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SPotlight Newsletter


Spotlight Newsletter

Winter Issue 2020

President’s Report

Soon it is time to celebrate the holiday season. Before doing so, I would like to take this chance to reflect on 2020. For me and the Society it started dramatically by the tragic passing of Carrie Markgraf — our newly appointed president of SPS. The Board of Directors (BoD) installed a succession plan that, supported by the members, trusted me with the 2020 presidential task. I would like to thank you all for that trust.

Early January we all learned about a virus that was on outbreak in countries like China and Japan. Soon after the annual Japanese SPS meeting was cancelled — one of many cancellation and changes in the scientific community we are all part of. During February and March it became clear that we were facing a pandemic outbreak and that the world as we knew it was changing. For the Society, we learned that we could not expect to conduct the 20-year anniversary meeting in Montreal as we have planned and looked forward to. But by diligence and hard work the AIM staff, Program Committee, CE Committee and the Abstract Committee we managed to put a very successful virtual annual meeting together — which kicked of September 14–17, 2020. And I was very happy to see the well-deserved recognition that Carrie was given at the SPS annual meeting.

2020 was also a year where a great number of safety pharmacology papers where published. I would like to point your attention to a just a few coming of out the greater SPS community/network: 1) An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation (Authier et al 2020); 2) Is there a role for the no observed adverse effect level in safety pharmacology? (Mow et al, 2020); 3) Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective. (Vargas et al, 2020). Please find full references and more interesting publications in the Publication section of this issue.

Despite the scientific success of the Annual Meeting, it did not create the revenue as our annual meetings usually do. Even though we are a not-for-profit-organization that relies heavily on our members voluntary work, we are also very much dependent on the annual meeting revenue to drive the Mission and business of SPS. This means that a big task for the BoD in 2021 will be to find ways to secure a sustainable business in an unpredictable world. There are several ways to do that e.g. create new revenue streams valuable to members and business partners, focus on “critical only” expenses and rely even more on you (our members and volunteers) in critical business tasks. We will investigate all possibilities as part of an “emerging issues business plan” and we would be pleased if you will let us know if you have any good ideas or suggestions in this direction that we as the Board can take on for 2021.

Fortunately, 2021 is already looking to be an exciting year for SPS. The great work done by the ICH E14/S7B Implementation Working Group (IWG) will continue and a very important implementation of this “Stage I” is ongoing and will continue in 2021 and beyond. We also expect that a “Stage II” dealing with “low risk drugs” (e.g. biologics) that might not require detailed clinical QT assessment will be something that will be looked into in the coming years. All business right down the center of the Safety Pharmacology Society. I would like to thank all the members of SPS that spend hours and hours on this to getting it right – to the benefit of all of us.

On a personal level I have really enjoyed this year as President and it has been a privilege to serve the Society. Thank you all for your support during this, to say the least different, year. I need to thank the AIM staff, in particular Krystle Correll (Executive Director) and her colleagues, as well as the Board of Directors for their support, conscientiousness, and perseverance in getting the work done and most importantly establishing a great virtual meeting despite the obvious challenges. I would like to give a special thank you to Mike Engwall for his unshakable and thorough support to SPS during his presidential period in the last 4 years and not the least I would like to thank him for being a great past president and a great help for me in 2020. THANK YOU.

Finally, please join me in welcoming Brian Roche as incoming President for 2021. I’m sure Brian’s experience, position, determination and many great ideas will bring new ways of thinking to the Society and continue to expand the footprint of SPS in 2021.


“If there’s a will, prosperity can’t be far behind” W.C Fields

Tomas Mow, DVM, PhD, DSP
President, Safety Pharmacology Society


Annual Meeting News

20 Years of Progress: Safety Pharmacology Society Virtual Meeting Highlights

SPS held its first virtual meeting September 14-17, 2020 which featured scientific sessions, virtual posters, Exhibit Hall, networking lounges, and several sponsored sessions all within our virtual environment. While we know that in-person interactions and events were missed by all this year, we thank you for navigating new ideas and technology with us and supporting the Society throughout the year. Our members, sponsors and partners have allowed SPS to fulfill our mission during these uncertain times, and we are grateful for the support.

As a reminder, all education content is available on-demand to registrants into early 2021, so be sure to take advantage of access while you can! If you did not participate and wish to prioritize your learning this winter, register before December 31st to gain immediate access to the online content from the Meeting.

Congratulations and thank you to the 2020 Program Committee for organizing this exceptional program of sessions and for the flexibility in implementing new process’ and technologies as we navigated the many changes of going virtual. We tried a few new formats this year, including rapid fire poster presentations and debate style sessions, both of which received positive feedback from participants. We also wish to thank the Continuing Education (CE) Committee for putting together six excellent Continuing Education courses which were held after the live meeting dates. Recognition goes to all the chairs, speakers, exhibitors, sponsors, poster authors and the many others whose efforts made this outstanding experience and program possible.

In addition to hosting high-quality scientific sessions and content, we also hosted two speed networking events and a 20th Anniversary Celebration! It was nice to see some new faces joining us online for the first time this year, and we look forward to welcoming you back next year.

Our partners and vendors shared their products, services, and expertise within the virtual exhibit hall where attendees and booth reps were able to chat and meet at their virtual booths to engage with whitepapers, videos, and studies/data. We hope you had a chance to pop into the amazing booth content during the live week; the booth content is available to all registrants on-demand (through early 2021) and exhibitors may be adding new items during that time.

On our final live day, we shared updates on the Society during our Members’ Meeting and Awards ceremony, including recognizing outgoing officers, poster award winners, publication award winners and even “passed the gavel” virtually.

Future Meeting Topics Feedback:

Each year, we ask you what topics you want to see presented at future meetings, the survey results from those who completed the post-meeting survey (below) show the top scientific topics that were requested. The 2021 Program and CE Committee planning has already started! If you have any suggestions for content, please email Rachel Woodson before January 15.

Early Safety Profiling and De-risking 41%
Translational Safety Pharmacology/Translational Medicines 41%
Regulatory Topics (CiPA, SEND, etc.) 38%
New Therapeutic Modalities (e.g., Gene therapies, microRNA, antibodies) 31%
Core Battery (CV, CNS, Respiratory) 22%
Immune System 22%
Integrative Pharmacology/Physiology 22%
Biomarkers in Safety Pharmacology 22%
Clinical Topics 19%
In Silico Approaches/Modeling 19%
Novel In Vitro Cell-Based Assays 19%

2020 Publication Award Recipients

During our 2020 Virtual Annual Meeting, September 14-17, 2020, the Safety Pharmacology Society recognized the award recipients for our Translational Safety Pharmacology Publication Award and Technological Innovation Publication Award. The publications are nominated by SPS Members, reviewed by the SPS Awards Committee, and selected based on Relevance to Safety Pharmacology, Potential impact on the industry/field, Novelty of the research/uniqueness of approaches and concepts, Advancement of research understanding, Quality of data, and Clarity of writing.

The Technological Innovation Publication Award went to Sophie Fletcher, Helen Maddock, Rob S. James, Rob Wallis & Mayel Gharanei for their publication The cardiac work-loop technique: An in vitro model for identifying and profiling drug-induced changes in inotropy using rat papillary muscles.

The Translational Safety Pharmacology Publication Award went to Hamid R. Amouzadeh, Isaiah Dimery, Jonathan Werner, Gataree Ngarmchamnanrith, Michael J. Engwall, Hugo M. Vargas, Deborah Arrindell for their publication Clinical Implications and Translation of an Off-Target Pharmacology Profiling Hit: Adenosine Uptake Inhibition In Vitro.

Our sincere congratulations to each author who contributed to these publications!


Save the Date! 2021 SPS Annual Meeting

Please save the date for our 2021 Annual Meeting to be held online and in-person in Brussels, Belgium at the Square Convention Centre over the dates of September 26–29, 2021.

Add to Calendar!  

As we say goodbye to 2020 and hello to a new year filled with promise, we recognize that most of us do not know quite what the world will look like in a few months. For this reason, we are presently planning for both online and in-person opportunities for our 2021 Meeting. We will continue to send out updates on the latest and greatest for our 2021 plans, as we build on lessons learned and your valuable feedback!


Partner with us in 2021!

The Safety Pharmacology Society thanks our 2020 Meeting Sponsors for their generous contributions and looks forward to partnering with you again in 2021. To pledge your support for the 2021 Annual Meeting, please contact Krystle Correll.

If you are looking for advertising opportunities, or would like to discuss partnership opportunities with SPS year-round, please visit our advertising page or contact Krystle Correll for a personalized partnership plan. We will be releasing some new partnership opportunities in early 2021 and would love to discuss them with you!


SPS NEWS

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! We look forward to working with SPS Members and our partners in 2021 and hope you stay happy and healthy.

(L to R): Mphatso Matenda, Registration and Membership, Rachel Woodson, Program Manager, Krystle Correll, Executive Director, Tierre Miller, Deputy Director, Amy Willis, Exhibits/Meeting Manager & Digital Event Specialist

JPTM Invitation to Submit Manuscripts

Dear 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.

You are invited to contribute to the 18th themed issue on “Methods in Safety Pharmacology”, especially if you presented at the recent Virtual Safety Pharmacology Society meeting held online. For this themed 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. 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 themed issue will be a primary resource aid to individuals in academia and industry who 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.

As the annual Guest Editor for this exciting themed issue I would very much welcome the opportunity to work with you on this project. Note that all manuscripts must only be submitted online or login to the Journal using your EVISE account by February 19, 2021.

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. The Journal received an Impact Factor of 2.25 from 2019 Journal Citation Reports (Clarivate Analytics, 2020).

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


ICH E14 and S7B: A Note from the SPS President

Dear Members of SPS,

Since the link between serious ventricular arrhythmias among patients taking e.g. terfenadine was discovered in the early 1990s, drug developers and regulators worldwide have searched for an optimal and efficient risk assessment of drug-induced QTc interval prolongation and torsades de pointes arrhythmia leading to release of the ICH S7B and ICH E14 in 2005; a topic that has been key to the Safety Pharmacology Society (SPS) since its inauguration in 2000. As we all acknowledge, these guidelines have been very successful but despite the concurrent release of the guidelines the recommended nonclinical evaluations of risk for QT prolongation unfortunately have minimal impact on the ICH E14-based recommendation for assessing clinical QTc prolongation.

Therefore, there is no doubt in my mind that the updated Q&A to the ICH E14 and ICH S7B as well as the effort in linking these guidelines together is a very important piece of work. On behalf of SPS, I wish to recognize and thank the many people in the ICH E14/S7B Implementation Working Group (IWG) who have worked diligently on getting the Q&As to the current stage; Step 2b and release for public consultation. As Past Presidents and Members of SPS, we wish to specifically recognize and thank Hugo Vargas, Jean-Pierre Valentin, Derek Leishman and Eric Rossman (In Vivo Project Manager) who have been at the front of this important work. They are also responsible for the very successful session on this topic at the SPS Virtual Annual Meeting on September 16, 2020 and we will continue to liaison with them to provide you with future updates and information.

We also thought it important to share the survey data from that session collected from the attendees who participated. To quote the survey data, “A majority of respondents (53%) believed that the Q&As will improve QTc/ proarrhythmia assessment” but the data also highlights some important concerns: “A majority of respondents (50%) do foresee issues with implementing the nonclinical strategy”.

I am pleased to see how these Q&As are re-enforcing the value of the nonclinical data generated to assess the overall risk for QTc-prolongation and torsades de pointes arrhythmia. As stated in the recently published paper by the IWG (Vargas HM et al, 2020) “The time has come to meaningfully merge nonclinical and clinical data to enable a more comprehensive, but flexible, clinical risk assessment strategy for QTc monitoring”.

To keep you informed on this important issue, we plan to host a series of webinars in 2021 for SPS Members. Members will receive updates on the Q&As and will have opportunities to provide input on the implementation process and finalization of the Q&A guideline updates.

Please watch for more information in the coming months through all SPS news outlets (website, newsletters, blogs and social media).

On behalf of SPS,
Tomas Mow, DVM, PhD, DSP
2020 President, Safety Pharmacology Society


NC3Rs Survey Invitation: Microsampling

NC3Rs has launched a survey to gather information on the current use of microsampling. If you use a microsampling technique within any research or safety study for new drugs and (agro)chemicals, we are interested to learn the 3Rs impacts you have achieved. If you do not use microsampling, please let us know your concerns and any barriers you may have experienced to help guide our future strategy.

Please download the survey (.XLSX format) and return it to Helen Prior by Friday 22 January 2021. It should take no more than 15 minutes.


Collaborations and Activities

2020

  • SOT Scientific Liaison Coalition (Member since 2011)
  • JSPS Meeting Participation (March 2020 - Cancelled)
  • SOT Global Gallery and Post-doc Mixer participant (March 2020 - Cancelled)
  • ACT Webinar Co-sponsor (February 2020 & May 2020)
  • UW Madison Distance Learning Course support (Year-round)
  • 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) (September 2020–September 2023)
  • SPS Virtual Annual Meeting (September 2020)
  • SPS Member participation in the ICH E14/S7B Implementation Working Group (IWG) (ongoing)

Upcoming Webinars

Upcoming Meetings


SPS Member News

Recent Publications of Interest

Discovery and characterization of ORM‐11372, a novel inhibitor of the sodium‐calcium exchanger with positive inotropic activity

Integration of mechanical conditioning into a high throughput contractility assay for cardiac safety assessment

An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation

Role of the rabbit whole-heart model for electrophysiologic safety pharmacology of non-cardiovascular drugs

INSPIRE: A European training network to foster research and training in cardiovascular safety pharmacology

Revisiting the hERG safety margin after 20 years of routine hERG screening

Is there a role for the no observed adverse effect level in safety pharmacology?

The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system

Twenty years of safety pharmacology model validation and the wider implications of this to drug discovery

Insights into toxicology, safety pharmacology, and drug dependence testing: The performance and predictive values of nonclinical tests

Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective

Blinded In Silico Drug Trial Reveals the Minimum Set of Ion Channels for Torsades de Pointes Risk Assessment

Confounders and Pharmacological Characterization When Using the QT, JTp, and Tpe Intervals in Beagle Dogs

Can We Panelize Seizure?