Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

Medical Devices

  • Share Share this page
-

FDA/AdvaMed Workshop: Gender Differences in Cardiovascular Device Trials, December 9, 2008

 Date, Time and Location

The meeting will be held on December 9, 2008 from 8:30 a.m. to 5 p.m. at the following location:

Food and Drug Administration
Building 2, Room 2047
10903 New Hampshire Ave.
Silver Spring , MD 20993

*Please allow sufficient time for security screening.

Back to Top Arrow

 Agenda (preliminary)

Time Agenda
8:30 – 9:00 Arrive at White Oak (security screening)
Registration/Continental Breakfast
9:00 – 9:05 Welcome
Thomas Maeder, Executive Director, MTLI, AdvaMed
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
9:05 – 9:20

Introduction: Conference Purpose Objectives
Kathleen Uhl, MD, Director, Office of Women’s Health, FDA
Kathryn O’Callaghan, Scientific Reviewer, FDA

  • Development of guidance on inclusion and analysis of women in clinical trials and related product labeling
  • Current FDA thinking on gender differences
    • The pharmaceutical model
    • The medical device world
9:20 – 10:20

Developing Safe and Effective New Medical Products in the US Regulatory Environment
Anthony Blank, Vice President Cardiovascular Regulatory Affairs,
Boston Scientific
Lyndall Erb, Maquet Cardiovascular

  • The regulatory clearance or approval process
  • The limits of regulatory and industry control
    • Social factors
    • Practice of medicine
  • Demonstrating safety and effectiveness
  • Examining clinically relevant differences for risk-based assessment of new technologies in subpopulations
  • Premarket vs postmarket clinical evidence
  • Balancing early patient access against clinical certainty
  • Gender-specific considerations in clinical study design
  • Gender-specific considerations in product design
10:20 – 10:40 BREAK
10:40 – 11:40

The Current State of Cardiovascular Treatment for Women
Jasmine Lane, Medtronic
Kim Skelding, MD, Medtronic

  • Gender-specific differences in cardiovascular disease
  • Gender-specific differences in treatment seeking
  • How industry can address gender-specific issues
11:40 – 12:00 Gender Bias in the Assessment of Coronary Heart Disease
Gabrielle Chiaramonte, PhD, Cornell University & New York Presbyterian Hospital
12:00 – 1:00 LUNCH
1:00 – 2:00

The CRO/IRB Perspective on Women in Clinical Trials
Elisa Harvey, DVM, Senior Regulatory Consultant, CardioMed Device Consultants
Patrice Desvigne-Nickens, MD, National Heart, Lung and Blood Institute

  • Historical perspective regarding inclusion of women in trials
  • Valid reasons for excluding women from trials
  • Challenges in recruitment and retention of women
  • NHLBI/NIH requirements and experience in the recruitment and retention of women in clinical trials
  • Lessons learned from WHI
2:00 – 2:30

The Investigator/Clinician Perspective on Women in Clinical Trials
Alexandra Lansky, Associate Professor of Clinical Medicine, Columbia University Medical Center

  • Determining if and when gender-specific issues affect the design and conduct of studies
  • Availability of appropriate treatment options for women
  • Effects of potential limitations on device use in women
2:30 – 2:45 The Patient Perspective on Women in Clinical Trials
Lisa Tate, Chief Executive Officer, WomenHeart
2:45 – 3:00 BREAK
3:00 – 3:30

The Biostatistician Perspective on Women in Clinical Trials
David Naftel, Professor of Surgery and Biostatistics, University of Alabama at Birmingham

  • Advantages and drawbacks to subgroup analyses
  • Statistical approaches to suspected differences in significant subpopulations
  • Validation of original product design safety and effectiveness considerations
3:30 – 4:00

Case Studies on Gender-Specific Trials
Don Middlebrook, Thoratec (invited)
Wai-Fung Cheong, Abbott

  • Industry examples of cardiovascular devices for which clinical studies were designed to include examination of possible gender differences
4:00 – 5:00

Final Discussion and Future Directions
Panel of Previous Speakers

  • Final summary and comments
  • Recommendations for FDA
  ADJOURNMENT

Back to Top Arrow

 Registration

Registration will be handled by AdvaMed. Please register online at: http://www.advamedmtli.org/go.cfm?do=Wercs.Display&WID=31.

Registration will be on a first-come, first served basis. Non-US citizens are subject to additional security screening, and should register as early as possible.

If you are an employee of the Department of Health and Human Services, please contact Kathryn O'Callaghan at kathryn.ocallaghan@fda.hhs.gov to determine if your registration fee will be covered by FDA.

Back to Top Arrow

 Contacts

The workshop organizer may be contacted at:

Kathryn O’Callaghan
Scientific Reviewer
Division of Cardiovascular Devices
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4182
Fax: (240) 276-4166
e-mail: kathryn.ocallaghan@fda.hhs.gov

    
-
-
-
-
-