{"id":32930,"date":"2018-11-13T15:56:27","date_gmt":"2018-11-13T20:56:27","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/speeding-the-drug-discovery-pipeline-with-open-innovation\/"},"modified":"2018-11-15T17:21:31","modified_gmt":"2018-11-15T22:21:31","slug":"speeding-the-drug-discovery-pipeline-with-open-innovation","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/speeding-the-drug-discovery-pipeline-with-open-innovation\/","title":{"rendered":"Speeding the Drug Discovery Pipeline with Open Innovation"},"content":{"rendered":"

INTRODUCTION<\/strong><\/p>\n

Drug discovery is more expensive than ever – the cost to bring a new drug to market is approximately $2B, and the odds of any project making it from inception to marketed drug are approximately 24 to 1 [1,2]. Between 85-90% percent of drugs fail in clinical trials, which are exceptionally costly failures for companies and patients [3]. To bring a new drug to market, pharmaceutical firms must typically 1) identify a disease of interest to treat 2) determine which protein or processes in a cell to target to treat that disease 3) perform high throughput screening (HTS) to test thousands, sometimes millions of chemicals, to identify which chemicals can modulate that target and 4) iteratively optimize that chemical for superior pharmacokinetic and pharmacodynamic properties that will make it an ideal drug for clinical trials [ 5,6].\u00a0 This is a costly and time-consuming pursuit, that involves safety and efficacy trials in mice and men, and there are pain points and compound attrition at every step in the process.<\/p>\n

As a result of these challenges, many pharmaceutical companies are looking to open innovation as a platform to speed discovery, reduce costs, and identify new market opportunities [6,7]. Perhaps the most prominent example of open innovation in the pharmaceutical industry is Eli Lilly\u2019s Open Innovation Drug Discovery (OIDD) platform. Launched in 2009, the OIDD was designed to bridge the gap between academic, small biotech, and industrial drug discovery to de-risk the discovery pipeline for Eli Lilly, and speed treatments to patients. This benefits Eli Lilly because it complements their own scientific discovery and screening teams by providing them access to a greater pool of talent, ideas, and compounds for high throughput screening and drug testing [8]. \u00a0Conversely, if projects or compounds submitted by academic researchers were deemed promising by Lilly, it would open the door to potential funding partnerships, royalty opportunities, and sponsored research [9].<\/p>\n

OPEN INNOVATION AT ELI LILLY<\/strong><\/p>\n

The OIDD provides external researchers seven areas of engagement with Eli Lilly in: Emerging biology, design, screening, animal health, compound acquisition, synthesis and neglected and tropical diseases [9]. Through their web-based portal system, external investigators are given access to Lilly\u2019s vast screening and chemistry capabilities. In one area of engagement, known as OIDD Screening, external scientists can submit their chemical compounds for testing in a battery of Lilly\u2019s biological assays to look for any potential compound \u201chits\u201d, which may indicate activity against a disease [10]. These \u201chits\u201d form the basis for new drugs and are vital to the pipeline, so the more chemical diversity the better. These compounds are run in Lilly\u2019s assays in a structure-blind fashion to protect the intellectual property rights of the investigator. Upon completion of the screening campaign, investigators are provided a data package, which forms the basis for future collaborations with Eli Lilly, should both sides decide to pursue them [8].<\/p>\n

Over the course of an 8-year period at OIDD, more than 40,000 submitted compounds have been tested, generating almost 2 million data points in biological assays, at a cost of approximately $7.1M USD, exclusive of FTE and equipment costs [8]. Over 400 affiliated institutions have formed partnerships with the OIDD platform and together published at least 23 papers over the last 7 years. At the time of writing, there were no published reports of successful transitions of submitted compounds to preclinical or clinical programs. This is demonstrative of the time and difficulties in translating early stage \u201chits\u201d to full-fledged drugs where hit rates in high throughput screens range from 0.1-1% [4].<\/p>\n

FUTURE of OIDD<\/strong><\/p>\n

In the short and medium term, the OIDD platform for identifying new chemical matter remains a relatively low-cost solution to expand the breadth and diversity in the Eli Lilly chemical library. Management can continue to maintain this solution utilizing existing infrastructure and maintain it as a fruitful collaborative opportunity for academics and small companies. \u00a0What remains to be seen will be the effectiveness of the program over time in generating new chemical entities for clinical trials. Due to the long product life cycle (7-10 years from screening to market), it may be some time before compounds from these collaborations can progress to marketed drugs, and the waiting game will continue. In the meantime, the OIDD should continue to aggressively pursue new partnership opportunities to de-risk their pipeline and speed discovery.<\/p>\n

Some companies have started sharing portions of their chemical libraries to gain access to more diverse compound scaffolds and increase the chance of meaningful discovery. Given the complexity of drug discovery and associated intellectual property, would it make sense to create bigger open platforms between companies through which they can begin to share more than just compounds? If delayed collaborations mean delayed treatments, should companies be doing more?<\/p>\n

(787 words)<\/p>\n

References<\/span>:<\/p>\n

1)\u00a0\u00a0\u00a0\u00a0\u00a0 Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. \u201cHow to improve R&D productivity: the pharmaceutical industry’s grand challenge.\u201d Nature Reviews Drug Discovery<\/em> 2010. 9(3):203-14.<\/p>\n

2)\u00a0\u00a0\u00a0\u00a0\u00a0 Scannell JW, Blanckley A, Boldon H, Warrington B., \u201cDiagnosing the decline in pharmaceutical R&D efficiency,\u201d Nature Reviews Drug Discovery<\/em> 2012 Mar 1;11(3):191-200.<\/p>\n

3)\u00a0\u00a0\u00a0\u00a0\u00a0 Wong CH, Siah KW, Lo AW. \u201cEstimation of clinical trial success rates and related parameters.\u201d Biostatistics<\/em>. 2018 Jan 31. doi: 10.1093\/biostatistics\/kxx069<\/p>\n

4)\u00a0\u00a0\u00a0\u00a0\u00a0 Hughes JP, Rees S,\u00a0 Kalindjian SB , Philpott KL. \u201cPrinciples of early drug discovery\u201d. British Journal of Pharmacology<\/em>. 2011 Mar; 162(6): 1239\u20131249.<\/p>\n

5)\u00a0\u00a0\u00a0\u00a0\u00a0 Gronde TV, Uyl-de Groot CA, Pieters T. \u201cAddressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.\u201d PLoS One<\/em>. 2017 Aug 16;12(8):e0182613.<\/p>\n

6)\u00a0\u00a0\u00a0\u00a0\u00a0 Mignani, S, Huber S, Tom\u00e1s H, Rodrigues J, Majoral JP. \u201cWhy and how have drug discovery strategies in pharma changed? What are the new mindsets?\u201d Drug Discovery Today<\/em>. 2016 Feb;21(2):239-49.<\/p>\n

7)\u00a0\u00a0\u00a0\u00a0\u00a0 Nilsson N, Minssen T. \u201cUnlocking the full potential of open innovation in the life sciences through a classification system.\u201d Drug Discovery Today<\/em>. 2018 Apr;23(4):771-775.<\/p>\n

8)\u00a0\u00a0\u00a0\u00a0\u00a0 Carrol GP, Srivastava S, Volini AS, Pi\u00f1eiro-N\u00fa\u00f1ez MM, Vetman T. \u201cMeasuring the effectiveness and impact of an open innovation platform,\u201d Drug Discovery Today<\/em>. 2017 May;22(5):776-785.<\/p>\n

9)\u00a0\u00a0\u00a0\u00a0\u00a0 Making life better together. <\/em>Eli Lilly corporate brochure, from Eli Lilly website, https:\/\/openinnovation.lilly.com\/dd\/includes\/pdf\/OIDD_Brochure.pdf, accessed November 2018.<\/p>\n

10)\u00a0\u00a0 Alvim-Gaston M, Grese T, Mahoui A, Palkowitz AD, Pineiro-Nunez M, Watson I. \u201cOpen innovation drug discovery (OIDD): a potential path to novel therapeutic chemical space.\u201d Current Topics Medicinal Chemistry<\/em>. 2014;14(3):294-303.<\/p>\n","protected":false},"excerpt":{"rendered":"

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