Sponsor Stage Ii

CURRICULUM VITAE

JUANA MARCIA PELEGRI Office: 305-***-****

Cell: 954-***-****

E-mail: ************@******.***

EDUCATION:

**/**** – Present Grand Canyon University Phoenix, AZ

Doctor of Philosophy General Psychology

Emphasis in Cognition and Instruction

01/2015 – 02/2017 Grand Canyon University Phoenix, AZ

Mater of Science in Psychology

Emphasis in General Psychology

12/2006 – 12/2013 Florida Atlantic University Davie, FL Bachelor of Arts in Experimental Psychology

Concentration in Research Psychology, Research

Mild cognitive impairment, Alzheimer's interviewer,

neurological testing, cross-culture bias/data entry

EMPLOYMENT:

IMIC Research April 2018-Present

Miami, FL

Psychometric Rater/CRC

Sub-Investigator

Administered psychometric efficacy scales based on protocol requirements. Such as;

CDR, ZBI TUB S-STS, GMHR, NPI, CSDD, ADAS-Cog, MMSE,

NPI, NPI-Q ADCS CGIC, CMAI, mRS, NIHSS, GOS-E TMT

BI, C-SSRS, MoCA, Vineland, WMS

Create source documents as per-protocol and study manuals.

Abstract medical history of the subject and assess subject protocol eligibility

Document date of training and signature of study personnel trained on study specific training logs

Collect documents needed to initiate the study and submit to the sponsor (e.g., FDA forms, 1572, CVs, financial disclosure).

Work with business development to create and implement recruitment strategies, in accordance, with Internal Review Board (IRB) requirements and approvals.

Conduct or participate in the informed consent process. Obtain informed consent signatures.

Answering any questions related to the study and study procedure as per protocol.

Screen Subject for eligibility using protocol-specific inclusion and exclusion criteria

Documenting each potential participant's eligibility and advise the sponsor of the potential subject.

Coordinate the subject's participation test and procedures.

Collect data as required by protocol and completion of Case Report Forms.

Maintains study timeline accuracy

Maintain adequate inventory of study supplies (e.g., urine pregnancy test, urine cups, and other study supply required)

Drug accountability of Investigational Product

Complete study documentation and maintain study files, in accordance, with the sponsor and IRB requirements including but not limited to filing deviations, reporting, and following up with AE and SAE.

Recruiting and maintaining communications with subjects

Maintain active and ongoing communications with sponsors.

Works with Principal Investigator to manage the day to day activities of the study including problem-solving, communication and protocol management

Lovgeveron, LLC December 2018 - April 2019

Miami, FL

Clinical Research Associate –In house

Ensure data quality and compliance with protocol, SOPs, and regulations at assigned study sites.

Monitor patient recruitment timelines at sites and report this information to assigned line manager.

Assist with the arranging of study start-up meetings.

Prepare for and attend investigator’s meetings, clinical monitoring staff meetings, and project team meetings.

Understand the protocol and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel.

Conduct clinical protocol training and Standard Operating Procedure (SOP) training.

Develop, implement, and track activities related to CRAs and clinical sites.

Conduct site selection activities including site selection visits.

Perform site qualification visits, initiation visits, interim monitoring visits, and close-out visits.

Write and review case report forms.

Responsible for checking supplies and site compliance with protocol and all current and relevant GCP and federal regulations.

Responsible for conducting source data verification and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit.

Write and submit site visit reports per specified timelines and guidelines.

The Neurology Research Group, LLC October 2017 - December 2018

Miami, FL

Psychometric Rater

Administered psychometric efficacy scales based on protocol requirements. Such as;

ZBI TUB S-STS, GMHR, NPI, CSDD, ADAS-Cog, MMSE,

NPI, NPI-Q ADCS CGIC, CMAI, mRS, NIHSS, GOS-E TMT

BI, C-SSRS, MoCA, Vineland, WMS

Determine the subject impression based on DSM IV and 5

Complete subject interviews to determine the level of function.

Alpha Science Research, LLC June 2016 -December 2018

Miami, FL

Clinical Research Associate/Coordinator

Create source documents as per-protocol and study manuals.

Abstract medical history of the subject and assess subject protocol eligibility

Document date of training and signature of study personnel trained on study specific training logs

Collect documents needed to initiate the study and submit to the sponsor (e.g., FDA forms, 1572, CVs, financial disclosure).

Work with business development to create and implement recruitment strategies in accordance with Internal Review Board (IRB) requirements and approvals.

Conduct or participate in the informed consent process. Obtain informed consent signatures.

Answering any questions related to the study and study procedure as per protocol.

Screen Subject for eligibility using protocol-specific inclusion and exclusion criteria

Documenting each potential participant's eligibility and advise the sponsor of the potential subject.

Coordinate the subject's participation test and procedures.

Collect data as required by protocol and completion of Case Report Forms.

Maintains study timeline accuracy

Maintain adequate inventory of study supplies (e.g., urine pregnancy test, urine cups, and other study supply required)

Drug accountability of Investigational Product

Complete study documentation and maintain study flies in accordance with sponsor and IRB requirements, including but not limited to filing deviations, reporting, and following up with AE and SAE.

Recruiting and maintaining communications with subjects

Maintain active and ongoing communications with sponsors.

Works with Principal Investigator to manage the day to day activities of the study including problem-solving, communication and protocol management

Clinical Trials of Florida, LLC April 2015 – December 2018

Miami, FL

Assistant Site Director (December 2016 to December 2018)

Quality Control/Clinical

Research Associate/Lead Clinical Research Coordinator

Responsible for creating Standard Operating Procedures (SOPs)

Verifying clinical compliance with applicable Standard Operating Procedures (SOPs) and regulations by performing daily internal audits.

Promotes Quality by preparing Project Specific Procedures, providing training to staff, and supporting the Quality Management System.

Responsibilities include but not limited to hosting client audits, conducting external reviews at clinical sites and vendor sites,

Reviewing clinical quality management plans, leading process improvement activities

Create source documents as per-protocol and study manuals

Abstract medical history of the subject and assess subject protocol eligibility.

Documents date of training and signatures of study personnel trained on study specific training log.

Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, financial disclosure).

Works with business development to create and implement recruitment strategies in accordance with Internal Review Board ORB) requirements and approvals.

Conducts or participates in the informed consent process. Obtain informed consent signatures

Answering any questions related to the study and study procedure as per protocol.

Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria.

Documenting each potential participant's eligibility and advising sponsor of likely subjects.

Coordinate the subject's participant tests and procedures.

Collects data as required by the protocol and completion of Case Report Forms.

Maintains study timeline accuracy.

Maintains adequate inventory of study supplies. (e.g., urine pregnancy test, urine cups, and any other study supply required)

Drug Accountability (Investigational product)

Completes study documentation and maintains study files, in accordance, with the sponsor and IRB requirements including but not limited to filing deviations, reporting and following up with

AE and SAE

Recruiting and maintaining communication with subjects

Maintains effective and ongoing communication with the sponsor

Design data collection forms, known as case report focus (CRFs)

Coordinate with the ethics committee, which safeguards the rights, safety, and wellbeing of all trial subjects

Identify and assess the suitability of facilities to use as the clinical trial site

Train the site staff to trial-specific industry standards

Monitor the trial throughout its duration, which involves visiting the trial sites regularly (e.g., The Neurology Group and Alpha Science Research

Verify that data entered on to the CRFs is consistent with patient clinical notes,

Collect completed CRFs from hospitals and general practices

Write visit reports and file and collate trial documentation and reports

Account for and return all un-used trial supplies

Close-down trial sites on completion of the trial

Archive study documentation and correspondence

11/1998 – Present Pulmonary Physicians of South Florida Miami, FL

Pan Am Office

Research Assistant, X-Ray tech

242 NE LeJeune Road Miami, FL 33126

RESEARCH TRAINING: EXPIRATION DATE

CITI GCP & HIPPA Certificate : July 2021

IATA June 2021

I.V. Certificate April 2021

DOCTORAL RESEARCH 2017-Present

Department of Psychology, Grand Canyon University

A Qualitative Study to Explore How Hispanic Immigrants in Florida Adapt to Using Non-native Language in the Workplace.

I conducted primary source research at numerous archives, examining publication history through multiple sources.

Examined the literature of Sigmund Freud, B.F. Skinner, Carl Jung, and John Watson exploring their publication records, construction of synthesis identity,

RESEARCH ASSISTANCE 2009-2013

Department of Psychology, Florida Atlantic University

Cross-Cultural Comparison of Community-Dwelling Adults' Willingness to be Screened for Cognitive Impairment and to Pursue Follow-up Diagnostic Evaluation

Use of the MC-FAQ and MMSE-FAQ in Cognitive Screening of Older African Americans, Hispanic Americans, and European Americans.

Cognates facilitation effect in balanced and non-balanced bilinguals using the Boston naming test. International Journal of Bilingualism.

RESEARCH TRIAL EXPERIENCE:

Phase III A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with XXXXX, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo. 2015

Phase III A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy and Safety of XXXXX, XXXXX, and XXXXX in Subjects with Moderate to Very Severe COPD, Compared with Placebo. 2015

Phase III A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of XXXX Relative to XXXXX and XXXXX on COPD Exacerbations over a 52-Week Treatment Period in Subjects with Moderate to Very Severe COPD. 2015

Phase III XX-XXXX-XXXX: A Phase 3, 12-week, Randomized, Double−Blind Placebo−Controlled Parallel-Group Study of Nebulized XX-XX XX in Subjects with Chronic Obstructive Pulmonary Disease. 2015

Phase III A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment with Nebulized SUN-XXX in Patients with COPD: XXXXXX-X (Glycopyrrolate For Obstructive Lung Disease Via Electronic Nebulizer). 2015

Phase III A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of XXXX, XXXXXX, XXXXX Compared with Symbicort ® Turbuhaler ® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease. 2015

Phase III A Randomized, Double-Blind Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment with Nebulized SUN-XXX in Patients with COPD: Golden-3 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer. 2015

Phase III A Phase 3, 12-week, Randomized, Double−Blind Placebo−Controlled Parallel Group Study of Nebulized TD−XXXX in Subjects with Chronic Obstructive Pulmonary Disease. 2015

Phase IIb A 12-Week Study to Assess the Efficacy and Safety of XXXX in Subjects with Treatment Refractory Chronic Cough. 2016

Phase III A Randomized, Double-Blind, Parallel-Group, Multi-Center Study to Assess the Efficacy and Safety of XXXX Compared to XXXX, XXXX, and Open-label SymbicortP® TurbuhalerP®, as an Active Control, on Lung Function over a 24-Week Treatment Period in Subjects with Moderate to Very Severe COPD. 2016

Phase III A 24-week treatment, multi-center, randomized, double-blinded, double-dummy, parallel-group, a clinical trial is evaluating the efficacy and safety of XXXXXX/XXXXXXX μg fixed-dose combination BID compared with each monotherapy XXXXXXXXXX and XXXXXXXXX and XXXXXXX QD when administered to patients with stable chronic obstructive pulmonary disease. 2016

Phase III A Double-blind, Randomized, Placebo-Controlled, Two Arm Multi-Center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of XXXXXXXX for Extended-Release Oral Suspension (XXXX) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy. 2016

Phase II A Dose-Ranging, Parallel-Group, Active (Spiriva® Respimat®) and Placebo-controlled Study to Assess Relative Bioavailability, Pharmacodynamics and Safety of Three Doses of XXXXXXXX Inhalation Solution in Subjects with Mild to Moderate Chronic Obstructive Pulmonary Disease. 2017

Phase III A 6-week, randomized, double-blind, placebo and active-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of 4 doses of XXXX pMDI (XXXXXXXXXXXXXX) in subjects with Chronic Obstructive Pulmonary Disease (COPD). 2017

Phase II A Dose-Ranging, Parallel-Group, Active XXXXX, and Placebo-controlled Study to Assess Relative Bioavailability, Pharmacodynamics, and Safety of Three Doses of XXXXXXX XXXXXXX Inhalation Solution in Subjects with Mild to Moderate Chronic Obstructive Pulmonary Disease. 2017

Phase III A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center study To assess the Efficacy and Safety of XXXX Compared to XXXX in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease. 2017

Sample The primary objective of this study is to obtain de-identified, clinically characterized

plasma specimens for use in assessing new biomarkers for the detection of neoplasms of

the lung. 2017

Sample To establish a control population to assess the performance of an investigational diagnostic test targeting lung neoplasms. 2017

Device The purpose of the trial is to evaluate the performance, comfort, and ease of use of the

XXXX Nasal Mask in the home environment in Obstructive Sleep Apnea. 2017

Device The purpose of the trial is to evaluate the performance, comfort, and ease of use of the

XXX Full Face Mask Seal in the home environment in Obstructive Sleep Apnea. 2017

Phase III A Randomized, Double-Blind, Parallel-Group, Multi-Center 24-Week Study Comparing

the Efficacy and Safety of Three Doses of XXXX to Placebo and Open-label XXXXX in

Subjects with Persistent Asthma. 2017

Phase III Safety and Efficacy Study of XXXXXX in Subjects with evidence of Early Alzheimer's Disease. 2017

Phase II Multicenter, randomized, double-blind, placebo controlled comparing XXXXX and XXXX of XXXXXXX with placebo over 52 weeks with subject mild Alzheimer's Disease dementia. 2017

Phase III Multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety and tolerability of XXXXXXX/ XXXXXX for the treatment of agitation in patients with dementia of the Alzheimer's type. 2017.

Phase IIb Randomized, blinded and placebo-controlled trial to evaluate the safety and efficacy of Logeveron Allogeneic Human Mesenchymal stem cells infusion in patients with aging Frailty 2017

Phase I Prospective, Randomized, Double-Blinded, Placebo-controlled, Trial to Evaluate the Safety and Potential Efficacy of Longeveron Allogeneic Human Mesenchymal Stem Cell (LMSCs) Infusion Versus Placebo in Patients with Alzheimer's Disease 2019.

Phase I Effects of Intravenous Delivery of Longeveron Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody Responses in Subjects with Aging Frailty 2018.

Phase 1 10 patient safety run-ins: all patients treated with LMSCs during Stage II surgery. 2018

Phase II 20 patients randomized 1:1 to receive either LMSCs or no cells (controls) during Stage II surgery. 2018.

Phase III Multi-center, randomized double-blind trial to fixed dose Brexpiprazole as combination therapy with Sertraline in the treatment of adult with Post-traumatic Stress Disorder. 2019

Phase III A Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XXXX (low-does Levetiracetam, 220mg, extended release tablet) on slowing down progression of mild cognitive impairment due to Alzheimer’s Disease 2020.

Phase III A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients with Mild to Moderate Alzheimer’s Disease. 2019

Phase III A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study with an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease 2019

Phase III Safety and Efficacy Study of XXX-XXX in Subjects with Evidence of Early Alzheimer's Disease 2019

Phase II PTI-125 for Mild-to-moderate Alzheimer's Disease Patients. 2019

Phase II PTI-125, 100 mg, for Mild-to-moderate Alzheimer's Disease Patients. 2019

Phase III Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease Mild Cognitive Impairment, Prodromal Alzheimer's Disease 2019

Phase III A 24-Month Study to Evaluate the Efficacy and Safety XXXX in Subjects with Early Alzheimer's Disease 2019

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