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Click here or scroll down to respond to this candidateCurriculum VitaeDbora Sassi Siviglia, MD, MS, FAANEMAIL AVAILABLEPhone: PHONE NUMBER AVAILABLE USAClinical Trial Manager, Project Manager, Translational and Systems Neuroscience, Clinical Trials, Clinical Neurology, Functional Neurosurgery, Clinical Operational Optimization, Co-inventor of the Protocol Neuroquiescence for Childrens EpilepsyNEUROCLINICAL & NEUROSURGICAL RESEARCH Project development and orchestration of neurosurgical approaches for different pathologies of the nervous system: Surgical access, Surgical anatomy, Stereotactic surgery, Epilepsy Surgery, Aneurysms, skull base tumors Monitored and coordinated clinical trials to ensure Good Clinical Practice in accordance with ICH-GCP standards and Federal Regulatory Requirements for Alzheimers, Epilepsy, Brain Tumors, Prostate Cancer, Breast Cancer Management, Supervision and Design to ensure proper adherence to protocols, laboratory source data, patient charts verification, and assess CRF entries. Team Functional Management of Endovascular Surgery Units in clinical trials: Epilepsy Surgery Program coordination, WADA Test performance (300 patients per year), first Epilepsy Surgery in Latin America using real-time monitoring via deeply implanted electrodes. Post-Stroke Neurophysiological Examination of patients with language disorders Toxicology: Alzheimers Disease and Occupational Poisoning - Methyl Mercury Toxicity (370 Dentist Professionals) Presurgical and Postsurgical assessment of neurophysiologic and neuropsychologic correlations BRAIN IMAGING: Performed and analyzed fMRI, MEG, ECG, and multichannel EEG for Epilepsy Degenerative Disorders and Spinal Cord InjuriesLABORATORY: Data analysis & statistical interpretation of results in animal model behavioral experiments in neuroscience and oncologic laboratory Experiments related with Biosynthesis of GABA Research, RT-PCR Western Blotting, ELISA Cloning Expression of GABA/Neurosciences Purification of N-Terminus/Neurosciences Laboratory for New Drugs Development Experiences in large and small animal surgery, behavioral tests, cell culture, clinical research, and neural signal processingRESEARCH: Direction, coordination, supervision, presentation and participation in the scientific meeting and conference related with Protein Crystallization of GABA Research Neurosciences Clinical Trials for Alzheimers disease, Spine Cord Injuries, Methyl Mercury Toxicity Glial Hypoxia and Remyelination for EpilepsyPROFESSIONAL EXPERIENCEUniversity of California San Francisco Department of Medicine - Cardiology Advance Heart Failure and Stroke: Clinical Research Lead April 2024 Projects: Medtronic HVAD, DTPAS (devices), review of DATA/Metrics for FDA Regulatory INTERMACS: Data Analysis and EntryPfizer: Data registryMerck and Sharp & Dohme LLCPARAGONIX: Guardian Heart Registry Preventing Cold Injury in Transplant & Advance Organ PreservationECMO Data Registry: Perfusion, Cannulation, Stroke ELSO Data Registry: ELSO - Extracorporeal Life Support Organization, ECMO Certification Coinventor of Neuroquiescence ProtocolA multiphasic noninvasive protocol for mitigating consequences of neuronal overactivity overconsuming oxygen causing glial, mitochondrial, and endothelial hypoxia, then fueling remyelination and neurometabolic reset. Also proved Dobutamine for neurological repurposing Neuroquiescence - A treatment for neurological and nervous system bioelectrical dysregulation associated with neuropathic pain, neurodegenerative disorders, and seizures - USPTO Patent 10,716,792 Neuroquiescence - A Treatment for Neurodevelopmental and Neurodegenerative Bioelectrical Dysregulation and Demyelination - U.S Patent 11,446,262 Issued 2022 Consultant - Post-Traumatic Stress Disorder and Traumatic Brain Injury Participated in site selection and in training site personnel including overseeing site monitoring of the trial and follow-up, and ensuring identified deficiencies were corrected. Developed and designed the protocols, documentation, and standard operating procedures for monitoring clinical trials, and evaluating alternative approaches for PTSD and TBI Conducted site initiation visits for study procedures, patient recruitment, retention requirements, regulatory requirements. Conducted monitoring visits to ensure the integrity of clinical data accuracy, accountability, and methods or procedures through review of case report forms (CRFs), source documents, medical records, and regulatory documents. Provided feedback to clinical sites, including a summary of overall site functioning, detected deficiencies, and corrective action needed.Arizona Center for Cancer CareClinical Trials Project Manager Consulting - Research Department Scottsdale, Arizona USA: June 2023 Provided and developed Statistical Biocomputing Analysis Developed, designed, and managed projects for sponsor including medical surgical device for breast cancer location. Conducted onsite monitoring clinical trials, providing feedback to clinical sites. Projects: BCL- Breast Cancer Locator- Medical Surgical Device Alliance A2220004 Oncology Studies- Phase III NRG Oncology studies, Novartis Pancreas trials Barrow Neurological Institute, St. Joseph Hospital and Medical Center Project Manager for Epilepsy Research DepartmentPhoenix Arizona USA: April 2022 March 2023 IRB member, project reviews and submissions, recruitment of clinical CRCs RedCap database, StudyTrack software, CareTune Petty Cash & Gift Card clinical research department distribution Projects:o Safety and therapeutic measures of transcranial cathodal direct current stimulation in patients with refractory Epilepsyo Medtronic: DBS, VNSo Critical Care Epilepsy Monitoringo Epilepsy Seizure Detection with Innovative Tripolar EEG o EEG Database Analysis for Critical Care patiento Biomarkers for monitoring the risk and treatment of status epilepticus via multi-organ functional network approach.Consulting - Epilepsy 2012 - 2020 USA, Latin America, and Europe Research areas: Functional Neurosurgery, Children's clinical antiseizure treatment and protocol developmentInstitute of Neurology Incorp CEO - Curitiba, Brazil 1981 - 2020 Inherited a 24-bed, three neurosurgeons, two surgical centers specifically for neurosurgery. Built a new location with 65-beds, twelve neurosurgeons in rotation, six surgical centers including Gama-Knife Neurosurgery for Aneurism and general neurovascular, Epilepsy, Brain Tumor Resection Coordination and Management of Clinical Department providing medical solutions for patients with neurological pathology. Mentor 1989-2020 - Mentoring and tutoring neurosurgical resident students participating in the accredited Medical Residency Programs by the Brazilian Ministry of Education and specialties societies in Neurosurgery, Neurology and Health in the Work Environment Professor Medical Surgical Anatomy II FAMECA, So Paulo, Brazil September 2020 Lectures; Neuroanatomy, Surgical History, Clinical Neurosurgery, and studies involving the subthalamic core in brain resection with Mulligan Technique in Epilepsy Surgery Florida Atlantic University - 2002-2012 Boca Raton, Florida, USA Protein Crystallization Research, GABA 65, EEG, fMRI Neurosciences Laboratory Clinical Research in Oncology, Alzheimers Disease collaboration with Boca Raton Clinical Research Institute Epilepsy and Alzheimers Disease Research Group - collaboration with Boca Raton Community Hospital Research Project and Gamma-band activity reflects the metric structure of rhythmic tone sequences in Cognitive Brain ResearchVita Hospital and Nacoes Hospital 1994-2000 - Curitiba, Parana, Brazil Lead Epilepsy Neurosurgeon Collaboration with Neurosurgery Service for the Skull Base Department o pre-operative and post-operative neuropsychological assessment protocol o WADA for EpilepsyEDUCATIONMD - Health Sciences, Medicine/Neurology, subspeciality in Neurosurgery Universidade Federal de Santa Catarina - Reg; Protocol number 0.004759/88-48 Total number of hours, Medicine: 9,180 Completed 1988 Master (specialization) in Medicine sub-areas - Occupational Health in Work Environment/Medicine/NeurologyUFPR Reg: ***13/97 Concepe Universidade Federal do Parana Conselho de Ensino, Pesquisa e Extensao GPA 3.223Monograph The use of neuropsychological assessment and occupational in workers exposed to different levels of Mercury Monograph Grade: 8.0 Completed 1997 Achieved registration to teach higher level education courses. Federal University of Parana, Curitiba, Parana, Brazil Master (specialization) Neuroscience/Learning and Memory / Neuropsychology Reg: 2379 Consepe Conselho de Ensino, Pesquisa e Extensao GPA 3.343 Completed April 1999.Pontificia Universidade Catolica of Parana Curitiba, Parana, Brazil B.S degree in Sciences of EducationTotal number of hours, Education: 4,364 Completed 1988 University Valley of Itajai - Univali, Itajai, Santa Catarina, Brazil Harvard Postgraduate Medical Education: Global Clinical Scholars Research Training 2023-2024 in progressProfessional HMX: Medicine-Cancer Genomics and Precision Oncology Harvard Medical School, April 2021 to November 2021, Boston Massachusetts Professional HMX: Novel Therapies for Chronic Inflammation, Autoimmunity, and Allergy Harvard Medical School, April 2021 to November 2021, Boston Massachusetts Hospital Israelite Alberta Einstein (HIAE) - Mechanical ventilation in COVID -19 and Neurological PatientsApril to October 2020 So Paulo BrazilDesign and Interpretation of Clinical TrialsJohn Hopkins University, February to April 2014Clinical NeurologyUniversity of California, San Francisco, January to March 2014 TRAINING & Certifications ELSO - Extracorporeal Life Support Organization, ECMO Certification The Framingham Heart Study Data Analysis Biomedical Research - Basic/Refresher - Biomedical Research Medidata Classic Rave EDC Essentials for Clinical Research Biomedical Responsible Conduct of Research CITI Conflicts of Interest - Conflicts of Interest Clinical Research Coordinator CRC Clinical Trials Involving Investigational Medical Devices (international focus) (ID 115437) GCP Social and Behavioral Research Best Practices for Clinical Research GCP Social and Behavioral Research Best Practices for Clinical Research (ID 132271) GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) (ID 115436) Good Clinical Practice - Investigator Initiated - Investigators & staff conducting research using investigational drugs/biology (ID 131278) Good Clinical Practice - Investigator Initiated - Investigators and staff conducting research using devices only. Good Clinical Practice - Investigators and staff conducting research using investigational drugs and devices. Good Clinical Practice - Investigators and staff conducting research using investigational drugs/biologics only. Good Clinical Practice - TransCelerate Requirements Good Clinical Practice (U.S. FDA Focus) Human Research - Biomedical Research (ID 8460) Institutional/Signatory Official: Human Subject Research (ID 115433) IRB Chair (ID 115432) John Hopkins University: Design and Interpretation of Clinical Trials NIH: Human Participant Protection Education for Research Teams NIH: Incorporating Cancer Clinical Trial Into your Practice. OSHA Bloodborne Pathogens RCR Basic Course EPIC REDCAP MEDRIO Cerner CRIO STATA Shipping and Transport of Regulated Biological Materials Social and Behavioral Responsible Conduct of Research (ID 115442) PUBLICATIONSNeuroquiescence - A Treatment for Neurodevelopmental and Neurodegenerative Bioelectrical Dysregulation and Demyelination - U.S Patent 11,446,262 Issued 2022Neuroquiescence - A treatment for neurological and nervous system bioelectrical dysregulation associated with neuropathic pain, neurodegenerative disorders, and seizures - USPTO Patent 10,716,792Gamma-Band activity reflects the metric structure of rhythmic tone sequences in Cognitive Brain Research - February 2005 - under the name Debora Yonezawa Tempo dependence of middle- and long-latency auditory responses: power and phase modulation of the EEG at multiple timescales - December 2004 under the name Debora Yonezawa MRI-guided stereo tactic implantation of depth electrodes in epilepsy surgery The first stereo tactic surgery for insertion of depth intern cerebral electrodes in epilepsy in Brazil Journal of Neuro-Psychiatric vol.57 n.3A So Paulo - September 1999 Debora Yonezawa LANGUAGES:English (USA-citizen), Portuguese (Brazilian Citizen), French (National French Diploma), German, Spanish |
