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Sponsored Presentations
Please download the Sponsored Presentation/Event Request Form and complete it to request an Ancillary Meeting for 2010. If you have any questions, please e-mail Clarissa Wilson.
Sponsored Presentation Form 
Charles River
The Use of New Methods or Technologies in Safety Pharmacology
Tuesday, September 21
8:00 AM–9:00 AM
Seaport World Trade Center—Cityview Ballroom 2
The field of safety pharmacology is uniquely positioned to facilitate the use of new technologies or novel end points to more effectively identify effects that may pose a risk to human volunteers and patients. The refinement of techniques to monitor functional end points is paramount to the advancement of our understanding of the impact novel drugs may have on specific organ systems and how these organ systems can evolve during development. Refinement of current techniques and incorporation of new technologies on toxicology studies will be reviewed with emphasis on obtaining reliable cardiovascular data in primates. Additionally, the incorporation of safety pharmacology end points onto juvenile studies, to aid in pediatric drug development, will be discussed; highlighting critical differences in cardiac ion channel expression in juvenile/adult dogs and its potential impact on drug development strategies.
Speakers:
- D. Salvail, IPS Therapeutique, Sherbrooke, Canada
- R. Chui, Amgen, Thousand Oaks, CA
- Third speaker to be announced
ADInstruments
Integrated Data Acquisition Solutions for Cardiovascular, Pulmonary,
and Organ Systems Research
Tuesday, September 21, 2010
12:00 NOON–1:30 PM
Seaport World Trade Center—Beacon Hill 1
Current safety pharmacology study design requires increasingly sophisticated and seamless hardware and software pairings at the lab bench. ADInstruments specializes in delivering acquisition of Cardiovascular Systems and Hemodynamics, Small and Large Animal Telemetry, Pulmonary Function and Organ, Tissue and Microvessel for pharmacologists interested in turn-key integrated solutions. This session will cover workflow advantages of a modular approach to post-hoc data analysis for raw data generated from electrophysiology, respiratory and organ/tissue protocols. Highlighting several pharmacology research facilities, attendees will learn take-home strategies to overcoming traditional pitfalls by utilizing the newest computing and instrumentation technologies available. Topics will also include the latest relevant advancements from business partner's Millar, Transonic Systems, DMT, Telemetry Research and Radnoti product lines. Proven compliance methods of managing data acquisition systems generated electronic records specific to a 21 CFR Part 11 environment will round out the session agenda.
emka Technologies
New Strategies for Arrhythmia Detection and Pulmonary Assessments in Drug Safety.
Tuesday, September 21
12:00 NOON–1:00 PM
Seaport World Trade Center—Cambridge
Detecting arrhythmias in data files lasting hours or days is challenging and time consuming. This presentation describes computerized methods that optimize efficiency and minimize time and resources. Strategies include full in-depth analysis followed by examination of analysis gaps, rapid RR detection with focus on apparent HR changes, and shape detection based on libraries of arrhythmias. Tools for extraction of specific data subsets may be used as secondary step to refine analysis. We present real-life examples and provide detailed information on strategies and time spent to process various ecg rhythm abnormalities.
Integration of multiple organ system evaluations into single studies can save time and resources. emkaBELT non-invasive telemetry can be incorporated into a variety of study designs to facilitate a thorough pulmonary assessment and meet S7a guidelines in freely roaming large animals. Data from recently completed studies will be presented.
Phylonix
Zebrafish: A Predictive Model for Assessing Drug Toxicity, Safety, and Efficacy
Tuesday, September 21
12:00 NOON–1:00 PM
Seaport World Trade Center—Cityview Ballroom 2
In this workshop, we will present an overview of in vivo assays for assessing drug toxicity and safety using this convenient and versatile model organism. We will also show drug efficacy data in several disease models. Drug effects on all major organs can be rapidly assessed in the transparent animal. Small amount of drugs are added directly to the fish water or injected. A statistically significant number of animals can be used for each study and results can be obtained in a few weeks. Zebrafish can be treated at 6 hours for developmental studies or on days 2–7 for studies that replicate effects in adults. Models for most major diseases, including: heart, liver, CNS, eye, and cancers, have been generated in zebrafish. Many studies show a striking correlation between results in zebrafish and results in mammals.
LAB Research
Progress in Core Battery Cardiovascular Safety Pharmacology
Tuesday, September 21
12:30 PM–1:30 PM
Seaport World Trade Center—Cityview Ballroom 1
Recent technological advances in cardiovascular safety pharmacology will be presented. First Part: An arrhythmia detection software was evaluated using ECG data from telemetered Beagle dogs (with and without LVP catheters), Cynomolgus monkeys and Gttingens minipigs. The technology was used to automatically detect atrio-ventricular type II block, sinusal pause, atrial, junctional and ventricular arrhythmias. Possible analysis strategies using this tool and the impact on safety pharmacology data interpretation will be discussed. Second Part: An innovative DII ECG lead configuration for in large animal telemetry will be presented. The new devices developed to minimize EMG artifacts, use a rounded tip negative lead inserted in the jugular vein and advanced to inch above the right atria and the positive lead is sutured to the diaphragm. Amplitudes and signal to noise ratios with this new ECG lead configuration and other conventional ECG methods will be discussed.
Data Sciences International
New Applications of Telemetric and Physiological Monitoring in Pharmacology
and Safety Pharmacology
Tuesday, September 21, 2010
6:00 PM–7:30 PM
Seaport World Trade Center—Beacon Hill 2–3
A Unique Educational (and Entertaining) Event Featuring DSI’s annual scientific…DATA BLAST!
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.
Ellegaard Göttingen Minipigs A/S
The Göttingen Minipig in Cardiovascular Safety Pharmacology
Tuesday, September 21, 2010
6:30 PM–8:30 PM
Seaport World Trade Center—Constitution
For several decades the Göttingen Minipig has been used in different aspects of biomedical research. During the past five years the use of the Göttingen Minipig in Cardiovascular safety pharmacology has steadily increased and much research remains to be done in the field.
During the session, findings from a Consortia Collaboration on the use of minipigs in cardiovascular safety pharmacology will be presented by participant companies. The presented data will be discussed and evaluated and the session will offer an opportunity to discuss with speakers and investigators.
ChanTest Corp.
New Preclinical Strategies for Accurate Prediction of Cardiac Risk
Wednesday, September 22
8:00 AM–9:00 AM
Seaport World Trade Center—Beacon Hill Room
Sudden cardiac death linked to non-cardiac drugs is a major cardiotoxicity issue for regulatory agencies. Improved predictivity in preclinical risk assessment can be achieved through the use of Stem Cell-derived Human Cardiomyocytes, cardiac ion channel screens and protein trafficking assays, and by considering rate-dependent effects on telemetered QT.
This session will provide insights on how these preclinical assays can be cost-effectively integrated into existing workflows for more thorough and accurate cardiac risk assessments. The interpretation and application of pharmacologically relevant data sets will be presented, along with case reports that resolve discordances with the traditional S7B approach.
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General Information 
