다_32
2.바이오테크놀로지의사업은다른사업들과다르다_33
3.바이오테크놀로지는정확히무엇인가?_33
4.바이오테크놀로지크러스터와바이오테크허브의광역화_35
5.바이오테크놀로지사업모델은무너졌는가?_39

2장.무엇이바이오테크엔터프리너를만드는가?·43
1.다른종_44
2.도전을인식해라:비용을계산하라_45
1)얼마나많은비용이드는가?_46
2)개인적비용_47
3.바이오테크엔터프리너의네가지배경_48
1)과학자들을위해서:사물vs.사람_49
2)사업가들을위해서:과학자들과대화하는요령_50
4.처음시작하는엔터프리너,처음시작하는사업_51
1)리더십을발휘하기전에다른지위를고려해보아라_51
2)부가적인사업기술을얻어라_53
3)젊은MBA를위해서_54
4)평생공부하는사람이되어라_55
5.바이오테크엔터프리너의필수조건_56
1)열정과비전_56
2)당신의장점과약점을알고있어라_56
3)새로운기술을빨리배워라_58
4)좋은사업감각_59
5)두언어를말하는능력을가져라;다방면의통역가가되어라_59
6)뭘모르는지모르는무지를경계하라_62
7)지식과지혜를얻어라_63
8)인내_64
9)깊은책임감을가져라_65
10)협상가가되어라_67
11)영향력있는내사람을넓혀라_67
12)창조성과변화_68
13)리더십과핵심가치들(corevalues)_69
6.요약_69

3장.Idea가지고시작하기:라이선싱과핵심자산(coreasset)보호하기·71
1.라이선싱전에고려해야할것들_72
1)이제품을위한실제의시장이존재하는가?_72
2)과학기술의질_75
3)이것은핵심기술인가아니면단지하나의제품인가?_76
4)위대한기술은훌륭한과학자와같이온다_78
5)다음에무엇을하는가?_78
2.지적재산권은무엇인가?_79
1)특허는무엇인가?_80
2)어떻게특허를얻는가?_81
3)특허의종류:전통적인일반정식특허(Traditional,Regular(nonprovisional))_83
4)특허의종류:임시특허(Provisional)_85
5)특허의종류:국제특허(International)_85
6)실시자유권(Freedom-to-Operate)평가얻기_86
7)기업비밀(TradeSecrets)_87
8)상표(Trademarks)_88
3.기술라이선싱과협상_89
1)전형적인라이선스구조는어떻게생겼나?_90
2)라이선싱협상시요소들_92
3)독점라이선스(ExclusiveLicenses)_93
4)비독점라이선스/공동독점라이선스(Nonexclusive/CoexclusiveLicenses)_93
4.요약_94

4장.올바른비즈니스모델(RightBusinessModel)과위험관리의중요성·97
1.비즈니스모델의예들_98
1)바이오테크놀로지비즈니스모델들_99
2)DrugRepositioning비즈니스모델_101
3)MolecularTesting비즈니스모델들_102
4)당신의기술을위한최상의비즈니스모델을어떻게결정하는가?_104
2.위험관리자되는법_105
1)위험을진단하고관리하는것이왜중요한가?_106
2)관리해야할필요가있는위험들은어떤것인가?_106
3.바이오테크회사의진단도구(Biotechevaluationtool)_108
4.요약_111

5장.법적으로회사설립하기·113
1.좋은변호사를찾기_114
1)어떤변호사가몇명이나필요한가?_115
2)회사변호사(CorporateAttorney)_116
3)특허변호사(PatentAttorney)_116
4)증권변호사(SecuritiesAttorney)_117
5)좋은변호사는어떻게찾을것인가?_118
6)비용은얼마나드는가?_120
2.회사이름결정하기_121
1)왜회사이름이중요한가?_122
2)회사이름은바꿀수있는가?_124
3.새회사를법인화하기(IncorporatingtheNewCompany)_125
4.소유권:주식발행(Ownership:IssuingStock)_127
1)어떤종류의주식을발행할것인가?_128
2)설립자의경우_129
5.어떤합의서(Agreement)가필요한가?_131
6.이사회(BoardofDirector)구성_132
1)이사와임원보험의중요성_132
2)이사들의책임_133
3)이사들에게어떻게보상할것인가?_136
7.과학기술의고문단(ScientificAdvisoryBoard)구성하기_137
1)고문단은누구이며무엇을하게되나?_137
2)SAB미팅은얼마나자주열리나?_138
3)SAB에게는어떻게보상하나?_139
4)임상고문단_140
8.TheVirtualCompany_140
9.요약_141

6장.제품개발과정:올바른과정을도표화하기·143
1.가치창조하기_144
2.바이오테크놀로지R&D:연구는작게,개발은크게_144
3.익숙지않은길에너무겁먹지말아라_145
4.두가지종류의제품개발카테고리_146
5.제품개발단계_148
6.“치료제”를위한개발단계_149
1)치료제:기초연구단계와TranslationalResearchStage_149
2)치료제:개발단계(DevelopmentStage)_151
3)치료제:리드및최적화단계(Lead/ProcessOptimizationStage)_152
4)치료제:전임상단계(PreclinicalTestingStage)_154
5)치료제:임상단계(ClinicalTestingStage)_155
6)치료제:허가리뷰단계(RegulatoryReviewStage)_159
7)치료제:스케일업과대량생산단계(Scale-upandManufacturingStage)_160
8)치료제:마케팅과성장단계(MarketingandGrowthStage)_160
7.“분석기기”를위한개발단계들_161
1)분석기기:기초연구단계와TranslationalResearchStage_161
2)분석기기:컨셉증명단계(Proof-of-Conceptstage)_162
3)분석기기:프로토타입개발(PrototypeDevelopment)_163
4)분석기기:임상확인단계(ClinicalValidationStage)_164
5)분석기기:허가리뷰단계(RegulatoryReviewStage)_165
6)분석기기:스케일업과대량생산단계(Scale-upandManufacturingStage)_165
7)분석기기:마케팅과성장단계(MarketingandGrowthStage)_165
8.제품개발의마일스톤_166
1)일단여러분의계획을적어라_168
9.제품개발시외부의지원_169
1)경쟁그랜트를따는것의중요성_171
2)SBIR의도움을받아상업화하기_171
10.시장개발및사업과회사의개발과정_172
11.요약_173

7장.마케팅전략개발하기·177
1.무엇이마케팅인가?_178
1)잘못된개념1:마케팅이뭐가그리어려운가?그냥만들어서팔면돼!_178
2)잘못된개념2:기술이좋으면,더많은사람들이제품을살거야_179
3)잘못된개념3:시장전략을지금고민할필요가있을까,나중에시간많을때마케팅에대해생각해볼게_180
2.마케팅개념의진화_181
1)제품개념(TheProductionConcept)_181
2)세일즈개념(Thesalesconcept)_182
3)마케팅개념(TheMarketingConcept)_182
4)제품을팔기위한시장의이해와평가_184
3.마케팅도구_185
1)세분화(Segmentation)_185
2)지리학적위치에의한세분화_185
3)인구학적특징에의한세분화_187
4)행동양식과이용도에의한세분화_187
5)표적화(Targeting)_188
6)포지셔닝(Positioning)_188
7)브랜딩(Branding)_189
4.시장조사와판단도구_190
1)1차와2차시장조사_190
2)시장크기와기회_191
5.바이오테크놀로지제품의세가지소비자들_193
1)환자들_193
2)의사들_193
3)보험회사들_194
6.시장개념을적용하는다섯단계과정_195
1)1단계:시장크기결정하기_195
2)2단계:표적시장세분화하기_196
3)3단계:표적시장에제품의가치위치를세우기_197
4)4단계:표적시장세분화대상에도착할수있는시장채널선택하기_198
5)5단계:시장전략을확인하고정비하기_199
7.다른바이오테크제품의예들_199
8.예:유방암의위험도를측정하는분자유전학적테스트_200
1)잠재시장크기결정하기_200
2)표적시장세분화하기_201
3)표적시장에가치위치를결정하기_202
4)표적시장에도달할수있는시장채널을평가하고고르기_203
5)시장전략을확인하고정비하기_204
9.예:독감에대한비강스프레이백신_204
1)잠재시장크기결정하기_204
2)표적시장세분화하기_205
3)표적시장에서가치위치를결정하기_206
4)표적시장에도달할수있는시장채널을평가하고고르기_207
5)시장전략을확인하고정비하기_207
10.시장개발시마일스톤_208
11.바이오테크제품의적용곡선_209
12.요약_210

8장.회사의재무?파트1:돈모으기,필요한자본과펀딩소스·213
1.돈모으기_214
1)왜우리의모든시간이돈을모으는데쓰는것같이보이는가?_214
2)강할때돈을모아라_215
3)필요한예상치보다더많은돈을모아라_215
4)다음라운드의자본을모으는걸너무오래미루지말아라_216
5)회사가치를너무크게계산하지말아라_218
6)새돈이오래된돈을몰아낸다_218
7)단지투자자가흥미있다고해서,투자를하지는않는다_218
2.얼마나많은기금을조성해야하나?_220
1)치료제의예상개발비용_222
2)진단테스트의예상개발비용_224
3)의료기기의예상개발비용_224
4)임상실험서비스:GenericandGenet