What are biomarkers?
Biomarkers are biological molecules found in the body that help discern some aspect about the pathophysiology of a disease. Biomarkers can be useful in helping understand which patients might do best on certain therapies (especially targeted therapies). Sometimes, development programs focus specifically on patients who meet a certain biomarker requirement (such as PDL1 expression above a certain thresold in solid tumors or existence of a specific genetic mutation)- examples such as this might be considered “precision medicine”.
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What is Biostatistics?
Biostatistics is a specialization in statistics that focuses on application of statistical methods to studies within the realm of biology. In the context of pharma, biostatistics is a function which owns the statistical work associated with clinical trail design and analyses.
Specifically, biostatisticians in pharma can be part of clinical development teams and advise on things like proper sample sizes to ensure power, the types of statistical analyses which might be appropriate for the endpoints of interest, potential issues which may make statistical interpretation difficult and how to avoid them, etc.
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What is Drug Discovery?
Drug discovery refers to the process of finding and optimizing specific molecules for testing in humans. It precedes human testing via the drug development process. Discovery can be broken up into several steps including target identification and validation, hit generation, and lead generation and optimization.
Target identification is the process by which a target is identified for a potential drug to work on. There are many steps that can be taken to further validate this target as something that will modify the disease or symptoms- these tests are part of the target validation process.
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What is Consumer Marketing?
Consumer Marketing focuses on advertising and messaging directly to patients. Tasks include market research to understand patient awareness and perceptions towards a brand (or disease state) and development of advertising pieces geared towards patients. Advertising may be through various mediums including print, audio (through radio, podcasts, etc.), television, and digital (online ads). Direct-to-consumer advertising is only legal in the United States and New Zealand and is controversial with proponents arguing that it increases awareness of treatment options and allows for better and more patient-centric care, while critics argue it raises healthcare spending by encouraging use of higher-priced branded drugs.
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What is Advanced Analytics?
Advanced Analytics is a term used in pharma often referring to the use of tools such as machine learning and artificial intelligence to help improve commercial targeting, market understanding (including segmentation), inform strategic decision-making, etc. This function is usually part of the commercial organization and supports marketing teams in making decisions on how to compete in the market. In many larger companies it will be a distinct team from Business Analytics, which tends to use more traditional methods, but it is possible for both to be part of the same group.
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What is Market Research in pharma?
Market research teams work on helping to better understand current perceptions and behaviors of HCPs and patients, especially regarding a particular disease state or drug product. Insights generated from market research activities can be used to inform strategic decision-making by the brand.
Market research professionals in pharma will typically work closely with the broader brand team, especially HCP marketing or consumer marketing to determine when and what studies are of most importance and what to ask within those studies.
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What is pharmaceutical sales?
Sales representatives cover specific geographies and call on potential prescribers of the product(s) they cover. The prescribers they call on are identified by HCP marketing teams often in collaboration with market research and business analytics. Sales teams are typically the largest field based teams in terms of headcount and they visit the broadest set of healthcare providers.
In the United States, sales representatives are restricted to a limited set of proactive communications and almost completely limited to content within the approved regulatory label for the product.
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Medical writing is a functional area which is tasked with production of key documents for the R&D organization including study protocols, statistical analysis plans, clinical study reports, investigator’s brochures, and briefing documents. These documents are often necessary for certain regulatory submissions and follow strict organizational structures. The International Conference of Harmonization (ICH) is the common standard used in many of these documents as it is accepted by authorities in the European Union, Japan, and the United States.
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What is Public Affairs and Patient Advocacy?
Public Affairs and Patient Advocacy (used interchangeably in this article) organizations partner with external patient advocacy organizations, support initiatives to highlight the patient voice, and work with legislative entities to share the company and patient views.
While there are usually teams that support specific therapeutic areas, these teams are sometimes restricted to unbranded communications only, especially in the United States. The goal is really to increase awareness of the disease state, the patient burden, and general under-treatment rather than specifically promoting one treatment over another.
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What is Pharmacovigilance?
Pharmacovigilance (also called drug safety) is responsible for monitoring data for adverse events associated with drug therapy. The group collects, organizes, and analyzes a constant in-flow of data to look for potential adverse drug reactions and works with regulatory colleagues to report them to regulatory agencies as required.
Adverse event reports can come in through many different mechanisms including direct patient reports through avenues like medical information, reports from physicians on visits by field personnel, and large datasets that the company may license.
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