Artur Lubyanoy

• Lead and Site contact for multiple studies
• Coordinated and assisted a team of 4 CRCs and 2 RAs.
• In depth knowledge with regulatory

Vaccines

• A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-XXXX, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Co-administered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine in Adults ≥ 50 Years of Age.
• A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-XXXX, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Co-administered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age.
• A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-XXXX for the Prevention of Illness Due to Influenza A.
• Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety and Immunogenicity of Vaccination with ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years and Older with a History of Urinary Tract Infection in the Past 2 Years.
• A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Safety and Efficacy of mRNA-XXXX Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older.
• A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-XXXX Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age.
• A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-COV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-COV-2 rS) with Matrix M1™ Adjuvant in Adult Participants 18 years with Pediatric Expansion in Adolescents (12 to
• A Phase 3, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Immunogenicity of a Modified RNA vaccine against Influenza Compared to Licensed Inactivated Influenza Vaccine in Healthy Adults 18 years of age or Older.
• A Phase 3, Randomized, Observer-blind, Active-control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-XXXX (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age.

Internal Medicine

• A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-controlled, Efficacy and Safety Study of CBP-XXXX in Patients with Moderate to Severe Persistent Asthma with Type 2 Inflammation.
• Phase 3 Randomized Double-Blind Placebo-Controlled 1-Year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (ADXXXX) to Placebo in Obstructive Sleep Apnea.
• A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilbesiran Used as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication.
• A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Dose Finding, Parallel Group Study to Assess Efficacy and Safety of PF-XXXX, and Open-Label Oral Semaglutide, in Adults with Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled on Metformin, and Separately PF-XXXX Compared to Matching Placebo in Adults with Obesity but Without T2DM.
• A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps.
• A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study To Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled Hypertension.
• An Interventional Phase 2/3, Adaptive, Multi-Center, Randomized, Double-Blind Study to Investigate Efficacy and Safety of Oral Sistunatovir Compared with Placebo in Nonhospitalized Symptomatic Adults with Respiratory Syncytial Virus Infection Who Are At Risk Of Progression to Severe Illness.

Women's Health

• A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept®, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability.
• A Phase 3, Open-label, Multi-Center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17estradiol Combined Oral Contraceptive (OG-XXXX) in Premenopausal Females Aged 14 to 35 Years (Inclusive).
• A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-XXXX in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety.
• A Phase 3 double-blind placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection (EVOGUARD).

Surgical

• A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multi-Center, Active and Placebo Controlled Trial to Evaluate the Analgesic Efficacy and Safety of NTM-001 (A Novel Formulation of Ketorolac Tromethamine Applied by Continuous Intravenous Infusion from a Pre-Mixed Bag) for the Treatment of Moderately Severe Postoperative Pain Following Bunionectomy.