{"id":31008,"date":"2018-11-13T19:57:48","date_gmt":"2018-11-14T00:57:48","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/organovo-bioprinting-your-liver-tissue\/"},"modified":"2018-11-13T20:23:08","modified_gmt":"2018-11-14T01:23:08","slug":"organovo-bioprinting-tissue-to-speed-up-drug-development","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/organovo-bioprinting-tissue-to-speed-up-drug-development\/","title":{"rendered":"Organovo: bioprinting tissue to speed up drug development"},"content":{"rendered":"

Bioprinting- \u201cthe liveliest\u2014literally\u2014field of 3D printing may sound like something from a sci-fi movie, but (spoilers) it\u2019s real and happening now\u201d [1<\/a>]. While technology is still in its early days of the ability to print entire organs, significant advances have been made in the ability to bioprint tissues and vascular structures (blood vessels).<\/p>\n

In fact, Organovo invented the world\u2019s first commercially available bioprinter Novogen MMX in 2009 which gained traction with academic and research labs (see Figure 1) [2<\/a>]. In big pharma drug development, bioprinting has remained a more distant reality up until the last few years. Organovo is changing this and has started to set up partnerships on development of bioprinted tissue with at least 6-10 major pharma companies, and most publicly with Merck\u00a0in 2015, creating the opportunity to accelerate drug development cycles\u00a0[3<\/a>, 4<\/a>].<\/p>\n

\"\"<\/a>
Figure 1: Timeline of evolution of bioprinting\u00a0[2<\/a>]<\/em><\/figcaption><\/figure>\n

What exactly is the Organovo technology<\/b><\/strong><\/h2>\n

Organovo offers customers (pharma companies and academic research facilities) \u201cstructurally and functionally accurate bioprinted human tissue models”, specializing in the liver [5<\/a>].\u00a0Much like traditional 3D printing, the NovoGen Bioprinter\u00ae Platform (MMX-07) does \u201cinkjet bio-printing\u201d – using \u201cbioink\u201d to print living cells layer-by-layer [2<\/a>]. Besides manufacturing the printer, Organovo sources normal or diseased human cells from its subsidiary Samsara and produces its own NovoGel\u00ae Bio-Ink to use as inputs into the printer platform. The bioprinted tissue output is used in predictive preclinical testing of drug compounds that is either performed by Organovo itself or the customer. See Figure 2.<\/p>\n

\"\"<\/a>
Figure 2: Human Liver Tissue Bioprinting process flow (Source: Organovo)<\/em><\/figcaption><\/figure>\n

 <\/p>\n

Why do we care?<\/b><\/strong><\/h2>\n
    \n
  1. More and better quality of drugs<\/b><\/strong> (with efficient toxicity studies) – Merck and Organovo hit their first key development milestone of their research partnership in April 2018, publishing scientific evidence that shows 3D printed tissue is better than 2D alternatives used in traditional pre-clinical testing\u00a0[6<\/a>]. Higher quality of testing using readily available bioprinted tissue means improved drugs and more drugs passing through the development process.<\/li>\n
  2. Shorter drug development cycle<\/b><\/strong> – Liver toxicity is the #1 reason pharma companies discard drug trials. Efficient toxicity studies using Organovo’s bioprinted tissue means disease evolution can be assessed in a more true-to-life way, and a go\/no-go decision can be made sooner in the drug development process [7<\/a>]. Further, by collaborating with pharma companies directly on research, the lag time of relevant research reaching industry-insiders is shortened.<\/li>\n<\/ol>\n

    Opportunities on the horizon<\/b><\/strong><\/h2>\n

    In the short term, Organovo has already joined the Advanced Regenerative Manufacturing Institute (ARMI) ecosystem which has 100 partners. ARMI has over $300M in funding and provides the opportunity to collaborate with others to engineer scalable manufacturing for bioprinted tissues [8<\/a>].<\/p>\n

    In the long term, Organovo is approaching the FDA in early 2020 with an investigative new drug (IND) application wherein its bioprinted liver tissue can be used for the treatment of rare diseases [9<\/a>]. CEO Keith Murphy and senior management has committed progress to the street \u00a0in multiple earnings calls towards filing an IND in 2020 for orphan designation [10<\/a>].<\/p>\n

    Longer term challenges and recommendations<\/b><\/strong><\/h2>\n
      \n
    1. Profitability<\/b><\/strong>: Organovo is one of the only publicly listed companies in the bioprinting industry and withstands constant scrutiny from the market. It has been unprofitable in the last few years, with falling share prices and will run into further cash flow problems if it needs to accelerate R&D to meet its 2020 targets. My (arguably) radical recommendation would be to consider taking the company private for a few years and raising cheaper capital from investors looking for long term returns.<\/li>\n<\/ol>\n
      \"\"<\/a>
      Figure 3: Falling stock price (Source: Capital IQ)<\/em><\/figcaption><\/figure>\n
        \n
      1. <\/b>Technical hurdles:<\/b><\/strong>\u00a0Significant technical challenges still exist with bioprinting around sensitivities of living cells and the construction of tissues.\u00a0 My recommendation would be to embrace open innovation (in the ARMI ecosystem or otherwise) and offer multiple academic institutions the opportunity to rapidly test Novogen bioprinting platform compatibility with more kinds of bioinks, biomaterials and thus more use cases simultaneously.<\/li>\n
      2. Competition<\/b><\/strong>: Several other startups are vying to achieve scalability in the space [2<\/a>,\u00a011<\/a>]. My recommendation would be to learn from their competitors’ business models. For example, Advanced Life Solutions\u2019s approach is to provide an end-to end solution. It sells its BioAssembly bot (6-arm robotic printer) printer directly to customer but makes profit from its bio-inks and pre-processing software technology that allows researchers to own the modeling of the human tissue [12<\/a>].<\/li>\n<\/ol>\n

         <\/p>\n

        Questions remaining in the Petri Dish<\/b><\/strong><\/h2>\n
          \n
        1. Approximately 1500 patients on the waitlist for liver transplants died in 2016 before they could receive an organ [13<\/a>]. How can Organovo build on competitor offerings in the bioprinting industry to save lives by printing new livers on demand?<\/li>\n
        2. What are the ethical concerns as Organovo aggressively approaches the FDA for the IND (Investigational New Drug) orphan drug status? Should bio-printed tissue \/ organs be regulated as biological products or drugs\/devices?<\/li>\n<\/ol>\n

           <\/p>\n

          (790 words)<\/p>\n

          Bibliography<\/strong><\/p>\n

          [1<\/a>]\u00a0Sirinterlikci, Arif, and Lauren Walk. 2014. “Bioprinting: Science or Fiction?“<\/i><\/em>,\u00a0SME 2014 Medical Manufacturing Yearbook of Manufacturing Engineering<\/em><\/p>\n

          [2<\/a>] Dababneh, Amer B., and Ibrahim T. Ozbolat. 2014. “Bioprinting Technology: A Current State-Of-The-Art Review”.\u00a0Journal Of Manufacturing Science And Engineering<\/i>\u00a0136 (6): 061016. doi:10.1115\/1.4028512.<\/p>\n

          [3<\/a>]\u00a0Organovo. April 22, 2015 Form 8-K,<https:\/\/www.sec.gov\/Archives\/edgar\/data\/1497253\/000156459015002746\/onvo-8k_20150421.htm><\/a>, accessed November 2018.<\/p>\n

          [4<\/a>]\u00a0Speights, Keith. 2018. “5 Things Organovo Holdings, Inc. Management Wants You To Know — The Motley Fool”.\u00a0The Motley Fool<\/i>. https:\/\/www.fool.com\/investing\/2016\/06\/13\/5-things-organovo-holdings-inc-management-wants-yo.aspx.<\/p>\n

          [5<\/a>] Organovo website<\/p>\n

          [6<\/a>]\u00a0Madden, Lauran R., Nguyen, Theresa V. et. al. “Bioprinted 3D Primary Human Intestinal Tissues Model Aspects of Native Physiology and ADME\/Tox Functions”. iScience<\/em>.\u00a0Volume 2, 2018, Pages 156-167, ISSN 2589-0042, https:\/\/doi.org\/10.1016\/j.isci.2018.03.015.
          \n(http:\/\/www.sciencedirect.com\/science\/article\/pii\/S2589004218300245)<\/p>\n

          [7<\/a>] “Better Tests For Liver Toxicity Would Mean More Medicines \u2014 And Safer Medicines \u2014 For Patients – American Chemical Society”. 2018.\u00a0American Chemical Society<\/i>. https:\/\/www.acs.org\/content\/acs\/en\/pressroom\/newsreleases\/2013\/september\/better-tests-for-liver-toxicity-would-mean-more-medicines-and-safer-medicines-for-patients.html.<\/p>\n

          [8<\/a>]\u00a0Organovo. Organovo and Samsara Sciences Partner with New Manufacturing USA Institute. [online] GlobeNewswire News Room. Available at: https:\/\/globenewswire.com\/news-release\/2018\/05\/03\/1495905\/0\/en\/Organovo-and-Samsara-Sciences-Partner-with-New-Manufacturing-USA-Institute.html [Accessed 13 Nov. 2018].<\/p>\n

          [9]\u00a0Organovo. Investor Presentation March 2018. Available at Capital IQ.<\/p>\n

          [10]\u00a0Organovo Holdings, Inc.\u00a0NasdaqGM:ONVO. FQ2 2019 Earnings Call Transcripts. Thursday, November 08, 2018 10:00 PM GMT . Available at Capital IQ.<\/p>\n

          [11] The Economist. “A Tissue of Truths – Printed human body parts could soon be available for transplant” Jan 28th 2017.<\/p>\n

          [12] Peels, Joris. 3Dprint.com<\/em> “Interview with Jay Hoying and Michael Golway of Bioprinting Company Advanced Solutions Life Sciences” November 7, 2018. [Accessed 13 Nov. 2018]<\/p>\n

          [13]\u00a0Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN\/SRTR 2016 Annual Data Report. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration; 2017 http:\/\/srtr.transplant.hrsa.gov\/annual_reports\/Default.aspx Accessed 12th November 2018<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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