{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T15:40:22Z","timestamp":1778859622316,"version":"3.51.4"},"reference-count":46,"publisher":"Public Library of Science (PLoS)","issue":"11","license":[{"start":{"date-parts":[[2022,11,18]],"date-time":"2022-11-18T00:00:00Z","timestamp":1668729600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-023749"],"award-info":[{"award-number":["INV-023749"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosglobalpublichealth.org"],"crossmark-restriction":false},"short-container-title":["PLOS Glob Public Health"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Preeclampsia and eclampsia are a leading cause of global maternal and newborn mortality. Currently, there are few effective medicines that can prevent or treat preeclampsia. Target Product Profiles (TPPs) are important tools for driving new product development by specifying upfront the characteristics that new products should take. Considering the lack of investment and innovation around new medicines for obstetric conditions, we aimed to develop two new TPPs for medicines to prevent and treat preeclampsia.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods and findings<\/jats:title>\n<jats:p>We used a multi-methods approach comprised of a literature review, stakeholder interviews, online survey, and public consultation. Following an initial literature review, diverse stakeholders (clinical practice, research, academia, international organizations, funders, consumer representatives) were invited for in-depth interviews and an online international survey, as well as public consultation on draft TPPs. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs. We performed 23 stakeholder interviews and received 46 survey responses. A high level of agreement was observed in survey results, with 89% of TPP variables reaching consensus (75% agree or strongly agree). Points of discussion were raised around the target population for preeclampsia prevention and treatment, as well as the acceptability of cold-chain storage and routes of administration.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>There is consensus within the maternal health research community on the parameters that new medicines for preeclampsia prevention and treatment must achieve to meet real-world health needs. These TPPs provide necessary guidance to spur interest, innovation and investment in the development of new medicines to prevent and treat preeclampsia.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pgph.0001260","type":"journal-article","created":{"date-parts":[[2022,11,18]],"date-time":"2022-11-18T18:22:06Z","timestamp":1668795726000},"page":"e0001260","update-policy":"https:\/\/doi.org\/10.1371\/journal.pgph.corrections_policy","source":"Crossref","is-referenced-by-count":9,"title":["Target product profiles for novel medicines to prevent and treat preeclampsia: An expert consensus"],"prefix":"10.1371","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1182-6679","authenticated-orcid":true,"given":"Annie Ra","family":"Mcdougall","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3340-9593","authenticated-orcid":true,"given":"Andrew","family":"Tuttle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maya","family":"Goldstein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1059-061X","authenticated-orcid":true,"given":"Anne","family":"Ammerdorffer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. Metin","family":"G\u00fclmezoglu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3214-7096","authenticated-orcid":true,"given":"Joshua P.","family":"Vogel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2022,11,18]]},"reference":[{"issue":"6","key":"pgph.0001260.ref001","doi-asserted-by":"crossref","first-page":"e323","DOI":"10.1016\/S2214-109X(14)70227-X","article-title":"Global causes of maternal death: a WHO systematic analysis","volume":"2","author":"L Say","year":"2014","journal-title":"Lancet Glob Health"},{"issue":"3","key":"pgph.0001260.ref002","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1053\/j.semperi.2009.02.010","article-title":"The global impact of pre-eclampsia and eclampsia","volume":"33","author":"L. Duley","year":"2009","journal-title":"Seminars in perinatology"},{"issue":"1","key":"pgph.0001260.ref003","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ejogrb.2013.05.005","article-title":"Global and regional estimates of preeclampsia and eclampsia: a systematic review","volume":"170","author":"E Abalos","year":"2013","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"issue":"7","key":"pgph.0001260.ref004","doi-asserted-by":"crossref","first-page":"1094","DOI":"10.1161\/CIRCRESAHA.118.313276","article-title":"Preeclampsia: Pathophysiology, Challenges, and Perspectives","volume":"124","author":"S Rana","year":"2019","journal-title":"Circ Res"},{"issue":"10","key":"pgph.0001260.ref005","article-title":"Antiplatelet agents for preventing pre-eclampsia and its complications","volume":"2019","author":"L Duley","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"pgph.0001260.ref006","unstructured":"WHO. WHO recommendations for prevention and treatment of pre-eclampsia and eclampsia. Geneva, Switzerland: 2011."},{"issue":"Suppl 1","key":"pgph.0001260.ref007","first-page":"1","article-title":"Saving Mothers\u2019 Lives: Reviewing maternal deaths to make motherhood safer: 2006\u20132008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom","volume":"118","author":"R Cantwell","year":"2011","journal-title":"BJOG: an international journal of obstetrics and gynaecology"},{"issue":"11","key":"pgph.0001260.ref008","first-page":"CD000025","article-title":"Magnesium sulphate and other anticonvulsants for women with pre-eclampsia","author":"L Duley","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"pgph.0001260.ref009","article-title":"Factors affecting use of magnesium sulphate for pre-eclampsia or eclampsia: a qualitative evidence synthesis","author":"KE Eddy","year":"2021","journal-title":"BJOG: an international journal of obstetrics and gynaecology"},{"issue":"1","key":"pgph.0001260.ref010","doi-asserted-by":"crossref","first-page":"e22","DOI":"10.1371\/journal.pmed.0050022","article-title":"Market failure and the poverty of new drugs in maternal health","volume":"5","author":"NM Fisk","year":"2008","journal-title":"PLoS Med"},{"issue":"6","key":"pgph.0001260.ref011","doi-asserted-by":"crossref","first-page":"662","DOI":"10.1111\/j.1365-3156.2011.02778.x","article-title":"Relative and absolute addressability of global disease burden in maternal and perinatal health by investment in R&D","volume":"16","author":"NM Fisk","year":"2011","journal-title":"Trop Med Int Health"},{"key":"pgph.0001260.ref012","unstructured":"Concept Foundation. Medicines for pregnancy specific conditions: research, development and market analysis 2021 [12 August 2021]. https:\/\/www.conceptfoundation.org\/global-news\/medicines-for-pregnancy-specific-conditions-research-development-and-market-analysis\/."},{"key":"pgph.0001260.ref013","unstructured":"FDA. Guidance for Industry and Review Staff Target Product Profile\u2014A Strategic Development Process Tool (Draft Guidance). 2007."},{"issue":"3","key":"pgph.0001260.ref014","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1038\/nrd.2016.264","article-title":"Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused","volume":"16","author":"A Tyndall","year":"2017","journal-title":"Nature reviews Drug discovery"},{"issue":"7","key":"pgph.0001260.ref015","doi-asserted-by":"crossref","first-page":"576","DOI":"10.1016\/j.tibtech.2017.02.011","article-title":"What\u2019s the Regulatory Value of a Target Product Profile?","volume":"35","author":"CD Breder","year":"2017","journal-title":"Trends Biotechnol"},{"key":"pgph.0001260.ref016","unstructured":"WHO. TDR: For research on diseases of poverty. Health Product Profile Directory 2021. https:\/\/www.who.int\/tdr\/diseases-topics\/product-directory\/en\/."},{"key":"pgph.0001260.ref017","unstructured":"UNICEF. Target product profiles (TPPs) [17 October 2022]. https:\/\/www.unicef.org\/supply\/target-product-profiles."},{"key":"pgph.0001260.ref018","unstructured":"WHO Target Product Profiles, Preferred Product Characteristics, and Target Regimen Profiles: Standard Procedure. Geneva, Switzerland."},{"issue":"1","key":"pgph.0001260.ref019","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1186\/s12916-020-01582-1","article-title":"Target Product Profiles for medical tests: a systematic review of current methods","volume":"18","author":"P Cocco","year":"2020","journal-title":"BMC Med"},{"issue":"9","key":"pgph.0001260.ref020","doi-asserted-by":"crossref","first-page":"e0237424","DOI":"10.1371\/journal.pone.0237424","article-title":"Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance: An expert consensus","volume":"15","author":"C Ferreyra","year":"2020","journal-title":"PLoS One"},{"issue":"1","key":"pgph.0001260.ref021","doi-asserted-by":"crossref","first-page":"e42","DOI":"10.1016\/S2352-3018(20)30234-4","article-title":"Multi-stakeholder consensus on a target product profile for an HIV cure","volume":"8","author":"SR Lewin","year":"2021","journal-title":"Lancet HIV"},{"key":"pgph.0001260.ref022"},{"issue":"2","key":"pgph.0001260.ref023","doi-asserted-by":"crossref","first-page":"e002067","DOI":"10.1136\/bmjgh-2019-002067","article-title":"Electronic clinical decision support algorithms incorporating point-of-care diagnostic tests in low-resource settings: a target product profile","volume":"5","author":"KG Pelle","year":"2020","journal-title":"BMJ Glob Health"},{"issue":"4","key":"pgph.0001260.ref024","doi-asserted-by":"crossref","first-page":"e001683","DOI":"10.1136\/bmjgh-2019-001683","article-title":"Developing and applying a \u2019living guidelines\u2019 approach to WHO recommendations on maternal and perinatal health","volume":"4","author":"JP Vogel","year":"2019","journal-title":"BMJ Glob Health"},{"issue":"9879","key":"pgph.0001260.ref025","doi-asserted-by":"crossref","first-page":"1747","DOI":"10.1016\/S0140-6736(13)60686-8","article-title":"Moving beyond essential interventions for reduction of maternal mortality (the WHO Multicountry Survey on Maternal and Newborn Health): a cross-sectional study","volume":"381","author":"JP Souza","year":"2013","journal-title":"Lancet"},{"issue":"9","key":"pgph.0001260.ref026","doi-asserted-by":"crossref","first-page":"1277","DOI":"10.1177\/1049732305276687","article-title":"Three approaches to qualitative content analysis","volume":"15","author":"HF Hsieh","year":"2005","journal-title":"Qual Health Res"},{"issue":"6","key":"pgph.0001260.ref027","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1159\/000490385","article-title":"External Validation and Clinical Usefulness of First Trimester Prediction Models for the Risk of Preeclampsia: A Prospective Cohort Study","volume":"45","author":"LJE Meertens","year":"2019","journal-title":"Fetal diagnosis and therapy"},{"key":"pgph.0001260.ref028","article-title":"Pravastatin, proton-pump inhibitors, metformin, micronutrients, and biologics: new horizons for the prevention or treatment of preeclampsia","author":"S Tong","year":"2020","journal-title":"Am J Obstet Gynecol"},{"issue":"2","key":"pgph.0001260.ref029","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1111\/1471-0528.16361","article-title":"Implementation of routine first trimester combined screening for pre-eclampsia: a clinical effectiveness study","volume":"128","author":"GP Guy","year":"2021","journal-title":"BJOG: an international journal of obstetrics and gynaecology"},{"issue":"10169","key":"pgph.0001260.ref030","doi-asserted-by":"crossref","first-page":"330","DOI":"10.1016\/S0140-6736(18)31818-X","article-title":"Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial","volume":"393","author":"GJ Hofmeyr","year":"2019","journal-title":"Lancet"},{"issue":"4","key":"pgph.0001260.ref031","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1161\/HYPERTENSIONAHA.119.14107","article-title":"Clinical Influence of Nonadherence With Prophylactic Aspirin in Preventing Preeclampsia in High-Risk Pregnancies: A Multicenter, Prospective, Observational Cohort Study","volume":"75","author":"R Shanmugalingam","year":"2020","journal-title":"Hypertension"},{"issue":"12","key":"pgph.0001260.ref032","doi-asserted-by":"crossref","first-page":"1516","DOI":"10.1111\/1471-0528.16319","article-title":"A core outcome set for pre-eclampsia research: an international consensus development study","volume":"127","author":"J Duffy","year":"2020","journal-title":"BJOG: an international journal of obstetrics and gynaecology"},{"key":"pgph.0001260.ref033","doi-asserted-by":"crossref","first-page":"e237","DOI":"10.1097\/AOG.0000000000003891","article-title":"American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 222: Gestational Hypertension and Preeclampsia","volume":"135","year":"2020","journal-title":"Obstet Gynecol"},{"key":"pgph.0001260.ref034","unstructured":"WHO recommendations: Drug teatment for severe hypertension in pregnancy. Geneva, Switzerland: 2018."},{"key":"pgph.0001260.ref035","unstructured":"WHO recommendations on drug treatment for non-severe hypertension in pregnancy. Geneva, Switzerland: 2020."},{"key":"pgph.0001260.ref036","article-title":"Antihypertensive drug therapy for mild to moderate hypertension during pregnancy","volume":"10","author":"E Abalos","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"issue":"9321","key":"pgph.0001260.ref037","doi-asserted-by":"crossref","first-page":"1877","DOI":"10.1016\/S0140-6736(02)08778-0","article-title":"Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial","volume":"359","author":"D Altman","year":"2002","journal-title":"Lancet"},{"issue":"10203","key":"pgph.0001260.ref038","doi-asserted-by":"crossref","first-page":"1011","DOI":"10.1016\/S0140-6736(19)31282-6","article-title":"Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial","volume":"394","author":"T Easterling","year":"2019","journal-title":"Lancet"},{"key":"pgph.0001260.ref039","unstructured":"American Collage of Obtertricians and Gynecologists. Task Force on hypertenion in pregnancy. Washington (DC): The American College of Obstetricians and Gynecologists: 2013."},{"issue":"6","key":"pgph.0001260.ref040","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1002\/uog.17455","article-title":"Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11\u201313 weeks\u2019 gestation: comparison with NICE guidelines and ACOG recommendations","volume":"49","author":"N O\u2019Gorman","year":"2017","journal-title":"Ultrasound Obstet Gynecol"},{"key":"pgph.0001260.ref041","article-title":"First trimester preeclampsia screening and prediction","author":"P Chaemsaithong","year":"2020","journal-title":"Am J Obstet Gynecol"},{"key":"pgph.0001260.ref042","unstructured":"PATH. Developing new diagnostic tools to improve preeclampsia screening 2021 [17 October 2022]. https:\/\/media.path.org\/documents\/PrCr_11.20_.pdf."},{"issue":"2","key":"pgph.0001260.ref043","doi-asserted-by":"crossref","first-page":"e001466","DOI":"10.1136\/bmjgh-2019-001466","article-title":"WHO recommendations on uterotonics for postpartum haemorrhage prevention: what works, and which one?","volume":"4","author":"JP Vogel","year":"2019","journal-title":"BMJ Glob Health"},{"issue":"13","key":"pgph.0001260.ref044","doi-asserted-by":"crossref","first-page":"2076","DOI":"10.1111\/1471-0528.13998","article-title":"Quality of oxytocin available in low- and middle-income countries: a systematic review of the literature","volume":"123","author":"MR Torloni","year":"2016","journal-title":"BJOG: an international journal of obstetrics and gynaecology"},{"key":"pgph.0001260.ref045","doi-asserted-by":"crossref","first-page":"n2103","DOI":"10.1136\/bmj.n2103","article-title":"Use of metformin to prolong gestation in preterm pre-eclampsia: randomised, double blind, placebo controlled trial","volume":"374","author":"CA Cluver","year":"2021","journal-title":"Bmj"},{"issue":"5","key":"pgph.0001260.ref046","doi-asserted-by":"crossref","first-page":"e558","DOI":"10.1016\/S2214-109X(21)00178-9","article-title":"Progressing the investment case in maternal and child health","volume":"9","author":"The Lancet Global Health","year":"2021","journal-title":"Lancet Glob Health"}],"container-title":["PLOS Global Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pgph.0001260","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,18]],"date-time":"2022-11-18T18:22:34Z","timestamp":1668795754000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pgph.0001260"}},"subtitle":[],"editor":[{"given":"Hannah","family":"Tappis","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2022,11,18]]},"references-count":46,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2022,11,18]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pgph.0001260","relation":{},"ISSN":["2767-3375"],"issn-type":[{"value":"2767-3375","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,18]]}}}