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The topics listed below will be presented during the 41st Annual Summer Meeting held at the Cheyenne Mountain Resort in Colorado Springs, Colorado. The meeting will be held July 12–16, 2015.
Ian C. Munro Keynote Lecture
Thomas Jones, Eli Lilly and Company
Chief Scientific Officer, Toxicology and Pathology
Eli Lilly and Company
Session Title: Thinking Inside the Box: Is the Current Pharmaceutical Toxicology Testing Paradigm Useful for Predicting Clinical Outcomes?
Session Summary: Pharmaceutical R&D offers a unique opportunity to evaluate the utility of nonclinical safety models in predicting human safety outcomes. ICH Guidance has established a common set of expectations for the nonclinical safety testing needed to enable human clinical trials and to support the global marketing authorization for novel drug candidates. While clinical development is generally regarded as safe, the current nonclinical safety testing paradigm, based largely on animal studies, has been challenged in recent years as being outdated and prone to inconsistency in predicting adverse responses humans. There is growing interest in the potential of innovative in silico and/or in vitro models to supplement, reduce, or even replace in vivo animal testing. However, the debate around the future of nonclinical safety testing has been hampered by an inability to define the performance characteristics of the current nonclinical safety testing paradigm. A quantitative framework model will be used to explore the performance of the current approach to nonclinical safety assessment used in pharmaceutical R&D. This framework model will also serve as the basis upon which to discuss approaches to improve human outcome prediction. While the presentation will focus on the testing approach used by the pharmaceutical industry, the principles that will be discussed are broadly applicable to all forms of toxicity testing.
- How Clear is our Vision Regarding Toxicity Testing in the 21st Century?
There has been quite an investment of resources and energy in toxicology (TT21C) since the landmark report Toxicity Testing in the 21st Century (TT21C): A Vision and a Strategy, the US National Academy of Sciences, in 2007, in which it was argued for change in the existing approach to toxicity testing. The ToxForum and toxicology community is challenged to critically re-evaluate and debate where we are and where we are going, at what pace, with what challenges/opportunities we are faced with.
- Assessing Scientific Confidence in 21st Century Non-Animal Alternatives for Safety Assessments
In response to the 2007 NRC vision for toxicity testing in the 21st century, there has been global momentum for the development of alternative testing methods, including methods such as high throughput assays and concepts such as the adverse outcome pathway (AOP) concept. The alternative methods often have unique challenges that make traditional validation efforts difficult, yet the need to assess the credibility of individual methods for the use in regulatory decision remains. Tools for assessing confidence for alternative methods will be presented along with case studies demonstrating the applicability of each tool to facilitate more widespread incorporation and acceptance of alternative testing methods into the safety assessment paradigm.
- Food Safety Considerations for Double Stranded RNAs: Plant Incorporated Protectants as a Case Study
Double stranded RNA (dsRNA) is being employed in agriculture to confer traits in biotechnology-derived crops and is being developed for topical use in the field. The use of RNA as a pesticide has been of great interest to US and international regulatory agencies and the state of the science on RNA interference continues to develop. This session is envisioned to review the latest Regulatory agency views on human safety of RNA for pesticidal uses, to recap the state of the science pertaining to ingested RNA animal feeding studies, and to provide empirical toxicology data as a case study for assessing the safety of a dsRNA plant incorporated protectant undergoing international regulatory reviews. This session aims provide stimulating discussion of the latest scientific research and regulatory science regarding agricultural applications of dsRNA, including its use as a pesticide.
- Particulate Matter Health Effects—Causation vs. Association: Borrowing Analytical Methods from Other Disciplines
Noted scholars in the area of air quality and environmental policy research have recently advanced the concept of confirming statistical associations observed in air pollution health effects/epidemiological studies, which typically use standard regression methods, by using quasi-experimental study designs and causal analyses (see Dominici et al, 2014 in Science). The basis for this recommendation for alternative methods is that the conventional regression statistical methods cannot adequately control for a myriad of potential confounders and competing risks. Moreover, those association-based methods can only assess cause and effect indirectly. This commentary has spawned research that (re)analyzes data from previous studies that reported positive associations, using causal modeling instead of conventional methods. Causation researchers will provide an overview of the distinction between conventional and causal methods and compare results using each method. Additionally, the question of "Should causal methods be construed as 'competing', or are they complementary?" will be addressed.
- Developmental Effects of Arsenic/Health Risk Assessment of Dietary Exposure to Inorganic Arsenic
Arsenic is a ubiquitous, naturally occurring element that may be regionally enhanced in abundance based on natural variations in soil and water concentrations and by human activities. It is found in both water and food crops including rice. Although arsenic is a well-known toxicant at high doses, new data suggesting potential developmental effects of arsenic at lower doses and challenges with risk assessment of low-level dietary arsenic exposure have motivated this symposium. Concern has been raised that many foods consumed by infants and children may contain enough arsenic to result in neurobehavioral dysfunction as well as increased cancer rates. Regulatory agencies, university researchers and industry scientists are all generating new data on arsenic to evaluate its potential to produce deleterious effects and understand its mode of action.
- Assessing Natural Product—Drug Interactions: An End-to-End Safety Framework
The safety of multi-ingredient dietary supplements is currently a very hot topic, due to concerns over herb-herb, herb-drug and nutrient-drug interactions. The NIH National Center for Complementary and Alternative Medicine (NCCAM), currently has an RFA to establish a Center of Excellence for Natural Product Drug Interaction Research. A primary expectation of such a Center will be "to establish a set of best practices to address the unique challenges related to the study of natural product interactions with drugs." This session will explore these challenges and discuss the critical pre and post-market components that should be included in a best practices (framework) approach.
- Drivers for Revision of ICH S5(R2) Reproductive Toxicity Guidelines: Labeling, Science, Inadequate Approaches, and Alternative Testing Approaches
This session will focus on the primary drivers for revising ICH S5(R2) Reproductive Toxicity guidance, including labeling, science, inadequate approaches, and alternative testing approaches. We will review the Regulatory and Pharmaceutical experiences regarding labeling and changes to the law, discuss deficiencies in current guidelines for establishing risk assessments, and review progress made by the Pharmaceutical Industry on in vitro, ex-vivo, and non-mammalian in vivo embryo-fetal development assays and the perspective from Regulatory Agencies on development of principles for possible regulatory acceptance of these alternative assays.
- Does GRAS Concept Still Work?
John Hallagan, FEMA
- FDA’s Perspective on the Current State and Future Direction of Juvenile Animal Testing to Support A Pediatric Development Program
Karen Davis-Bruno, US FDA CDER
- Cumulative Risk Assessment—An Update
Timothy Pastoor, HESI
- Pharmacokinetic Analysis and Comparison of Caffeine Administered Rapidly or Slowly in Coffee Chilled or Hot vs. Chilled Energy Drink in Healthy Young Adults
John White, Washington State University
- Electrophile-Mediated Protein Modification via Bioactivation: Impact on Food and Chemical Safety
Serrine Lau, University of Arizona
Cheyenne Mountain Resort
3225 Broadmoor Valley Road
Colorado Springs, CO 80906
A Unique Southern Colorado Resort Destination
Equal parts world-class meeting facility and four-diamond resort, the multifaceted Cheyenne Mountain Resort is a place where the possibilities are as endless as the views. For meetings, spectacular indoor and outdoor venues create the backdrop for imaginative events, allowing attendees to enjoy the beautiful setting while remaining productive and inspired.
The Toxicology Forum has reserved a limited block of discounted rooms for meeting attendees.
Attendee Room Rate: $199++
Housing Reservations: 800.588.0250
Housing Deadline: This deadline has passed, the room rate is now offered based on the hotel’s availability.
Amy Willis for alternative housing suggestions or with questions.
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