Concept Foundation (non-profit)

Concept Foundation is pleased to share the publication of a systematic review on factors affecting the inclusion of pregnant and lactating women in #clinicalTrials. This mixed-methods systematic review is published in PLOS Medicine, in collaboration with the #Gender and Women’s Health Unit at University of Melbourne and Burnet Institute, Australia, and JAWAHARLAL NEHRU MEDICAL COLLEGE, India. 💡 We systematically explored eight databases, to generate evidence on the facilitators and barriers impacting pregnant and lactating women’s participation in trials. Our findings show that there is a wide range of factors that play a role - operating at various levels across regulation, statutes, #policies, funding, #research #ethics boards, #healthSystems, health workers, women, and their families. Today, pregnant women are systematically excluded from clinical trials, which translates into millions of women not fully benefitting from scientific advances - living with the uncertainty about potential adverse effects from drugs, and being deprived of the latest biomedical innovations and of optimal interventions that are tailored to the specific circumstances of pregnancy. To increase the number of meaningful clinical trials in pregnant women globally, we need a better understanding of the #knowledge of, and #attitudes and preferences towards, clinical trials. Our systematic review offers comprehensive #evidence synthesis, and recommended strategies to address barriers and optimise pregnant and lactating women’s participation in clinical trials - which can ultimately improve #womensHealth.   You can access the review here: https://lnkd.in/e8M2PMyJ   #maternalHealth #healthEquity #reproductiveHealth #genderBias #AIMproject

Why is it important that sexual and #reproductiveHealth #medicines are #qualityAssured? What difference would it make, if we made sure that the medicines that women receive are all quality-assured? 💡 In a first-of-its-kind publication, Concept Foundation and University of North Carolina at Chapel Hill (UNC) UNC Eshelman School of Pharmacy show that the use of quality-assured uterotonic medicines do not only impact #womensHealth – but can also have significant #economic #impact, for #healthSystems, women and their families, and entire countries. 💡 Through a modelling study, we demonstrate the benefits of improving the quality of uterotonics to reduce #postpartumHaemorrhage (#PPH) and #maternalMortality. Concept Foundation and UNC developed a decision-tree model to examine the economic and health impact of substandard uterotonics, through case studies in three sub-Saharan African countries: #Ghana, #Nigeria, and #Senegal. The recently published paper outlines the results from the modelling exercise in Ghana – showing that by ensuring use of quality-assured uterotonics in the country, would result in millions of dollars in cost savings and improve maternal health outcomes for the government and families in the country.   💡 This article, published in PLOS Global Public Health, is the first to demonstrate the economic burden associated with poor-quality uterotonics. The findings indicate the economic benefits of safeguarding medicine quality in low-and middle-income countries (#LMICs), and the importance of doing so to achieve #UniversalHealthCoverage (#UHC) and the United Nations’ Sustainable Development Goals (#SDGs). Improving access to quality-assured uterotonics without financial hardship requires multi-sectoral efforts to tackle health system challenges. At Concept Foundation, we support manufacturing, registration, procurement and use of #SRH medicines that are quality-assured. Read the full paper on our unique findings in Ghana, and stay tuned for our upcoming #research results from Nigeria and Senegal. https://lnkd.in/eR_b_tQp

Concept Foundation’s latest board meeting took place in Geneva, Switzerland, and served as a great opportunity to discuss our future #strategy and explore opportunities that can support our continuous work to drive #RandD, support #manufacturing and registration of #qualityAssured SRH #medicines, and advocate for implementation in low- and middle- income countries (#LMICs). A heartfelt thank you goes out to our board members, whose invaluable input energized us to keep working towards a world where all women and girls can access sexual and #reproductiveHealth medicines when they need them - without having to worry about how to afford these products, or whether they are effective and safe.   We would like to extend a special note of gratitude to Elizabeth Lule, who is sadly stepping down as Chair of the Board after many years of tireless dedication to supporting our organization with her profound expertise in and passion for #SRH issues. While we will miss Elizabeth, we are also very happy to welcome Pisake Lumbiganon as our new Chair of the Board, transitioning from having been Vice-Chair. As a Professor of obstetrics and gynecology, and immediate past president of The Asia & Oceania Federation of Obstetrics & Gynaecology (AOFOG), Pisake brings a wealth of relevant experience in SRHR to his new role as Chair. Pictured in the photos are the members of the Board: Elizabeth Lule | Pisake Lumbiganon | Jeff Spieler | Agnes Saint-Raymond | Silke Lindenberg, Dr. | Luis Bahamondes | Andrea Lucard | Nicolette Loonen  as well as team members from our Geneva office: Ahmet Metin Gülmezoglu  | Lester CHINERY | Anne Ammerdorffer | Carolin Ekman | Alessandra Fleurent | Milena Micunovic | Sara Rushwan | Jennifer Scott

📽 WEBINAR RECORDING NOW ONLINE! DIAGNOSIS IN THE DARK: The need for R&D of #diagnostics for #preEclampsia      In our latest webinar, we discussed pre-eclampsia diagnostics and how they can improve #womensHealth - and the urgent need for accelerated investment in #research and development of diagnostics for what is still one of the leading causes of #maternalMortality. ➡ Learn more about the recently published report from Concept Foundation (non-profit), Policy Cures Research and Burnet Institute, on the pipeline analysis of #RandD of pre-eclampsia diagnostics. ➡ Joshua Vogel, Burnet Institute moderates a conversation between Cécile Ventola, PhD, Policy Cures Research; Koiwah Koi Larbi BSc, LL.B, LL.M, Action on Pre-Eclampsia (APEC), Ghana; Mushi Matjila, Groote Schuur Hospital, University of Cape Town; and Alice Hurrell, King's College London, about novel technologies in the space of pre-eclampsia diagnostics. https://lnkd.in/gQWP5bbx

This is a wonderful report by Policy Cures Research. It shows the massive impact of R&D investments in tackling neglected diseases, some of which, we should say are not neglected anymore! Between 2013 and 2023 123 new products have been approved for neglected diseases. My heart sinks when I think about #onlytwodrugsever for maternal health have been approved în the last 30 years. I have to correct myself, an additional two drugs have been approved by US FDA for use in postpartum depression since 2019. I can imagine that for 123 products approved there must have been more than 1000 that were properly researched and failed to get to the approval stage for some reason. Without a similar investment to accelerate innovations for women during pregnancy, lactation and any other time in their lives we will not have any good, safe solutions. We need #Partnerships, #Collaboration and #Genderequity in #SRHR to make progress in this field. Through our partnership with Policy Cures Research and Burnet Institute we just published our analysis of the pipelines and market failures in maternal health https://lnkd.in/eyAnqfJT We need similar partnerships to those in neglected diseases in #SRHR. Concept Foundation (non-profit)

Pregnant women are systematically excluded from all phases of drug research and development. The logical - and unacceptable - consequence is a dearth of effective medicines for complications of pregnancy, even life-threatening conditions. Our Accelerating Innovation for Mothers (AIM) collaboration with Concept Foundation (non-profit) and Policy Cures Research is trying to change that. See our analysis of the systemic barriers and the solutions we need in our The Lancet Global Health paper out this week: https://lnkd.in/gp5KfhV5 Burnet Institute

📢 DRUG DROUGHT IN MATERNAL HEALTH: ANALYSIS OF 20 YEARS OF #MEDICINES HIGHLIGHTS URGENT NEED FOR PUBLIC-PRIVATE #PARTNERSHIPS TO ACCELERATE R&D For several serious #maternalHealth issues, it is unlikely that there will be any new, game changing drugs before the end of the #SustainableDevelopmentGoals (#SDGs) era in 2030. In a paper published in The Lancet Global Health, Concept Foundation (non-profit), Policy Cures Research and Burnet Institute outline a mapping of all medicines that have been used/investigated for use between 2000-2020, for 5 #pregnancy specific conditions.   We expose a strikingly limited interest in #innovation and in medicines specifically developed for pregnant and lactating women. We also propose realistic solutions – which rely on collective action from #academia, the #pharmaceutical industry, #donors, #regulatory agencies, #governments and #civilSociety. 💡MATERNAL HEALTH KNOWLEDGE IS NOT TRANSLATED INTO MEDICINES 🔸It is striking how many more medicines are under development for much rarer conditions than pregnancy-related ones. 🔸Only 50% of all candidate medicines identified were in active development. Only 64 candidates were in late-stage #RandD. 💡PREGNANT WOMEN WORLDWIDE ARE TREATED WITH MEDICINES NOT DESIGNED FOR PREGNANCY 🔸Only 1/3 of the candidate medicines (and only 1/4 of the active ones) were developed specifically for any of the five maternal health conditions accounting for most of the direct maternal deaths/severe maternal morbidities. 2/3 candidates were initially developed for another condition. 🔸There is not a single medicine developed specifically for #preEclampsia / #eclampsia. 💡FACTORS HAMPERING R&D: 🔸Lack of industry incentives due to relatively high #costs + #risks and low #profit, especially in terms of introducing products in #LMICs. 🔸#Gender bias in #research, systematically excluding pregnant/lactating women from #clinicalTrials. ➡ PROPOSED SOLUTIONS: 🔹LONG-TERM COMMITMENT FROM PHARMA AND DONORS, strategically and financially investing over 10-15 yrs to support innovations from academia and #startUps. 🔹INSURANCE DE-RISKING: governments and donors guaranteeing a sales #price and purchase quantity for LMICs, similarly to what has been done for #vaccines. Pooling money into “catastrophe risk funds” to cover cost of R&D related #insurance and liability. 🔹THE ROLE OF REGULATORY AUTHORITIES: Researchers proactively proposing and showing interest in new solutions, supporting #regulatory agencies to implement these. 🔹#ADVOCACY FOR INCLUSION OF PREGNANT WOMEN IN RESEARCH incl governments ownership and engagement with #CSOs to inform and create #demand. 👉 Read more about our research & access the paper: https://bit.ly/3VFCNX6 The study conducted under the Accelerating Innovation for Mothers (#AIMproject) covers 5 conditions: #preterm labour/birth; #preElampsia/eclampsia; intrauterine growth restriction; #postpartumHaemorrhage #PPH; intrapartum fetal distress.

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♀️♀️♀️ Full house when Concept Foundation (non-profit) and GENDRO.ORG held two sessions at the Geneva Health Forum conference, asking our distinguished panel and curious audience if a #feminist global #health #policy is the way to go to spur #innovation in #womensHealth. A rich conversation with an impressive line-up of panelists, and a dedicated audience that energized, challenged and inspired us! Dr Lindsay Keir and Anne Ammerdorffer gave us an overview of recent work that Concept Foundation and Policy Cures Research have undertaken in the space of women's health, including to map the R&D landscape of #medicines addressing women's health issues, and to develop #TPPs for #pregnancy conditions. Under the excellent moderation of Shirin Heidari and Ahmet Metin Gülmezoglu, our panelists brought a wealth of knowledge, experience and perspectives on gender and health. Thank you, Andrea Lucard; Montasser Kamal; Iren Bagdasarian; Sabrina Badir; Edith Roset Bahmanyar; Temitayo Erogbogbo; Martina Penazzato for your interesting viewpoints. Among many other angles, we discussed how to tackle #gender biases in #research; accountability; the roles of different stakeholders in advancing #RandD in women’s health; the dynamics between #science, #advocacy and #politics; and the terminology used to advocate for health research with a gender lens. #AIMproject #healthForAll #GHF2024 #globalHealth #SDGs #pharmaceutical