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Keeping Pace with Technology: Molecular Diagnostics Regulation and Reimbursement

Start Date: 09.17.2008
End Date: 09.17.2008
Time: 11:00 a.m. to 6:00 p.m.
Where: Gen-Probe Incorporated, 10210 Genetic Center Drive San Diego, Calif. 92121








Speakers

Mari Baker
CEO
Navigenics


Alberto Gutierrez, Ph.D.
Deputy Director
New Product Evaluation
FDA

Richard Jove, Ph.D.
Director, Beckman Research Institute
City of Hope

Hank Nordhoff
Chairman and CEO
Gen-Probe Incorporated


Hakan Sakul, Ph.D.
Senior Director and Global Head of Diagnostics
Pfizer Global R&D

Patrick Terry
Co-founder and Director
Consumer Advocacy & Governmental Affairs, Genomic Health, Inc.

Robert Di Tullio
Vice President, Regulatory Affairs & Quality
ProteoGenix, Inc.

Timothy Wollaeger

Timothy Wollaeger
Managing Director
Sanderling Ventures

The in vitro diagnostics (IVD) industry is characterized by a diverse, constantly evolving technology base that regularly produces new opportunities and applications. Similarly, a growing understanding of the molecular basis of cancer and other chronic diseases is opening up new realms of medicine to the possibilities of molecular diagnostic testing. While the science and technology of advanced diagnostics have progressed apace, federal and state government regulatory and reimbursement agencies have not kept up.

 To address the increasing number and complexity of policy issues facing California's molecular and IVD firms, California Healthcare Institute (CHI) has gathered national experts for a high-level half-day forum, Wednesday, September 17, at Gen-Probe Incorporated in San Diego.

Please view our schedule of engaging industry leaders and come discuss ways federal and state government policies can keep pace with innovation.

Wednesday, September 17, 2008
10:00 a.m. to 6:00 p.m.
Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, California 92121

 

 

 

 

 


 

10:00 a.m.  - 11:30 a.m.

 CHI DIAGNOSTICS (Dx) WORKING GROUP MEETING
 (Closed to DxWG Members Only)

11:30 a.m.  - 12:00 p.m.

 CONFERENCE REGISTRATION

12:00 p.m.  - 12:15 p.m.

 WELCOME REMARKS

12:15 p.m.  - 1:30 p.m.

 LUNCH

  • Alberto Gutierrez, Ph.D., deputy director, Office of In Vitro Diagnostic Device (OIVD) Safety and Evaluation, Center for Devices and Radiological Health (CDRH), FDA
  • Richard Jove, Ph.D., director, Beckman Research Institute, City of Hope

1:30 p.m.  - 2:30 p.m.

 EMERGING REGULATORY TRENDS

  • Mari Baker, CEO, Navigenics
  • Robert Di Tullio, vice president, Regulatory Affairs & Quality, ProteoGenix, Inc
  • Sheri Hall, vice president, Regulatory Affairs & Quality, BD
  • Hakan Sakul, Ph.D., senior director and global head of diagnostics, Pfizer Global Research and Development

2:30 p.m.  - 3:00 p.m.

 BREAK

3:00 p.m.  - 3:45 p.m.

 A 21st CENTURY PAYMENT FRAMEWORK

  • Jeff Bush, director, Corporate Reimbursement, BD
  • Patrick Terry, co-founder and director, Consumer Advocacy & Governmental Affairs, Genomic Health, Inc.

3:45 p.m.  - 4:15 p.m.  

 FUNDING DIAGNOSTICS INNOVATION: A VC PERSPECTIVE

  • Tim Wollaeger, managing director, Sanderling Ventures

4:15 p.m.  - 5:00 p.m.

 DIAGNOSTICS, PERSONALIZED MEDICINE AND KEY ISSUES IN HEALTHCARE    REFORM

  • Mara Aspinall, senior advisor, Genzyme Corporation
  • Hank Nordhoff, chairman and CEO, Gen-Probe Incorporated

5:00 p.m.  - 6:00 p.m.

 CLOSING RECEPTION

6:00 p.m.

 CONFERENCE ADJOURNS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Sponsors:

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Cost:
CHI members: $50
CHI Diagnostics Working Group members: $50
Non-members: $100

Cancellation Policy


Click here for Registration Information