Deciphering the Therapeutic Stem Cell Strategies of Large and Midsize Pharmaceutical Firms

References

• Cambrosio A , KeatingP . Between fact and technique: the beginnings of hybridoma technology . J. Hist. Biol.25 , 175 – 230 ( 1992 ).
   PubMed Web of Science ®Google Scholar
• Glassman RH , SunAY . Biotechnology: identifying advances from the hype . Nat. Rev. Drug Discov.3 , 177 – 183 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Jack A . Merck to cut 8,500 more jobs . The Financial Times , 2 October ( 2013 ).
   Google Scholar
• Nelson AL , DhimoleaE , ReichertJM . Development trends for human monoclonal antibody therapeutics . Nat. Rev. Drug Discov.9 , 767 – 774 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Aggarwal S . What’s fueling the biotech engine – 2012 to 2013 . Nat. Biotechnol.32 , 32 – 39 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Mullin E . Biotech products in Big Pharma clinical pipelines have grown dramatically . Fierce Biotech , 18 November ( 2013 ).
   Google Scholar
• Assink M . Inhibitors of disruptive innovation capability: a conceptual model . Eur. J. Innov. Manag.9 , 215 – 233 ( 2006 ).
   Google Scholar
• Christensen CM . The Innovator’s Dilemma: When New Technologies Cause Great Firms to Fail.Harvard Business School Press , Boston, MA, USA ( 1997 ).
   Google Scholar
• Ettlie J , BridgesWP , O’KeefeRD . Organization strategy and structural differences for radical versus incremental innovation . Manag. Sci.30 , 682 – 695 ( 1984 ).
   Web of Science ®Google Scholar
• Hamel G , PrahaladCK . Corporate imagination and expeditionary marketing . Harv. Bus. Rev.69 , 81 – 92 ( 1991 ).
   PubMed Web of Science ®Google Scholar
• Henderson R . Underinvestment and incompetence as responses to radical innovation: evidence from the photolithographic alignment equipment industry . Rand J. Econ.24 , 248 – 270 ( 1993 ).
   Web of Science ®Google Scholar
• Leifer R , Colarelli O’ConnorG , RiceM . Implementing radical innovation in mature firms: the role of hubs . Acad. Manag. Exec.15 , 102 – 113 ( 2001 ).
   Google Scholar
• Stringer R . How to manage radical innovation . Calif. Manag. Rev.42 , 70 – 88 ( 2000 ).
   Web of Science ®Google Scholar
• Vertès AA . Knowing when to adopt stem cell technologies . MedNous , July–August ( 2010 ).
   Google Scholar
• Vertès AA . Time to engage with stem-cell therapeutics . MedNous , April ( 2012 ).
   Google Scholar
• Ewing R . Khosla chides Big Oil for lack of biofuels appetite . Reuters,6 June 2011 . 
   Google Scholar
• Lane J . BP Biofuels: time for “the really hard yards” in biofuels commercialization . Biofuels Digest,13 March (2013) .
   Google Scholar
• Linton JD , WalshST . Extracting value form learning curves: integrating theory and practice . Creativity Innov. Manag.22 , 10 – 25 ( 2013 ).
   Web of Science ®Google Scholar
• Vertès AA , InuiM , YukawaH . Implementing biofuels on a global scale . Nat. Biotechnol.24 , 761 – 764 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Harding R . A mysterious divergence . The Financial Times , 25 July ( 2013 ).
   Google Scholar
• Bruneel J , van de VeldeE , ClarysseB , GemmelP . Improving the success of radical innovation projects within established firms: engaging employees across different hierarchal levels . Technol. Anal. Strateg. Manag.24 , 951 – 965 ( 2012 ).
   Web of Science ®Google Scholar
• Vertès AA . Creating an Effective Clinical Delivery Plan for Cell Therapies.Genetics Policy Institute, FL, USA ( 2009 ).
   Google Scholar
• Vertès AA . Adoption of therapeutic stem cell technologies by large pharmaceutical companies . In: The Delivery of Regenerative Medicines and Their Impact on Healthcare.PrescottCD , PolakJ . (Eds)CRC Press , FL, USA, 153 – 175 ( 2010 ).
   Google Scholar
• Aldridge S .  Regenerative medicine: small steps towards the great leap forward .  Pharmafile ,   16 August 2010 .
   Google Scholar
• Netterwald J . Stem cell technologies boost regenerative medicine: symbiotic relationship expected to lead to new therapies for diseases . Genet. Eng. News29, 18 ( 2009 ).
   Google Scholar
• Vertès AA . Roche’s perspective on how the cell and gene therapy sector is reaching maturity and driving value . Presented at:Phacilitate. Cell and Gene Therapy Forum, 2009.Washington, DC, USA , 26–28 January 2009.  
   Google Scholar
• Colarelli O’Connor G , McDermottCM . The human side of radical innovation . J. Eng. Technol. Manag.21 , 11 – 30 ( 2004 ).
   Web of Science ®Google Scholar
• Villiger R , BogdanB . Dissecting monoclonal antibody mega-deals . mAbs1 , 172 – 178 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Alsberg E , RowleyJA . Technologies for enhancing tissue engineering: materials and environments for guiding stem cell function. Preface . Tissue Eng. A15, 203 – 204 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Coutu DL , MoïraF , GalipeauJ . Mesenchymal stem cells and tissue repair . In: Regenerative Therapy Using Blood-Derived Stem Cells.AllanDS , StrunkD . (Eds)Humana Press , New York, NY, USA , 35 – 51 ( 2012 ).
   Google Scholar
• Rossbach M , HadenfeldM , BrüstleO . Industrial applications of stem cells . In: Translational Stem Cell Research.HugK , HermerénG . (Eds)Humana Press , New York, NY, USA , 91 – 103 ( 2011 ).
   Google Scholar
• Vanek PG . Lonza cell therapy . Future Med.3 , 237 – 241 ( 2008 ).
   Google Scholar
• Bergman K , GraffGD . The global stem cell patent landscape: implications for efficient technology transfer and commercial development . Nat. Biotechnol.25 , 419 – 424 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Konski AF , SpielthennerDJ . Stem cell patents: a landscape analysis . Nat. Biotechnol.27 , 722 – 726 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Boregowda SV , PhinneyDG . MSCs: paracrine effects . In: Mesenchymal Stromal Cells: Biology and Clinical Applications.HemattiP , KeatingP . (Eds)Springer , New York, NY, USA , 145 – 167 ( 2013 ).
   Google Scholar
• Caplan A , BruderSP . Mesenchymal stem cells: building blocks for molecular medicine in the 21st century . Trends Mol. Med.7 , 259 – 264 ( 2001 ).
   PubMed Web of Science ®Google Scholar
• Carroll J . J&J gambles $12.5 million in rare Big Pharma bet on a stem cell therapy . Fierce Biotech , 6 January ( 2014 ).
   Google Scholar
• Anonymous . Medtronic Annual Report: Transforming for Growth.Medtronic, MN, USA ( 2012 ).
   Google Scholar
• Vinas T . Medtronic stakes position in cardiac stem-cell therapy.   www.industryweek.com/archive/medtronic-stakes-position-cardiac-stem-cell-therapy ( 2005 ).
   Google Scholar
• Anonymous . Cellerix raises €27 million in a first closing . Fierce Biotech , 11 November ( 2009 ).
   Google Scholar
• Anonymous . Promethera raises $31.4m to progress progenitor cell therapy for liver diseases . Genet. Eng. News , 28 March ( 2012 ).
   Google Scholar
• Anonymous . Celgene touts pipeline, stem cell drug at R&D day . Fierce Biotech , 9 April ( 2010 ).
   Google Scholar
• Anonymous . Celgene Annual Report . Celgene, NJ, USA ( 2011 ).
   Google Scholar
• Mullin E . ViaCyte, Inc. raises $10.6 million in a private financing to support clinical development of its cell therapy product for insulin dependent diabetes . Fierce Biotech , 10 July ( 2013 ).
   Google Scholar
• Ben-David U , GanQF , Golan-LevTet al. Selective elimination of human pluripotent stem cells by an oleate synthesis inhibitor discovered in a high-throughput screen . Cell stem cell12 , 167 – 179 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Lou KJ . Small molecules vs. teratomas . Sci. Bus. Exch.6 , 1–2 ( 2013 ).
   Google Scholar
• Anonymous . Roche to lead Israel stem cell consortium . BioJerusalem,3 April 2011 .
   Google Scholar
• Vertès AA . Syndicate innovation venturing . Challenges3 , 70 – 83 ( 2012 ).
   Google Scholar
• Thompson K . Cell Therapy Catapult to work with GlaxoSmithKline on Cell Therapies ( 2013 ). www.innovateuk.org/-/cell-therapy-catapult-to-work-with-glaxosmithkline-on-cell-therapies  
   Google Scholar
• Haussecker D . The business of RNAi in 2012 . Mol. Ther. Nucleic Acids1 , e8 ( 2012 ).
   PubMedGoogle Scholar
• Anonymous . The Future of Monoclonal Antibodies – Market Forecasts to 2015, Competitive Benchmarking, Product Pipeline and Deals Analysis, GBI Research (2009) . www.gbiresearch.com  
   Google Scholar
• Tirrell M , LachapelleT . Pharmasset sets Inhibitex-to Achillion drugmakers deals: real M&A . Business Week , 22 November ( 2011 ).
   Google Scholar
• Christensen CM , KaufmanSP , ShihWC . Innovation killers: how financial tools destroy your capacity to do new things . Harv. Bus. Rev.86 ( 1 ), 98 – 105, 137 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Sheridan C . Gene therapy finds its niche . Nat. Biotechnol.29 , 121 – 128 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Yla-Herttuala S . Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union . Mol. Ther.20 , 1831 – 1832 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Berkrot B . Gilead could have had Pharmasset cheap: founder . Reuters,22 November 2011 .
   Google Scholar
• Senior M .  Sovaldi makes blockbuster history, ignites drug pricing unrest .  Nat. Biotechnol.32 ( 6 ),  501 – 502  ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Kessel M . The problems with today’s pharmaceutical business – an outsider’s view . Nat. Biotechnol.29 , 27 – 33 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Harrison C . Patent watch: the patent cliff steepens . Nat. Rev. Drug Discov.10 , 12 – 13 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Mason C , BrindleyDA , Culme-SeymourEJ , DavieNL . Cell therapy industry: billion dollar global business with unlimited potential . Regen. Med.6 , 265 – 272 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Mason C , McCallMJ , Culme-SeymourEJet al. The global cell therapy industry continues to rise during the second and third quarters of 2012 . Cell Stem Cell11 , 735 – 739 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Hamel G . The ghost of the Politburo   (2010) . www.managementexchange.com/barrier/ghost-politburo  
   Google Scholar
• Herper M . A decade in drug industry layoffs . Forbes , 14th April (2011 ).
   Google Scholar
• Anonymous . Novo Nordisk Annual Report 2005.   Novo Nordisk, Bagsværd, Denmark ( 2005 ).
   Google Scholar
• Anonymous . Novo Nordisk Annual Report 2010.   Novo Nordisk, Bagsværd, Denmark ( 2010 ).
   Google Scholar
• Bonner-Weir S , WeirGC . New sources of pancreatic beta-cells . Nat. Biotechnol.23 , 857 – 861 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Guo T , HebrokM . Stem cells to pancreatic beta-cells: new sources for diabetes cell therapy . Endocr. Rev.30 , 214 – 227 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Vertès AA . Stem cell commmercialization and partnering – a GTCBio conference . Reuters , 20 April 2012 .
   Google Scholar
• Vertès AA . World stem cell summit 2012 . Reuters , December ( 2012 ).
   Google Scholar
• Danneels E . Disruptive technology reconsidered: a critique and research agenda . J. Prod. Innov. Manag.21 , 246 – 258 ( 2004 ).
   Web of Science ®Google Scholar
• Bull ND , MartinKR . Concise review: toward stem cell-based therapies for retinal neurodegenerative diseases . Stem Cells29 , 1170 – 1175 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Coffey P . Stemming vision loss with stem cells: seeing is believing . Future Med.4 , 505 – 507 ( 2009 ).
   Google Scholar
• Jenq RR , van den BrinkMR . Allogeneic haematopoietic stem cell transplantation: individualized stem cell and immune therapy of cancer . Nat. Rev. Cancer10 , 213 – 221 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Mimeault M , BatraSK . Concise review: recent advances on the significance of stem cells in tissue regeneration and cancer therapies . Stem Cells24 , 2319 – 2345 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Nuzzi R , GunettiM , RustichelliDet al. Effect of in vitro exposure of corticosteroid drugs, conventionally used in AMD treatment, on mesenchymal stem cells . Stem Cell Int. 2012, 946090 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Jimenez J . The CEO of Novartis on growing after a patent cliff . Harv. Bus. Rev.90 , 39 – 42 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Baron F , StorbR . Allogeneic hematopoietic cell transplantation as treatment for hematological malignancies: a review . Springer Semin. Immunopathol.26 , 71 – 94 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Gluckman E . History of cord blood transplantation . Bone Marrow Transplant.44 , 621 – 626 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Thomas ED . Bone marrow transplantation: a review . Semin. Hematol.36 , 95 – 103 ( 1999 ).
   PubMed Web of Science ®Google Scholar
• Anonymous . Baxter initiates Phase III adult stem cell clinical trial for chronic cardiac condition . Baxter Press Release ( 2012 ).
   Google Scholar
• Christopherson   KW   2nd , PaganessiLA , NapierS , PorechaNK . CD26 inhibition on CD34+ or lineage- human umbilical cord blood donor hematopoietic stem cells/hematopoietic progenitor cells improves long-term engraftment into NOD/SCID/Beta2null immunodeficient mice . Stem Cells Dev.16 , 355 – 360 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Robinson SN , SimmonsPJ , ThomasMWet al. Ex vivo fucosylation improves human cord blood engraftment in NOD-SCID IL-2Rgamma(null) mice . Exp. Hematol.40 , 445 – 456 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Sackstein R . Re: “Ex vivo fucosylation improves human cord blood engraftment in NOD-SCID IL-2Rgamma(null) mice” . Exp. Hematol.40 , 518 – 519 ( 2012 ).
   PubMedGoogle Scholar
• Bayon Y , EllisonS , VertèsAAet al. Commercialization of regenerative products: the academic-industry partnership . Tissue Eng. B doi:10.1089/ten.teb.2012.0683 ( 2013 ) (Epub ahead of print) .
   Web of Science ®Google Scholar
• Castiaux A . Radical innovation in established organizations: being a knowledge predator . J. Eng. Technol. Manag.24 , 36 – 52 ( 2007 ).
   Web of Science ®Google Scholar
• Anonymous .  2010 Cephalon Annual Report.Cephalon, PA, USA ( 2010 ).
   Google Scholar
• Berkrot B . Interview: Mesoblast’s Cephalon deal was late CEO’s vision . Reuters , 2 March ( 2011 ).
   Google Scholar
• Vertès AA . The cell therapy commercialisation summit . Reuters , 21st September ( 2011 ).
   Google Scholar
• Kresge N , LangrethR . Teva bets on stem cells, cancer in $6.2 billion bid for Cephalon . Bloomberg , 3 May ( 2011 ).
   Google Scholar
• Crunkhorn S . Deal watch: shire increases focus on regenerative medicine . Nat. Rev. Drug Discov.11 ( 6 ), 430 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Tozer D . The story of Advanced BioHealing: commercializing bioengineered tissue products . Future Med.6 , 157 – 161 ( 2011 ).
   Google Scholar
• Anonymous . Shire adds new technology platform and phase 2 product candidate to its Regenerative Medicine business . Shire Press Release , 12 April ( 2012 ).
   Google Scholar
• Palmer E . Shire cuts Dermagraft, takes $650 million loss . FiercePharma , 17 January ( 2014 ).
   Google Scholar
• Taupin P . OTI-010 Osiris Therapeutics/JCR Pharmaceuticals . Curr. Opin. Investig. Drugs7 , 473 – 481 ( 2006 ).
   PubMedGoogle Scholar
• Bird J . Japan Pharma: peer set overview . Datamonitor, London, UK ( 2012 ).
   Google Scholar
• Kobayashi A . Launch of a National Mandatory Chronic Disease Prevention Program in Japan . Dis. Manag. Health Outcomes16(4) , 217 – 225 ( 2008 ).
   Google Scholar
• Anonymous . Dainippon invests in Retina Institute, gets stem cell technology . BioSpectrum , 1st April ( 2013 ).
   PubMedGoogle Scholar
• Bushell-Embling D . Aussie stem cell firms jump on Japan fast-track (2013).   http://lifescientist.com.au/content/biotechnology/article/aussie-stem-cell-firms-jump-on-japan-fast-track-784414693
   Google Scholar
• Cyranoski D . Japan to offer fast-track approval path for stem cell therapies . Nat. Med.19 , 510 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Anonymous . Cell Replacement Therapy Using ES Cells: Potential Application to the Treatment of Parkinson’s Disease , Kyowa Hakko Kogyo Co. Ltd, Tokyo, Japan ( 2000 ).
   Google Scholar
• Kunisato A , WakatsukiM , KodamaY , ShinbaH , IshidaI , NagaoK . Generation of induced pluripotent stem cells by efficient reprogramming of adult bone marrow cells . Stem Cells Dev.19 , 229 – 238 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Toyooka Y ,  TsunekawaN ,  AkasuR ,  NoceT .  Embryonic stem cells can form germ cells in vitro .  Proc. Natl Acad. Sci. USA100 ,  11457 – 11462  ( 2003 ).
   PubMed Web of Science ®Google Scholar
• Imamura M , AoiT , TokumasuAet al. Induction of primordial germ cells from mouse induced pluripotent stem cells derived from adult hepatocytes . Mol. Reprod. Dev.77 , 802 – 811 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Licata P . Biotech joint venture Azienda Farmaceutica-Università. Chiesi, spinoff in provetta . El Mundo , 24 April ( 2009 ).
   Google Scholar
• Culme-Seymour EJ , DavieNL , BrindleyDA , Edwards-PartonS , MasonC . A decade of cell therapy clinical trials (2000-2010) . Regen. Med.7 , 455 – 462 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• McGlynn M . Industry voices: a pivotal time for stem cell therapeutics, as first clinical data emerges . Fierce Biotech , 15 July ( 2013 ).
   Google Scholar
• McKernan R , McNeishJ , SmithD . Pharma’s developing interest in stem cells . Cell Stem Cell6 , 517 – 520 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Gardner TA , ElzeyBD , HahnNM . Sipuleucel-T (Provenge) autologous vaccine approved for treatment of men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer . Hum. Vaccines Immunother.8 , 534 – 539 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Staton T . Dendreon’s Provenge sales disappoint once again with 17% decline . Fierce Pharma , 9 May ( 2013 ).
   Google Scholar
• Schulze U , RingelM . What matters most in commercial success: first-in-class or best-in-class?   Nat. Rev. Drug Discov.12 , 419 – 420 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Barton-Burke M , DwinellDM , KafkasLet al. Graft-versus-host disease: a complex long-term side effect of hematopoietic stem cell transplant . Oncology (Williston Park)22 , 31 – 45 ( 2008 ).
   PubMedGoogle Scholar
• Gratwohl A , NiederwieserD . History of hematopoietic stem cell transplantation: evolution and perspectives . Curr. Probl. Dermatol.43 , 81 – 90 ( 2012 ).
   PubMedGoogle Scholar
• Mason C , DunnillP . A brief definition of regenerative medicine . Regen. Med.3 , 1 – 5 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Baron F , LechanteurC , WillemsEet al. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning . Biol. Blood Marrow Transplant.16 , 838 – 847 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Le Blanc K , RasmussonI , SundbergBet al. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells . Lancet363 , 1439 – 1441 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• von Bonin M , StolzelF , GoedeckeAet al. Treatment of refractory acute GVHD with third-party MSC expanded in platelet lysate-containing medium . Bone Marrow Transplant.43 , 245 – 251 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Evans JB , SyedBA . New hope for dry AMD?   Nat. Rev. Drug Discov.12 , 501 – 502 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Stern JH , TempleS . Stem cells for retinal replacement therapy . Neurotherapeutics8 , 736 – 743 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Clinical Trials database . http://clinicaltrials.gov  
   Google Scholar