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SPotlight Newsletter


Spotlight Newsletter

President’s Report

The 19th Annual Meeting of the Society in Barcelona, Spain in September, was a very successful and informative conference. I was impressed by the excellent diversity, innovation, and quality of scientific topics. We had 486 attendees, with 6 CE courses with 24 speakers (and a mini-course), 43 scientific talks, 172 posters, and 51 exhibitors. The meeting’s success is due to all attendees, presenters, and exhibitors. Thanks for all your contributions!

The Safety Pharmacology Society, formed in 2000 from the General Pharmacology Interest Group, has supported the emerging discipline of safety pharmacology since then. While the initial focus was largely driven by the small molecule portfolios, the membership is now dealing with a plethora of new modalities which require modification of the study designs and techniques to provide evaluations of functional effects a variety of molecules (small and large) across the three vital organ systems (cardiovascular, central nervous system and respiratory). Then, as now, there was a strong focus on the issue of drug-induced torsade de pointes. Much has changed within the last 19 years and the ICHS7B is being amended to include a Q&A section which should reflect the recent developments on that topic and provide guidance on how preclinical data can be leveraged to reduce the need for thorough QT studies. In parallel, there is a reconsideration of what studies are critical to a filing package and whether it is time to reconsider the value of other studies. Artificial intelligence and machine learning continue to be popular topics across the posters and presentations. Finally, there is a growing appreciation of the expertise and experience that resides with safety pharmacology experts. There are opportunities to leverage that expertise and experience in specific therapeutic areas seeking confirmation of efficacy for novel molecules and modalities. The collaborative spirit demonstrated by consortia continues to benefit our Society and that cooperative mode will be critical as we address the challenges before us. The SPS, through its regular webinars, CE courses, regional meetings and of course the annual meeting, supports the membership at the cutting edge of emerging (and traditional) science and technology.

I have really enjoyed my year as President and it has been an honor to serve you all. I have learned a lot. Thank you all for your support during 2019. I would like to thank the AIM staff, in particular, Krystle Correll (Executive Director) and her colleagues as well as the Board of Directors for their dedication, innovation and professionalism.

Finally, please join me in welcoming Carrie Markgraf-Blum as incoming President for 2020. Carrie is already collecting ideas on how we can commemorate the 20th anniversary of the Society.

I hope to see you all in Montréal next September and wish you all a relaxing winter break!

Michael Engwall, DVM, PhD, DSP
President, Safety Pharmacology Society


Annual Meeting News

2019 Annual Meeting Highlights

Barcelona served as the wonderful host city for the 2019 SPS Annual Meeting. The Meeting, held September 23–26, featured scientific sessions and Continuing Education (CE) courses, scientific posters, an Exhibit Hall, and several sponsored sessions/receptions.

Congratulations and thank you to the 2019 Program Committee for organizing this exceptional program of sessions. Thanks also to the Continuing Education (CE) Committee for putting together six excellent Continuing Education courses and a Midday 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 Monday with our CE courses. Morning courses offered were AM1: Variability, Uncertainty and Probability in Safety Pharmacology Decision Making; AM2: Advanced Therapy Medicinal Products (ATMPs): Real World Approaches and Safety Concerns (Jointly hosted by the German Society of Pharmacology); and AM3: Insights on Secondary Pharmacology in Drug Development. The Midday Mini-Course covered a “Introduction and Overview to the Field of Safety Pharmacology”. In the afternoon, we had PM1: Current Topics in Central Nervous System Assessment; PM2: Cardiovascular Translation from Animals to Man; and PM3: Safety Assessment of New Therapeutic Modalities.

Networking Picture from AM2019 Meeting

We hosted our New Members and First-time attendees at our 2nd Annual networking event. This event took place just before the Welcome Reception and was a fantastic way for our newer members to meet seasoned members to build their network and build mentor relationships. Following our networking event, the Welcome Reception and Exhibition Opening kicked off the week on Monday evening where attendees enjoyed networking, learning about vendor services and catching up with colleagues.

Exhibithall Entrace Picture from AM2019 Meeting

The rest of the week was filled by two tracks which ran concurrently, pertinent to all areas of safety pharmacology, featuring our Tuesday Keynote by Kevin Eggan, PhD, Harvard Stem Cell Institute, Cambridge, MA, who spoke on The Utility of Human Stem Cell Models of Nervous System Disorders: Progress and Clinical Proof of Concept and our second Plenary Keynote on Wednesday, Michael Burczynski, PhD, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, who spoke on Leveraging the In Silico World of Data to Identify Personalized Medicine Approaches for Novel Drug Targets.

Within the tracks, scientific topics covered were: Emerging In Vitro Models and Their Application in Safety, Hot Topics in the Central Nervous System, Can Safety Pharmacology Studies Support the Assessment of Immune-Related Adverse Events?, Thoughts on Translation, How Clinicians and Clinical Pharmacologists View Safety Pharmacology Data, Recent Trends in High Performance Computing for Safety Pharmacology, What Do Biomarkers Mark? A Safety Pharmacology Perspective, Impact of Early Safety Pharmacology Derisking Strategies and Techniques, Strategies for Getting to FIH and Beyond Efficiently and Safely and Revisiting ICH S7A and S7B.

The slides for approved presentations are available to all registered attendees online.

More than 170 posters were presented on Tuesday and Wednesday in the Exhibit Hall, which featured 50 vendors offering products and services related to safety pharmacology. During the program, we also featured 20 SPS Oral Communications which were selected from the abstract submissions.

Outreach event picture

On Tuesday afternoon, the Academic Outreach Committee hosted its 2nd Annual student and academic speed networking lunch where everyone participated in “speed networking” with SPS Members. We hope that everyone learned something new and were able to build their networks. We look forward to building on this event and offering them again at future meetings. On Thursday morning, SPS President Michael Engwall 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. Engwall officially announced the “passing of the gavel” to 2020 SPS President, Dr. Carrie Markgraf. The Society thanks Dr. Engwall for his leadership as president of the Society for the past year. Dr. Engwall recognized the Jr. Investigator and Student Travel Award recipients, Publication award winners, and announced the Jr. Investigator Poster Competition recipients.

Prof. Brian D. Guth

The 2019 Distinguished Service Award Recipient, Prof. Brian D. Guth, was introduced by Dr. Frederick Sannajust and welcomed to the stage to give his personal insights and journey during his presentation Recollections of Becoming a Safety Pharmacologist. We highly recommend reading the interview in the 2019 Fall Issue of SPotlight to learn more about Prof. Guth.


2019 Publication Award Recipients

Last year, we introduced three new publication awards (Translational Safety Pharmacology; Most Impactful Publication; Technological Innovation) at the 2019 Annual Meeting during the Awards Ceremony, the recipients are listed below. Congratulations to all who contributed to these publications!

Most Impactful Publication Award

James J. Lynch III, Emilie Rossignol, Joerg J. Moehrle, Terry R. Van Vleet, Kennan C. Marsh, Toufan Parman, Jon Mirsalis, Sean E. Ottinger, Jason A. Segreti, Mohan Rao, Scott W. Mittelstadt

For the publication: Increased Stress Associated With Head-Out Plethysmography Testing Can Exacerbate Respiratory Effects and Lead to Mortality in Rats

Technological Innovation Award

Emmanuel Boulay, Matthew M. Abernathy, Ray Chui, Gregory S. Friedrichs, Nicolas Gendron-Parra, Andrea Greiter-Wilke, Jean-Michel Guillon, John E. Koerner, Ariane Menard, Jill Steidl-Nichols, Jennifer Pierson, Michael K. Pugsley, Eric I. Rossman, David Strauss, Eric Troncy, Jean-Pierre Valentin, Todd Wisialowski, Simon Authier

For the publication: A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium

Translational Safety Pharmacology Award

Sabina Paglialunga, Bruce H. Morimoto, Matthew Clark, Gregory S. Friedrichs

For the publication: Translatability of the S7A Core Battery Respiratory Safety Pharmacology Studies: Preclinical Respiratory and Related Clinical Adverse Events


2019 Post Meeting Survey Results



See You in Montréal!

We look forward to seeing you in Montréal for our 2020 SPS Annual Meeting. Program planning began on December 11, and we are excited to share the details with you on our website in the New Year. So, save the date for September 13–16, 2020 and we hope to see you at the Palais des congrés de Montréal in the Fall!


Pledge Your Support for 2020!

The Safety Pharmacology Society thanks all our 2019 sponsors for their generous contributions, and looks forward to partnering with you again in 2020. To pledge your support for the 2020 Meeting, please contact Krystle Correll.

If you are looking for advertising opportunities during the Annual Meeting, or year-round, please visit our advertising page.


Exhibitors, Booth sales are open for 2020!

The Safety Pharmacology Society thanks all 51 companies who joined us in 2019 as Exhibitors! We hope to see you again in Montréal, Canada. If you wish to sign up for your booth for 2020, please contact Amy Willis, or visit our Exhibitor Portal.


SPS NEWS

Regional Meeting Summaries: Northeast and Bay Area

SPS Northeast Regional Meeting: Skating Ahead of the Puck: Safety Pharmacology for Evolving Therapeutic Modalities

The 2019 Northeast Regional Meeting was hosted by Charles River Laboratories in Shrewsbury, MA on October 17. A total of 55 delegates discussed important topics surrounding the issue of “Safety Pharmacology for Evolving Therapeutic Modalities”. The full agenda can be found here.

Attendees took the opportunity to network and view posters and tabletop vendors during lunch, breaks and reception.

We wish to thank the following Vendors and Sponsors for their partnership and support of this Meeting:

We also wish to recognize the organizers of the Meeting: Donald Hodges, Alan Bass, Susan Goody, Andrew Sonderfan, Robert Dunn, Malar Pannirselvam, Amy Kim, and Samuel Chuang.

SPS Bay Area Regional Meeting: Current Topics in CNS Safety Pharmacology
The second Regional Meeting took place on November 8 and was hosted by Genentech in South San Francisco, CA. A total of 37 delegates discussed issues around the subject “Current Topics in CNS Safety Pharmacology”. The full agenda can be found here.
Attendees took the opportunity to network and view posters and tabletop vendors during lunch, breaks and reception.

We wish to thank the following Vendors and Sponsors for their partnership and support of this Meeting:



We also wish to recognize the organizers of the Meeting: Dale Stevens, Dinah Misner, Carrie McMahon, Ray Chui, Michael Pugsley, Chris Mathes, and Najah Abi-Gerges.

Thank you again for the support from the volunteer organizers, vendors and sponsors of our 2019 Regional Meetings. We hope to see you at a future SPS Regional Meeting!


Educational Symposium at 40th Annual Meeting of the American College of Toxicology (ACT), Phoenix, AZ

On November 19, 2019, SPS members participated in a symposium entitled ‘Safety Pharmacology for Toxicologists: Incorporating functional endpoints into toxicology studies and highlighting proposals for changes in guideline requirements’ during the ACT annual meeting in Phoenix, AZ. This session was developed by the SPS Board of Directors as part of liaison activities between other scientific societies and was co-sponsored by Charles River Laboratories and WuXi AppTec.  The aim of the session was to update toxicologists on the latest developments within the field of safety pharmacology, focusing on the increased application and acceptance of functional endpoints within investigative and regulatory toxicology studies, but also the ongoing discussions into potential changes to regulatory guidelines in the future.
Speakers covered the background and perspectives for including safety pharmacology assessments within toxicology studies, with data and case-studies for cardiovascular and CNS (functional observational battery) assessments.  Further presentations discussed the predictivity of respiratory data and the proposed ICH S7B/E14 Q&A document. Finally, an FDA speaker provided a regulatory perspective for the number of toxicology studies and common safety pharmacology assessments reviewed for various drug modalities.
The session was attended by 230+ delegates and a LinkedIn post after the session has been viewed in excess of 3,500 times!

Group Photo from ACT Annual Meeting 2019

Left to right: Hugo Vargas (Amgen), Helen Prior (NC3Rs), Stephanie Born (Merck), Brian Roche (CRL, co-chair), Marie-Luce Rosseels (UCB, co-chair), Sabina Paglialunga (Celerion), Amy Avida (FDA) and Simon Authier (CRL).


Thank You and Season’s Greetings 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 Manuscripts

Colleagues,
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 17th special issue of the journal on this topic, especially if you have presented at the recent Safety Pharmacology Society meeting in Barcelona, Spain. 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. All methods manuscripts must describe techniques that are utilized, optimized and validated according to international ethics and scientific quality standards and 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 used in the conduct of 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 or login to the Journal using your EVISE account by February 14, 2020.

This issue will, as in the past, be of significant value to readers because of the expanded topics presented and discussed at the Safety Pharmacology Society meeting in Barcelona. The Journal received an Impact Factor of 2.68 from 2018 Journal Citation Reports (Clarivate Analytics, 2019).

Note that each manuscript will be subjected to the normal peer review process and should conform to the “Instructions to Authors” details. 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 nineteen 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 $5,000. In addition to expanding our educational webinar offerings to include more presentations from our academic colleagues, donations will be also used to support Junior/Student Travel Award opportunities for the Annual Meeting, and new initiatives identified by members in our most recent benchmark survey.

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 $10, $50, $100, or an amount you generously feel appropriate. It all matters.

If each SPS Member contributes just $10 each, we will reach our goal easily! Any amount you can contribute will go a long way to ensure that we can continue to pursue these opportunities and more in 2020. The 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.

SPS Headquarters


11th Annual Japanese Safety Pharmacology Society Meeting

Date: February 28 (Fri)-29 (Sat), 2020
Venue: Showa University Kamijo Memorial Hall
Abstract submission deadline: January 17, 2020 (Friday)

President: Satoshi Nagata (LSI Medience)
Website


Collaborations and Activities

2019
SOT Scientific Liaison Coalition (Member since 2011)
JSPS Meeting Participation (March 2019)
SOT Global Gallery and Post-doc Mixer participant (March 2019)
UW Madison Distance Learning Course support (April–November 2019)
ASCPT Webinar share with SPS Members (May 2019)
SPS is Partner Organization in the EU Commission Grant: INnovation in Safety Pharmacology for Integrated cardiovascular safety assessment to REduce adverse events and late stage drug attrition (INSPIRE) (May 2019–September 2023)
EFPIA/PhMRA/JPMA/S7B-E14 working group support of face to face meeting
Drug Safety South Africa support/meeting participation
ACT sister society gallery (poster) and CE course


Upcoming Webinars


Upcoming Meetings


Member News

Recent Publications of Interest