|
|
|
8th EDRN Steering Committee Meeting
|
Agenda
Monday, June 23, 2003
Workshop on Moving Biomarkers from Validation to the Commericialization Pathway
Workshop Agenda (Draft)
| 12:00 - 1:45 pm | Moving Biomarkers from Validation to a Commercialization
Pathway: Regulatory Requirements and Programmatic Objectives
Moderators:
Mukesh Verma, PhD
NCI EDRN Program Director
Wendy Patterson, Esq
NCI Technology Transfer Branch |
| 12:00 - 12:10 pm | Overview:
Wendy Patterson, Esq
NCI Technology Transfer Branch |
| 12:10 - 12:30 pm | Summary of FDA Requirements:
Steven J Gutman, PhD, MBA
Director, FDA/CDRH Office of
In Vitro Diagnostic Device Evaluation and Safety |
| 12:30 - 1:00 pm | MSA 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 pm | SELDI/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 pm | Discussion |
| 1:45 - 2:00 pm | Break |
| 2:00 - 3:45 pm | Intellectual Property Strategies for Commercialization of EDRN Validated
Biomarkers: Government, Academic, and Industry
Perspectives
Moderators
Jacob Kagan, PhD
NCI EDRN Program Director
Wendy Patterson, Esq
NCI Technology Transfer Branch |
| 2:00 - 2:30 pm | Government Perspective:
Wendy Patterson, Esq
Senior Advisor, NCI Technology Transfer
Branch
J Terry Lynch, MBA
Licensing Officer, NIST Technology Partnerships Division |
| 2:30 - 3:00 pm | Academic 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 pm | Industry 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 pm | Subcommittee Meetings (By Invitation Only) |
| 4:00 - 6:00 pm | Discussion on Biorepository with Dr Ann Barker, Deputy
Director, NCI (Closed Meeting, EC and all Chairs to Attend) |
| 6:00 - 7:00 pm | Dinner |
| 7:00 - 8:00 pm | Subcommittee 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 am | Registration and Continental Breakfast |
| 8:00 - 8:30 am | Introduction
William Bigbee and University of Pittsburgh Officials |
| 8:30 - 8:40 am | Welcome & Approval of January 2003 SC minutes
David Sidransky |
| 8:40 - 8:50 am | Welcome
Peter Greenwald |
| 8:50 - 9:10 am | NCI Update
Sudhir Srivastava |
| 9:10 - 9:30 am | NCI Strategic Initiative
Anna Barker
Deputy Director of the National Cancer Institute |
| 9:30 - 9:40 am | A Critique of the EDRN: Successes and Failures
Bernard Levin
Chair
EDRN Network Consulting Committee |
| 9:40 - 10:15 am | Guest 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 am | Break |
| 10:30 am - Noon | EDRN High Risk Cohorts: Resource for Validation Studies
Moderators
Wendy Wang
Jacob Kagan
Speakers:
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 pm | Lunch
EC Meeting (Working Lunch) by Invitation Only |
| 1:00 - 1:30 pm | Antibody Arrays
Moderators
Jeffrey Marks
Jacob Kagan
Speaker: Brian Haab
Van Andel Research Institute |
| 1:30 - 1:45 pm | Update: EDRN Antibody Array Project
Jacob Kagan |
| 1:45 - 2:15 pm | MALDI - TOF and Biomarker Discovery
Yingming Zhao |
| 2:15 - 5:00 pm | Collaborative Group Meeting (by Invitation Only) |
| 5:00 7:00 pm | Dinner (On Your Own) |
| 7:00 - 7:15 pm | Collaborative Group Reports |
| 7:15 - 9:00 pm | Collaborative Showcase: Prostate and Urologic Cancers Group |
Wednesday, June 25, 2003
| 7:00 - 8:00 am | Continental Breakfast |
| 8:00 - 8:30 am | Guest Speaker
The proteome of DNA replication in cancer
Linda H Malkas |
| 8:30 - 9:00 am | MALDI/SELDI - TOF - MS proteomic profiling for cancer early
detection and molecular diagnosis - summary of latest studies
William L Bigbee |
| 9:00 - 10:30 am | Highlights 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 am | Highlights of the Associate Membership Program (Continued)
Suggested topics for discussion:
- Sponsor's interactions with AM, collaboration and benefits to EDRN
- Specific examples in terms of resource sharing and or technology transfer
- Suggestions to integrate AM in additional EDRN activities
- How does AM benefit EDRN goals and vise versa
|
| 10:30 - 10:45 am | Break |
| 10:45 - 11:00 am | Administrative Issues |
| 11:00 am | Noon Update: EDRN Bioinformatics Infrastructure and Tools
Moderators: Sudhir Srivastava, Donald Johnsey
Speakers: Daniel Crichton
Mark Thornquist
Heather Kincaid |
| 12:00 - 1:00 pm | Lunch |
| 1:00 - 3:00 pm | EDRN 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 pm | New Business |
| 3:15 pm | Adjourn |
Back to top
|
|
