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Contemporary
Concepts In Toxicology
Society of Toxicology
 
Workshop
on Non-clinical Safety Evaluation of Preventive Vaccines: Recent
Advances and Regulatory Considerations
 Proceedings
for day 1 and day 2 are now available. Please click the links provided below;
word doc and PDF versions are supplied for your convenience. For speaker
presentations please click on the presenter's name.
Workshop
Agenda
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Day
1
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Non-Clinical
Safety Assessment
of Preventive Vaccines
(word
doc version) (PDF
version) |
Day
2
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Reproductive
Toxicity Assessment of Preventive Vaccines
(word
doc version) (PDF
version)
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8:30
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Welcome,
K. Midthun, FDA |
8:30
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Introductory
remarks, M. Miller, Office of Women°s
Health, FDA |
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8:45
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FDA
perspective, E. Sutkowski, FDA |
8:45
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Reproductive
toxicity assessment of preventive vaccines, M.
Gruber, FDA |
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9:15
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Industry
perspective, F. Verdier, Aventis Pasteur
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9:30
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Human
T and B cell development,
R.
Insel, University of Rochester School of Medicine
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9:45
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Coffee
break
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10:00
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Coffee
break |
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10:00
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Roundtable
discussion: Scientific and technical challenges in preclinical
safety testing of vaccines
Moderator for
Topics 1 and 2:
S. Hargus, FDA
Topic
1: The relevance of animal studies for non-clinical safety
evaluation of vaccines,
Chairperson:
B. Ledwith, Merck
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10:15
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Maternal
immune system stimulation and effects on fetal teratogenesis,
S.
Holladay, College of Veterinary Medicine at Virginia Polytechnic
Institute
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11:00
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Topic
2: Applicability of traditional drug toxicity study designs
for safety evaluation of vaccines,
Chairperson:
G. Warner, Wyeth Pharm.
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10:45
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Developmental
immunotoxicology,
R. Smialowicz, Immunotoxicology Branch,
US EPA
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12:00PM
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Registrant
Luncheon
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11:15
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Roundtable
discussion:
Moderators for
Topics 1 through 4:
M. Gruber
and M. Serabian, FDA
Topic
1: Study design,
Chairperson:
M. Christian, Argus Research Laboratories
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1:00
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Roundtable
discussion (cont.)
Moderator for
Topics 3 and 4:
R. House, Dynport Vaccine CO.
Topic
3: Animal models appropriate for assessing immunotoxicology
and immunopathology,
Chairperson:
M. Luster, CDC, NIOSH
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12:15PM
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Registrant
Luncheon
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2:00
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Topic
4: Safety evaluation of adjuvants: should they be considered
separately or only in the context of the final vaccine?
Chairperson:
N. Garcon, GSK
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1:15
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Topic
2: Immunological endpoints,
Chairperson: F. Verdier, Aventis Pasteur
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3:00
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Coffee
break
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2:15
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Topic
3: Developmental endpoints,
Chairperson:
J-W. van der Laan, RIVM
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3:30
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Autoimmunity-Hypersensitivity
and vaccine safety assessment: 1- Status of non-clinical methods
for autoimmunity, P.- H. Lambert, WHO Center for Vaccinology,
University of Geneva(30 min); 2- Status of non-clinical methods
for hypersensitivity, F. Verdier, Aventis-Pasteur (10 min);
3- Discussion/Q & A session (35 min)
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3:00
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Coffee
break
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4:45
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Adjourn
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3:30
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Topic
4: Animal models,
Chairperson:
P. Barrow, MDS Pharma Services Preclinical
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Questions
Day 1 |
4:30
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Questions
Day 2 |
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4:45
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Adjourn |
Organizing
Committee Members
Marion Gruber,
Ph.D., Office of Vaccines Research and Review, Center for Biologics
Evaluation and Research, US Food and Drug Administration, Rockville,
MD
Elizabeth
Sutkowski, Ph.D., Office of Vaccines Research and Review, Center
for Biologics Evaluation and Research, US Food and Drug Administration,
Rockville, MD
Mercedes
Serabian, M.S., D.A.B.T., Office of Therapeutics Research and
Review, Center for Biologics Evaluation and Research, US Food and
Drug Administration, Rockville, MD
Sally Hargus,
Ph.D., Office of Vaccines Research and Review, Center for Biologics
Evaluation and Research, US Food and Drug Administration, Rockville,
MD
Christine
Everett, M.P.H., Office of Women's Health, US Food and Drug
Administration, Rockville, MD
Francois
Verdier, Ph.D., Pharm.D., Product Safety Assessment, Aventis
Pasteur SA, Marcy l'Etoile, France
Robert V.
House, Ph.D., DynPort Vaccine Company LLC, Frederick, MD
Kenneth L.
Hastings, Dr.P.H., D.A.B.T., Office of Drug Evaluation IV, Center
for Drug Evaluation and Research, US Food and Drug Administration,
Rockville, MD
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