What is Competitive Intelligence?
Competitive Intelligence is tasked with monitoring the competitive landscape for a given area and to stay abreast of external updates in the space that may impact the business. Professionals in this area will often send out internal communications as updates surface on competitor activities including clinical trial readouts, announcements on new development plans, new commercial deals of interest, etc. The information gathered and collated by Competitive Intelligence can be crucial in informing the strategy for internal assets throughout the lifecycle and for forecasting the market potential for specific drugs.
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What is Clinical Development?
Clinical Development teams lead the design and execution of clinical trials. They oversee cross-functional workstreams consisting of several potential areas including biostatistics, regulatory (if the trial is for approval or label enhancement), medical, clinical documentation/medical writing, and pharmacokinetics. Clinical Development is ultimately responsible for the details of a clinical trial including creation and finalization of the final study protocol. They also oversee any amendments to the protocol if needed.
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What is pharmaceutical forecasting?
Forecasting is a critical function in biopharma as it is in most corporate settings, especially when it comes to public companies. Forecasters in pharma are responsible for creating models that predict sales of a product over time. Models can be structured in various ways and might be patient-level, script-level, or market-level. Forecasting teams may create forecasts which are shared with external stakeholders usually through the Investor Relations group in addition to doing a lot of work for internal forecasting purposes including assessment of various investment and strategic scenarios.
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What is Scientific Communications?
As the name implies, this functional area focuses on the dissemination of scientific content. Key activities including supporting field-based medical teams (such as MSLs/RMLs and potentially medical payer-facing field teams) with content creation and approval for use with customers, managing the publication process for medical abstracts, posters, and manuscripts, and potentially conducting trainings for field-based teams.
Content Development for Medical Field Teams
Field teams usually have a set of deliverables that are approved at any given time for use with the customers that they call upon.
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What is Business Analytics?
Business Analytics functions in pharma analyze data to understand the market and sales growth. They work closely with the Brand and sales teams to generate insights into what may be driving or hindering sales growth, where opportunities may lie, and gaps in the current plan. The Business Analytics team is the internal expert on the datasets and supports the broader commercial team with their needs, often presenting data based on requests or that they believe are of importance to the overall brand strategy and operations.
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What is Business Development and Licensing?
Business development and licensing (BD&L) in biopharma refers to assessment and execution of potential opportunities for partnerships, acquisitions, mergers, and other deal-making. Professionals in BD&L follow developments in research and development at other companies and in the general scientific community and conduct due diligence on specific opportunities. There is typically a very rigorous process of due diligence in an attempt to de-risk opportunities before a company commits to an agreement.
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What is Medical Affairs?
Medical affairs is a broad functional group encompassing many different functions within it and centered around scientific exchange and medical guidance on clinical development. Medical strategy for each product is typically driven by medical directors who make key decisions especially as they relate to evidence generation, communication with physicians, and publications of trial and real world evidence. Medical affairs is the umbrella organization for other medical functions including medical information, independent medical education, scientific communications and publications, medical science liaisons (MSLs), and potentially HEOR.
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What is Regulatory Affairs?
The Regulatory Affairs group is tasked with ensuring compliance to regulatory body requirements and setting the strategy around communications with the agency. There are several distinct functions which fall under the Regulatory umbrella within a pharmaceutical company including Regulatory Strategy, Regulatory Ad/Promo, and Regulatory Labeling.
What is Regulatory Strategy?
Regulatory Strategy team members often sit on cross-function development teams and help ensure appropriate development of clinical trials from the perspective of the local regulatory requirements and what would be needed in order to achieve the aspired labeling.
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What is Medical Information?
Medical Information is a functional area within a pharmaceutical company that delivers drug information to customers. Inquiries can come through call centers, online, via medical field teams, or through direct interface with customers at medical congresses. Call centers are usually run by third party agencies which pharmaceutical companies contract with. Internal members of the med info team often manage the agency and provide guidance on how to handle requests, with requests that do not fit into guidance or those of higher complexity being routed to them.
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What is a Medical Science Liaison?
A Medical Science Liaison (MSL) is a field-based employee who is part of the Medical Affairs organization. They focus on one product or one therapeutic area and typically cover a set geography similar to sales reps, but unlike sales reps they can partake in scientific exchange with providers who they call upon. This means that they can discuss scientific publications and address matters which are off-label.
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