Strategic Product Launch
Expert-defined terms from the Graduate Certificate in Strategic Pharma Marketing Strategies course at Greenwich School of Business and Finance. Free to read, free to share, paired with a globally recognised certification pathway.
Adverse Event (AE) #
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Related terms: Adverse reaction, Serious adverse event.
Adverse Reaction (AR) #
Any harmful or undesirable reaction resulting from medication or other pharmaceutical treatment. Related terms: Adverse event, Serious adverse event.
Brand Positioning #
The way a brand is perceived in the minds of customers, relative to competitors. It involves differentiating the brand and creating a unique impression. Related terms: Branding, Differentiation strategy, Unique Selling Proposition (USP).
Clinical Development Plan (CDP) #
A detailed plan outlining the clinical trials and studies required to prove the safety and efficacy of a drug, leading to its approval and launch. Related terms: Clinical trial, Phase I, Phase II, Phase III, Phase IV.
Clinical Trial #
A research study conducted to evaluate the safety and efficacy of a new drug or medical device. Clinical trials are typically conducted in four phases. Related terms: Clinical Development Plan (CDP), Phase I, Phase II, Phase III, Phase IV.
Differentiation Strategy #
A marketing approach that distinguishes a product or service from others, making it more attractive to a particular target market. Related terms: Brand Positioning, Unique Selling Proposition (USP).
Go #
to-Market (GTM) Strategy: A comprehensive plan that outlines the steps and resources required to successfully launch a new product or service into the market. Related terms: Product launch, Launch plan, Launch execution.
Key Opinion Leader (KOL) #
An individual who is highly respected and influential in a specific field, often consulted by organizations and peers for their expert opinions. Related terms: Thought leader, Influencer.
Labeling Requirements #
Regulations and guidelines that dictate the content, format, and presentation of product labeling information, ensuring compliance with legal and industry standards. Related terms: Product packaging, Product information leaflet (PIL), Summary of Product Characteristics (SmPC).
Launch Execution #
The process of implementing the go-to-market strategy, coordinating all activities, resources, and stakeholders involved in introducing a new product or service to the market. Related terms: Go-to-Market (GTM) Strategy, Product launch, Launch plan.
Launch Plan #
A detailed document outlining the steps, resources, and timelines required to successfully launch a new product or service into the market. Related terms: Go-to-Market (GTM) Strategy, Product launch, Launch execution.
Marketing Authorization Application (MAA) #
A formal application submitted to regulatory authorities, seeking approval to market a new pharmaceutical product. Related terms: New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA).
Marketing Mix #
The set of tactical and strategic tools a company uses to promote its products or services in the market, often described by the "4Ps" - Product, Price, Promotion, and Place. Related terms: Product launch, Go-to-Market (GTM) Strategy.
New Drug Application (NDA) #
A formal application submitted to the Food and Drug Administration (FDA) by pharmaceutical companies seeking approval to market a new drug in the United States. Related terms: Marketing Authorization Application (MAA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA).
Patient #
Reported Outcomes (PROs): Measures of a patient's health status or quality of life, reported directly by the patient, without interpretation by a clinician or anyone else. Related terms: Health-Related Quality of Life (HRQoL), Clinical Outcome Assessment (COA).
Pharmacovigilance #
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Related terms: Adverse Event (AE), Adverse Reaction (AR), Serious adverse event.
Phase I #
The initial stage of clinical trials, focusing on establishing the safety and dosage range of a new drug in a small group of healthy volunteers (typically 20-100 participants). Related terms: Clinical trial, Clinical Development Plan (CDP), Phase II, Phase III, Phase IV.
Phase II #
The second stage of clinical trials, focusing on evaluating the efficacy and side effects of a new drug in a larger group of patients (typically 100-300 participants) with the condition the drug is intended to treat. Related terms: Clinical trial, Clinical Development Plan (CDP), Phase I, Phase III, Phase IV.
Phase III #
The final stage of clinical trials, focusing on confirming and expanding the safety and efficacy data of a new drug in large groups of patients (typically 1,000-3,000 participants) in various clinical settings. Related terms: Clinical trial, Clinical Development Plan (CDP), Phase I, Phase II, Phase IV.
Phase IV #
Post-marketing surveillance, focusing on monitoring the long-term safety and efficacy of a new drug in real-world clinical practice, often involving thousands of patients. Related terms: Clinical trial, Clinical Development Plan (CDP), Phase I, Phase II, Phase III.
Product Differentiation #
The process of distinguishing a product or service from others in the market, often achieved through unique features, benefits, or positioning. Related terms: Brand Positioning, Differentiation Strategy, Unique Selling Proposition (USP).
Product Launch #
The introduction of a new product or service into the market, involving the execution of a well-planned and coordinated go-to-market strategy. Related terms: Go-to-Market (GTM) Strategy, Launch plan, Launch execution.
Product Life Cycle (PLC) #
The series of stages a product goes through, from its initial development and launch to its eventual decline and withdrawal from the market. Related terms: Introduction, Growth, Maturity, Decline.
Product Packaging #
The physical design, materials, and labeling of a product, often used to differentiate it from competitors and communicate key information to consumers. Related terms: Product labeling, Product information leaflet (PIL).
Product Positioning #
The process of establishing a unique and differentiated image for a product in the minds of consumers, often achieved through strategic marketing efforts. Related terms: Brand Positioning, Differentiation Strategy, Unique Selling Proposition (USP).
Product Roadmap #
A high-level visual summary that maps out the vision, direction, and timeline for a product or product line. Related terms: Go-to-Market (GTM) Strategy, Product launch, Launch plan.
Regulatory Affairs #
The function responsible for ensuring that a company's products comply with all applicable regulations and standards, often involving interactions with regulatory authorities. Related terms: Marketing Authorization Application (MAA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA).
Serious Adverse Event (SAE) #
An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Related terms: Adverse Event (AE), Adverse Reaction (AR).
Stake #
Stake