Safety Pharmacology satisfies a key requirement in the process of drug development. Safety Pharmacology studies are required to assess the impact of a new chemical entity (NCE) or biotechnology-derived product for human use on vital organ systems before first-in-man drug testing. Safety Pharmacology studies are defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.
The field of Safety Pharmacology is rapidly developing since the ratification of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH S7A guidance) in November 2000, as well as the incorporation of the Safety Pharmacology Society in 2001. The demand for safety Pharmacologists is greater now than ever before. A career in Safety Pharmacology will be filled with variety, challenges and growth like no other field.
Although the article linked below applies to the greater field of toxicology, it is very relevant to a discussion of the workforce situation for Safety Pharmacology. Opportunities Abound in Toxicology, Brian Vastag, United States, June 20, 2008.
Safety pharmacology plays a critical role in the pharmaceutical industry, by providing valuable insight into potential adverse effects of drug candidates. These data are used to guide physicians in the safe conduct of clinical trials thru design and execution. A core battery of Safety Pharmacology tests are required by international regulatory guidelines (ICH S7A/S7B) prior to initiation of the first human dose of an investigational medicine. This core battery of tests includes cardiovascular function, respiratory function (e.g. Plethysmography), and CNS behavior (e.g. Irwin, Functional observational battery). Other supplemental tests may be conducted to assess other organ systems if a need is identified.
Safety pharmacologists may be responsible for planning, conducting, and reporting of in vivo and in vitro cardiovascular, respiratory and neurobehavioral assays to evaluate potential unanticipated pharmacodynamic effects of test articles prior to introduction in humans. Additionally, writing detailed scientific reports/manuscripts and preparing documents for regulatory filings both nationally and internationally are frequently required.
Finally, a safety pharmacologist can also perform additional testing aimed at defining the possible mechanisms for unwanted side effects. These types of studies are a stimulating and challenging area of safety pharmacology. Each new drug tested is unique in both mechanistic and therapeutic terms, which means that the safety pharmacologist has an opportunity to develop creative testing strategies. These projects frequently can lead to presentations at internationally renowned meetings and publications in scientific journals.
In terms of day to day work, safety pharmacologists will work with many individuals both within and outside of the company. These individuals include scientific colleagues involved with the daily activities of the core battery of studies. The safety pharmacologist will also collaborate with members from other departments such as toxicology, drug metabolism, basic science and quality assurance in the design and execution of studies both within his organization and at outside contract research organizations. As a study director, the safety pharmacologist will prepare study protocols and write reports on completed studies. In many cases the Safety Pharmacologist will work within a contract research organization and provide critical expertise for organizations that do not have the specialized in-house capabilities of a Safety Pharmacologist. The safety pharmacologist will also interact with vendors to troubleshoot technical problems or to discuss new technologies available in the field. As the company expert, he may also be called upon to interact with regulatory agencies to respond to questions as they arise. A Safety Pharmacologist will have a high impact and dynamic position in any organization whether in a pharmaceutical company or contract research organization.
Pierre Morissette, PhD
Senior Research Pharmacologist
Merck & Co., Inc.
Safety and Exploratory Pharmacology
Safety pharmacology studies, which investigate potential undesirable pharmacodynamic effects of a test substance on physiological function in relation to exposure, play an important role in determining whether and how (dose regime, subject selection) a novel test substance can be administered safely to human subjects.
Core studies on key systems (central nervous, respiratory, and cardiovascular systems) constitute an important component of the initial safety evaluation, and are reviewed prior to the first administration to human studies. Hazard identification and risk evaluation are key aspects of the evaluation, and can be critical in design of clinical trials.
Pharmacologist/toxicologists are tasked with reviewing safety pharmacology studies, and interact with other members of the review team, which include medical officers, clinical pharmacologists, chemists and project managers. Pharmacologists/toxicologists also interact with industry scientists to evaluate specific concerns related to mechanism of action and empirical findings seen in other studies or with similar test substances.
John Koerner, PhD
Division of Cardiovascular and Renal Products Center for Drug Evaluation and Research
US Food and Drug Administration