About

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.

Key concepts and body of knowledge of Project Management (PM) applied to the specifics of the drug development process. PM theory and language. The life cycle of a project: Initiating, Planning, Executing, Monitoring and Control, and Closing. Predictive, adaptive and hybrid PM frameworks and tools. Project Charter, statement-of-work, scope of work, work-breakdown structure, project network and timelines. Critical path method and earned value analysis to adjust schedules, allocate resources, and implement corrective actions. Risk management in pharmaceutical projects. An overview of documents management and decision-making strategies.

Explores business aspects of pharmaceutical product development and post-approval product maturation. Covers startup financing, risk management, intellectual property considerations, supply chain management, and strategic decision-making, as applied to both large and small pharmaceutical companies.

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 investigational new drug application (IND). Drug discovery (target identification, target validation, and hit-to-lead) preclinical CMC activities, and preclinical pharmacology, pharmacokinetic, and toxicology studies as they apply to both small and large molecule drugs.

Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.

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.

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.