As gastroenterology fellows ponder their futures, one career path is often overlooked. Working in the pharmaceutical or biotechnology industry is a path that is not often at the top of career option lists. It is a rare occurrence for fellows to transition immediately into an industry position as opposed to a clinical or academic post. Initial clinical experience, caring for patients, and gaining experience with health economic challenges in today’s complex environment are considered invaluable assets for job applicants seeking industry positions. A minimum of 3-5 years of real-world clinical care experience will greatly enhance applicants’ marketability as “clinical experts” who can provide meaningful value to industry employers.
Dr. Mark B. Sostek
What exactly does “industry” mean? Traditionally it includes pharmaceutical and/or biotechnology (discovery, development, manufacture, sales, and marketing of small or large molecules), contract research organizations (CROs), and medical device companies. The variety in terms of size, scope, and reach of these companies is truly staggering and includes: entrepreneurial small startups (fewer than 20 employees, one location), midsize companies (more than 200 employees), and global multinational worldwide behemoths (“big pharma” with more than 50,000 employees and numerous facilities with diverse geographic locations). There are certain geographic regions of the United States where many companies’ headquarters are concentrated. At present (although this certainly can change over time), Cambridge, Mass.; New Jersey; Philadelphia; Raleigh-Durham, N.C.; and the San Francisco Bay Area are “hot areas.”
The breadth of “specialty” areas in industry for experienced clinicians is wide and includes: discovery, translational medicine, early- and late-stage clinical development, medical affairs, patient safety, epidemiology, and commercial development. For those interested in transitioning into industry, it is ideal to have a preferred area in mind so that training and education while in fellowship and clinical practice can be directed to that topic.
Discovery and translational medicine
These areas focus on preclinical development of small and large molecules from first concept until first-in-human studies and filing of an investigational new drug application (IND) with regulatory agencies. Translation of basic science concepts into potentially clinically useful “candidate” molecules requires a strong basic knowledge of science in addition to clinical experience. A passion for bridging novel concepts from “bench” to nonhuman studies is critical for success in this area.
Early-stage clinical development
Early-stage clinical development focuses on progressing discovery candidates to first-in-human studies (phase 1 in healthy volunteers) through phase 2 proof-of-concept studies (PoC). PoC studies typically involve first proof in a clinical trial in the target population that the drug under development may provide clinical benefit. These studies typically include 50-200 subjects with tight inclusion and exclusion controls. Intellectual rigor and scientific curiosity, as well as a passion for protecting patient safety, are essential for success as an early-stage drug developer.
Late-stage clinical development
Late-stage clinical development involves designing, conducting, and executing very large clinical studies (typically with hundreds to thousands of patients) that will provide the necessary rigorous pivotal clinical data supporting new drug marketing applications (NDAs). Relatively few drug candidates successfully make it to this stage of development and these studies are extremely expensive (sometimes hundreds of millions of dollars). This stage of development requires close collaboration with numerous company functions including regulatory, biostatistics, patient safety, clinical pharmacology, clinical operations, and manufacturing, as well as commercial colleagues. In addition to strong clinical expertise, this stage of drug development requires excellent communication, with leadership skills and attention to detail as well. Successfully shepherding a drug candidate through to Food and Drug Administration or other regulatory agency approval is an extremely satisfying experience, which can lead to meaningful differences for patients.
