Product Development Partnerships Research Articles

A New Product Development Partnership Model for Antibiotic Resistance.

Antibiotics have prevented countless deaths from common infections and have made possible many modern medical procedures. Over the past few decades, antibiotic-resistant bacteria have become a global threat, spreading between healthcare facilities and throughout communities worldwide at an alarming pace. Antibiotic overuse and misuse in humans, animals, and the environment accelerate resistance by selecting for bacteria with antibiotic-resistant traits, which then become predominant and infect others. Meanwhile, few antibiotics remain active against the most resistant bacteria. There is an urgent need for new antibiotics and other antibacterial products to replace second-line and last resort therapies when they no longer work. This Article proposes a new U.S.-based, non-governmental, not-for-profit product development partnership (PDP) model specifically designed for antibacterial development. This new model should both supplement and complement existing government-led efforts and should be built with mechanisms in place to balance the values of innovation, access, and conservation.

Exploring the Obstacles to Implementing Economic Mechanisms to Stimulate Antibiotic Research and Development: A Multi-Actor and System-Level Analysis.

This Article examines the potential stakeholder-related obstacles hindering the implementation of mechanisms to re-ignite the development of novel antibiotics. Proposed economic models and incentives to drive such development include: Public Funding of Research and Development ("R&D"), Tax Incentives, Milestone Prizes, End Payments, Intellectual Property ("IP") and Exclusivity Extensions, Pricing and Reimbursement Incentives, Product Development Partnerships ("PDPs"), and the Options Market for Antibiotics model. Drawing on personal experience and understanding of the antibiotic field, as well as stakeholder consultation and numerous expert meetings within the DRIVE-AB project and Uppsala Health Summit 2015, the Authors identify obstacles attributable to the following actors: Universities and Research Institutes, Small and Medium-sized Enterprises ("SMEs"), Large Pharmaceutical Companies, Marketing Approval Regulators, Payors, Healthcare Providers, National Healthcare Authorities, Patients, and Supranational Institutions. The analysis also proposes a characterization and ranking of the difficulty associated with implementing the reviewed mechanisms. Public Funding of R&D, Pricing and Reimbursement Incentives, and PDPs are mechanisms expected to meet highly systemic barriers (i.e., obstacles across the entire antibiotic value chain), imposing greater implementation challenges in that they require convincing and involving several motivationally diverse actors in order to have much effect.

Progress Report on Neglected Tropical Disease Drug Donation Programs

PurposeNeglected tropical diseases (NTDs) impose a significant burden on public health, particularly in developing nations. Many can be treated cost-effectively with drugs donated or offered at or below marginal cost. In 2012, the World Health Organization published an NTD roadmap that outlined a strategy for the prevention, control, and eradication of 17 NTDs by 2020. Inspired by this roadmap, executives from 13 pharmaceutical companies, government agencies, and other interested parties signed the London Declaration on Neglected Tropical Diseases in January 2012. In this paper, we will assess progress in meeting commitments on drug donations laid out in the London Declaration. MethodsWe conducted Medline and LexisNexis searches of peer-reviewed publications and trade journals, as well as product development partnership and government reports. Subsequently, we designed a survey instrument and surveyed 10 company signatories (companies with drug donation programs) to the London Declaration to determine current donations and pledges. FindingsNine of 10 companies with donation programs responded to the survey. The respondents reported substantial progress in meeting the goals laid out in the London Declaration. Survey respondents maintained 17 drug donation programs across 10 disease categories. In 2014, companies donated >1 billion treatments, with a dollar value of nearly $1.5 billion. However, not all donated products were distributed to patients in need. In addition, 4 of the 17 programs were slated to end before 2020, three of the 17 programs did not report explicit program objectives, and 7 of 17 did not measure the impact of programs in terms of numbers of patients treated. None of our survey respondents reported on whether the programs were leading to a reduction in disease prevalence. ImplicationsDonations are a necessary but insufficient condition for patient access to neglected disease drugs. Additional resources must be allocated to ensure delivery of donated products to patients. In addition, drug donation programs should provide explicit descriptions of program objectives, measurements of the impacts of their programs, and extension of all donation commitments through 2020. To achieve this, multiple stakeholders with a vested interest in reducing the burden of neglected diseases must collaborate in a multipronged approach toward NTD elimination.

Advancing a vaccine to prevent hookworm disease and anemia

A human hookworm vaccine is under development and in clinical trials in Africa and the Americas. The vaccine contains the Na-APR-1 and Na-GST-1 antigens. It elicits neutralizing antibodies that interfere with establishment of the adult hookworm in the gut and the ability of the parasite to feed on blood. The vaccine target product profile is focused on the immunization of children to prevent hookworm infection and anemia caused by Necator americanus. It is intended for use in low- and middle-income countries where hookworm is highly endemic and responsible for at least three million disability-adjusted life years. So far, the human hookworm vaccine is being developed in the non-profit sector through the Sabin Vaccine Institute Product Development Partnership (PDP), in collaboration with the HOOKVAC consortium of European and African partners. We envision the vaccine to be incorporated into health systems as part of an elimination strategy for hookworm infection and other neglected tropical diseases, and as a means to reduce global poverty and address the Sustainable Development Goals.

Advancing a vaccine to prevent human schistosomiasis

Several candidate human schistosomiasis vaccines are in different stages of preclinical and clinical development. The major targets are Schistosoma haematobium (urogenitial schistosomiasis) and Schistosoma mansoni (intestinal schistosomiasis) that account for 99% of the world's 252 million cases, with 90% of these cases in Africa. Two recombinant S. mansoni vaccines – Sm-TSP-2 and Sm-14 are in Phase 1 trials, while Smp80 (calpain) is undergoing testing in non-human primates. Sh28GST, also known as Bilhvax is in advanced clinical development for S. haematobium infection. The possibility remains that some of these vaccines may cross-react to target both schistosome species. These vaccines were selected on the basis of their protective immunity in preclinical challenge models, through human immune-epidemiological studies or both. They are being advanced through a combination of academic research institutions, non-profit vaccine product development partnerships, biotechnology companies, and developing country vaccine manufacturers. In addition, new schistosome candidate vaccines are being identified through bioinformatics, OMICs approaches, and moderate throughput screening, although the full potential of reverse vaccinology for schistosomiasis has not yet been realized. The target product profiles of these vaccines vary but many focus on vaccinating children, in some cases following mass treatment with praziquantel, also known as vaccine-linked chemotherapy. Several regulatory pathways have been proposed, some of which rely on World Health Organization prequalification.

International Partnership for Therapeutic Drug Development of NTDs by DNDi

The Drugs for Neglected Diseases initiative (DNDi), with headquarters in Geneva, is a non-profit drug research and development (R&D) organization and Product Development Partnership (PDP) which was established in 2003 by 7 founding organizations such as Médecins Sans Frontières (MSF), the Pasteur Institute, The Specific Programme for Research and Training in Tropical Diseases (WHO-TDR), etc. DNDi has worked mainly on the development of new treatments for neglected tropical diseases (NTDs), which is difficult to achieve under market economy conditions. DNDi has promoted overall drug discovery research including the screening of drug candidates, hit to lead, lead optimization, pre-clinical and clinical studies in the area of infectious diseases with a focus on malaria, sleeping sickness (human African trypanosomiasis; HAT), Chagas disease, leishmaniasis, filarial diseases and pediatric formulations for HIV treatment. DNDi's achievements include the development of novel therapies based on patient needs through innovative partnerships with over 130 organizations in industry, government, academia, and public institutions around the world. To date, DNDi has registered 6 novel treatments adapted to the needs of patients in poor countries, and has another 12 novel entities in development. DNDi Japan is a Japanese non-profit organization (NPO) based on the global principles of DNDi and, as the only PDP in Japan, is supporting NTD drug discovery projects in collaboration with Japanese pharmaceutical companies, academic institutions and government agencies by utilizing Japan's excellent R&D capabilities to develop new treatments for NTDs in order to contribute to global health.

Development and Distribution of Drugs for NTDs: Efforts of One Pharmaceutical Company

The Pharmaceutical Industry is expected to play a proactive global role in combatting neglected tropical diseases (NTDs) and other tropical diseases affecting low-income countries. Such a role would include novel medicine R&D, manufacturing and distribution. In order to succeed in this role, several challenges need to be overcome: a) the economic challenge or cost benefit balance for the development of these medicines, and b) sparse in-house experience with these diseases within the Industry. During the last decade, the Product Development Partnership (PDP) model has become an effective strategy to address such challenges. Organizations such as the Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), TB alliance, PATH (formerly the Program for Appropriate Technology in Health), and others have linked pharmaceutical companies, funding organizations, academic researchers and others, and have thus been able to successfully populate treatment pipelines directed at NTDs, Malaria, tuberculosis (TB), and human immunodeficiency virus (HIV)/AIDS. In this paper, our experience working with one of these organizations, DNDi, is described. We have been collaborating with DNDi in evaluating the actions of Eisai's antifungal compound, E1224, in a clinical study for treating Chagas Disease. In addition, other Eisai initiatives directed at NTDs and improving patients' access to medicines are introduced.

Translational Activities to Enable NTD Vaccines.

There is an urgent need to develop new vaccines for tuberculosis, HIV/AIDS, and malaria, as well as for chronic and debilitating infections known as neglected tropical diseases (NTDs). The term "NTD" emerged at the beginning of the new millennium to describe a set of diseases that are characterized as (1) poverty related, (2) endemic to the tropics and subtropics, (3) lacking public health attention and inadequate industrial investment, (4) having poor research funding and a weak research and development (R&D) pipeline, (5) usually associated with high morbidity but low mortality, and (6) often having no safe and long-lasting treatment available. Many additional challenges to the current control and elimination programs for NTDs exist. These include inconsistent performance of diagnostic tests, regional differences in access to treatment and in treatment outcome, lack of integrated surveillance and vector/intermediate host control, and impact of ecological climatic changes particularly in regions where new cases are increasing in previously nonendemic areas. Moreover, the development of NTD vaccines, including those for schistosomiasis, leishmaniasis, leprosy, hookworm, and Chagas disease are being led by nonprofit product development partnerships (PDPs) working in partnership with academic and industrial partners, contract research organizations, and in some instances vaccine manufacturers in developing countries. In this review, we emphasize global efforts to fuel the development of NTD vaccines, the translational activities needed to effectively move promising vaccine candidates to Phase-I clinical trials and some of the hurdles to ensuring their availability to people in the poorest countries of Africa, Asia, Latin America, and the Caribbean.

Fostering incentives for research, development, and delivery of interventions for neglected tropical diseases: lessons from malaria

Making existing medical technologies accessible and incentivizing the development of new medicines for neglected diseases are major global health policy challenges. Where market incentives are not enough, additional policies and incentives are required to engage the private and public sectors. There have been major advances in tackling global health issues in the last decade with increasing funding for R&D for neglected diseases from high-income countries and from private foundations. Malaria is an illustrative example of both great progress and of continuing challenge. This paper reviews relevant incentives for progress towards malaria control, elimination, and eradication. We describe in depth the most relevant incentives―product development partnerships (PDPs), open source databases (OSDs), priority review vouchers (PRVs), and advance market commitments (AMCs). Finally we evaluate their achievements―existing anti-malarial tools and interventions―and discuss the R&D incentives required to generate further interventions to meet the malaria eradication goal and tackle neglected diseases.

Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis

ProblemNew drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities.ApproachWe carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues.Local settingTrials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials.Relevant changesExtensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services.Lessons learntClinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.

Challenges and Opportunities While Developing a Group A Meningococcal Conjugate Vaccine Within a Product Development Partnership: A Manufacturer's Perspective From the Serum Institute of India.

Background. In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate vaccines for sub-Saharan Africa.Method. From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration.Results. SIIL successfully scaled up production of a group A meningococcal conjugate vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was submitted to the Indian authorities in April 2009 and WHO in September 2009. Export license was granted in December 2009, and WHO prequalification was obtained in June 2010. Vaccine was introduced at public scale in Burkina Faso that December. The group A meningococcal conjugate vaccine was named MenAfriVac, and is the first internationally qualified vaccine developed outside of big pharma.Conclusions. The project proved to be a sound investment for SIIL and is a concrete example of the potential for PDPs to provide needed products for resource-poor countries.

New Vaccines for the World's Poorest People

The 2000 Millennium Development Goals helped stimulate the development of life-saving childhood vaccines for pneumococcal and rotavirus infections while greatly expanding coverage of existing vaccines. However, there remains an urgent need to develop new vaccines for HIV/AIDS, malaria, and tuberculosis, as well as for respiratory syncytial virus and those chronic and debilitating (mostly parasitic) infections known as neglected tropical diseases (NTDs). The NTDs represent the most common diseases of people living in extreme poverty and are the subject of this review. The development of NTD vaccines, including those for hookworm infection, schistosomiasis, leishmaniasis, and Chagas disease, is being led by nonprofit product development partnerships (PDPs) working in consortia of academic and industrial partners, including vaccine manufacturers in developing countries. NTD vaccines face unique challenges with respect to their product development and manufacture, as well as their preclinical and clinical testing. We emphasize global efforts to accelerate the development of NTD vaccines and some of the hurdles to ensuring their availability to the world's poorest people.

Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp).

Expression, purification, and characterization of the Necator americanus aspartic protease-1 (Na-APR-1 (M74)) antigen, a component of the bivalent human hookworm vaccine

Over 400 million people living in the world's poorest developing nations are infected with hookworms, mostly of the genus Necator americanus. A bivalent human hookworm vaccine composed of the Necator americanus Glutathione S-Transferase-1 (Na-GST-1) and the Necator americanus Aspartic Protease-1 (Na-APR-1 (M74)) is currently under development by the Sabin Vaccine Institute Product Development Partnership (Sabin PDP). Both monovalent vaccines are currently in Phase 1 trials. Both Na-GST-1 and Na-APR-1 antigens are expressed as recombinant proteins. While Na-GST-1 was found to express with high yields in Pichia pastoris, the level of expression of Na-APR-1 in this host was too low to be suitable for a manufacturing process. When the tobacco plant Nicotiana benthamiana was evaluated as an expression system, acceptable levels of solubility, yield, and stability were attained. Observed expression levels of Na-APR-1 (M74) using this system are ∼300 mg/kg. Here we describe the achievements and obstacles encountered during process development as well as characterization and stability of the purified Na-APR-1 (M74) protein and formulated vaccine. The expression, purification and analysis of purified Na-APR-1 (M74) protein obtained from representative 5 kg reproducibility runs performed to qualify the Na-APR-1 (M74) production process is also presented. This process has been successfully transferred to a pilot plant and a 50 kg scale manufacturing campaign under current Good Manufacturing Practice (cGMP) has been performed. The 50 kg run has provided a sufficient amount of protein to support the ongoing hookworm vaccine development program of the Sabin PDP.

The human hookworm vaccine: recent updates and prospects for success.

Approximately 440 million people globally are afflicted by hookworm disease, one of the 17 WHO-recognized neglected tropical diseases (NTDs). The iron-deficiency anaemia attributed to this disease contributes to at least 3.2 million disability-adjusted life years (DALYs) according to the Global Burden of Disease Study 2010. The current WHO-recommended control strategies rely primarily on mass drug administration or preventive chemotherapy. However, evidence is starting to accumulate confirming that preventive chemotherapy alone will not be sufficient to reduce the reinfection rates of hookworm, especially in areas of heavy transmission. The global health and research community is currently building a consensus stressing the need for the advancement of research and innovation to bridge the gaps and identify new public health interventions for diseases such as hookworm and other NTDs. This paper presents the strategies used by the Sabin Vaccine Institute Product Development Partnership (Sabin PDP) in their ongoing endeavour for the development of a human hookworm vaccine. Recent updates and the current prospects for success of an effective human hookworm vaccine, as a new technology to be linked to or combined with drug interventions, are presented.

Improving Access to Medicines in Low‐Income Countries: A Review of Mechanisms

Individuals in low‐income countries (“LICs”) often lack access to appropriate medicines. The multi‐disciplinary nature of this problem requires a holistic approach. Whereas, other writings on the topic tend to focus on one or a small number of issues, often from the perspective of a single discipline, this paper seeks to consider the major issues from a multi‐disciplinary perspective. It first considers mechanisms for improving the availability of medicines in LICs, through grants, prizes, treaties, advance market commitments, priority review and product development partnerships to incentivize and fund R&D for neglected diseases. The paper then assesses mechanisms for improving affordability of medicines in LICs, such as differential pricing mechanisms, monopsonies, patent law flexibilities and human rights obligations. Next, the paper reviews mechanisms for improving the efficacy of medicines in LICs, including authentication, criminalization, international and national enforcement and communication and education. Finally, the paper examines mechanisms for improving the obtainability of medicines in LICs, through low‐cost intervention, task‐shifting, efficient regulation, grass‐roots service provision and education. The paper concludes by identifying areas warranting further research.

An open source business model for malaria.

Greater investment is required in developing new drugs and vaccines against malaria in order to eradicate malaria. These precious funds must be carefully managed to achieve the greatest impact. We evaluate existing efforts to discover and develop new drugs and vaccines for malaria to determine how best malaria R&D can benefit from an enhanced open source approach and how such a business model may operate. We assess research articles, patents, clinical trials and conducted a smaller survey among malaria researchers. Our results demonstrate that the public and philanthropic sectors are financing and performing the majority of malaria drug/vaccine discovery and development, but are then restricting access through patents, ‘closed’ publications and hidden away physical specimens. This makes little sense since it is also the public and philanthropic sector that purchases the drugs and vaccines. We recommend that a more “open source” approach is taken by making the entire value chain more efficient through greater transparency which may lead to more extensive collaborations. This can, for example, be achieved by empowering an existing organization like the Medicines for Malaria Venture (MMV) to act as a clearing house for malaria-related data. The malaria researchers that we surveyed indicated that they would utilize such registry data to increase collaboration. Finally, we question the utility of publicly or philanthropically funded patents for malaria medicines, where little to no profits are available. Malaria R&D benefits from a publicly and philanthropically funded architecture, which starts with academic research institutions, product development partnerships, commercialization assistance through UNITAID and finally procurement through mechanisms like The Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S.’ President’s Malaria Initiative. We believe that a fresh look should be taken at the cost/benefit of patents particularly related to new malaria medicines and consider alternative incentives, like WHO prequalification.

Evaluation of product development partners using an integrated AHP-VIKOR model

Purpose– Today, customers are generally perceived to be demanding higher quality and better performing products, in shorter and more predictable development cycle-times and at a lower cost. These market pressures drive firms to collaborate with possible partners in product development (PD) processes. However, the selection of a suitable partner for an effective PD is not an easy decision and is associated with complexity. The purpose of this paper is to propose an integrated multi-criteria decision-making (MCDM) approach to effectively evaluate PD partners.Design/methodology/approach– The proposed evaluation procedure consists of several steps. First, based on a literature review and expert validation, the strategic main and sub-criteria of the PD partner selection process that companies consider the most important are identified. After constructing the evaluation criteria hierarchy, the criteria weights are calculated by applying the Analytic Hierarchy Process (AHP) method. The VIKOR (a compromise ranking) method is used to obtain the final partner ranking results. A case study is given to demonstrate the potential of the methodology. In the last part of the study, a sensitivity analysis is performed to determine the influence of criteria weights on the decision making process.Findings– The PD partner evaluation model contains three main criteria, namely, partner, collaboration and PD-oriented criteria, with 13 sub-criteria. The market position, competency of the partner, compatibility, technical expertise and complementarity are found as the most considerable evaluation criteria for the ABC case company. Results of the sensitivity analysis from different cases demonstrate that the integrated AHP-VIKOR model is quite sensitive to the weights assigned to the evaluation criteria. This finding underlines the importance of forming a capable, qualified group of experts for the decision-making procedure. The results of the empirical study show that the proposed evaluation framework is practical for solving partner selection problems.Originality/value– Partner selection is critical to the success of a collaborative PD process. The main contribution of this paper is the definition and development of an effective evaluation framework to guide managers for suitable PD partner selection. In our knowledge, there exists no study in the literature that combines the established AHP VIKOR model for PD partner selection problem. This study can be useful to researchers to better understand PD partner selection problem theoretically, as well as to organizations in designing better satisfying PD partner evaluation systems.

From vaccines and in vitro diagnosis reagents to similar biotherapeutics production in Brazil: A case study

This article describes the technological trajectory of the Institute of Technology in Immunobiologicals (Bio-Manguinhos) of a public institution (Fiocruz) linked to the Brazilian Ministry of Health, showing how it affected the learning process and the technological capabilities accumulation. It also tackled the government policies to stimulate the local production of similar biotherapeutics through the productive development partnerships, and the regulatory framework involved in this process. Bio-Manguinhos was created in the second half of 1976 aiming to supply the Brazilian National Program of Immunizatio (NPI) created in 1973, by organizing an incipient vaccine production done in several different research laboratories of Fiocruz. Since then, through different types of technology agreements and maintaining the investments on intrinsic technological development, the Institute had an extraordinary growth. Today it is responsible for more than 60% of the vaccines distributed to the Brazilian population, supplies diagnostic kits for several public programs and became an innovative organization launching high-tech kits intrinsically developed. In 2006, Bio-Manguinhos entered the biopharmaceutical field and is becoming the vanguard production in the country for different types of treatment covered by the government. This paper also shows the public health policies that focus to induce the local biological production by stimulating partnerships between public and private companies, the impact of the local production and the changes in the regulatory environment to follow the new scenario. Through different types of technology agreements, Bio-Manguinhos today produces more than 100 million doses of vaccines, including technologically complex ones as streptococcus pneumonia 10 valent. The technological trajectory of the in vitro diagnosis tests was similar to the vaccines, whereas the institute began supplying to the ministry of health programs tests produced in old technological platforms and then became an innovative organization launching high-tech products. Through this case it is possible to realize the learning process as well as the technological capabilities accumulation of Bio-Manguinhos.

Can medical products be developed on a non-profit basis? Exploring product development partnerships for neglected diseases

Reliance on market forces can lead to underinvestment in social welfare enhancing innovation. The lack of new medical products in the area of neglected diseases is a case in point. R&D for neglected diseases has increased with new funding and collaborations taking place mainly through product development partnerships (PDPs). PDPs are self-governing, private non-profit R&D organizations. In contrast to push and pull instruments designed to address private-sector R&D underinvestment, PDPs have emerged voluntarily to address this public health challenge. In this study we examine how non-profit R&D collaboration for neglected diseases takes place through PDPs. We find that PDPs act as ‘system integrators’ that leverage the resources and capabilities of a network of public, philanthropic and private-sector partners. This paper contributes to an understanding of R&D in a non-profit context and highlights the importance of collaboration and non-market institutions for promoting innovation where market failures occur.