The Honorable Claude Allen
Deputy Secretary of Health and Human Services

From all poster abstracts submitted in the area of anti-microbial resistance, the session chair and session subcommittee have selected several abstracts. The authors have been invited to give slide presentations. Their posters will also be available in the breakout room. Dr. Sundlof will open the session with an overview of the topic, followed by slide presentations, and ending with a discussion.

• Identification of Significant Co-resistance among Quinupristin-Dalfopristin-Resistant Enterococcus faecium Isolated from Retail
  J. R. Hayes¹, D. D. Wagner¹ , L. L. English¹, P. J. Carter¹ , T. Proescholdt², K. Y. Lee ², D. G. White ¹, ¹OR, CVM, FDA, Laurel, MD , ²OSC, CVM, FDA, Rockville, MD
  Abstract
  
  
• The use of disk diffusion to screen for antimicrobial resistance in Campylobacter
  S. M. Bodeis¹ , R. D. Walker¹ , I. R. Nachamkin² , P. F. McDermott¹ , ¹CVM Office of Research, Laurel, MD, ²University of Pennsylvania School of Medicine
  
  
• Acquisition of Multi-Drug Resistance in the Emerging Foodborne Pathogen Salmonella Newport
  M. K. Mammel ¹ , E. W. Brown ¹ , J. E. LeClerc¹ , J. M. Besser², D. J. Boxrud², K. E. Smith² , T. A. Cebula¹, ¹OARSA, FDA, Laurel, MD , ²Minnesota Dept of Health, Minneapolis, MN

• Multi-faceted Effects of Diet on Health
  F. Xavier Pi-Sunyer, M.D., M.P.H., Director, New York Obesity Research Center, Columbia University
  Abstract
  
  
• Psychosocial, Economic and Marketplace Influences on Sound Nutrition
  David L. Katz, M.D., MPH, FACPM, FACP, Director, Yale Prevention Research Center, Yale University
  Abstract
  
  
• Panel Discussion - Impact of applied nutrition on FDA's regulatory mission across Centers
  

  Panelists: Alan Rulis, Ph.D (CFSAN, panel leader), F. Xavier Pi-Sunyer, M.D., M.P.H. (Columbia University), David Katz, M.D., M.P.H. (Yale University), Richard Williams, Ph.D. (CFSAN), Sanford Miller, Ph.D. (Virginia Polytechnic Institute and State University), William Dietz, M.D. (CDC)

• Introduction to Critical Path Research
  Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
  
  
• Innovative Technology Advancing Public Health: CBER Critical Path Opportunities
  Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation & Research
  Abstract
  
  
• High-Intensity Focused Ultrasound for Tissue Thermal Ablation: Potential Applications and Critical Path Opportunity
  Gerald R. Harris, Center for Devices & Radiological Health
  Abstract
  
  
• Model-based Drug Development and Regulatory Review
  Donald R. Stanski, M.D., Scientific Advisor to the Center Director, Center for Drug Evaluation & Research, FDA, Professor of Anesthesia, Stanford University
  Abstract
  
  

• FDA's Counter-terrorism Program
  Margaret Glavin, Assistant Commissioner for Counter-terrorism, FDA
  
  
• Development of Medical Countermeasures for Threat Agents when Ethics Prohibit the Use of Human Subjects: The Case of Plague
  Lewis Schrager, M.D., Center for Drug Evaluation & Research, FDA
  Abstract
  
  
• Evaluation of Smallpox Vaccine Potency and Safety: Reducing (or Managing) the Risk of Adverse Outcomes
  Hana Golding, Ph.D., Center for Biologics Evaluation & Research, FDA
  Abstract
  
  
• Lessons from the Hepatitis A Outbreak of 2003
  David Acheson, M.D., Center for Food Safety & Applied Nutrition, FDA
  Abstract
  
  

From all poster abstracts submitted in the area of methods development, the session chair and session subcommittee have selected several abstracts. The authors have been invited to give slide presentations. Their posters will also be available in the breakout room. Mr. Marzilli will open the session with an overview of the topic, followed by slide presentations, and ending with a discussion.

• DNA Microarray for Food Safety Analysis
  N. Sergeev^1,2, M. Distler³, S. Courtney³, S. F. Al-khaldi², D. Volokhov⁴, V. Chizhikov⁴, A. Rasooly^1,2,5, ¹FDA Center for Devices and Radiological Health, ²FDA Center for Food Safety and Applied Nutrition, ³JIFSAN-University of Maryland, ⁴FDA Center for Biologics Evaluation and Research, ⁵NIH-National Cancer Institute
  Abstract
  
  
• Real-Time PCR assay for the detection of Salmonella in Foods
  C. M. Cheng , K. T. Van , W. S. Lin , N. N. Tran , L. C. Phan , PRL-SW, Irvine, CA
  Abstract
  
  
• Liver Cancer Analysis Using Cross Species Mapping Based on Rat Gene Expression Profiling
  H. Fang¹, W. Tong¹, S. H. Yim², J. M. Ward², R. Perkins¹, Y. P. Dragan¹, ¹FDA, ²NCI
  Abstract
  
  
• Evaluation of the Real Time PCR Assay for Rapid, Specific Detection and Enumeration of Enterobacter sakazakii in Infant Formula
  K. H. Seo¹, G. Thammasuvimol¹, M. L. Kotewicz², R. E. Brackett¹, ¹OPDF, FDA, College Park, MD, ² OARSA, FDA, Laurel , MD
  Abstract
  
  
• Fluorescence based multiplex PCR assay for simultaneous detection of Category A select bacterial agents and parasitic pathogens
  A. Selvapandiyan , S. Kerby , R. Duncan , H. L. Nakhasi , Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER, FDA, Bethesda, MD 20892

• The Battle Between Homeostatic and Non-homeostatic Factors in the Control of Body Weight
  Hans-Rudolf Berthoud, Ph.D., Pennington Biomedical Research Center, Louisiana State University
  Abstract
  
  
• Environmental Imprinting on Genetically Determined Obesity Circuits
  Barry E. Levin, Ph.D., New Jersey Medical School
  Abstract
  
  
• Panel Discussion - Defining Long-term Biological Research Needs on Obesity for FDA's Regulatory Mission
  
  

  Introductory Presentation: FDA Research Activities Related to Obesity
  William Slikker, Ph.D., National Center for Toxicological Research, FDA
  
  Panelists: David Acheson, M.D. (CFSAN, Panel Chair), F. Xavier Pi-Sunyer, M.D., M.P.H. (Columbia University), Patricia Beaston, M.D., Ph.D. (CDER), Hans-Rudolf Berthoud, Ph.D. (LSU), Barry Levin, Ph.D. (NJ Medical School), Bill Slikker, Ph.D. (NCTR), Aron Yustein, Ph.D. (CDRH)

• Introduction and Overview
  Daniel Casciano, Ph.D., National Center for Toxicological Research, FDA
  
  
• Recent Policy Developments for Pharmacogenomics Data Submission and Analysis
  Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
  Abstract
  
  
• Microarray Assessment of Cell Substrates and Embryonic Stem Cells
  Raj Puri, M.D., Ph.D., Center for Biologics Evaluation & Research, FDA
  Abstract
  
  
• Pharmacogenomics: The Presxent and Future
  Luke Ratnasinghe, Ph.D., National Center for Toxicological Research, FDA
  Abstract
  
  
• Microarray-Based Methods for Microbial Gene Expression Profiling and Strain Identification
  Scott Jackson, Ph.D., Center for Food Safety & Applied Nutrition, FDA
  Abstract
  
  

• Vulnerability Assessments and Prioritization Robert E. Brackett, Ph.D., Center for Food Safety & Applied Nutrition, FDA
  Abstract
  
  
• Detection Methods and Laboratory Activities Supporting FDA's Food Defense Program
  Arthur Miller, Ph.D., Center for Food Safety & Applied Nutrition, FDA
  Abstract
  
  
• State Perspectives on Food Security Issues
  Laurence Barrett, Ph.D., Division of Food, Drug and Radiation Safety, California Dept. of Health Services
  Abstract
  
  
• Incident Management/Response and Recovery
  Ellen F. Morrison, Division of Emergency and Investigational Operations, FDA
  Abstract
  
  
• Communication
  Peter J. Pitts, Associate Commissioner for External Relations, FDA
  
  

This session, which will be open at no cost to the public, will feature several talks on FDA science issues, presented in non-scientific terms, by some of the Agencies top scientists.

• Children in Clinical Trials: Neither Second Class Citizens nor Guinea Pigs
  Murray A. Lumpkin, M.D., Acting Deputy Commissioner for International and Special Programs, FDA
  
  
• Personalized Medicine: The Power of Proteomics and What It means to the Consumer
  Emanuel Petricoin, Ph.D., Co-Director, NCI-FDA Clinical Proteomics Program, Center for Biologics Research & Evaluation, FDA
  
  
• Is It Really Safe? Understanding Food Safety for the Non Scientist
  Robert E. Brackett, Ph.D., Director, Center for Food Safety & Applied Nutrition, FDA
  
  

In this plenary session, the chair and speakers will explore current research trends and initiatives that will impact the development of future products regulated by the FDA.

• Perinatal Carcinogenicity of Drug Combinations used to Prevent Mother-to-Child Transmission of HIV (IAG with the NTP)
  Frederick A. Beland, Ph.D., National Center for Toxicological Research, FDA
  
  
• Decontamination of Surgical and Other Instruments Exposed to TSE Agents (OSHC project)
  Stanley Brown, Ph.D., Center for Devices & Radiological Health, FDA
  
  
• Evolution of Microbial Pathogens: Forensic Strategies for Strain Identification (MOU with the FBI and Homeland Security)
  J. Eugene Leclerc, Ph.D, Center for Food Safety & Applied Nutrition, FDA
  Abstract
  
  
• Cow-Calf Model for Evaluation of Maternal Transfer of Drug Residues (OWH Project)
  Alberto Chiesa, D.V.M., Ph.D., Center for Veterinary Medicine, FDA
  Abstract
  
  
• Setting Standards for Adenoviral Vectors (Co-sponsorship Agreement)
  Andrew Byrnes, Ph.D., Center for Biologics Evaluation & Research, FDA
  Abstract

• The Science of Quality by Design
  Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
  Abstract
  
  
• Design of Experiments - Optimization Strategies
  Fernando Muzzio, Ph.D., Rutgers University
  Abstract
  
  
• Variation Risk Management
  Anna Thornton, Ph.D., Analytics Corporation
  Abstract
  
  
• Whole Product Life Cycle
  Alford Taylor, M.S., Center for Devices & Radiological Health
  Abstract

• Potential for Incorporation of Nantochnology into FDA-Regulated Products
  Larry Kessler, Sc.D., Office of Science and Engineering Laboratories, Center for Devices & Radiological Health (CDRH), FDA
  
  
• Nanotechnology for Drug Delivery and Targeted Imaging
  James Baker, M.D., Ruth Dow Doan Professor and Director, Center for Biologic Nanotechnology, The University of Michigan
  Abstract
  
  
• Environmental Impact of Engineered Nanomaterials
  Vicki Colvin, Ph.D., Center for Biological and Environmental Nanotechnology Rice University
  Abstract
  
  
• National Nanotechnology Initiative: Benefits and Responsibilities
  Cecelia Mertzbacker, Ph.D., Agency Representative, National Science and Technology Council, Executive Office of the President
  Abstract

• Medwatch - The FDA Safety Information and Adverse Event Reporting System
  Norman Marks, M.D, M.P.H., Center for Drug Evaluation & Research, FDA
  Abstract
  
  
• Medication Errors - Strategies for Improving Safety
  Charles Hoppes, R.Ph., M.P.H., Center for Drug Evaluation & Research, FDA
  Abstract
  
  
• The Vaccine Adverse Event Reporting System - A Tool for Safety and Surveillance
  Jane Woo, Ph.D., M.P.H., Center for Biologics Evaluation & Research, FDA
  Abstract
• Pharmacovigilance and Risk Management Practice for Drug Products
  Min Chen, Ph.D., Center for Drug Evaluation & Research, FDA
  Abstract
  
  
• Medical Device Adverse Event Review - Promoting Patient Safety
  Suzanne Rich, R.N., M.A., Center for Devices & Radiological Health, FDA
  Abstract
  
  
• Assessing Adverse Events for Foods & Supplements
  Susan Walker, M.D., Center for Food Safety & Applied Nutrition, FDA
  
  
• Adverse Event Analysis of Gene Therapy Clinical Trials based on a Comprehensive Database: What are the Risks?
  Steven Hirschfeld, M.D., Ph.D., Center for Biologics Evaluation & Research, FDA
  Abstract
  
  

• Scaleable Information Infrastructure at the NLM
  Michael Gill, Electronics Engineer, Communications Engineering Branch of the Lister Hill National Center for Biomedical Communications, National Library of Medicine
  
  
• Industry Participation in the Internet2 Community
  Jesus Salillas, Director of Research and Development, Prous Science
  
  
• Internet2 and Health Science Initiativesinitiatives
  Mary Kratz, Program Manager, Internet2 Health Sciences.
  
  
• Q&A/Open Discussion
  Kathleen Morrish, IT Director, Scientific Computing, FDA
  
  

• Improving Biotechnology Manufacturing Through Pilot Plant Research
  Jennifer Hunter-Cevera, Ph.D., University of Maryland Biotechnology Institute
  
  
• The Role of Medical Imaging in Clinical Trials
  Martha Gray, Ph.D., Division of Health Science and Technology, Harvard-MIT
  Abstract
  
  
• Statistical Approaches to Improving Clinical Trial Design
  Scott Zeger, Ph.D., Dept. of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University

• What We Know and Do Not Know about Chemical/Light-induced Reactions in Man
  Howard I. Maibach, M.D., Dept. of Dermatology, UCSF
  Abstract
  
  
• Animal Studies for the Assessing Safety of Sunscreen, Cosmetics and Drugs
  Paul C. Howard, Ph.D., National Center for Toxicological Research, FDA
  Abstract
  
  
• Overview of Ongoing Human Studies at the FDA Photosciences Facility
  Janusz Z. Beer, M.D., Center for Devices & Radiological Health, FDA
  Abstract
  
  
• Regulatory Implication of Experimental Data
  Paul C. Brown, Ph.D. Center for Drug Evaluation & Research, FDA
  Abstract
  
  
• Panel Discussion

  Panelists: Linda Katz, M.D., M.P.H. (CFSAN), Howard Maibach, M.D. (UCSF), Andrija Kornhauser, M.D. (CFSAN), Paul Howard, Ph.D. (NCTR). Janusz Beer, M.D., (CDRH), Sharon Miller, Ph.D., (CDRH), Paul Brown, Ph.D. (CDER)

• Human Proteome Organization and its Role in Public Health and Awareness
  Samir Hanash, M.D, Ph.D., Department of Pediatics,University of Michigan
  Abstract
  
  
• The Liver Proteome
  Rick Edmonson, Ph.D., National Center for Toxicological Research, FDA
  
  
• Proteomic Technologies for Enhancing Drug Development
  Stan Hefta, Ph.D., Bristol Myers-Squib (invited)
  
  
• Clinical and Translational Applications of Proteomics
  Emmanuel Petricoin, Ph.D., Center for Biologics Evaluation & Research, FDA

• Early Human Pharmacokinetic Studies Using Microdosing - Scientific and Regulatory Perspective
  Professor R. Colin Garner, Ph.D., D.Sc., B.Sc., FRCPath, Xceleron Ltd.
  Abstract
  
  
• Computer Aided Diagnosis (CAD): The Current State and Future for this Technology
  Nicholas Petrick, Ph.D., Center for Devices and Radiological Health, FDA
  Abstract
  
  
• NeuroImaging: New Approaches for Neurotoxicology
  William Slikker, Jr., Ph.D., National Center for Toxicological Research, FDA
  Abstract
  
  
• Pharmaceutical Applications of Near Infrared Chemical Imaging
  Robbe Lyon, Ph.D., Center for Drug Evaluation & Research, FDA
  Abstract