Product Development Partnerships Research Articles

Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries.

Monoclonal antibodies (mAbs) are revolutionizing management of non-communicable diseases in high-income countries and are increasingly being advanced for a range of infectious diseases (IDs). However, access to existing mAbs is limited in low- and middle-income countries (LMICs), and investment in developing fit-for-purpose mAbs for IDs that disproportionately affect LMICs has been limited. Underlying these access barriers are systemic challenges, including a lack of commercial incentives to target LMIC markets and complexity in manufacturing and regulatory processes. Novel strategies are needed to overcome systemic access barriers for mAbs. We outline key areas where new approaches could address these barriers, based on a multistakeholder consultation in March 2023. Three disease-market archetypes are identified to guide thinking about business models tailored to different contexts. New business models are needed to incentivize development and manufacturing of ID mAbs and to ensure mAbs are optimized with a target product profile and cost of goods that enable use in diverse LMIC settings. Lessons can be applied from voluntary licensing strategies and product development partnerships that have shown success in catalysing development and affordable supply for a range of infectious diseases. Technology transfer will be key to expand LMIC research and manufacturing capacity and to enable sustainable and diversified supply. Improved market intelligence, demand aggregation mechanisms, and portfolio-based manufacturing models could be used to de-risk commercial investment and establish a sustainable manufacturing ecosystem for affordable mAbs. Novel regulatory approaches and robust technology transfer may reduce data requirements and timelines for biosimilar approvals. Trailblazer products, with coordinated "end-to-end" support from funders, can demonstrate proof of concept for pathways to accessible mAbs across a broader range of LMICs. Research funders; local, regional, global health agencies; and, private sector partners should commit to implementing innovative partnerships and end-to-end strategies that enable equitable access to mAbs for infectious diseases in LMICs.

Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials.

Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.

The role of global health partnerships in vaccine equity: A scoping review.

The emergence of global health partnerships (GHPs) towards the end of the twentieth century reflected concerns about slow progress in access to essential medicines, including vaccines. These partnerships bring together governments, private philanthropic foundations, NGOs, and international agencies. Those in the vaccine field seek to incentivise the development and manufacture of new vaccines, raise funds to pay for them and develop and support systems to deliver them to those in need. These activities became more critical during the COVID-19 pandemic, with the COVAX Facility Initiative promoting global vaccine equity. This review identifies lessons from previous experiences with GHPs. Findings contribute to understanding the emergence of GHPs, the mechanisms they leverage to support global access to vaccines, and the inherent challenges associated with their implementation. Using Arksey and O'Malley's method, we conducted a scoping review to identify and synthesise relevant articles. We analysed data thematically to identify barriers and opportunities for success. We included 68 eligible articles of 3,215 screened. Most (65 [95%]) were discussion or review articles describing partnerships or programmes they supported, and three (5%) were commentaries. Emerging themes included policy responses (e.g., immunisation mandates), different forms of partnerships arising in vaccine innovation (e.g., product development partnerships, public-private partnerships for access), and influence on global governance decision-making processes (e.g., the rising influence of foundations, diminishing authority of WHO, lack of accountability and transparency, creation of disease silos). If global health partnerships are to maximise their contributions, they should: (1) increase transparency, especially regarding their impacts; (2) address the need for health systems strengthening; and (3) address disincentives for cooperative vaccine research and development partnerships and encourage expansion of manufacturing capacity in low and middle-income countries.

O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Patentes, acesso e produção local de medicamentos: reflexões a partir de experiências no SUS

Abstract This article aims to contribute to the literature and to the national and global debate on overcoming the polarization related to the legal and administrative aspect of the innovation process, seeking to focus on patents as a conditioning factor of the technological trajectories that enable learning in the productive scope. It was based on a theoretical and political framework related to innovation and access to medicines, especially regarding Intellectual Property rights, and on a critical-reflexive analysis of Intellectual Property instruments used in Productive Development Partnerships (PDP), developed by a public national institute for synthetic drug technology. The results demonstrate the importance of making patent rights compatible with the construction of technological and innovation capacities in the country, which are linked to universal access, especially when they involve products that are intended to treat serious, technologically complex and high-cost diseases. In conclusion, to overcome technological dependence and expand access to medicines in Brazil, the State must seek a balance between public and private interests in the healthcare area, articulate the existing legal instruments and align its health, industry, ST&I and intellectual property policies.

Enabling product development partnerships to bring forward the next generation of health technologies.

Over the past quarter century, product development partnerships (PDPs) have importantly brought health technologies, particularly for neglected diseases, to market for low- and middle-income countries (LMICs). With public sector financing, PDPs de-risk the gulf between where the global burden of disease falls and where paying markets exist. From fighting COVID-19 to developing novel antibiotics, the work of PDPs now extends beyond these traditional bounds. As PDPs have shepherded more health technologies to market, they are also confronting new access challenges. This article lays out 5 areas to strategically leverage the PDP model for better access to new health technologies. Making the case for enhanced support of the PDP approach will require greater transparency, as well as recognition of the contributions made by both public and private sector partners. The governance and funding of PDPs must be accountable to meeting the needs and building capacity of target beneficiaries in LMICs. To take an end-to-end approach, PDPs must work in tandem with other public sector institutions as well as local manufacturers as part of a larger innovation ecosystem. PDPs will need to keep pace with both the dynamics of diseases and markets in delivering the next generation of much needed health technologies.

Global regulatory reforms to promote equitable vaccine access in the next pandemic.

There is broad consensus that the global response to the Covid-19 pandemic was inadequate, leading to unacceptable levels of avoidable morbidity and mortality. Three strategic missteps led to the lack of equitable vaccine access: The heavy reliance on commercial vaccine manufacturers in high-income countries (HICs) versus low- and middle-income countries (LMICs); the emergence of vaccine nationalism restricting and delaying the supply of vaccines to LMICs; and an inadequate support or recognition for LMIC national regulatory authorities. To avoid these inequities in a future pandemic, we focus on three successful vaccine development and technology transfer case studies-the Hepatitis B vaccine produced in South Korea in the 1980s; the Meningitis A vaccine for Africa led by Program for Appropriate Technologies in Health (PATH) and the World Health Organization (WHO) in the 2000s; and a recombinant SARS CoV-2 protein-based vaccine technology from the Texas Children's Hospital transferred to India and to Indonesia. In addition to expanding support for academic or non-profit product development partnerships, our analysis finds that an essential step is the strengthening of selected LMIC regulatory systems to become Stringent Regulatory Authorities (SRAs), together with a re-prioritization of the WHO Prequalification (PQ) system to ensure early vaccine availability in LMICs especially during pandemics. Advancing LMIC National Regulatory Authorities (NRAs) to Stringent Regulatory Authorities (SRAs) status will require substantial resources, but the benefits for future pandemic control and for health in LMIC would be immense. We call on the WHO, United Nation (UN) agencies and SRAs, to collaborate and implement a comprehensive roadmap to support LMIC regulators to achieve stringent status by 2030.

Key Contributions by the Swiss Tropical and Public Health Institute Towards New and Better Drugs for Tropical Diseases.

Thanks to its expertise in clinical research, epidemiology, infectious diseases, microbiology, parasitology, public health, translational research and tropical medicine, coupled with deeply rooted partnerships with institutions in low- and middle-income countries (LMICs), the Swiss Tropical and Public Health Institute (Swiss TPH) has been a key contributor in many drug research and development consortia involving academia, pharma and product development partnerships. Our know-how of the maintenance of parasites and their life-cycles in the laboratory, plus our strong ties to research centres and disease control programme managers in LMICs with access to field sites and laboratories, have enabled systems for drug efficacy testing in vitro and in vivo, clinical research, and modelling to support the experimental approaches. Thus, Swiss TPH has made fundamental contributions towards the development of new drugs - and the better use of old drugs - for neglected tropical diseases and infectious diseases of poverty, such as Buruli ulcer, Chagas disease, food-borne trematodiasis (e.g. clonorchiasis, fascioliasis and opisthorchiasis), human African trypanosomiasis, leishmaniasis, malaria, schistosomiasis, soil-transmitted helminthiasis and tuberculosis. In this article, we show case the success stories of molecules to which Swiss TPH has made a substantial contribution regarding their use as anti-infective compounds with the ultimate aim to improve people's health and well-being.

Estratégias de inovação em medicamentos e vacinas no âmbito do Ceis – modelos, mecanismos e expectativas

ABSTRACT The article aimed to present relevant and original information about the innovation strategies used by Official Pharmaceutical Laboratories (LFO) to reduce the vulnerabilities of the Brazilian Unified Health System (SUS) and the productive and technological capacity of the Health Economic-Industrial Complex. The methods used included a literature review and the analysis of primary data from interviews conducted in two of the largest LFOs in the country. Their efforts and results in Research and Development (R&D) and incorporation of medicines and vaccine technologies were identified and analyzed, with emphasis on Productive Development Partnerships (PDP). Although R&D activities still need to advance, benefits were brought about by technology transfer agreements, especially by PDPs. However, the industrial and technological capacity of the Institutes is still limited and lacks investments, which hinders technological accumulation and diffusion. Thus, improvements are necessary so that the innovation strategies for the SUS present more effective results and can be reversed to the welfare of society.

Public-Private Partnerships and the Landscape of Neglected Tropical Disease Research: The Shifting Logic and Spaces of Knowledge Production.

Until the recent spread of public-private partnerships, pharmaceutical firms had avoided research and development into neglected tropical diseases (NTDs). Because these are diseases that affect the poorest populations in developing regions, research and development initiatives have for the most part depended on the resources and expertise drawn from academia, international organizations, and intermittent state interventions in disease-endemic countries. Over the last few decades, however, public-private product development partnerships (PDPs) have been introducing new collaborative agreements in which the existing resources and expertise combine with the those traditionally withheld by the pharmaceutical industry and global health NGOs. This paper explores recent transformations in the representation of NTDs by examining the shifting logic and spaces of knowledge production which the advent of PDPs has enabled. An analysis of two case studies focused on Chagas disease-related initiatives addresses recurring preoccupations in Science, Technology and Society studies as well as in critical analyses of PDPs: that is, the back-and-forth movement of the disease from being an object of scientific inquiry to a public health concern, and the legitimacy risks and material asymmetries entailed in global health PDPs. Both cases show that it is major global health stakeholders and experts in non-endemic countries, rather than transnational pharmaceutical firms, that exert the greatest influence upon these changing representations: PDPs attempt to expand the preexisting biomedical focus on NTDs by means of incorporating "real world" drug development preoccupations (which I term epistemic shifts), but they also combine their stated global humanitarian aim with security concerns about the diseases spreading to non-endemic, industrialized countries (which I term geographical shifts).

Collaborations between product development partnerships and the World Health Organization.

Collaborations between product development partnerships and the World Health Organization.

The concept of the health economic-industrial complex in practice: a look at productive development partnerships

Resumo Partindo do conceito do Complexo Econômico-Industrial da Saúde, o artigo teve como objetivo central realizar uma análise do modelo de política proposto pelas Parcerias para o Desenvolvimento Produtivo (PDPs) e de seus principais resultados, por meio de um balanço crítico do grau de cumprimento dos principais objetivos explícitos da política. A partir da realização de uma extensa revisão bibliográfica de materiais referentes à temática das PDPs, a contribuição central do artigo consiste na realização de uma síntese organizada dos principais argumentos das potencialidades e dos limites associados ao modelo das PDPs diante dos objetivos a que se que propõem, separados pelas categorias de compras públicas, produção nacional de medicamentos, processos de inovação e impactos sociais, trazendo reflexões acerca de possíveis aprimoramentos para que sejam alcançados de forma ainda mais exitosa.

A Strategic Partnership for Medicine Creation and Access to Medicine for Neglected Tropical Diseases

Neglected tropical diseases (NTDs) are communicable diseases that are uncommon in developed countries but epidemic in developing countries of the tropical and subtropical regions around the world. One of the important contributions expected of pharmaceutical companies is the development and provision of drugs effective against NTDs. Firstly, Eisai has distributed at price zero to endemic countries worldwide diethylcarbamazine (DEC) tablets for patients suffering with lymphatic filariasis (LF). Eisai's efforts toward improving global health have resulted in a rich portfolio of assets addressing six infectious diseases: malaria, tuberculosis, Chagas disease, LF, leishmaniasis, and mycetoma. As the most advanced project, Eisai has developed E1224, which is available in both intravenous and oral formulations, and delivers ravuconazole, the active form of fosravuconazole, with a long plasma half-life. The first clinical trials of E1224 for Chagas disease have already been completed, led by the Drugs for Neglected Diseases initiative (DNDi). As a result, parasite clearance was observed with E1224 during the treatment phase, but parasite regrowth was observed after the end of drug administration. On the other hand, a clinical trial for eumycetoma in collaboration with DNDi is ongoing supported by the Global Health Innovative Technology (GHIT) Fund. In this manner, Eisai will continue its Medicine Creation research projects in collaboration with various Product Development Partnerships (PDPs) and academia.

Partnership Activity for Neglected Tropical Diseases

Delivering new medicines to patients suffering from Neglected Tropical Diseases (NTD) is a major challenge. There are various hurdles to be overcome, such as the large number of patients in a large number of different regions, the lack of marketability, and resistance to medicines. Takeda Pharmaceutical Company Limited (Takeda) is following a corporate mission of "striving towards better health for patients worldwide though leading innovation in medicine". These guiding principles lead to the values of Integrity, Fairness, Honesty and Perseverance that make up what we call "Takeda-ism". As part of its contribution to R&D for NTDs, Takeda collaborates with global Product Development Partnerships (PDPs). In this symposium, the "Drug Discovery Booster" project to accelerate and expand discovery of new drugs for Leishmaniasis and Chagas disease with Drugs for Neglected Diseases initiative (DNDi) and other pharmaceutical companies is introduced. Proprietary compound libraries and the drug discovery expertise of various partners was applied to this new drug discovery approach. An overview of our research projects in malaria, tuberculosis, and NTD is also presented. In addition to these, Takeda's Access to Medicines (ATM) strategy and activities are introduced. Lastly, we discuss a new open innovation model which is accelerated by partnership with a variety of organizations and how Takeda achieves its sustainable development goal (SDG) targets.

Alternative funding models for medical innovation: the role of product development partnerships in product innovation for infectious diseases

ABSTRACT Over the past years, there has been an increasing trend in the number of product development partnerships (PDPs), primarily seeking to discover and produce new products in response to the global health threat posed by infectious diseases. This research exploits public and subscription-based databases to examine PDPs’ attributes and their impact on medical innovation in infectious diseases. We find that i) non-private funding is beneficial in the early stages of drug development by PDPs, ii) specific funder and product types are essential for the success of products developed by PDPs, iii) public sector funding is more common in products with lower chances of being approved, and iv) the lower the scientific advances in a sub-disease area are, the lower the likelihood of a product in that area of succeeding.

POSA213 Product Development Partnerships (PDPS) and Pharmaceutical Innovation

Product Development Partnerships (PDPs) are a rational economic response to the lack of incentives for private pharmaceutical R&D in areas of low expected returns but high unmet need (e.g., neglected tropical and infectious diseases, rare diseases). In this research, i) we examine how different types of PDP are associated with the likelihood of product approval, i.e., successful pharmaceutical innovation, and ii) whether some types of PDPs stimulate drug development effectively in the early stages.

The Extent of New Product Development Partnership between Universities and the Manufacturing Firms in Ghana

The importance of new product development in building both technological and technical capacity of university and firm cannot be overemphasized. Collaborations between HE and industry in NPD is conceived as mutual interaction for skills acquisition and economic improvement. The study was designed to determine the extent of new product development partnership between HEIs and the manufacturing firms. A survey was conducted, and a sample of 400 was drawn from both HE and industry; the data were then analyzed using structural equation modeling (SEM) software of EQS version 6.2.The results revealed that there is weak interaction between HE and industry, also there is no formal partnership between the two on new product development. in order to strengthen the mutual relationship, a conceptual model had been developed after a careful examination and assessment of the key factors of NPD and after preliminary CFA analysis conducted to establish the determinants of the main construct. A nine-factor model was then developed for university and industry. The study therefore recommends that higher education and industry adopt this new model for effective partnership on NPD.

Preventing the Next Pandemic and Tackling Antiscience: An Interview with Peter Hotez

This interview was conducted by Atiya Henry, Commissioning Editor of Future Microbiology. Peter JHotez, MD, PhD is Dean of the National School of Tropical Medicine and Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine. He is an internationally recognized physician-scientist in neglected tropical diseases and vaccine development. As head of the Texas Children's Center for Vaccine Development, he leads a team and product development partnership for developing new vaccines for hookworm infection, schistosomiasis, leishmaniasis, Chagas diseaseand SARS/MERS/SARS-2 coronavirus. DrHotez has authored more than 500 original papers and is the author of four single-author books. Most recently as both a vaccine scientist and autism parent, he has led national efforts to defend vaccines and to serve as an ardent champion of vaccines going up against a growing national 'antivax' threat.

Assessment of the economic savings and advantages of Productive Development Partnerships

The policy for Productive Development Partnerships emerged in Brazil as a Federal Government strategy to strengthen the Health Economic-Industrial Complex. Although the first partnership dates back to 2009, the regulatory framework was only consolidated in 2014, when eight policy objectives were described. Of these, this article is intended to specifically evaluate the fourth objective: "to protect the interests of the Public Administration and society by seeking economic savings and advantage, considering prices, quality, technology, and social benefits". An assessment of the policy results was performed through a mixed methodological approach, by proposing four assessment indicators. The quantative analysis results confirmed a reduction in the purchase price for 37 of the 39 drugs assessed after the policy implementation, while there was an increase in the amounts purchased in 38 of the 39 drugs. On the other hand, the qualitative analysis revealed a lack of planning by public administrators and lack of compliance with the policy guidelines related to the principle of advantageousness. Approximately 40% of the drugs studied did not undergo a health technology assessment by the Brazilian National Commission for the Incorporation of Technologies in the Unified Health System, raising doubts with regards to the advantage for the Public Administration, which is measured by the cost-effectiveness of the drugs incorporated by the policy.