EDUCATION:
| B.Sc. |
|
Chemistry
and Biology, University of Miami, Coral Gables, Florida
(1975) |
|
EXPERIENCE:
|
CURRENT
POSITION
(Feb. 2007 - present) |
|
Senior
Consultant Biologics Consulting Group Inc.
San Mateo, CA. |
| |
|
|
| July
2005 - Jan. 2007 |
|
Senior
Director, Corporate GMP Compliance, Genentech
South San Francisco, CA |
| |
|
| Sept
2004 - July 2005 |
Vice
President, Global Quality Control, ID Biomedical
Corporation
Laval, Quebec, Canada |
| |
|
| Jan
2003 - Sept 2004 |
Vice
President, Quality, Project Manager, Biological
Warfare Vaccine System Support, Shire Biologics
Laval, Quebec, Canada |
| |
|
|
| Aug
1998 - Jan 2003 |
|
Senior
Director of Quality Systems, Acambis
Cambridge, MA |
| |
|
|
| Apr
1999 - Jan 2002 |
|
Senior
Director of Regulatory & Quality Affairs, Acambis
Cambridge, MA |
| |
|
|
| Aug
1998 - Apr 1999 |
|
Senior
Director of Quality Assurance & Validation, Acambis
Cambridge, MA |
| |
|
|
| May
1997 - July 1998 |
|
Director
of Quality Control, Creative Biomolecules
Hopkinton, MA |
| |
|
|
| Apr
1992 - May 1997 |
|
Director
of Quality Assurance & Quality Control, ImmuLogic
Pharmaceutical Corporation
Waltham, MA |
| |
|
|
| 1988
- 1992 |
|
Quality
Control Manager, Genzyme Corporation
Cambridge, MA |
CONTINUING
EDUCATION
| 2003 |
Tulane
University, Freeman School of Business, MBA Certificate
Program |
| 2002 |
Kellogg
School of Management, Evanston, IL, Executive Development
Program for Senior Regulatory Professionals |
| Dec
1989 |
Northeastern
University, Boston, Massachusetts, Postgraduate course:
Electro analytical Chemistry |
| July
1981 |
University
of Tennessee, Memphis, Tennessee, Postgraduate course:
Preparation of Parenteral Medications |
| 1976
- 1978 |
Department
of Biochemistry, School of Medicine, University of Miami,
Coral Gables, Florida, Biochemistry & Molecular
Biology courses |
PROFESSIONAL
SOCIETIES
-
PDA
Canadian Chapter, Secretary (2004-2006)
-
National
Institutes of Health/ National Institute of Allergy &
Infectious Diseases, Special Emphasis Panel Meeting
-
DMID
Clinical Trials Management", Chairperson (May 2003)
-
National
Institutes of Health/ National Institute of Allergy &
Infectious Diseases, Special Emphasis Panel Meeting (2001)
SELECTED
ORAL PRESENTATIONS
| April
2006 |
Annual
PDA Meeting, Speaker -Vaccines Focus Group., Challenges
and Insight into Preparation for an FDA Inspection"
(Anaheim, CA) |
| September
2005 |
Joint
FDA/PDA Conference, Speaker -Vaccines Focus Group, Round
Table Discussion (Washington D.C.) |
| September
2004 |
Joint
FDA/PDA Conference (Washington D.C.) |
| May
2004 |
RAPS
Canadian Conference (Toronto, ON, Canada) |
| April
2004 |
World
Vaccine Congress, Speaker "Working with governments
to accelerate vaccine candidates' time to market (Montreal,
Canada) |
| April
2004 |
BioDefense
Conference, (Washington D.C.) |
| October
2003 |
BioDefense
Conference, (Washington D.C.) |
| October
2003 |
Workshop
on Counter Terrorism Products Regulated by the Center
for Biologics Evaluation and Research: Effective Strategies
to Assist in Product Development (Bethesda, MD) |
| October
2003 |
Canadian
Conference on Counter-Terrorism and Public Health (Toronto,
ON, Canada) |
| July
2003 |
RAPS
Due Diligence Conference (Rockville, MD) |
| BIBLIOGRAPHY |
| 1. |
Clinical
proof of principle for ChimeriVax™: recombinant live,
attenuated vaccines against flavivirus infections, et
all, Vaccines, Volume 20, Issues 7-8, January 20002, Pages
1004-1018 |
| 2. |
Comparative
safety and immunogenicity of two yellow fever 17D vaccines
(ARILVAX™ and YF-VAX®) in a Phase III multicenter,
double-bind clinical trial, et all, American Journal of
Tropical Medicine and Hygiene, Vol. 66, No. 5, 533-541 |
Page
Updated
June 16, 2008
|
