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DAY ONE, November 4
MORNING SESSION (9 a.m. to 11:45) Building 1, CSU Room 2058
Assistant Commissioner for Public Affairs, George Strait
WELCOME and OPENING REMARKS
FDA Commissioner Margaret A. Hamburg M.D.
SESSION 1 - FDA’s role in H1N1
First topic: Seeing what the immune system sees during an influenza infection
Hana Golding, M.D., chief, Laboratory of Retrovirus Research, Center for Biologics Evaluation and Research (CBER)
Using whole genome fragment display libraries to rapidly identify immune system targets on influenza viruses is giving researchers critical information needed to design effective vaccines, tests and therapies.
Second topic: Providing the tools for making and testing H1N1 vaccine
Zhiping Ye, Ph.D., Laboratory of Pediatric and Respiratory Viral Diseases, CBER
CBER researchers have played an important role in developing the H1N1 vaccine by analyzing the replication potential of the virus, preparing candidate vaccine strains for manufacturers to evaluate, testing of seed viruses; preparing, testing and calibrating reagents used by manufacturers to measure vaccine potency and conducting lot release and associated testing.
Third topic: Influenza Antivirals and Emergency Use Authorization
Wendy Carter, M.D., Division of Anti-Viral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research
Two classes of drugs are available to treat influenza but they have certain limitations. During the current H1N1 medical emergency, the FDA has invoked a mechanism known as Emergency Use Authorization to treat those people who cannot be treated by FDA-approved medications.
SESSION 2 - Proteomics – an Alternative to Antibiotic Use In Animals?
Jamie Boehmer, Ph.D., biologist, Office of Research, Center for Veterinary Medicine (CVM)
Scientists involved in biomarker research at CVM are utilizing the latest proteomic to analyze biologically complex samples, including various animal tissues and bovine milk and bronchial fluid, to help identify several candidate biomarkers of inflammatory disease in food animals, as well as elucidate proteins that could ultimately serve as alternatives to antibiotic use in food animals.
SESSION 3 - Orphan Drugs: Making Miracles for People Who Need Them
Tim Cote, M.D., M.P.H., director, FDA Office of Orphan Products Development
The Orphan Drug Act spawned an entire biotech industry and transformed lives by making possible the creation of hundreds of new drugs for people with rare diseases. Enzyme replacements for rare inborn errors of metabolism, snake bite anti venom and antidotes for plutonium poisoning, were all made possible through this system of "designating" promising compounds as orphan drugs.
12 PM WORKING LUNCH AND NEWS CONFERENCE, CSU 2047
Margaret A. Hamburg, M.D., Commissioner Food and Drugs
Dr. Hamburg will appear at a news conference.
1:00 TOUR OF CDRH LABS AT WHITE OAK
- Building 64-3015
- Biosensors involving fluorescence resonance energy transfer using peptide substrates
- Kim Sapsford, Ph.D
- Building 64-4067
- Biomarkers of Kidney Injury: Better Tools to Improve Public Health
- Ron Brown
- Building 62-3135
- Computational models of imaging for evaluation of novel 3D breast imaging systems
- Aldo Badano, Ph.D
- Building 62-G105
- The changing electromagnetic environment: implications for medical devices
- Howard Bassen
AFTERNOON SESSION (2:30 p.m. to 5:15 pm), CSU 2058
SESSION 4 - Cellular Therapy: Cell therapies: Getting from Sky High Potential to Safe and Effective Products
Steve Bauer, Ph.D., Chief, Cellular and Tissue Therapy Branch, CBER
Malcolm Moos, M.D., Ph.D., Senior Investigator, Cellular Tissue Therapies Branch, CBER.
Cellular therapy breakthroughs in the laboratory promise exciting new treatments for heart disease, brain disorders, musculoskeletal illnesses, joint damage, and other ailments. However, there are many hurdles to clear between promise and practice including development of properly controlled manufacturing processes and test methods.. CBER scientists are working to better understand how best to regulate these complex products so that they move through the investigational phase to approval as quickly as possible. There are close parallels between what happens in the body’s normal repair processes, what happens during manufacture of therapeutic cells and tissues, and the processes used by the best tissue engineering system of all: the developing embryo. CBER scientists have exploited these parallels to identify novel control mechanisms that help govern cell and tissue characteristics and in turn help identify cell markers that can predict whether stem cell-derived products are safe and effective.
SESSION 5 - Renal Biomarkers
Peter Goering, Ph.D., Research Toxicologist, Center for Devices and Radiological Health
The current tests to detect kidney damage are relatively insensitive. A significant amount of kidney damage can occur before it is detected using the gold standard tests of blood urea nitrogen and creatinine. As a result, investigators at FDA are collaborating with scientists at Harvard University and elsewhere to develop more sensitive and clinically relevant tests.
SESSION 6 - Personalized Medicine – The Promise Becomes Real
Issam Zineh, PharmD, MPH, associate director for Genomics, Office of Clinical
Pharmacology, Office of Translational Sciences, CDER
Elizabeth Mansfield, Ph.D., director, Personalized Medicine, Office of In Vitro Diagnostic Evaluation and Research, CDRH
Personalized medicine is the use of information and data about a patient’s genetic makeup, lifestyle, medications and diseases to optimize medical treatments. FDA’s current role in this evolving field will be discussed from two different vantage points: prescription drugs and in vitro diagnostic tests.
DAY TWO: NOVEMBER 5
MORNING SESSION (9 a.m. to 1 p.m.), CSU 2058
SESSION 1 - Discovery in Plant Bacteria: Are These Killer Compounds Novel Sources of Human Antibiotics and Eco-Friendly Weapons Against Food-borne Pathogens?
Eric Brown, Ph.D., chief of the Molecular Methods and Subtyping Branch, Division of Microbiology, and senior research microbiologist, Center for Food Safety and Applied Nutrition (CFSAN)
Tests are underway of bacteria that can be unleashed on plants to keep them from becoming infected by food-borne pathogens, and whose toxins also might form the basis of new antibiotics for serious human infections of many kinds -- not just those acquired from food. These bacteria also kill or inhibit a wide variety of other food-borne pathogens, including some bacteria that have become increasingly drug resistant. The compounds appear harmless to humans and wildlife, thus far. CFSAN is developing these bacteria and their toxins not only for their potential to treat vegetables, pre-harvest, against a variety of harmful bacterial contaminants, but also for their potential to be used as the basis for novel human antibiotics.
SESSION 2 - Tapping Microbial Genomes to Speed Outbreak Investigations and Mark Changes in Virulence and Other Traits
Joseph Leclerc, Ph.D., director, Division of Molecular Biology, Office of Applied Research and Safety Assessment, CFSAN
CFSAN laboratories have developed technologies that will result in faster identification and tracking of food-borne bacteria strains causing outbreaks. The technologies include sequencing of single-nucleotide polymorphisms, for food-borne pathogens; DNA microarray analysis, for gene profiling and differentiation of strains; optical mapping of chromosomes, for discovery of novel gene insertions and deletions; and phenotypic microarray of pathogens' metabolic functions, for strain characterization.
SESSION 3 - Computational Models of Imaging for Evaluation of Novel 3D Breast Imaging Systems
Aldo Badano, Ph.D., Office of Science and Engineering Laboratories, CDRH
CDRH scientists have developed a state-of the art-accurate computational model of X-ray imaging physics that is being used to address premarket and postmarket questions related to imaging efficacy and radiation safety. Many outside organizations have requested access to these tools and/or collaboration with the FDA program, thus leveraging FDA’s own efforts to address a broader range of questions regarding X-ray imaging that are of importance to public health.
10: 30-11:30 TOUR of CDER Labs at White Oak
Division of Applied Pharmacology Research, Laboratory of Clinical Pharmacology
Life Sciences Building (Building 64; 2nd Floor
- Investigational Pathology
- Molecular Toxicology Laboratory
- Laboratory of Clinical Pharmacology
SESSION 4 – Leading Scientific Innovations Through Partnerships: A Women’s Health Perspective
Kathleen Uhl, M.D., Assistant Commissioner for Women’s Health, FDA
Ameeta Parekh, Ph.D., research and development director, Office of Women’s Health Research and Development Program
Historically, women were under-represented in clinical research resulting in knowledge gaps in the understanding of sex differences in disease and response. The Office of Women’s Health has been a leader in advocating for inclusion of women in clinical trials and has supported several scientific innovations (e.g. the Data Standardization Initiative) to close the existing knowledge gap and to advance public health to a higher stratum.
SESSION 5 - Update on FDA’s Critical Path Program
Leonard Sacks, M.D., acting director, FDA’s Office of Critical Path Initiative
The Critical Path Initiative is the FDA's national strategy for transforming the way FDA-regulated products are developed, evaluated, manufactured, and used often in collaboration with other federal agencies, patient groups, academic researchers industry and other stakeholders. In the short time since its inception, the Initiative has seen the number of its projects grow from 40 in 2006 to 95 in 2009. The new director of the Initiative will provide a forward-looking update of the Initiative’s activities.
SESSION 7 - Future of Science at FDA
Jesse Goodman, M.D., M.P.H., Acting Deputy Commissioner and Chief Scientist
The chief scientist will discuss his plans for advancing science at FDA.
12:45 p.m. -1 p.m. Box Lunch/ Board Bus for CVM Lab Tour
1:00 p.m. - Bus Departs for CVM Lab Tour from Front Door of Building One
1:15 - 2:45 p.m. CVM Lab Tour, Laurel, MD.
Office of Research, Center for Veterinary Medicine
CVM will host a tour of its research campus including external buildings and laboratory components.
SESSION 8 at CVM: DNA Barcoding of Fish
Haile Yancy, Ph.D., Research Biologist, CVM, Office of Research
DNA barcoding is a new technique that uses a short DNA sequence from a standardized and agreed-upon position in the genome as a molecular diagnostic for species-level identification. A standardized method for DNA barcode generation has been developed and is currently in an inter-laboratory validation study. Several recent regulatory cases, including import violations and outbreak investigations involving seafood contamination with marine toxins were solved using DNA barcoding. In all cases, DNA barcoding was used successfully to determine product identity. In addition, a regulatory DNA barcode database has been established. By utilizing this database, a fast, easy, and reliable real-time PCR assay was developed and validated. The real-time assay is currently being used by ORA to help enforce FDA’s 1997 BSE feed ban.
2:45 END/Bus Departs for WO