Continuing Education Courses
(additional fee; see registration page)
Live courses to be held once a week between September 23–October 29; all courses will be available on-demand. See Full Program for Additional Information and Course Dates.
Use of Artificial Intelligence (AI)/Machine Learning (ML) in Drug Development and Safety
Artificial Intelligence (AI) and Machine Learning (ML) are two major fields of computational science that are making major inroads in safety pharmacology and toxicology. Both ML and AI approaches are data-driven however differ on the model complexity as AI models can require significantly more data. ML models are useful to understand how explanatory variables define the risk of adverse events. AI models identify nonlinear patterns in the absence of human intervention. The knowledge of the principles underlying ML and AI will help the safety pharmacologist to understand the extent of its application in nonclinical safety. AI and ML approaches could possibly help better understand safety risk during preclinical development. No deep knowledge of algebra, probability or statistics is required. The basic principles of AI and ML will be introduced in the course. Specific examples from the safety pharmacology/toxicology will foment the acquired knowledge.
Safety Pharmacology of the Senses
Most people are familiar with the classic five senses of sight, hearing, touch, smell and taste. However, the concept of a sense can be extended to include sensations such as hunger or thirst. Other senses such as thermoception, equilibrioception, proprioception, nociception, or even a sense of the passage of time. These ‘senses’ are all very important in determining or quality of life. We’re also aware of very small acute changes in some of these ‘senses’. Given the potential impact of these ‘senses’ on our overall quality of life there is a question of how a safety pharmacologist characterizes and quantifies an impact on these senses. Following an overview of the senses and some examples of drug effects on these we will be presented with focused examples. We will start with the example of temperature, since this is a relatively simple signal which can be recorded in our animal species. We are all well enough aware of seasonal fevers and chills to know that it is something we can be acutely aware of. We will then look at assessing an impact on vision (and how we can take advantage of equilibrioception in measuring vision). We will close the session with consideration of the ear and ototoxicity and the impact on hearing and balance.
Imaging Technologies in Safety and Preclinical Research
Imaging technologies are increasingly being used in preclinical drug development. These technologies enable non-invasive measures of tissue, or organ function or structure in vivo. These tools can add value to preclinical studies by enabling dynamic observations on the same animal and by offering possible clinical translation. They have evolved a lot over the last decade and are now more and more used as support to preclinical development. Imaging can be helpful to refine safety assessment in the cardiovascular field, to confirm target engagement of a new candidate drug in animals before starting clinical trials, or can be applied in some disease models.
The course will cover the following:
- An introduction to imaging technologies in preclinical research
- Echocardiography in preclinical animal models
- PET Imaging as support to Neuroscience drug discovery
Enough time will be kept to discuss real life case studies. This is a unique opportunity to keep you informed about a very promising and rapidly advancing field.
The Power of Safety Pharmacology in Drug Development
Each of a safety pharmacologist’s tests have two kinds of power – discriminatory power and predictive power. Appropriate use of the right power in the right way is vital for quality decisions in drug discovery and development. To understand the two types of power, consider two questions:
- What is the probability that my test will be positive given that the test compound is known to have this safety issue? This is the discriminatory power of the assay and we’d term this particular probability the sensitivity of the test.
- What is the probability MY compound will have this safety issue given that the test result was positive? This is the predictive power of the test and this particular probability is called the positive predictive value.
These two types of power are often confused. It is likely that the safety pharmacologist and their colleagues are actually most interested in question two and are most interested in predictive power. To answer question two, you need to know the answer to question one. However, you also need to know one other element. This element or context of test application can make all the difference in predictive power and could mean that applying the test and acting on the result may actually be doing more harm than good. Furthermore, the answers to each question are seldom known with absolute precision, this means that in decision-making you need to set a threshold for predictive power which is necessary for the decision and also the confidence level with which you will accept that the threshold has been met. Effectively a probability that you have attained a probability. Certainty is not possible and this probability-driven approach is inevitable. Experienced safety pharmacologists applying good judgement is a reflection of them applying this probabilistic approach intuitively. This course will illustrate how to build the components of this process such that a participant will grow in experience and judgement in a manner which can be articulated and shared to come to a common understanding of risk. This course will include how to determine discriminatory power by discussing topics such as sensitivity, specificity, ROC curves, likelihood ratio and weight of evidence. The course will also demonstrate how to determine the predictive power by discussing prevalence and prior probabilities coupled to discriminatory power.
Watch Your Tone: Intended and Unintended Effects on the Autonomic Nervous System and the Downstream Impact on Key Organ Systems
The autonomic nervous system (ANS) consists of the sympathetic and parasympathetic branches working in balance to regulate many critical organ systems and physiological processes including the cardiovascular, pulmonary and digestive systems. The ANS also impacts other physiologic processes such as circadian rhythms and sleep cycles. There are numerous drugs that are targeted to modulate the sympathetic and parasympathetic branches; however, therapeutics can also unintentionally impact the ANS, resulting in altered physiology. As a result, the drug industry needs to be aware of how changes in autonomic tone modulate key organ systems and how to quantify the impact on each system. The goals of this course are to present basic foundational knowledge of ANS anatomy and physiology, as well as advances in translational autonomic testing. In addition, methods to assess autonomic tone in the preclinical drug development setting will be presented with a focus on the use of heart rate variability to understand sympathetic and parasympathetic balance. Finally, specific case studies and examples will be presented to put the newly acquired information into practice.
Advances in In Vitro/Ex Vivo Assays
In vitro and ex vivo techniques that gauge the cellular and organ responses to new molecular entities are major components of the battery of assays used in preclinical drug development. As new methods are becoming available, the question rises to what extent they can unveil new cellular mechanisms or safety risks. In this course we will discuss the basic principles and advances in two cell monitoring assays including impedance spectroscopy and high content imaging, and a toxicologic assay based on digital pathology. The course will focus on experimental set ups, data acquisition, data analysis (including statistics and algorithm development), scientific interpretation and data storage. The course will show several case studies describing how the techniques can be used to tackle scientific questions and include suggestions for navigating the regulatory challenges. A basic understanding of putative assay approaches and their respective benchmarks are decisive to determine the molecular mechanisms underlying drugs effects, safety risks and assess the translatability to clinical findings.
Mini Course: This one-hour course is available at no additional charge with an Annual Meeting Registration. Date announced soon.
The Diplomate in Safety Pharmacology: Introduction, Scope and Preparation Strategies
The Diplomate in Safety Pharmacology, a certification in Safety Pharmacology created by the SPS, will celebrate its 8th anniversary in 2020. This mini-session will present and discuss the format, scope and potential preparation strategies for the DSP. The process to prepare the examination, set the pass score and recent changes to the exam structure will be reviewed in an interactive session. Comments and experience from successful DSP candidates will be shared as informal discussion at the end of the session.
(Available in Virtual Meeting Platform)
The meeting materials are restricted to 2020 Meeting Registrants. All materials will be available within the virtual meeting platform during and after the event. Once the event is open, please login to access materials