Scientific Liaison Coalition (SLC)
A partnership of scientific societies with the goal of improving public health through a collaborative interdisciplinary approach.
Current Participating SLC Organizations
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Issue StatementCommunicating Biomedical Health-Related Research Findings: A Guide to Maintaining Balance and Avoiding Common Pitfalls
All webinars are viewable in a protected format to prevent downloading.
Upcoming SLC Webinar
An SLC Work Group comprised of Mary Jeanne Kallman, Safety Pharmacology Society; Donna Mendrick, Society of Toxicology; and Arun Pandiri, Society of Toxicologic Pathology, has developed a Use of Animal Models of Disease for Toxicity Prediction Webinar Series. This series will provide pharmaceutical industry, and regulatory perspectives on this topic. The dates and speakers are listed below: All webinars will be held from 11:00 am–12:30 pm ET.
Animal Models of Human Disease for Nonclinical Safety—Why, What and When…, Tuesday, June 21, 11:00 AM–12:30 PM ET
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.
Regulatory Perspective on the Use of Animal Models of Disease in Drug Development
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.
The Use of Animal Models of Disease in Safety Assessments
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.
Precision Medicine—Getting Personal on Safety
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.
Industry Perspective on Biomarkers: The Use of Biomarkers in Clinical Development of Novel Drugs
Biomarker Utility and Acceptance in Drug Development and Clinical Trials: An FDA Regulatory Perspective
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.
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Gatekeeper and Watchman: the Microbiome Enters the Picture
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.
Nonclinical Safety Testing
Presented by: Thomas W. Jones, PhD, Chief Scientific Officer, Toxicology & Pathology, Eli Lilly and Company
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.
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
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.
*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
For more information, contact Marcia Lawson.