Program Agenda

Program


Saturday, October 18

Diplomate in Safety Pharmacology (DSP) Certification Exam: For more details and to register for the exam, please visit the DSP page.

Sunday, October 19

Half-Day Continuing Education Courses: For more information please visit the Continuing Education page.

Monday, October 20, AM

Keynote Plenary: The Past, Present, and Future of Alzheimer’s Disease Research
Neil Buckholtz, PhD, Division of Neuroscience (DN) at the National Institute on Aging, National Institutes of Health, Bethesda, MD, United States

Track A: Cardiovascular 1

The industry standard for assessment of pre-clinical cardiovascular safety has focused on drug induced changes on heart rate, blood pressure and electrophysiology. A fundamental property of the cardiovascular system that has not been consistently investigated is the inotropic state of the heart which impacts cardiac output and blood pressure. Reasons that the effects of drugs on contractility have not been investigated include lack of agreement on appropriate methods to interrogate these effects and lack of understanding regarding the translation of preclinical results to the clinic. The purpose of this session is to bring together speakers on appropriate methods for investigating left ventricular function. In addition, results from the HESI Cardiac Safety Initiative will be presented showing the predictivity of pre-clinical studies.

Track B: Central Nervous System

This session will focus on safety assessment in a range of areas related to the CNS. One presentation is on testing in juvenile animals, an area until now, not in the focus of the Safety Pharmacologist. Further presentations will address safety issues associated with the visual system, which is a relatively new field in this context. The abuse liability potential of large molecules is a novel concept and will be the topic of a further talk. Finally, convulsive potential of novel compounds is often underestimated. The US Food and Drug Administration perspective and recommendations for resolving-issues to convulsions are in the focus of the final talk.

Monday, October 20, PM

Track A: Noncardiac Ion Channels

Cardiac ion channels receive a lot of attention in safety pharmacology. However, drug discoverers need to remember noncardiac ion channels, too. In this session, experts from the ion channel field in drug discovery will present recent and relevant findings from work related to selectivity and trafficking of ion channels related to important therapeutic areas such as pain and cystic fibrosis.

Track B: Peripheral Neuropathy

Peripheral neuropathy is damage or disease affecting nerves, which may affect sensation, movement, gland or organ function, and other aspects of health, depending on the type of nerve affected. Common causes include systemic diseases such as diabetes or leprosy, vitamin deficiency, medication such as chemotherapy, traumatic injury, excessive alcohol consumption, immune system disease, infection, or it may be inherited and present since birth. The objective of this session is to present a clinical overview of peripheral neuropathy, including preclinical assessment, clinical translation, clinical translation, and risk validation. Additionally this session will look at examples of peripheral neuropathies associated with oncolytics and diabetic neuropathy.

Tuesday, October 21, AM

Track A: Cardiovascular 2

Often drug development decisions are not black and white and each drug development program offers its own unique set of challenges. In the case of cardiotoxocity testing, the changing regulatory landscape also adds to this challenge making it difficult to navigate the safest, most efficient development path. What are the decision factors when the preclinical cardiotoxicity data is not black and white? Is this automatically a reason to stop compound development? What if the preclinical data is clean followed by an unexpected signal in the clinic? How do regulators approach evaluating conflicting preclinical cardiotoxicity results? The objective of this session is to highlight how those in industry and regulatory agencies have tackled some of these challenges with the goal of providing insight into different approaches that could be used to safely and efficiently move compound development forward.

Track B: Regulatory

Focus of the session will be a discussion of regulatory guidances that were recently issued. The first two presentations will focus on the Draft Guidance on Abuse-Deterrent Opioid Formulations. Speakers will summarize industry and regulatory discussion of expectations and application of the challenges of the guidance to new drug applications. The topic for the latter presentations will include a discussion of the challenges of approving treatments that need to be tested in biohazard containment and finally a perspective of how the industry is doing a decade after implementation of the S7 guidance documents.

Tuesday, October 21, PM

Track A: Novel Assays for Safety Pharmacology Assessment: Zebrafish (Sushi or Science?)

Models are what make the world go ‘round…. Or at least that is what safety pharmacologists think. Animal models are key to nonclinical safety testing, but validation data is needed to understand and interpret the results. The first session, “Zebrafish (sushi or science?)” will feature early safety assessment screening using zebrafish, focusing on the areas of QT prolongation, seizure liability, abuse liability and GI dysfunction.

Track (cont’d) A: Nausea and Vomiting, Not a Gagging Matter

Nausea and vomiting are a common side effect of chemotherapy with a global market of > $2.5 billion market. Additionally, nausea and vomiting are common adverse events seen in Phase 1 studies. The second part of the session, “Nausea and vomiting: Not a gagging matter” will feature two talks on animal models of emesis with a detailed discussion of the mechanism and a comparison of species, highlighting how animal models for emesis can be used in safety assessment.

Track B: Should the Sleep State be a Target for Safety Pharmacology?

The sleep state is known to have a restorative function and disruption can lead to adverse cardiovascular and CNS effects. Physiological changes that occur during sleep include decreases in airway tone and respiratory drive, which can lead to adverse events such as sleep disordered breathing and apnea. The objective of this session is to present the methodologies used to monitor the stages of sleep in animal models, review the physiological changes associated with the sleep state, discuss the causes and consequences of sleep disruption and sleep apnea, and ultimately address the question of whether there are drug targets associated with sleep that could impact safety and should be addressed in safety pharmacology studies.

Wednesday, October 22, AM

SPS Annual Members Meeting, Awards Ceremony, and Distinguished Service Award Presentation

Plenary: Update and Perspectives on Comprehensive In Vitro Proarrhythmia Assay (CIPA)

Drug induced proarrhythmia continues to be a major issue in pharmaceutical discovery and development. The current approach for assessing this risk can identify drugs as having increased risk despite having no demonstrated proarrhythmia.

Recent discussions between regulatory agencies, academics and the pharmaceutical industry have begun to outline a new approach that has potential to improve the prediction of proarrhythmic risk. The purpose of this session is to bring together experts in the primary areas that have been included in this new analysis, update the audience on progress and the plan to move forward. Finally, the goal is to have an open discussion regarding the pros and cons of this new testing proposal.

Wednesday, October 22, PM

Plenary (Cont’d): Update and Perspectives on Comprehensive In Vitro Proarrhythmia Assay (CIPA)

Presidents Summary

Meeting Adjourns