{"id":23493,"date":"2021-02-26T08:22:00","date_gmt":"2021-02-26T08:22:00","guid":{"rendered":"https:\/\/sagaciousresearch.com\/blog\/?p=23493"},"modified":"2024-11-12T06:28:08","modified_gmt":"2024-11-12T06:28:08","slug":"pharmaforum-expediting-innovation-in-the-rare-disease-domain","status":"publish","type":"post","link":"https:\/\/sagaciousresearch.com\/blog\/pharmaforum-expediting-innovation-in-the-rare-disease-domain","title":{"rendered":"Pharmaphorum &#8211; Expediting innovation in the rare disease domain"},"content":{"rendered":"\n<p><strong>Rare diseases affect a fraction of the population \u2013&nbsp;<a href=\"https:\/\/www.weforum.org\/reports\/global-access-for-solving-rare-disease-a-health-economics-value-framework\" target=\"_blank\" rel=\"noreferrer noopener\">450 million<\/a>+ people globally. However, its effects can be equally severe and life-threatening as other prevalent diseases. For Rare Disease Day, Tarun Kumar Bansal discusses why we need to expedite innovation in the rare disease domain.<\/strong><\/p>\n\n\n\n<p>Every time a patient with a rare condition walks into a hospital, doctors face the probable challenge of starting from scratch. Meanwhile, the patient goes through an array of experiences until their condition is diagnosed and the treatment begins.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69d90bf985502\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69d90bf985502\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/sagaciousresearch.com\/blog\/pharmaforum-expediting-innovation-in-the-rare-disease-domain\/#Challenges_in_rare_disease_diagnosis_and_therapy\" >Challenges in rare disease diagnosis and therapy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/sagaciousresearch.com\/blog\/pharmaforum-expediting-innovation-in-the-rare-disease-domain\/#The_brighter_side_%E2%80%93_innovations_in_rare_disease\" >The brighter side \u2013&nbsp;innovations in rare disease&nbsp;&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Challenges_in_rare_disease_diagnosis_and_therapy\"><\/span>Challenges in rare disease diagnosis and therapy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The field of medicine is riddled with challenges pertaining to diagnosis and finding treatment therapies for rare diseases. As per WHO, 5000-8000 rare diseases exist across the globe, it signifies the urgent need for expediting innovations in the rare disease domain.<\/p>\n\n\n\n<p>With only &lt;10% of the affected people having treatment for their rare condition, the question remains \u2013 what impedes the process of developing a treatment for such diseases? Here are the challenges that the medical community faces, most of which relate to the lack of research data, high cost of developing treatments or orphan drugs and greater chances of failure.<strong>&nbsp;<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Small sample size in trials:&nbsp;<\/strong>Finding eligible patients for clinical trials of orphan medicines is a big challenge. The domain is marred with&nbsp;<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/february-2020\/rising-to-the-challenges-of-developing-rare-disease-treatments\/\" target=\"_blank\" rel=\"noreferrer noopener\">poorly-developed study endpoints<\/a>&nbsp;and insufficient patient data. This leaves the medical community struggling to measure how the drug impacts the patient\u2019s disease progression.<\/li>\n\n\n\n<li><strong>Diagnosis challenge:&nbsp;<\/strong>Poor and incomplete understanding of the pathophysiology of the disease affects the accurate diagnosis of a rare condition. A patient with a rare disorder visits several specialists, and an accurate diagnosis can even take five years. Furthermore, there is a lack of data that can be used to improve the medical community\u2019s ability to spot and diagnose such rare disorders.<\/li>\n\n\n\n<li><strong>Collecting data on orphan drugs<\/strong>: Collecting data related to rare diseases and orphan drugs already existing in the market is a time and cost-intensive process. Organizations spend a fortune on building internal teams for collecting this relevant information. Therefore, both these factors impede the research and development teams\u2019 process of fostering innovations in the rare disease domain.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_brighter_side_%E2%80%93_innovations_in_rare_disease\"><\/span>The brighter side \u2013&nbsp;innovations in rare disease&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Novel therapy approval<\/strong>: Despite challenges, there has been considerable progress in developing treatment and diagnosis in the rare disease sector. In 2019, the Food and Drug Administration\u2019s Center for Drug Evaluation and Research (CDER) approved several novel therapies for patients suffering from rare disorders such as cystic fibrosis, erythropoietic protoporphyria and neuromyelitis. Nearly&nbsp;<a href=\"https:\/\/www.fda.gov\/news-events\/fda-voices\/innovation-new-drug-approvals-2019-advances-patient-care-across-broad-range-diseases\" target=\"_blank\" rel=\"noreferrer noopener\">44%<\/a>&nbsp;of the drug approvals by the CDER in 2019 were related to orphan drugs.<\/li>\n<\/ul>\n\n\n\n<p>Moreover, after the passage of the Orphan Drug Act 1983, the FDA has approved nearly 500 orphan drugs, with 233 of them being approved between the year 2005 and 2015 alone. This is in stark contrast to ten orphan drugs approved in the 1970s, before the act was passed.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Increased patent filing:<\/strong>&nbsp;Patent data is a valuable source to measure the extent of innovations in any sector for researchers to innovate. Therefore, aggressive patent filings have been witnessed in rare disease domain for conditions such as Angelman Syndrome, choroideremia, Addison\u2019s disease and spinal muscular atrophy. The upsurge in the innovation index related to rare diseases also indicates a spike in innovations.<\/li>\n\n\n\n<li><strong>Innovation in diagnosis:<\/strong>\u00a0Rare disease diagnosis has also seen improvements in terms of innovation. Genetic testing has played a big role in enhancing the diagnosis process. For instance, the UK government\u2019s\u00a0100K Genomes Project\u00a0has achieved its goal of sequencing the genomes of 100,000 people in 2019. This data can help researchers and strategists learn more about such conditions for the betterment of the rare disease community.<\/li>\n<\/ul>\n\n\n\n<p>For instance, 300+ patents have been filed for Angelman Syndrome and 200 patents for Choroideremia in the last five years, with 100 patents for Spinal muscular atrophy (SMA) filed in the last two years.<\/p>\n\n\n\n<p>Here are a few facts and figures based on our patent research:<\/p>\n\n\n\n<p>Some of the major companies working in the rare disease sector are: Bristol Myers, Pfizer, Novartis, Amgen, Abbvie and Takeda. Meanwhile, major academic institutions that are working in the rare disease sector include: University of South Florida, INSERM, John Hopkins University, University of South California, etc. Also, when we consider the major geographies working in the rare disease sector, we find that USA, Europe, Canada, China and Korea hold key positions; with USA and Europe contributing more than 50% of the patents filed in the rare disease sector.<\/p>\n\n\n\n<p>Similarly, patent landscape analysis has been instrumental in identifying the major techniques for diagnosis such as: hybridisation, ubiquitination, cytometry and sequencing. The analysis also classifies major classes of compounds used to prepare drugs for the treatment of rare diseases, such as: Imidazoles, Azepines, Indoles, Pyrroles, Quinolines and Pyridines.<\/p>\n\n\n\n<p>Currently, pharmaceutical firms are readily&nbsp;directing&nbsp;their R&amp;D departments to research on orphan drugs to find out new possibilities and even get details of current solutions to develop fast. The move is highly motivated by the growth rate of the rare disease drugs market \u2013 it is growing faster than the market for traditional drugs.<\/p>\n\n\n\n<p>In an effort to expedite the rare disease innovations, Sagacious IP is hoping to help innovators and strategists acquire new ideas and develop therapies\/diagnoses quicker through a database that provides a patent set.<\/p>\n\n\n\n<p>Since all innovations are patented first, innovators and strategists can gain access to relevant information related to developments in the rare diseases sector and get new ideas through this database. The information can then be filtered to help researchers develop further technologies based on existing ones, and more importantly \u2013 avoid patent litigations!<\/p>\n\n\n\n<p>Time is utterly valuable in the medical domain, especially in the rare disease sector which requires more innovations to prevent loss of lives. Researchers and strategists spend a significant amount of time and money on researching and finding cures for rare diseases. Collecting refined and focused information can be a time-consuming and costly task so quick innovations in the rare disease domain can improve a patient\u2019s quality of life.<\/p>\n\n\n\n<p>Therefore, overcoming barriers such as a lack of readily available information in the rare disease sector can significantly expedite the pace of innovation by fostering new treatment therapies, which would ultimately result in the betterment of the rare disease community.<\/p>\n\n\n\n<p>Originally published on: <a href=\"https:\/\/pharmaphorum.com\/r-d\/views-analysis-r-d\/expediting-innovations-in-rare-disease-domain\/\">https:\/\/pharmaphorum.com\/r-d\/views-analysis-r-d\/expediting-innovations-in-rare-disease-domain\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Rare diseases affect a fraction of the population \u2013&nbsp;450 million+ people globally. However, its effects can be equally severe and life-threatening as other prevalent diseases. For Rare Disease Day, Tarun Kumar Bansal discusses why&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":23494,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"coauthors":[983],"class_list":["post-23493","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-media-spotlights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmaphorum - Expediting innovation in the rare disease domain - Sagacious IP<\/title>\n<meta name=\"description\" content=\"Rare diseases affect a fraction of the population \u2013\u00a0450 million+ people globally. 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