Medical Devices

Public Workshop: The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program Launch: Educate, Enable, Enlist and Explore - HoW to Improve the Health of Women, June 24-25, 2013

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program Launch: Educate, Enable, Enlist and Explore - HoW to Improve the Health of Women.”

CDRH is developing a Health of Women (HoW) Program to explore some of the unique issues related to the performance of medical devices in women, and seeks public input on the priority activities.  The workshop is planned as the Health of Women Program launch.

The mission of the HoW program is to improve the health of women by:

  • improving the availability, consistency and communication of sex-specific information for the safe and effective use of medical devices in women;
  • addressing identified gaps and unmet needs through targeted resources; and
  • fostering the development of innovative strategies, technology and clinical study paradigms.

The CDRH HoW program seeks to bring together clinicians, researchers, academia, government agencies, industry, and patient / advocacy groups in an effort to 1) Develop Device-Specific Clinical Study Recruitment & Retention Strategies; 2) Improve Analysis and Communication of Sex-Specific Findings to Providers and Patients; 3) Develop a Priority Research Road Map for the HoW Device Ecosystem. The workshop focus will be device- and disease-specific, patient-centered and action-oriented.


Date, Time and Location

The meeting will be held on June 24 and 25, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus, Building 66
Rooms G512 and G514
10903 New Hampshire Avenue
Silver Spring
, MD, 20993

*Please allow sufficient time for security screening.

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Agenda

June 24, 2013

7:30 -8:30 AM

Registration

8:30 AM

Welcome Remarks

Michelle McMurry-Heath, MD, PhD
Associate Director for Science, Center for Devices and Radiological Health (CDRH)

Helen Barr, MD
Acting Deputy Director and Senior Medical Officer, Office of Women’s Health, Food and Drug Administration (FDA)

Nancy Lee, MD
DHHS Deputy Assistant Commissioner for Women’s Health

FDA Commissioner Margaret Hamburg, MD via video

8:45 AM

Setting the Stage & Workshop Goals
Kathryn O’Callaghan & Nada Hanafi, MSc, MPH
Senior Science Health Advisors, CDRH/FDA

PLENARY 1: HIGHLIGHT DEVICE-SPECIFIC
RECRUITMENT & RETENTION STRATEGIES

9:00 – 10:15 AM

Session 1: Barriers & Strategies—What Do We Already Know?
Chairs: Sharonne Hayes, MD & Bray Patrick-Lake, BS MFS

9:15 AM

Clinical Trial Enrollment: NIH Experience
Patrice Desvigne-Nickens, MD
Medical Officer, Heart Failure and Arrhythmias Branch, Division of Cardiovascular Science, NHLBI/NIH

9:30 AM

Beyond the Color Line: Race, Ethnicity and Willingness of Women to Participate in Medical and Public Health Research
Stephen Thomas, PhD
Director, University of Maryland Center for Health Equity

 

9:45 AM

Opportunities for Recruitment & Retention in Clinical Research: The Clinical Research Coordinator Perspective
Ellen Pinnow, MSc
Investigational Device Exemption Staff, CDRH/FDA

 

10:00 AM

Reprogramming Referral Bias: Case Study—OB/GYN Clinic Partners for Cardiovascular Trials
Jerri Anne Johnson, MEd
Director, Coronary Market Development, Abbott Vascular

10:15 AM

Question & Answer

10:30 AM

Break

10:45–11:45 AM

Session 2: Device-Specific Case Studies

10:45 AM

Device Industry Perspective Based on an Industry Survey of AdvaMed Member Companies
Kimberly Wong Oleson
Vice President of Global Clinical Operations, Medtronic Clinical Research Institute

11:00 AM

Root Cause Analysis: Why Women Don’t Enroll in Medical Research—A Cardiovascular Case Study
Brooke Allocco, MD, MBA
Vice President, CRM Clinical Communications and Education, Boston Scientific Corporation

Jeanne Poole, MD
Professor, Department of Medicine, Division of Cardiology
Director, Electrophysiology/Arrhythmia Service, University of Washington 
 

11:15 AM

Are strict enrollment criteria the culprit?  Case study – Orthopedic Trials
Nancy Lynch, MD
Advisorthopaedics Incorporated

11:30 AM

Question & Answer


 

11:45 PM

Lunch Program - Food for Thought: Accelerating Clinical Trial Recruitment through Fox Trial Finder
Lily Cappelletti
Associate Director, Research Partnerships, Michael J Fox Foundation for Parkinson’s Research

PLENARY 2: IMPROVE ANALYSIS & COMMUNICATION OF
SEX-SPECIFIC FINDINGS TO PROVIDERS & PATIENTS

12:45 PM

Working Smarter to Achieve Medical Advance: Communication Strategies for the Healthcare Provider Audience
Virginia Miller, PhD
Professor of Surgery and Physiology, College of Medicine, Mayo Clinic

1:00 PM

Innovative Tools to Enable Shared Decision-Making and Improve Care for Women: Case Study—ePRISM
John Spertus, MD, MPH
Lauer/Missouri Endowed Chair and Tenure Professor, University of Missouri – Kansas City

1:15 PM

Patient Reported Outcomes in Clinical Care: Case Study—The MSKCC BREAST-Q Experience
Andrea Pusic, MD, MHS
Associate Attending Surgeon, Sloan-Kettering Cancer Treatment Center

1:30 PM

Gender and Patient Reported Outcomes
Manuel Bayona, MD, MS, PhD
Division of Epidemiology, CDRH/FDA

1:45 PM

Interpretation and Reporting of Sex/Gender Subgroup Findings in Completed Clinical Studies and Study Design with Anticipated Sex/Gender Difference
Lilly Yue, PhD
Deputy Director, Division of Biostatistics, CDRH/FDA
  

2:00 PM

Panel & Audience Discussion

2:15 PM

Break

2:30 PM

Breakout Session 1 & 2

3:30 PM

Break

3:45 PM

Breakout Session 1 & 2 (continuation)

4:45 PM

Action Plan Summary / End of Day One
Nada Hanafi, MSc, MPH & Kathryn O’Callaghan

Day Two

June 25, 2013
7:00 -8:00 AMRegistration
8:00 AMWelcome Remarks
CDRH Director Jeffrey Shuren, MD, JD
Plenary 3: Developing a Priority Research Road Map
for the HoW Device Ecosystem
8:05 AMNIH Strategic Goals to Improve the Health of Women
Janine Clayton, MD 
Director, Office of Research on Women’s Health, NIH

 
8:25 AMSetting the Stage: A Research Road Map to Highlight Priority Areas
Michelle McMurry-Heath, MD, PhD
Associate Director for Science, CDRH/FDA
8:35 AMProposed Approach to Gap Analysis to Inform Research Agenda Prioritization for the HoW Device Ecosystem
Danica Marinac-Dabic, MD, PhD
Director, Division of Epidemiology, CDRH/FDA
8:45 AMPanel Discussion
Chair: Michelle McMurry-Heath, MD, PhD
Janine Clayton, MD, Director, NIH ORWH
Marietta Anthony, PhD, Consultant, Office of Women’s Health, FDA
Steve Pollack, PhD, Director, Office of Science and Engineering Labs, CDRH
Dr. Danica Marinac-Dabic, Director, CDRH/DEPI
 
9:00 -11:45AM
Research Session 1: Focus on Musculoskeletal
Session Chair: Joan McGowan, PhD
Director, Division of Musculoskeletal Diseases, NIAMS/NIH
9:05 AMSex and Risk of Hip Implant Failure
Yelizaveta Torosyan, MD, PhD 
Division of Epidemiology, CDRH/FDA
9:15 AMInvestigating the Mechanical Causes of Higher Metal-on-Metal Hip Implant Failure Rates in Women
James Coburn, ScB, ScM
Division of Physics, CDRH/FDA
9:25 AMGender Disparity in the Rates of Use of Total Joint Arthroplasty Surgery
Mary O’Connor, MD
Professor/Chair of the Department of Orthopaedic Surgery at the Mayo Clinic, Jacksonville, FL
Cory Borkhoff, PhD
Scientist, Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada
9:45 AMUnderstanding Heterogeneity in Clinical Research with a Focus on Gender
Joel Gagnier, PhD, MSc
Assistant Professor, University of Michigan
9:55 AMQuestion & Answer
10:15 AMGenetics of Osteoporosis and OA
Braxton Mitchell, PhD, MPH
University of Maryland School of Medicine
10:25 AMThe Role of Ultrasound in the Management of Osteoporosis
Keith Wear, PhD
Division of Imaging and Applied Mathematics, CDRH/FDA
10:35 AMBone Quality and Strength and Fracture Prevention
Tony Keaveny, PhD
Director, Berkeley Orthopaedic Biomechanics Laboratory, UC Berkeley
10:45 AMDoes Bone Strength in Women Differ?
Karl Jepsen, PhD
Professor / Associate Chair Research, University of Michigan
10:55 AMWrist Fragility Fractures
Amy Ladd, MD
Chief of Chase Hand & Upper Limb Center, Stanford University School of Medicine
11:05 AMDevice Considerations in Osteoporosis and Women's Health: An Industry Perspective
Rachel Wagman, MD
Global Development Leader, Bone Therapeutic Area, Amgen
11:15 AMSWHR Efforts on Musculoskeletal Health
Christine Carter, PhD, MPH
Vice President for Scientific Affairs, Society for Women’s Health Research
11:25 AMQuestion & Answer
11:45 AMLunch
 
12:45 – 2:45 PM
Research Session 2: Focus on Cardiovascular
Session Chair:  Suzanne Baron, MD
Division of Cardiovascular Devices, CDRH/FDA
12:45 PMChallenges in Gender Representation Across Clinical Trials-How Can We Impact This?
Kate Rumrill, MBA
Vice President of Global Clinical Affairs, Covidien
1:00 PMSAFE PCI for Women
Mitch Krucoff, MD
Duke University Medical Center
1:15 PMDiagnostic Dilemmas in Women with Heart Disease: Is there a Role for Genomics?
Alexandra Lansky, MD
Director, Interventional Cardiovascular Research, Yale School of Medicine
1:30 PMSCAI-WIN/ACC Gender Data Forum & TAVI-Female Registry
Roxana Mehran, MD
Director of Interventional Cardiovascular Research and Clinical Trials, Mount Sinai School of Medicine, New York
1:45 PMCardiac Resynchronization Therapy; What We Know (and Don’t Know) about Gender Differences in Response to Therapy
Kim Selzman, MD, MPH
Medical Officer, Division of Cardiovascular Devices, CDRH/FDA

Daniel Caños, PhD, MPH
Division of Epidemiology, CDRH/FDA
Robbert Zusterzeel, MD
Division of Physics, CDRH/FDA
2:15 PMGender Disparities in Endovascular Treatment Options for Infrarenal Abdominal Aortic Aneurysms
Tina Morrison, PhD
Division of Cardiovascular Devices, CDRH/FDA
2:30 PMQuestion & Answer
2:45 PMBreak
3:00 – 4:30 PMResearch Session 3: Focus on Women's Specific Topics
Session Chair: Elaine Blyskun
Chief, Obstetrics and Gynecology Devices Branch, CDRH/FDA
 3:00 PMBuilding National Infrastructure for Postmarket Surveillance of Breast Implants
Nilsa Loyo-Berrios, PhD, MSc
Associate Director Post-Approval Studies Program, Division of Epidemiology, CDRH/FDA
3:15 PMThe Need to Assess the Effects of Medical Devices in Women with Fibroids Who Wish to Preserve Fertility 
Sharon Andrews, MSc
Obstetrics and Gynecology Device Branch, CDRH/FDA
3:30 PMProstate Specific Antigen as a Biomarker for Semen Exposure
Sharon Andrews, MSc
Obstetrics and Gynecology Device Branch, CDRH/FDA
 3:45 PMMRI in Pregnant Patients: Analysis of Radio-Frequency Heating
Leonardo Angelone, PhD
Division of Physics, CDRH/FDA
 4:00 PMDevelopment of the Uro-gynecology Mesh Registry
Colin Anderson-Smits, MPH
Division of Epidemiology, CDRH/FDA
4:15 PMQuestion & Answer
4:30 PMWorkshop Summary
Michelle McMurry-Heath, MD, PhD
Associate Director for Science, CDRH/FDA
5:00 PMAdjourn

Plenary 1

Chairs:

Sharonne Hayes, MD
Professor of Medicine and Cardiovascular Diseases
Founder, Mayo Clinic Women’s Heart Clinic

Bray Patrick-Lake, BS, MFS
Director of Stakeholder Engagement, CTTI
Founder & President, PFO Foundation

Plenary 2

Chairs:

John Spertus, MD, MPH
Lauer/Missouri Endowed Chair and Tenured Professor, University of Missouri

Dipti Itchhaporia,MD
Immediate Past Chair, Board of Governors, American College of Cardiology

Martha Nolan, JD
Vice President, Public Policy, Society for Women’s Health Research

Plenary 3

Chair:

Michelle McMurry-Heath, MD, PhD
Associate Director for Science, CDRH/FDA

Panelists:

Janine Clayton, MD
Director, National Institute of Health, Office of Research on Women’s Health

Marietta Anthony, PhD
Consultant, Office of Women’s Health, FDA

Steve Pollack, PhD
Director, Office of Science and Engineering Laboratories, CDRH/FDA

Danica Marinac-Dabic, MD, PhD
Director, Division of Epidemiology, CDRH/FDA

Plenary Session Presentations:

Quantitative Ultrasound and the Management of Osteoporosis

Plenary Chairs and Panelists

Participant Workbook

The Participant Workbook is available in PDF format.

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Registration

As of June 14, online registration is now closed.

Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. Early registration is recommended because facilities are limited and, therefore, the FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be provided beginning at 7:30 a.m. on the day of the public workshop.

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Workshop Details

This public workshop will also be webcast. Individuals participating by webcast will be able to view and hear the plenary sessions, but due to technical constraints, will not be able to view the topic-focused breakout sessions. Persons interested in viewing the Webcast must register online by 5 p.m. on June 14, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after June 19, 2013.  If you have never attended a Connect Pro event, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview.

Food and beverages will be available for purchase by participants during the workshop breaks.

If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Joyce Raines, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, joyce.raines@fda.hhs.gov.

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Contact Us

The workshop organizers may be contacted at:

Kathryn O’Callaghan
Senior Science Health Advisor
Office of the Director
Center for Devices and Radiological Health
Food and Drug Administration
Phone: 301-796-6349
e-mail: kathryn.ocallaghan@fda.hhs.gov

Nada Hanafi
Senior Science Health Advisor
Office of the Director
Center for Devices and Radiological Health
Food and Drug Administration
Phone: 301-796-5427
e-mail: nada.hanafi@fda.hhs.gov

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