Denise A. Cloutier

**** ** **** *****

Gainesville, FL 32608

352-***-****

Cell: 352-***-****

ab7v42@r.postjobfree.com

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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