R&D dictionary

the World Health Organization defines access as coordinated set of activities needed to ensure that the products developed will ultimately have an equitable public health impact. Achieving that impact requires products that are available, affordable, acceptable to end users, and adopted into LMIC [low- and middle-income country] health systems.

a mechanism for incentivizing private-sector investment in R&D by providing an upfront financial commitment, through a legally binding contract, to guarantee the future purchase, at an agreed-upon price, of a vaccine or health product not yet developed and available.

research to advance knowledge without a specifically envisioned or immediate practical application. Also referred to as pure research or fundamental research.

the stage of biomedical product development that involves safety and efficacy testing in humans. Also known as clinical trials.

a research study of human subjects designed to determine whether a biomedical product or behavioral intervention is safe and effective.

a network of experts, hospitals, and research centers that work together to carry out clinical trials and share knowledge and best practices. CTNs can be organized based on geography or specific health areas, and can be useful in attracting more trial enrollees, enrolling patients from diverse settings, and building expertise around conducting clinical trials for underaddressed health areas, including rare, orphan, and neglected diseases and in pediatric populations.

the process of introducing a new product or method into the market.

diseases that are transmissible from person to person, either directly or via an external vector. Also referred to as contagious diseases.

a term used in drug development to refer to molecules that affect the human body in a manner that could provide health benefits. Chemical compounds form the basis of drugs.

a database of information on pharmaceutical compounds or a collection of the physical compounds themselves that organizations can utilize to identify new clinical applications for existing compounds. A compound library can be privately owned by a single organization, shared in a consortium, or completely open source.

a license granted by a government to a third party giving it permission to produce a patented product or use a patented manufacturing/production process without the consent of the patent holder. Compulsory licensing is an exception to the general rules governing patent protection. In the context of global health, it is an approach that can be used by governments to allow generic production of patented pharmaceutical products to meet a pressing public health need.

the legal protection of an originator pharmaceutical company's data that prevents other parties from using the data for a commercial purpose for a set period. In practice, it prevents a generic manufacturer from using the originator's data to obtain regulatory approval and market authorization of a generic product during the period of data exclusivity. The length of exclusivity differs across jurisdictions.

an approach or model that seeks to separate the costs and risks of R&D from the commercial sale price of a health product.

a type of incentive mechanism for health R&D that offers a monetary prize to the first innovator to develop a product that meets specific guidelines.

a practice used by pharmaceutical companies to extend their patent coverage by making reformulations or variations of an existing drug without necessarily changing therapeutic effectiveness of the product.

a drug that is comparable, or bioequivalent, to a brand-name drug in dosage form, strength, safety, quality, performance characteristics, and intended use. Generics can be marketed after the expiration of the innovator's patent or other exclusive rights.

the broad scope of activities focused on reducing the vulnerability of people around the world to acute or rapidly spreading risks to health, particularly those that threaten to cross international borders. Often used to refer both to interventions against naturally occurring disease outbreaks and preventing or mitigating acts of bioterrorism.

a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The precise nature of these standards is set by stringent regulatory authorities.

the combination of people, institutions, resources, financing, and management that culminate in the delivery of health interventions or services to a target population.

a mechanism intended to encourage greater private-sector investment and engagement in R&D for diseases and health areas for which a limited commercial market exists. Examples of incentive mechanisms include prizes, priority review vouchers, advance market commitments, and tax credits.

diseases caused by pathogens, including bacteria, fungi, viruses, or parasites. Infectious diseases that can spread from person to person are known as contagious or communicable diseases.

a mechanism or approach intended to supplement traditional sources of financing for global health R&D. Examples of innovative financing mechanisms include pooled funds and product development partnerships.

the exclusive rights, often temporary, granted by the state for the use of intellectual creations. In the global health field, IP is a charged issue because it can be seen as providing protections that incentivize R&D for new health technologies, while also imposing barriers to product access.

the legal permission granted by a national regulatory authority to allow the marketing or distribution of a health product after evaluation for safety, efficacy, and quality. Colloquially referred to as regulatory approval. Once a product is authorized, it is included among a registry of authorized products and is said to be registeredвor have registration. In some cases, market authorization can also be referred to as licensing.

the term referring to a range of interventions to shape the supply and demand of products and health services in a given market. Market shaping interventions typically involve three approaches: (1) reducing transaction costs by lowering structural hurdles to market interaction; (2) increasing market information by generating new data or increasing the availability of data to reduce information asymmetry between parties; and (3) balancing supplier and buyer risks by transferring risk to donors or purchasers to encourage more active engagement by suppliers in the market. The end goal of market shaping is to expand access to health technologies and interventions. Also referred to as market dynamics or market facilitation.

a drug, biological product, or device that treats, identifies, or prevents harm from a biological, chemical, radiological, or nuclear agent that may cause a public health emergency.

an incentive mechanism whereby product developers receive predetermined monetary rewards as they complete milestones in the R&D process for a target product. Also known as milestone incentive or milestone payment.

category of health technologies that combine protection against multiple risks, such as unintended pregnancy, HIV/AIDS, and sexually transmitted infections.

an initiative between two or more sectors, including the public (government), private (industry), and social (nonprofit, philanthropic, and academic) sectors to advance the development and delivery of goods and services to the public. Each partner brings resources and expertise to the table, while sharing risk. A term often used interchangeably with public-private partnership.

the regulatory entity responsible for ensuring that products (normally pharmaceuticals and biological products) are evaluated for safety, efficacy, and quality before they enter the local market.

a medically diverse group of diseases that meet the following three criteria: (1) they disproportionately affect people in developing countries; (2) there is a need for new products to address them (either there is no existing product or improved or additional products are needed); and (3) there is market failure (there is an insufficient commercial market to attract R&D by the private sector). The G-FINDER survey is the most commonly referenced list of neglected diseases, currently including 35 diseases in its scope.

a medically diverse group of tropical diseases, common in low- and middle-income countries, for which limited or no commercial market exists to spur R&D for health technologies. Different organizations define this set of diseases differently, but one of the most commonly referenced is the World Health Organizationв's list of NTDs, which includes Buruli ulcer, Chagas disease, dengue and chikungunya fever, dracunculiasis, echinococcosis, endemic treponematoses, foodborne trematodiases, human African trypanosomiasis (sleeping sickness), leishmaniasis, leprosy, lymphatic filariasis (elephantiasis), onchocerciasis (river blindness), rabies, schistosomiasis, soil-transmitted helminthiasis, taeniasis/cysticercosis, and trachoma.

medical conditions or diseases that are non-infectious and non-transmissible from person to person.

a nonprofit organization that brings together stakeholders from the private, public, and philanthropic sectors to research, develop, and support access to new health technologies that target the health needs of low- and middle-income countries. A term used interchangeably with product development partnerships.

an agreement between patent holders to share proprietary molecules, drugs, manufacturing processes, etc., to stimulate collective R&D. Patents may be shared royalty free or in exchange for payment. An example of a patent pool in practice is the Medicines Patent Pool, established by UNITAID to encourage development and access to antiretroviral medicines for HIV/AIDS in low- and middle-income countries. Companies and government agencies contribute intellectual property to the pool, which other manufacturers can use to produce more affordable generic versions of medicines in return for paying a royalty patent to the patent holder.

a term used in R&D to refer to the collection of health technologies or products under development by either a single organization or multiple organizations.

a financing mechanism whereby private, philanthropic, and/or public donors collectively put money together to jointly finance R&D projects. This approach is intended to leverage contributions from multiple donors to fund R&D projects for diseases and conditions with limited commercial market, while de-risking investment by any one donor.

an approach to investing in R&D that involves creating a balanced mix of projects pursued based on consideration of risk, yield of return, and the short-term or long-term nature of a project.

the collection of processes and activities a regulatory authority or manufacturer uses to monitor the safety and effectiveness of medical products once they are on the market. Also known as postapproval surveillance.

the stage of biomedical product development that takes place before any testing in humans begins, during which feasibility, dosing, or safety information is collected. Also referred to as preclinical studies.

a World Health Organization (WHO) mechanism to facilitate access to health products that meet globally agreed upon safety, efficacy, and quality standards. After first receiving market authorization for a product from a national regulatory authority—typically a stringent regulatory authority—a manufacturer can apply for WHO prequalification. WHO reviews the product for safety, efficacy, and quality and if it meets standards, the product is prequalified, allowing it to be purchased by global procurers like the United Nations and Gavi, the Vaccine Alliance. Not all products are eligible for WHO prequalification or are required to go through prequalification to be eligible for procurement.

a mechanism intended to incentivize R&D for neglected or rare diseases by rewarding developers of a health product for these diseases with a voucher for accelerated regulatory review, which they can apply to another health product or sell to another entity. In the United States, there is a priority voucher program through the US Food and Drug Administration for neglected tropical diseases, rare pediatric diseases, and medical countermeasures.

a term used in the global health field to refer to any entity purchasing biomedical products or other health goods for distribution to a given population. Procurement entities can be national agencies or global bodies like Gavi, the Vaccine Alliance and the Global Fund. The goals of procurement entities are to ensure adequate supply, negotiate prices, and expand access to health technologies.

a nonprofit organization that brings together stakeholders from the private, public, and philanthropic sectors to research, develop, and support access to new health technologies that target the health needs of low- and middle-income countries. A term used interchangeably with nonprofit product developers.

a contractual arrangement or initiative between a public agency (federal, state, or local) and a private sector entity to advance the development and delivery of goods and services to the public. Each partner brings resources and expertise to the table, while sharing risk. A term often used interchangeably with multisector partnership.

an incentive mechanism to entice product developers or other innovators by offering rewards or reducing risks for the development and delivery of successful products. Pull mechanisms are designed to reward the outputs of research. Examples of pull mechanisms include advance market commitments, priority review vouchers, and prizes.

an incentive mechanism that uses funding to accelerate R&D and lower costs before a product's success can be determined. The goal of the mechanism is to move risks primarily to the funder and away from the product developer. Examples of push mechanisms include direct grants to fund R&D, systems that share R&D costs and material across stakeholders, and mechanisms to raise new funds including sin and luxury taxes.

a term used in drug development to refer to a specific combination of drugs and technologies used together to address a health need.

a process to define technical requirements that are uniform across participating national regulatory authorities in different nations. The goal is to improve efficiency of product development and registration while reducing the burden of registering a product in multiple countries.

the reduction in the effectiveness of a pharmaceutical agent, such as an antibiotic, antimicrobial, or antifungal, in treating or curing a disease or condition due to changes in the cause of the disease that allow it to continue to grow in the presence of the pharmaceutical agent that would normally have killed it or limited its growth.

the process of expanding the coverage or availability of health technologies and interventions in targeted areas. Also referred to as scaling, scaling up, or bringing to scale.

a national regulatory authority (NRA) that applies globally agreed upon standards for quality, safety, and efficacy. To qualify as an SRA, an NRA must be a member, observer, or associate of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

the sequence of organizations, people, activities, and resources involved in physically moving a health technology from supplier through eventual delivery to the end user.

a tool used by a product developer to define the desired characteristics or features of a health product it is pursuing development of and the studies or activities that must be completed to demonstrate the performance, efficacy, and safety of the product. TPPs function as a clear statement of the desired outcome of the product development effort. Frequently TPPs used by product development partnerships also include specific access criteria to ensure that the product reaches those who need it most.

the process of transferring scientific findings or knowledge from one organization to another, typically for the purpose of furthering product development and bringing a product to market. This is usually carried out through intellectual property licensing agreements between organizations.

the stage of the research process in which basic research discoveries are translated into treatments, techniques, or tools for treating patients. Translational research is an iterative process of validating, refining, and testing combinations of compounds and products that is often slow, expensive, and unsuccessful.

colloquial term typically referring to the translational stage of research in which many promising compounds fail to become effective treatments or tools.

an animal or organism capable of transmitting a bacteria, virus, or parasite.

any effort to limit or stop a vector's ability to pass a bacteria, virus, or parasite from one person to the next.

diseases that can be passed from animals to humans.