Career Opportunities in the Pharmaceutical Industry

By Scott A. Mogull | Member

In this article, I provide an overview of the pharmaceutical drug development and commercialization processes and highlight opportunities for technical communicators to contribute to the development of regulatory documentation and technical marketing materials.

Product Development and Regulatory Genres

The drug development process is a complex, multi-disciplinary endeavor that requires years of investigation, development, trials, and formal reporting of data to the U.S. Food and Drug Administration (FDA). The mission of the FDA is to balance the therapeutic benefit of an agent with the severity of side effects. The FDA states, “No drug is absolutely safe; all drugs have side effects. ‘Safe’ in this sense means that the benefits of the drug appear to outweigh the risks.” Both traditional chemical agents and the newer biotechnology therapeutics undergo a similar regulated process, although in this article, I focus on therapeutic drugs produced by pharmaceutical companies.

Prior to beginning a clinical trial, pharmaceutical companies conduct pre-clinical studies of therapeutic agents. Laboratory formulations of the therapeutic agent are tested in animal studies that model the disease condition in human populations. The objectives of the pre-clinical testing are to establish baseline information for dosage, efficacy, toxicity, and dependency. This is an important step in the process, as most drugs that undergo pre-clinical (or animal) testing are terminated at that stage—often because of a major problem that arose in the baseline information. Therefore, many potential therapeutics never reach the FDA for review and evaluation.

If a therapeutic agent exhibits promising results from the pre-clinical trial, pharmaceutical companies prepare and submit an Investigational New Drug Application (IND) to the FDA. The IND’s purpose is to ensure that humans are not exposed to undue risk. The IND contains the following information:

introductory statement and general investigational plan
investigator’s brochure, which provides technical information about the therapeutic drug to those conducting clinical trials
protocol for the conduct of each proposed clinical trial
chemistry, manufacturing, and control information of the therapeutic drug

Drug studies can only begin in human subjects once the IND has been approved by the FDA and the local institutional review boards (IRBs) of the hospitals and/or research institutions that are involved in the clinical research trial. Although the IND is, in practice, the first document in the drug development process, it is not officially a legal requirement to begin clinical trials. Technically, the IND is an exemption to the federal law that prevents drugs from being transported or distributed across state lines without proper approval. The IND serves to exempt a pharmaceutical company from that restriction and enables a national clinical trial.

In clinical trials, pharmaceutical companies evaluate the effectiveness of a therapeutic agent by treating humans with a specific disease. Best research design practices often include randomized, double-blind, and placebo-controlled studies in which a causative relationship can be established between the therapeutic drug and the outcomes of treatment. Pharmaceutical companies usually design clinical trials by comparing their new agent agains a placebo or non-treatment condition. The comparison must be conducted in large populations in order to establish statistical significance of the therapeutic agent—although safety must be demonstrated before a large-scale clinical trial can be started. In some cases, the placebo or non-treatment condition may be purposely excluded from a clinical trial because of ethical implications of withholding potential treatment from diseased patients.

Once the IND is approved, pharmaceutical companies begin national testing of therapeutic agents in humans. The most common process for a therapeutic agent is to progress through four phases of clinical trials. Phase 1 studies are conducted in approximately 20 to 80 healthy volunteers in order to determine an agent’s safety and risk. If a therapeutic agent does not exhibit any unacceptable side effects, it may pass to Phase 2. The focus of Phase 2 clinical trials is on the effectiveness of the agent for the treatment of specific diseases. Much like the design of pre-clinical studies in animals, Phase 2 clinical trials are composed of many individuals (a few dozen to a few hundred people) with a test and control condition. Efficacy and continued safety must be demonstrated in Phase 2 in order for an agent to progress to the large-scale Phase 3 clinical trial. A phase 3 clinical trial may include several hundred to several thousand people. The objective of Phase 3 is to expand on the efficacy and safety information, including a study of different populations, dosages, and combinations with other drugs.

The FDA requires pharmaceutical companies to provide an updated Investigator’s Brochure (IB) to each principal investigator prior to the start of each phase of clinical trial. The IB is required to contain all known and relevant information regarding the therapeutic agent, including:

a description of the drug substance and the formulation
a summary of the pharmacological and toxicological effects
a summary of information relating to the agent’s safety and effectiveness in humans
a description of possible risks and adverse reactions—including safety precautions or special monitoring that the investigator should take

Following the successful completion of clinical trials, pharmaceutical companies submit a New Drug Application (NDA) to the FDA’s Center for Drug Evaluation and Research (CDER). If the therapeutic agent is a biological agent, companies must submit a similar document, the Biologics License Application (BLA) to the FDA’s Center for Biologics Evaluation and Research (CBER). Whether an NDA or a BLA, the application includes the following major sections:

animal pharmacology and toxicology study data
manufacturing information to demonstrate that the company can properly manufacture the drug
the company’s proposed label for the drug, which provides technical information about the drug, uses for which the drug has been shown to be effective, possible risks, and how to properly administer or take the drug

The NDA or BLA is the official application to the FDA for evaluating a new drug for marketing in the United States. Most applications are reviewed within 10 months, although priority drugs are typically reviewed in six months.

Product Commercialization and Technical Marketing Genres

Technical communicators often focus on the role of technical writers during product development, as described above. Yet, for technical communicators looking for new opportunities, the genre of technical marketing in the pharmaceutical, biotechnology, and health care industries might be particularly interesting. This genre is important as the application of science and technology to human health increases the demand to communicate effectively to the public (potential health care consumers) as well as to health care professionals.

The interdisciplinary relationship between technical communication and marketing was addressed in Technical Communication. The guest editors, King and Matherne (1995), stated, “Marketing will also underscore the necessity for writers to know the products they are promoting—benefits, features, and functions.” In fact, as these authors reported, “Typical ‘Madison Avenue’ marketing organizations, however, were ill prepared for the demands of promoting technical products. They often didn’t understand the products they were promoting.” Although many technical writers like to distinguish their writing from advertising, the lines blur in high-tech industries, especially in the emerging technologies using biological and nanotechnology for health care applications, where communicators need to have a technical understanding of the product.

Technical marketing includes the creation of product brochures (for health care consumers and professionals), television advertisements, print advertisements, press releases, websites, and even health care awareness campaigns. In fact, many technical resources and materials developed by technical communicators are also used to help commercialize a product. For example, clinical study reports, scientific publications, technical presentations, and white papers are all technical resources that, when the data is good, can be used to help commercialize a product.

Unlike other industries, however, the FDA monitors the marketing and advertising of pharmaceutical companies. According to the FDA, any therapeutic claim must be accurate and not mislead the consumer. Print advertisements must have a “fair balance” between the space devoted to benefit and risk information and the space allotted to a summary of side effects, contraindications, and precautions directly from the product’s label.

What This Means for Technical Communicators

In this article, I have divided the opportunities for technical communicators into product development and commercialization. The communication genres that have been highlighted are the required regulatory documentation and the subsequent marketing and advertising that are necessary to inform potential customers (including physicians and patients) about a new product. Technical communicators have become integral to product development, using their skill to understand and communicate complex information within a company and to government regulators. However, marketing and advertising departments are another place where technical writers and editors can thrive. In the case of pharmaceutical companies, technical communicators are essential to the efforts to communicate how health care technologies work, and to compare a therapeutic agent’s benefits with its side effects. As technical communicators assume these roles, they will make substantial contributions to the education of health care consumers.

Scott A. Mogull (mogull@uw.edu) is completing a dissertation on pharmaceutical marketing in the Technical Communication & Rhetoric Program at Texas Tech University. This August, he will be an assistant professor in the department of English at Clemson University, which offers a masters in professional communication and specialization in health communication.

Product Development and Regulatory Genres

Product Commercialization and Technical Marketing Genres

What This Means for Technical Communicators

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