Scientific Liaison Coalition (SLC)
Improving the ability of societies to partner with other domestic and international organizations with the goal of advancing science to improve human and environmental health
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Issue StatementCommunicating Biomedical Health-Related Research Findings: A Guide to Maintaining Balance and Avoiding Common Pitfalls
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Toxicity and Efficacy of Stem Cells as Therapeutic Products for Humans and Animals
Stem-cell based therapies are becoming very popular in humans and animals for many conditions. However, much still needs to be understood in terms of their toxicity and efficacy. We will have two speakers from the US Food and Drug Administration (US FDA). The first is from the Center for Biologics Evaluation and Research (CBER) discussing their use in humans and the second speaker is from the Center for Veterinary Medicine (CVM) who will discuss the challenges in their veterinary use.Registration
Stem Cell-based Therapies: FDA/CBER Preclinical Regulatory Considerations presented by Wei Liang, PhD, Pharm/Tox Branch 1, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), Office of Tissues and Advanced Therapies (OTAT), CBER, US FDA
The conduct of a clinical trial for an investigational stem cell-based product is governed by the Code of Federal Regulations (CFR) Title 21, Part 312 to ensure the safety and rights of subjects in all phases of a clinical investigation. According to 21 CFR 312.23(a)(8), the sponsor needs to provide adequate information derived from pharmacology and toxicology studies to support a conclusion that the proposed clinical trial is reasonably safe and scientifically feasible to conduct. Preclinical evaluation of stem cell-based products in vitro and in animals is a key element in the overall benefit:risk assessment. The primary goals of preclinical studies for stem cell-based therapies are to establish the scientific rationale to support the planned clinical investigation and to assess the potential toxicities associated with administration of the stem cell-based product. Considerations for preclinical assessment of stem cell-based products are discussed in the "Guidance for Industry: Preclinical Assessment oof Investigational Cellular and Gene Therapy Products," which was released by CBER in November 2013.
This presentation will discuss (1) potential safety concerns associated with stem cell therapies, (2) preclinical testing programs for stem cell therapies to support an investigational new drug (IND) submission for a first-in-human clinical trial, and (3) early communications with FDA/CBER/OTAT via pre-pre-IND interactions and pre-IND meetings.
Safety of Cell-Based Products for Animal Use: presented by Lynne Boxer, DVM, CVM, Office of Foods and Veterinary Medicine, US FDA
Cell-based products for animal use, including stem cell products, that meet the definition of a new animal drug require US FDA approval to be legally marketed. Thus, approval of these products requires a demonstration of safety, effectiveness, and manufacturing quality. While there is increasing interest in the potential therapeutic applications for cell-based products, there are also challenges associated with assessment of the safety and quality of these products. This talk will discuss the specific safety considerations for cell-based products, as well as an overview of what is known about adverse events in veterinary species.
Peer-Reviewed Publications Webinar Series: The Future of Publishing
The Future of Publishing
Presented by Gary W. Miller, PhD, Professor of Environmental Health and Associate Dean of Research in the Rollins School of Public Health at Emory University. Dr. Miller, Editor-in-Chief of Toxicological Sciences, will provide his views on some of the trends and explain what the Journal is doing to keep abreast of these challenges. Over the past decade there have been several major changes in the scientific publication landscape. Increasing access to scientific findings, through a combination of open access and making primary data more readily available, have been major drivers of these changes. Investigators are sharing more of their data through websites and data repositories. The use of preprints to share findings in advance of publication also is increasing in the biomedical sciences. There has also been rapid growth in the number of journals with a less than stellar reputation. Such predatory journals pose a threat to the research community. Dr. Miller has been a member of the Society of Toxicology since graduate school. He currently directs the HERCULES Exposome Research Center (NIEHS P30 and the Emory CHEAR (NIEHS U2C), as well at Emory’s NIEHS T32 training grant. His research is focused on environmental drivers of neurodegeneration.
Peer-Reviewed Publications Webinar Series
How to Get Published in Peer-Reviewed Journals
Presented by Mary Beth Genter, PhD, DABT, ATS, Professor, Department of Environment Health, University of Cincinnati. She is currently (2008–present) Editor-in-Chief of International Journal of Toxicology, the official journal of the American College of Toxicology. The webinar “How to Get Published in Peer-Reviewed Journals” will provide advice, examples, and guidance on writing and publishing effective scientific manuscripts. Topics will include a review of tips for good study design, a discussion of constructing an effective abstract, and important considerations when writing a manuscript, including the choice of a journal to which a manuscript will be submitted, word usage, data presentation, and authorship considerations. We conclude with a discussion of predatory journals, and how and why to avoid publishing in them. Dr. Genter also is a member of the Toxicology in Vitro Editorial Board, and a reviewer for approximately two dozen papers for other journals per year. Dr. Genter serves on the Council of the Society of Toxicology (2016–2019) and recently completed a term on the National Toxicology Program Board of Scientific Counselors (2013–2017). She is a member of the American College of Toxicology, the Society of Toxicology, the Association for Chemoreception Sciences, and Sigma Xi.
Series—Predicting Adverse Effects Before They Occur: Teratogens as an Example
The Next Thalidomide
Presented by Anthony B. Scialli, MD, a teratologist and board-certified obstetrician-gynecologist. Dr. Scialli is Adjunct Professor in the Departments of Obstetrics and Gynecology and of Pharmacology and Physiology at Georgetown University School of Medicine, where he was a full-time Professor and director of the Residency Training Program until 2003, and Clinical Professor in Obstetrics and Gynecology at George Washington University, where he continues to see patients. His presentation will address disease prevention. One reason to work in toxicology is to prevent episodes of human disease before they occur by identifying and avoiding exposures that are likely to be harmful. In developmental toxicology, this practice is sometimes called, preventing the next thalidomide. Of course, one limitation on this idea is the fact that the next thalidomide has already occurred, several times in fact. It can be instructive to review these episodes and learn from them where the failures occurred. In some cases (isotretinoin, valproic acid), well characterized warnings were not noticed by clinicians or patients. In other cases (diethylstilbestrol, warfarin), the sensitive developmental period in humans was outside the observation period of standard experimental protocols. In yet other cases (mycophenolate), the problem was the importance of the drug for the health of the patient and the need to wait for a critical epidemiological mass to establish causation. Fundamental to the use of traditional experimental protocols is the belief that laboratory animal response predicts human response, but it has been clear for decades that this belief is an artifice of the dosing regimens used in the experimental studies. By using high enough dose levels, any chemical can be made to look teratogenic, a principle enunciated by David Karnofsky in 1965. Because of this principle, experimental animal studies can look highly predictive if we accept any developmental endpoint at any dose as a positive, and if we are not too worried about false alarms. We hope that the use of alternative test strategies and better characterization of mechanisms of abnormal development will make experimental protocols more predictive of human response, but it is not a foregone conclusion that they will do so.
In Bed with the Devil: Recognizing Human Teratogenic Exposures
Presented by Jan Friedman, MD, PhD, a clinical geneticist and Professor of Medical Genetics at the University of British Columbia (UBC). In the past decade, Dr. Friedman has been a pioneer in the development and application of cytogenetic and genomic tools to understand the genetic causes and clinical consequences, and improve diagnosis of, intellectual disability syndromes. His presentation will address the challenge to recognize that an exposure is teratogenic when the fewest possible babies have been harmed. Recognizing exposures that are teratogenic in humans requires: (1) babies who have been harmed by the exposure; (2) a way to associate the maternal exposure to the babies’ birth defects (hypothesis generation); and (3) a way to prove that the observed association is causal (hypothesis testing). Proving an association is probably causal as quickly as possible means making this call before the definitive study has been done. A weight-of-evidence approach is used, taking each study for what it is worth, but no more. Dr. Friedman has published more than 270 peer-reviewed papers and has written six books and edited two others. He is the Director of CAUSES Clinic at BC Children’s Hospital. This research clinic provides advanced DNA testing, clinical interpretation, genetic counselling, and personalized recommendations for treatment for children with complex, undiagnosed medical conditions.
Epidemiology of Vaccine Refusal
Presented by Presented by Saad B. Omer, MBBS MPH PhD FIDSA, William H. Foege Professor of Global Health and Professor of Epidemiology & Pediatrics at Emory University, Schools of Public Health and Medicine. He also is a faculty member at the Emory Vaccine Center. Vaccines are among the most efficacious and cost-effective prevention tools. However, the success of an immunization program depends on high acceptance and coverage. There is evidence of an increase in vaccine refusal in the United States and of geographical clustering of vaccine refusers resulting in outbreaks. Children with exemptions from school immunization requirements (a measure of vaccine refusal) are at increased risk of measles and pertussis and can infect others who are too young to be vaccinated, cannot be vaccinated for medical reasons, or were vaccinated but did not have a sufficient immunological response to the vaccine. Parents of children with non-medical exemptions to immunization requirements have been documented to have perceptions of lower susceptibility to and severity of vaccine preventable diseases and perceptions of lower safety and efficacy of vaccines compared to parents of vaccinated children. Moreover, compared to parents of vaccinated children, vaccine hesitant parents had less trust in the government and the health care system. There is a need for development of a robust evidence base of effective interventions for reducing vaccine hesitancy. Potential interventions include: effective provider-parent communication tools, rational administrative requirements for granting exemptions, and informed declination. Given the geographic clustering of refusers, theses interventions must be locally relevant.
Polypharmacy and the Challenges of Optimizing Pharmacotherapy in Complex Patients
Presented by Cathy Yeung, Pharm D, PhD, MPH; Assistant Professor, Department of Pharmacy, University of Washington School of Pharmacy, Seattle, Washington. One of the greatest challenges facing clinical pharmacists is the rapid growth of polypharmacy, in which patients are prescribed 10 or more medications, and the associated increased risks of adverse drug reactions, drug-drug interactions, and drug-disease interactions. Selection of drugs, doses, and timing of doses is particularly difficult in patients who are elderly or have accompanying organ impairment (liver, kidney). Drug pharmacokinetics in the setting of polypharmacy and organ impairment is complicated by overlapping clearance modalities, including drug metabolizing enzymes and drug transporters. In this webinar, we will review major pathways of drug metabolism and identify clinically relevant drug transporters. The impact of renal impairment on non-renal drug clearance will be discussed. Finally, a clinically relevant drug metabolism/drug transporter/food interaction will be presented. Dr. Yeung’s training encompasses clinical pharmacy, medicinal chemistry, pharmacokinetics, and epidemiology. Her research focuses on optimizing pharmacotherapy in patients with chronic kidney disease using molecular tools to probe proximal tubule transport, mathematical modeling of substrate transit in the proximal tubule, innovative 3-dimensional microfluidic models, and clinical pharmacokinetics studies.
Biology of Vaccines and Molecular Evolution of Viruses
Animal Models of Human Disease for Nonclinical Safety—Why, What and When…
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.
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.View Webinar Recording
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
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