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EDUCATION:
| M.S. |
Biomedical
Engineering, University of Alabama Birmingham (1992) |
| B.S. |
Biomedical
Engineering, Tulane University (1989) |
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EXPERIENCE:
CURRENT
POSITION Oct. 2007 to present: |
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Senior
Consultant,
Biologics
Consulting Group, Inc., Catawba, NC.
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| Mar.
1994 - Sep. 2007 |
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Biomedical
Engineer, FDA/CDRH/ODE/DAGID, Dental Devices Branch,
Rockville, MD.
- Extensive
experience in review of 510ks including some for implantable
devices which contain clinical data and some for device
/drug combinations (oral wound dressings).
- Over
thirteen years of experience reviewing IDEs including
those which result in both PMAs and 510ks.
- Nine
years of experience as a PMA team leader for 5 companies'
products.
- Reviewed
many requests for classification (513g) and requests
for designation, and am familiar with these processes
and how they involve interaction with the Program
Operations Staff and the Office of Combination Products.
- Long
term projects with combination products involved working
with CDER, ODE clinicians, statisticians, and patient
labeling staff to approve clinical trials for dental
bone filling materials containing therapeutic proteins
and then reviewing the PMA.
- Served
as team leader for the first bone filling material
PMA approved which contained PDGF and also for the
first dental bone filling material PMA approved which
contained rhBMP-2.
- Worked
on the rhBMP-2 project for thirteen years and the
PDGF project for six years.
- Served
as senior engineer for the following product areas:
- tissue
engineered dental bone grafting materials,
- oral
wound dressings,
- lubricants
for dental handpieces,
- endosseous
dental implants, including their abutments and
CAD/CAM systems used for designing them in the
dental office
- temporomandibular
joint prostheses,
- oral
and maxillofacial bone plates, screws and distractors
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CONTINUING
EDUCATION:
| Course
Title |
Sponsor |
Date |
| American
Association of Dental Research Annual Meeting |
IADR/AADR |
March
2007 |
| TMJ
Bioengineering Conference |
NIH,
University of Kansas |
May
2006 |
| American
Association of Dental Research Annual Meeting |
AADR |
March
2006 |
| Advancing
the Frontiers of Bioscience and Nanotechnology |
NIST |
June
2005 |
| Methods
for Enhancing the Efficiency of Dental/Oral Health
Clinical Trials: Current Status, Future Possibilities |
NIH |
May
2004 |
| American
Association for Dental Research Annual Meeting |
IADR/AADR |
March
2004 |
| Syposium
on Metrology and Standards for Cell Signaling: Impact
on Tissue Engineering |
NIST |
October
2003 |
| Engineering
Tissue Growth International Conference and Exposition |
Pittsburgh
Tissue Engineering Initiative |
March
2003 |
| Combination
Products: Intercenter Collaborative Review |
FDA |
October
2002 |
| 21st
Southern Biomedical Engineering Conference |
Southern
Biomedical Engineering Conference |
September
2002 |
| Surfaces
in Biomaterials |
FDA |
Jan.
and Feb. 2002
|
| Advances
in Tissue and Genetic Engineering for the Treatment
of Arthritic Diseases |
The
Knowledge Foundation |
September
2000 |
Reference
Data for Biomaterials
Workshop
|
NIST |
July
2000 |
| Gordon
Research Conference on Tissue Engineering, Biomaterials
and Biocompatibility |
Gordon
Research Conference |
July
1999 |
| International
Symposium on Advanced Materials with Biomedical
Applications |
NIST |
June
1999 |
| Regulations
Writing Course |
FDA |
January
1999 |
| Special
Topics in Biomaterials |
UMBC |
August
1998 |
| Tissue
Engineering III |
FDA |
February
1998 |
| Gordon
Research Conference on Biomaterials: Biocompatibility/Tissue
Engineering |
Gordon
Research Conference |
July
1997 |
| Assessment
of Medical Devices Polymers |
FDA |
October
1996 |
| Introduction
to and Current Perspectives on Tissue Engineering |
NIH |
June
1996 |
| Interface
of Biomechanics and Cell Biology in Orthopedics |
Johns
Hopkins |
June
1996 |
| Cells
and Materials |
Scanning
Microscopy International |
May
1996 |
| Biological
Response to Orthopedic Implants |
Johns
Hopkins |
April
1996 |
| Tissue
Engineering |
FDA |
February
1996 |
| 1996
Joint Symposium on Clinical Trial Design and Analysis
in Periodontics |
NIH |
Jan-Feb.
1996 |
| Gordon
Research Conference on Biocompatibility and Biomaterials |
Gordan
Research Conference |
July
1995 |
| Total
Joint Replacement Workshop |
NIST |
March
1995 |
| Workshop
on Tissue Engineering |
NIST |
November
1994 |
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HONORS
& AWARDS
| Award
(Date) |
Awarding
Organization |
Citation |
| FDA
Outstanding Service Award (2006) |
FDA |
CDRH
Premarket Submission Quality Review Group: For exceptional
performance and participation in the Center's pilot
program to assess the quality of biocompatibility,
sterilization, and statistical reviews of pre-market
submissions. |
| Letter
of Appreciation (2004) |
FDA |
For
serving as a center standards liaison representative
and STG member |
| Award
of Appreciation (2001) |
ASTM |
In
appreciation of your outstanding efforts on ASTM
Committee F4 |
| CDRH
Special Recognition Award (2000) |
FDA |
For
significant service and dedication to the Office
of Device Evaluation as ODE Division Focal Points. |
| Certificate
of Appreciation (1997) |
FDA |
For
your dedication to ODE as shown by your willingness
to serve as an ODE Focal Point in addition to performing
your regular duties. |
| FDA
Group Recognition Award (1996) |
FDA |
For
participation in the FDA Intercenter Tissue Engineering
Working Group |
| FDA
Group Recognition Award (1995) |
FDA |
For
successful implementation of new initiatives, new
management techniques and an increase in productivity
since their inception in fiscal year 1994. |
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PARTICIPATION
IN INTERNATIONAL AND NATIONAL STANDARDS ORGANIZATIONS
- U.S.
Expert to ISO TC 106 SC8 Dental Implants Working
Group On Mechanical Testing
- ADA/ANSI
Subtag to ISO TC 106 SC8 Working Group Chairperson
on Mechanical
Testing of Dental Implants
- FDA
Liaison to ISO TC 106 Dentistry SC8 Dental Implants
- FDA
Liaison to ISO TC 106 Dentistry Working Group
on Biocompatibility
- FDA
Liaison to ADA/ANSI Subtag of ISO TC 106
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OUTSIDE
PROFESSIONAL ADVISORY AND CONSULTING ACTIVITIES
Member
of University of Alabama Birmingham Department
of Biomedical Engineering
Advisory Group
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FDA
SPECIAL ASSIGNMENTS AND ADVISORY ACTIVITIES
Chairperson
of the CDRH Biocompatibility Assessment Group
DAGID
Biocompatiblity Focal Point
Mentoring of new DAGID biomedical engineers
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PUBLICATIONS
Charlene
M. Flahiff, Angela S. Blackwell, J. Marcus Hollis,
and Dale S. Feldman. "Analysis of a biodegradable
composite for bone healing," Journal of Biomedical
Materials Research, 32,419-424 (1996).
A.E.
Steedley (maiden name), R.C. Anderson, M.W. Bidez,
D.S.Feldman. "Finite Element Model of a Biodegradable
Intrameduallary Rod," Transactions of the
Society for Biomaterials, 16, 51 (1990).
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OTHER
PUBLICATIONS
ISO/CD
22794 Dentistry - Implantable materials for bone
reconstruction in oral and maxillofacial surgery
- Contents of a technical file.
ISO
22803 Dentistry - Membrane materials for guided
tissue regeneration in oral and maxillofacial
surgery - Contents of a technical file. September
1, 2004.
Dental
Devices; Reclassification of Root-Form Endosseous
Dental Implants and Endosseous Implant Abutments.
Final Rule. Federal Register 69, 92 May 12, 2004.
Guidance
for Industry and FDA Staff: Class II Special Controls
Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Implant Abutments.
May 12, 2004.
ISO
14801 Dentistry - Fatigue testing for endosseous
dental implants. May 13, 2003.
Dental
Products Devices; Reclassification of Endosseous
Dental Implant Accessories. Final Rule. Federal
Register 65, 196 October 10, 2000.
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Page
Updated:
October 2, 2007
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