World Health Organisation (WHO)
The United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable.
Vaccine Innovation Prioritisation Strategy (VIPS)
A partnership between Gavi, WHO, Bill & Melinda Gates Foundation, UNICEF, and PATH aiming to pursue a common agenda of identifying and driving high priority vaccine product innovations forward to address the most important barriers to immunization and improve coverage and equity
USA National Institute of Allergy and Infectious Diseases (US NIAID)
One of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services.
Technical Transfer (TT)
The process of transferring, technology methods, or processes from one organisation to another.
Telethon Kids Institute (TKI)
An Australian medical research institute focused on the prevention of pediatric disease and the development of improved treatments to improve the health and wellbeing of children.
Strategic Advisory Group of Experts on Immunization (Infection SAGE)
The principal advisory group to the World Health Organization (WHO) for vaccines and immunization. It advises WHO on global policies and strategies, ranging from vaccine and technology, research and development, to delivery of immunization and its linkages with other health interventions.
Regulatory Agency/Ethics Committee (RA/EC)
A body responsible for overseeing and ensuring compliance with ethical standards, regulations, and guidelines in research involving human participants.
Regulatory Agency/Ethics Committee (RA/EC)
A body responsible for overseeing and ensuring compliance with ethical standards, regulations, and guidelines in research involving human participants.
Product Development for Vaccines Advisory Committee (PDVAC)
An independent standing WHO committee of experts which provides external advice to WHO related to priority infectious disease pathogens, associated vaccine and monoclonal antibody product development approaches and related manufacturing and delivery technologies.
Product Development Partnership (PDP)
A collaborative arrangement between public, private and non-profit sectors to develop and provide access to new health products – especially vaccines, therapeutics, and diagnostics – for poverty-related and neglected diseases.
Partnerships for African Vaccine Manufacturing (PAVM)
A continental autonomous health agency of the African Union established to support public health initiatives of Member States and strengthen the capacity of their public health institutions to detect, prevent, control and respond quickly and effectively to disease threats.
Korea Ministry of Trade, Industry and Energy (MOTIE)
A government agency of Korea responsible for formulating and implementing policies related to trade, industry and energy.
Korea Ministry of Health and Welfare (MOHW)
A government agency of Korea responsible for public health, social welfare, and health policy.
Korea Ministry of Food and Drug Safety (MFDS)
A government agency of Korea responsible for promoting the public health by ensuring the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics as well as supporting the development of the food and pharmaceutical industries.
Korea International Cooperation Agency (KOICA)
A government agency of Korea founded by the Ministry of Foreign Affairs responsible for implementing official development assistance (ODA) programs and projects in partner countries around the world.
Korea National Institute of Health (KNIH)
A research institute of biomedical and public health under the Korea Ministry of Health and Welfare.
Korea Ministry of National Defense (KMND)
A government agency of Korea responsible for overseeing the country’s defense policies and operations.
Korea Disease Control and Prevention Agency (KDCA)
A government agency of Korea responsible for public health management and disease control.
IVI Europe Regional Office (Swedish funding) (IERO)
The branch of the IVI responsible for managing and coordinating operations, partnerships, and initiatives related to vaccine research and public health advocacy within the European region.
Harvard School of Public Health (HSPH)
A global community committed to building a world with health, dignity, and justice for every human being.
Global Burden of Disease (GBD)
A comprehensive global research program of disease burden that assesses mortality and disability from major diseases, injuries, and risk factors.
Coalition for Epidemic Preparedness Innovations (CEPI)
A global partnership working to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats.
Bill & Melinda Gates Foundation (BMGF)
A private philanthropic foundation founded by Bill Gates and Melinda Gates.
Global Alliance for Vaccines and Immunization (GAVI)
An international organisation with the goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.
Cross Sectional Study (CSS)
A type of observational study that analyzes data from a population, or a representative subset, at a specific point in time.
Antimicrobial Consumption (AMC)
Estimates of aggregated data, often obtained from import, manufacturer, or reimbursement records.
Acceptance Criteria
Numeric limits, ranges, or other appropriate scales used to determine the acceptability of test results.
Acellular vaccine
A vaccine containing partial cellular material as opposed to complete cells.
Acid Dissociation Constant (pKa)
The equilibrium constant of the dissociation reaction of an acid.
X-ray Crystallography
The study of crystals and their structure by means of X-ray diffraction.
X-ray Diffraction
Phenomenon in which the atoms of a crystal, by virtue of their uniform spacing, cause an interference pattern of the waves present in an incident beam of X-rays.
Xenobiotic
Relating to or denoting a substance, typically a synthetic chemical, that is foreign to the body or to an ecological system.
Volume of distribution(Vd)
A pharmacokinetic parameter representing an individual drug’s propensity to either remain in the plasma or redistribute to other tissue compartments.
Trial Statistician
A statistician with adequate education on clinical trials, substantial experience in conducting clinical trials, and practical responsibility for all statistical tasks related to clinical trials.
Ultraviolet Ray (UV)
Invisible energy in the wavelength range from 100 to 400 nanometers (nm).
Valuation
The act or process of making a judgment about the price or value of something.
Virion
The infectious form of a virus as it exists outside the host cell, consisting of a nucleic acid core, a protein coat, and, in some species, an external envelope.
Surrogate Marker
A laboratory measurement or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and is expected to predict the effect of the therapy.
Systematic Review
Study that involves thorough examination of all literature on a specific topic, applying explicit selection and exclusion criteria to choose relevant literature, conducting quality assessments of the selected literature, and synthesizing research findings.
Target Market Profile (TMP)
The set of attributes that relate to a target population. It typically includes demographic, psychographic, and geographic factors.
Target Product Profile (TPP)
Strategic guidance which outlines the desired ‘profile’ or characteristics of a target product that is aimed at a particular disease or diseases.
Targeted Protein Degradation (TPD)
The use of heterobifunctional small molecule “Degraders”, such as PROTAC® Degraders, to achieve knockdown of target proteins within cells.
Targeted Release
A formulation designed to release the drug after it has reached the target site.
Temporal association
Two or more events that occur around the same time whether causally related or not, chance occurrences.
Teratogenicity
Of, relating to, or causing developmental malformations in a fetus or unborn baby.
Tertiary structure
The folding of the secondary structure into distinct arrangements known as domains.
Thermogravimetric Analysis (TGA)
A method of thermal analysis in which the mass of a sample is measured over time as the temperature changes.
Thermostability
The ability of a substance to resist irreversible change in its chemical or physical structure.
Structure-property relationships (SPRs)
The connection between the structure and the way a product behaves.
Subinvestigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
Submission Unit
A collection of documents pertaining to a particular clinical study protocol and/or medical product accompanied by the associated reference information officially provided to the regulatory authority. This is usually done to comply with a specific regulatory purpose or decision.
Sensitivity Analysis
Determination of how different values of an independent variable affect a particular dependent variable under a given set of assumptions. In meta-analysis, sensitivity analysis means testing the robustness of the results by analyzing how the inclusion or exclusion of a specific primary study in the meta-analysis changes the overall results, thereby assessing the impact of that particular study on the meta-analysis outcome.
Serology
Measurement of antibodies and other immunological properties present in blood serum.
Seroprevalence
The level of a pathogen in a population, as measured in blood serum.
Serosurvey
A study measuring the proportion of persons in a community that have antibodies (due to vaccination or previous exposure) to a given agent.
Significance level
The probability of the study rejecting the null hypothesis, given that the null hypothesis is true.
Stereochemistry
A form of isomerism in which molecules have the same molecular formula and sequence of bonded atoms (constitution), but differ in the three-dimensional orientations of their atoms in space.
Small Interfering RNA (siRNA)
A class of double-stranded RNA at first non-coding RNA molecules, typically 20–24 (normally 21) base pairs in length, similar to miRNA, and operating within the RNA interference (RNAi) pathway.
Solution Stability
The property of a drug that does not undergo decomposition or reaction within a solution.
Source Data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
Source Data Verification (SDV)
The process of verifying whether the data obtained from the source documents accurately reflect the source documents.
Source Document
Original documents, data and records of the subject before, during and after the trial that allows independent observer to reconfirm the data and reconstruct the trial as it happened.
Stakeholders
A person, group or organization with a vested interest, or stake, in the decision-making and activities of a business, organization or project.
Statistical inference
The process of using sample statistics to answer questions about population parameters.
Selection Bias
Type of bias introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population intended to be analyzed.
Reference Material
Biological material of defined biological activity which can be used as calibrant and/or positive control and/or monitor.
Reference Standard
Biological material of defined biological activity which can be used as calibrant and/or positive control and/or monitor.
Regression
A measure of the relation between the mean value of one variable (e.g. output) and corresponding values of other variables (e.g. time and cost).
Relative risk
The ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.
Replication
The repetition of a scientific experiment or trial to obtain a consistent result.
Reporting Bias
type of selection bias that occurs when the results of a study are skewed due to the way they are reported.
Reproducibility
The extent to which consistent results are obtained when an experiment is repeated.
Reproductive toxicology
Study of occurrence of adverse effects on the male and female reproductive system due to exposure to chemicals or physical agents.
Reviewable Unit
A collection of one or more Submission Units grouped together (usually by subject) that collectively become part of a Submission for purpose of review.
Risk Difference (RD) / Excess risk / Attributable risk
Difference between the risk of an outcome in the exposed group and the unexposed group.
Risk of Bias (RoB)
The risk that a study’s results will overestimate or underestimate a true intervention effect.
Risk Ratio (RR)
The ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.
Scalable
Used to describe a system that can be made larger, without affecting its performance.
Secondary endpoint
Endpoint that may provide supportive information about a therapy’s effect on the primary endpoint or demonstrate additional effects on the disease or condition.
Secondary structure
Local spatial conformation of the polypeptide backbone excluding the side chains. It is formally defined by the pattern of hydrogen bonds between the amino hydrogen and carboxyl oxygen atoms in the peptide backbone. The two most common secondary structural elements are alpha helices and beta sheets.
Recombinant DNA (rDNA)
An artificially made DNA strand that is formed by the combination of two or more gene sequences.
Protocol
Documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials.
Protocol Amendment
Protocol that have been revised to implement changes such as updating I/E criteria, clarifying points of confusion, and adding or removing required study procedures.
Quantitative Synthesis
A method such as meta-analysis, decision analysis, cost-effectiveness analysis that uses statistical techniques to organize and combine the results of primary studies to summarize them.
Query
A request for clarification regarding the clarity of data collected during the clinical trial process, asking the investigator to address errors or inconsistencies identified by the sponsor or sponsor-related personnel during their review of the data.
Raman probe
The device used in Raman spectroscopy to connect the spectrometer to the sample.
Random-Effect Method
A statistical model where the model parameters are random variables. In case of clinical trials, the reason for heterogeneity among the included studies in a meta-analysis is explained by not only variation within each primary study but also between the primary studies.
Randomization / Random Allocation
An experimental technique for assigning human participants or animal subjects to different groups in an experiment using randomization.
Randomized Controlled Trials
Form of scientific experiment used to control factors not under direct experimental control. By randomly allocating participants among compared treatments, an RCT enables statistical control over predicted or unpredicted influences that influence study outcomes.
Recombinant
Of or resulting from new combinations of genetic material or cells; the genetic material produced when segments of DNA from different sources are joined to produce recombinant DNA.
Placebo
A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.
Population
The entire population to which the intervention of a clinical trial or research study is applied.
Primary objective
the main goal or purpose that guides someone’s actions or decision-making process.
Positive predictive value
The ratio of patients truly diagnosed as positive to all those who had positive test results.
Primary structure
The characteristic sequence of amino acids forming a protein or polypeptide chain, considered as the most basic element of its structure.
Post Market Surveillance
Practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market, thereby further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Principal Investigator
The individual who assumes full responsibility for the research project including supervision of co-investigators, key personnel, and the Institutional Review Board (IRB) submission process.
Post Market Surveillance (PMS)
The practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market.
Principal Investigator (PI)
The holder of an independent grant and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial.
Preclinical
Relating to or denoting the stage of drug testing that precedes the clinical stage.