Curriculum: Global Regulatory Affairs in Drug Development

This course provides graduate students with an overview on legal and regulatory aspects relevant to drug and medical device development. This includes intellectual properties protection, global legal and regulatory requirements, protection of human subjects and ethics in clinical research and essential elements of management of global projects. Case studies will be included to underline how regulatory strategiesimpact product marketing and life cycle management. Throughout the course, students will integrate knowledge using specific industry examples with the goal to identify critical decision points in the development that impact success of a new drug or medical device on the market.

This course is an introduction to the discovery and early development (ie, prior to pre-clinical) of small molecule therapeutics and biopharmaceuticals such as proteins, peptides, vaccines, cell and gene therapies, and nucleotide based products. Introductions to the major classesand categories of drugs and biological will be provided including some principles of pharmacologysuch as drug targets/receptors and drug-receptor interactions. Methods and principles of drug/biologics discovery will be addressed from serendipitous observation to current approaches such as HTS, computational, combinatorial chemistry, and bioinformatics. Comparison of manufacturing methodology of drugs and biologics will be provided along with special clinical and regulatory considerations for biologic products. Additionally, emphasis will be given to major therapeutic areas (oncology, CNS, cardiovascular, Infectious Diseases/AIDS) in terms of approaches currently in use and in development along with addressing the unmet needs in each area.

The course is designed to teach students regulatory framework for the pre-clinical evaluation of the safety and efficacy of a molecular entity/lead compound identified in the drug discovery/early development phases for submission of the IND application. Major emphasis will be placed on the principles of pharmacokinetics/toxicokinetics and ADME processes(Absorption, Distribution, Metabolism and Excretion) so that safe (and efficacious) dosing regimens can be recommended for the early clinicaldevelopment phases. Differences between conventional (small molecules) vs. macromolecules and biologicals will be underscored.

This course is designed to provide an understanding of the studies conducted in support of the development of drug product (formulation/dosage form) and medical devices necessary to seek regulatory approval. An emphasiswill be placed on pre-formulation/formulation studies for optimizing lead compounds during earlystages of drug development, current good manufacturing practices (cGMP) and FDA/ICH guidelines for formulation components, processes and equipment, stability testing programs and overall quality assurance. Special aspects of formulation of biologicals and medical devices will also be discussed.