Upload File

fda advisory committee meeting

13
FDA Advisory Committee Meeting Transmissible Spongiform Encephalopathies October 14, 2004 Steve Figard, Ph.D. Senior Scientist Abbott Diagnostics And a Host of Others… Performance of the Enfer TSE Test with Front End Automation

Upload: gili

Post on 22-Feb-2016

43 views

Category:

Documents


0 download

Report

Tags:

DESCRIPTION

FDA Advisory Committee Meeting. Transmissible Spongiform Encephalopathies October 14, 2004. Performance of the Enfer TSE Test with Front End Automation. Steve Figard, Ph.D. Senior Scientist Abbott Diagnostics And a Host of Others…. Overview. Brief Overview of the Enfer TSE Assay - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: FDA Advisory Committee Meeting

FDA Advisory Committee MeetingTransmissible Spongiform EncephalopathiesOctober 14, 2004

Steve Figard, Ph.D.Senior Scientist

Abbott Diagnostics

And a Host of Others…

Performance of the Enfer TSE Test with

Front End Automation

Page 2: FDA Advisory Committee Meeting

Overview

Brief Overview of the Enfer TSE AssayAutomation of “Front End”Brief Data Review – External Evaluation

– Specificity– Sensitivity– Autolyzed Samples

Page 3: FDA Advisory Committee Meeting

Enfer Assay Overview

Sample Preparation

Cut tissue

Homogenize

Clarify in centrifuge plate

Immune Reactions

Primary anti-PrP rabbit polyclonal

Secondary goat anti-rabbit IgG-HRP

Sample Treatment

Transfer to test platePK digestion of PrPc

nonspecific adsorption of PrPSc

NaCl wash

GuHCl/NaOH incubation

Signal Generation

Add substrate

Read signal

Front End Automation

Page 4: FDA Advisory Committee Meeting

USDA-APPROVED ENFER TESTAutomation of “Front End”

Safer Sample Cutting

– new plastic tool

Faster Sample Homogenization

– new automated instrument

Easier Sample Handling

– new tube replaces bag

Streamlined Sample Processing

– minimized transfer

Same High Performance

Page 5: FDA Advisory Committee Meeting

SAFER SAMPLE CUTTING

Plastic PunchBladereplaced by

• No sharps• Standard cuts

• Easy disposal• Rapid

• Inexpensive

Page 6: FDA Advisory Committee Meeting

TubeBagreplaced by

EASIER SAMPLE HANDLING

Page 7: FDA Advisory Committee Meeting

Time To Process 8 Samples:

2 Stomachers – 240 seconds (4 minutes) 1 ETDS – 10 seconds

ETDS VIIIStomacherreplaced by

FASTER SAMPLE HOMOGENIZATION

Page 8: FDA Advisory Committee Meeting

STREAMLINED SAMPLE PROCESSINGSame Tube Moves Through Process

Final component ofnew automation

Page 9: FDA Advisory Committee Meeting

Streamlined Sample Processing withTecan Genesis RSP

Automated sample pipetting– ETDS tube to centrifuge plate– centrifuge plate to test plate

Automated addition of EB2 (PK) to test plateApproximately 5 min for one plate (44 samples)ETDS VIII racks fit directly into TecanOther “standard” features of automation

– disposable tips – no cross contamination

– liquid detection system for tips– bar code reader (POSID)

Page 10: FDA Advisory Committee Meeting

HIGH PERFORMANCESpecificity Testing - LGC

Page 11: FDA Advisory Committee Meeting

HIGH PERFORMANCESensitivity/Autolyzed Samples

200 positive samples from OTM population– collected and frozen at least a year and in good condition– confirmed by BioRad/Prionics WB

200 negative samples from fallen stock– in state of “severe autolysis” – worst case sample type– confirmed by BioRad/Prionics WB

Autolyzed samples can have high levels of protease inhibitors which can affect Proteinase K digestion and possibly result in a false positiveAll samples were supplied as homogenates, not tissueTesting done at Veterinary Laboratories Agency, Newcastle, UK

Page 12: FDA Advisory Committee Meeting

HIGH PERFORMANCESensitivity/Autolyzed Samples

Positive vs. Negative (Autolyzed) Sampleswith Enfer Front End Automation

(n = 200 for each population)

Bins - S/CO's

0.0 1.020

0.040

0.060

0.080

0.010

00.0

1200

.0

Freq

uenc

y

012345

20

40

60

80

100

120

140

160

180

Neg (Autolyzed) Positives Cu

toff

Negative (Autolyzed) Positive

Mean 0.026 327Median 0.013 287

SD 0.073 -Range -0.114 - 0.899 12.3 - 1217

SD from Mean to Cutoff 13.3 -

100 % Sensitivity100% Specificity

in this samplepopulation

Page 13: FDA Advisory Committee Meeting

Questions?

[email protected]


FDA Briefing Document for Nonprescription Drugs Advisory … · 2013-07-31 · 1 . FDA Briefing Document for . Nonprescription Drugs Advisory Committee . Triamcinolone Acetonide Nasal

SDA/CTFA Topical Antimicrobial Coalition Presentation to FDA Nonprescription Drugs Advisory Committee March 23, 2005

FDA Briefing Document Committee Meeting February 09, · PDF fileAAC Brief BLA 125544 CT-P13, a proposed biosimilar to Remicade. FDA. Briefing Document Arthritis Advisory Committee

Non-Persuasive Communication Baruch Fischhoff FDA Risk Communication Advisory Committee August 14, 2008

FDA Advisory Committee Briefing Document A Joint …/media/Supporting... ·  · 2013-05-01A Joint Meeting of the Medical Imaging Drugs Advisory Committee ... FDA Reviewer Summaries

FDA Anthrax Advisory Committee

FDA Briefing Document, Psychopharmacologic Drugs Advisory Committee … FDA Briefing Document Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting February 3, 2016 Topic: Cognitive

FDA Briefing Document Arthritis Advisory Committee … · BLA 761042 AAC Brief GP2015, a proposed biosimilar to Enbrel 1 . FDA Briefing Document . Arthritis Advisory Committee Meeting

SEARLE CIVIL JUSTICE INSTITUTE FDA ADVISORY …masonlec.org/site/rte_uploads/files/SCJI/SCJI Report, FDA Advisory...searle civil justice institute fda advisory committees: conflicts

FDA Blood Products Advisory Committee 95 th Meeting 21 July 2009 Update: 21 st Meeting FDA Transmissible Spongiform Encephalopathies Advisory Committee

EXPAREL - fda.gov · EXPAREL Briefing Document: 14-15 February 2018 FDA Advisory Committee Meeting. FDA ADVISORY COMMITTEE MEETING BRIEFING DOCUMENT . EXPAREL® (bupivacaine liposome

FDA Arthritis Committee (AAC) FDA Introductory Remarks€¦ · FDA Arthritis Advisory Committee (AAC) FDA Introductory Remarks BLA 761057: Sirukumab for the treatment of adult patients

FDA Briefing Document Gastrointestinal Drug Advisory ... · FDA Briefing Document . Gastrointestinal Drug Advisory Committee Meeting . October 18, 2018 . The committee will discuss

External Peer Review of the FDA Office of Regulatory Affairs Pesticide Program FDA Science Board Advisory Committee Meeting Nov. 4, 2005

Robert Duncan, Ph.D. DETTD, CBER, FDA Blood Products Advisory Committee August 2, 2011

FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE (PADAC) MEETING/media/Supporting... · 2015-12-07 · PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE (PADAC) MEETING. December 9, 2015 . FDA

Scientist Professional Advisory Committee 1200 1300 … · Scientist Professional Advisory Committee ... Jessica Mentoring Subcommittee Chair Yes ... LCDR Steele, Matthew FDA Yes

FDA Advisory - fda.gov.ph

ARAVA - Aventis 7-Aug-15 MM-1 FDA ArthritisAdvisory Committee March 5, 2003 FDA Arthritis Advisory Committee March 5, 2003 ARAVA ® (Leflunomide) Aventis

Blood Products Advisory Committee · The attached package contains background information prepared by the Food and Drug Administration (FDA) for the members of the Advisory Committee

FDA Advisory Committee for Pharmaceutical Science—March 13, 2003

FDA Briefing Document · FDA Briefing Document Peripheral and Central Nervous System Drugs. Advisory Committee Meeting January 22, 2016 NDA 206488 Eteplirsen

1 Romiplostim FDA Overview Oncologic Drugs Advisory Committee Meeting Oncologic Drugs Advisory Committee Meeting Faranak Jamali, MD March 12, 2008

FDA Briefing Document JOINT MEETING OF THE ... · fda briefing document . joint meeting of the gastrointestinal drugs advisory committee and drug safety and risk management advisory

FDA Briefing Document Oncologic Drugs Advisory Committee

FDA Blood Products Advisory Committee Meeting 03 August 2011 Gaithersburg MD Summary of Transmissible Spongiform Advisory Committee Meeting 01 August 2011

Vol No March , 2020 · 2020-03-20 · BIOSIMILARS 15 Biosimilar Competition: Still More Focus On FDA Than FTC ADVISORY COMMITTEES 18 Recent And Upcoming FDA Advisory Committee Meetings

FDA Pediatric Advisory Committee June 30, 2005 Marsha D. Rappley, MD

ALO-02Extended-Release Capsules FDA Advisory · PDF fileFDA Advisory Committee Meeting Briefing Document ... FDA Advisory Committee Meeting Briefing Document ... eDiary Electronic

18 th Meeting of FDA TSE Advisory Committee: 31 October 2005 Summary FDA Blood Products Advisory Committee 85 th Meeting 03 November 2005 Holiday Inn Gaithersburg

FDA Briefing Document - Strategic Transactions/media/Supporting... · FDA Briefing Document . Oncologic Drugs Advisory Committee Meeting . September 12, 2013 . sBLA 125409/51 . Pertuzumab

MM-1 FDA Advisory Committee April 26, 2001 KETEK ™ (telithromycin)

FDA Recalls Risk Communication Advisory Committee David K. Elder Director, Office of Enforcement

FDA Briefing Document: Vaccines and Related Biological Products ... · FDA Briefing Document . Vaccines and Related Biological Products Advisory Committee Meeting . September 19,