Capstone Certificate in Applied Drug Development

Explores strategies for navigating key phases of the graduate student experience: transitioning into graduate school, the formation of professional identity, and charting post-graduation career pathways within the pharmaceutical sciences. Builds skills needed for success in graduate-level coursework, as well as professional competencies valued in today’s scientific workplace. Focuses on effective scientific communication, career development, collaboration skills, personal reflection, self-advocacy, metacognitive practices for learning, and commitment to personal integrity—and how each of these connect to the core concepts of the Wisconsin Experience.

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.

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.

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

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.

• Biochemical and spectrophotometric basis of molecular target assays in drug development.
• Different types of in vitro and cellular assays – how to choose the best one for the problem at hand.
• On-target and off-target activity.
• Uses and limitations of biochemical assays, biomarkers, and animal models.
• Challenges of translating pre-clinical data into clinical assumptions.
• Biases on non-quantifiable data.
• Critical evaluation of case studies and experimental assays on infectious diseases, auto-immune diseases, and CNS disorders.
• Designing proper assays according to drug development projects.hypotheses