2006 FDA Science Forum
A Century of FDA Science: Pioneering the Future of Public Health
April 18-20, 2006
Washington, DC Convention Center
Program
Also available in PDF (80 Kb)
| TUE, April 18 Welcome Plenary Lecture Breakout Sessions 1-6 Poster Session Public Session |
WED, April 19 Plenary Lecture Breakout Sessions 7-12 Breakout Sessions 13-18 |
THU, April 20 Plenary Session Breakout Sessions 19-23 |
Tuesday, April 18, 2006 | ||
| 7:30 am - 5:00 pm Level 2 - L Street Bridge | REGISTRATION
All Attendees Must Register (On-site registration only after April 12). | |
| 7:30 am Level 2 - Hall D |
POSTER SETUP
| |
| 8:15 am - 8:45 am Level 3 - Ballroom C | WELCOME Norris E. Alderson, Ph.D., Associate Commissioner for Science, FDA Andrew von Eschenbach, M.D., Acting Commissioner of Food and Drugs The Honorable Michael O. Leavitt, Secretary of Health and Human Services Remarks on the 100th Anniversary of the Pure Food and Drugs Act | |
| 8:45 am - 10:00 am Level 3 - Ballroom C | PLENARY SESSION: Historical Perspectives on FDA Science Historical Perspectives on FDA Science
This session will begin with a presentation of a brief history of the events leading up to the 1906 act by former FDA Chief Counsel Richard Cooper. Following this introduction, a panel of former FDA officials, will explore how major scientific accomplishments of FDA have impacted the development of the products, process and regulations of today. Richard M. Cooper, Esq. Gail Sherman RADM John C. Villforth (retired) J. Richard Crout, M.D. John E. Vanderveen, Ph.D. Richard E. Geyer, Esq. | |
| 10:00 am - 10:30 am Level 2 - Hall D | BREAK
| |
| Level 2 Meeting Rooms | BREAKOUT SESSIONS 1 - 6 (concurrent) | |
| 10:30 am - 12:30 pm Level 2 - Room 201 |
Breakout Session 1 - FDA Science at the Centennial: History and Perspective Co-Chairs: Suzanne Junod, Ph.D., FDA History Office, Office of Regulatory Affairs, FDA John Swan, FDA History Office, Office of Regulatory Affairs, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | FDA: Past and Present Free Market Issues Dan Carpenter, Ph.D., Professor of Government, Harvard University | |
| 11:00 am | Regulating Teratogens: Fetal Alcohol Syndrome and its Regulatory Implications Janet Golden, Ph.D., Professor of History, Rutgers University | |
| 11:25 am | Mid-Century Drug Regulation Case Study Jeremy Greene, M.D., UCSF/Harvard | |
| 11:50 am | Thalidomide as Seen from an International Perspective Arthur Daemmrich, Chemical Heritage Foundation, Philadelphia | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 202A |
Breakout Session 2 - Seafood Safety: From Algae to Aquaculture Co-Chairs: Marleen Wekell, Ph.D., Director, Office of Research, CVM, FDA Robert Dickey, Ph.D., Research Biologist, Office of Seafood, CFSAN, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | Monitoring Drug Residues and Zoonotic Disease in Domestic and Iimported Aquaculture Products Renate Reimschuessel, V.M.D., Ph.D. Research Biologist, Office of Research, CVM, FDA | |
| 11:00 am | The Changing Seascape of Vibrio Ecology and Food Safety Management Angelo DePaola Jr., Ph.D., Research Microbiologist, Office of Seafood, CFSAN, FDA | |
| 11:25 am | Seafood Toxins: New Challenges, New Solutions Sherwood Hall, Ph.D., Supervisory Chemist, FDA, Office of Seafood, CFSAN, FDA | |
| 11:50 am | Standards, Facility Certification, and Food Safety Verification as Means of Assuring Food Safety of Farmed Shrimp George Chamberlain, Ph.D., President, Global Aquaculture Alliance, St. Louis, MO | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 202B |
Breakout Session 3 - Preparing for and Preventing a Modern Plague: Focus on Avian Flu Co-Chairs: Stephen Sundlof, D.V.M., Ph.D. Director, CVM, FDA Richard Diamond, M.D.,M.P.A., Office of the Director, CBER, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | Avian influenza: Another "Mother of All Pandemics" or a "Swine Flu Debacle" - Applying Lessons from History Today Jeffrey Taubenberger, M.D., Ph.D., Chief, Department of Cell Pathology, Armed Forces Institute of Pathology | |
| 11:00 am | Avian Influenza: Where did it Come From, How Can it Spread, & How Can We Control It? Daniel Perez, Ph.D., Assistant Professor, VA/MD Regional College of Veterinary Medicine, University of Maryland | |
| 11:25 am | The "Nuts and Bolts" of Vaccine Development - What are the Options for Maximizing Availability, Efficacy, & Safety? Jerry Weir, Ph.D., Office of Vaccines Research and Review, CBER, FDA | |
| 11:50 am | Tough Choices: Planning and Implementing the U.S. Strategy for Prevention and Control of Pandemic Influenza Bruce Gellin, M.D., M.P.H., Director, National Vaccine Program Office, DHHS | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 207B |
Breakout Session 4 - Nanotechnology Co-Chairs: Steven Pollack, Ph.D., Office of Science and Engineering Laboratories, CDRH, FDA
Nakissa Sadrieh, Ph.D., Associate Director for Research Policy and Implementation, CDER, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | Quantum dots: Emerging Applications in Biology, Imaging and Medicine Igor L. Medintz, Ph.D., Center for Bio/Molecular Research, Naval Research Laboratory | |
| 11:00 am | The Toxicology of Nanomaterials: Size, Number and Surface as Determinants of Toxicity Günter Oberdörster, D.V.M., Ph.D., Dept of Environmental Medicine, University of Rochester | |
| 11:25 am | Preclinical Characterization of Nanomaterials Intended for Cancer Diagnostics and Therapeutics Scott E. McNeil, Ph.D., Director, Nanotech Characterization Laboratory, NCI-Frederick, NIH | |
| 11:50 pm | From Microscopy Toward Nanoscopy and Nanobiosensing: How to Break the Diffraction Barrier in Subwavelength Nanoscale Ilko K. Ilev, Ph.D., Division of Physics, OSEL, CDRH, FDA | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 207A |
Breakout Session 5 - Clinical Trials and Statistics: A Glance at the Past and Present and a Look to the Future Co-Chairs: Robert O'Neill, Ph.D., Director, Office of Biostatistics, CDER, FDA Greg Campbell, Ph.D., Office of Surveillance and Biometrics, CDRH, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | A History of Clinical Trials from post Harris Kefauver, 1962, to the Present Robert O'Neill, Ph.D., Director, Office of Biostatistics, CDER, FDA | |
| 11:00 am | The Future of Clinical Trials David DeMets, Ph.D., Professor of Biostatistics and Medical Informatics, University of Wisconsin | |
| 11:25 am | The Future of Clinical Trials John Feussner, M.D., M.P.H., F.A.C.P., Chairman, Department of Medicine, Medical University of South Carolina | |
| 11:50 am | The Future of Clinical Trials - an Industry Perspective Steve Snapinn, Ph.D., Amgen, Inc. | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 206 |
Breakout Session 6 - Omics along the Critical Path to New Medical Products Co-Chairs: Yvonne Dragan, Ph.D., Director, Division of Systems Toxicology, NCTR Felix Frueh, Ph.D., Associate Director for Genomics, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA | |
| 10:30 am | Introduction to Omics along the Critical Path to New Medical Products Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA | |
| 10:55 am | Impact of Omics on various R&D steps leading faster to better drugs Jacky Vonderscher, Ph.D., V.P., Global Head of Biomarker Development, Novartis Institutes for Biomedical Research, Inc. | |
| 11:20 am | Combining Different -Omics into a Coherent Approach for Modern Drug Development Klaus Lindpaintner, M.D., Ph.D., VP and Director, Roche Genetics, F. Hoffmann-La Roche AG, Basel, CH | |
| 11:45 pm | Toward Systems Toxicology: An Integrated OMICs Platform Yvonne Dragan, Ph.D., Director, Division of Systems Toxicology, NCTR, FDA | |
| 12:00 pm | The Impact of Pharmacogenomics at the FDA: A Glimpse at the Past and Future Michael Orr, Staff Fellow, CDER, FDA | |
| 12:30 pm - 1:30 pm | LUNCH (on your own) Restaurants within walking distance of the Convention Center | |
| 1:30 pm - 4:30 pm Level 2 Hall D | POSTER SESSION Poster Authors should be at their Poster for Questions and Discussion. Boards with even numbers (e.g. A-02): 1:30 pm - 3:00 pm Boards with odd numbers (e.g. B-15): 3:00 pm - 4:30 pm | |
| 1:30 pm - 4:30 pm Level 2 - Room 202B | PUBLIC SESSION: "ASK FDA" (This session is free but attendees should register) | |
Wednesday, April 19, 2006 | ||
| 7:30 am - 5:00 pm Level 2 - L Street Bridge | REGISTRATION
All Attendees Must Register (On-site registration only after April 12).
| |
| 8:30 am - 9:30 am Level 3 - Ballroom C | PLENARY LECTURE: Creating the FDA for the 21st Century Andrew von Eschenbach. M.D., Acting Commissioner of Food and Drugs | |
| 9:30 am - 10:00 am Level 2 - Hall D | BREAK
| |
| Level 2 Meeting Rooms | BREAKOUT SESSIONS 7 - 12 (concurrent) | |
| 10:00 am - 12:00 pm Level 2 - Room 201 |
Breakout Session 7 - Body Marking: Tattoos, Permanent Make-up and Laser Removal Co-Chairs: Linda Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors, CFSAN, FDA Paul Howard, Ph.D., Photosciences Laboratory, NCTR, FDA | |
| 10:00 am | Introduction Paul Howard, Ph.D., Photosciences Laboratory, NCTR, FDA | |
| 10:05 am | FDA Interest: Regulatory Status, Knowledge Gap Linda Katz, M.D., M.P.H., Director, Office of Colors and Cosmetics, CFSAN, FDA | |
| 10:30 am | The Marketplace: Chemistry Bhakti Petigara, Ph.D., Office of Colors and Cosmetics, CFSAN, FDA | |
| 10:55 am | Adverse Events: Premier Case Study Masja Straetemans, Ph.D., National Center for Environmental Health, CDC, Atlanta | |
| 11:20 am | Dermatological Implications: Tattoo Removal Rox Anderson, M.D., Professor in Dermatology, Harvard Medical School, Director, Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, MA | |
| 11:45 pm | Questions and Discussion | |
| 10:00 am - 12:00 pm Level 2 - Room 202A |
Breakout Session 8 - Partnering on the Critical Path to New Products Co-Chairs: Wendy Sanhai, Ph.D., Senior Scientific Advisory, Office of the Commissioner, FDA Michelle Chenault, Ph.D., Deputy Director, Medical Device Fellowship Program, CDRH, FDA | |
| 10:00 am | Introduction Co-chairs | |
| 10:05 am | C-Path Partnerships - The Predictive Safety Test Consortium and others in development Ray Woosley, M.D., Ph.D., President, C-Path Institute, Tucson, Arizona | |
| 10:30 am | Imaging as a Biomarker - FDG PET in Non-Hodgkin's Lymphoma George Mills, M.D., Director, Division of Medical Imaging and Hematological Products, Office of New Drugs, CDER, FDA | |
| 10:55 am | Numerical Models and Tools - "The Virtual Family" Wolfgang Kainz, Ph.D., Visiting Scientist, OSEL, CDRH, FDA | |
| 11:20 am | Utilization of FDA's ECG Warehouse for monitoring cardiac safety in medical product development Mitchell W. Krucoff, M.D., FACC, Professor of Medicine and Director, Cardiovascular Devices Unit, Duke Clinical Research Unit, Duke University Medical Center | |
| 11:45 am | Questions and Discussion | |
| 10:00 am - 12:00 pm Level 2 - Room 202B |
Breakout Session 9 - Rapid Detection of Multiple Pathogens Co-Chairs: Thomas Cebula, Ph.D., Director, Office of Applied Research and Safety Assessment, CFSAN, FDA Carl Sciacchitano, M.S., Director, Division of Field Science, ORA, FDA | |
| 10:00 am | Introduction Co-chairs | |
| 10:05 am | Can microbial Genomics Help Re-define a Species? Implication of the "pan-genome" Jacques Ravel, Ph.D., the Institute for Genomic Research, Rockville, MD | |
| 10:30 am | Tiling Arrays and Optical Mapping: Their Use in Tracking Enteric Pathogens Thomas Cebula, Ph.D., Director, OARSA, CFSAN, FDA | |
| 10:55 am | The TIGER Universal Pathogen Sensor David Ecker, Ph.D., Chief Scientific Officer, Ibis Technologies | |
| 10:20 am | Public Health Laboratory Current and Future Rapid Detection Systems/Technologies for Biothreat Agent Detection Richard Meyer, Ph.D., CDC | |
| 11:45 pm | Wrap-up - Identifying Bottlenecks Carl Sciacchitano, M.S., Division of Field Science, ORA, FDA Questions and Discussion | |
| 10:00 am - 12:00 pm Level 2 - Room 207B |
Breakout Session 10 - Bioinformatics Co-Chairs: Fred Farmer, Ph.D., Chief Information Officer, FDA Josep Prous, Ph.D., M.A., Executive Vice-President, Prous Science | |
| 10:00 am | Introduction Co-chairs | |
| 10:05 am | A Brief History of Scientific Computing in the Center for Food Safety & Applied Nutrition (CFSAN) at FDA Larry Dusold, M.S., CFSAN | |
| 10:30 am | What the IUPAC Chemical Identifier (INChi) means to you Stephen Heller, Ph.D., National Institute of Standards and Technology | |
| 10:55 am | Bioinformatics at Johnson & Johnson: the Future of FDA-Regulated Products Lance Riggio., Ph.D., Director of Informatics, Johnson and Johnson | |
| 11:20 am | HealthGrid: Grid Technologies for Biomedicine Mary E. Kratz, MT (ASCP), University of Michigan Medical School Information Services | |
| 11:45 pm | Questions and Discussion | |
| 10:00 am - 12:00 pm Level 2 - Room 207A |
Breakout Session 11 - Risk-Based Inspections and Surveillance Co-Chairs: David Horowitz, Esq., Office of Regulatory Affairs, FDA Malcolm Bertoni, M.S., Office of Policy and Planning, OC, FDA | |
| 10:00 am | Introduction Co-chairs | |
| 10:05 am | Overview of Risk-based Prioritization for Inspection at FDA Kara Morgan, Ph.D., Office of Policy and Planning, OC, FDA | |
| 10:15 am | CDER Risk-based Prioritization Model for Inspection John Gardner, M.D., DrPH., Office of Compliance, CDER, FDA | |
| 10:35 am | CDRH Risk-Based Inspection Process Karen L. Moss, Director, Division of Risk Management Operations, CDRH, FDA | |
| 10:55 am | NRC's Risk-Informed Apporach for the Materials Program Thomas Young, Senior Project Manager/Health Physicist, Office of Nuclear Material and Safeguards, U.S. Nuclear Regulatory Commission | |
| 11:20 am | The Consequence Management System Andrew Jaine, Ph.D., BT Safety LLC | |
| 11:45 am | Questions and Discussion | |
| 10:00 am - 12:00 pm Level 2 - Room 206 |
Breakout Session 12 - Personalized Medicine Co-Chairs: Sue-Jane Wang, Ph.D., Associate Director, Office of Biostatistics, Office of Pharmacoepidemiology and Statistical Science (OPSS), CDER, FDA William Slikker, Ph.D., Acting Director, NCTR, FDA | |
| 10:00 am | Introduction Co-chairs | |
| 10:05 am | The Importance of Personalized Medicine: What It Is and why It Is Critical Catherine Wheeler, M.D., Global Product Director, Oncology, AstraZeneca | |
| 10:30 am | Regulatory Pathways to Personalized Medicine Douglas Throckmorton, M.D., Deputy Director, CDER, FDA | |
| 10:55 am | Molecular Epidemiological Tool Kit for Personalized Medicine Luke Ratnasinghe, Ph.D., Director, Center for Structural Genomics, NCTR, FDA | |
| 11:20 am | Statistical Classification Methods for Getting from Concept to Reality: Using High-dimensional Genomic and other Biomarkers to Assign Patients to Therapies Hojin Moon, Ph.D., Mathematical Statistician, NCTR, FDA | |
| 11:45 pm | Questions and Discussion
| |
| 12:00 pm - 1:30 pm | LUNCH (on your own) Restaurants within walking distance of the Convention Center) | |
| 12:00 pm - 1:30 pm Level 2 - Room 209 | AWARDS LUNCHEON
Awardees and Center Directors only | |
| 1:30 pm - 2:15 pm Level 3 - Ballroom C | PLENARY LECTURE: FDA's International Role in the World of the 21st Century Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs | |
| Level 2 Meeting Rooms | BREAKOUT SESSIONS 13 - 18 (concurrent) | |
| 2:30 pm - 4:30 pm Level 2 - Room 201 |
Breakout Session 13 - Obesity Co-Chairs: Robert E. Brackett, Ph.D., Director, CFSAN, FDA Van S. Hubbard, M.D., Ph.D., Senior Advisor to the Secretary on Obesity and Director, Nutrition Research Coordination, NIH | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | From Challenges to Funding Opportunities in Obesity: NIH Perspective on Initiative Development Philip F. Smith, Ph.D., Director, Office of Obesity Research, NIH | |
| 3:00 pm | Obesity Research at the Agency for Healthcare Research and Quality Iris R. Mabry, M.D., M.P.H., Senior Advisor on Obesity Issues, Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and Quality, DHHS | |
| 3:25 pm | Obesity Prevention and Control: from Surveillance to Public Health Impact Dixie E. Snider, M.D., M.P.H., Chief Science Officer, Office of the Director, PASSWORD | |
| 3:50 pm | Nutrition Information and Obesity: CFSAN's Qualitative and Quantitative Findings Steven Bradbard, Ph.D., Consumer Studies Specialist, CFSAN, FDA | |
| 4:15 pm | Questions and Discussion | |
| 2:30 pm - 4:30 pm Level 2 - Room 202A |
Breakout Session 14 - Bringing Home Biomarkers: Science, Regulation, and Common Sense Co-Chairs: Kathryn M. Carbone, M.D., Associate Director for Research, CBER, FDA Sousan Altaie, Ph.D., Scientific Policy Advisor, Office of In Vitro Diagnostics, CDRH, FDA | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | CDER & Biomarkers: Clinical Endpoints Shirley Murphy, M.D., Deputy Director, Office of Counterterrorism and Pediatric Drug Development, CDER, FDA | |
| 3:00 pm | CDRH and Biomarkers: Strategies for the Eevelopment of in vitro Diagnostics Francis Kalush, Ph.D., Office of In Vitro Diagnostics, CDRH, FDA | |
| 3:25 pm | CBER and Biomarkers of Product Quality Kathryn M. Carbone, M.D., Associate Director for Research, CBER, FDA | |
| 3:50 pm | Novel Biomarkers of Early Kidney Damage in Drug Development Martin Shaw, Senior Scientific Officer, Biomarkers, Biotrin International | |
| 4:15 pm | Questions and Discussion | |
| 2:30 pm - 4:30 pm Level 2 - Room 202B |
Breakout Session 15 - Current Challenges in the Treatment of Parasitic Diseases in Humans and Animals Co-Chairs: Donald Prater, D.V.M., Office of New Animal Drug Evaluation, CVM, FDA Leonard Sachs, M.D., Office of New Drugs, CDER, FDA | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | Parasite Control in the Face of Widespread Drug Resistance: Changing Roles and Responsibilities for Advisors and Regulatory Officials? Ray Kaplan, D.V.M., Ph.D., University of Georgia, Athens, Georgia | |
| 3:00 pm | Anthelmintic Resistant Parasites in Ruminants (Cattle) Louis Gasbarre, Ph.D., USDA, Maryland | |
| 3:25 pm | Anthelmintic Resistant Parasites in Ruminants: Producer Point of View Larry Smith, D.V.M., L. L. Smith Research and Development, Wisconsin | |
| 3:50 pm | Resistant Parasites in Humans Leonard Sacks, M.D., Office of New Drugs, CDER, FDA | |
| 4:15 pm | Questions and Discussion | |
| 2:30 pm - 4:30 pm Level 2 - Room 207B |
Breakout Session 16 - Combination Products Co-Chairs: Heather Rosecrans, Head of Premarket Notification Section, CDRH, FDA Mark D. Kramer, Director, Office of Combination Products, OC, FDA | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | Case Study: Cordis Cypher Sirolimus-Eluting Stent Ron Dadino, Vice President, Pharmaceutical and Package Development, Cordis, a Johnson & Johnson Company | |
| 3:00 pm | Case Study: Boston Scientific Taxus Paclitaxel-Eluting Stent Kathleen M. Miller, Ph.D., Corporate Research Fellow, Boston Scientific | |
| 3:25 pm | Regulatory Challenges Ashley Boam, M.S., Chief, Interventional Cardiology Devices Branch, ODE, CDRH, FDA | |
| 3:50 pm | Drug-eluting Stents: Pharmaceutical Challenges Kasturi Srinivasachar, Ph.D., Office of New Drug Quality Assureance, CDER, FDA | |
| 4:10 pm | Beyond Drug-eluting Stents: the next Frontier in Drug Delivery Bozena Michniak-Kohn, Ph.D., M.R.Pharm.S., Associate Professor of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers University | |
| 2:30 pm - 4:30 pm Level 2 - Room 201 |
Breakout Session 17 - Advances and Frontiers in Using Records Databases for Surveillance of Medical Products Co-Chairs: RADM Steven Galson, M.D., M.P.H., Director, CDER, FDA Gerald Dal Pan, M.D., M.H.S., Director, Office of Drug Safety, CDER, FDA | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | Drug safety in the Department of Veterans Affairs Francesca Cunningham, Pharm.D., Department of Veterans Affairs | |
| 3:00 pm | Frontiers in Surveillance of Medical Devices Rosalie A. Bright, Sc.D., Office of Surveillance and Biometrics, CDRH, FDA | |
| 3:25 pm | Prompt, Active Identification of ADR Signals using Population-based Data Richard Platt, M.D., M.S., Professor and Chair, Dept. of Ambulatory Care and Prevention, Harvard Medical School | |
| 3:50 pm | Medications - Adverse Events, Unanticipated Benefits and What to Do About Them - the Indiana Experience J. Marc Overhage, M.D., Regenstrief Institute for Health Care, Indiana University School of Medicine | |
| 4:15 pm | Questions and Discussion | |
| 2:30 pm - 4:30 pm Level 2 - Room 206 |
Breakout Session 18 - The Impact of the Pediatric Experience on the FDA: Where We Have Been
and Where We Are Going Co-Chairs: Rosemary Roberts, M.D., Director, Office of Counterterrorism and Pediatric Drug Development, CDER, FDA William Slikker, Ph.D., Acting Director, NCTR, FDA | |
| 2:30 pm | Introduction Co-chairs | |
| 2:35 pm | Adult/Pediatric Differences in PK/PD: What we have learned and the future Rosemary Roberts, M.D., Director, Office of Counterterrorism and Pediatric Drug Development, CDER, FDA | |
| 3:00 pm | Differences between Adults and Children - Issues in the Development and Evaluation of Medical Devices Aron Yustein, M.D., Deputy Director, Office of Device Evaluation, CDRH, FDA | |
| 3:25 pm | Use of Preclinical Juvenile Animal Models in Designing Studies for Children William Slikker, Ph.D., Acting Director, NCTR, FDA | |
| 3:50 pm | Current Ethical Concerns in Pediatric Research Sara Goldkind, M.D., M.A., Office of Pediatric Therapeutics, FDA | |
| 4:15 pm | Questions and Discussion
| |
Thursday, April 20, 2006 | ||
| 7:30 am - 11:00 am Level 2 - L Street Bridge | REGISTRATION
All Attendees Must Register (On-site registration only after April 12).
| |
| 8:30 am - 10:00 am Level 3 - Ballroom C | PLENARY SESSION: Public Health Preparedness
Margaret O'K. Glavin, Moderator Associate Commissioner for Regulatory Affairs, FDA ADM John Agwunobi Assistant Secretary for Health, US Department of Health and Human Services Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases, NIH Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research, FDA | |
| 10:00 am - 10:30 am Level 2 - Hall D | BREAK
| |
| Level 2 Meeting Rooms | BREAKOUT SESSIONS 19 - 23 (concurrent) | |
| 10:30 pm - 12:30 pm Level 2 - Room 201 |
Breakout Session 19 - Blood and Tissue Safety Co-Chairs: Jonathan Goldsmith, M.D., Deputy Director, Office of Blood Research and Review (OBRR), CBER, FDA
Tomislav Modric, D.V.M., Ph.D., Office of New Animal Drug Evaluation (ONADE), CVM, FDA | |
| 10:30 am | Introduction - History of Blood and Tissue Product Regulation Jonathan Goldsmith, M.D., OBRR, CBER, FDA | |
| 10:35 am | Blood Substitutes: a Moving Target Abdu Alayash, Ph.D., OBRR, CBER | |
| 11:00 am | TSEs Robert Rowher, Ph.D., Head, Neurovirology Laboratory, VA Maryland Healthcare System | |
| 11:25 am | Xenotransplantation Technology David Cooper, M.D., Ph.D., Professor of Surgery, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center | |
| 11:50 am | Xenotransplantaion and Viral Safety Carolyn Wilson, Ph.D., OCGT, CBER, FDA | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 202A,B |
Breakout Session 20 - Public Health During Natural Disasters: The FDA Katrina-Rita Experience Co-Chairs: RADM Richard Barror., Chief Engineer, USPHS CAPT Dary Hanes, Ph.D., Office of Applied Research and Safety Assessment, CFSAN, FDA | |
| 10:35 am | Coordinating the FDA Response to Katrina and Rita Ellen Morrison, Director, Office of Crisis Management | |
| 11:00 am | Medical Care, Support, Supplies and Pharmaceuticals in the Field Setting CDR Sarah Linde-Feucht, M.D., Office of Orphan Product Development, FDA | |
| 11:25 am | Implementing a Continuity of Operations (COOP) Plan Tyler Thornburg, Director, New Orleans Office, Office of Regulatory Affairs, FDA | |
| 11:50 am | Food Safety and Inspectional Issues Chester Morris, Director of State Programs, SE Region, ORA Atlanta | |
| 12:15 pm | Concluding Remarks | |
| 10:30 pm - 12:30 pm Level 2 - Room 207B |
Breakout Session 21 - Minimally Invasive Devices Co-Chairs: Joshua Pfefer, CDRH Gerry Harris, CDRH | |
| 10:30 am | Introduction Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA | |
| 10:40 am | Optical Coherence Tomography for Detection of Atherosclerotic Plaque Guillermo J. Tearney, M.D., Ph.D., Associate Professor of Pathology, Wellman Center for Photomedicine, Harvard Medical School | |
| 11:05 am | Some Recent Advances in Therapeutic Ultrasound Lawrence Crum, Ph.D., Director, Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA | |
| 11:30 am | Recent Advances in Medical Imaging Kyle Myers, Ph.D., Laboratory Leader, Medical Imaging and Diagnostics, Division of Imaging and Applied Mathematics, OSEL, CDRH, FDA | |
| 11:55 am | Image-guided Surgery and Drug Therapy Bradford Wood, M.D., Interventional Radiologist, Diagnostic Radiology Department, Clinical Center, National Institutes of Health | |
| 12:20 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 207A |
Breakout Session 22 - Managing Uncertainty in Risk Assessment: Probabilistic Approaches Co-Chairs: Robert Buchanan, Ph.D., Director, Office of Science, CFSAN, FDA Gregg Claycamp, Ph.D., Risk Assessment Manager, ONADE, CVM, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | Probabilistic Approaches to Characterization of Toxicity Lorenz Rhomberg, Ph.D., Principal, Gradient Corporation | |
| 11:00 am | Hierarchical Probabilistic Models for Managing Uncertainty Ralph Kodell, Ph.D, Director, Division of Biometry and Risk Assessment, NCTR, FDA | |
| 11:25 am | Statistics, Public Health, and Probability Clark Carrington, Ph.D., Office of Plant and Dairy Foods, CFSAN, FDA | |
| 11:50 am | Misuse and Non-Use of Uncertainty Analysis in Health Risk Assessment Adam Finkel, D.Sc, Professor, UMDNJ School of Public Health and Visiting Professor, Princeton University | |
| 12:15 pm | Questions and Discussion | |
| 10:30 pm - 12:30 pm Level 2 - Room 206 |
Breakout Session 23 - Novel Approaches to Cancer Therapy and Monitoring Co-Chairs: Robert Justice, M.D., CDER, FDA Raj Puri, M.D., Ph.D., CBER, FDA | |
| 10:30 am | Introduction Co-chairs | |
| 10:35 am | Development and Evaluation of Targeted Cancer Therapies Amna Ibrahim, M.D., Acting Medical Team Leader, CDER FDA | |
| 11:00 am | Challenges in the Development of Therapeutic Cancer Vaccines Ke Liu, M.D., Ph.D. Medical Officer, CBER, FDA | |
| 11:25 am | Novel issues in Cancer Therapy: Autoimmunity and Therapeutic Response Jim Yang, M.D., National Cancer Institute | |
| 11:50 am | The Emerging Role and Challenges for Imaging in Drug Development Lawrence Schwartz, M.D., Director, Magnetic Resonance Imaging, Memorial Sloan - Kettering Cancer Institute | |
| 12:15 pm | Questions and Discussion
| |
| 12:30 pm | Adjourn - 2006 FDA Science Forum Ends | |