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Functions R&D

Biostatistics

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. They help ensure that the clinical trials run by pharma and the associated statistical analysis plans are in line with broader statistical good practices.

Once data are collected, biostatistics also owns the actual execution of analyses per the statistical analysis plan. Biostatistics in pharma is often also charged with owning the post-hoc analysis work for presentation at congresses or publication as well as for potential uses for regulatory of health technology assessment purposes.

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Functions

Drug Discovery

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.

Once a target is identified, potential drug agents (“hits”) can be identified and tested through various screening procedures to test their ability to bind the identified target as well as to quantify how they may interact with other potential parts of the body (especially as they may lead to side effects). Through screening of what is often thousands of potential compounds, a lead compound may be identified as one that is particularly promising.

The lead itself will then be tested in greater rigor and potentially optimized to add or improve on favorable characteristics. Once a lead is optimized, it is ready to go into pre-clinical studies including animal testing.

The drug discovery process often involves trial-and-error and a lot of back-and-forth. Sometimes things may not flow completely as described above, depending on new things that are learned about a molecule as it is studied. The discovery process, as with drug development has to often find a balance between derisking (reducing the chances for failure in clinical trials) a potential agent and moving it forward for preclinical and clinical testing so that it can eventually be available to patients and be marketed by the company- much of these decisions come down to an art rather than just science.

Derek Lowe is a discovery scientist who often blogs about new methods, data, and industry affairs.

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Functions

Consumer Marketing

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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Market Research

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. The data generated are vital in understanding the market (including informing segmentation), the opportunity, and in setting and refining the strategy. Specific deliverables such as sales master visual aids can also be tested to determine what is most effective with providers (or potential ads to see what is most effective with patients).

Market research of payers can also be conducted in support of market access and pricing.

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Functions

Advanced Analytics

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.

Advanced Analytics has been a growing part of the pharma armamentarium as companies look to make more data-driven decisions and as these methods have generally become more accessible.