New Drug Discovery and Development
The course provides knowledge of the current and, future trends in new drug discovery, including, both chemical and biological molecules, in the context of contemporary and emerging technologies, discovery strategies, and the overarching drug discovery paradigm. The course will explore safety, efficacy and toxicology regulatory guidelines developed by the International Committee on Harmonization, under the Code of Federal Regulations for the US Food and Drug Administration, and as promoted by the international Safety Pharmacology Society. The course explores all phases of new drug discovery and pre-clinical development leading to first-in-human clinical trials.
Pharmacological Principles and Receptors
Fundamentals of pharmacodynamics, pharmacokinetics, and drug absorption, distribution, metabolism and elimination, as well as theories underlying and applications of dose-response curves and radioligand binding experiments are covered.
Scientific Communication in Pharmacology introduces students to important skills needed to integrate and apply scientific knowledge by critically evaluating scientific literature, interpreting data, and effectively communicating scientific outcomes through oral communication. Topics will center around tools useful for searching scientific literature, understanding common laboratory techniques, critical analysis of scientific data, methods in effective oral communication of scientific research and practical experience in research and literature presentation. Upon completion of this course, students will have the necessary tools to begin work on their Capstone project. In addition, students will also develop skills important for lifelong career development by participating in special workshops and lectures designed to introduce them to career opportunities in the sciences and will complete an individual development plan (IDP), which will be reviewed by the course director.
Principles of Safety Pharmacology
Preclinical Drug Safety is a critical step in the drug development process. New chemical and biologic molecules must be evaluated for their potential to cause harm in “off-target” organ systems at therapeutic doses and above (Safety Pharmacology) or at high doses for increased duration (Drug Toxicology). These two equal, but distinct, components of preclinical drug safety (Safety Pharmacology and Drug Toxicology) are vital for protecting the public against harmful drugs and are required components of the FDA drug approval process.
This course, The Principles of Safety Pharmacology, will introduce students to the field of Safety Pharmacology, also known as secondary or off-target pharmacology. This field explores the impact of newly discovered drugs on critical physiological systems that are vital for life (e.g., cardiovascular system, central nervous system, and respiratory system) as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH guidance). This course will provide an overview of the field, introduce key principles, including regulatory aspects of the field and will help prepare students for careers in preclinical and clinical drug safety including opportunities in government regulatory agencies or the private sector (e.g., pharmaceutical companies or contract research organizations).
Good Laboratory Practice
The course will review the history of GLP in drug development; general provisions of CFR21, part 58; organization of a GLP unit and required training of personnel; setting up of a drug testing facility; standard operational procedures of the testing facility; procurement, determination of purity, handling and storage, preparation and stability of the test article (new drug); standard operating procedures and protocols of experiments; and recording, storage and reporting of data. The course will also include basis for disqualification or suspension of a testing facility by FDA and the appeal process for reinstatement or final disqualification or suspension. Students will also be taught how to inspect a GLP compliant drug testing facility and how to prepare a high qualify final study report.
Drug toxicology is an essential component of the drug development process and is a required component before use in humans (requirement for IND approval). The field of preclinical drug toxicology is distinct from safety pharmacology as it looks to evaluate the propensity of a new drug candidate to cause harm at chronic, high dose treatments. Several systems are evaluated including, the Immune System, Nervous System, Cardiovascular System, Developmental & Reproductive Toxicology (DART), Genetic Toxicology, and Carcinogenicity. This course will connect students with experts currently working in the field of drug toxicology while providing key insight to the regulatory aspects associated with evaluating a new drug for toxicity.
The course will provide students with a solid foundation in pharmacology, drug classes, exemplars, and mechanics of action and organ system applications.
Ethics in Research
This course introduces students to ethical theories generally and the ethical and regulatory issues they are likely to encounter as researchers. Student will learn to identify issues, analyze ethical issues in research and to develop coherent justifications for their ethical and responsible conduct of research.
Fall and Spring Semester
MS students will work in a research laboratory to familiarize themselves with research techniques. A series of laboratory rotations may be used to explore laboratory choices or a student may continue in the same lab to develop laboratory skills as well as specialized techniques.
A faculty-guided seminar-style class which includes seminar presentation, group discussion and written critiques of presentations. Graduate students in Pharmacology participate in seminar each term.
Experimental Methods in Nonclinical Safety Assessment
This course focuses on the necessary nonclinical drug safety studies required by the FDA. Students will integrate and apply knowledge gained from Safety Pharmacology and Drug Toxicology courses as they "develop" their assigned drug through the necessary safety assessments as outlined by the ICH guidelines and the FDA. Students will also gain a behind the scenes look at the drug development process with on-site tours of regional pharmaceutical safety facilities. This course also includes a Capstone component. Students will perform a critical analysis of published literature on a pharmacologic/toxicologic topic of interest. The written capstone will include a 6-page summary that describes the current knowledge in the field with students proposing their scientific next steps.