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Why isHR inthe BiotechIndustrydifferent?
Biotechnologyisone of the mostresearchintensive industriesinthe world. The firstbiotechnology
productearningFDA approval was forsynthetic“human”insulinin1982 and was developedby
GenentechandEli Lilly.
Accordingto the Bureauof Labor Statistics,there are 2,323 biomedical companiesinCalifornia,
employinganestimated267,271 people. The BayAreaemploys51,255 people,or19.2% of this
total. Los Angeles(42,383) and Orange (30,092) Countiesemploymore thanSanDiego(27,510)
County.
By sector,Californiabiomedical employmentisgreatestinthe Medical devices,instrumentsand
diagnosticsareawith40.2% of the total (107,467 people). Biopharmaceuticalsisnextwith30.9%
and Academicresearchat14.8%. Between2006 – 2010 there wasflatcumulative growthinthe
biomedical workforce inCalifornia.
Time and cost to market: BiotechandPharma productstake an average of 10 – 15 yearsto bringa
drug to getto market,withcostsof over$1.3 billion. Accordingtoarecentarticle inForbes
magazine writerMatthewHerper,“The average drugdevelopedbyamajorpharmaceutical
companycosts at least$4 billion,anditcan be as much as $11 billion,” Herperalsowrites“fewer
than 1 in 10 medicinesthatstartbeingtestedinhumanclinical trialssucceed.6” Unlike the high
techindustry,the life science industryrequiressignificantlymore timeandmoneybefore bringinga
drug,device ordiagnostictomarket.
Multi-functional Interdependencies: Due tothe complex nature of product developmentinthe life
sciences,andthe likelihoodof there beingacross-matrix environmentwithinthe company,itcan
take many yearsof experience foranexecutiveorindividual todeveloptheirexpertise,understand
cross-functional roles/responsibilitiesandpriorities,andbe able toeffectivelynavigatecritical
decisionpointsinthe process.
RegulatoryAgencies: CBER/CDER– There are regulatoryhurdlesthatthe FDA hasset forsmall
moleculesandbiologicstoensure theirsafetybefore,during andafterthe drugreachesthe market.
Unlike otherindustries,CBERandCDER require truckloadsof information(nowterabytesof data
withelectronicsubmissions)tobe documentedandsubmittedbefore productapproval. Highly
documentedandregulatedGoodlaboratory,clinical andmanufacturingpractices(alsoknownas
GLP, GCP and GMP) are requiredtobe compliantwithgoverningagenciesandare auditedroutinely.
Clinical Trials/design: Thiscanbe an art as muchof a science,withacomplex setof variablesto
consider. MD/PhDexpertsfrommanydisciplinesconverge todesignthe optimal trial thatwill
impactthe greatestnumberof patientswhile limitingtoxicside effects.
Postproduct approval: The FDA oftenrequiresthatcompaniescontinueto collectdatafromdoctors
and patientsandmayrequire additionalpost-marketingorregistrystudiesafteraproductis
approved – thistakesa significantamountof time andexpense. Some findingsleadtoadditional
productindicationsandpossiblemarketingopportunitiesif the companiesare willingtosponsor
more clinical trialsforthose indications(i.e.productscanonlybe promotedforon label indications)
Financing: A varietyof optionsare necessaryforgeneratingcapital duringresearch,preclinical and
clinical stages. Grants,VC funding,productpartnering,outlicensing,alliances,are the mostlikely
source of capital. These daysIPO’sare extremelyrare andgenerallyneedtobe supportedbylate
stage clinical programs,inferringthat itisnot alwaysa reliable equitygeneratingstrategyfora
company.
Risk: Small biotech/specialtypharmacompaniesare riskybusinesses –few generate sufficient
capital to complete the drugdevelopmentcycle. Manyoutside the industryconsiderthe smaller
companiesthe equivalentof aprojectteamin a largercompany.
ProfitMargins: Once a drug ison the market,it’spossible tosee 75- 80% profitmargins,depending
on the alternative drugsavailable.Historically - althoughlesscommontoday - itis notunusual fora
biotechcompanytobe publicwithoutproductrevenue formanyyears.
Virtual Companies: One of the trendsindrug developmentistohire veryexperiencedexpertsin
theirdomainandoutsource variousfunctions –almostall functions canbe outsourced:research,
preclinical development,clinical trials,manufacturing,sales,IT –and HR - includingstaffingand
payroll.
It’sa small world: Giventhe numberof science PhD’sinbiotech,andthe limitednumberof biotech
“clusters”aroundthe country,there are a lotof people thatknow eachother. More than other
industrynetworks,those whoworkinthe biotech/pharmaindustryhave stronginformal
connections –includinghusbands/wivesthatworkinthe industry.
IndustryInfluencers:
• Intellectual Property
• FDA/Compliance
• Government&ThirdParty Payers
• Wall Street
• Patients/AdvocacyGroups
• Academia/KeyOpinionLeaders
• BigPharma
The interdependenciesbetweenbiotech/specialtypharmacompaniesandthese marketinfluences
are complex andall impactbusinessstrategy. Eachindustryinfluencercanadverselyimpacta
companyand mostare factoredintoa company’sbusinessstrategy.
UnderstandingScientists: ThishasbeenwrittentosupportHR/ODprofessionalsinunderstanding
theirinternal customers.
Academics: Ittakes5- 8 yearsof graduate workto be a PhD scientist,some have anadditional 1-3
yearsof postgraduate research – andmost are fundedbygrants,earningaminimal livingastheygo
throughschool.
Data: Scientistsare taughtthatdata, factsand researchtrumpseverything.
“A” players: Scientiststendtobe highachieversandlesstolerantof peoplethatare not equally
“smart” or data driven. Theyare usedto gettinghighmarksfor theircreative ideas,rationalthinking
and intelligence.
ManagementSkills: ManyScientistsare promotedintomanagementbecause of theirscientificskills
and accomplishmentwhichare notalwaysa proxyfortheirpeople/managerial talentorprospects.
Competition: Some PhD’swere taughttothrive onconflict,heateddiscussions,andargumentsto
vetideassothat the bestideawouldrise tothe top. It is notuncommonfor some academiclabsto
purposefullysettheirgraduate studentsand/orpostdocsagainsteachothertomaximize
productivityandpublications.
Lineage/advisors: Inthe academicworld,whoyouhave studiedundercanbe more importantthan
one’sscientificfocus. Lineage iskeyasthisisalsoone’snetworkaftergraduating(like goingto
Harvard vs.a communitycollege).
Publishingpapers: It’sall aboutpublishingpapersinacademia - the more paperswithyourname as
one of the authors(preferably“lead”author),andthe more referencedthe paper,the better. In
general,yourtitle,youridentityandyourcareerisshapedbythe papersyou write. Thisisalsoa
place where companiesare different –there istensionbetweenallowingpublishingof apaperand
divulgingprogramstatusandcorporate intellectual property(IP)
Source : MaryAnn Ireland
Recommendedby:
CHRISTOPHERT. ANDERSON,SPHR,CBS
Vice President,HumanResources
Mölnlycke HealthCare,Atlanta,GA
email:ctanderson209@sbcglobal.net
https://www.linkedin.com/in/chrisandersonsphr
Mölnlycke HealthCare,AbbottLaboratories, HospiraInc.,Hill-Rom,The Ertl Company
Pharma,Pharmaceuticals,Biopharm, Biopharmaceuticals,Medical Devices,Biotech,Biotechnology
http://www.zoominfo.com/z/ChrisAnderson
http://www.yatedo.com/p/CHRISTOPHER+ANDERSON/normal/e23ed9da3ff1b552ba6fcd85dff79f0c
https://www.intelius.com/Find-Phone-Address/Dubuque-IA/Christopher-Anderson.html
https://www.visualcv.com/christopher-t-anderson
https://connect.data.com/contact/view/t3nVaN-mtGLcWTv2axRPyg/christopher-t-anderson
about.me/c.anderson
https://docs.google.com/document/d/1AR4wGYccj9mU4c_LM0HWM8mxGfbszz0v1FCHAd-
J0PA/edit?usp=sharing
https://drive.google.com/file/d/0B9UWO5DpC2g6N3E0RktyOXk1bkk/view?usp=sharing
https://chrisandersonweb.wordpress.com/2016/07/08/christopher-t-anderson-sphr-cbs/
http://www.slideshare.net/JeromeMatthews1/christopher-anderson-vice-president-human-
resources-63899602
https://www.scribd.com/document/317951809/Christopher-Anderson-Vice-President-Human-
Resources
https://issuu.com/christophertanderson/docs/christopher_anderson_vice_president
https://plus.google.com/106489559400980295140/posts/58TnambS599
http://christopher-t-anderson.blogspot.in/2016/07/christopher-t-anderson-sphr-cbs.html
https://penzu.com/p/b337af8c
http://christanderson-things.tumblr.com/post/147232131622/christopher-t-anderson

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Christopher Anderson SPHR CBS VP HR Why is hr

  • 1. Why isHR inthe BiotechIndustrydifferent? Biotechnologyisone of the mostresearchintensive industriesinthe world. The firstbiotechnology productearningFDA approval was forsynthetic“human”insulinin1982 and was developedby GenentechandEli Lilly. Accordingto the Bureauof Labor Statistics,there are 2,323 biomedical companiesinCalifornia, employinganestimated267,271 people. The BayAreaemploys51,255 people,or19.2% of this total. Los Angeles(42,383) and Orange (30,092) Countiesemploymore thanSanDiego(27,510) County. By sector,Californiabiomedical employmentisgreatestinthe Medical devices,instrumentsand diagnosticsareawith40.2% of the total (107,467 people). Biopharmaceuticalsisnextwith30.9% and Academicresearchat14.8%. Between2006 – 2010 there wasflatcumulative growthinthe biomedical workforce inCalifornia. Time and cost to market: BiotechandPharma productstake an average of 10 – 15 yearsto bringa drug to getto market,withcostsof over$1.3 billion. Accordingtoarecentarticle inForbes magazine writerMatthewHerper,“The average drugdevelopedbyamajorpharmaceutical companycosts at least$4 billion,anditcan be as much as $11 billion,” Herperalsowrites“fewer than 1 in 10 medicinesthatstartbeingtestedinhumanclinical trialssucceed.6” Unlike the high techindustry,the life science industryrequiressignificantlymore timeandmoneybefore bringinga drug,device ordiagnostictomarket. Multi-functional Interdependencies: Due tothe complex nature of product developmentinthe life sciences,andthe likelihoodof there beingacross-matrix environmentwithinthe company,itcan take many yearsof experience foranexecutiveorindividual todeveloptheirexpertise,understand cross-functional roles/responsibilitiesandpriorities,andbe able toeffectivelynavigatecritical decisionpointsinthe process. RegulatoryAgencies: CBER/CDER– There are regulatoryhurdlesthatthe FDA hasset forsmall moleculesandbiologicstoensure theirsafetybefore,during andafterthe drugreachesthe market. Unlike otherindustries,CBERandCDER require truckloadsof information(nowterabytesof data withelectronicsubmissions)tobe documentedandsubmittedbefore productapproval. Highly documentedandregulatedGoodlaboratory,clinical andmanufacturingpractices(alsoknownas GLP, GCP and GMP) are requiredtobe compliantwithgoverningagenciesandare auditedroutinely. Clinical Trials/design: Thiscanbe an art as muchof a science,withacomplex setof variablesto consider. MD/PhDexpertsfrommanydisciplinesconverge todesignthe optimal trial thatwill impactthe greatestnumberof patientswhile limitingtoxicside effects. Postproduct approval: The FDA oftenrequiresthatcompaniescontinueto collectdatafromdoctors and patientsandmayrequire additionalpost-marketingorregistrystudiesafteraproductis approved – thistakesa significantamountof time andexpense. Some findingsleadtoadditional productindicationsandpossiblemarketingopportunitiesif the companiesare willingtosponsor more clinical trialsforthose indications(i.e.productscanonlybe promotedforon label indications) Financing: A varietyof optionsare necessaryforgeneratingcapital duringresearch,preclinical and clinical stages. Grants,VC funding,productpartnering,outlicensing,alliances,are the mostlikely source of capital. These daysIPO’sare extremelyrare andgenerallyneedtobe supportedbylate stage clinical programs,inferringthat itisnot alwaysa reliable equitygeneratingstrategyfora company.
  • 2. Risk: Small biotech/specialtypharmacompaniesare riskybusinesses –few generate sufficient capital to complete the drugdevelopmentcycle. Manyoutside the industryconsiderthe smaller companiesthe equivalentof aprojectteamin a largercompany. ProfitMargins: Once a drug ison the market,it’spossible tosee 75- 80% profitmargins,depending on the alternative drugsavailable.Historically - althoughlesscommontoday - itis notunusual fora biotechcompanytobe publicwithoutproductrevenue formanyyears. Virtual Companies: One of the trendsindrug developmentistohire veryexperiencedexpertsin theirdomainandoutsource variousfunctions –almostall functions canbe outsourced:research, preclinical development,clinical trials,manufacturing,sales,IT –and HR - includingstaffingand payroll. It’sa small world: Giventhe numberof science PhD’sinbiotech,andthe limitednumberof biotech “clusters”aroundthe country,there are a lotof people thatknow eachother. More than other industrynetworks,those whoworkinthe biotech/pharmaindustryhave stronginformal connections –includinghusbands/wivesthatworkinthe industry. IndustryInfluencers: • Intellectual Property • FDA/Compliance • Government&ThirdParty Payers • Wall Street • Patients/AdvocacyGroups • Academia/KeyOpinionLeaders • BigPharma The interdependenciesbetweenbiotech/specialtypharmacompaniesandthese marketinfluences are complex andall impactbusinessstrategy. Eachindustryinfluencercanadverselyimpacta companyand mostare factoredintoa company’sbusinessstrategy. UnderstandingScientists: ThishasbeenwrittentosupportHR/ODprofessionalsinunderstanding theirinternal customers. Academics: Ittakes5- 8 yearsof graduate workto be a PhD scientist,some have anadditional 1-3 yearsof postgraduate research – andmost are fundedbygrants,earningaminimal livingastheygo throughschool. Data: Scientistsare taughtthatdata, factsand researchtrumpseverything. “A” players: Scientiststendtobe highachieversandlesstolerantof peoplethatare not equally “smart” or data driven. Theyare usedto gettinghighmarksfor theircreative ideas,rationalthinking and intelligence. ManagementSkills: ManyScientistsare promotedintomanagementbecause of theirscientificskills and accomplishmentwhichare notalwaysa proxyfortheirpeople/managerial talentorprospects. Competition: Some PhD’swere taughttothrive onconflict,heateddiscussions,andargumentsto vetideassothat the bestideawouldrise tothe top. It is notuncommonfor some academiclabsto purposefullysettheirgraduate studentsand/orpostdocsagainsteachothertomaximize productivityandpublications.
  • 3. Lineage/advisors: Inthe academicworld,whoyouhave studiedundercanbe more importantthan one’sscientificfocus. Lineage iskeyasthisisalsoone’snetworkaftergraduating(like goingto Harvard vs.a communitycollege). Publishingpapers: It’sall aboutpublishingpapersinacademia - the more paperswithyourname as one of the authors(preferably“lead”author),andthe more referencedthe paper,the better. In general,yourtitle,youridentityandyourcareerisshapedbythe papersyou write. Thisisalsoa place where companiesare different –there istensionbetweenallowingpublishingof apaperand divulgingprogramstatusandcorporate intellectual property(IP) Source : MaryAnn Ireland Recommendedby: CHRISTOPHERT. ANDERSON,SPHR,CBS Vice President,HumanResources Mölnlycke HealthCare,Atlanta,GA email:ctanderson209@sbcglobal.net https://www.linkedin.com/in/chrisandersonsphr Mölnlycke HealthCare,AbbottLaboratories, HospiraInc.,Hill-Rom,The Ertl Company Pharma,Pharmaceuticals,Biopharm, Biopharmaceuticals,Medical Devices,Biotech,Biotechnology http://www.zoominfo.com/z/ChrisAnderson http://www.yatedo.com/p/CHRISTOPHER+ANDERSON/normal/e23ed9da3ff1b552ba6fcd85dff79f0c https://www.intelius.com/Find-Phone-Address/Dubuque-IA/Christopher-Anderson.html https://www.visualcv.com/christopher-t-anderson https://connect.data.com/contact/view/t3nVaN-mtGLcWTv2axRPyg/christopher-t-anderson about.me/c.anderson https://docs.google.com/document/d/1AR4wGYccj9mU4c_LM0HWM8mxGfbszz0v1FCHAd- J0PA/edit?usp=sharing https://drive.google.com/file/d/0B9UWO5DpC2g6N3E0RktyOXk1bkk/view?usp=sharing https://chrisandersonweb.wordpress.com/2016/07/08/christopher-t-anderson-sphr-cbs/ http://www.slideshare.net/JeromeMatthews1/christopher-anderson-vice-president-human- resources-63899602