Manager Therapy
Resume:
Denise A. Cloutier
Gainesville, FL 32608
Cell: 352-***-****
**********@*****.***
Professional Objective
To obtain a position with an organization that will enable me to expand my
knowledge and skills.
Education
Bachelor of Science Major: Microbiology December 1994
University of Florida Minor: Chemistry
Professional Experience
Coordinator of Research Programs July 1997 - current
Pediatric Cardiology
University of Florida
* Top Research Coordinator for all of the projects associated with Dr. Barry
Byrne’s Gene Therapy Research program to include GLP preclinical
toxicology and biodistribution studies leading to Phase I/II Patient Clinical
Trials.
* Process patient specimens for cryosectioning and biochemical analysis.
* Aid in the all grant submissions. Write yearly progress reports to comply with
all NIH deadlines as well as to other subcontractors.
* Manage over two million dollars in grant funds.
* Supervise 15 lab personnel.
* Play key role in supervising, hiring and training of all personnel to include
graduate students, technicians and OPS personnel.
* Mentor summer interns from the SSTP (Student Science Training program)
offered through UF.
* Coordinate all EH&S safety documentation and inspections for Biological,
Chemical and Radioisotope use.
* Responsible for all recombinant DNA and biological registrations.
* Generate all SOP’s which are directly responsible for converting the lab to be
GLP compliant.
* Write and maintain all IACUC Approved Animal Use projects.
* Serve as a member of the Institutional Biosafety Committee (IBC) at UF for
the past two years and review all proposals regarding recombinant DNA
research conducted at or sponsored by the institution to insure compliance
with the appropriate regulations and guidelines.
* Specific lab functions include; Study coordinator for several large NIH funded
studies and well as some private contracts. Large-scale growth of plasmids for
DNA isolations and sub-cloning, rAAV vector production as well as
enzymatic assays to assess biological functions. In vitro studies which utilize
small animal models to assess the efficacy and treatment using Gene Therapy
techniques as well as protein replacement strategies. Genotyping and
maintenance for all of our Knockout animal models. In vivo studies using
primary cell lines as well as the isolation of embryonic fibroblasts for
replacement studies.
Applied Genetics Lab September 1996-July 1997
Alachua, FL
Senior Biological Scientist
Infectious Diseases December 1994-September 1996
University of Florida
Senior Lab Technician
Rheumatology & Clinical Immunology April 1993-December 1994
OPS student assistant
Computer Experience
Microsoft Office Suite, Sigma Plot, KC4, Clone Manager and Align Plus,
Honors & Scholarships
Member of Phi Theta Kappa, National Honor Society
Awarded a Merit Scholarship
Publications & Abstracts
1. Fraites TJ Jr, MR Schleissing, RA Shanely, GA Walter, DA Cloutier, I Zolotukhin, DF
Pauly, N Raben, PH Plotz, SK Powers, PD Kessler, and BJ Byrne. 2002. Correction of
the enzymatic and functional deficit in a model of Pompe’s disease using recombinant
adeno-associated virus vectors. Molecular Therapy. 5(5 Pt 1):571-8.
2. Pauly D, T Fraites, M Schleissing, D Cloutier, PD Kessler, and BJ Byrne. 1999.
Correction and transfer of enzyme activity using adenovirus encoding human and
murine acid -glucosidase. American Society of Gene Therapy, 2nd Annual Meeting.
Washington, DC.
3. Fraites TJ Jr, MR Schleissing, KM Owens, DA Cloutier, I Zolotukhin, N Raben, PH
Plotz, PD Kessler, BJ Byrne. 2000. Recombinant adeno-associated virus mediated
correction of murine acid -glucosidase deficiency. American Society of Gene
Therapy, 3rd Annual Meeting. Denver, CO.
4. Fraites TJ Jr, C Charron, DA Cloutier, I Zolotukhin, SL Porvasnik, N Raben, PH
Plotz, GA Walter, and BJ Byrne. 2002. Recombinant AAV-mediated correction of
skeletal muscle biochemical and functional defects in a mouse model of glycogen
storage disease type II, Pompe disease. American Society of Gene Therapy, 5th
Annual Meeting. Boston, MA.
Fraites TJ Jr, SA Germain, KS Cahill, DA Cloutier, SL Porvasnik, I Zolotukhin, GA
5.
Walter, and BJ Byrne. 2002. Gene replacement therapy for glycogen storage disease
type II with recombinant adeno-associated virus serotype 1 (AAV1) vectors.
American Heart Association, 75th Scientific Sessions. Chicago, IL. Submitted.
6. C. Pacak, C. Mah, B. Thattaliyath, M. Lewis, D. Cloutier, I. Zolotukhin, A. Tarantal,
B. Byrne. Recombinant Adeno-Associated Virus Serotype 9 Leads to Preferential
Cardiac Transduction In Vivo.
7. Rucker M, Fraites TJ, Jr., Porvasnik SL, Lewis MA, Zolotukhin I, Cloutier DA et al.
Rescue of enzyme deficiency in embryonic diaphragm in a mouse model of
metabolic myopathy: Pompe disease. Development 2004; 131(12):3007-3019.
8. Christina A. Pacak, Gabriel S Gaidosh, Denise Cloutier, Irene Zolotukin, Kevin
Campbell, Glenn A. Walter, Barry J Byrne. rAAV-Mediated Gene Therapy to Treat
Limb Girdle Muscular Dystrophy Type 2D (LGMD-2D). June 2004 American
Society of Gene Therapy, Minneapolis MN.
9. Christina A. Pacak, Gabriel S Gaidosh, Denise Cloutier, Irene Zolotukin, Kevin
Campbell, Glenn A. Walter, Barry J Byrne. Oral and Poster Presentations: rAAV-
Mediated Gene Therapy to Treat Limb Girdle Muscular Dystrophy Type 2D
(LGMD-2D). November 2003 Gene Therapy Symposium, Sonoma CA.
10. Falk DJ, Mah CS, Cloutier DA, Fuller DD, Byrne BJ. 2009. Rapid rAAV-mediated
Improvement of Respiratory Function in an Animal Model of Pompe Disease. The American
Society of Gene Therapy 12th Annual Meeting. San Diego, California.
11. Mah CS, Falk DJ, Germain SA, Kelley JS, Lewis MA, Cloutier DC, DeRuisseau LR, Conlon
TJ, Cresawn KO, Fraites TJ Jr, Campbell-Thompson M, Fuller DD, Byrne BJ. Gel-mediated
delivery of AAV1 vectors corrects ventilatory function in Pompe mice with established
disease. Mol Ther. 2010 Mar;18(3):502-10. Epub 2010 Jan 26. PMID: 20104213
12. Pompe disease gene therapy. Byrne BJ, Falk DJ, Pacak CA, Nayak S, Herzog RW, Elder
ME, Collins SW, Conlon TJ, Clement N, Cleaver BD, Cloutier DA, Porvasnik SL, Islam S,
Elmallah MK, Martin A, Smith BK, Fuller DD, Lawson LA, Mah CS. Hum Mol Genet. 2011
Apr 15;20(R1):R61-8. Epub 2011 Apr 25.PMID:21518733
13. Byrne BJ, Falk DJ, Pacak CA, Nayak S, Herzog RW, Elder ME, Collins SW, Conlon TJ,
Clement N, Cleaver BD, Cloutier DA, Porvasnik SL, Islam S, Elmallah MK, Martin A,
Smith BK, Fuller DD, Lawson LA, Mah CS. Pompe disease gene therapy. Hum Mol Genet.
2011 Apr 15;20(R1):R61-8. Epub 2011 Apr25. PMID:21518733 [PubMed - in process
14. DJ Falk, MS Soustek, CS Mah, DA Cloutier, SA Germain, JS Kelley, KE Erger, TJ Conlon,
N Clement, and BJ Byrne. Acid Alpha-Glucosidase Delivery Using Adeno-Associated Virus-
2/9 in Adult Animals Improves Respiratory and Cardiac Function in Pompe Disease. (target
Mol Ther)
15. DJ Falk, CS Mah, MS Soustek, DA Cloutier, DD Fuller, BJ Byrne. Intrathoracic
administration of rAAV2/9 restores motoneuron and diaphragm function in Pompe Disease.
(target PNAS)
16. Falk DJ, Mah CS, Soustek MS, Lee KZ, Elmallah MK, Cloutier DA, Fuller DD,
Byrne BJ. Intrapleural Administration of AAV9 Improves Neural and
Cardiorespiratory Function in Pompe Disease. Mol Ther. 2013. doi:
10.1038/mt.2013.96. PubMed PMID: 23732990.
17. Conlon TJ, Erger K, Porvasnik S, Cossette T, Roberts C, Combee L, Islam S, Kelley J,
Cloutier D, Clement N, Abernathy CR, Byrne BJ. Preclinical Toxicology and Biodistribution
Studies of Recombinant Adeno-associated Virus 1 (AAV1) human acid alpha-glucosidase
(GAA). Human Gene Therapy Clinical Dev. 2013
Abstracts:
DJ Falk, CS Mah, DA Cloutier, MA Lewis, DD Fuller, and BJ Byrne. Rapid rAAV-
mediated Improvement of Respiratory Function in an Animal Model of Pompe Disease.
12th Annual ASGT meeting, San Diego, May 2009.
DJ Falk, MS Soustek, CS Mah, DA Cloutier, SA Germain, and BJ Byrne. Systemic V2/9
Vectors Improve Cardiac Function in Pompe Disease. 13th Annual ASGCT meeting,
Washington DC. Mol Therapy Volume 18, Supplement 1, May 2010 S231. #596
DJ Falk, MS Soustek, CS Mah, DA Cloutier, SA Germain, JS Kelley, KE Erger, TJ
Conlon, N Clement, and BJ Byrne. Acid Alpha-Glucosidase Delivery Using Adeno-
Associated Virus-2/9 in Adult Animals Improves Respiratory and Cardiac Function in
Pompe Disease. 2nd Conference on Clinical Research for Rare Diseases, Bethesda, MD,
September 2010.
DJ Falk, MS Soustek, CS Mah, DA Cloutier, SA Germain, JS Kelley, KE Erger, TJ
Conlon, N Clement, and BJ Byrne. Systemic delivery of AAV9 augments cardiac and
respiratory function in a murine model of Pompe disease. 10th Annual Gene Therapy
Symposium; Sonoma, CA, November 2010.
DJ Falk, MS Soustek, CS Mah, DA Cloutier, SA Germain, JS Kelley, KE Erger, TJ
Conlon, N Clement, and BJ Byrne. Next generation treatment of Pompe disease using
systemic gene transfer with AAV9. 7th Annual World Lysosomal Storage Disease
Symposium; Las Vegas, NV. Molecular Genetics and Metabolism 2011 Feb; 102(2):S18.
doi:10.1016/j.ymgme.2010.11.062
DJ Falk, MS Soustek, M ElMallah, JR Nicks, DA Cloutier, DD Fuller, L Notterpek, BJ
Byrne. Restoration of the neuromuscular junction with AAV9 in Pompe Disease.
University of Florida, Pediatrics Science Day, May 2012.
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