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8th EDRN Steering Committee Meeting


Monday, June 23, 2003
Workshop on Moving Biomarkers from Validation to the Commericialization Pathway
Workshop Agenda (Draft)
12:00 - 1:45 pmMoving Biomarkers from Validation to a Commercialization Pathway: Regulatory Requirements and Programmatic Objectives

Mukesh Verma, PhD
NCI EDRN Program Director
Wendy Patterson, Esq
NCI Technology Transfer Branch
12:00 - 12:10 pmOverview:
Wendy Patterson, Esq
NCI Technology Transfer Branch
12:10 - 12:30 pmSummary of FDA Requirements:
Steven J Gutman, PhD, MBA
Director, FDA/CDRH Office of In Vitro Diagnostic Device Evaluation and Safety
12:30 - 1:00 pmMSA Validation Study:
Mark Schoenberg, MD
Johns Hopkins Medical Institution
Sigrid M Volko, PhD
Assistant Director, Johns Hopkins University Office of Licensing and Technology Development
Robert Kalik, Esq
Cangen International Corp
1:00 - 1:30 pmSELDI/Prostate Validation Study:
O John Semmes, PhD
Eastern Virginia Medical School
[Senior Patent Counsel TBD], Esq
Ciphergen Biosystems, Inc
William Grizzle, PhD, MD
University of Alabama at Birmingham
Ian Thompson, MD
University of Texas Health Science Center at San Antonio
1:30 - 1:45 pmDiscussion
1:45 - 2:00 pmBreak
2:00 - 3:45 pmIntellectual Property Strategies for Commercialization of EDRN Validated Biomarkers: Government, Academic, and Industry
Jacob Kagan, PhD
NCI EDRN Program Director
Wendy Patterson, Esq
NCI Technology Transfer Branch
2:00 - 2:30 pmGovernment Perspective:
Wendy Patterson, Esq
Senior Advisor, NCI Technology Transfer Branch
J Terry Lynch, MBA
Licensing Officer, NIST Technology Partnerships Division
2:30 - 3:00 pmAcademic Perspective:
Elaine Brock, Esq
Director, University of Michigan Medical School Office of Technology Transfer & Corporate Research
Sigrid M Volko, PhD
Assistant Director, Johns Hopkins University Office of Licensing and Technology Development
Dean E Brenner, MD
University of Michigan Medical Center
O John Semmes, PhD
Eastern Virginia Medical School
3:00 - 3:30 pmIndustry Perspective:
Bayer Corporation:
[Senior Patent Counsel TDB], Esq
Peter J Maimonis, PhD
Associate Director, Oncology Research
Abbott Laboratories/Vysis:
William E Murray, Esq
Senior Counsel, Patents & Trademarks
Steven Seelig, MD, PhD
Divisional Vice President, Research & Development
Cangen International Corporation:
Robert Kalik, Esq
Chief Operating Officer
4:00 - 6:00 pmSubcommittee Meetings (By Invitation Only)
4:00 - 6:00 pmDiscussion on Biorepository with Dr Ann Barker, Deputy Director, NCI (Closed Meeting, EC and all Chairs to Attend)
6:00 - 7:00 pmDinner
7:00 - 8:00 pmSubcommittee and Liaison Reports
SPORE: Adi Gazdar
PCPT: Ian Thompson
AACR: William Bigbee
ASCO: Austin Doyle
CGN: Steven Skates
MMHCC: Jeffrey Marks

Tuesday, June 24, 2003
7:00 - 8:00 amRegistration and Continental Breakfast
8:00 - 8:30 amIntroduction
William Bigbee and University of Pittsburgh Officials
8:30 - 8:40 amWelcome & Approval of January 2003 SC minutes
David Sidransky
8:40 - 8:50 amWelcome
Peter Greenwald
8:50 - 9:10 amNCI Update
Sudhir Srivastava
9:10 - 9:30 amNCI Strategic Initiative
Anna Barker Deputy Director of the National Cancer Institute
9:30 - 9:40 amA Critique of the EDRN: Successes and Failures
Bernard Levin Chair
EDRN Network Consulting Committee
9:40 - 10:15 amGuest Lecture Cancer: What have we learned and how can we apply it?
Lee Hartwell
President and Director
Fred Hutchinson Cancer Research Center
10:15 - 10:30 amBreak
10:30 am - NoonEDRN High Risk Cohorts: Resource for Validation Studies
Wendy Wang
Jacob Kagan
Patrice Watson
Xifeng Wu (Margaret Spitz's laboratory)
William Rom
Ian Thompson
Sandra Hoffman (Kathy Helzlsouer's lab)
Daniel Cramer/ Ian Jacobs
12:00 - 1:00 pmLunch
EC Meeting (Working Lunch) by Invitation Only
1:00 - 1:30 pmAntibody Arrays
Jeffrey Marks
Jacob Kagan
Speaker: Brian Haab
Van Andel Research Institute
1:30 - 1:45 pmUpdate: EDRN Antibody Array Project
Jacob Kagan
1:45 - 2:15 pmMALDI - TOF and Biomarker Discovery
Yingming Zhao
2:15 - 5:00 pmCollaborative Group Meeting (by Invitation Only)
5:00 7:00 pmDinner (On Your Own)
7:00 - 7:15 pmCollaborative Group Reports
7:15 - 9:00 pmCollaborative Showcase: Prostate and Urologic Cancers Group

Wednesday, June 25, 2003
7:00 - 8:00 amContinental Breakfast
8:00 - 8:30 amGuest Speaker
The proteome of DNA replication in cancer
Linda H Malkas
8:30 - 9:00 amMALDI/SELDI - TOF - MS proteomic profiling for cancer early detection and molecular diagnosis - summary of latest studies
William L Bigbee
9:00 - 10:30 amHighlights of the Associate Membership Program
Moderators: Mukesh Verma, Wendy Wang
Speakers: Ying - Hsiu Su/Timothy Block, Thomas Jefferson University

Detection of tumor - related genetic and epigenetic modifications in urine
Edward Patz/Jeffrey Marks, Duke University

Expression Profiling with a MALDI - TOF Platform Identifies Serum Markers for Lung Cancer Eleftherios Diamandis/Sudhir Srivastava,
University of Toronto
Carolyn Muller, University of Texas, Dallas
David Bowtell/ Stephen Meltzer

Strategies for the development of biomarkers of gastric cancer
Mai Brooks/ David Chia

Angiogenesis and breast cancer detection and prevention
Panel Discussion: EDRN Associate Membership Program (AM) and its Accomplishments
Panelists: EDRN Sponsoring PIs
9:00 - 10:30 amHighlights of the Associate Membership Program (Continued)
Suggested topics for discussion:
  1. Sponsor's interactions with AM, collaboration and benefits to EDRN
  2. Specific examples in terms of resource sharing and or technology transfer
  3. Suggestions to integrate AM in additional EDRN activities
  4. How does AM benefit EDRN goals and vise versa
10:30 - 10:45 amBreak
10:45 - 11:00 amAdministrative Issues
11:00 amNoon Update: EDRN Bioinformatics Infrastructure and Tools
Moderators: Sudhir Srivastava, Donald Johnsey
Speakers: Daniel Crichton
Mark Thornquist
Heather Kincaid
12:00 - 1:00 pmLunch
1:00 - 3:00 pmEDRN Computational Tools for Biomarker Discovery and Validation
Moderator: Sudhir Srivastava
Speakers: Steven Skates, Brigham and Women's Hospital
Ziding Feng, Fred Hutchinson Cancer Center
Zhen Zhang/Dan Chan, Johns Hopkins (Alan Partin's Group)
UCLA (David Chia's Group)
Florin Selaru/Stephen Meltzer, University of Maryland
3:00 - 3:15 pmNew Business
3:15 pmAdjourn

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