Spring Issue 2015
Welcome to the spring 2015 edition of Spotlight. As President, I have been very privileged to meet many members of the society from all sides of the continent. For those that I have not met yet, I am sincerely looking forward to it, and hope to see you soon.
It is my real pleasure to introduce you to the concept of what the society would refer to as “Design the Future” rather than react to the future nexus of Pharmacologists, Toxicologists, Physiologists, and scientists from regulatory agencies. The Design the Future of the society shall be, what I believe will take the society to its next level, prioritizing activities that move us to a position where the society meets the needs of your future nexus. I along with your fellow colleagues need your help in order to Design the Future. We need you to please send every single need that you come across on a daily basis to me or to the Executive Director, Krystle Correll. This is a challenge to all current members of the society which I believe we can all engage in to your benefit. Our aim is to grow our membership base by 8–10% over the next 18 months.
The Board of Directors continues to look for ways, through our strategic planning, to focus our efforts on preparing for the next 3–5 years, including;
- A joint SPS/JSPS/CSPT meeting to be held in 2016
- Expand the SPS’s global presence
This issue of Spotlight provides you with:
- All the information needed to register and attend the 15th Annual meeting in Prague
- An overview of the December CIPA meetings
- How to join the new interest group that will be focusing on “New Interest Group on Human iPSC-derived Neurons”
- 2015 DSP certification exam information and registration link
…and much more!
I would like to conclude this short note by reminding you that our 2015 program has gelled nicely and promises to be another scientifically packed time in Europe this fall.
Alfred Botchway, PhD, DSP
Annual Meeting News
2015 Annual Meeting Registration Now Open!
On behalf of the SPS Officers and Board of Directors, we would like to invite you and your colleagues to attend our 15th Annual Meeting, September 28–October 1, 2015, at the Prague Congress Centre in the romantic, architectural, and historic city of Prague, Czech Republic.
The 2015 Scientific Program will feature a diverse range of scientific sessions organized into two theme tracks and covering issues specific to important therapeutic areas, new regulatory developments and new technologies so that attendees can stay abreast of new content and developments in all areas of safety pharmacology. The meeting will also offer a broad Continuing Education program both on an introductory level as well as advanced courses for the expert. A preliminary program outline is now available on the Annual Meeting website.
In an effort to support attendance from our younger colleagues, please note that SPS offers Student and Junior Travel Awards. Also, please consider submitting an abstract for presentation as a poster. From these submissions a variety will also be selected for short oral communications. The deadline to submit an abstract for poster presentation is June 15.
We cordially invite you to become a member of SPS, get involved in our ongoing activities and join us in Prague for our 15th Annual Meeting this September!
Highlights of the Annual Meeting
- A dynamic forum for best practice sharing within industry, CRO’s, academics and regulators
- Sessions on some of the hottest topics in safety pharmacology related research
- 6 CE Courses taught by experts in the field
- Plenary Keynote Speakers by a key opinion leaders
- Exhibit hall offering access to industry vendors
- Poster sessions featuring cutting-edge research
- Networking opportunities with a global community of scientists from regulatory, industry, and academia
- Award opportunities to bring together Student and Jr. Investigators with seasoned scientists, while sharing their research
- Exhibitor Sponsored Sessions by leading technology and service providers showcasing their new offerings and research
Who Attends the Meeting?
Headquarters Hotel—Corinthia Hotel Prague
The Corinthia Hotel Prague is the official SPS Headquarters Hotel. SPS has negotiated a room block with the Hotel at the group rate of €113.85/night (Including breakfast, taxes, and fees)
Corinthia Hotel Prague
Prague 4, 140 69
Tel: +420 261 191 111
To make reservations, please use the online reservation system, or call +420 261 191 238/239 and identify yourself as part of the Safety Pharmacology group.
The deadline for reservations at the Corinthia Hotel Prague is August 25.
Waived Registration—US Federal and International Regulatory Agency Employees
In order to facilitate greater interaction with our regulatory colleagues, all US federal employees, and international regulatory agency employees may register to attend the 2015 SPS Annual Meeting in Prague at no charge. Waived registration is available to all active U.S. federal employees, and all active employees at international regulatory agencies (must show valid regulatory/government ID at registration).
Registration is required by September 1.
The meeting also offers a Continuing Education program (available for an additional fee) both on an introductory level as well as advanced courses for the expert. A preliminary program outline is now available on the Annual Meeting website.
2015 Call for Jr. Investigator and Student Travel Award Applications
Attention Junior Investigators and Students!
To encourage and support world-wide representation of students and junior investigators at the SPS Annual Meeting, the Society offers Junior Investigator Travel Awards and Student Travel Awards. The deadline for submitting award applications is July 1, 2015.
The deadline to submit your abstract online for the award is June 15, 2015. All other award application materials are due by July 1, 2015.
Please visit our website for complete details on Travel Award eligibility.
2015 Sponsorship Opportunities
The Society fosters scientific research, education, and dissemination of scientific information through meetings and other scientific interactions. Together with regulators and companies such as yours, the Society is working to bring safe and affordable new treatments to the market.
SPS is in the process of planning our 2015 multidisciplinary Annual Meeting to be held September 28–October 1, 2015, in Prague, Czech Republic. The meeting attracts over 450 safety pharmacologists from around the globe.
It is through the generous support of companies like yours that SPS has been able to offer affordable educational programs to a global audience. We hope that you will consider supporting the Society by becoming a sponsor of the 2015 Annual Meeting. Your support of the Society will be highlighted on our web site, in Annual Meeting materials and more, thereby increasing your visibility to your prospective customers.
Please refer to the 2015 Sponsorship information sheet showing the various Sponsorship Levels and detailed list of benefits that SPS will offer in return for your support.
If you have questions regarding sponsorship opportunities, please contact Krystle Correll.
On behalf of the Board of Directors, I thank you for your consideration, and hope that you and your colleagues will join us for our 15th Annual Meeting in Prague!
Exhibit Opportunities at the 15th Annual SPS Meeting
Networking + Science at the premier event for the safety pharmacology industry.
All exhibitors receive two full-conference badges to attend scientific sessions, scientific abstract presentations, daily lunches, and breaks built into programming for networking on the show floor.
Don’t wait! Join us today to become part of this extraordinary program!
Call for Nominations
The Safety Pharmacology Society invites your nominations of individuals to serve in the leadership of the Society. The elected terms will commence on January 1, 2016.
The open positions for the 2016 election are:
- Vice President-Elect is a 4-year commitment which automatically progresses through the positions of Vice President, President and Past President. In addition, the Vice President-Elect serves as the Chair of the Abstract Committee, and as Vice President serves as the Chair of the Program Committee for the year that they hold those positions. It is preferred that one has previous experience on the board prior to nomination as part of the presidential chain in the society.
- Secretary-Elect is a 1-year commitment followed by a 2-year commitment as Secretary.
- Board of Director Member is a 2-year commitment (4 positions open for nomination).
- Nominating Committee is a 1-year commitment (4 positions open for nomination).
Each candidate nominated should be a current member of the Society.
To make a nomination, a CV and a single paragraph statement of the vision for the future of the society should be sent to the committee. Members may submit multiple nominations for consideration by the Nominating Committee and are encouraged to nominate themselves. It is the nominator’s responsibility to obtain permission from the nominee and agreement to serve if elected.
The Nominating Committee will compile the final slate for the 2016 ballot. Ballots will be sent to members in good standing in July 2015.
The responsibilities of the SPS leadership roles are described in the Safety Pharmacology Society Bylaws.
Thank you for your continued interest and support of the Safety Pharmacology Society, and we look forward to seeing you at our next annual meeting in Prague, Czech Republic, September 28–October 1, 2015. To register for the meeting or to learn more about the scientific program please visit 2015 Annual Meeting website.
Derek J. Leishman, PhD, DSP
Chair, SPS Nominating Committee
SPS Southern California Regional Meeting on Cardio-Oncology
Cardio-Oncology: Where Safety Pharmacology Fits In
The symposium will focus on safety pharmacology approaches to cardio-oncology from cellular assays to clinical support. There will be a series of speakers in the morning, a lunch and an opportunity to view posters afterwards. We encourage attendees to bring posters, including those that may have been presented at previous SPS meetings.
Organizers: Hugo Vargas, Mike Engwall, Jonathan Heyen, Sian Ratcliffe, and Paul Butler
Location: Pfizer Campus, La Jolla, California
Date: Friday, June 5, 2015
Time: Registration 8:00 AM–9:00 AM, Meeting 9:00 AM–4:00 PM
Registration is free; however you must register online to reserve your spot at the meeting. Space is limited and is available on a first-come, first-serve basis. Should the event fill to capacity, a waitlist will be created.
CIPA December Meeting Overview
The CSRC/HESI/FDA/SPS CIPA Update Workshop on December 11, 2014 in Silver Spring, Maryland was a follow-up meeting to the July 2013 workshop on Rechanneling the Current Cardiac Paradigm. The December update workshop brought together global regulators, academicians, drug developers and CRO scientists and focused on providing information on the latest project developments. A full summary is now available online.
Know Someone Who Has Substantially Contributed to the Field of Safety Pharmacology?
The Safety Pharmacology Society Distinguished Service Award (DSA) is an honor given to an individual who has substantially contributed to the field of Safety Pharmacology.
The following criteria will be considered for nominees:
- Specific research achievements
- Champions of the field
- Lifelong contribution to the field
- Substantial specific contribution
- Visionary direction
- Regulatory decisions
- Science of the field
- Collaboration between industry and academia
The Distinguished Service Award Nomination Deadline is May 1, 2015. Please submit your nominations to SPS Headquarters for this coveted award to honor your fellow safety pharmacologist.
Please visit the SPS Website to download the Distinguished Service Award Nomination Application.
How to Nominate an Individual:
- Complete the DSA Application—Please note: the Award Criteria (above) must be addressed in the application or letter of support.
- Submit one letter of support for the nominee, with two SPS member signatures
- Submit the nominee’s curriculum vitae.
- Submit any supporting documentation that may indicate the nominee’s achievement in safety pharmacology
Submit the application and supporting documents via email (PDF) toSPS Headquarters by May 1, 2015.
Please note: Only Members may nominate an individual for the DSA, although the DSA nominee does not have to be a member. A member may not nominate more than one person per year. The Distinguished Service Award (DSA) will be given every year, although there shall be no obligation or duty to make such award when, in the sole opinion of the committee, there is no qualified nominee. The Distinguished Service Award Committee conducts an in-depth review of all nominations, and looks forward to hearing from you soon.
We look forward to receiving your nominations!
2015 Diplomate in Safety Pharmacology (DSP) Certification Exam and Preparation
The Safety Pharmacology Society invites you to register to participate in our Diplomate in Safety Pharmacology (DSP) certification exam this fall in Prague, Czech Republic, on September 27, 2015.
This initiative was started in 2013 to promote and recognize expertise in the field of Safety Pharmacology. The examination is offered once yearly at the SPS Annual Meeting and the ceremony for new Diplomates will be held at the Annual Meeting the following year. The first DSP examination was held in Rotterdam on September 15, 2013.
The Safety Pharmacology Society recognizes a certification exam program as an important step in the development of the discipline. The DSP, created with participation of representatives from industry, academia and regulatory agencies, is aimed to reflect the perspective from major stakeholders in drug development. The first examination in North America will be offered at the SPS Annual meeting in Prague, Czech Republic on September 27, 2015. The registration deadline is September 1.
All details relative to the certification exam process including eligibility, study materials, scientific scope, and examination format are presented on the DSP website. We are also excited to inform you that we have a three-part webinar series recording, focused on key areas of our discipline, is available to assist you in preparation for taking the exam.
We look forward to seeing you in Prague.
Join the New SPS Interest Group on Human iPSC-derived Neurons and In Vitro Evaluations for CNS Safety Pharmacology
The situation around human iPSC-derived neurons is a little different from that of human iPSC-derived cardiomyocyte. Because iPS-technology is improving so rapidly, honest and deep discussions from industry, government, and academia are required. SPS member Dr. Kaoru Sato, PhD, Division of Pharmacology, National Institute of Health Sciences Japan, proposed that the Society provide a platform, in the form of an interest group to support these discussions. The SPS Board recently approved the formation of this interest group.
If you are interested in joining this group, please visit the group’s SPShare page and on the right side of the page, click the button that says “join community.”
If you wish to receive an email notification when discussions are added, please be sure to also click the button on the right side of the discussions section that says "subscribe to topic". We will be sending out a welcome email shortly, but in the meantime please read what Dr. Sato had to say on the topic below.
“At present, in the process of the drug development, most of the CNS safety pharmacological tests are in vivo test. When needed, the follow-up in vitro tests are also performed. When these nonclinical studies terminate, the developmental phase moves into the clinical study in human. Although species differences have long been concerned, few solutions have been presented so far. When hiPSC-derived neurons were introduced in 2007, they attracted attention to overcome such species differences by applying them to nonclinical studies. But at the same time, we were aware that we had not discussed enough about the potentials of the in vitro evaluations as the CNS safety pharmacological tests.
Therefore the purpose of this interest group would be to discuss both of ‘the potentials of the in vitro evaluations’ and ‘the replacement of the evaluations by hiPSC-derived neurons if they have common intercellular- or intracellular mechanisms.’ Because iPS-technology is improving so rapidly, honest and deep discussions from industry, government, and academia are required. In Japan, they just launched the ‘INCENS’ (iPS nonclinical experiments for nervous system) project with the support from ministry of health, labor, and welfare, Japan.”
SPS Collaborations and Activities
SOT Scientific Liaison Coalition (Member since 2011)
SPS Ion Channel Working Group (Created November 2013)
SLC Webinar (February 2015)
SOT Global Gallery participant (March 2015)
UW Madison Distance Learning Course support (March–September 2015)
SPS Southern California Regional Meeting on Cardio-Oncology (June 2015)
SOT Scientific Liaison Coalition (Member since 2011)
SPS Ion Channel Working Group (Created November 2013)
UC Davis Cardio Symposium support (February 19–21, 2014)
Participant Global Gallery SOT (March 2014)
University of Wisconsin Online learning Course Support (April–May 2014)
NC3Rs /MHRA Workshop Collaboration (July 2014)
TAMU Lecture Series Support (Fall 2014)
CSRC/HESI/FDA/SPS CIPA Update Workshop (December 11, 2014)
Registration for all upcoming Webinars: Coming Soon!
April 9, 2015 11:00 AM ET
Title: Nonclinical PK modeling
Presenter: Martin Beliveau, MSc, PhD, Pharsight Consulting Services™
Title: Allergenicity of biotechnologies in Nonclinical Studies
Presenter: Kenneth L Hastings, DrPH, DABT, Fellow ATS, Hastings Toxicology Consulting LLC
April 16, 2015 11:00 AM ET
Title: Comprehensive In Vitro Proarrhythmia Assay (CIPA): An Update from An Industry Perspective
Presenter: Bernard Fermini, PhD
Title: Ion Channel Discipline Lead Global Safety Pharmacology, Pfizer
Presenters: Hugo Vargas, PhD, DSP, Scientific Director, Toxicology Sciences, Amgen and Gary Gintant, PhD, Research Fellow, AbbVie
April 30, 2015 11:00 AM ET
Title: Preclinical Abuse Liability Screening: Using The Troubles and Tribulations of Tramadol as a Model
Presenter: David Gauvin, PhD, Director, Neurobehavioral Sciences at MPI Research
Title: Clinical Drug Abuse Liability Testing
Presenter: Lorraine Rusch, PhD, Vice President, Vince and Associates Clinical Research
May 7, 2015 11:00 AM ET
Title: Nonclinical Safety Testing for Central and Distal Axonopathies
Presenter: Joseph Arezzo, PhD, Professor of Neuroscience and Neurology, Albert Einstein College of Medicine
Title: CNS Safety Pharmacology: Beyond Core Expectations
Presenter: Will Redfern, BSc (Hons), PhD, FSB, FBPhS, DSP, Drug Safety & Metabolism, AstraZeneca UK
May 21, 2015 11:00 AM ET
Title: Nonclinical Safety Ophthalmology Studies
Presenters: Margaret E. Collins, MS, Associate Director, Ocular Toxicology, Charles River;
Brian Christian, PhD, DABT, Director, Nonclinical Safety Assessment, Covance;
and John Kapeghian, PhD, DABT, Senior Director Toxicology, CiToxLAB
Please visit the SPS Calendar to see important upcoming meetings!