Monday, September 19, 2011
AM Courses: 08:00–12:00
AM1: Intermediate Cardiovascular
This Intermediate Cardiovascular course is intended for individuals with previous knowledge of cardiovascular safety pharmacology as well as those interested in learning more about cardiovascular safety studies. This is an “everything you want to know about cardiovascular system” course. With an over-arching leaning toward safety pharmacology applications, lectures covered in this course will include overviews of electrophysiology, electrocardiography, cardiovascular physiology-contractility, hemodynamics, the utility of stem cell technologies, and non-invasive measurements of cardiac function. Active participation from the attendees is highly encouraged.
AM2: Study Design—Considerations for Balancing the Scientific, Economic, and Regulatory Equation
Historically, the design of Safety Pharmacology study packages has had three primary drivers: scientific, economic, and regulatory, with the focus being to provide confidence in target safety. More recently, new technologies and increased business pressures have resulted in expansion of that original focus to include aspects of compound safety and compound selection. These new technologies provide opportunities to design single studies capable of providing data that previously required multiple studies. The advent of these efficient and effective study designs provides for Safety Pharmacology involvement in the earliest stages of the developmental continuum. This course will examine how we can leverage these technologies to create unique multi-targeted study designs applicable to the early development space, providing new approaches to balancing the scientific, economic, regulatory equation.
AM3: Supplemental Safety Pharmacology Studies
The ICH S7A guidelines have recommended that when concerns arise from core battery studies, clinical trials, post marketing surveillance, or from other nonclinical studies, then it is prudent to conduct supplemental safety pharmacology studies. These supplemental studies are designed to evaluate potential adverse pharmacodynamic effects on organ system functions not addressed by the core battery or repeated dose toxicity studies. This course will provide to individuals involved in the development of therapeutic agents. The session will focus on study designs and sample results used to evaluate the Renal/Urinary, autonomic and Gastrointestinal system, and understanding the physiological basis of the supplemental tests.
AM4: Microsampling Techniques and Novel Applications in Exposure Assessment
This course will deliver general principles and technologies of modern pharmacokinetic sampling, data acquisition, manipulation and interpretation, and current status of microsampling/dried blood spot technologies for safety pharmacologists. Recent advances in microsampling and enhanced bioanalytical assay sensitivity afford opportunities to improve study data quality, reduce animal study numbers (Refinement and Reduction improvements) and to identify biomarkers with which to mitigate risk in human clinical trials. Participants will; 1) Identify the reasons to consider inclusion of test article exposure measurements in safety pharmacology study plans; 2) Identify regulatory guidance and regulation pertinent to test article exposure monitoring in safety pharmacology study designs; 3) Identify specific strategies, advantages and disadvantages for exposure monitoring in study plans; and 4) Identify new technologies and techniques that reduce or eliminate obstacles to test article exposure monitoring in safety pharmacology studies.
Lunchtime Mini Course: 12:30–13:30
PM9: Lunchtime Mini Course: Case Studies—The Journey from PreClinical to Clinical
The intent of this course is as an interactive facilitated discussion. The course instructors will present scenarios and facilitate the discussion with course participants. Course participants are encouraged to submit brief cases (3 to 4 PowerPoint slides) to the course facilitators prior to the meeting to allow broader experiences for the discussion.
PM Courses: 14:00–18:00
PM5: Drug Abuse Liability Testing
Drug abuse liability testing has become a hot topic in drug development and in particular within the nonclinical safety evaluation area since the release of the EMEA guideline (March 2006), the ICH guideline (June 2009) and recently the U.S. FDA draft guidance (January 2010).
This course is meant to give an overview of the various topics within this field. New technologies that might help in the evaluation of withdrawal will be demonstrated.
Given some case studies, the impact of a preclinical abuse liability assessment of new compounds will be discussed with regard to the translational approach and the possible ways to move forward in late drug development and beyond.
PM6: ECG Interpretation
A decade on from the formation of the Safety Pharmacology Society, scientist in the field across the world continue to have to review ECGs as an essential tool to the assessment of effects on the heart. Abnormalities such as arrhythmias, myocardial infarctions, atrial enlargements, ventricular hypertrophies, and bundle branch blocks can be discerned on an ECG. This course will be taught by world leaders in the fields of safety pharmacology and electrophysiology. This CE course is designed to help students, technicians and other allied health personnel acquire the skills to analyze and interpret fundamental changes in ECG morphology and identify common waveform abnormalities. The course will be a combined lecture and workshop, covering topics such as basic electrocardiography including a qualitative and quantitative assessment of the ECG waveforms.
By the end of the day, attendees are expected to be able to:
- Identify the components of a normal ECG
- Recognize common abnormalities
- Perform quantitative measurement of ECG intervals
Sample ECGs will be provided and, following practical, hands on instruction, attendees will be expected to read and interpret a test set. The intent of this course is as an interactive facilitated discussion. The course instructors will present scenarios and facilitate the discussion with course participants. Course participants are encouraged to submit sample ECGs (3 PowerPoint slides) to the session Chair prior to the meeting to allow broader experiences for the discussion.
Participation in the CE course, Intermediate Cardiovascular Safety Pharmacology, is strongly recommended prior to attending this class.
PM7: Principles of Best Practice: How Will You Know When You Get There?
Closer and closer attention is being paid to safety issues with new medicines. The safety pharmacology studies are no exception. Questions on comparison of effects from animal and man and the predictivity of the animal studies for outcomes in man are increasingly common. The “QT issue” which was largely credited as the subject that framed the emerging Safety Pharmacology Society’s focus and foundation has given us all considerable experience in examining these translation questions. In facilitating comparison across studies, species and organizations it has never been more important that key features of study design, quality and reproducibility be described and across all the organ system studies within the scope of safety pharmacology assessment. This course will enable experts and novice attendees alike to discuss past performance, current study design and future directions pertaining to Safety Pharmacology Best Practices. This course will focus on the core organ systems, CV, CNS, Respiratory and supplemental GI/Renal. Presenters will address the following questions through the frame of their experience and in the interest of furthering the Safety Pharmacology Discipline:
- What needs to be put in place prior to study start
- positive controls
- power analysis
- historical database
- variability control charting
PM8: Safety Pharmacology Endpoints: Integration into Toxicology Studies
Safety Pharmacology studies are typically conducted as stand-alone studies where exposure of test subjects to a given test article is limited to one administration at each dose level. Although these dedicated studies provide invaluable information to assess potential risk to vital organ systems of participants in first-in-human studies, the integration of Safety Pharmacology assessments into repeat dose toxicity studies allows evaluation of functional changes following administration of multiple doses. Such study designs are being made possible with the advancement of minimally invasive technologies, and may provide for a more robust safety evaluation—better predicting potential risk in later clinical trials where exposure to the test article is of longer duration. The course will focus on how to best integrate safety pharmacology endpoints into repeat dose toxicity studies, the advantages and disadvantages of dosing so, and the critical scientific and regulatory factors to keep in mind.
CE Course Registration - If you have previously registered for the Annual Meeting and would like to add a CE course, please contact SPS Headquarters for processing, or simply complete a Registration Form and indicate that you are adding a CE course. Form can be faxed or mailed to SPS.