Glossary

Business glossary

A shared, governed list of business terms and metrics with agreed definitions and owners, so that a word like 'active patient' or 'net sales' means the same thing across an organization.

Catalyst calendar

A timeline of upcoming events likely to change the prospects of a product or company, such as regulatory decisions, data readouts, advisory committee meetings, congress presentations, patent expiries and launches.

Competitive intelligence (CI)

The legal and ethical collection and analysis of information about competitors, used to anticipate their moves and plan a response. In pharma it centers on pipelines, trials, regulatory decisions, labels, access, patents and deals.

Complete response letter (CRL)

A letter from the US Food and Drug Administration stating that it has completed its review of a drug or biologic application and cannot approve it in its current form, with the deficiencies that need to be addressed.

Data catalog

An organized, searchable inventory of an organization's data assets, with descriptions, owners and context, that helps people find and understand the data they need.

Data dictionary

A reference that documents the tables and fields in a data set: what each contains, its type and allowed values, where it comes from and how it should be used.

Data governance

The policies, roles and processes that determine how an organization's data is defined, owned, protected, changed and used, so that it can be trusted.

Data lineage

The record of where a piece of data came from, how it was transformed along the way, and where it is used, from source systems through to reports and dashboards.

Evidence gap (data gap)

A question that matters to clinicians, patients, payers or regulators that the existing evidence does not yet answer well.

Formulary (drug formulary)

The list of medicines a health plan or pharmacy benefit manager covers, usually organized into tiers that set what patients pay, with conditions attached to some drugs.

Gross-to-net (GTN)

The difference between a medicine's sales at list price and the net revenue the manufacturer actually receives after rebates, discounts, fees and other deductions.

Health economics and outcomes research (HEOR)

The discipline that generates evidence on the economic value and patient outcomes of a treatment, such as cost-effectiveness, budget impact and quality of life, to support decisions by payers and health technology assessment bodies.

Health technology assessment (HTA)

A systematic evaluation of the clinical and economic value of a medicine or other health technology, used by health systems and payers to decide whether, and on what terms, to fund it.

Key opinion leader (KOL)

A clinician or researcher whose expertise and standing influence how others in their field think about a disease or its treatment. Many companies now prefer terms such as external expert or scientific leader.

KPI drift (definition drift)

What happens when a metric with one name comes to be calculated in different ways by different teams or at different times, so that reports disagree and nobody is sure which number is right.

Line of therapy (LOT)

The position of a treatment in the sequence a patient receives: first-line is the initial treatment for a condition, second-line follows when the first stops working or is not tolerated, and so on.

Loss of exclusivity (LOE)

The point at which a medicine's patents and regulatory exclusivities expire or are overcome, allowing generic or biosimilar competitors to enter the market.

Medical information (MI)

The Medical Affairs function that answers questions about a company's products from healthcare professionals, patients and others, with accurate, balanced and referenced scientific information.

Medical intelligence

The ongoing work of gathering, analyzing and sharing scientific, clinical, regulatory and competitive information so that a pharmaceutical company's medical organization can make better decisions.

Medical science liaison (MSL)

A field-based scientific expert in a pharmaceutical company's Medical Affairs function, usually with an advanced degree such as a PharmD, PhD or MD, who engages in non-promotional scientific exchange with clinicians and researchers.

New-to-brand prescriptions (NBRx)

A measure of patients starting a brand who have not had it during a set lookback period, including patients new to treatment, switching from another product, or adding the brand to their regimen.

Orphan drug designation (ODD)

A status granted by a regulator to a medicine being developed for a rare disease, which brings incentives such as a period of market exclusivity once the medicine is approved for that disease.

PDUFA date (PDUFA goal date)

The date by which the US Food and Drug Administration aims to complete its review of a drug or biologic application, under goals set by the Prescription Drug User Fee Act.

Pharmacovigilance (PV)

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem, as defined by the World Health Organization.

Pharmacy benefit manager (PBM)

A company that manages prescription drug benefits on behalf of health plans and employers, building formularies, negotiating rebates with manufacturers, contracting pharmacy networks and processing claims.

Prior authorization (PA)

A requirement by a health plan that a prescriber obtain approval before a medicine will be covered, usually by showing that the patient meets set clinical criteria.

Publication planning

The strategic planning of how a company's research is communicated to the scientific community through journal articles, congress abstracts and presentations, in line with good publication practice.

Real-world evidence (RWE)

Clinical evidence about the use and potential benefits or risks of a medical product, derived from analysis of real-world data such as electronic health records, claims, registries and other data collected outside conventional clinical trials.

Share of voice (SOV)

A product's share of the total conversation in its market. In medical affairs it usually means share of publications and congress presentations; in marketing it means share of promotional activity or spend.

Step therapy (step edit)

A coverage rule that requires a patient to try one or more preferred, usually lower-cost, treatments before a health plan will cover another.