William Egan, PharmaNet

John Petricciani, IABS

Carmen Jungbäck, PEI

Isabelle Pierard, GSK

Ivana Knezevic, WHO

Jim Robertson, NIBSC 

John Lewis, Crucell

Rebecca Sheets, NIAID / NIH

Keith Peden, FDA

Kathy Zoon, NIAID / NIH

Ian Gust,University of Melbourne

Tony Lubiniecki, Johnson & Johnson

Ryoko Krause, IFPMA

David Onions, BioReliance

07:30

Registration 

08:00

Continental breakfast

08:45

Welcome

Johannes Löwer, IABS

09:00

Introduction and overview

John Petricciani, IABS : Slides

Amy Rosenberg, FDA : Slides

09:30

Overview of routine tests for adventitious agents.

Rebecca Sheets, NIAID : Slides    Abstract

10:00

Assessment of the potential of the 9CFR method currently used in the production of biologicals to detect bovine/porcine viruses with human host range.

Carol Marcus-Sekura, BASI Biotechnology Assessment Service : Slides    Abstract

 10:30

Coffee Break

11:00

Panel Discussion

Chair: Kathryn Zoon, NIAID

12:00

Lunch

Recent Technological Advances

13:00

Identification of viral contaminants using the Ibis PLEX-ID biosensor.

Rangarajan Sampath, Ibis Biosciences: Abstract

13:20

Microbial detection array for product safety and public health.

Crystal J. Jaing, Lawrence Livermore National Laboratory : Slides   Abstract

13:40

New microfluidic tools for the simultaneous detection of pathogens using quantitative PCR.

Astrid Ferlinz, Life Technologies : Slides    Abstract

14:00

Massively Parallel Sequencing (MP-Seq), a New Tool For Adventitious Agent Detection and Virus Discovery.

David Onions, BioReliance : Slides    Abstract   

14:20

Detection and characterization of novel infectious agents.

Randall Kincaid, DTRA : Abstract 

14:40

New electron microscopy (EM) technology provides unprecedented resolution in 3D.

Elizabeth Fischer, NIAID : Abstract

15:00

Coffee Break

15:30

Panel Discussion

Chair: Kathryn Zoon, NIAID

17:00

End of Day 1

07:00

Continental breakfast

08:00

How a new technology raised regulatory issues and how they were resolved: the PERT assay.

Keith Peden, FDA : Slides    Abstract

08:20

Detection of viral contamination and minority variants using metagenomics.

Eric Delwart, UCSF : Slides    Abstract

08:40

PCV-1 detection in Rotavirus vaccine: a case study in the risk assessment for adventitious agent testing.

Corine Lecomte, GSK : Slides    Abstract

09:00

CBER evaluation of porcine circovirus in rotavirus vaccines.

Philip Krause, FDA: Abstract

09:20

Sensivity of an alternative format and readout for an in vitro PCV infectivity assay.

Paul Duncan, Merck Research Laboratories : Slides    Abstract

09:40

XMRV: discovery, progress, and controversies. 

Arifa S. Khan, FDA : Slides

10:00

Break  

10:30

Infectious endogenous retroviruses in pet vaccines.

Massimo Palmarini, MRC-University of Glasgow : Slides    Abstract

10:50

Panel Discussion

Chair: Philip Minor, NIBSC

11:30

Lunch

12:30

Lay inferences about adventitious agents

Baruch Fischhoff, Carnegie Mellon University : Slides    Abstract 

13:10

Human vaccines and TSE agents: a case study in risk evaluation and risk management.

William Egan, PharmaNet : Slides    Abstract

13:30

Assessing risk when an adventitious agent is found.

Christoph Conrad, WHO : Slides

13:50

Case studies

Stress test of proposed WHO guidelines for Adventitious AGents Investigations.

Tara Tagmyer, Merck & Co. : Slides

Laurent Mallet, Sanofi Pasteur

Philip Krause, CBER

15:00

Coffee Break

15:30

Panel discussion

Chairperson: Karen Midthun, FDA

16:30

Conclusions and recommendations

William Egan, PharmaNet

16:45

End of the meeting