SLC

Scientific Liaison Coalition (SLC)

Mission

A partnership of scientific societies with the goal of improving public health through a collaborative interdisciplinary approach.

  • Strengthening partnerships among scientific and health-based organizations to increase awareness of the impact of toxicology and related subjects on human health.
  • Functioning as a means to enhance cooperation among societies as equals with the goal of accomplishing tasks benefiting human health and disease prevention through joint and several shared activities.

Current Participating SLC Organizations

Dues Structure

Yearly Participation Dues Levels:
$1,000 for Organizations with Less Than 1,000 Members
$2,000 for Organizations with More Than 1,000 But Less Than 5,000 Members
$3,000 for Organizations with More Than 5,000 Members

Annual Reports

SLC Annual Report June 2016

SLC Annual Report January 2015

SLC Annual Report January 2014

Issue Statement

Communicating Biomedical Health-Related Research Findings: A Guide to Maintaining Balance and Avoiding Common Pitfalls

Webinars

All webinars are viewable in a protected format to prevent downloading.

Upcoming SLC Webinar

The Safety of Dietary Supplements: Focus on Liver Injury
Scheduled for 2017 TBD

Presented by Victor Navarro, MD

Ellen Silbergeld, PhD

Dr. Navarro is Chairman, Division of Hepatology, Einstein Healthcare Network, Professor of Medicine, Jefferson Medical College, Philadelphia, Pennsylvania. Dietary supplements are used commonly in the US, as they are around the world, for many purposes. However, in most countries, their approved use is predicated upon a history of safety use, or at least a paucity of evidence to prove their harm. In the US, there is no requirement to prove supplement safety before marketing, and mechanisms to monitor marketed products for safety and ongoing compliance to manufacturing requirements and regulation are outstripped by the numbers of supplements, manufacturers, and outlets for their distribution. Against this backdrop, there are instances in which supplements have irrefutably caused end organ injury. As regards the liver, an organ at the forefront of biochemical detoxification within the body, there are ample reports of attributable injury. In fact, some injuries resulting from marketed supplements have been severe enough to lead to death and liver transplantation. The goals of this webinar are 1) review the regulatory framework for dietary supplements in the US and abroad; 2) discuss the types of end organ injuries that have resulted from supplements; 3) provide evidence linking some supplements and/or their ingredients to liver injury; and 4) discuss strategies to mitigate the problem of liver injury resulting from dietary supplements.


Previous Webinars

Biology of Vaccines and Molecular Evolution of Viruses
Tuesday, November 1, 11:00 AM–12:30 PM ET USA 

Presented by Paul E. Turner, PhD, Chair of Ecology and Evolutionary Biology, Yale University, Microbiology Faculty, Yale School of Medicine, New Haven, Connecticut. This presentation will cover fundamentals of virus molecular evolution, and the biology of vaccines. This webinar will summarize the challenges of developing evolution-proof vaccines, such as those against rapidly evolving targets, particularly RNA viruses. An emphasis will be on past vaccine successes, such as the global vaccination program that eradicated variola virus (causative disease agent of smallpox in humans). In addition, the presentation will contrast the evolutionary reasons why other efforts have been modest or completely ineffective. The talk will cover some current theory and experiments that predict that incomplete (leaky) vaccines may dangerously select for increased virulence in pathogens, and that frequent (e.g., annual) vaccination in systems such as influenza may be less effective than infrequently administered vaccines. These recent controversial predictions and other considerations will be used to discuss the biological and evolutionary risks associated with vaccination efforts. Dr. Paul Turner received his PhD in 1995 from the Center for Microbial Ecology at Michigan State University. He did postdoctoral work at the National Institutes of Health, University of Valencia in Spain, and University of Maryland, College Park.

View Webinar Recording


Animal Models of Human Disease for Nonclinical Safety—Why, What and When…
Tuesday, June 21, 11:00 AM–12:30 PM ET

Ellen Silbergeld, PhD

Presented by Sherry J. Morgan, DVM, PhD, ACVP, ABT, ABVT joined Abbott/AbbVie, Inc. in 1990. She currently serves a dual role as a pathologist and a Director of Scientific Projects, providing toxicology and pathology guidance for Discovery and Development projects. Dr. Morgan also provides interpretative nonclinical risk assessment summaries of numerous potential in-licensing compounds, helping to guide the selection process of novel compounds. She is board certified by the American College of Veterinary Pathologists, the American Board of Veterinary Toxicologists, and the American Board of Toxicology. Her publication list includes approximately 30 journal articles, 20 book chapters, and 30 abstracts/posters. Topics on the use of animal models span therapeutic indications including oncology, joint diseases, neurodegeneration, cardiovascular disease, and endocrine and metabolic diseases. She also has contributed to the validation of non-invasive imaging technologies using traditional pathology endpoints. In this presentation, the rationale for the use of animal models of disease will be discussed as it pertains to different adverse drug reactions for which there is relatively low predictability with conventional animal models. Some of the possible reasons for lack of concordance between different organ systems will be covered as well. The presentation will conclude with general recommendations when considering using an animal model of animal disease as well as some examples of studies involving animal models of disease.

This presentation was sponsored by AbbVie, which contributed to the design, research, and interpretation of data, writing, reviewing, and approving the publication. Sherry Morgan is an employee of AbbVie.

 

View Webinar Recording


Regulatory Perspective on the Use of Animal Models of Disease in Drug Development
Tuesday, May 31, 2016, 11:00 AM–12:30 PM ET

Presented by: Sruthi King, PhD, Pharmacology/Toxicology Team Leader in the Division of Clinical Review in the Office of Generic Drugs within the Center for Drug Evaluation and Research at the US Food and Drug Administration (CDER/FDA). Prior to her current role, Dr. King was a primary nonclinical reviewer for seven years in the Division of Gastroenterology and Inborn Errors Products in the Office of New Drugs within CDER/FDA. She has spoken on the topic of using animal models for nonclinical safety assessment and their utility in supporting rare disease drug development, most recently at the 2015 Annual Meeting of the American College of Toxicology. Dr. King also has co-authored a chapter on this topic in second edition of Pediatric Drug Development: Concepts and Applications. The objective of this presentation is to highlight current regulatory practices within CDER/FDA with case studies in which animal models of disease were used in nonclinical safety studies. At this time, the FDA recommends the use of animal models of disease be used in “proof of concept” studies, unless the sponsor provides acceptable justification that the animal model is the most relevant species for pharmacology and toxicology testing. However, the use of animal models, particularly for rare disease drugs, is increasing and regulators are tasked with determining whether the data generated in these models are adequate to support drug development and approval of safe and effective therapies, with limited clinical trial data. In general, nonclinical studies to support clinical trial initiation and ongoing development of small molecules and biologics are guided by ICH M3 and ICH S6; however, review divisions may apply regulatory flexibility.

 

View Webinar Recording


The Use of Animal Models of Disease in Safety Assessments
Tuesday, May 17, 2016, from 11:00 AM–12:30 PM ET

Presented by: Diann L. Blanset, PhD, DABT, Boehringer Ingelheim. Preclinical safety studies for proposed pharmaceutical products are usually conducted in healthy animals. The appropriate species for these studies are selected based on the relative pharmacological activity/potency and metabolite profiles between the proposed species and humans. The studies are then designed to mimic the clinical dosing regimen with respect to the route of administration, duration of treatment, and dosing interval. As these studies are conducted in healthy animals, they generally mimic the characteristics of the clinical population for first in human (FIH) Phase I trials in normal subjects (healthy volunteers). However, they do not mimic the characteristics of subjects in later clinical trials or in FIH Phase I trials conducted in subjects with disease. This deviation from the principle of mimicking the clinical conditions of use can be very important in certain disease indications where the disease condition can dramatically affect the safety of the pharmaceutical. The aim of this webinar is to review the use of animal models of disease in the evaluation of exaggerated pharmacology and toxicity to improve the relevance and extrapolation of the assessments to the intended disease population. The basic principles of the use of animal models of disease will be reviewed as well as the advantages and disadvantages of these models. In addition, specific examples of the use of these models in safety assessments will be presented.


View Webinar Recording


Precision Medicine—Getting Personal on Safety
Tuesday, March 1, 2016, from 11:00 AM–12:30 PM ET

Ellen Silbergeld, PhD

Presented by: Sian Ratcliffe, PhD, is General Toxicology Site Lead in Drug Safety R&D at Pfizer, Groton, Connecticut, USA. Prior to holding her current role, Dr. Ratcliffe was the Global Head of Safety Pharmacology. During her 16 year tenure at Pfizer, she also has held other senior leadership roles in Clinical Development, Safety Risk Management, and Regulatory Affairs, managing projects throughout development stages from research to post-approval in the Neurology, Psychiatry, Pain, Women’s Health, Pulmonary Vascular Disease, and Respiratory therapeutic areas. Dr. Ratcliffe has a keen research interest in precision medicine, translational, and predictive safety projects and is actively engaged with the US Food and Drug Administration and the National Cancer Institute on PredicTox, a systems pharmacology project to examine cardiotoxicity associated with tyrosine kinase inhibitors. Prior to joining Pfizer, Dr. Ratcliffe worked for Elsevier as an editor for a number of the Trends journals. Sian has a PhD in Pharmacology from the University of Cambridge (1996) where she also held postdoctoral research and academic posts.


View Webinar Recording


Industry Perspective on Biomarkers: The Use of Biomarkers in Clinical Development of Novel Drugs
Wednesday, October 28, 2015, 11:00 AM–12:30 PM ET USA

Presented by: Gene Marcantonio, MD, PhD, Associate Vice President, Translational Pharmacology at Merck Research Laboratories (MRL). Dr. Marcantonio provides an overview of how biomarkers are used in clinical trials in the pharmaceutical industry. Most of the discussion focuses on fit for purpose biomarkers developed in order to make critical decisions in early drug development. He discusses the role of target engagement markers to set dose ranges in order to build adequate clinical safety margins. Furthermore, the role of these target engagement markers in determining the level of engagement necessary to translate from a preclinical proof of concept (POC) into a clinical POC study is discussed. In addition, Dr. Marcantonio reviews the development of specific examples of biomarkers for selective androgen responses. Biomarker development studies as well as follow up phase 1 studies are also reviewed. Dr. Marcantonio joined MRL in 2007 and has been involved in the early clinical development of a number of compounds in multiple disease areas and now is the lead for Infectious Diseases and Vaccines as well as for Immunology.


View Webinar Recording


Biomarker Utility and Acceptance in Drug Development and Clinical Trials: An FDA Regulatory Perspective
Tuesday, September 8, 2015, from 11:00 AM–12:30 PM ET USA

Presented by: Shashi Amur, PhD, Scientific Lead of the Biomarker Qualification Program in the Office of Translational Sciences, Center for Drug and Evaluation Research (CDER), US Food and Drug Administration (FDA) and Christopher L. Leptak, MD, PhD, Biomarker and Companion Diagnostics Lead for the Office of New Drugs within CDER/FDA and Co-Director of the Biomarker Qualification Program. Dr. Amur's current research interests include biomarkers in Autoimmune Diseases and in Alzheimer’s disease, drug-induced liver toxicity, pharmacogenomics, and HLA-associated adverse events. She is Past Chair of the Pharmacogenomics Focus Group, American Association of Pharmaceutical Scientists. The focus of Dr. Leptak's work is on biomarker development and diagnostic device utility in clinical trials and drug development, both for drug-specific programs as well as qualification. He is charged with identifying policy, process, and regulatory science needs within the co-development space and is involved in multiple inter-office and inter-center working groups to address those needs.


View Webinar Recording

Gatekeeper and Watchman: the Microbiome Enters the Picture
Tuesday, April 28, 2015, 11:00 AM–12:30 PM EDT

Ellen Silbergeld, PhD

Presented by: Ellen Silbergeld, PhD, Professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. Her research and professional activities bridge science and policy, with a focus on the incorporation of mechanistic toxicology into environmental and occupational health policy. Dr. Silbergeld also directs a Fogarty Training Program in NonCommunicable Diseases, which is collaboration between Hopkins and the School of Public Health of Mongolia.



View Webinar Recording


Nonclinical Safety Testing

Presented by: Thomas W. Jones, PhD, Chief Scientific Officer, Toxicology & Pathology, Eli Lilly and Company

Thomas W. Jones

On Wednesday, February 4, 2015, the Scientific Liaison Coalition (SLC) hosted a webinar, “Prediction Is Very Difficult, Especially If It Is About the Future: How Well Does Toxicology Testing Predict Clinical Outcomes?“

Dr. Jones is the Chief Scientific Officer, Toxicology and Pathology, Eli Lilly and Company. He is currently Past Chair of the Preclinical Safety Leadership Group within the International Consortium for Innovation and Quality in Pharmaceutical Development. He also serves as the nonclinical safety representative for the Development Special Emphasis Panel supporting the National Cancer Institute Experimental Therapeutics (NExT) Program.

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Progress Made on Tox21: A Framework for the Next Generation of Risk Science

Moderator: Daniel Krewski, PhD, MHA, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa

Daniel Krewski

On October 1, 2014, the Scientific Liaison Coalition (SLC) hosted a webinar, Progress Made on Tox21: A Framework for the Next Generation of Risk Science, presented by Daniel Krewski. The Society of Toxicology (SOT) is a participating member of the SLC. Dr. Krewski is currently Professor of Epidemiology and Community Medicine and Scientific Director of the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa. He served as Chair of the National Research Council’s Committee on Toxicity Testing and Assessment of Environmental Agents, which published its influential report, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” published in June of 2007.

View Webinar Recording*

*Note to Mac users: Due to software incompatibilities, it is advisable that you view this recording on a PC.

SLC News Articles from the Communiqué Blog

SOT FutureTox III Attracts Scientists from Around the Globe

Progress Made on Tox21: A Framework for the Next Generation of Risk Science SLC Webinar Now Online

FutureTox II CCT Draws Participants from Across the US and Around the Globe

SLC Receives Funds From FutureTox II CCT to Support Its Mission: Opportunity Open to RC, SIG, and SS

For more information, contact Marcia Lawson.