Cardiovascular Physiology, Pharmacology and Safety
A Practical Review
Knowledge of the cardiovascular physiology, pharmacology, and safety is a key to moving drug projects forward. A drug development scientist must also understand cardiovascular receptor pharmacology.
This course will provide pharmacological strategies for management and correction of cardiovascular diseases. You will also learn safety issues associated with the cardiovascular system. At the end of this course, you will have a cardiovascular system “toolbox” at your disposal. This will help you make smart decisions based on proven science and avoid common pitfalls.
All course modules are 100% online and webinar-based. You may attend a live webinar or listen to a recording later. Prerecorded lectures are also available on demand. Course materials include case studies based on real life scenarios.
This course is part of the Drug Product Development Certificate. It fulfills one elective. You may take the course as is or as part of the certificate.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
Please contact Eric Buxton to qualify for the academic rate.
This course is online and self-paced. You may register at any time and complete the curriculum at your own pace by June 30, 2023.
Course Objectives
The purpose of this course is to provide the learner with a basic review of the fundamental physiological processes of the cardiovascular system and pharmacological strategies for management or correction of cardiovascular diseases. It will also address safety issues associated with drugs affecting the cardiovascular system. Topics covered in this course include:
Physiological considerations associated with the cardiovascular system including autonomic nervous system, renal and respiratory systems
Fluid compartments and their regulation; distribution of fluid volumes
Electrical conduction of the heart (ion channel function and cardiac arrhythmias)
Cardiac muscle function
Cardiovascular system function - flow, blood pressure and heart rate; how blood pressure is regulated
Cardiovascular receptor pharmacology
Drug exposure to cardiac tissue and vascular system; PK/PD modeling; autoradiography
Pharmacological considerations in the treatment of the disease states listed above
Cardiovascular safety consideration of the development of oncology agents, biologics, RNAi therapy, gene therapy, peptides, small molecules, vaccines, and implantation devices
Overview of cardiovascular consideration in the drug development process from chemist to market
Upon completion of the program the learner should be able to:
Describe the physiological regulation of the cardiovascular system and what makes it work;
Discuss cardiovascular receptor pharmacology;
Identify the actions of various pharmacological classes of drugs which are associated with the therapeutic management of different diseases;
Explain the drug development of novel compounds for treatment of heart disease;
Describe the safety assessment of non-cardiac novel compounds-bringing safe compounds to the market; and
Apply information in the course through case studies on drug development or post market reconsiderations (eg. Vioxx, Seldane, etc)
Course Outline
Unit
Topic
Subtopics
1
Physiological Regulation of the
Cardiovascular System
1.0 Cardiovascular System Part 1 1.1 Overview of the anatomical and physiological regulation of the cardiovascular system 1.2 What are the parts that makes it work 1.3 Pulmonary & Systemic Circulatory System
2
Physiological Considerations with the Cardiovascular System
2.0 Cardiovascular System Part 2
2.1 Overview of the physiological regulation of the cardiovascular system
2.2 Autonomic Nervous System 2.3 Blood Flow and Blood Component Functions
3
Kidney and Fluid Regulation and Blood Pressure
3.0 Kidney and Fluid Regulation
3.1 Fluid compartments and their regulation 3.2 Distribution of fluid volumes
4
Cardiovascular System Function
4.0 Receptor Pharmacology 4.1 Mechanisms of Receptors
·Describe the different classes of receptors (e.g. G-protein coupled receptors, ion receptors, etc) and the lock and key or nuclear target
·Learn the different classes of receptor ligands
·Recognize the differences between agonists, partial agonists, and antagonists 4.2 Receptor Families/Subtypes 4.3 Dose Response curves, Structure Activity Relationships 4.4 Novel targeting/delivery ideas: nanoparticles, phage, lipids, etc
6.1 Differences for cardiovascular safety consideration of the development of small molecules, vaccines, and implantation devices 6.2 Cardiovascular safety consideration of the development of oncology agents (especially kinase inhibitors), biologics, and peptides 6.3 Future cardiovascular safety consideration of the development of DNA/RNAi therapy
7
PK/PD Modeling and Biomarkers
7.0 CV Study Design and PK/PD
7.1 CV Biomarkers 7.2 PK and PD associations 7.3 Regulatory Guidance 7.4 Available technologies 7.5 Applications
8
Case Studies
Instructors
Kristy D. Bruse, PhD, DSP (Diplomate in Safety Pharmacology)
Integrated Physiology and Pharmacology Consulting, LLC
Robert Kaiser, PhD, DABT
Principal Research Scientist at Minnesota Children's Hospital
Children's Hospitals and Clinics of Minnesota
Hugo M. Vargas, PhD, DSP Scientific Director
Integrated Discovery & Safety Pharmacology
Amgen, Inc
Program Coordinator
Eric Buxton, PhD
Division of Pharmacy Professional Development 777 Highland Avenue Madison, WI 53705 (608) 262-2431 FAX (608) 265-2259 eric.buxton@wisc.edu