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Glossary

Glossary of terms

Plain-English definitions for the acronyms, methods and frameworks our teams actually use, written by people who file the dossiers, not pulled from a textbook.

XYZ

A

6

Accelerated approval

Accelerated approval is a regulatory pathway that allows earlier market access for therapies that address serious conditions and fill an unmet medical need based on surrogate endpoints.

Addressable population

The addressable population is the subset of patients within a broader disease area who meet specific criteria for treatment with a given product or intervention.

Advisory board

An advisory board is a structured meeting where external experts provide insights to support strategic, clinical, or scientific decision-making in pharmaceutical development.

Artificial intelligence

Artificial intelligence (AI) refers to computer systems designed to perform tasks that typically require human intelligence, such as learning, reasoning, and decision-making.

Asset evaluation

An asset evaluation establishes the attractiveness, market potential and likelihood of success for an internal or external asset.

Attribution

Attribution refers to the process of linking a scientific, clinical, or strategic outcome to a specific source, action, or stakeholder, ensuring transparency and traceability.

B

4

Benefit-risk assessment

Benefit-risk assessment is the structured evaluation of a treatment’s positive therapeutic effects against its potential risks, informing regulatory and clinical decisions.

Bibliometrics

Bibliometrics refers to the quantitative analysis of academic publications used to evaluate research performance and influence.

Biosimilar

A biosimilar is a biologic medicine that is highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or efficacy.

Burden of proof

In market access and regulatory contexts, burden of proof refers to the obligation of pharmaceutical companies to demonstrate the value, efficacy, and safety of their products to key stakeholders.

C

11

Channel strategy

Channel strategy refers to how pharmaceutical companies engage different communication and access pathways to reach key stakeholders across medical, payer, and patient channels.

Clinical benefit

Clinical benefit refers to the positive impact a treatment has on patient health, including symptom relief, disease modification, or survival improvement.

Clinical development

Clinical development is the systematic process of testing a new medical intervention in humans to establish its safety and efficacy.

Clinical differentiation

Clinical differentiation is the degree to which a product stands out from alternatives based on its therapeutic profile, safety, or ease of use.

Clinical landscape

The clinical landscape refers to the current state of clinical development activity within a specific disease area, including ongoing and completed trials, treatment approaches, and emerging standards of care.

Clinical meaningfulness

Clinical meaningfulness describes the real-world relevance of a treatment’s effects on outcomes that matter to patients, providers, and payers.

Collaboration network

A collaboration network is a visual or analytical representation of co-authorship and institutional relationships within scientific research communities.

Comparative effectiveness

Comparative effectiveness assesses how two or more interventions perform relative to each other for a defined patient population, using direct trials, indirect comparisons or real-world studies.

Competitive landscape

The competitive landscape refers to the current set of products, companies, and strategies competing within a specific therapeutic area, market, or indication.

Conference landscape

The conference landscape refers to the network of scientific and medical meetings where new clinical data, research, and strategic priorities are presented and discussed.

Conference planning

Conference planning is the strategic coordination of a pharmaceutical company’s activities before, during, and after a scientific or medical meeting to maximize scientific impact and stakeholder engagement.

D

10

Decentralised clinical trial (DCT)

A decentralized clinical trial (DCT) is a study that uses digital tools and remote methods to reduce or eliminate the need for in-person site visits.

Development pipeline

A development pipeline is the collection of drug or therapy projects that a company, disease area or industry has in discovery and development at a given time, from early research to possible market approval.

Digital activity

Digital activity refers to the online engagement of stakeholders across platforms such as social media, webinars, and digital conferences, providing insights into their interests, influence, and network.

Digital landscape

The digital landscape refers to the network of online platforms, behaviors, and content shaping scientific dialogue, stakeholder engagement, and perception within a therapeutic area.

Digital listening

Digital listening is the continuous monitoring and analysis of online conversations to capture insights on stakeholder perspectives, emerging topics, and perceptions of scientific data.

Digital Opinion Leader (DOL)

A DOL is an influential person or organization with a large online presence, often on social media, in the healthcare or pharmaceutical industry.

Digital transformation

Digital transformation is the integration of digital technologies into core pharmaceutical operations to enhance scientific, clinical, and commercial performance.

Disease burden

Disease burden refers to the total impact of a health condition on individuals, healthcare systems, and society, including clinical, economic, and quality-of-life dimensions.

Disease severity

Disease severity refers to the extent or intensity of a condition’s impact on a patient’s health, functioning, and quality of life.

Dose optimisation

Dose optimization is the process of identifying the most effective and safe drug dose for a specific patient population.

E

7

Early access program (EAP)

An early access program (EAP) allows patients with serious or life-threatening conditions to access investigational therapies prior to full regulatory approval.

Eligibility criteria

Eligibility criteria are the inclusion and exclusion rules that define which participants can enroll in a clinical trial.

Engagement planning

Engagement planning is the strategic design of how and when to interact with external stakeholders to support scientific, clinical, and commercial goals.

Epidemiology

Epidemiology is the study of the distribution, patterns and determinants of health across defined populations.

Evidence generation programme

An evidence-generation program is a coordinated plan for producing clinical, real-world, and economic data to support the value and positioning of a pharmaceutical product.

Evidence hierarchy

An evidence hierarchy is a ranked framework that classifies types of evidence based on their methodological rigor and reliability.

External control arm

An external control arm uses data from outside a clinical trial to serve as a comparator for evaluating a treatment’s effectiveness.

F

3

Feasibility planning

Feasibility planning is the process of evaluating whether a clinical trial or development strategy can be successfully executed based on operational, scientific, and market factors.

First-author

First-author refers to the person listed first on a scientific publication and generally recognised as its primary contributor. The status can indicate research leadership but should be interpreted alongside contribution statements and disciplinary conventions.

Formulary inclusion

Formulary inclusion is the decision by a healthcare payer or institution to list a pharmaceutical product as an approved treatment option.

G

3

Gap analysis

Gap analysis identifies missing evidence, insights, alignment or capabilities by comparing the current position with defined strategic, regulatory or stakeholder requirements.

Generic medicine

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

Global value dossier (GVD)

A global value dossier (GVD) is the central evidence document a manufacturer builds so local teams can make a consistent case for a product's value to payers and HTA bodies.

Market accessHEORValue communicationHTA

H

5

Health economic model

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

Health Economics and Outcomes Research (HEOR)

HEOR is the discipline focused on evaluating the economic value, clinical outcomes, and humanistic impact of healthcare interventions to inform decision-making.

Health technology assessment (HTA)

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

HEOR stakeholder

An HEOR stakeholder is an individual or organisation that uses, assesses or influences health economics and outcomes research to guide reimbursement, policy, coverage or treatment adoption.

HTA submission

An HTA submission is a formal package of clinical, economic and wider evidence provided to an assessment body to support reimbursement, funding or formulary decisions.

I

10

Impact factor

An impact factor is a bibliometric score VISFO uses to rank the influence of an expert — whether a key opinion leader, digital opinion leader, key clinical investigator, payer-influencing expert, rising star or co-author — using publication volume, journal quality, authorship position and citation reach.

Implementation science

Implementation science studies how evidence-based therapies, guidelines and practices are adopted, delivered and sustained in real-world healthcare settings.

Incidence

Disease incidence is the occurrence of new cases in a defined population over a specified period. It can be measured as cumulative incidence or as a rate based on person-time at risk.

Inclusion/exclusion criteria

Inclusion and exclusion criteria define who can or cannot participate in a clinical trial, based on factors like disease state, age, comorbidities, or prior treatment.

Indication

An indication is the specific disease, condition, symptom or patient setting for which a treatment or intervention is approved or authorised.

Indication assessment

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

Institutional affiliation

Institutional affiliation is the academic, research, clinical or healthcare organisation with which a professional is formally associated. It provides context for their work, networks and potential influence.

Integrated evidence plan (IEP)

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

Internal buy-in

Internal buy-in is cross-functional agreement and practical support for a strategic decision, investment or action plan within a pharmaceutical organisation.

Investigator-initiated study (IIS)

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

J

1

Journal prestige

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

K

3

Key Clinical Investigator (KCI)

A Key Clinical Investigator (KCI) is a highly experienced healthcare professional with a proven track record in conducting successful clinical trials.

Key Opinion Leader (KOL)

A Key Opinion Leader (KOL) is a highly influential and respected expert in their field who shapes opinions and decisioning.

Key Opinion Leader (KOL) mapping

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

L

4

Launch sequence optimisation

Launch sequence optimization is a strategic process that determines the best order and timing for launching a new drug across different markets.

Lifecycle evidence generation

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

Line of therapy

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

Literature library

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.

M

14

Market Access

Market Access is a function within pharmaceutical and biotechnology companies ensuring that the patients most likely to benefit from a new drug can access it, and that the drug is both cost-effective for healthcare systems and commercially viable for the manufacturer.

Market Access Key Opinion Leader (MAKOL)

A Market Access Key Opinion Leader (MAKOL) is a recognized expert who regularly publishes on market access themes, for example, disease burden, treatment cost-effectiveness and reimbursement challenges, within a specific therapeutic area.

Market conditioning

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

Market potential

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

Market shaping

Market shaping is the deliberate effort to influence how a disease or treatment category is understood and managed by changing evidence, care pathways, stakeholder expectations or access conditions.

Market value

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.

Medical Affairs

Medical Affairs communicates scientific evidence to healthcare professionals, payers and policymakers, while bringing external insights back into strategy to support the safe and effective use of treatments.

Medical insight capture

Medical insight capture is the process of collecting, analyzing, and synthesizing insights from healthcare professionals to inform strategy and decision-making.

Medical Science Liaison (MSL)

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

Medical strategy

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

Morbidity rate

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

Mortality rate

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

Multi-stakeholder engagement

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

Multiplicity

Multiplicity refers to the increased risk of false-positive results when multiple statistical tests are performed in a clinical trial.

N

1

Net clinical benefit

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

O

2

Observational study

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

Outcomes-based agreement

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

P

16

Patient advocacy group

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

Patient engagement

Patient engagement is the active involvement of patients in the design, development, and evaluation of healthcare strategies, including clinical trials and evidence generation.

Patient-reported outcomes (PROs)

Patient-reported outcomes are direct reports from patients about their symptoms, functioning, quality of life or treatment experience, without interpretation by clinicians.

Payer Influencing Key Opinion Leader (PIKOL)

A Payer Influencing Key Opinion Leader (PIKOL) is a key influencer of healthcare policy and reimbursement decisions.

Peer-to-peer engagement

Peer-to-peer engagement is non-promotional interaction between medical professionals that supports scientific education, evidence sharing and clinical discussion, often facilitated by field medical teams.

Pharmacovigilance

Pharmacovigilance is the science and practice of monitoring, detecting, assessing, and preventing adverse effects or other drug-related problems after a product has entered the market.

Placebo-controlled study

A placebo-controlled study is a clinical trial in which the effects of an investigational treatment are compared against an inactive substance that mimics the treatment but has no therapeutic effect.

Population health impact

Population health impact is the measurable or projected effect of a therapy or strategy on disease burden, healthcare use, morbidity or mortality across a defined population.

Predictive analytics

Predictive analytics uses statistical models and machine learning to forecast outcomes such as patient response, trial performance, market uptake and access challenges, helping pharma teams plan under uncertainty.

Prevalence

Prevalence is the proportion of a defined population that has a disease at a specified point in time. It supports disease-burden analysis, population forecasting and access planning.

Price benchmarking

Price benchmarking is the process of comparing the price of a pharmaceutical product to similar therapies across markets to inform pricing strategy and negotiation.

Price potential

Price potential refers to the estimated price a pharmaceutical product could reasonably achieve based on its clinical value, competitive positioning, and payer willingness to pay.

Pricing and reimbursement

Pricing and reimbursement refers to the processes by which a pharmaceutical product is assigned a price and granted coverage or funding by healthcare payers.

Product value communication

Product value communication is the strategic process of articulating the unique attributes, patient benefits, and economic value of a drug or therapy.

Publication strategy

A publication strategy is a structured plan for disseminating scientific and clinical data through peer-reviewed journals and congresses to support a product’s development and value story.

Publication type

Publication type categorizes scientific articles by format and purpose, influencing how they are perceived and weighted in bibliometric analysis.

Q

2

Qualitative research

Qualitative research is a method used to gather non-numerical insights into stakeholder behaviors, perceptions, motivations, and decision-making processes.

Quantitative research

Quantitative research involves the collection and statistical analysis of numerical data to identify patterns, test hypotheses, or measure outcomes.

R

10

Real-world data (RWD)

Real-world data (RWD) refers to health-related data collected outside of traditional clinical trials, used to understand how treatments perform in routine clinical practice.

Real-world effectiveness

Real-world effectiveness measures how well a treatment performs in routine clinical practice, outside the controlled environment of clinical trials.

Real-world evidence (RWE)

Real-world evidence (RWE) refers to clinical insights derived from the analysis of real-world data (RWD), used to evaluate how treatments perform outside of controlled trial settings.

Regulatory strategy

Regulatory strategy defines the pathways, evidence, submissions and authority interactions used to obtain and maintain product authorisation across target markets.

Regulatory submission

A regulatory submission is the formal dossier sent to a health authority to seek approval for a medicine, indication, formulation or regulated change, supported by quality, safety and efficacy evidence.

Reimbursement landscape

The reimbursement landscape comprises the policies, payer requirements, assessment routes and pricing mechanisms that determine whether and how a therapy is funded.

Research and development (R&D)

Research and development (R&D) is the process of discovering, designing, and testing new pharmaceutical products to advance medical science and improve patient outcomes.

Rising Star

A Rising Star is a medical or scientific professional in the early to mid-stage of their career who demonstrates potential to become a prominent and influential voice in their field.

Risk factor

A risk factor is any attribute, condition, or behavior that increases the likelihood of developing a disease or experiencing an adverse health outcome.

Risk-sharing agreement

A risk-sharing agreement is a contract in which a pharmaceutical company and payer share financial or clinical risk according to a treatment’s real-world performance.

S

8

Scientific exchange

Scientific exchange is the transparent, balanced and non-promotional sharing of evidence and medical knowledge between life sciences companies and external stakeholders to support clinical understanding and informed decisions.

Scientific landscaping

Scientific landscaping is the systematic analysis of published and emerging research to identify trends, gaps, and strategic opportunities within a therapeutic area.

Sentiment analysis

Sentiment analysis is the use of natural language processing (NLP) and machine learning to evaluate the tone and emotional context of written or spoken content.

Share of voice

Share of voice (SOV) is a metric that measures the proportion of total mentions or visibility a product, brand, or company receives within a defined competitive or thematic space.

Stakeholder mapping

Stakeholder mapping is the creation of a comprehensive overview of key stakeholders relevant to a particular therapeutic area, indication, condition or product.

Stakeholder segmentation

Stakeholder segmentation is the process of categorizing healthcare stakeholders into groups based on shared attributes, interests, or behaviors to tailor engagement strategies.

Stakeholder sentiment

Stakeholder sentiment is the perceived tone, attitude or emotional response of healthcare professionals, payers, patients and other influencers towards a product, topic or company.

Surrogate endpoint

A surrogate endpoint is a biomarker or intermediate measure used instead of a direct measure of clinical benefit because it is expected to predict that benefit.

T

5

Target product profile (TPP)

A target product profile defines the desired clinical, safety and commercial attributes of a future therapy. It aligns development, regulatory, medical affairs and market access teams on what success should look like.

Thought leader

A thought leader is an individual widely recognized for their expertise, original ideas, and ability to influence thinking and practice within a specific field.

Time-to-peak-uptake

Time-to-peak uptake is the period after launch before a product reaches its highest observed level of prescribing or use in a defined market, indication and population.

Treatment landscape

The treatment landscape describes current standards of care, approved and emerging therapies, treatment sequencing, clinical practice and unmet needs within a defined disease area.

Trial site analysis

Trial site analysis is the evaluation of potential clinical trial sites to optimize study performance.

U

2

Unbranded engagement

Unbranded engagement provides balanced scientific or educational communication about a disease, unmet need or treatment approach without promoting a specific product.

Unmet need

Unmet need refers to a gap in medical care where current treatment options are inadequate, unavailable, or ineffective for a specific patient population or condition.

V

2

Value proposition

A value proposition is an evidence-based summary of a product’s clinical, economic and humanistic benefits, explaining how it addresses unmet need, improves outcomes and justifies its price.

Voice of the customer

Voice of the customer (VoC) is a structured approach to gathering and analysing stakeholder needs, expectations, experiences and behaviours to inform pharmaceutical decisions.

W

2

Willingness to pay

Willingness to pay refers to the maximum amount a healthcare payer, provider, or system is prepared to spend for a treatment, based on its perceived value and health outcomes.

Workflow integration

Workflow integration refers to the alignment of a product or tool with the routines and systems used by healthcare professionals in clinical practice.

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