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ACT 35TH ANNUAL MEETING SURVEY

200%
1.MEMBERSHIP STATUS
2.AFFILIATION
3.HOW DID YOU HEAR ABOUT THE MEETING?
4.PLEASE EVALUATE THE OVERALL QUALITY OF THE SESSIONS

MONDAY PLENARY LECTURE—Deborah Blum

"The Poisoner's Guide to Life"
5.Symposium 1—From Mice to Men, Development of Human Drugs and Biologics under the Animal Rule
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Animal Model Qualification Process and the Medical Countermeasures Initiative—Owen McMaster
Development of Brincidofovir for the Treatment of the Treatment of Smallpox under the Animal Rule—Lars C. Trost
Utilizing Well-Characterized Drug Development Tools for The Assessment of Medical Countermeasures: Anthrax Antitoxins—Gabe Meister
Development of an Anthrax Vaccine under the Animal Rule: A Case Study—Barbara Mounho-Zamora
6.Symposium 2—What the AEL is the NOAEL?
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Recommended Practices for Defining and Communicating Adversity for Nonclinical Study Data—James A. Popp
Determining Adverse Histopathology using a Weight of Evidence Approach—Daniel J. Patrick
NOAEL Selection and Risk Assessment for Biologics and Other Nontraditional Small Molecules—Laine Peyton Myers
When Should Pharmacology/Superpharmacology Be Considered Adverse (Ever?)—Christopher Horvath
7.Symposium 3—Systems Toxicology: The Future of Risk Assessment
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Translating Systems Toxicology-Based Assessment into Risk Management—Thomas Hartung
Experimental Enablers: The Pan-Omics View—Marcel Leist
Computational Enablers: From Data Integration to Dynamic Modeling—Thomas B. Knudsen
Implementing Systems Toxicology Approaches—Julia Hoeng
8.Symposium 4—Anti-Drug Antibody-Independent Immune Responses to Biologics in Rodent Studies—Regulatory Success in Early Drug Development
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Clinical Impact of Rodent-Specific Immune-Related Reactions to Human Proteins—Joy Cavagnaro
Non-ADA Mediated Anaphylactoid Reactions in Toxicology Studies with Rodents—Krishna Allamneni
Immunotoxicoloogy Tools to Characterize Species-Specific Immune Reactions—Florence G. Burleson
Regulatory Perspectives on the Rodent-Specific Immune Reactions—Jane Sohn
9.Symposium 5—Use of Humanized Mouse Models in DMPK and Safety Testing of Compounds
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Nearly Human—The Potential of Chimeric Mice with Livers Colonized with Human Hepatocyte—Ian D. Wilson
Application of Humanised Mouse Models to Study Anticancer Drug Efficacy and Toxicity—Charles Roland Wolf
Utility of Humanized Mice in the Assessment of Biological Drug Products—Kristina Howard
Humanized Mouse Models—Applications in Preclinical Testing—Alema Galijatovic-Idrizbegovic
Regulatory Perspective on Alternative Animal Models—Mark W. Powley
10.Symposium 6—Targeted Cancer Therapeutics: Concepts and Strategies to Improve Oncology Drug Development
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Introduction: Targeted Cancer Therapies: Concepts and Strategies to Improve Oncology Drug Development—Elaine Knight
Cancer Biology and the Discovery of Targeted Therapies—Alan C. Rigby
Targeted Anticancer Pharmaceuticals: Off-Target and On-Target Toxicities—Vijayapal Reddy
Transforming the NCI Experimental Therapeutic Program as It Relates to Clinical Evaluation of Targeted Therapies—S. Percy Ivy
Regulatory Perspective on the Development of Targeted Anticancer Therapeutics—Todd R. Palmby
11.Symposium 7—Breathe In, Breathe Out, It's Easy: What You Need to Know about Developing Inhaled Drugs
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Overview: It Sucks and Blows, Lung Function—Jeff Tepper
Dose is Dose, Right? Determining Pulmonary Dose in Clinical and Nonclinical Studies—Philip Kuehl
You Need How Much!!! Test Article Conservation During In Vivo Inhalation Studies—Stuart Cracknell
Tour of the Respiratory Tract with Stops at Sites of Toxicological Significance—Kristen Nikula
Regulatory Considerations in Nonclinical Safety Evaluations of Inhalation Drugs—Luqi Pei
12.Symposium 8—Cardiovascular Safety Evaluation—In Vitro to Humans
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Cardiovascular Safety Assessments During Drug Development: Current Approach and the Need for a New Paradigm—Philip Sager
In Vitro Cardiovascular Safety—Discovery Screen to GLP Studies—Bernard Fermini
Integrated Systems for Evaluation of Cardiovascular Electrophysiology Safety: Secondary In Vitro Assays and In Vivo Evaluations—Gary Gintant
Regulatory Thinking of the Current Guidelines on Cardiovascular Evaluation—Beyond QTc—Norman Stockbridge
Experiences with Elements of Comprehensive In Vitro Proarrhythmia Assay (CiPA)—Arthur “Buzz” Brown
13.Symposium 9—Centrally Administered Compounds in Small and Large Species—Dose Routes, Study Considerations, and Data Interpretation
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Development of CNS Administered Biologics: Overview, Challenges, and a Case History—Brian R. Vuillemenot
Methodology of Central Drug Delivery and Cerebrospinal Fluid Collection in the Sheep, Dog and Rat Model—Eric Adams
Procedures for Intrathecal Drug Delivery and CSF Sampling in Nonhuman Primates Studies—Sven Korte
Morphologic Assessment of Studies Involving Direct Delivery to the Central Nervous System—Mark T. Butt
14.Symposium 10—Cytokines: The Good, the Bad, and the Deadly
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Cytokine Explosion: Rocking the World of Toxicology—Thulasi Ramani
Therapeutic Cytokine-Blocking Antibodies—Daniel Weinstock
Safety Evaluation of Cytokine Therapeutics: Translation of Preclinical Data to the Clinic—Barbara Mounho-Zamora
Targeting Cytokine Pathways to Treat Disease—Patricia Ryan
Beyond TeGenero—Development of Targeted Therapeutics without Deadly Consequences—Theodora Salcedo
Cytokines as Biomarkers for Immunotoxicity—Gregory Bannish
15.Symposium 11—Differentiating Adverse from Adaptive Changes in Toxicology
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A Whole-Animal Overview of Adaptive versus Adverse Change—Peter C. Mann
Identifying Adverse Organ Responses: The Liver as Paradigm—Robert R. Maronpot
Using Toxicogenomics in Assessing Adaptive versus Adverse Effects—Russell Thomas
Differentiating Adaptive and Adverse Changes: A Regulatory Perspective—Timothy J. McGovern
16.Symposium 12—In Silico Methods for Mutagenicity Prediction vis a vis ICH M7 Guidance
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Risk Characterization of Mutagenic Impurities—Joel Bercu
Regulatory Implementation of ICH M7—Mark W. Powley
Living with ICH M7: The Practical Application of Two In Silico Systems in Screening for GTIs—Nigel Greene
ICH M7: Risk Assessment with In-House and Off-the-Shelf In Silico Mutagenicity Predictors—Robert A. Jolly
Using In Silico Tools for the Assessment of Genotoxic Impurities—Chris Barber
Physico-Chemical Modulation of DEREK Structural Alerts—Vijay K. Gombar
17.WEDNESDAY PLENARY LECTURE—Alison Van Eenennaam, PhD

"Food and Feed Safety of Genetically Modified Organisms: The Hype and the Facts"
18.Symposium 13—Novel Therapeutics in Oncology: Recent Advances and Considerations for Nonclinical Safety Evaluation
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Antibody Drug Conjugates: Recent Developments and Future Perspectives—Laurie Tatalick
Advances in Bispecific Antibodies Facilitating Novel Therapeutic Opportunities—Paul Moore
Nonclinical Safety Evaluation of Novel Ab-based Therapeutics for Oncology—Magali Guffroy
Using the Power of the Immune System to Target Cancer—David W. Clarke
19.Symposium 14—Applied Nanotoxicology
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Introduction to Applied Nanomaterial Toxicology and Applied Nanotoxicology for Pharmaceuticals and Medical Devices—Dave Hobson
Assessing the Biological Fate of Ingested Nanomaterials—Steve Roberts
Nanoparticles as an Emerging Environmental and Occupational Hazard—Toxicology Prospective—Anna Shvedova
Consumer Product Example: Strategies for Setting Occupational Exposure Limits for Engineered Titanium Dioxide Nanomaterials—David Warheit
Applied Considerations for Safety Assessment of Food Products and Food Packaging Containing Nanomaterials—Robin Guy
20.Symposium 15—Stem Cells Research
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Where Is the Field of Regenerative Medicine Going?—Alan Trounson
Applications of Stem Cell Technologies in Drug Discovery—Kyle Kolaja
Pathology Techniques to Aid the Development and Understanding Advanced Therapy Medicinal Products (ATMPs)—Klaus Weber
Advancing Engineered Lung Tissues to the Clinic: Considerations for Animal Models and Toxicology Studies—Thomas Petersen
21.Symposium 16—Safety Assessment Updates for Preventive Vaccines and Vaccine Adjuvants
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Rationale for Use of Adjuvants in Vaccines and Overview of Adjuvant Classes and Pathways—Jayanthi Wolf
Regulatory Update including New WHO Guidelines for Adjuvanted Vaccines and Clinical Considerations—Carmen Collazo-Custodio
Safety Considerations for Adjuvants including Update from HESI Meeting on Adjuvants and Autoimmunity—Ozzie Berger
Safety Considerations for Adjuvants including Update from HESI Meeting on Adjuvants and Autoimmunity—Sarah Gould
Maternal Immunization and Nonclinical Safety Assessment—Martha Leibbrandt
Safety Assessment of Residuals and Contaminants in Vaccines—Deborah L. Novicki
22.Symposium 17—Hot Topics
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FDA Tobacco/eCig Initiatives—Michael Orr
Update on Biosimiliars—Barbara J. Mounho-Zamora
Animal Rights Extremists—John Sancenito
Update on FDA/CDER Guidances, Initiatives; ICH Activities—Timothy J. McGovern
PETA Questions the Value of AAALAC Accreditation—What Is Going on Here?—David G. Serota
Update on Activities around the Ebola Outbreak—Beth Leffel
FDA Perspectives on Ebola Issues—Christopher Ellis
23.What Topic(s) Would You Like to See included in Future Programs?
24.Would You be Interested in Serving as a Symposium Moderator or Speaker?
25.If YES, please complete the following:
26.WELCOME RECEPTION - Please evaluate the quality of this special event
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27.AWARDS CEREMONY AND LUNCHEON - Please evaluate the quality of this special event
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28.POSTER RECEPTION - Please evaluate the quality of the poster session
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29.TOXTROT - Please evaluate this new event
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Free T-Shirt
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30.TUESDAY BREAKFAST RECEPTION IN EXHIBIT HALL. New in 2014, in lieu of Tuesday Plenary Lecture.
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31.WINE TASTING (if applicable, for members only)— Please evaluate this new event
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Member Benefit
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