Sponsored Sessions/Presentations
Organizations associated with SPS as Exhibiting Companies and/or Sponsors are welcome to host Sponsored Presentations/Functions. All Sponsor Presentations/Functions must be pre-approved by SPS Headquarters.
The fee for hosting such an event is $1,000 U.S., and includes the following: listing on the SPS Annual Meeting Web site, listing in the Final SPS Program, and two pre-meeting e-mail announcements distributed by SPS Headquarters.
Please fill out the application and return it to Laura Helm.
ChanTest Corporation
September 20, 2011
12:00–13:00
Congress Innsbruck—New Orleans
Perfecting Nonclinical Cardiac Risk Assessment
There is general agreement that hERG in vitro assay, a primary means of classifying investigational drugs with the potential to prolong the QT interval, lacks sufficient sensitivity and specificity to predict that clinical risk of QT prolongation and Torsades de Points. We have recently begun a collaboration with the U.S. FDA designed to improve predictivity. ChanTest will provide key cardiac ion channels responsible for the QT by screening our Cardiac Ion Channel Panel™ and human stem cell-differentiated cardiomyocytes with ˜ 77 reference compounds. U.S. FDA will curate the relevant clinical data for QT, TdP, PK, and ADME. Various models will be used to interpret the predictivity of the different nonclinical assays.
CiToxLAB
September 20, 2011
12:00–13:15
Congress Innsbruck Rennweg—Grenoble
Safety Pharmacology: Regulatory Considerations and Characterization of the Göttingen Minipig
The Göttingen minipig is widely used for regulatory toxicology studies but faces an information gap pertaining to safety pharmacology studies using this species. Considerations to the use of Göttingen minipigs in drug development will be presented with species specific characteristics of the model. A practical approach to cardiovascular, respiratory and central nervous system pharmacology using the minipig will be presented. The seminar will be followed by round table discussions with the panel and attendees while lunch will be served.
Session Chair: Niels-Christian Ganderup (Ellegaard Göttingen Minipigs)
Göttingen Minipigs in Regulatory Toxicology and Safety Pharmacology (Roy Forster, CiToxLAB)
Cardiovascular safety pharmacology using Göttingen minipigs (Abdel el Amrani, CiToxLAB)
Respiratory and central nervous system safety pharmacology using Göttingen minipigs (Simon Authier, CiToxLAB)
NOTOCORD
September 20, 2011
12:30–13:45
Congress Innsbruck—Freiburg
Current Trends in Safety Pharmacology and NOTOCORD Software Solutions
For the last 2 years, the pharmaceutical industry made a shift in priorities by subcontracting some ancillary drug testing activities to speed-up release on market of biology/oncology drugs.
Discover how NOTOCORD, the only independent software provider, can leverage your current equipment in order to save money and help in using recent new sensing/automation technologies for in vivo recordings.
Topics:
- Processing with different hardware / sensors providers (DSI / Konigsberg / Telemetry Research / Transonic…)
- Automated arrhythmia screening with new ARR30a module
- High Throughput Assay using cardiac stem cells
- Upgrade Validation Assistance service to dramatically speed-up validation
Hear it from our clients / partners as they share their experience.
Please come and join us for a friendly and informative discussion over Wine & Cheese.
Data Sciences International
September 20, 2011
18:30–20:00
Congress Innsbruck—Brussels
A Unique Education (and Entertaining) Event
Featuring DSI’s annual scientific…
Data Blast!
New Applications of Telemetric and Physiological Monitoring in Pharmacology and Safety Pharmacology
Live presentations will include brief overviews of the newest safety pharmacology applications using wired and wireless telemetry with automated analysis to monitor and analyze physiological data. Twenty brief presentations will focus on the most current applications and new method advances in Cardiovascular, CNS, and Respiratory safety pharmacology data assessment. This is a unique opportunity to meet and talk with your peers about their recent research in a relaxed and informal setting. Regional Refreshments and Beverages will be served.
CEREP
September 21, 2011
7:30–8:30
Congress Innsbruck—New Orleans
How In Vitro Testing Can Help Anticipate In Vivo Toxicity?
In the last decade, early on screening for off target effects, using receptor and enzyme profiling, has become widely used to anticipate compound failure in clinic. Several guidelines (EMEA, FDA, ICCVAM, and ECVAM) are not insisting on reducing animal testing. Therefore CEREP more assays are becoming available to anticipate compounds toxicity very early in the development process and before in vivo testing: models for prediction of LD50 in rodents and LC50 in human are available; species or tissue specific toxicity can be addressed by a testing on an adapted panel of cell lines, even metabolites toxicity can be evaluated in vitro. We will discuss some of those possibilities.
Charles River
September 21, 2011
12:00–13:00
Congress Innsbruck—Strassburg
Translation and Validation of Preclinical QT Analysis in Man: Novel Analysis of Continuous ECG Data
Continuous beat-to-beat ECG acquisition is now the default procedure in most preclinical, and more recently, clinical QT studies. Scrutiny of these data has confirmed rate-independent QT variability in the dog, cynomolgus monkey, and man, further confounding the accurate interpretation of experimental results which are typically derived from 80–120K beats for each experimental period. This symposium describes recent results which provide the first direct validation and translation of the preclinical QT assessment of moxifloxacin to man. Recently published novel approaches to the analysis of continuous ECG data employing continuous means and bootstrapped 95% confidence intervals will be presented. While continuous ECG acquisition was not incorporated into the E14 Guidance, the novel statistical methods presented remain consistent with the overall E14 intent and will enable investigators to more fully leverage the intrinsic power of continuous ECG acquisition.
Session Chairs: Henry Holzgrefe, CRL, and Georg Ferber, Member of ICH E14 statistical discussion group
Data Sciences International
September 21, 2011
12:00–13:00
Congress Innsbruck—Brussels
Physiologic Monitoring Breakthroughs: First Look at a Revolutionary Platform
The use of wireless monitoring of animal physiology has led to many scientific findings and new areas of research. Of course with every advance, researchers ask even more questions, both scientific and practical. “What is the true state of these animals? How would being housed in a group affect their physiology? Are my animals still in the right cages? Do I have enough battery life to conduct another experiment?”
Please join us for an informative session about DSI’s TruSense Telemetry platform. DSI has been hard at work for many years developing these new tools to help in your scientific inquiries, delivering improvements and efficiencies in the way you conduct your day to day experiments and research. Our speakers will share their personal experience, product application information, and their thoughts on promising new research opportunities created by this new innovative research platform.
emka Technologies
September 21, 2011
12:00–13:00
Congress Innsbruck Rennweg—New Orleans
Advances in Large Animal Cardio Pulmonary Data Analysis
The presentation will focus on three topics related to large animal data analysis:
- Arrhythmia detection from ecg using computerized multithread fast data analysis complemented by a number of specific tools to ease the final review by the end user.
- Pulmonary function assessment based on dual belt respiration inductance plethysmography and a variety of software functions and parameters enhancing the detection of phase shift as an indicator of bronchoconstriction.
- Ambulatory noninvasive blood pressure measurements with special focus on dogs and primates and software tools to provide automated analysis and easy control of data quality.
Items will be discussed based on concrete examples of recent work and validation studies performed in industry.
Telemetry Research
September 21, 2011
12:00–13:00
Congress Innsbruck—Grenoble
Chronic Measurement of Cardiac Contractility Via Telemetry; A New Paradigm in Safety Pharmacology
Simon Malpas (Chief Scientist and Founder Telemetry Research)
Measurements of cardiac contractility in conscious freely moving animals are uncommon yet could offer considerable opportunity for understanding cardiovascular disease progression and treatment. We have developed a new high-fidelity solid-state pressure sensor telemetry device for chronically measuring left ventricular pressure (LVP) and dP/dt in freely moving rats. In conjunction with Novartis Pharmaceuticals and the University of Auckland we describe the surgical approaches, circadian variation in parameters and responses to a range of compounds (propranolol, isoproterenol, verapamil and levosimendan). Data was measured up to 85 days after implant. We will discuss the pitfalls and possibilities associated with the chronic measurement of LVP in conscious rats.