[ { "key": "KM3TT9TK", "version": 94, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/KM3TT9TK", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/KM3TT9TK", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2615577, "username": "aalix15", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/aalix15", "type": "text/html" } } }, "creatorSummary": "Li et al.", "parsedDate": "2014-06-11", "numChildren": 0 }, "data": { "key": "KM3TT9TK", "version": 94, "itemType": "journalArticle", "title": "Mipomersen is a Promising Therapy in the Management of Hypercholesterolemia: A Meta-Analysis of Randomized Controlled Trials", "creators": [ { "creatorType": "author", "firstName": "Na", "lastName": "Li" }, { "creatorType": "author", "firstName": "Qing", "lastName": "Li" }, { "creatorType": "author", "firstName": "Xia-Qiu", "lastName": "Tian" }, { "creatorType": "author", "firstName": "Hai-Yan", "lastName": "Qian" }, { "creatorType": "author", "firstName": "Yue-Jin", "lastName": "Yang" } ], "abstractNote": "Introduction By inhibiting apolipoprotein B (ApoB) synthesis, mipomersen can significantly reduce ApoB-containing lipoproteins in hypercholesterolemic patients. Objective This study sought to ascertain both the extent to which mipomersen can decrease ApoB-containing lipoproteins and the safety of mipomersen therapy. Methods Studies were identified through PubMed, CENTRAL, Embase, Clinical Trials, reviews, and reference lists of relevant papers. The efficacy endpoints were the changes in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), ApoB, and lipoprotein (a) [Lp(a)]. The safety endpoints were the incidence of injection-site reactions, flu-like symptoms, and elevated transaminases. Results Six randomized controlled trials with 444 patients were included in the analysis. Compared with the placebo group, patients who received mipomersen therapy had a significant reduction in LDL-C (33.13 %), as well as a reduction in non-HDL-C (31.70 %), ApoB (33.27 %), and LP(a) (26.34 %). Mipomersen therapy was also associated with an obvious increase in injection-site reactions with an odds ratio (OR) of 14.15, flu-like symptoms with an OR of 2.07, and alanine aminotransferase levels ≥3 × the upper limit of normal with an OR of 11.21. Conclusions Mipomersen therapy is effective for lowering ApoB-containing lipoproteins in patients with severe hypercholesterolemia. Future studies exploring how to minimize side effects of mipomersen therapy are needed.", "publicationTitle": "American Journal of Cardiovascular Drugs", "publisher": "", "place": "", "date": "2014/06/11", "volume": "14", "issue": "5", "section": "", "partNumber": "", "partTitle": "", "pages": "367-376", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Am J Cardiovasc Drugs", "DOI": "10.1007/s40256-014-0077-0", "citationKey": "", "url": "http://link.springer.com/article/10.1007/s40256-014-0077-0", "accessDate": "2016-04-11T05:23:08Z", "PMID": "", "PMCID": "", "ISSN": "1175-3277, 1179-187X", "archive": "", "archiveLocation": "", "shortTitle": "Mipomersen is a Promising Therapy in the Management of Hypercholesterolemia", "language": "en", "libraryCatalog": "link.springer.com", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Cardiology", "type": 1 }, { "tag": "Pharmacology/Toxicology", "type": 1 }, { "tag": "Pharmacotherapy", "type": 1 } ], "collections": [], "relations": {}, "dateAdded": "2016-04-11T05:23:08Z", "dateModified": "2016-04-11T05:23:08Z" } }, { "key": "U39BZGRN", "version": 93, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/U39BZGRN", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/U39BZGRN", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/438467/items/X6VJF59W", "type": "application/json" } }, "meta": { "createdByUser": { "id": 2640151, "username": "sarahhn", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/sarahhn", "type": "text/html" } } } }, "data": { "key": "U39BZGRN", "version": 93, "parentItem": "X6VJF59W", "itemType": "attachment", "linkMode": "imported_url", "title": "Snapshot", "accessDate": "2015-12-01T07:22:23Z", "url": "http://www.ncbi.nlm.nih.gov/books/NBK56179/", "note": "", "contentType": "text/html", "charset": "utf-8", "filename": "NBK56179.html", "md5": "d23cce153a2a57c012fa98e1a10d9316", "mtime": 1448954543318, "tags": [], "relations": {}, "dateAdded": "2015-12-01T07:22:23Z", "dateModified": "2015-12-01T07:22:23Z" } }, { "key": "X6VJF59W", "version": 92, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/X6VJF59W", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/X6VJF59W", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2640151, "username": "sarahhn", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/sarahhn", "type": "text/html" } } }, "creatorSummary": "Development et al.", "parsedDate": "2010", "numChildren": 1 }, "data": { "key": "X6VJF59W", "version": 92, "itemType": "journalArticle", "title": "Development of New Therapeutic Drugs and Biologics for Rare Diseases", "creators": [ { "creatorType": "author", "firstName": "Institute of Medicine (US) Committee on Accelerating Rare Diseases Research and Orphan Product", "lastName": "Development" }, { "creatorType": "author", "firstName": "Marilyn J.", "lastName": "Field" }, { "creatorType": "author", "firstName": "Thomas F.", "lastName": "Boat" } ], "abstractNote": "Once a potential therapeutic drug or biologic has been discovered, the process of developing the therapeutic for a particular disease, whether rare or not, begins with preclinical development and continues through increasingly complex and demanding phases of clinical testing to support approval for marketing. Much of what is done throughout the process of drug development is driven by necessary regulations that require the sponsor of a new drug to demonstrate its safety and efficacy. (Figure 5-1 depicts the process, in simplified form, from the earliest basic investigations through studies undertaken after a product has been approved for marketing.) Although public and nonprofit organizations have sometimes taken a product through this process, this work, which is expensive and risky, has traditionally been done within pharmaceutical and biotechnology companies. Approximately 10 percent of potential therapeutics that effectively pass preclinical development reach the market, and the cost for each is estimated to average from $100 million to more than $1 billion, depending on the disease and other factors and taking the cost of failed drugs into account (see, e.g., DiMasi et al., 2003; PhRMA, 2007; Gassman et al., 2008). According to one study of the 50 largest pharmaceutical firms, about one in six new drugs that entered clinical testing eventually received approval for marketing, but this rate varied widely by therapeutic class and was slightly higher for drugs licensed into a company than for drugs originated by the company (27 percent versus 16 percent) (DiMasi et al., 2010). The proportion of orphan drug approvals accounted for by large pharmaceutical companies has grown in recent years (Tufts Center, 2010), but the committee found no analysis of the success rate specific to orphan drugs.", "publicationTitle": "", "publisher": "", "place": "", "date": "2010", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/books/NBK56179/", "accessDate": "2015-12-01T07:22:21Z", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "en", "libraryCatalog": "www.ncbi.nlm.nih.gov", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-12-01T07:22:21Z", "dateModified": "2015-12-01T07:22:21Z" } }, { "key": "QXPF4HCC", "version": 91, "library": { "type": "group", "id": 438467, "name": "ALS 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"partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "http://textbookofbacteriology.net/antiimmuno.html", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-12-01T06:51:28Z", "dateModified": "2015-12-01T06:52:57Z" } }, { "key": "NP3N5EU8", "version": 87, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/NP3N5EU8", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/NP3N5EU8", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/438467/items/7QTUNI8R", "type": "application/json" } }, "meta": { "createdByUser": { "id": 2615577, "username": "aalix15", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/aalix15", "type": "text/html" } } } }, "data": { "key": "NP3N5EU8", "version": 87, "parentItem": "7QTUNI8R", "itemType": "attachment", "linkMode": "imported_url", "title": "Snapshot", "accessDate": "2015-12-01T05:31:10Z", "url": "http://www.rand.org/pubs/research_briefs/RB9572.html", "note": "", "contentType": "text/html", "charset": "utf-8", "filename": "RB9572.html", "md5": "add4889268fedb69fe986a1271dd3cfb", "mtime": 1448947872000, "tags": [], "relations": {}, "dateAdded": "2015-12-01T05:31:10Z", "dateModified": "2015-12-01T05:31:10Z" } }, { "key": "7QTUNI8R", "version": 86, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/7QTUNI8R", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/7QTUNI8R", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2615577, "username": "aalix15", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/aalix15", "type": "text/html" } } }, "creatorSummary": "Harris et al.", "parsedDate": "2011", "numChildren": 1 }, "data": { "key": "7QTUNI8R", "version": 86, "itemType": "webpage", "title": "Seasonal Flu Vaccination", "creators": [ { "creatorType": "author", "firstName": "Katherine M.", "lastName": "Harris" }, { "creatorType": "author", "firstName": "Jürgen", "lastName": "Maurer" }, { "creatorType": "author", "firstName": "Lori", "lastName": "Uscher-Pines" }, { "creatorType": "author", "firstName": "Arthur L.", "lastName": "Kellermann" }, { "creatorType": "author", "firstName": "Nicole", "lastName": "Lurie" } ], "abstractNote": "RAND researchers found that less than half of U.S. adults received flu vaccinations in 2010. Strategies to increase flu vaccination rates should include stronger efforts to address public skepticism and negative perceptions.", "websiteTitle": "", "websiteType": "Product Page", "date": "2011", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.rand.org/pubs/research_briefs/RB9572.html", "accessDate": "2015-12-01T05:30:58Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-12-01T05:30:58Z", "dateModified": "2015-12-01T05:30:58Z" } }, { "key": "MRPBFAR9", "version": 85, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/MRPBFAR9", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/MRPBFAR9", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2654577, "username": "ckang15", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/ckang15", "type": "text/html" } } }, "creatorSummary": "Magil", "parsedDate": "2009-10-23", "numChildren": 0 }, "data": { "key": "MRPBFAR9", "version": 85, "itemType": "presentation", "title": "Developing a Biotherapeutic: From Clone to Clinic", "creators": [ { "creatorType": "presenter", "firstName": "Sheila G.", "lastName": "Magil" } ], "abstractNote": "", "presentationType": "", "date": "October 23, 2009", "meetingName": "Bench to Pilot Plant Symposium", "place": "Cambridge, MA", "series": "", "sessionTitle": "", "DOI": "", "citationKey": "", "url": "http://www.bptc.com/sites/default/files/presentations/developingabiotherapeutic.pdf", "accessDate": "", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-12-01T04:37:54Z", "dateModified": "2015-12-01T04:40:29Z" } }, { "key": "I3PAZIQG", "version": 81, "library": { "type": "group", "id": 438467, "name": "ALS 333 Xialivir Wooooo", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/438467/items/I3PAZIQG", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_333_xialivir_wooooo/items/I3PAZIQG", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2605659, "username": "saberguy91", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/saberguy91", "type": "text/html" } } }, "lastModifiedByUser": { "id": 2654577, "username": "ckang15", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/ckang15", "type": "text/html" } } }, "creatorSummary": "Tuse et al.", "parsedDate": "2014-05-29", "numChildren": 3 }, "data": { "key": "I3PAZIQG", "version": 81, "itemType": "journalArticle", "title": "Manufacturing Economics of Plant-Made Biologics: Case Studies in Therapeutic and Industrial Enzymes, Manufacturing Economics of Plant-Made Biologics: Case Studies in Therapeutic and Industrial Enzymes", "creators": [ { "creatorType": "author", "firstName": "Daniel", "lastName": "Tuse" }, { "creatorType": "author", "firstName": "Tiffany", "lastName": "Tu" }, { "creatorType": "author", "firstName": "Karen A.", "lastName": "McDonald" }, { "creatorType": "author", "firstName": "Tiffany", "lastName": "Tu" } ], "abstractNote": "Production of recombinant biologics in plants has received considerable attention as an alternative platform to traditional microbial and animal cell culture. Industrially relevant features of plant systems include proper eukaryotic protein processing, inherent safety due to lack of adventitious agents, more facile scalability, faster production (transient systems), and potentially lower costs. Lower manufacturing cost has been widely claimed as an intuitive feature of the platform by the plant-made biologics community, even though cost information resides within a few private companies and studies accurately documenting such an advantage have been lacking. We present two technoeconomic case studies representing plant-made enzymes for diverse applications: human butyrylcholinesterase produced indoors for use as a medical countermeasure and cellulases produced in the field for the conversion of cellulosic biomass into ethanol as a fuel extender. Production economics were modeled based on results reported with the latest-generation expression technologies on Nicotiana host plants. We evaluated process unit operations and calculated bulk active and per-dose or per-unit costs using SuperPro Designer modeling software. Our analyses indicate that substantial cost advantages over alternative platforms can be achieved with plant systems, but these advantages are molecule/product-specific and depend on the relative cost-efficiencies of alternative sources of the same product., Production of recombinant biologics in plants has received considerable attention as an alternative platform to traditional microbial and animal cell culture. Industrially relevant features of plant systems include proper eukaryotic protein processing, inherent safety due to lack of adventitious agents, more facile scalability, faster production (transient systems), and potentially lower costs. Lower manufacturing cost has been widely claimed as an intuitive feature of the platform by the plant-made biologics community, even though cost information resides within a few private companies and studies accurately documenting such an advantage have been lacking. We present two technoeconomic case studies representing plant-made enzymes for diverse applications: human butyrylcholinesterase produced indoors for use as a medical countermeasure and cellulases produced in the field for the conversion of cellulosic biomass into ethanol as a fuel extender. Production economics were modeled based on results reported with the latest-generation expression technologies on Nicotiana host plants. We evaluated process unit operations and calculated bulk active and per-dose or per-unit costs using SuperPro Designer modeling software. Our analyses indicate that substantial cost advantages over alternative platforms can be achieved with plant systems, but these advantages are molecule/product-specific and depend on the relative cost-efficiencies of alternative sources of the same product.", "publicationTitle": "BioMed Research International, BioMed Research International", "publisher": "", "place": "", "date": "2014/05/29, 2014/05/29", "volume": "2014, 2014", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "e256135", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1155/2014/256135, 10.1155/2014/256135", "citationKey": "", "url": "http://www.hindawi.com/journals/bmri/2014/256135/abs/, http://www.hindawi.com/journals/bmri/2014/256135/abs/", "accessDate": "2015-11-30T18:55:28Z", "PMID": "", "PMCID": "", "ISSN": "2314-6133, 2314-6133", "archive": "", "archiveLocation": "", "shortTitle": "Manufacturing Economics of Plant-Made Biologics", "language": "en", 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