What is Safety Pharmacology?
Why a career in Safety Pharmacology?
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.
The Role of a Safety Pharmacologist in the Pharmaceutical Industry
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
The Role of Safety Pharmacology in a Regulatory Agency (US FDA)
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
Safety Pharmacology Society is a nonprofit organization that promotes knowledge, development, application, and training in Safety Pharmacology—a distinct scientific discipline that integrates the best practices of pharmacology, physiology and toxicology. The objective of Safety Pharmacology studies is to further the discovery, development and safe use of biologically active chemical entities by the identification, monitoring and characterization of potentially undesirable pharmacodynamic activities in nonclinical studies. The Safety Pharmacology Society also supports the human safety of drugs and biologicals by fostering scientific research, education, and dissemination of scientific information through meetings and other scientific interactions.
The Society is committed to uniting the global safety pharmacology community in the development and safe medical use of biologically active molecular entities by bridging across disciplines to allow the identification, characterization, and monitoring of potentially undesirable pharmacodynamic activities in nonclinical studies and guiding their translation into clinical trials.
Purpose: Safety pharmacology leaders providing answers to critical questions that matter to patients, regulators, and scientists.
- Advancing the Science
SPS Values: Scientific Excellence, Knowledge, Improving human and animal life, Collaboration and Cooperation, Integrity, Quality, and Respect for individual diversity, initiative, education and personal development.
Board of Directors
Board of Directors
Jill Dalton, David Gallacher, Dinah Misner, Tomas Mow, Brian Roche, Marie Luce A. Rosseels, Todd Wisialowski, Tanja Zabka
For descriptions and charges for all current SPS Committees, please visit our Committee page.
Please visit SPShare (login required) to view the current Committee Rosters
Historical Review: Origins, Practices, and Future of Safety Pharmacology
Derek J. Leishman
Mary Jeanne Kallman
Michael R. Gralinski
Peter K.S. Siegl
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Looking for exposure to potential new customers within the safety pharmacology community? SPS is pleased to announce their latest resource to serve the community, the Vendor Directory! The Vendor Directory is unique because it allows vendors to maximize their marketing dollars by combining online advertising to their target market as well as the opportunity to send out one direct email to SPS Members. Here are a few highlights of the Vendor Directory:
- The Vendor Directory targets those who are directly connected to the Safety Pharmacology Society as members. Our average member count is 450.
- Two listing types are availableat two price points, $150 and $300 (see full details in the information guide …).
- You provide the information to ensure the directory is as updated and accurate as possible (one revision allowed within the calendar year).
- Add your logo, business description, services provided, and contact details.
- Linked directly to your company website.
- Available online 24/7 and is mobile compatible.