Glossary of terms

A generic is a medication that is chemically equivalent to an approved brand name drug and intended to provide the same clinical benefit at a lower cost.

A global value dossier (GVD) is a comprehensive document that compiles all supporting evidence for a product’s value, created for use in payer and HTA submissions across global markets.

An HEOR stakeholder is an individual or organisation that relies on health economics and outcomes research to inform decisions in healthcare policy, reimbursement, or treatment adoption.

An HTA submission is a formal package of clinical and economic evidence submitted to a health technology assessment body to support product reimbursement or funding.

A health economic model is a structured tool used to estimate the costs and outcomes linked to a healthcare intervention over time.

HEOR is the field dedicated to assessing the economic value, clinical outcomes, and humanistic effects of healthcare interventions to support decision making.

A health technology assessment (HTA) is a systematic evaluation of the clinical, social, economic, and ethical implications of a new medical intervention or technology.

Implementation science is the study of how to support the adoption and integration of evidence based practices within real world healthcare settings.

In epidemiology, incidence is the rate at which new cases of a disease arise in a population over a defined time period.

Inclusion and exclusion criteria specify who may or may not participate in a clinical trial, based on factors such as disease state, age, comorbidities, or prior treatment.

Indications are the specific medical conditions or diseases for which a treatment or intervention is authorised.

An indication assessment is the strategic evaluation of market opportunities across multiple potential indications to determine which to prioritise for development and launch, aiming to maximise the commercial success of a new product or medical device.

An insight is understanding drawn from data or lived experience that highlights a trend, need, or opportunity.

Institutional affiliation refers to the academic, research, or clinical organisation with which a healthcare professional is formally associated.

An integrated evidence plan (IEP) outlines the coordinated generation of clinical, economic, and real world data to support a product’s lifecycle strategy.

An intelligence board is an expert curated synthesis of evidence, data, and strategic insights created to support pharmaceutical decision making on specific questions or topics.

Internal buy in refers to securing cross functional agreement and support for a strategic decision, investment, or action plan within a pharmaceutical organisation.

An investigator initiated study (IIS) is a clinical or scientific study designed and led by an independent researcher, often supported with funding or materials from a pharmaceutical company.

A JCA is an EU level evaluation of the clinical effectiveness and safety of a new medicine, providing a single standardised clinical assessment usable by all EU member states. It focuses solely on clinical evidence, not pricing, reimbursement, or country specific economic evaluations, which remain the responsibility of national HTA bodies.

Journal prestige refers to the perceived authority, influence, and visibility of a scientific journal within its field, extending beyond its impact factor alone.

A key clinical investigator (KCI) impact factor is a proprietary bibliometric based metric used to identify and rank KCIs.

The key opinion leader (KOL) impact factor is a proprietary bibliometric based metric used to identify and rank KOLs.

A key clinical investigator (KCI) is a highly experienced healthcare professional with a demonstrated track record in conducting successful clinical trials.

A key opinion leader (KOL) is a highly influential and respected expert in their field who helps shape opinions and decision making.

Key opinion leader (KOL) mapping is the process of identifying and analysing key opinion leaders based on their influence, expertise, and relevance to a specific therapeutic area or strategy.

Launch sequence optimization is a strategic process that defines the optimal order and timing for introducing a new drug across different markets.

Lifecycle evidence generation is the strategic planning and execution of data generation activities across a product’s development, launch, and post-market phases.

Line of therapy refers to the sequence in which treatments are administered to a patient, typically classified as first line, second line, or third line based on clinical guidelines or prior treatment history.

A literature library is a curated collection of publications relevant to a specific individual, topic, or strategy, used to support insight generation and engagement planning.

Market access is a function within pharmaceutical and biotechnology companies that ensures patients who are most likely to benefit from a new drug can obtain it, and that the drug remains cost effective for healthcare systems and commercially viable for the manufacturer.

Marketing authorization is the regulatory status granted by agencies such as the FDA, EMA, or MHRA that permits a drug to be marketed and prescribed. To receive marketing authorization, a medicine must demonstrate clinical benefit and meet required safety, efficacy, and quality standards.

Market conditioning is the strategic process of shaping stakeholder awareness, perceptions, and expectations ahead of a product launch or clinical milestone.

Market potential is the estimated maximum revenue opportunity for a pharmaceutical product within a defined population, therapeutic area, or geographic region.

Market shaping is the deliberate effort to redefine or broaden a therapeutic space by influencing standards of care, stakeholder behaviour, or access pathways.

Market value refers to the current or projected financial worth of a pharmaceutical product or therapeutic area based on real world sales, pricing, and market dynamics.

A Medical Science Liaison (MSL) is a scientific expert who engages with healthcare professionals to share clinical data and gather insights that inform medical and commercial strategy.

Medical affairs is a strategic function within the pharmaceutical, biotechnology, and consumer healthcare industries that communicates scientific data to healthcare professionals, payers, and policymakers.

Medical insight capture is the process of gathering, analysing, and synthesising insights from healthcare professionals to guide strategy and decision making.

Medical strategy is the plan that directs how scientific and clinical knowledge is generated, interpreted, and communicated across a product’s lifecycle.

Modeling is the process of applying mathematical frameworks to simulate clinical, economic, or epidemiological scenarios that support pharmaceutical decision making.

Morbidity rate is a measure of how often a disease or health condition occurs within a specific population over a defined period of time.

Mortality rate is a measure of how often death occurs in a defined population over a specified period, often used to assess the severity or impact of a disease.

Multi stakeholder engagement refers to the coordinated interaction with diverse healthcare decision makers, including providers, payers, regulators, and patient advocates.

Multiplicity refers to the heightened risk of false positive findings when multiple statistical tests are conducted within a clinical trial.

Net clinical benefit refers to the overall advantage of a treatment when balancing its therapeutic effects against its risks in real world patient care.

An observational study is a non interventional research design that examines outcomes in patients receiving routine medical care.

An outcomes based agreement ties a drug’s reimbursement to the real world results it delivers in a patient population.

A patient advocacy group is an organisation that represents the interests of individuals affected by a specific disease or condition, often influencing research, policy, and access.