Lori Villarreal

Seasoned Clinical Operations Associate Director with 24 years of clinical research experience, adept in people management and clinical monitoring, excelled in enhancing CRA talent development and streamlining project logistics. Spearheaded innovative training programs and risk assessment processes, ensuring project excellence and operational efficiency.

Phase I Study Designs:

· First-in-human (FIH)

· Single Ascending Dose (SAD)

· Multiple Ascending Doses (MAD)

· ECG-QTc, BA/BE,

· Drug-Drug Interaction (DDI)

· Food Effect (FE)

· Absorption Distribution Metabolism and Excretion (ADME)

· Adhesion

· Hormonal Contraception

· Monoclonal Antibodies and Biologics

Therapeutic Experience:

· Circulatory: Hypertension, Atrial Fibrillation, Acute Coronary Syndrome, Thrombocytopenia

· Dermatology: Herpes Simplex Labialis, Acne, Rosacea

· Digestive System: Dyspepsia, Non-Alcoholic Steatohepatitis, hepatic impairment

· Endocrine/Metabolic: Type II Diabetes, Weight Loss, Hypercholesterolemia, Gout

· Genitourinary: Oral Contraception, Endometriosis, Erectile Dysfunction, Renal Insufficiency, Herpes Genitalia

· Immunology: Inflammation

· Infections/Parasitic Diseases: Adult Vaccinations, Urinary Tract Infections, Infant Vaccinations, Children Vaccinations, Anca-associated vasculitis

· Mental Disorders: General Anxiety Disorder, Insomnia

· Musculoskeletal: Osteoarthritis

· Nervous System/Sense Organs: Carpal Tunnel Syndrome, Epilepsy, Migraines, Alzheimer’s Disease, Anesthesia

· Oncology: Colorectal Cancer

· Rare Disease: Hypophosphatasia

· Respiratory: Chronic Bronchitis

· Women’s Health: Lactation

Associate Director, Clinical Operations

· Pulmonary: A Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of XXX for the Treatment of Pulmonary Arterial Hypertension

· Rare Disease: A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXX in Adults with Hypophosphatasia

· Immunology: A First-in-Human, Phase 1, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XXX in Healthy Adult Subjects

· Nervous System/Sense Organs: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of XXX in Healthy Subjects

· Nervous System/Sense Organs: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of XXX Following Single Ascending Dose Administration to Healthy Volunteers

· Nervous System/Sense Organs: A Single-Center, Double-Blind, Placebo-Controlled Phase 1a Fed-Fasted, Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral Dose of XXX in Healthy Male and Female Subjects

· Infections/Parasitic Diseases: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of XXX in Healthy Adults

· Oncology: A Phase 1, Two-Period, Fixed-Sequence Crossover Study to Assess the Effect of XXX, a Strong CYP1A2 Inhibitor, on the Pharmacokinetics of XXX Following Administration of XXX in Healthy Subjects

· Oncology: A Phase 1, Open-Label, Randomized, Parallel Design Study to Evaluate the Effects of XXX and XXX on Single-dose Pharmacokinetics of XXX in Healthy Adult Participants

· Nervous System/Sense Organs: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXX in Anesthetized Adults

· Circulatory: A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of XXX, a CYP3A and P-glycoprotein inhibitor, and the Effect of XXX, a CYP Enzyme Inducer, on the Pharmacokinetics, of XXX in Healthy Volunteers

· Endocrine/Metabolic: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of XXX on the Pharmacokinetics of a Single Oral Dose of XXX

· Genitourinary: A two-part, randomized, double-blind, single-dose, crossover study to compare formulations produced by two methods of manufacture for bioequivalence and dissolution in healthy adult volunteers

· Respiratory: An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous XXX When Delivered with a Safety Syringe Device or an Autoinjector in Healthy Adult Volunteers

Principal CRA

· Circulatory: A Clinical Outcomes Study of XXX versus Placebo in Subjects with Acute Coronary Syndrome (ACS) to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

· Endocrinology: A Phase III, Placebo-Controlled Evaluation of the Safety and Efficacy of XXX in the Prevention of Type II Diabetes in Adolescents

· Infections/Parasitic Diseases:  Phase IV – Prospective, observational safety study of patients with granulomatosis with polyangitis (Wegner’s) or microscopic polyangiitis treated with XXX

· Oncology: A Phase 2, Open Label, Multicenter, Randomized Trial Comparing XXX in Combination with XXX with XXX in Combination with XXX in Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

· Oncology:  Phase III, multicenter, international, randomized, double-blind, placebo-controlled study of XXX vs. XXX plus placebo in patients with front-line metastatic soft tissue sarcoma

· Women’s Health:  An Open-label, Single Initial-dose, Multi-center Study to Assess the Transfer of XXX from Plasma to Breast Milk Following Administration of XXX to Lactating Women Undergoing a Needed Procedure

Senior CRA

· Circulatory:  A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of XXX in Patients with Recent Onset Symptomatic Atrial Fibrillation

· Endocrine/Metabolic:  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study To Determine The Efficacy and Safety of XXX When Used in Combination With XXX With or Without XXX In Subjects With Type 2 Diabetes Mellitus

· Endocrine/Metabolic:  A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study To Determine The Efficacy and Safety of XXX When Used in Combination With XXX Plus XXX Compared With XXX Plus XXX and Placebo And With XXX Plus XXX and XXX In Subjects With Type 2 Diabetes Mellitus

· Endocrine/Metabolic:  A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study To Determine The Efficacy and Safety of XXX When Used in Combination With XXX Compared With XXX Plus XXX, XXX Plus XXX, and XXX Plus Placebo In Subjects With Type 2 Diabetes Mellitus

· Endocrine/Metabolic:  A Randomized, Open-Label, Parallel-Group, Multicenter Study To Determine The Efficacy and Long-Term Safety of XXX Compared With XXX In Subjects With Type 2 Diabetes Mellitus

· Infections/Parasitic Diseases:  A phase III, double-blind, randomized study to evaluate the immunogenicity and safety of XXX influenza vaccine compared to XXX influenza vaccine administered intramuscularly in children aged 3 to 17 years and to describe the safety and immunogenicity of XXX influenza vaccine in children aged 6 to 35 months

· Infections/Parasitic Diseases:  A phase III randomized, partially-blind, controlled, multi-country, multi-centre study to evaluate the immunogenicity, reactogenicity and safety of XXX influenza vaccine and to evaluate the clinical consistency of three production lots of XXX in terms of immunogenicity, when administered intramuscularly to adults 18 years of age and older

· Musculoskeletal:  Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of XXX with Vehicle in Patients Undergoing Allograft ACL Reconstruction

· Musculoskeletal:  Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of XXX with Vehicle in Patients Undergoing Autograft ACL Reconstruction

· Respiratory:  Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of XXX in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)

· Respiratory:  A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of XXX Nasal Aerosol (320 mcg once daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)

CRA III

· Circulatory:  A Phase IV multi-center, double-blind, randomized, placebo-controlled study of the safety and tolerance of XXX in subjects with asthma or chronic obstructive pulmonary disease (COPD).

· Circulatory:  A Phase IV multi-center, double-blind, randomized, placebo-controlled study of the safety and tolerance of XXX in subjects with renal insufficiency.

· Dermatology:  A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of XXX with XXX in the Treatment of Adults with Complicated Skin and Skin Structure Infection

· Endocrine/Metabolic: A Phase II, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Treatment with XXX in Subjects with Type 2 Diabetes.

· Endocrine/Metabolic: A Double-Blind, Placebo-Controlled Randomized Study of the Safety and Efficacy of a Combination of Insulin and XXX mg or XXX mg of XXX in the Treatment of Patients with Type 2 (Non-Insulin Dependent) Diabetes Mellitus.

· Endocrine/Metabolic: A Multi-center, Double-Blind, Randomized, Placebo-and Active-Controlled, Parallel Study to Evaluate the Glucose and Lipid Altering Efficacy and Safety of XXX in Patients with Type 2 Diabetes.

· Endocrine/Metabolic: A Multi-center, Double-Blind, Randomized, Placebo-and Active-Controlled, Parallel Study to Evaluate the Glucose and Lipid Altering Efficacy and Safety of XXX in Patients with Type 2 Diabetes already on XXX.

· Endocrine/Metabolic: A Double-Blind, Multicenter, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of XXX QD in Comparison to XXX BID in Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM).

· Endocrine/Metabolic: A Double-Blind, Multicenter, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of XXX versus XXX versus XXX in Drug Naïve Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM).

· Endocrine/Metabolic: A Double-Blind, Placebo-Controlled Randomized Study of the Safety and Efficacy of a XXX versus XXX versus XXX in the Treatment of Type 2 (Non-Insulin Dependent) Diabetes Mellitus.

· Respiratory:  Phase III, Randomized, Double-blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of XXX in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF)

CRA II

· Digestive System:  A Phase 2, Randomized, Double‑Blind, Parallel‑Group, Placebo‑Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Activity of XXX in Adults with Non‑Alcoholic Steatohepatitis (NASH)

· Nervous System/Sense Organs: A Sequential, Open-Label Study of the Pharmacokinetics and Safety of XXX Relative to XXX in Adult Patients with Epilepsy.

· Mental Disorder:  A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of XXX on Sleep using a Post Sleep Questionnaire-Interactive Voice Response System (PSQ-IVRS) in an “At-Home Setting” in an Adult Population with Chronic Insomnia”.

· Mental Disorder:  A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Polysomnographic and Outpatient Study to Assess the Efficacy and Safety of XXX in Adult Primary Insomnia Patients.

· Mental Disorder:  An Evaluation of the Ocular Surface Health in Subjects Using XXX Ophthalmic Solution Versus XXX Ophthalmic Solution

CRA I

· Nervous System/Sense Organs:  A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the XXX with Placebo in Patients with Pain from Carpal Tunnel Syndrome.

· Nervous System/Sense Organs:  Phase III, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with XXX on Measures of Cognition Activities of Daily Living Global function in Subjects with Mild Dementia of the Alzheimer’s Type.

· Nervous System/Sense Organs:  Phase III Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with XXX on Measures of Cognition Activities of Daily Living Global function in Subjects with Mild Dementia of the Alzheimer’s Type.

Trials Managed While a Study Coordinator

· Circulatory: A Randomized, Double-Blind, Active-Controlled Comparison of XXX and XXX in Subjects with Newly Diagnosed or Established Hypertension.

· Circulatory: A Randomized, Double-Blind Comparison of XXX and XXX in the Treatment of Mild to Moderate Hypertension.

· Circulatory: Open Label Use Of XXX In The Treatment Of Mild To Moderate Hypertension: An Extension Of Protocol XXX.

· Circulatory: A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Phase IV Study Comparing XXX Versus XXX Taken Orally for 8 Weeks in Patients With Stage I or II Hypertension.

· Dermatology: A Randomized, Double-Blind, Placebo Controlled, Study of the Safety and Efficacy of Topical Applications of XXX to Recurrent Lesions Associated with Herpes Simplex Labialis.

· Dermatology: A Phase IV, Double-Blind, Multi-center, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD Deficient Subjects With Acne Vulgaris Treated With XXX.

· Dermatology:  A multicenter, open-label, single-arm study to evaluate the safety and pharmacokinetics of XXX single 1500 mg dose in adolescents with recurrent herpes labialis

· Dermatology: A Phase II, Randomized, Partial-Blind, Parallel Group, Active and Vehicle-Controlled, Multi-Center Study of the Safety and Efficacy of XXX in Subjects With Rosacea.

· Digestive System: A Trial Evaluating the Efficacy and Safety of XXX for Treating Heartburn in Frequent Sufferers.

· Endocrine/Metabolic: XXX and XXX in Patients with Primary Hypercholesterolemia, CHD or Multiple Risk Factors.

· Endocrine/Metabolic: Long-Term, Open-Label, Safety and Tolerability Study of XXX in Addition to XXX in Subjects with Primary Hypercholesterolemia Who Have Previously Completed the 12 Week Double Blind Study.

· Endocrine/Metabolic: A 12 Week Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Assess Safety and Efficacy of XXX Compared to XXX in Obese Patients.

· Endocrine/Metabolic: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with XXX in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

· Endocrine/Metabolic A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with XXX in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

· Genitourinary: A 12-month, Open Label Study to Test the Safety of XXX for Oral Contraception in Women of Childbearing Potential.

· Genitourinary: Pharmacokinetics of Orally Administered XXX in Subjects with Mild to Severe Renal Insufficiency.

· Genitourinary: Open Study to Further the Safety and Reactogenicity of XXX with XXX in Women with No Previous History of Herpes Genitalia.

· Genitourinary: Phase III Study of XXX in Women with Endometriosis in US and Canada.

· Genitourinary: A Randomized, Double Blind, Parallel Group Study to Compare the Safety and Efficacy of XXX and XXX in the Treatment of Uncomplicated Female Urinary Tract Infection.

· Genitourinary: An Open-Label Study to Evaluate the Efficacy and Safety of XXX Administered "On Demand" to Men of Various Populations with Erectile Dysfunction.

· Genitourinary:  A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of XXX in Subjects with Renal Impairment

· Infections/Parasitic Diseases: Randomized, Double Blind (Double Dummy), Parallel Group Pilot Study to Assess the Comparative Efficacy, Safety, and Tolerability of Once Daily Extended Release and BID Immediate Release XXX Formulations in Female Patients with Uncomplicated Urinary Tract Infections (UTI).

· Infections/Parasitic Diseases: A Comparative Trial of the Safety One Dose of an XXX Versus XXX in Healthy Children in the US Aged 11 to 18 Years.

· Infections/Parasitic Diseases: A Comparative Trial of the Safety One Dose of an XXX Versus XXX in Healthy Children in the US Aged 2 to 10 Years.

· Infections/Parasitic Diseases: A Comparative Trial of the Safety One Dose of an XXX Versus XXX in Healthy Adults in the US Aged 18 to 56 Years.

· Infections/Parasitic Diseases: A Trial of the Lot Consistency of an XXX and the Safety of Immunogenicity of XXX Compared with XXX among Healthy Adults in the US.

· Infections/Parasitic Diseases: A Comparison of the Safety, Tolerability, and Immunogenicity of XXX Versus XXX in Healthy Children 12 to 18 Months of Age.

· Infections/Parasitic Diseases: An Evaluation of Safety and Tolerability of Administration of XXX to Healthy Children at 4 to 6 Years of Age.

· Infections/Parasitic Diseases: A Lot Comparison of the Safety, Tolerability, and Immunogenicity of XXX Versus XXX versus XXX in Healthy Newborns 2 Months of Age.

· Infections/Parasitic Diseases: A Comparison of the Safety, Tolerability, and Immunogenicity of XXX Versus XXX in Healthy Newborns 2 Months of Age.

· Infections/Parasitic Diseases: A Comparison of the Safety, Tolerability, and Immunogenicity of XXX in Healthy Newborns 2 Months of Age When Given With and Without Prevnar.

· Infections/Parasitic Diseases: A Trial Evaluating the Safety, Tolerability, and Immunogenicity of XXX Given to Healthy Infants at 15 Months of Age.

· Infections/Parasitic Diseases: Observer-Blinded, Randomized, Phase III Study to Investigate the Non-inferiority of XXX versus XXX as vaccines for Japanese Encephalitis in healthy subjects.

· Infections/Parasitic Diseases:  A phase III, double-blind, randomized study to evaluate the immunogenicity and safety of XXX influenza vaccine compared to XXX influenza vaccine administered intramuscularly in children aged 3 to 17 years and to describe the safety and immunogenicity of XXX influenza vaccine in children aged 6 to 35 months

· Musculoskeletal: A Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of XXX (XXX mg/day) and XXX (XXX mg/day) in the treatment of Osteoarthritis of the Hip or Knee.

· Nervous System/Sense Organs: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of XXX in Acute Treatment of Migraine.

· Nervous System/Sense Organs: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Multiple Dosages of XXX in Acute Treatment of Migraine.

· Nervous System/Sense Organs: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Injectable XXX in Acute Treatment of Migraine.

· Nervous System/Sense Organs: An Observational, Multiple-Attack Study In Migraineurs To Determine The Incidence and Impact of Migraine Relapse and Recurrence Associated With XXX Treatment.

· Nervous System/Sense Organs: A Survey of Random Patients to Evaluate the Effectiveness of a General Anxiety Disorder Questionnaire in Diagnosing GAD.

· Respiratory: The Efficacy and Safety of 5 Days XXX Versus 10 Days XXX in the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB).