Clinical and Preclinical Research

Claudia Garcia

******************@*****.***

Mobile : 786-***-****

Current Position

Doctors Research Network

S. Miami, FL 33143

Clinical Research Coordinator

June 2016- present

Education

Bachelor of Science in Biochemistry and Molecular Biology, 2008-2013

University of Havana, Havana, Cuba

Pursued graduate-level coursework (MS in Biochemistry and Molecular Biology), 2013-2015

Undergraduate Research, Thesis Project, Jun 2012-Jul 2013

Mapped the epitope of an antibody against the human epidermal growth factor receptor (hEGFr) using phage display technology.

Experience

Research associate, Regulation Dynamics of the Immune System Group, Sept 2014- Dec 2015

Center for Molecular Immunology, Havana, Cuba

Collected and quantified hEGF and hTGFβ (human Transforming Growth Factor beta) from cancer patients before and after chemotherapy and from healthy donors as part of a clinical trial.

Obtained a recombinant hTGFβ mutant fused to an Fc fragment using optimized plasmid vectors for transient transfection and expression on HEK 293T and CHO K1 cell lines.

Improved the stability of the fusion protein by inserting structurally different linkers between the hTGFβ and the Fc protein fragments and evaluated the expression of all the variants.

Research associate, Biological Models Group, Sept 2013 - Sept 2014

Center for Molecular Immunology, Havana, Cuba

Evaluated the putative use in diagnostic kits for arthritis of gold nanoparticles conjugated to an antibody that recognizes human CD6.

Characterized in vitro and in vivo three rat antibodies against human CD6 in order to use them as biological models for preclinical research.

Published work

Tundidor, Y., Garcia-Hernandez, C. P., Pupo, A., Infante, Y. C., & Rojas, G. (2014). Delineating the functional map of the interaction between Nimotuzumab and the epidermal growth factor receptor. mAbs, 6(4), 1013–1025. http://doi.org/10.4161/mabs.28915

Clinical Research Experience

Anacor Pharmaceuticals, TAV-ONYC-401, Jun 2016-current

An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KERYDIN® (tavaborole) topical solution, 5% in the Treatment of Onychomycosis of the Toenail in Pediatric Subjects Ages 6 to 16 Years and 11 Months.

Electrochemical Oxygen Concepts, Inc, TCO2-2012-01, Jun 2016-current

A Prospective, Randomized, Double-blind, Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers.

Dipexium Pharmaceuticals, DPX-305, Jun 2016-current

A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults with Mild Infections of Diabetic Foot Ulcers.

Tactile Medical, 6010, Jun 2016-current

Randomized Trial Comparing a Dual Action Pneumatic Compression System against Multi-Layer Bandaging Systems: A non-inferiority study.

Valeant Pharmaceuticals, V01-108A-401, Aug 2016-current

A Multicenter, Open Label, Single-arm Study Evaluating the Safety and Pharmacokinetics of Efinaconazole 10% Topical Solution in Subjects with Mild to Severe Onychomycosis of the Toenails.

Mimedx, ECDFU001, Aug 2016-current

A Multicenter Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in The Management of Diabetic Foot Ulcers.

Skills

CITI Program GCP training, Biomedical Research and Conflicts of Interest Courses, June 2016

EDC systems for clinical data entry (Medrio, Openclinica, Clincapture, Datatrak, Clindex, Oracle Inform)

Software: GraphPad Prism, Gene runner, Pymol, BLAST, Vector NTI, VMD, ClustalW, Geneious, MS Office, use of search engines and academic databases for advanced research functions

Protein expression, purification, quantification/Fusion proteins/Lentivirus/Phage display of antibody fragments and other proteins

Purification and quantification of nucleic acids/Gene cloning/PCR/Site directed mutagenesis

ELISA/Western blotting/Agarose gel electrophoresis/SDS-PAGE/Spectrophotometry

Molecular modeling and computer analysis of mutagenesis data

In vitro and in vivo assays/ Animal handling/Clinical trials

Mammalian Cell culture/Bacterial cell culture/Flow cytometry

Bilingual Spanish and English (written & verbal)

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