NCI/FDA Workshop: Research Strategies, Study
Designs and Statistical Approaches to Biomarkers Validation for Cancer
Diagnosis and Detection on July 28-29, 2004
The National Cancer Institute in cooperation with the Food and Drug
Administration (FDA), invite you to participate in the workshop to be
held in Gaithersburg, MD on July 28-29, 2004. The workshop is designed
to review the basic considerations underpinning the study design, statistical
methodologies and validation approaches to rapidly advancing field of
cancer biomarker and consider approaches to their validation for clinical
utility, including randomized controlled-trial (RCT)- based and non-RCT
based validation designs.
Invited speakers and discussion panelists will address the various
aspects of biomarker validation: high throughput, high-dimensional
data analysis deriving from genomic and proteomic technologies and
statistical considerations on study designs for data collection including
preprocessing of data.
The workshop participants will also discuss the FDA guidelines for
technology and biomarker evaluation, analytical performance characteristics,
biomarker validation regulatory requirements for commercialization,
unconventional approaches to data validation and analysis, approaches
to piggybacking validation study to ongoing prevention and treatment
trials, case-control study designs based on completed trials, and
suitability of samples for proteomics and genomic assays for validation
study;
A major goal of this workshop is to stimulate discussions related
to statistical considerations of cancer biomarker validation for cancer
detection and diagnosis and to develop a position paper on state-of-the-art
in biomarker validation study.
IVD Roundtable 510(k) Workshop on April 20-21, 2004 The Office of In Vitro Diagnostic Devices at The Center for
Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA), and the Association of Medical Diagnostics Manufacturers (AMDM)
will co-sponsor the IVD Roundtable 510(k) Workshop on April 20-21, 2004
at the Double Tree Hotel, 1750 Rockville Pike, Rockville, MD. The objective
of the IVD Roundtable 510(k) Workshop is to foster communication between
the professional, manufacturing and regulatory community. This interactive
workshop provides an opportunity to hear about 510(k) submissions from
the FDA people who actually review the submissions. Helpful tips and
guidance from experienced industry regulatory affairs personnel will
also be provided.
|Agenda|
Dr. Steve Gutman in his presentation at the October 24th, 2003, FDA/Industry
IVD Roundtable meeting held in Rockville, MD, focused on risk analysis
and risk management plans for IVD products and on recalls.
[Text] [Powerpoint]
Don St. Pierre, Deputy Director, of OIVD provided an overview of the
OIVD and an update on experience and progress since its formation during
the Regulatory Affairs Professionals Society (RAPS) 2003 Annual Conference
held on October 19-22, 2003 at the Baltimore Waterfront Marriott Hotel
in Baltimore, MD. Hot topics such as current initiatives including Total
Product Life Cycle (TPLC), IVD Compliance, and new approaches to pre-market
review were discussed.
[Text] [Powerpoint]
[Text] [Powerpoint]
Dr. Sally Hojvat, the Director of Microbiology Division, OIVD, presented
an Overview of the newly formed OIVD in the 2003 Educational Conference
IVD Focus XII, sponsored by the Association of Medical Diagnostics Manufacturers
in San Diego on September 18-19, 2003.
Dr. Tim O’Leary, Director, and Dr. Maria Chan, Senior Reviewer,
of the Immunology and Hematology Division, in OIVD presented in a CDC-sponsored
conference surrounding Quality Control material for Genetic Testing
in Atlanta, Georgia on September 15-16, 2003. The conference has three
main goals:
· To review the current and future needs for QC materials for
genetic tests;
· To describe the efforts to produce materials suitable for positive
QC for genetic tests
· To develop a sustainable, practical means to provide QC materials
to genetic testing laboratories at a reasonable cost.
Dr. Steve Gutman, Director of OIVDwpresented in the Device Assessment
Think Tank meeting sponsored by the Clinical Education & Events,
Duke Clinical Research Institute, on September 14-16, 2003, held in
Rockville, MD.
Dr. Steve Gutman, Director of OIVD represented the FDA in a CDC-sponsored
meeting addressing the Laboratory component of the preparedness plan.
He will be providing guidance regarding issues surrounding testing done
with “home-brew” assays. The meeting is scheduled for September
18th, 2003, in Atlanta Georgia.
Dr. Steve Gutman, Director of OIVD represented the FDA in the CLIAC
meeting held on September 17-18, 2003 in Atlanta Georgia.
13th Annual Medical Device Submission Workshop Don St. Pierre, the OIVD Deputy Director, presented the audience
with updates in OIVD at the 13th Annual Device Submission Workshop sponsored
by the Advanced Medical Technology Association (AdvaMed) held in Washington
D.C. on June 4-5, 2003
[Text] [Powerpoint]
Clinical Ligan Assay Society Meeting
Steve Gutman, M.D., Director of the OIVD, Discussed the “FDA’s Role
in the Regulation of In Vitro Diagnostics” and the “The Creation of
the OIVD” during a meeting sponsored by the Clinical Ligan Assay Society
on May 10, 2003 in Hunt Valley, MD
[Text] [Powerpoint]
[Text] [Powerpoint]
Annual Meeting of the Pan America Society for Clinical Virology
on April 27-30, 2003
Kathy Wright, Senior Reviewer, Discussed “How Decision Making
Drives Viral Testing” during the Clinical Virology Symposium in
conjunction with the annual meeting of the Pan America Society for Clinical
Virology held in April 27-30, 2003, in Clearwater, FL
[Text] [Powerpoint]
[Abstract]
Association of Medical Dianostics Manufacturers (AMDM) Annual
Meeting on April 24-25, 2003 Dr. Elizabeth Mansfield Discussed the content of the newly
released Guidance Document entitled "Multiple Tests for Heritable
DNA Markers, Mutations and Expression Patterns" at the Banbury
Conference at the Banbury Center, Cold Spring Harbor, NY held on April
13-15, 2003 as well as at the Association of Medical Diagnostics Manufacturers
(AMDM) Annual Meeting on April 24-25, 2003
[Text] [Powerpoint]
IVD Roundtable 510(k) Workshop
on April 22-23, 2003 The Center for Devices and Radiological Health (CDRH) of the
Food and Drug Administration (FDA), and the Association of Medical Diagnostics
Manufacturers (AMDM) co-sponsored the IVD Roundtable 510(k) Workshop
on April 22-23, 2003 at FDA’s Parklawn Building, in Rockville,
MD. The objective of the IVD Roundtable 510(k) Workshop was to foster
communication between the professional, manufacturing and regulatory
community. This interactive workshop provided an opportunity to hear
about 510(k) submissions from the FDA people who actually review the
submissions. Helpful tips and guidance from experienced industry regulatory
affairs personnel was also provided.
Abbreviated 510(k)s by Vernonica Calvin [Text] [Powerpoint]
Consensus Standards by Ginette Y. Michaud [Text] [Powerpoint]
How to Work with FDA: Industry Perspective by Mark A. Del Vecchio;
Director, Regulatory and Clinical Affairs, Digene Corporation [Text]
[Powerpoint]
CBER 510(k) Issues by Sheryl A. Kochman
[Text] [Powerpoint]
Premarket Notification (510(k)) by Marjorie Shulman
[Text] [Powerpoint]
The Pre-IDE Process by Sousan S. Altaie
[Text] [Powerpoint]
Replacement Reagent Policy Update (Data for Commercialization of
Original Equipment Manufacturer, Secondary and Generic Reagents for
Automated Analyzers issued 6/10/96) by Jim Callaghan
[Text] [Powerpoint]
Bioresearch Monitoring & In Vitro Diagnostic Devices by Jean
Toth-Allen
[Text] [Powerpoint]
Update 2003: FDA & CLIA by Clara Sliva
[Text] [Powerpoint]
Parting Shots: IVD Roundtable 510(k) Workshop by Steven I. Gutman,
MD
[Text] [Powerpoint]
