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11thAnnual FDA Science Forum

April 27-28, 2005
Washington, DC Convention Center



Final Program

Tuesday, April 26, 2005
  
1:00 pm - 5:00 pm

FREE Public Session

Personalizing Your Healthcare: The Best Consumer is an Educated Consumer
Chair: Janet Woodcock, M.D., Acting Deputy Commissioner for Operations

The FDA is committed to increasing health literacy and informing consumers. This free session will provide members of the general public the opportunity to hear about the science behind Personalized Medicine, Generic Drugs and the new Dietary Guidelines, issues of critical importance to the FDA. Presentations will be from national experts in these fields.
  • The Importance of Being a Smart Health Consumer
    Harvey Fineberg, M.D., Ph.D., President, Institute of Medicine

  • Personalized Medicine - What is it? How Will it Affect Your Health Care?
    Felix Frueh, M.D., Center for Drug Evaluation and Research, FDA and
    J. Brian Munroe, President, Personalized Medicine Coalition

  • Generic Drugs - Are They Really as Good?
    Jack Billi, M.D., Associate Vice President, University of Michigan and
    Gary Buehler, R.Ph., Director, Office of Generic Drugs, FDA

  • Are You What You Eat? A Critical Look at the New Dietary Guidelines for
    Americans, the Science of Nutrition, and Personal Choices for a Healthier Life.
    Moderator:
    Barbara Schneeman, Ph.D. Center for Food Safety and Applied Nutrition, FDA
    Panelists:
    Lawrence J. Appel, M.D., M.P.H., Johns Hopkins Medical School
    CAPT. Penelope Royall, P.T., M.S.W., Deputy Asst. Secretary for Health, HHS
    Beth Johnson, M.S., R.D., Senior Advisory to the Secretary, USDA


 
Wednesday, April 27, 2005
  
7:30 am - 5:00 pm
Level 2 - L Street Bridge		Registration
7:30 am - 8:30 pm
Level 2 - Hall D		Poster Setup
8:30 am - 9:00 am
Level 3 - Ballroom C		WELCOME AND OPENING REMARKS

Lawrence X. Yu, Ph.D., Chair, Science Forum Organizing Committee
Keith Carson, Chairman, Williamsburg BioProcessing Foundation
Norris Alderson, Ph.D, Associate Commissioner for Science
Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs
9:00 am - 10:00 am
Level 3 - Ballroom C		 KEYNOTE ADDRESS

Michael O. Leavitt
Secretary, U.S. Department of Health and Human Services


10:00 pm - 10:30 am
Level 2 - Hall D		Break

10:30 am - 11:30 am
Level 3 - Ballroom C		 Special Plenary Lecture

Advancing Health through Innovations in Bioengineering
Robert S. Langer, D.Sc., Kenneth J. Germeshausen Professor of Chemical and Biomedical Engineering, Massachusetts Institute of Technology


11:30 am - 1:00 pm
Level 2 - Hall D		Poster Session & Exhibits with Box Lunch
(Poster Presenters should be available at their posters for this session)

11:30 am - 1:30 pm
Level 2 - Room 204C		FDA Statistical Association Meeting
Level 2Breakout Sessions 1-6 (concurrent)
1:00 pm - 2:50 pm
Level 2 - Room 206
Breakout Session 1: Nanomedicine: Nonclinical and Clinical Implications

Co-Chairs:
Stanley Brown, D.Eng., Biomaterials Engineer, Office of Science and Engineering Laboratories, CDRH, FDA and
Jan Simak, Ph.D., Visiting Scientist, Laboratory of Cellular Hematology, CBER, FDA
1:05 pm
Nanotechnology Treatment Applications
Jennifer West, Ph.D., Isabel C. Cameron Professor of Bioengineering, Rice University
1:30 pm
Nanotechnology and Biomimics
Thomas J. Webster, Ph.D., Assistant Professor of Biomedical Engineering, Purdue University
1:55 pm
Nanoparticles and Safety
Paul Howard, Ph.D., Division of Biochemical Toxicology, NCTR, FDA
2:20 pm
Nanotechnology Diagnostic Applications
Chad Mirkin, Ph.D., George B. Rathman Professor, Department of Chemistry, Northwestern University


1:00 - 2:50 pm
Level 2 - Room 207A
Breakout Session 2: Use of Animal Models of Disease for Preclinical Evaluation of Safety and Efficacy

Co-Chairs:
Ronald P. Brown, M.S., DABT, Toxicologist, Division of Biology, CDRH, FDA and
Yvonne P. Dragan, Ph.D., Director, Systems Toxicology Division, NCTR, FDA
1:05 pm
Rodent Models of Cardiopulmonary Diseases in Air Pollution Health Effects Studies
Urmila P. Kodavanti, Ph.D., Pulmonary Toxicology Branch, Experimental Toxicology Division, National Health and Environmental Effects Research Laboratory, US Environmental Protection Agency, Research Triangle Park, NC
1:30 pm
Severe Pulmonary Pathology after Intravenous Administration of Adenoviral Vectors in Cirrhotic Rats
Jeffrey S. Smith, Ph.D., CBER, FDA.
1:55 pm
Rat Models of Cardiovascular and Renal Disease
Howard Jacob, Ph.D., Professor of Physiology and Human and Molecular Genetics, Medical College of Wisconsin
2:20 pm
Animal Models to Predict Human Cancer Chemoprevention
Ernest T. Hawk, M.D., M.P.H., Director, Office of Centers, Training and Resources, NCI, NIH


1:00 - 2:50 pm
Level 2 - Room 207B
Breakout Session 3: Dose Exposure Response Issues: Biologics vs. Small Molecules

Co-Chairs:
Don Stanski, M.D., Scientific Advisor to the Director, CDER, FDA and
Mercedes Serabian, M.S., DABT, Chief, Pharmacology/Toxicology Branch, CBER, FDA
1:05 pm
Dose Response Issues for Small Molecules
Joga Gobburu, Ph.D., Team Leader, Pharmacometrics, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA
1:30 pm
Dose Response Issues for Biologics
Iftekhar Mahmood, Ph.D., Office of New Drugs (ODEVI), CDER, FDA
1:55 pm
The Importance of Dose Response for Small Molecules
Raymond Miller, Ph.D., Senior Director, Pharmacometrics, Pfizer Global Research and Development, Pfizer Inc.
2:20 pm
The Importance of Dose Response for Biologics
James Green, Ph.D., Senior VP, Preclinical & Clinical Development Sciences, Biogen Idec, Inc.


1:00 - 2:50 pm
Level 2 - Room 202B
Breakout Session 4: Emerging Techologies For Cancer Diagnosis and Treatment

Co-Chairs:
Karen Weiss, M.D., ODE VI, Office of New Drugs, CDER, FDA and
Miriam Provost, Ph.D., Deputy Director, Division of General, Restorative, and Neurological Devices, CDRH, FDA
1:05 pm
Partnering Bioengineering and Genomic Testing
Pamela Klein, M.D., Ph.D., Group Director, Clinical Oncology, Genentech, Inc.
1:30 pm
Image Guided Interventions for Treatment of Solid Tumors
Jonathan B. Kruskal, M.D., Ph.D., Director, Abdominal Imaging, Beth Israel Deaconess Medical Center, Harvard Medical School
1:55 pm
Nanoparticles for Molecular Imaging and Targeted Drug Delivery in Oncology and Cardiovascular Disease
Gregory Lanza, M.D., Ph.D., Barnes-Jewish Hospital, Washington University, St. Louis
2:20 pm
The New Office of Oncology Products in CDER: Changes to Enhance Customer Needs
Steven Galson, M.D., Acting Director, CDER, FDA


1:00 - 2:50 pm
Level 2 - Room 202A
Breakout Session 5: The Public Health Significance of Pathogens: BSE/TSE

Co-Chairs:
George Graber, Ph.D., Supervisory Animal Scientist, CVM, FDA and
John M. Hicks, D.V.M., M.P.H., Risk Assessment Project Manager, CFSAN, FDA
1:05 pm
Understanding the Evolving Science of BSE/TSE
Will Hueston, D.V.M., Ph.D., Professor, College of Veterinary Medicine and School of Public Health, University of Minnesota
1:30 pm
Overview of Regulatory Aspects of BSE/TSE (regarding safety of medical products)
David Asher, M.D., CBER, FDA
1:55 pm
Animal Feed Controls for Prevention of BSE/TSE
Burt Pritchett, D.V.M., M.S., CVM, FDA
2:20 pm
Safety Aspects of Gelatin
Patrick Goossens, President, Gelatin Manufacturers of Europe, Belgium


1:00 - 2:50 pm
Level 2 - Room 201
Breakout Session 6: Challenges in Post-marketing Management of Risk and its Evaluation in the General Population

Co-Chairs:
Paul Seligman, M.D., M.P.H., Director, Office of Pharmacoepidemiology and Statistical Science, CDER, FDA and
Thomas Gross, M.D., M.P.H., Director, Division of Post-Marketing Surveillance, CDRH, FDA
1:05 pm
Industry Perspective on Risk Management
Peter Honig, M.D., Sr. Vice President, Merck
1:30 pm
FDA Risk Management: Drug Perspective
Florence Houn, M.D., Director, Office of Drug Evaluation III, CDER, FDA
2:20 pm
FDA Risk Management: Device Perspective
Neal Muni, Ph.D., Office of Device Evaluation, CDRH, FDA
1:55 pm
Research Drug & Device Therapeutics
Robert M. Califf, M.D., Professor of Cardiology, Duke Clinical Research Institute


2:50 pm - 3:20 pm
Level 2 - Hall D		Break

Level 2 Twelve Roundtable Discussions with FDA Leaders (concurrent)
3:20 pm - 5:00 pm
Level 2 - Room 204B
Interactive Session 1 - Antimicrobial Resistance: "Scientific Issues and Future Challenges"

Moderator:
Patrick McDermott, Ph.D., Div of Animal and Food Microbiology, Office of Research, CVM

Discussion Topics:
  • Does disease prevention from vaccination decrease resistance?
  • What is the potential for antimicrobial resistance gene transfer in commensal organisms?
  • What is the impact of antimicrobial resistance monitoring and surveillance on risk assessment?
Panel Members:
John Powers, M.D.,FACP, FIDSA, Lead Medical Officer for Antimicrobial Drug Development & Resistance Initiatives, ODE IV, CDER
Xing Tang, M.D., Visiting Scientist, CDRH
J. Gene LeClerc, Ph.D., Director, Division of Molecular Biology, Office of Applied Research and Safety Assessment (OARSA), CFSAN
Margaret C. Bash, M.D., M.P.H., Medical Officer, Laboratory of Bacterial Polysaccharides, Office of Vaccines Research and Review, CBER
Carl E. Cerniglia, Ph.D., Director, Division of Microbiology, NCTR
Atin Datta, Ph.D., Senior Microbiologist, Division of Field Science, ORA


3:20 pm - 5:00 pm
Level 2 - Room 201
Interactive Session 2 - Biostatistics and Biometrics: "FDA Biostatistics Programs: Current Challenges and Cutting Edge Issues"

Moderator:
Robert O'Neill, Ph.D., Director, Office of Biostatistics, CDER


Discussion Topics:
  • How should we design, analyze and interpret microarray data?
  • What are the potential methods for controlling and interpreting multiplicity?
  • What are the challenges in quantitative risk assessment with animal and human focus?
  • What are some of the new study designs and analytical methods being proposed for classifications and predictions for diagnostic test evaluations?
  • What are current challenges in statistical methodology for product evaluation?
Panel Members:
Anna Nevius, Supervisory Mathematical Statistician, Biometrics Team Scientific Support Staff, ONADE, CVM
Greg Campbell, Ph.D.; Greg Campbell, Ph.D.; Director, Division of Biostatistics, Office of Surveillance and Biometrics, CDRH
Curtis Barton, Ph.D., Biomedical Statistician, Division of Mathematics, Office of Scientific Analysis and Support (OSAS), CFSAN
Peter A. Lachenbruch, Director, Division of Biostatistics, OBE, CBER
Ralph L. Kodell, Director, Division of Biometry and Risk Assessment, NCTR


3:20 pm - 5:00 pm
Level 2 - Room 204A
Interactive Session 3 - Botanical Drugs and Dietary Supplements: "Scientific Issues and Regulatory Perspectives"

Moderator:
Susan Walker, M.D., Supervisory Medical Officer

CFSAN Guest Speakers:
Negash Belay, Ph.D., Consumer Safety Officer, Office of Food Additive Safety, CFSAN and
Linda Pellicore, Ph.D., Supervisory Toxicologist, Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN


Discussion Topics:
  • Does the existence of botanical drugs and dietary supplements pose a compromise to the safety and wholesomeness of the nation's food supply?
  • What are the challenges to predicting and monitoring target human and animal safety for consumption of such products?
  • What areas of scientific research would best aid FDA regulators in dealing with dietary supplements and botanical drugs?
Panel Members:
Shaw Chen, M.D., Medical Officer, Office of New Drugs, ODE V, CDER
William J. Burkholder, D.V.M., Ph.D., DACVN, Veterinary Medical Officer, Office of Surveillance and Compliance, Division of Animal Feeds, CVM
Dan Lyle, Ph.D., Office of Science and Engineering Laboratories, Division of Biology, CDRH
Julian E. A. Leakey, Ph.D., DABT, Office of Scientific Coordination, NCTR
George Salem, Division of Field Science, ORA


3:20 pm - 5:00 pm
Level 2 - Room 207A
Interactive Session 4 - cGMP Compliance and Inspection: "Current Approaches to Regulating Product Quality Through cGMP Oversight"

Moderator:
Dave Horowitz, Esq., Director, Office of Compliance, CDER


Discussion Topics:
  • How does risk management relate to each Center's inspection activities?
  • How do modern quality systems approaches relate to each Center's GMPs?
  • How do pre and post market review activities relate to GMP inspectional programs?
  • What are the efforts to harmonize GMPs with international regulatory approaches?
Panel Members:
Mai Huynh M.S., Team Leader, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM
Gladys Rodriguez, Director, Division of Enforcement B, CDRH
Joseph Baca, Director, Office of Compliance (OC), CFSAN
Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER
Rebecca A. Asente, M.S., R.D., Compliance Officer, New Orleans District Office, Southeast Region, ORA


3:20 pm - 5:00 pm
Level 2 - Room 209A
Interactive Session 5 - Clinical Trials: "Innovative Trial Designs and Evaluation for Medical Product Development"

Moderator:
Douglas C. Throckmorton, M.D., Acting Deputy Director, CDER


The session will highlight critical issues facing each Center, to include:
  • How can utilizing animal data enhance trial design and conduct?
  • What are current obstacles in pediatric trial design and conduct?
  • How will developments in drug safety impact trial design and conduct?
Panel Members:
Elizabeth Luddy, D.V.M., VMO, Office of New Animal Drug Evaluation, Division of Therapeutic Drugs for Non-Food Animals, CVM
Ron Yustein, M.D., Clinical Deputy Director, Office of Device Evaluation, CDRH David Acheson, M.D., Chief Medical Officer and Director Office of Food Safety, Defense and Outreach, CFSAN
Cynthia A. Rask, M.D., Director, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Cellular, Tissue and Gene Therapies, CBER
William Slikker, Jr., Ph.D., Deputy Director of Research, NCTR


3:20 pm - 5:00 pm
Level 2 - Room 209B
Interactive Session 6 - Dermatology: "Modern Approaches to Assess Safety, Irritancy, and Absorption of Topically Applied Substances"

Moderator:
Jonathan Wilkin, M.D., Director, Division of Dermatology and Dental Drug Products, CDER


Discussion Topics:
  • Can assessing systemic safety, photo safety, and local irritancy using animal studies predict human or target animal risk exposure?
  • What is the capability of predictive in vitro testing to replace animal testing and animal models?
Panel Members:
Guilin Qiao, D.V.M., Ph.D., Pharmacologist, Office of New Animal Drug Evaluation, Division of Therapeutic Drugs for Non-Food Animals, CVM
Stephen P. Rhodes, USPHS, Branch Chief, Plastic and Reconstructive Surgery Devices, Division of General, Restorative and Neurological Devices, Office of Device Evaluation, CDRH
Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors, CFSAN
Paul C. Howard, Ph.D., Division of Biochemical Toxicology, NCTR


3:20 pm - 5:00 pm
Level 2 - Room 207B
Interactive Session 7 - Genomics and Proteomics: "Translating the Science into Regulatory Decision-Making"

Moderator:
Thomas A. Cebula, Director, Office of Applied Research and Safety Assessment, CFSAN


Discussion Topics:
  • Is the science adequately established for regulatory applications?
  • What are the bottlenecks to facilitate efficient transition into regulatory decision-making?
  • What steps are needed to validate new techniques?
Panel Members:
Lawrence Lesko, Ph.D., Director, Office of Clinical Pharmacology and Biopharmaceutics, CDER
Michele C. McGuinness, Ph.D., Biologist, Division of Production Drugs: Swine and Poultry Drugs Team, Office of New Animal Drug Evaluation, CVM
Steven Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and Patient Safety, CDRH
Konstantin Chumakov, Ph.D., D.Sci., Chief, Laboratory of Methods Development, Division of Viral Products, Office of Vaccines Research and Review, CBER
James C. Fuscoe, Ph.D., Director, Center for Functional Genomics, NCTR
Lawrence D'Hoostelaere, Ph.D., ORA


3:20 pm - 5:00 pm
Level 2 - Room 204C
Interactive Session 8 - Immunology: "Host-Product Interactions and Immune Responses"

Moderator:
Amy Rosenberg, Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER


Discussion Topics:
  • What can we learn about unwanted immunogenicity from desired immunogenicity?
  • Which animal models can be used to predict unintended immunologic responses?
  • Do stem cells or their differentiated progeny either stimulate or suppress immune responses to antigens on their surfaces?
Panel Members:
Mike J. Myers, Research Pharmacologist, CVM
Carolyn Neuland, Ph.D., Chief, Gastroenterology and Renal Devices Branch, Division of Reproductive, Abdominal, and Radiological Devices, Office of Device Evaluation, CDRH
Dennis M. Hinton, Ph. D., Acting Director, Division of Toxicology, Office of Applied Research and Safety Assessment, Office of Science, CFSAN
Suzanne Epstein, Chief, Laboratory of Immunology and Developmental Biology, Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies, CBER


3:20 pm - 5:00 pm
Level 2 - Room 206
Interactive Session 9 - Issues in Manufacturing and Control for Drugs, Biologics, Devices, and Food: "Manufacturing Process Understanding, PAT, and Pre-Market Review"

Moderator:
Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER


Discussion Topics:
  • What are the next steps in progression towards the "Desired State" and anticipated requirements for proceeding to "manufacturing process understanding"?
  • How much will manufacturing process understanding impact current FDA quality assessment, including establishment of specification for product quality?
  • How can elements of manufacturing science and process control from various industries be shared to develop best practices?
Panel Members:
Dennis M. Bensley Jr., Ph.D., Team Leader, ONADE, CVM
Ann M. Ferriter, Reviewer, Division of General and Restorative Devices, CDRH
Don L. Zink, Ph.D., Lead Scientist, Office of Plant and Dairy Foods, CFSAN
Joan C. May, Ph.D., Director, Laboratory of Analytical Chemistry, Office of Vaccines Research and Review, CBER
Jim Dunnie, CSO, Division of Field Investigations, ORA


3:20 pm - 5:00 pm
Level 2 - Room 202A
Interactive Session 10 - Microbiology: Molecular Characterization of Micro Organisms to Improve Public Health - "Technology and Issues"

Moderator:
Arthur J. Miller, Ph.D., Lead Scientist for Microbiology and Associate Director, Joint Institute for Food Safety and Applied Nutrition, Office of Science, CFSAN


Discussion Topics:
  • What is the status of the current characterization technologies?
  • Which of upcoming near future characterization technologies will have the most impact?
  • What is the potential for these technologies to identify and diagnose pathogenic agents in biologics, foods and implanted devices?
  • How will new technologies promote product safety and bioterrorism preparedness?
Panel Members:
Shukal Bala, Ph.D., Lead Microbiologist, Division of Special Pathogen and Immunologic Drug Products, Office of Drug Evaluation IV, CDER
Robert D. Walker, M.S., Ph.D., Director, Division of Animal and Food Microbiology, Office of Research, CVM
Chiu S. Lin, Ph.D., Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, CDRH
Hira Nakhasi, Ph.D., Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER
Mark E. Hart, Ph.D., Division of Microbiology, NCTR
Karen Kreuzer, Science Branch Director, Denver District, ORA


3:20 pm - 5:00 pm
Level 2 - Room 209C
Interactive Session 11 - Post Marketing Epidemiological Safety Assessment: Current FDA Approaches and Upcoming Challenges

Moderator:
Robert Ball, M.D., M.P.H., Sc.M., Chief, Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, CBER


Discussion Topics:
  • How do various FDA Centers weigh different types of evidence from case reports to results from trials, investigations and epidemiologic studies in their ongoing evaluation of the benefits and risks of products?
Panel Members:
Paul Seligman, M.D., M.P.H., Director, Office of Pharmacoepidemiology and Statistical Science, CDER
Victoria Hampshire, V.M.D., Senior Regulatory Officer, Office of Surveillance and Compliance, CVM
Tom Gross, M.D., M.P.H., Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH
Deborah A. Street, Ph.D., Team Leader, Epidemiology Team, Office of Scientific Analysis and Support, CFSAN Luke D. Ratnasinghe, Ph.D., Director, Center for Structural Genomics, NCTR


3:20 pm - 5:00 pm
Level 2 - Room 202B
Interactive Session 12 - Toxicology: "The Role of Regulatory Toxicology in the 21st Century"

Moderator:
William T. Allaben, Ph.D. F.A.T.S., Associate Director for Scientific Coordination, Division of Research, NCTR, FDA National Toxicology Program Liaison, NCTR


Discussion Topics:
  • What are the current challenges to novel product safety assessment?
  • How can we utilize Toxicogenomics to conduct Risk Assessment?
  • How do we assess local and systemic affects of monomer and polymer exposure from implanted materials?
  • What are the hurdles to studying the toxicology of nano scale materials?
  • Why are other scientific disciplines detracting students from toxicology?
Panel Members:
David Jacobson-Kram, Ph.D., DABT, Associate Director for Pharmacology and Toxicology, Office of New Drugs, CDER
John D. McCurdy, Ph.D., DABT, Regulatory Chemist/Toxicologist, Division of Animal Feeds, Office of Surveillance and Compliance, CVM
Raju Kammula, D.V.M., Ph.D., DABT, Veterinary Medical Officer/Chief Toxicologist, Office of Device Evaluation, CDRH
Dave Hattan, Ph.D., Senior Toxicologist, Office of Food Additive Safety, CFSAN
Mercedes Serabian, M.S., DABT, Chief, Pharmacology/Toxicology Branch, CBER


5:00 pm - 6:30 am
Level 2 - Hall D		POSTER RECEPTION - Exhibits

 
Thursday, April 28, 2005
  
7:30 am - 5:00 pm
Level 2 - L Street Bridge		Registration
9:00 am - 10:00 am
Level 3 - Ballroom C		FDA Scientific Awards Ceremony
9:00 am - 10:00 am
Level 3 - Ballroom C		 Meet the Center Directors

The Science behind the Headlines: A Conversation with the FDA Center Directors
Moderated by Mark Barnett
  • Jesse Goodman, M.D., M.P.H., Center for Biologics Evaluation and Research
  • Daniel Schultz, M.D., Center for Devices and Radiological Health
  • Steven K. Galson, M.D., M.P.H., Center for Drug Evaluation and Research
  • Robert E. Brackett, Ph.D., Center for Food Safety and Applied Nutrition
  • Stephen F. Sundlof, D.V.M., Ph.D., Center for Veterinary Medicine
  • Daniel A. Casciano, Ph.D., National Center for Toxicological Research
  • Steve M. Niedelman, Assistant Commissioner for Regulatory Affairs, Office of Regulatory Affairs


10:00 am - 10:30 am
Level 2 - Hall D		Break

Level 2Breakout Sessions 7 - 13 (concurrent)
10:30 am - 12:30 pm
Level 2 - Room 206
Breakout Session 7:   Level 2 - Room 206
Integration of Pharmacogenetics and Pharmacogenomics into Drug Development and Clinical Practice

Co-chairs:
Janet Woodcock, M.D., Acting Deputy Commissioner for Operations and
Dan Casciano, Ph.D., Director, NCTR, FDA
10:40 am
Pharmacogenetics in Drug Discovery and Treatment
Jeffrey M. Drazen, M.D., Editor-in-Chief, NEJM, Professor of Medicine, Harvard Medical School
11:05 am
Pharmacogenomics and Molecular Epidemiology
Fred F. Kadlubar, Ph.D., Director, Division of Molecular Epidemiology, NCTR, FDA
11:30 am
Use of Pharmacogenomics and Pharmacogenetics in Clinical Drug Development
Allen D. Roses, M.D., Senior Vice President, Genetics Research, GlaxoSmithKline
11:55 am
Translation of Pharmacogenomics and Pharmacogenetics: A Regulatory Perspective
Lawrence Lesko, Ph.D., Director, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA


10:30 am - 12:30 pm
Level 2 - Room 207A
Breakout Session 8: Predictive Models for Bioavailability and Effectiveness

Co-Chairs:
Steven Galson, M.D., Acting Director, CDER, FDA and
Marlene E. Haffner, M.D., M.P.H., Rear Admiral/USPHS, Director, Office of Orphan Products Development, FDA
10:40 am
Predicting Oral Drug Absorption and Bioavailability: Fiction and Facts
Gordon L. Amidon, Ph.D., Charles Walgreen, Jr., Charles Walgreen, Jr., Professor of Pharmacy, University of Michigan
11:05 am
Predicting Drug Metabolism and Drug-Drug Interactions
Jerry Collins, Ph.D., Director, Division of Clinical Pharmacology Research, CDER, FDA
11:30 am
Biosimulation of Human Physiology & Pathophysiology - Cells to Clinical Response
Mikhail Gishizky, Ph.D., Chief Scientific Officer, Entelos
11:55 am
Molecular Modeling and Computer Simulation in the Characterization of Vaccines and Adjuvants
Richard Pastor, Ph.D., Supervisory Research Chemist, CBER, FDA


10:30 am - 12:30 pm
Level 2 - Room 207B
Breakout Session 9: Clinical Biomarkers in Biologics and Drug Development: Efficacy Assessment and Pharmacodynamics

Co-Chairs:
Robert Temple, M.D., Director, Office of Medical Policy, CDER, FDA and
Peter Lachenbruch, Ph.D., Director, Division of Biostatistics, CBER, FDA
10:40 am
Biomarkers for Inflammation, Atherosclerotic Vascular Disease and Plaques
Steven Nissen, M.D., Vice Chairman, Professor of Medicine, The Cleveland Clinic Foundation
11:05 am
Biomarkers as Endpoints in the Study and Treatment of Cancer
Thomas Fleming, Ph.D., Professor, Dept. of Biostatistics, University of Washington
11:30 am
Considerations in Evaluation of Surrogate Endpoints in Clinical Trials
Victor De Gruttola, Ph.D. Harvard School of Public Health
11:55 am
FDA History/Experience in Use of Biomarkers in Adjudicated Studies
Robert Temple, M.D., Director, Office of Medical Policy, CDER, FDA


10:30 am - 12:30 pm
Level 2 - Room 202B
Breakout Session 10: Product Manufacturing Science: Process and Quality Control

Co-Chairs:
Steve M. Niedelman, Assistant Commissioner for Regulatory Affairs, ORA, FDA and
Helen Winkle, Director, Office of Pharmaceutical Science, CDER, FDA
10:40 am
Pharmaceutical Manufacturing in the 21st Century
G. K. Raju, Ph.D., Executive Director, MIT/PHARMI MIT Program on the Pharmaceutical Industry, MIT
11:05 am
Challenges and Opportunities in Enhancement of the CMC Section: Quality - by - Design
Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER, FDA
11:30 am
The Case for Manufacturing Science
Gerry Migliaccio, Ph.D., Vice President, Global Quality Operations, Pfizer Inc.
11:55 am
Risk Based cGMP Inspection
John E. Simmons, Ph.D., Director, Division of New Drug Chemistry I, CDER, FDA


10:30 am - 12:30 pm
Level 2 - Room 202A
Breakout Session 11: Genetically Engineered Food

Co-Chairs:
Adele Turzillo, Ph.D., Biologist, CVM, FDA and
Kathleen Jones, Ph.D., Consumer Safety Officer, Office of Regulations and Policy, CFSAN, FDA
10:40 am
Oversight of Foods Derived from Genetically Engineered Plants and Animals
Eric Flamm, Ph.D., Office of the Commissioner, FDA
11:05 am
Transgenic Food Animals
Kurt Zuelke, Ph.D., USDA
11:30 am
Assessing the Allergenicity of Food from Genetically Modified Organisms
Richard Goodman, Ph.D., Professor, Food Science & Technology, University of Nebraska - Lincoln
11:55 am
Development and Impact of Golden Rice
Jorge Mayer, Ph.D., Campus Technologies, Freiburg, Germany


10:30 am - 12:30 pm
Level 2 - Room 201
Breakout Session 12: Emerging Infectious Diseases and Bioterrorism - Preparing for Timely Approval of Safe and Effective Antimicrobiologicals, Vaccines, and Antisera

Co-Chairs:
Bill Rodriguez, M.D., Science Director for Pediatrics, Office of Counterterrorism and Pediatric Development, CDER, FDA and
Carl Cerniglia, Ph.D., Divisional Director of Microbiology, NCTR, FDA
10:40 am
Development of Therapies for Anthrax Disease: an Example of a Critical Path
Mary Purucker, M.D., Ph.D., Chief, Division of Counterterrorism, Office of Counterterrorism and Pediatric Drug Development, CDER, FDA
11:05 am
Lethal Factor Inhibition as Adjunct Therapy for Established Anthrax Infection
Jeffrey D. Hermes, Ph.D., Director of Human and Animal Infectious Diseases Research, Merck Research Laboratories
11:30 am
Scientific Challenges in Evaluation of Vaccines and Antisera as Countermeasures to Anthrax: What do we Know and What do We Need to Know?
Drusilla Burns, Ph.D., Chief, Laboratory of Respiratory and Special Pathogens, Office of Vaccine Research and Review, CBER, FDA
11:55 am
Priorities in Planning for the Next Influenza Pandemic
Jon McCullers, M.D., Department of Infectious Diseases, St. Jude Children's Research Hospital


10:30 am - 12:30 pm
Level 2 - Room 204A&B
Breakout Session 13: Biological Product Safety - Case Studies and Potential Developments

Co-Chairs:
Keith Carson, Chairman, Williamsburg BioProcessing Foundation and
Carolyn Wilson, Ph.D., Office of Cellular, Tissue and Gene Therapies, CBER, FDA
10:30 am
Introduction
10:40 am
Preclinical Models for Safety Testing: National Toxicology Program Evaluation of the Safety of Retroviral Vectors
Carolyn Wilson, Ph.D., Laboratory of Immunology and Virology, Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, CBER, FDA
11:05 am
Safety Issues Pertaining to Biologic Follow-On Products
Mark F. Witcher, Ph.D., Pro Re Nata, Inc.
11:30 am
Characterization of the Derivatized Haemophilus Influenza Type B Polysaccharide Intermediate for PedvaxHIB, and Its Relationship to Product Safety
Qiuwei Xu, Ph.D., Merck Research Laboratory, West Point, PA
11:55 am
Panel Discussion with Speakers:
Discussion Leader, Keith Carson, Chairman, Williamsburg BioProcessing Foundation
  • Processes used to address biologics safety issues
  • Use of pharmacogenomics to identify individuals with productspecific risk factors
  • Avoiding problems in the future with better characterization methods and more predictive preclinical models


12:30 am - 2:00 pm
Level 2 - Hall D		Posters & Exhibits with Box Lunch


12:30 am - 2:00 pm
Level 2 - Room 209C		FDA Intercenter Neurotoxicity Working Group meeting

12:30 am - 2:00 pm
Level 2 - Room 204C		FDA Risk Assessment Working Group meeting

Level 2Breakout Sessions 14-19 (concurrent)
2:00 - 4:00 pm
Level 2 - Room 206
Session 14: Bioengineering of Cells and Tissues

Co-Chairs:
Deborah Hursh, Ph.D., Senior Staff Fellow, Office of Cellular, Tissue and Gene Therapies, CBER, FDA and
Lisa Troutman, M.S., D.V.M., Veterinary Medical Officer, Office of New Animal Drug Evaluation, CVM, FDA
2:10 pm
Crossroads in Cell Therapy, Gene Therapy, and Tissue Engineering
Daniel R. Salomon, M.D., Director, Scripps Center for Organ & Cell Transplantation
2:35 pm
Progress in Using (registry) Embryonic Stem Cell Lines to Develop Cell Therapies
Jane Lebkowski, Ph.D., Senior Vice President, Regenerative Medicine, Geron Company
3:00 pm
Tissue and Gene Therapies - Regulatory Challenges of Novel Treatments
Celia M. Witten, Ph.D., M.D. Director, Office of Cellular, Tissue & Gene Therapies, CBER, FDA
3:25 pm
Engineering Cells, Tissues, and Organs in Biotech Animals: Scientific and Regulatory Challenges
Larisa Rudenko, Ph.D., CVM, FDA


2:00 - 4:00 pm
Level 2 - Room 207A
Breakout Session 15: Nonclinical Toxicogenomic Studies and Challenges in Molecular Risk Assessment

Co-Chairs:
John Leighton, Ph.D., DABT, Senior Advisor for Biotechnology, Office of New Animal Drug Evaluation, CVM, FDA and
Syed F. Ali, Ph.D., Senior Biomedical Research Scientist, Head, Neurochemistry Laboratory, Division of Neurotoxicology, NCTR, FDA
2:10 pm
Challenges in Molecular Risk Assessment
David Jacobson-Kram, Ph.D., DABT, Associate Director for Pharmacology and Toxicology, CDER, FDA
2:35 pm
Integrating "Predictive" Technologies within a Highly Regulated Drug Development Environment
Frank Sistare, Ph.D., Senior Executive Director, Dept. of Laboratory Sciences & Investigative Toxicology, Merck Research Laboratories
3:00 pm
Transcriptional Profile of Rat Striatum by Serial Analysis of Gene Expression (SAGE): Effects of Methamphetamine Administration
Jean Lud Cadet, M.D., National Institute on Drug Abuse
3:25 pm
Predictive Toxicogenomics - Fact or Myth?
Cindy Afshari, Ph.D., Associate Director, Amgen Inc., Thousand Oaks, CA


2:00 - 4:00 pm
Level 2 - Room 207B
Session 16: Adaptive Study Designs to Meet Special Challenges in the Measurement of Efficacy and Safety

Co-Chairs:
Robert O'Neill, Ph.D., Director, Office of Biostatistics, CDER, FDA and
Mary A. Foulkes, Ph.D., Acting Director, Office of Biostatistics and Epidemiology, CBER, FDA
2:10 pm
Clinical Use of Adaptive Study Design in the Measurement of Safety and Efficacy
Jerold Schindler, Dr. PH, Assistant Vice President, Biostatistics and Clinical Information Systems, Wyeth Research
2:35 pm
Concepts and Methodology of Adaptive Study Design
Peter Bauer, Ph.D. ,O. Univ.-Prof. Dr., Head of the Department, Institut für Medizinische Statistik, Vienna
3:00 pm
Issues and Opportunity of Adaptive Study Design
Bruce Turnbull, Ph.D., Professor, School of Operations Research and Industrial Engineering, Cornell University
3:25 pm
Role of Adaptive Study Design in Clinical (Genomic) Studies
Sue Jane Wang, Ph.D., Delegate IPRG, Acting Statistics Team Leader and Expert Mathematical Statistician, Division of Biometrics II, Office of Biostatistics, CDER, FDA


2:00 - 4:00 pm
Level 2 - Room 202B
Breakout Session 17: Delivery for Drugs and Biologics: Biomaterials Science and Engineering

Co-Chairs:
Subhas Malghan, Ph.D., Deputy Director, Office of Science and Engineering Laboratories, CDRH, FDA and
John Marzilli, Deputy Associate Commissioner for Regulatory Affairs, FDA
2:10 pm
Novel Technologies for Delivering Insulin and Other Peptide Drugs
David C. Klonoff, M.D., F.A.C.P. , Medical Director, Mills-Peninsula Diabetes Research Institute
2:35 pm
Materials Science Aspects of Controlled Drug Delivery Systems
David Saylor, Ph.D., Division of Chemistry and Materials Sciences, CDRH, FDA
3:00 pm
Device Industry Perspective on Systems for Protein Delivery
Kevin Skinner, Genzyme, Medtronic MiniMed Inc.
3:25 pm
Regulatory and Science Issues Associated with Drug Eluting Stents
Doug Throckmorton, M.D., Acting Deputy Center Director, CDER, FDA


2:00 - 4:00 pm
Level 2 - Room 202A
Breakout Session 18: Emerging Analytical Technology for Detecting Toxins

Co-Chairs:
Dave Wagner, Ph.D., Animal Feeds Research Program Leader, CVM, FDA and
Steven Musser, Ph.D., Chief, Instrumentation and Biophysics Branch, CFSAN, FDA
2:10 pm
Rapid Toxin Detection Using the 'Lab on a Chip'
Greg E. Collins, Ph.D., Naval Research Laboratory
2:35 pm
Instrument-Based Methods for MultiToxin Detection
John H. Callahan, Ph.D., Research Chemist, CFSAN, FDA
3:00 pm
Novel Methods for the Speciation of Metals in Botanical Products
R. Kenneth Marcus, Ph.D., Department of Chemistry, Clemson University
3:25 pm
Molecularly Imprinted Sensors for Food Safety Applications
George Murray, Ph.D., Principal Professional Scientist, Applied Physics Laboratory, Johns Hopkins University


2:00 - 4:00 pm
Level 2 - Room 201
Breakout Session 19: FDA Leveraging Program

Co-Chairs:
Donald Zink, CFSAN, FDA and
Norris Alderson, Ph.D., Associate Commissioner for Science, FDA
2:10 pm
Opportunities for Enhancing FDA, Academic and Industrial Science Programs through Partnerships
Norris Alderson, Ph.D., Associate Commissioner for Science, FDA
2:25 pm
Co-development of Pharmacogenomic based Medical Products
Christopher J. Webster, BVM&S, M.S., Ph.D., MRCVS, Director, Regulatory Strategy and Intelligence, Millennium Pharmaceuticals, Inc.
3:00 pm
PQRI and FDA: How Good Science Results in Good Regulation
Helen Winkle, Director, OPS, CDER, FDA
3:25 pm
Researching Practical Effective Approaches to Improving Food Safety during Manufacturing
Martin Cole, Ph.D., Director, National Center for Food Safety Technology, Illinois Institute of Technology


4:00 pm Adjourn - 2005 FDA Science Forum Ends
 
  


2005 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA | HHS
Last updated on 2005-JUL-20 by frf