Winter Issue 2014
Welcome to the third quarterly SPotlight Newsletter of the Safety Pharmacology Society (SPS). As the year comes to a close, it’s time to reflect and provide you with an update on the latest SPS activities that have taken place over the last few months. In this issue you will find a summary of the highlights of the very successful 2014 annual meeting as well as the results of the post meeting survey. Your feedback is indeed very important to us, enabling to better serve all the SPS members. I look forward to seeing you all in Prague for another successful meeting under the leadership of Alfred Botchway, the 2015 SPS President.
In 2014, SPS has engaged in a number of collaborations and activities summarized in this issue and aimed at better serving the safety pharmacology discipline and ultimately all individuals involved in safety pharmacology related activities. A stronger SPS will provide greater opportunities to educate scientists worldwide and to develop, strengthen and embrace the latest scientific and technological development in the field of safety pharmacology. An even stronger, more impactful SPS will no doubt contribute to discovering and developing novel, innovative medicines that will benefit patients in need.
I’d like to personally thank all the sponsors, meeting exhibitors, Board of Directors, members of SPS committees and every members, contributors and participants who make the SPS a healthy and successful organization.
I wish you all and your families a happy holiday season and a 2015 Happy New Year.
With best regards,
Jean-Pierre Valentin, PhD, HDR, ERT, CBiol, FSBiol, FRCPath, DSP
Washington, DC served as the perfect host city for the 14th Annual Meeting of the Safety Pharmacology Society. The Meeting, held October 18–22, featured scientific sessions and Continuing Education (CE) courses, scientific posters, an Exhibit Hall, and several exhibitor hosted sessions/receptions.
Congratulations and thank you to the 2014 Program Committee for organizing this exceptional program of sessions. Thanks also to Continuing Education Committee for putting together six fantastic Continuing Education (CE) courses. Recognition also goes to all of the session and CE course chairs, speakers, exhibitors, sponsors, and the many others whose efforts made this outstanding program possible.
The week kicked off on Sunday with our six CE courses, three concurrent in the Morning, and three concurrent in the afternoon. Courses offered on Sunday were: AM 1: Cardiac Electrophysiology: The Biophysics of Ion Channels for the Safety Pharmacologist, AM 2: Excelling in EEG, AM 3: Translational Medicine: Case Studies for the Application of Safety Pharmacology to Clinical Development, PM 1: The Application of In Silico Computational Modeling to Safety Pharmacology, PM 2: Translation of CNS Data to Problem Solving as it Relates to Suicidal Ideation and Abuse Liability, PM 3: Respiratory System Safety Pharmacology and Case Studies.
|Dr. Neil Buckholtz speaks to
a full crowd.
The rest of the week was filled by two tracks which ran concurrently, pertinent to all areas of safety pharmacology, featuring: Keynote by Neil S. Buckholtz, PhD, Division of Neuroscience (DN) at the National Institute on Aging, National Institutes of Health, Bethesda, MD, United States on The Past, Present, and Future of Alzheimer’s disease Research, Plenary by David A. Kass, MD, Abraham and Virginia Weiss Professor of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, United States on Cardiac Pressure-Volume Analysis—A Practical Perspective. Within the tracks, scientific topics covered were: Models for Cardiac Assessment, Central Nervous System, Noncardiac Ion Channels, Peripheral Neuropathy, Cardiovascular Dysfunction, Regulatory Guidance, Novel Assays for Safety Pharmacology Assessment: Zebrafish (Sushi or Science?) and Nausea and Vomiting: Not a Gagging Matter, Respiratory: Should the Sleep State be a Target for Safety Pharmacology?, Update and Perspectives on Comprehensive In Vitro Proarrhythmia Assay (CIPA).
The slides from approved presentations from the 2014 meeting are available to all registered attendees online.
|Dr. Valentin passing the gavel
to Dr. Botchway.
Over 150 posters were presented during exhibit hours on Monday, and Tuesday, in the Exhibit Hall featuring 49 vendors related to safety pharmacology.
On Wednesday afternoon, SPS President Jean-Pierre Valentin welcomed attendees to the Annual Member’s Meeting and Awards Ceremony. Plaques were presented to each of the outgoing officers with thanks for their service to the society. Dr. Valentin then officially passed the gavel to Dr. Alfred Botchway, who thanked him for this leadership as president of the society for the past year. Dr. Valentin recognized the Jr. Investigator and Student Travel award recipients as well as announced the Jr. Investigator Poster Competition recipients. The 2014 Distinguished Service Award Recipient, Dr. Will S. Redfern, was introduced and welcomed to the stage to give his DSA presentation on “Safety Futurology: From Virtuous to Virtual.”
The closing topic, Update and Perspectives on Comprehensive In Vitro Proarrhythmia Assay (CIPA) drew a crowd as speakers covered updates from different perspectives on the initiative.
|CIPA fills the room on the final day of the Meeting.|
We are looking forward to seeing you in Prague, Czech Republic for the 15th Annual Safety Pharmacology Society Meeting. The annual meeting program planning is already underway and we are taking all of your feedback and topic suggestions into consideration while planning. We hope to see you in 2015!
The Safety Pharmacology Society is honored to recognize its 2014 Junior Investigator and Student Travel Award recipients. Please be sure to view their posters at the Annual Meeting.
Junior Investigator Travel Award Recipients:
Siddhartha Bhatt, Pfizer
Ivy Garfinkel, Merck
Krishna S. Naruganahalli, Indian Institute of Science
Sara Dutta, University of Oxford
Mayel Gharanei, Inocardia
XueJun Wu, GlaxoSmithKline
Student Travel Award Recipients:
Kylie Beattie, University of Oxford
Larissa Butler, AstraZeneca
Junior Investigator Poster Competition Recipients:
1st Place: XueJun Wu
Poster #90: A Retrospective Comparison of Heart Rate and QT Variability, Using Total Instability Index, for the Prediction of Ventricular Arrhythmias in Dogs
2nd Place: Yukie Ueyama
Poster #88: Electro-Mechanical Effects of Common Anesthetic Agents: Assessment of Electrocardiographic and Functional Liabilities in Conscious Telemetered Guinea Pigs
3rd Place: Helen Maddock
Poster #67: Validation of the Rat Papillary Work-Loop Assay to Assess Inotropic Drug Effects
($6,000 to $9,999)
($3,000 to $5,999)
(Up to $2,999)
Special Mention and Thanks to:
Braintree Scientific, Inc.—Committee Shirts
Data Sciences International (DSI)—Lanyards
ACEA Biosciences, Inc.
Alpha MED Scientific Inc.
Axion BioSystems, Inc.
Calvert Laboratories, Inc.
Cellular Dynamics International, Inc. (CDI)
Data Sciences International (DSI)
EMKA Technologies Inc
Huntingdon Life Sciences/Harlan Laboratories
Ionic Transport Assays/IonsGate Preclinical Services
IPS Therapeutique Inc.
Multi Channel Systems
Nanion Technologies Inc
Pinnacle Technology Inc.
Q State Biosciences
Sophion Bioscience A/S
Takara Bio Europe AB
TSE Systems, Inc.
Since its launch in January 2014, the ICWG has been actively working to address important questions related to best practices including:
As a first step, a survey was sent out to active SPS members with the purpose of collecting frequency/type data on the commonly used ion channels in the various laboratories, in order to gather qualitative information on their relevance to drug-induced cardiac safety concerns, and proarrhythmia. Results from this survey were used to identify seven ion channels of interest (IKr, IKs, Ito, IK1, ICa and INa (peak and late)) and guide the development of recommended protocols in an effort to generate data to be used for in silico AP simulations. These protocols focus not only on defining potency but also address potential effects on kinetics and state dependency, while being practical and amenable to HTS. Preliminary data have been generated for a few key channels, and are currently being shared with the in silico group with the expectation that a number of iterations may be required initially to define the most valuable inputs required to evaluate the proarrhythmic potential of new drugs. The ICWG is looking forward to the next steps of integrating and interpreting ion channel and in silico data, in an effort to fully validate the CiPA paradigm. A summary of work done by the ICWG in 2014 is below:
The ICWG designed and delivered two sets of protocols for all seven ion channels
Dynamic block result summary
Data was used by ISWG to train/improve current in silico model.
Additional information on the work of the ICWG in support of CiPA was presented at the annual SPS meeting on October 22, 2014 (Plenary: Update and Perspectives on CiPA), and the CSRC/HESI/US FDA/SPS CIPA Update Workshop on December 11, 2014.
In 2015, the ICWG hopes to:
|Najah Abi-Gerges||AstraZeneca (Co-Chair)|
|Tom Colatsky||US FDA|
|William Crumb||Zenas Technologies|
|Bernard Fermini||Pfizer Inc (Co-Chair)|
|Jules C. Hancox||Bristol University|
|John Koerner||US FDA|
|Zhihua Li||US FDA|
|Stanley Nattel||Montreal Heart Institute|
|Gail Robertson||Wisconsin University|
|David Strauss||US FDA|
|Jamie Vandenberg||Victor Chang Cardiac Research|
Formal review of examinations for the Diplomate in Safety Pharmacology (DSP) has been completed and notifications to all those who took the exam in 2014 have been sent. If you took the exam and have not yet received notification of your results, please contact Krystle Correll.
Registration for all upcoming Webinars: Coming Soon!
Date/Time: January 29, 2015 11:00 AM ET
Title: Cross Species Translation of Drug-Induced Heart Rate and Blood Pressure Effects in Rat, Dog, and Nonhuman Primate to Human—How Predictive Are Preclinical Models?
Presenter: Jill Steidl-Nichols, PhD, Associate Research Fellow, Pfizer
Title: Nonclinical Cardiovascular Safety Testing: Moving Forward
Presenter: Douglas C. Throckmorton, MD, Deputy Director for Regulatory Programs, CDER, US FDA
Date/Time: March 5, 2015 11:00 AM ET
Title: Safety Testing for Antiarrhythmic Drugs
Presenter: Michael J. Curtis, PhD, DSP, FHEA, FBPharmacolS, Cardiovascular Division, Faculty of Life Sciences & Medicine, Rayne Institute, King’s College London
Date/Time: April 16, 2015 11:00 AM ET
Title: Comprehensive In Vitro Proarrhythmia Assay (CIPA): An Update from An Industry Perspective
Presenters: Hugo Vargas, PhD, DSP, Scientific Director, Toxicology Sciences, Amgen, and Gary Gintant, PhD, Research Fellow, AbbVie
2014 Webinar Recordings (FREE for all SPS Members!)
Please visit the SPS Calendar to see important upcoming meetings!