{"id":34561,"date":"2018-11-13T18:25:12","date_gmt":"2018-11-13T23:25:12","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/a-3d-printed-liver-not-ready-for-prime-time\/"},"modified":"2018-11-15T18:42:58","modified_gmt":"2018-11-15T23:42:58","slug":"a-3d-printed-liver-not-ready-for-prime-time-2","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/a-3d-printed-liver-not-ready-for-prime-time-2\/","title":{"rendered":"A 3D-printed liver: not ready for prime time?"},"content":{"rendered":"

\"\"<\/a><\/h3>\n

Source: Organovo website (http:\/\/www.organovo.com)<\/p>\n

 <\/p>\n

Organovo<\/strong><\/h3>\n

Organovo (NASDAQ: ONVO) is a San Diego-based company founded in 2007 with licenses to organ printing intellectual property [1]. Since its launch, Organovo has developed several products primarily for pharmaceutical research (drug profiling services), with a long-term goal of developing therapeutic tissues for transplant. As of 2016, their clients included seven major pharmaceutical companies including Merck and Roche [2].<\/p>\n

\"\"<\/a><\/p>\n

Source: Organovo 2018 Investor Report<\/p>\n

Medical and Scientific Challenges <\/strong><\/h3>\n

Transplant medicine:<\/strong> Despite advancements in medical therapies, demand for transplant organs is significant. Transplant waiting lists can extend for months to years. Development of 3D-bioprinted tissues could help reduce demand for transplants.<\/p>\n

Pharmaceutical development: <\/strong>In drug development, significant gaps remain between in vitro<\/em> (benchtop) testing and in vivo<\/em> testing (animal studies and human clinical trials). 3D-bioprinted tissues could help reduce the need for use of laboratory animals or help predict adverse effects.<\/p>\n

Challenges in 3D-bioprinting<\/em><\/h4>\n
    \n
  1. Scaffolding:<\/strong> Tissues are composed of not only cells. Scaffolding material known as the extracellular matrix is required to hold cells in space. The microarchitecture of the extracellular matrix can be quite complex. Finding an appropriate scaffold material to house cells is difficult.<\/li>\n
  2. Multiple cell types:<\/strong> Organs often consist of more than one type of cell. Various cell types often reside in specific locations with respect to other cell types to form a specific tissue architecture.<\/li>\n
  3. Vascular supply: <\/strong>Without an existing network of vessels, nutrients and oxygen supply to tissues are limited but diffusion. Thus, there is difficulty supplying the nutrients to a 3D-printed tissue more than a millimeter thick.<\/li>\n<\/ol>\n

    Pharmaceutical Testing Business Model<\/strong><\/h3>\n

    Organovo developed in vitro<\/em> models using a proprietary bioprinting process that primarily involves human cells without a scaffold or integrated biomaterials [4]. The company\u2019s business model focuses around selling pharmacologic testing services using 3D-bioprinted tissues. For example, Organovo uses a liver tissue model, the ExVive Human Liver Tissue for toxicity testing [2].<\/p>\n

    \"\"<\/a><\/p>\n

    Source: Organovo 2018 Investor Report<\/p>\n

    Using 3D-bioprinted tissue provides advantages compared to a typical 2D monolayer culture (classically, cells on a petri dish). For example, the ExVive tissue lasts longer and shows stronger correlation with clinical results [2] [5]. However, given the pharmaceutical development process, in vivo<\/em> studies on animals and human trials are still required.<\/p>\n

    Developing therapeutic liver tissue for transplant<\/strong><\/h3>\n

    In 2016, CEO Keith Murphy announced human liver tissue for transplant as Organovo\u2019s first therapeutic paltform [2]. The company\u2019s proof-of-concept demonstrated thin layers of human liver tissue growing in mice with circulation of known liver enzymes [5].<\/p>\n

    However, significant development hurdles remain. The proof-of-concept cannot be much thicker than 1 millimeter given the general issue of vascular supply as previously described [2]. Similarly, the graft is significantly smaller than the volume required for a liver transplant. Thus, this platform is only designed to be a one year bridge-to-transplant for patients with existing but diminished liver function rather than replacing a liver outright [2].<\/p>\n

    \"\"<\/a><\/p>\n

    Source: Organovo 2018 Investor Report<\/p>\n

    Next Steps<\/strong><\/h3>\n

    In the short term, Organovo needs to consider the profitability of its business given their core business model of providing pharmaceutical services. Their current services fill a small gap for pharmaceutical companies. Ultimately their success will stem from their product differentiation in providing value to pharmaceutical companies in bridging traditional in vitro<\/em> research to in vivo<\/em> testing with 3D-bioprinted tissues.<\/p>\n

    Regarding continued innovation, Organovo also needs to consider its R&D budget wisely. In 2016, 15% of the R&D budget was dedicated towards development of its therapeutic liver tissue platform. However, it is unclear that this therapeutic model will be (a) successful or (b) profitable, given its narrow patient population and limited applicability. Furthermore, given its current primary business model of pharmaceutical services, Organovo cannot afford to fall behind in innovation with respect to tissues for pharmecutical testing. Perhaps management should consider earmarking at least 75% of its R&D budget towards developing new services and products or updating existing services.<\/p>\n

    The Future of Organovo<\/strong><\/h3>\n

    Despite Organovo filling a small need in pharmacologic testing by using 3D-bioprinted tissues like the ExVive, animal studies and human clinical trials are ultimately needed to secure approval for a new drug. Should companies continue pay for products like those developed by Organovo or just go straight to animals studies and clinical trials?<\/p>\n

    Moreover, philosophically, should Organovo focus on developing therapeutic platforms like transplantable liver tissue when industry-wide problems like vascular supply still exist? Or should they save their R&D budget for when academic research has advanced further?<\/p>\n

     <\/p>\n

    (Word count: 720)<\/p>\n

     <\/p>\n

    Footnotes<\/h3>\n
      \n
    1. Organovo (2018), \u201cOrganovo History\u201d, https:\/\/organovo.com\/about\/history\/<\/a>, accessed November 2018.<\/li>\n
    2. Keith Murphy, \u201cOrganovo\u2019s Bioprinting Platform: Enabling 3D, architecturally correct, fully human tissue for drug discovery and transplantation, given at Cell & Gene Meeting on the Mesa, San Diego, CA, October 5, 2016, https:\/\/organovo.com\/cell-gene-meeting-mesa\/<\/a>, accessed November 2018.<\/li>\n
    3. Sean V Murphy and Anthony Atala, \u201c3D bioprinting of tissues and organs,\u201d Nature Biotechnology<\/em> 32 no. 8 (2014): 773.<\/li>\n
    4. DeeAnn Visk, \u201cWill Advances in Preclinical In Vitro Models Lower the Cost of Drug Development?\u201d Applied In Vitro Toxicology<\/em>, 1 (2015):1.<\/li>\n
    5. Ellen P Neff, \u201cPrinting cures: Organovo advances with 3D-printed liver tissue\u201d Lab Anim (NY)<\/em>. 46 (2017): 57.<\/li>\n<\/ol>\n

       <\/p>\n

      Banner image source: https:\/\/techcrunch.com\/2018\/06\/25\/implantable-3d-printed-organs-could-be-coming-sooner-than-you-think\/<\/p>\n","protected":false},"excerpt":{"rendered":"

      Additive manufacturing \u2013 also known as 3D-printing \u2013 has gained significant traction in commercial industries. In the medical community, there is promise of applying additive manufacturing techniques to tissue engineering, with the hope of developing replacement organs, ending the current unsatisfiable demand for transplants.<\/p>\n

      Organovo is a company developing 3D-bioprinted products for pharmacologic research and development, with a longer-term goal of developing printed tissue platforms. But is there truly a need for 3D-bioprinted products in this space? And is the idea of a 3D-printed organ merely a pipe dream?<\/p>\n","protected":false},"author":11930,"featured_media":34609,"comment_status":"open","ping_status":"closed","template":"","categories":[3340,221,4951,4954,4678,4952,4953],"class_list":["post-34561","hck-submission","type-hck-submission","status-publish","has-post-thumbnail","hentry","category-additive-manufacturing","category-biotech","category-organ","category-organ-transplant","category-organovo","category-tissue","category-tissue-engineering","hck-taxonomy-organization-organovo","hck-taxonomy-industry-biotechnology","hck-taxonomy-country-united-states"],"connected_submission_link":"https:\/\/d3.harvard.edu\/platform-rctom\/assignment\/rc-tom-challenge-2018\/","yoast_head":"\nA 3D-printed liver: not ready for prime time? - Technology and Operations Management<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/a-3d-printed-liver-not-ready-for-prime-time-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A 3D-printed liver: not ready for prime time? - Technology and Operations Management\" \/>\n<meta property=\"og:description\" content=\"Additive manufacturing \u2013 also known as 3D-printing \u2013 has gained significant traction in commercial industries. 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