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Identifies and examines the key domestic regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry. Highlights current and emerging FDA regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.

The pharmaceutical and biopharmaceutical industries have strict documentation and production requirements. Prepares the learner to work in a regulated environment. Explains roles and responsibilities across multiple disciplines and proper documentation practices. Prepares learner for protocol, report creation and audit responses. Discusses specifications, guidances and root-cause analysis.

Provides an introduction to key terminology and lays a foundation of the critical body of knowledge project team members must master in a contemporary drug development enterprise. The latest project management theory is integrated with practical techniques and tools so that course participants learn to properly manage and schedule quality, budget, and progress objectives. Provides an overview of the economic structures, management and policy issues that drive and challenge the pharmaceutical and biotechnology industries.

Explores the process of bringing pharmaceutical products to market, particularly as it applies to the scaling up, manufacturing, and maintenance phases that come after FDA approval of a product is obtained. Identifies various factors that impact the life cycle management of pharmaceutical products from development to sustained large-scale distribution, such as: target product profile (TPP), chemistry, manufacturing and controls (CMC), active pharmaceutical ingredient (API) supply chain considerations, raw materials shortages, demand planning/forecasting, and post-approval regulatory considerations.

Teaches the theory and application of many common laboratory techniques and instruments used in drug discovery and development. Includes a laboratory component to teach safety and basic techniques necessary for working in a lab. Instruction begins with basic techniques and builds upon these techniques to instruct in proper sample preparation and handling for analysis using a variety of analytical instrumentation.

Provides a high-level overview of how data analysis techniques augment the drug discovery and development process. Focuses on project-based skills-building through the application of industry-standard software and use of public databases. Explores best practices for data processing and management to ensure experimental reproducibility. Develops troubleshooting skills through critical evaluation of data analysis results and root cause analysis.

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

Summation of core coursework to a real-world project and/or internship experience. Synthesis of knowledge, skills and abilities to demonstrate aptitude for careers in respective industries.

Introduction to basic concepts of drug delivery and action, methods used to study drug action. Includes a brief survey of drugs acting on the cardiovascular system, the central nervous system and other drug targets.

Overview of the drug development process from discovery to approval. Process of drug development from target identification to investigational new drug (IND) submission including tenets of rational drug design, preclinical CMC activities, and preclinical pharmacology, pharmacokinetic, and toxicology studies. Small and large molecules (biologics/biotherapeutics) will be covered. Brief history of drug development and various case studies offering insights into preclinical drug development.

Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.

Quantitative aspects of drug absorption, distribution, metabolism, and excretion. Philosophy and applications of pharmacokinetic modeling and its use in clinical practice.

Provides a foundational understanding of how chemical features can influence the biological activity of a molecule on molecular targets within the central nervous system (CNS), how alteration of signaling through these targets occurs and leads to physiologically relevant changes, and how major classes of pharmaceuticals acting on the central nervous system are applied in healthcare settings to improve patient outcomes. Integration between concepts arising at the chemical, molecular, cellular, systems, organism, and societal levels will be explored.

Gain additional understanding of how chemical features can influence the biological activity of a molecule on molecular targets within the central nervous system, how alteration of signaling through these targets occurs and leads to physiologically relevant changes, and how major classes of pharmaceuticals acting on the central nervous system are applied in healthcare settings to improve patient outcomes. Integration between concepts arising at the chemical, molecular, cellular, systems, organism, and societal levels will be explored.

Provides an in-depth introduction to the molecular and cellular principles of pharmacology. Emphasis is on the mechanisms of drug and small molecule action in cells, with a particular focus on downstream signaling pathways, second messenger systems, protein kinase cascades, and the regulation of gene transcription.

Course designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications used for each topic.