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SPotlight Newsletter


Spotlight Newsletter

Spring Issue 2018

President's Report

Welcome to the Spring Issue of the SPotlight Newsletter.

The Spring Issue highlights the 2018 Annual Meeting and updates on collaborations, publications, and news from SPS and your colleagues. We also have some important SPS leadership roles to fill in 2019 so be sure to read the Call for Nominations and put forth names of individuals you believe would make a great addition to the Board of Directors.

The global safety pharmacology community comes together annually at the Safety Pharmacology Society (SPS) Annual Meeting, which this year will be held for the second time in Washington, DC. This promises to be an exciting meeting in a very vibrant city. Michael Engwall and the Program Committee have been working hard to deliver an excellent scientific program addressing emerging and hot topics across the spectrum of safety pharmacology. Similarly, Tomas Mow and the CE Committee have been identifying areas of educational demand for both new and experienced safety pharmacologists and are finalizing the CE courses.

In addition, the SPS is hosting three regional meetings this year, on focused topics across the globe including California, Boston, and Brussels locations. Topics, dates, and further information will be announced soon. I would like to highlight our recent collaborations with two national safety pharmacology societies: R.L Hamlin, M, Pannirselvam and K. Derekhchan were invited by the German Society of Experimental Clinical Pharmacology and Toxicology to speak at the 3rd Pharm Tox Summit in Göttingen, Germany last month. In addition, I was invited to speak at the Annual Meeting of the Japanese Safety Pharmacology Society in Tokyo in February and to present at the Annual Meeting of the Society of Applied Human Pharmacology in April in Munich, Germany. We also had SPS delegates participating in the Global Gallery Poster and Coffee at the SOT Annual Meeting in March. Lastly, we are pleased that two SPS symposia proposals were accepted by the EUROTOX and our society strategic plan manuscript was recently published in JPTM. As you can see, we are actively involved in various initiatives, including the FDA’s CiPA initiative.

If you are looking for a quick way to catch up on the latest research on your own time, please be sure to take time to review our upcoming 2018 webinars (held monthly), covering a broad range of topics. These webinars are free for all SPS Members and regulatory agency employees. If you are interested in becoming a member and gaining access to these webinars, please contact SPS Headquarters for more information.

I would also encourage you to consider taking the Diplomate in Safety Pharmacology certification exam held just prior to the 2018 SPS Annual Meeting. We are currently updating our list of resources to help you prepare for this exam. It's a very comprehensive exam spanning across all aspects of safety pharmacology, we now have over 60 diplomates certified…so why not you?

Wishing you all a very healthy and happy Spring and a wonderful year ahead!

Sincerely,

Martin Traebert, PhD, DSP
President, Safety Pharmacology Society


Annual Meeting News

2018 Annual Meeting Registration and Abstract Submission Now Open!

On behalf of the Safety Pharmacology Society (SPS), we would like to invite you and your colleagues to attend the 2018 SPS Annual Meeting, September 30–October 3, 2018, at the Marriott Wardman Park Hotel in Washington, DC.

Over the last few months, the 2018 Program Committee has been hard at work organizing a scientific program that includes topics of interest to SPS Members and colleagues. The 2018 Scientific Program has been finalized and features a diverse range of issues such as Opiates, Secondary Pharmacology, Next Generation Non-opiate Pain Management, Safety Pharmacology/FDA Discussion on the Gastrointestinal System, CiPA Real-life Implementation, Cardio GPCR, Cardio-Oncology, Central Nervous System and Sensory Assessments: Established and Emerging Nonclinical Drug Safety Testing Strategies, Advanced Imaging Techniques in Preclinical Safety, In Silico Approaches, Phase I Trial Design and Translation to Clinical Data, Preclinical to Clinical—Case Studies and much more! This will ensure attendees can stay abreast of new content and developments in key areas of interest.

The meeting also offers a broad Continuing Education program including introductory level as well as advanced courses for the expert. A preliminary program outline is now available on the 2018 Meeting website. We will also be holding the certification exam for the Diplomate in Safety Pharmacology on September 29, 2018 at the Wardman Park Hotel and invite all interested SPS members to consider sitting the exam this year.

In an effort to support attendance from our younger colleagues, please note that there are expanded opportunities for Student and Jr. Investigator 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 presentation is June 15, and there is a fee of $40 to submit (fee is waived for those submitting for award consideration).

We also would like to highlight our Exhibit Hall, which will feature over 50 vendors offering direct access to CROs, as well as a variety of service and technology providers exhibiting the latest trends, technology, and developments relevant to the field.

We cordially invite you to become a member of our Society, become involved in our ongoing scientific activities and join us in Washington, DC for our 2018 Annual Meeting this Fall!

Sincerely,

Dr. Martin Traebert
SPS President 2018

Dr. Michael Engwall
SPS Vice President and Program Chair 2018

Highlights of the Annual Meeting
  • A dynamic forum for best practice sharing within industry, CRO’s, academics and regulators
  • Scientific Sessions organized by SPS Members
  • 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 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

Headquarters Hotel Reservations

The Washington Marriott Wardman Park is the headquarters hotel. We have negotiated a room block with the hotel at the group rate of $239 exclusive of taxes.

The headquarters hotel is located in the Northwest DC’s Woodley Park neighborhood, a quiet oasis in the heart of the city with 16 acres of gardens, just steps away from the Metro, Adams Morgan and Dupont Circle. The SPS Annual Meeting will take place in the Washington Marriott Wardman Park.

Washington Marriott Wardman Park
2660 Woodley Road NW
Washington, DC 20008
USA

To make reservations, please use the online reservation system, or call +1 202.328.2000 and identify yourself as part of the SPS group rate.

SPS does NOT work with a housing/hotel reservations company. The only way to reserve your hotel room with the SPS block is to use the link listed on our website or call the hotel directly. Communications from persons other than SPS are not authorized and should be regarded as spam.

The deadline for reservations at the Marriott Wardman Park is September 4.


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 2018 SPS Annual Meeting in DC 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.


2018 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 Meeting, the Society offers Junior Investigator Travel Awards and Student Travel Awards. The deadline for submitting award applications is July 1, 2018.

The deadline to submit your abstract online for the award is June 15, 2018. All other award application materials are due by July 1, 2018.

Please visit our website for complete details on Travel Award eligibility.


SPS Sponsorship Increases Visibility: Pledge Your 2018 Support Today!

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 2018 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 2018 Sponsorship Levels showing the detailed list of benefits/recognition that SPS can offer in return for your support. If a formal grant/support request needs to be submitted online, we would be happy to complete the next steps to ensure we comply with your company's policy.

If you have questions regarding sponsorship opportunities, please contact Krystle Correll with SPS Headquarters.


Exhibit Opportunities at the 2018 Annual Meeting



2018 booth sales are under way, with spots filling up fast. The SPS Annual Meeting includes two days of poster presentations, breaks, meals, and receptions in the exhibit hall to drive attendee traffic to your booth. Don't miss your opportunity to connect with over 500 high-level industry professionals this Fall!

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!

Reserve your booth today!


Marketing & Advertising Opportunities

Is your company looking for greater exposure?

We have various advertising opportunities available to Sponsors and Exhibitors to ensure your presence is seen by all 450+ attendees who will be joining us in Washington, DC. In addition, we have opportunities for companies who wish to advertise beyond the Meeting!

Annual Meeting Marketing & Advertising Opportunities
  • Exhibitor Sponsored Session
  • Final Program Advertisement
  • Email Communications
  • Bag Inserts
  • Mailing List Rental
  • Lanyards
  • Mobile App push notifications
SPS Year-Round Marketing & Advertising Opportunities
  • Vendor Directory
  • Mailing List Rental
  • Job Postings

Please contact Amy Willis for further information on how to take advantage of these opportunities. Don't delay; some of these are limited and first come-first serve!


SPS NEWS

Call for Nominations

Dear SPS Member,

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, 2019.

The open positions for the 2019 election are:

  • Vice President-Elect is a 4-year 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.
  • Treasurer-Elect is a 1-year commitment followed by a 2-year commitment as Treasurer.
  • 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).

The responsibilities of the SPS leadership roles are described in the Safety Pharmacology Society By-Laws.

Each candidate nominated should be a current member of the Society. Members may submit multiple nominations for consideration.

To nominate another individual: It is the nominator's responsibility to obtain permission from the nominee to be considered for the ballot and their agreement to serve, if elected. The Nominator must also ask the Nominee to send a current CV and a single paragraph statement regarding their background and experience that makes them appropriate for the position for which they are being nominated and their vision for the future of the Society to Krystle Correll before the deadline (May 2, 2018). Members may submit multiple nominations for consideration by the Nominating Committee.

To nominate yourself: We encourage SPS Members to nominate themselves. By nominating yourself you are giving permission to be considered for the ballot and agreeing to serve, if elected. You must provide a CV and single paragraph statement regarding your background and experience that makes you appropriate for the position for which you have nominated yourself and your vision for the future of the Society to Krystle Correll before the deadline (May 2, 2018).

The Nominating Committee will compile the final slate for the 2019 ballot. Ballots will be sent to members in good standing in July 2018.

Thank you for your continued interest and support of the Safety Pharmacology Society, and we look forward to seeing you at the 2018 SPS Annual Meeting in Washington, DC, September 30–October 3, 2018. To register for the meeting or to learn more about the scientific program please visit the 2018 Annual Meeting Website.

Best regards,

The Nominating Committee


Three SPS Regional Meetings Planned for 2018

In 2018 SPS has plans underway to support three regional meetings. SPS Regional Meetings utilize local SPS members and speakers to host one-day meetings in regional locations in order to present safety pharmacology topics to individuals who may not be able to travel to the SPS Annual Meeting. While it may not always be possible, our goal is to keep these meetings free to attend and they are always open to local SPS Members and Nonmembers. Locations and details are still being finalized but we plan to have an East coast, West coast and European based regional meetings this year. As information becomes available we will share it on the website and via email.


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. Please consider submitting a nomination for someone you believe should be honored for their contributions.

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 and technology of the field
  • Education
  • Mentorship in the field
  • Collaboration between industry, academia, and regulatory

The Distinguished Service Award Nomination Deadline is May 1, 2018. 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:

  1. Complete the DSA ApplicationPlease note: the Award Criteria (above) must be addressed in the application or letter of support.
  2. Submit one letter of support for the nominee, with two SPS member signatures.
  3. Submit the nominee's curriculum vitae.
  4. Submit any supporting documentation that may indicate the nominee’s achievement in safety pharmacology

Submit the application and supporting documents via email (PDF) to SPS Headquarters by May 1, 2018.

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.

We look forward to receiving your nominations!


2018 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 Washington, DC on September 29, 2018. The registration deadline is September 1.

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.

All details relative to the certification exam process including eligibility, study materials, scientific scope, and examination format are presented on the DSP website. We encourage you to review the three-part webinar series recording (Under previously recorded Webinars, year is 2014), focused on key areas of the discipline in order to assist you in preparation for taking the exam.

Register for the DSP Exam today!


SPS Member Representation at the Japanese Safety Pharmacology Society (JSPS) Meeting

Dr. Martin Traebert, SPS President, represented the Safety Pharmacology Society (SPS) at the 2018 Japanese Safety Pharmacology Society (JSPS) meeting which was held at the University of Tokyo in February. Dr. Traebert spoke on the topic of Integration of iPS cells into safety pharmacology assessments: Challenges and opportunities.

The hospitality of the JSPS organizers was remarkable and truly appreciated. A rich and dynamic program was presented by JSPS membership including the topics of Regulatory perspectives on the practical use of the CiPA assessment, Comprehensive simulation study on cardiac excitation-contraction coupling, Challenge for the prediction of adverse events on the central nervous system, and covered various talks on the Cardiovascular System. The full agenda from the Meeting can be found here.


2018 German Society of Pharmacology and Toxicology Modular Training Programme in Toxicology: Modular Safety Pharmacology Course Report

Andrea Greiter-Wilke and Martin Traebert organized, for the 11th year, a one-week postgraduate course on safety pharmacology in February 2018 in Basel, Switzerland. This year there were 28 participants. The course module is a joint effort between the Swiss Society of Toxicology and the German Society of Pharmacology and Toxicology. The SPS members Marie-Luce Rosseels, Theo Dinklo, Mark Deurinck, Liudmila Polonchuk, Sonia Roberts and Heike Schauerte were so kind to contribute with exciting lectures in their areas of expertise. The remaining topics were covered by experts from Roche, Novartis and academia. We wish to thank everyone for their contributions and participation.

The course provided a broad overview on the organ systems of interest as well as standard tests to investigate drug effects on these systems. Each organ system was introduced before detailed information on the safety pharmacology aspects was provided. Integration of safety pharmacology findings in an overall risk assessment will be demonstrated. Concordance data and case reports provided the evidence how meaningful pre-clinical data are for the clinical situation. Lab tours provided insight into the daily routine and demonstrate some key models for the safety pharmacology assessment of drug candidates.

At the end of this one-week course participants gained a clear understanding of the various tests used and the role of safety pharmacology in the drug development process. The one-week course was concluded with a written exam.


DGPT/SPS German PharmTox Summit CE Course Report: Advanced Course Pharmacology—Preclinical Drug Development

The Advanced Course Pharmacology—Preclinical Drug Development held at the German PharmTox Summit on February 26, 2018 was supported by SPS and the German Centre of Cardiovascular Research (DKZ). The course was a full success, with approximately 50 course participants. The SPS contributed to the course with support for three speakers: Robert Hamlin (QTest Labs and The Ohio State University), Malar Pannirselvam (Vertex Pharmaceuticals), and Kathy Derakhchan (Shire Pharmaceutical). These speakers had previously given similar presentations during the 2017 SPS CE Courses in Berlin. The other speakers who contributed to the Course were: Amy Pointon (SPS Member, AstraZeneca), Claudia Noack (Bayer) and Enno Klussmann (Leibnitz Institute). Each talk had extensive discussion and the participants received printed hand-outs of the slides.

We wish to thank Prof. Wolfram-Hubertus Zimmermann and Dr. Franz J. Hock for their efforts in organizing the Course.


SPS Collaborations and Activities

2018
SOT Scientific Liaison Coalition (Member since 2011)
JSPS Meeting Participation (February 2018)
SLC Webinar (February 2018)
DGPT/SPS German Pharm-Tox Summit course support/participation (February 2018)
SOT Global Gallery participant (March 2018)
UW Madison Distance Learning Course support (April-May 2018)

2017
SOT Scientific Liaison Coalition (Member since 2011)
JSPS Meeting participation (February 2017)
SLC Webinar (February 2017)
SOT Global Gallery participant (March 2017)
German Pharm-Tox Summit Meeting participation (March 2017)
UW Madison Distance Learning Course support (April-September 2017)
CSPS Meeting participation and book chapter submission (May 2017)
SPS/NC3Rs Joint Regional Meeting: Coventry, UK (May 2017)
SPS/STP Joint Regional Meeting: Boston (May 2017)
SPS/ACT/STP Joint Survey on Current Practices in Nonclinical Toxicology (November 2017)


Upcoming Webinars

Upcoming Meetings


SPS Member News

International 3Rs prize awarded to SPS Members for computer modelling that predicts human cardiac safety better than animal studies

Work on an in silico model that predicts cardiotoxicity more accurately than animal studies has won the International 3Rs prize, awarded by the The National Centre for the 3Rs (NC3Rs) and sponsored by GSK. The winning paper from SPS member Dr. Elisa Passini and colleagues from the University of Oxford and Janssen Pharmaceutica, describes in silico drug trials using the 'Virtual Assay' software developed at the University of Oxford. The prize was presented at a ceremony on March 12, 2018 and consists of an £28,000 grant and a £2,000 personal award.

The University of Oxford team is collaborating with several pharmaceutical companies, who are using and evaluating the Virtual Assay software, which also won the SPS Technological Innovation Award in 2017. Follow this link for further information and to download the free software.


Publications of Interest

Gauvin DV, Zimmermann ZJ, Code R, Baird TJ. The drug discrimination assay: Interpretative value of partial generalization for drug schedule control actions. J Pharmacol Toxicol Methods. 2017 Dec 11;90:48–57.

Goversen, et al, 2018. A Hybrid Model for Safety Pharmacology on an Automated Patch Clamp Platform: Using Dynamic Clamp to Join iPSC-Derived Cardiomyocytes and Simulations of Ik1 Ion Channels in Real-Time. Front. Physiol. 8:1094 doi: 10.3389/fphys.2017.01094

Gryshkova V, Fleming A, McGhan P, De Ron P, Fleurance R, Valentin JP, Nogueira da Costa A. miR-21-5p as a potential biomarker of inflammatory infiltration in the heart upon acute drug-induced cardiac injury in rats. Toxicol Lett. 2018 Jan 19;286:31–38. doi: 10.1016/j.toxlet.2018.01.013. [Epub ahead of print]

Mulder P, de Korte T, Dragicevic E, Kraushaar U, Printemps R, Vlaming MLH, Braam SR, Valentin JP. Predicting cardiac safety using human induced pluripotent stem cell-derived cardiomyocytes combined with multi-electrode array (MEA) technology: A conference report. J Pharmacol Toxicol Methods. 2018 Jan 17. pii: S1056–8719(17)30500–2. doi: 10.1016/j.vascn.2018.01.003. [Epub ahead of print] Review.

Obergrussberger, et al, 2018. An update on the advancing high-throughput screening techniques for patch clamp-based ion channel screens: implications for drug discovery. Expert Opinion on Drug Discovery. 13:269-277. doi: 10.1080/17460441.2018.1428555.

Park E, Gintant GA, Bi D, Kozeli D, Pettit SD, Pierson JB, Skinner M, Willard J, Wisialowski T, Koerner J, Valentin JP. Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium. Br J Pharmacol. 2018 Feb;175(4):606–617. doi: 10.1111/bph.14101. Epub 2018 Jan 15.

Pugsley MK, Authier S, Koerner JE, Redfern WS, Markgraf CG, Brabham T, Correll K, Soloviev MV, Botchway A, Engwall M, Traebert M, Valentin JP, Mow TJ, Greiter-Wilke A, Leishman DJ, Vargas HM. An overview of the safety pharmacology society strategic plan. J Pharmacol Toxicol Methods. 2018 Jan 9. pii: S1056–8719(17)30576–2. doi: 10.1016/j.vascn.2018.01.001. [Epub ahead of print]