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SPotlight Newsletter


Spotlight Newsletter

Winter Issue 2017

President's Report

Those of us fortunate to attend the 17th Annual Meeting of the Society in Berlin in September, were part of a very successful and informative conference. I’d like to take this opportunity to thank all attendees, presenters and exhibitors at the Berlin SPS for making it the success it was. We had 468 attendees from 29 countries, with 6 CE courses (and a mini-course), 45 invited speakers, 181 posters and 42 exhibitors.

When the Safety Pharmacology Society was formed in 2000, it reflected the predominant focus of safety pharmacologists world-wide at the turn of the millennium, which was applying mainly in vivo techniques to evaluate functional effects of small molecules across the 3 vital organ systems (cardiovascular, CNS and respiratory), within large pharma and CROs. Then, as now, there was a strong focus on the thorny issue of drug-induced torsade de pointes. However, fast-forward to 2017, and so much has changed. This year, for the first time, the proportion of posters using in vivo techniques contributed less than 50% to the total. The ‘gap’ has been filled by posters on in vitro and in silico approaches, with most of the in vitro-based posters focusing on human induced pluripotent stem cells (hiPSCs). This mixed tool box (in silico, in vitro and in vivo) for safety pharmacology brings together scientists from broader backgrounds at the annual meeting, which can only be a healthy thing. The contribution from academic groups has increased. We are also (as a discipline and a society) having to address preclinical portfolios that are no longer entirely small molecule-based, with the development of monoclonal antibodies, antisense oligonucleotides, modified RNA, bicyclic peptides, anticalins, PROTACs, etc. These new modalities (and small molecule projects) are increasingly targeting enzymes and kinases. Therefore, the latter-day safety pharmacologist must be, first and foremost, a strong pharmacologist, with a solid grounding in cell biology and in vivo physiology, but also requires an ever-broadening skill set to use the tools that are available in the most effective way. The SPS, through its regular webinars, CE courses and the annual meeting itself, maintains its members at the cutting edge of all of this emerging (and traditional) science and technology.

During 2017, we introduced three new awards (Translational Safety Pharmacology; Most Impactful Publication; Technological Innovation) and updated the Wikipedia pages for Pharmacology, Safety Pharmacology and the Safety Pharmacology Society to reflect our discipline more accurately to the wider world.

I have enjoyed my year as President and it has been an honor to serve you all. Thank you all for your support during 2017. I would particularly like to thank Krystle Correll (Executive Director) and the Board of Directors for their dedication, innovation and professionalism. Please join me in welcoming Martin Traebert as incoming President.

I hope to see you all in Washington D.C. next September. Meanwhile, have a relaxing winter break!

Will Redfern, PhD
President, Safety Pharmacology Society


Annual Meeting News

2017 Annual Meeting Highlights

Berlin served as the wonderful host city for the 2017 SPS Annual Meeting. The Meeting, held September 24–27, featured scientific sessions and Continuing Education (CE) courses, scientific posters, an Exhibit Hall, and several sponsored sessions/receptions.

Congratulations and thank you to the 2017 Program Committee for organizing this exceptional program of sessions. Thanks also to Continuing Education (CE) Committee for putting together six excellent Continuing Education courses and a lunchtime mini-course. Recognition also goes to all 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 CE courses. Morning courses offered were AM1: Safety Pharmacology: Understanding Safety and Preclinical Derisking Strategies, AM2: The Role of Classical Pharmacology in Nonclinical Safety Assessment, and AM3: Hands-On Training in Electrocardiography of Laboratory Animals (Interactive Course). The Lunchtime mini-course covered SEND Submissions for Safety Pharmacology. In the afternoon, we had PM1: Current Topics and Best Practices for Central Nervous System Safety Pharmacology, PM2: Building on the Classics: The Emerging Role of Stem Cell-Based Techniques in Safety Pharmacology Assessments, and PM3: “Non-Trivial Pursuit:” A Game Challenging Safety Pharmacologists for a Piece of the (IND) Pie.

The Welcome Reception and Exhibition Opening kicked off the week on Sunday evening with SPS President, Will Redfern, giving a warm welcome to all. Attendees enjoyed networking and catching up with colleagues, all while enjoying local food, wine and beer.

The rest of the week was filled by two tracks which ran concurrently, pertinent to all areas of safety pharmacology, featuring: Keynote by Vera Regitz-Zagrosek, MD, Charité Institute of Gender in Medicine, Berlin, Germany who spoke on Gender Differences in Cardiovascular Diseases and our second Plenary Keynote on Tuesday, Birgit Mazurek, PhD, Tinnitis Center, Charité—Universitätsmedizin Berlin, Berlin, Germany, who spoke on The Pathophysiology and Treatment of Tinnitus.

Within the tracks, scientific topics covered were: Oncology Drug Safety Testing in the 21st Century, Updates on the Hot Topics within CNS, Current Topics in the Translation and Validation of Safety Pharmacology Studies, Best Practices for New Biological Entities and New Modalities, Disease Models and Personalized Medicine, In Vitro Microphysiological Systems to Predict Safety, In Silico Modeling for Cardiac Drug Safety, Animal Models and Species Selection, CiPA Challenges and Opportunities from Nonclinical, Clinical, and Regulatory Perspectives and Interactive Case Studies. The slides from approved presentations from the 2017 meeting are available to all registered attendees online.

More than 180 posters were presented during exhibit hours on Monday and Tuesday in the Exhibit Hall, which featured 42 vendors related to safety pharmacology. During the program, we also featured 20 SPS Oral Communications selected from the abstract submissions.

On Wednesday morning, SPS President Will S. Redfern welcomed attendees to the Annual Members’ Meeting and Awards Ceremony. Certificates were presented to each of the outgoing officers with thanks for their service to the Society. Dr. Redfern then officially passed the gavel to Dr. Martin Traebert, who thanked him for this leadership as president of the Society for the past year. Dr. Redfern recognized the Jr. Investigator and Student Travel Award recipients, Publication award winners, and announced the Jr. Investigator Poster Competition recipients. The 2017 Distinguished Service Award Recipient, Dr. Alan S. Bass, was introduced and welcomed to the stage to give his thoughtful DSA presentation on “Challenges That Make a Difference as Safety Pharmacologists.” We highly recommend reading the interview in the 2017 Fall Issue of Spotlight to learn more about Dr. Bass.


2017 Publication Award Recipients

During 2017, we introduced three new publication awards (Translational Safety Pharmacology; Most Impactful Publication; Technological Innovation) the recipients were announced during the Awards Ceremony at the 2017 Annual Meeting, and are listed below. Congratulations to all who contributed to these publications!

2017 Publication Award Recipients:

Most Impactful Publication Award
Sid Bhatt
For the publication titled: Statistical power analysis of cardiovascular safety pharmacology studies in conscious rats

Technological Innovation Award
Elisa Passini
For the publication: Virtual Assay: A User-Friendly Framework for In Silico Drug Trials in Populations of Human Cardiomyocyte Models

Translational Safety Pharmacology Award
Chris Regan
For the publication: Assessment of the Clinical Cardiac Drug-Drug Interaction Associated with the Combination of Hepatitis C Virus Nucleotide Inhibitors and Amiodarone in Guinea Pigs and Rhesus Monkeys


2017 Post Meeting Survey Results


See You in Washington, DC!

We look forward to seeing you in Washington, DC for our 2018 SPS Annual Meeting. Program planning is already underway, and we are excited to share the details with you on our website in the New Year. So, save the date for September 30–October 3, 2018 and we hope to see you in Washington, DC at the Marriott Wardman Park Hotel!


Pledge Your Support for 2018!

The Safety Pharmacology Society thanks all our 2017 sponsors for their generous contributions, and looks forward to partnering with you again in 2018. To pledge your support for the 2018 Meeting, please contact Krystle Correll.


Exhibitors, Booth sales are open for 2018!

The Safety Pharmacology Society thanks all 42 companies who joined us in 2017 as Exhibitors! We hope to see you again in Washington, DC. If you wish to sign up for your booth for 2018, please contact Amy Willis, or visit our 2018 Exhibitor Portal.


SPS News

Thank You from SPS Headquarters!

From all of us at SPS Headquarters, we wish you a wonderful holiday season and a happy New Year!


JPTM Invitation to Submit

Dear Safety Pharmacology Society Members,

The Journal of Pharmacological & Toxicological Methods is the leading international journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists and publishes focused issues that are devoted to a single research topic. Once again, the forthcoming focused issue centers on "Methods in Safety Pharmacology". You are invited to contribute to this, the 15th special issue of the journal on this topic, especially if you have presented at the recent Safety Pharmacology Society meeting in Berlin, Germany. For this special issue, you are asked to write a manuscript that may be an "Appraisal of state-of-the-art" or "Historical review" or simply describe a particular model, method, technique or apparatus used in the conduct of Safety Pharmacology studies. This focused issue will be devoted to manuscripts that describe reviews/methods of fundamental importance to Safety Pharmacology. Methods manuscripts should describe techniques that are utilized, optimized and validated according to international ICH ethics and scientific quality standards that reflect proper study design, conduct of experiments, data recording methods and data reporting practices. Thus, as it has in the past, this issue will be a primary resource aid to individuals in academia and industry that are interested in understanding Safety Pharmacology principles/methods and will provide a comprehensive overview of the most advanced procedures in Safety Pharmacology studies today. 

On behalf of the Journal and the Safety Pharmacology Society, I am inviting expert researchers who actively conduct studies of this nature, and especially those who presented at the latest SPS meeting, to submit manuscripts for inclusion in this focused issue of the Journal of Pharmacological & Toxicological Methods. As the annual Guest Editor for this exciting focused issue I would very much welcome the opportunity to work with you on this project. Note that manuscripts should be submitted online using this link: https://www.journals.elsevier.com/journal-of-pharmacological-and-toxicological-methods or login to the Journal using your EVISE account (see Instructions to Authors for details) by February 16, 2018.

This issue will be of greater significant value to readers than previous issues because of the expanded topics presented and discussed at the Safety Pharmacology Society meeting in Berlin, Germany. The Journal received an Impact Factor of 2.38 from Thomson Reuters Journal Citation Reports 2016. 

Note that each manuscript will be subjected to the normal peer review process and should conform to the "Instructions to Authors" details as outlined in the attached information. Should you have any further questions please do not hesitate to contact me. I thank you in advance and look forward to hearing from you regarding this endeavor.

Yours sincerely,

Michael K. Pugsley, MSc., PhD., FBPhS., DSP, Associate Editor
Journal of Pharmacological & Toxicological Methods


Year-End Giving? Don't Forget SPS!

Colleagues,

I write today to ask you to consider a personal donation to the Safety Pharmacology Society (SPS). For seventeen years, SPS has served as the leading voice for the global safety pharmacology community, and we hope to continue to provide answers to critical questions that matter to patients, regulators, and scientists for many years to come.

We have a year-end fundraising goal of $5,500. If our goal is reached, those funds will be used to support two additional Junior/Student Travel Award opportunities for the Annual Meeting ($1,500 each), and two new career development and training support opportunities for students/post-docs ($2,000 each).

If each SPS Member contributes just $12 each, we will reach that goal easily! Any amount you can contribute will go a long way to ensure that we can continue to pursue these new opportunities in 2018 and beyond.

Just over the last year, we have produced sixteen educational webinars, increased the number of Jr. Investigator and Student Travel Award opportunities, partnered with educational institutions to provide distance learning courses, and held two regional meetings to expand SPS' impact beyond our Annual Meeting.

In 2018, we anticipate continuing these initiatives and with your support will do more for our community!

SPS provides the platform to share resources, research, and best practices, but we cannot do our job without the involvement and representation of all of you. That's why we are asking you directly to consider sending SPS a tax-deductible, charitable donation. Every contribution, large or small, makes a huge difference to SPS. As the end of the year approaches, please give what you can, whether it is $15, $50, $100, or an amount you generously feel appropriate. It all matters.

The Safety Pharmacology Society and your colleagues thank you for your consideration of a donation to SPS and appreciate your support for the betterment of the science and our discipline, and we welcome your continued commitment and input. Your contribution is a key element in the on-going success of the Society and our commitment to invest in the future. We look forward to continued success, thanks to the generosity of individuals like you.

Thanks for your consideration and generosity. Together we will continue to make a difference.



SPS Headquarters


2017 Diplomate in Safety Pharmacology (DSP) Results

Formal review of examinations for the Diplomate in Safety Pharmacology (DSP) has been completed and notifications to all those who took the exam in 2017 will be sent before December 31. If you took the exam and do not receive notification of your results by this date, please contact Krystle Correll.


NC3Rs Cardiovascular Showcase Event

Central London, March 23, 2018

This one-day event will highlight the wide range of NC3Rs projects within cardiovascular science and will bring together a diverse group of scientists working to advance the application of the 3Rs in cardiovascular research and safety assessment. Presentations and posters will showcase the wide range of cardiovascular projects for basic research, as well as drug efficacy and safety studies supported by the NC3Rs.  During the afternoon, three interactive workshops will run:

  1. Funding workshop: To highlight our funding opportunities and encourage applications to the NC3Rs-BHF PhD Studentship scheme for 2018.

  2. Development of an adverse outcome pathway (AOP) for cardiotoxicity: To share and discuss the outcomes from a NC3Rs strategic award describing mechanisms for L-type calcium channel mediated cardiotoxicities.

  3. Increasing the adoption of social-housing during telemetry recordings: To share and discuss experiences and information to encourage wider adoption of this refinement across species, for telemetry studies performed for academic research, safety pharmacology or toxicology purposes.

Attendance is free, but registration is essential (by February 8, 2018). For further information and registration, please click here.


British Pharmacological Society and The Physiological Society In Vivo Co-hosted Workshop summary

Recently the British Pharmacological Society (BPS) contacted SPS to request collaboration on an initiative to address in vivo education, research and training in the UK.  A major outcome of the BPS's 'Focus on Pharmacology' project was a 2016 review of the Integrative Pharmacology Fund (IPF), a shared venture between AstraZeneca, GlaxoSmithKline, Pfizer, public funders and the BPS to help support in vivo knowledge and skills. The impact of the £22m (~$30m) fund over its 12-year lifetime was evaluated and recommendations made for in vivo education, research and training.

Drawing upon expertise from across the in vivo community, the BPS and The Physiological Society co-hosted a workshop in London on November 21 to discuss how these recommendations might be implemented. Future challenges arising from a changing scientific landscape were discussed as well as how best to nurture networks of good practice. The BPS will condense the outputs of these discussions and produce a report that will inform the necessary next steps for the in vivo community to ensure a sustainable and well-rounded future in vivo landscape. SPS President, Will Redfern, attended this workshop. 

Along with other learned societies, SPS will 'co-badge' this initiative, including an undergraduate in vivo curriculum.  This will not require any financial input from SPS, but we have offered to supply course materials relating to safety pharmacology. Although this initiative is UK-focused, SPS members world-wide will be able to adapt this curriculum for use in their own territories.


New Report Promotes Regulatory Efficiency in Animal Research

FASEB, AAMC, COGR and NABR have shared a report of interest to the SPS community, "Reforming Animal Regulations: Workshop Recommendations to Reduce Regulatory Burden."

Please see the summary below highlighting the report. To read the complete report, please visit their website.

Summary
A new set of recommendations proposes changes to federal regulations, policies, and guidelines governing the use of animals in research. Directed to federal agencies involved in the oversight of federally funded animal research — primarily the U.S. National Institutes of Health and the U.S. Department of Agriculture — the recommendations aim to address the numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare. The proposed changes ensure that standards of care in animal research are maintained and would have the practical effect of promoting efficiency among researchers.

The report grew out of an April 2017 workshop convened by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), and the Council on Governmental Relations (COGR), with support from the National Association of Biomedical Research (NABR). The workshop participants sought to identify federal requirements that demand significant administrative effort but do not enhance animal welfare.

The use of animals in research continues to be vital to understanding human and animal disease, and researchers take their commitment to the humane care and use of research animals seriously. The sponsoring organizations hope this report will aid federal agencies and Congress in reducing the significant inefficiencies in the animal research oversight process.


HTS in Cardiac Safety Symposium Summary

On September 24, 2017 at the Maritim Hotel Berlin, a meeting was held to discuss the current status of HTS in cardiac safety.

The on-going comprehensive in vitro pro-arrhythmia assay (CiPA) initiative aims to improve drug safety testing and help more beneficial chemical entities reach the market. The project consists of three main parts, which include 1) electrophysiological investigation of drug effects on human ventricular ion channels, 2) characterization of the in-silico cardiac safety model predictions, 3) assessment of discrepancies and gaps in fully integrated biological systems (human induced pluripotent stem-cell- derived cardiac myocytes (iPSC- CMs) and the human ECG).

To assess and validate drug effects on hiPSC-CMs in a combined measurement of cardiac excitation and contraction, a subset of compounds which are part of the Phase II CiPA study were tested. Current results investigated with state-of-the art instrumentation were presented and discussed. Experiments were conducted across independent laboratories testing 12 reference compounds in different independent commercially available hiPSC-CMs.

Speakers and topics:

Dr. Said el Haou, Metrion Biosciences: "In depth profiling of human iPSC-CM — from electrophysiology to phenotypic assays"

Dr. Matt Burnham, AstraZeneca: "Impedance and field potential in 3D: cardiomyocyte co-culture spheroids and the CardioExcyte 96 platform"

Dr. Takasuna Kiyoshi, Daiichi Sankyo/ Novare: "Comprehensive in vitro cardiac safety assessment using human stem cell technology (CSAHi: HEART initiative) -The second stage"

Dr. Teun de Boer, University of Utrecht: "Dynamic clamping on a Patchliner: adding virtual IK1 channels to cardiomyocytes"

Dr. Matthias Gossmann, Innovitro: "CardioExcyte 96 meets CellDrum: True Contractility in High Performance"

Dr. Sonja Stoelzle-Feix, Nanion Technologies: "HTS in cardiac safety with SyncroPatch 384 PE"

Data sets and further information from this meeting are available here.


9th Japanese Safety Pharmacology Society Annual Meeting


Date: February 9 (Fri) – 10 (Sat), 2018
Venue: The University of Tokyo, Yayoi Auditorium, Ichijo Hall / Annex Seihoku Gallery
President: Hiroyuki Ando, PhD (Ono Pharmaceutical Co., Ltd)
View Program (Draft) Please note that presentation titles and time tables, still being tentative, may be subject to amendment during arrangement.

SPS Members Co-Direct 2018 Safety Pharmacology Course

SPS Members, Andrea Greiter-Wilke (F. Hoffmann–La Roche Ltd) and Martin Traebert (Novartis Ltd.) are co-directing the DGPT/Swiss Society of Toxicology Safety Pharmacology Course to be held in Basel, Switzerland over the dates of February 5–9, 2018. This course is part of the DGPT Modular Training Programme in Toxicology ("Fachtoxikologe/in DGPT") and registration should be made via the German Society of Toxicology. Additional information can be found online.


Collaborations and Activities

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 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

Recent Publications of Interest

Reminiscing about Jan Evangelista Purkinje: a pioneer of modern experimental physiology

Can Nonclinical Repolarization Assays Predict the Results of Clinical Thorough QT Studies? Results from a Research Consortium

Adult Human Primary Cardiomyocyte-Based Model for the Simultaneous Prediction of Drug-Induced Inotropic and Pro-arrhythmia Risk