Rinaldo Caro Sanchez

Board certified in Internal Medicine, serving our diverse community for more than 14 years as Primary investigator and primary care physician. I have established over the years a solid professional relationship with sub investigators in Pulmonology, Nephrology, Cardiology, Psychiatry, Gastroenterology, Oncology, Dermatology, Infectious Diseases, Psychiatry, Rheumatology, Pain Management, Endocrinology, Neurology, Radiology, and Interventional Radiology.

Board Certified, Internal Medicine

• Melgar-Caro Med Center and Community Research (MCMCR), Primary Care Physician/Principal Investigator, 08/01/23- Present
• University of Medicine and Dentistry of New Jersey, Internal Medicine Residency, 07/01/07-06/30/10
• University School of Medicine of Havana, Cuba, Doctor of Medicine, 09/01/96-07/31/02
• Internal Medicine Board Certified, Florida Medical License, ME 106399, Advanced Principal Investigator Physician Certification (APICPC), CCRPS, ACLS/BCLS certified, Member of Society of Hospitalist Medicine, Good clinical practice, Human subject training, Rating Scales related to Dementia, Agitation, Depression, Dermatology, Psychiatry, Baptist Hospital of Miami, Internal Medicine Physician, 07/01/17-03/17/25
• Kendall Regional Medical Center, Internal Medicine, Hospitalist Physician, Core Faculty of Internal Medicine Residency Program, 09/01/10-06/30/17.
• University of Medicine and Dentistry of New Jersey, Internal Medicine Resident, 07/01/07, 06/30/10.
• Best Choice Medical & Research Service, Inc, Principal Investigator, 02/01/21- 07/31/23.
• Verus Clinical Research Corporation, Principal Investigator-Sub Investigator, 08/01/16-01/31/22.
• Pan American Health Center, Medical Director/Primary Care Provider/Principal Investigator, 06/01/10-07/31/16
• Closely worked with pharmaceutical companies and IRBs as Principal Investigator and Sub Investigator with adult subjects for multiple therapeutic indications and devices from phase I to IV for more than 14 years.

o Closely worked with pharmaceutical companies and IRBs as Principal Investigator and Sub

Investigator with adult subjects for multiple therapeutic indications and devices from phase I to IV.  o A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,

parallel-group trial with a quetiapine arm to evaluate the efficacy, tolerability, and safety of oral Bl

1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

o Randomized, double-blind (patient, investigator), placebo-controlled, Parallel-group, single-dosing study on safety, tolerability, pharmacokinetic and preliminary efficacy of Bl 1569912 as adjunctive

therapy in patients with major depressive disorder.

o A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the

Efficacy,  Safety,  and  Tolerability  of  AVP-786  (Deudextromethorphan  Hydrobromide

[d6DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the

Alzheimer's Type.

o Phase 4, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks IP bid for smoking cessation in subjects with and

without a history of psychiatric disorders.

o A multicenter randomized, double-blind, placebo-controlled 12 week study to evaluate the safety and efficacy of oral Difelikefalin in advanced chronic kidney disease subjects with moderate to severe

pruritus with an up to 52 week long term extension.

o A randomized, double-blind, placebo-controlled, efficacy, safety, and tolerability study of IP in the treatment of elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimerls type.

A phase Ill randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of ip once daily over 26 week treatment period in patients with schizophrenia (connex2).

o Study in stabilized schizophrenic patients to evaluate the pharmacokinetics of IP and IP when IP is administered from a polyurethane implant.

Phase III Randomized, double-blind, placebo-controlled, three-arm, 12-month, safety and efficacy study of ip monotherapy in subjects with alzheimer's disease followed by a 12-month open-label treatment.

o Ahead 3-45 study: a placebo-controlled, double-blind, parallel-treatment arm, 216 week study to evaluate efficacy and safety of treatment with IP in subjects with preclinical alzheimer's disease and elevated amyloid (a45 trial) and in subjects with early preclinical alzheimer's disease and intermediate amyloid (a3 trial).

o A placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm safety and efficacy of IP in subjects with early alzheimer's disease.

o A phase III, open-label, parallel-group, 2-arm study to investigate amyloid plaque clearance with IP compared with IP in participants with early symptomatic alzheimer's disease.

o A phase Ill, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of IP in patients with early (prodromal to mild) alzheimer's disease.

o A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of

AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer's Type.

o An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with

Dementia of Alzheimer's Type.

A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 when administered to participants with Alzheimer's disease and vascular pathology.

o A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's

Disease.

o Assessment of safety and efficacy measured by amyloid reduction of Remternetug in early symptomatic

Alzheimer's disease. Jl G-MC-LAKC.

o Randomized, Delayed Start, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study of Piromelatine 20 Mg in Participants with Mild Dementia due to Alzheimer's Disease.

o Multicenter, double-blind, parallel-group, randomized, 48 weeks, dose-ranging, placebo-controlled

phase Il trial to evaluate efficacy, safety and tolerability of multiple subcutaneous doses of IP in patients with non-alcoholic steatohepatitis (NASH) and fibrosis.

o A 26-week, phase 2b, 2-part, randomized, double-blind, placebo-controlled, parallel group, doseranging study to evaluate the efficacy and safety of ip administration in adults with obesity.

o A phase 2a, 2-part, randomized, double-blind, double-dummy placebo-controlled, parallel-group (sponsor open) study to assess pharmacodynamics and safety of IP coadministered with IP in adult participants with presumed nonalcoholic steatohepatitis (nash).

o A randomized, double-blind, placebo-controlled, multicentre, phase 3 study evaluating long-term efficacy and safety of IP in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (f2)/fibrosis 3 (f3) stage of liver fibrosis.

A phase 2, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dosefinding, parallel group study to assess efficacy and safety of ip alone and when administered with

IP in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3. oA phase II, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacodynamic

effects of IP in obese subjects with non-alcoholic fatty liver disease

(NAFLD)/ non-alcoholic steatohepatitis (NASH).

o A Phase lla, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis.

Efficacy and safety investigation of NNCOI 94-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial.

o A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and

Efficacy of NGIOI Administered Orally to Patients with Gastroparesis.

o A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as

Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with

Presumed Non-Alcoholic Steatohepatitis (NASH).

o Cardiometabolic risk, obesity and cardiovascular disease in people with spinal cord injury.

o A randomized, double-blind trial to test higher- versus lower-doses of IP on inflammatory markers and platelet biomarkers and nitric oxide formation & endothelial function in secondary prevention (pts w/chronic stable coronary disease).

Zilebesiran as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication.

o Phase Ill, randomized, double-blind, parallel-group, event-driven, cardiovascular safety study with BI

456906 administered subcutaneously compared with placebo in participants with overweight or obesity.

o Multi-center, randomized, double-blind, placebo-controlled study of IP in patients with mildmoderate covid-19.

o A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and

Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19.

A multicenter, randomized, double-blind, parallel group phase Il study to evaluate the safety, tolerability and pharmacokinetics of a second-generation IP material in non-hospitalized participants with mild to moderate coronavirus disease 2019 (covid-19).

o A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody IP for the early treatment of coronavirus disease 2019 (covid-1 9) in nonhospitalized patients.

o A phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody IP given intramuscularly versus intravenously for the treatment of mild/moderate

coronavirus disease 2019 (covid-19) in high-risk non-hospitalized patients.

o A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBl-0451 Compared with Placebo in Non hospitalized

Symptomatic Adults with COVID-19 (PBl-0451-0002).

o A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants.

o A single-dose, open-label, parallel-group, matched trial evaluating the pharmacokinetics of oral IP tablets in subjects with normal renal function and renally impaired subjects.

o A phase Il study to evaluate the safety and efficacy of OQLOII on VEGFR inhibitor associated hand foot skin reaction in cancer patients.

o A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety

Study of Povorcitinib in Participants with Inadequately Controlled Moderate to Severe Asthma.

A Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and Safety of EDP-938 in non-hospitalized adults with acute respiratory syncytial virus infection who are at high risk for complications.

o A Randomized, double blind study assessing the long term effect of Dupilumab on prevention of

Lung function decline in patient with moderate to severe asthma.

o A phase 3 study to evaluate the efficacy, immunogenicity, and safety of respiratory syncytial virus

(RSV) prefusion f subunit vaccine in adults.

o A phase 1/2 randomized study to evaluate the safety, tolerability, and immunogenicity of a modified

RNA vaccine against influenza in healthy individuals.

o A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the

Recombinant MVA-BN@ -RSV Vaccine in Adults 260 Years of Age.

o An open-label, non-randomized, multi-center pivotal Phase 3 study to evaluate the efficacy and safety of PET imaging with [18F] PI-2620 for the detection of tau deposition when compared to post-mortem

histopathology short title: [1 8F] PI-2620 Phase 3 histopathological study.o Closely worked with pharmaceutical companies and IRBs as Principal Investigator and Sub

Investigator with adult subjects for multiple therapeutic indications and devices from phase I to IV.  o A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,

parallel-group trial with a quetiapine arm to evaluate the efficacy, tolerability, and safety of oral Bl

1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

o Randomized, double-blind (patient, investigator), placebo-controlled, Parallel-group, single-dosing study on safety, tolerability, pharmacokinetic and preliminary efficacy of Bl 1569912 as adjunctive

therapy in patients with major depressive disorder.

o A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the

Efficacy,  Safety,  and  Tolerability  of  AVP-786  (Deudextromethorphan  Hydrobromide

[d6DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the

Alzheimer's Type.

o Phase 4, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks IP bid for smoking cessation in subjects with and

without a history of psychiatric disorders.

o A multicenter randomized, double-blind, placebo-controlled 12 week study to evaluate the safety and efficacy of oral Difelikefalin in advanced chronic kidney disease subjects with moderate to severe

pruritus with an up to 52 week long term extension.

o A randomized, double-blind, placebo-controlled, efficacy, safety, and tolerability study of IP in the treatment of elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimerls type.

A phase Ill randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of ip once daily over 26 week treatment period in patients with schizophrenia (connex2).

o Study in stabilized schizophrenic patients to evaluate the pharmacokinetics of IP and IP when IP is administered from a polyurethane implant.

Phase III Randomized, double-blind, placebo-controlled, three-arm, 12-month, safety and efficacy study of ip monotherapy in subjects with alzheimer's disease followed by a 12-month open-label treatment.

o Ahead 3-45 study: a placebo-controlled, double-blind, parallel-treatment arm, 216 week study to evaluate efficacy and safety of treatment with IP in subjects with preclinical alzheimer's disease and elevated amyloid (a45 trial) and in subjects with early preclinical alzheimer's disease and intermediate amyloid (a3 trial).

o A placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm safety and efficacy of IP in subjects with early alzheimer's disease.

o A phase III, open-label, parallel-group, 2-arm study to investigate amyloid plaque clearance with IP compared with IP in participants with early symptomatic alzheimer's disease.

o A phase Ill, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of IP in patients with early (prodromal to mild) alzheimer's disease.

o A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of

AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer's Type.

o An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with

Dementia of Alzheimer's Type.

A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 when administered to participants with Alzheimer's disease and vascular pathology.

o A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's

Disease.

o Assessment of safety and efficacy measured by amyloid reduction of Remternetug in early symptomatic

Alzheimer's disease. Jl G-MC-LAKC.

o Randomized, Delayed Start, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study of Piromelatine 20 Mg in Participants with Mild Dementia due to Alzheimer's Disease.

o Multicenter, double-blind, parallel-group, randomized, 48 weeks, dose-ranging, placebo-controlled

phase Il trial to evaluate efficacy, safety and tolerability of multiple subcutaneous doses of IP in patients with non-alcoholic steatohepatitis (NASH) and fibrosis.

o A 26-week, phase 2b, 2-part, randomized, double-blind, placebo-controlled, parallel group, doseranging study to evaluate the efficacy and safety of ip administration in adults with obesity.

o A phase 2a, 2-part, randomized, double-blind, double-dummy placebo-controlled, parallel-group (sponsor open) study to assess pharmacodynamics and safety of IP coadministered with IP in adult participants with presumed nonalcoholic steatohepatitis (nash).

o A randomized, double-blind, placebo-controlled, multicentre, phase 3 study evaluating long-term efficacy and safety of IP in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (f2)/fibrosis 3 (f3) stage of liver fibrosis.

A phase 2, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dosefinding, parallel group study to assess efficacy and safety of ip alone and when administered with

IP in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3. oA phase II, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacodynamic

effects of IP in obese subjects with non-alcoholic fatty liver disease

(NAFLD)/ non-alcoholic steatohepatitis (NASH).

o A Phase lla, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis.

Efficacy and safety investigation of NNCOI 94-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial.

o A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and

Efficacy of NGIOI Administered Orally to Patients with Gastroparesis.

o A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as

Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with

Presumed Non-Alcoholic Steatohepatitis (NASH).

o Cardiometabolic risk, obesity and cardiovascular disease in people with spinal cord injury.

o A randomized, double-blind trial to test higher- versus lower-doses of IP on inflammatory markers and platelet biomarkers and nitric oxide formation & endothelial function in secondary prevention (pts w/chronic stable coronary disease).

Zilebesiran as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication.

o Phase Ill, randomized, double-blind, parallel-group, event-driven, cardiovascular safety study with BI

456906 administered subcutaneously compared with placebo in participants with overweight or obesity.

o Multi-center, randomized, double-blind, placebo-controlled study of IP in patients with mildmoderate covid-19.

o A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and

Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19.

A multicenter, randomized, double-blind, parallel group phase Il study to evaluate the safety, tolerability and pharmacokinetics of a second-generation IP material in non-hospitalized participants with mild to moderate coronavirus disease 2019 (covid-19).

o A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody IP for the early treatment of coronavirus disease 2019 (covid-1 9) in nonhospitalized patients.

o A phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody IP given intramuscularly versus intravenously for the treatment of mild/moderate

coronavirus disease 2019 (covid-19) in high-risk non-hospitalized patients.

o A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBl-0451 Compared with Placebo in Non hospitalized

Symptomatic Adults with COVID-19 (PBl-0451-0002).

o A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants.

o A single-dose, open-label, parallel-group, matched trial evaluating the pharmacokinetics of oral IP tablets in subjects with normal renal function and renally impaired subjects.

o A phase Il study to evaluate the safety and efficacy of OQLOII on VEGFR inhibitor associated hand foot skin reaction in cancer patients.

o A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety

Study of Povorcitinib in Participants with Inadequately Controlled Moderate to Severe Asthma.

A Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and Safety of EDP-938 in non-hospitalized adults with acute respiratory syncytial virus infection who are at high risk for complications.

o A Randomized, double blind study assessing the long term effect of Dupilumab on prevention of

Lung function decline in patient with moderate to severe asthma.

o A phase 3 study to evaluate the efficacy, immunogenicity, and safety of respiratory syncytial virus

(RSV) prefusion f subunit vaccine in adults.

o A phase 1/2 randomized study to evaluate the safety, tolerability, and immunogenicity of a modified

RNA vaccine against influenza in healthy individuals.

o A Randomizeo Closely worked with pharmaceutical companies and IRBs as Principal Investigator and Sub

Investigator with adult subjects for multiple therapeutic indications and devices from phase I to IV.  o A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,

parallel-group trial with a quetiapine arm to evaluate the efficacy, tolerability, and safety of oral Bl

1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

o Randomized, double-blind (patient, investigator), placebo-controlled, Parallel-group, single-dosing study on safety, tolerability, pharmacokinetic and preliminary efficacy of Bl 1569912 as adjunctive

therapy in patients with major depressive disorder.

o A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the

Efficacy,  Safety,  and  Tolerability  of  AVP-786  (Deudextromethorphan  Hydrobromide

[d6DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the

Alzheimer's Type.

o Phase 4, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks IP bid for smoking cessation in subjects with and

without a history of psychiatric disorders.

o A multicenter randomized, double-blind, placebo-controlled 12 week study to evaluate the safety and efficacy of oral Difelikefalin in advanced chronic kidney disease subjects with moderate to severe

pruritus with an up to 52 week long term extension.

o A randomized, double-blind, placebo-controlled, efficacy, safety, and tolerability study of IP in the treatment of elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimerls type.

A phase Ill randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of ip once daily over 26 week treatment period in patients with schizophrenia (connex2).

o Study in stabilized schizophrenic patients to evaluate the pharmacokinetics of IP and IP when IP is administered from a polyurethane implant.

Phase III Randomized, double-blind, placebo-controlled, three-arm, 12-month, safety and efficacy study of ip monotherapy in subjects with alzheimer's disease followed by a 12-month open-label treatment.

o Ahead 3-45 study: a placebo-controlled, double-blind, parallel-treatment arm, 216 week study to evaluate efficacy and safety of treatment with IP in subjects with preclinical alzheimer's disease and elevated amyloid (a45 trial) and in subjects with early preclinical alzheimer's disease and intermediate amyloid (a3 trial).

o A placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm safety and efficacy of IP in subjects with early alzheimer's disease.

o A phase III, open-label, parallel-group, 2-arm study to investigate amyloid plaque clearance with IP compared with IP in participants with early symptomatic alzheimer's disease.

o A phase Ill, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of IP in patients with early (prodromal to mild) alzheimer's disease.

o A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of

AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer's Type.

o An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with

Dementia of Alzheimer's Type.

A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 when administered to participants with Alzheimer's disease and vascular pathology.

o A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's

Disease.

o Assessment of safety and efficacy measured by amyloid reduction of Remternetug in early symptomatic

Alzheimer's disease. Jl G-MC-LAKC.

o Randomized, Delayed Start, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study of Piromelatine 20 Mg in Participants with Mild Dementia due to Alzheimer's Disease.

o Multicenter, double-blind, parallel-group, randomized, 48 weeks, dose-ranging, placebo-controlled

phase Il trial to evaluate efficacy, safety and tolerability of multiple subcutaneous doses of IP in patients with non-alcoholic steatohepatitis (NASH) and fibrosis.

o A 26-week, phase 2b, 2-part, randomized, double-blind, placebo-controlled, parallel group, doseranging study to evaluate the efficacy and safety of ip administration in adults with obesity.

o A phase 2a, 2-part, randomized, double-blind, double-dummy placebo-controlled, parallel-group (sponsor open) study to assess pharmacodynamics and safety of IP coadministered with IP in adult participants with presumed nonalcoholic steatohepatitis (nash).

o A randomized, double-blind, placebo-controlled, multicentre, phase 3 study evaluating long-term efficacy and safety of IP in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (f2)/fibrosis 3 (f3) stage of liver fibrosis.

A phase 2, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dosefinding, parallel group study to assess efficacy and safety of ip alone and when administered with

IP in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3. oA phase II, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacodynamic

effects of IP in obese subjects with non-alcoholic fatty liver disease

(NAFLD)/ non-alcoholic steatohepatitis (NASH).

o A Phase lla, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis.

Efficacy and safety investigation of NNCOI 94-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial.

o A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and

Efficacy of NGIOI Administered Orally to Patients with Gastroparesis.

o A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as

Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with

Presumed Non-Alcoholic Steatohepatitis (NASH).

o Cardiometabolic risk, obesity and cardiovascular disease in people with spinal cord injury.

o A randomized, double-blind trial to test higher- versus lower-doses of IP on inflammatory markers and platelet biomarkers and nitric oxide formation & endothelial function in secondary prevention (pts w/chronic stable coronary disease).

Zilebesiran as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication.

o Phase Ill, randomized, double-blind, parallel-group, event-driven, cardiovascular safety study with BI

456906 administered subcutaneously compared with placebo in participants with overweight or obesity.

o Multi-center, randomized, double-blind, placebo-controlled study of IP in patients with mildmoderate covid-19.

o A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and

Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19.

A multicenter, randomized, double-blind, parallel group phase Il study to evaluate the safety, tolerability and pharmacokinetics of a second-generation IP material in non-hospitalized participants with mild to moderate coronavirus disease 2019 (covid-19).

o A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody IP for the early treatment of coronavirus disease 2019 (covid-1 9) in nonhospitalized patients.

o A phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody IP given intramuscularly versus intravenously for the treatment of mild/moderate

coronavirus disease 2019 (covid-19) in high-risk non-hospitalized patients.

o A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBl-0451 Compared with Placebo in Non hospitalized

Symptomatic Adults with COVID-19 (PBl-0451-0002).

o A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants.

o A single-dose, open-label, parallel-group, matched trial evaluating the pharmacokinetics of oral IP tablets in subjects with normal renal function and renally impaired subjects.

o A phase Il study to evaluate the safety and efficacy of OQLOII on VEGFR inhibitor associated hand foot skin reaction in cancer patients.

o A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety

Study of Povorcitinib in Participants with Inadequately Controlled Moderate to Severe Asthma.

A Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and Safety of EDP-938 in non-hospitalized adults with acute respiratory syncytial virus infection who are at high risk for complications.

o A Randomized, double blind study assessing the long term effect of Dupilumab on prevention of

Lung function decline in patient with moderate to severe asthma.

o A phase 3 study to evaluate the efficacy, immunogenicity, and safety of respiratory syncytial virus

(RSV) prefusion f subunit vaccine in adults.

o A phase 1/2 randomized study to evaluate the safety, tolerability, and immunogenicity of a modified

RNA vaccine against influenza in healthy individuals.

o A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the

Recombinant MVA-BN@ -RSV Vaccine in Adults 260 Years of Age.

o An open-label, non-randomized, multi-center pivotal Phase 3 study to evaluate the efficacy and safety of PET imaging with [18F] PI-2620 for the detection of tau deposition when compared to post-mortem

histopathology short title: [1 8F] PI-2620 Phase 3 histopathological study.o Closely worked with pharmaceutical companies and IRBs as Principal Investigator and Sub

Investigator with adult subjects for multiple therapeutic indications and devices from phase I to IV.  o A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,

parallel-group trial with a quetiapine arm to evaluate the efficacy, tolerability, and safety of oral Bl

1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

o Randomized, double-blind (patient, investigator), placebo-controlled, Parallel-group, single-dosing study on safety, tolerability, pharmacokinetic and preliminary efficacy of Bl 1569912 as adjunctive

therapy in patients with major depressive disorder.

o A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the

Efficacy,  Safety,  and  Tolerability  of  AVP-786  (Deudextromethorphan  Hydrobromide

[d6DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the

Alzheimer's Type.

o Phase 4, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks IP bid for smoking cessation in subjects with and

without a history of psychiatric disorders.

o A multicenter randomized, double-blind, placebo-controlled 12 week study to evaluate the safety and efficacy of oral Difelikefalin in advanced chronic kidney disease subjects with moderate to severe

pruritus with an up to 52 week long term extension.

o A randomized, double-blind, placebo-controlled, efficacy, safety, and tolerability study of IP in the treatment of elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimerls type.

A phase Ill randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of ip once daily over 26 week treatment period in patients with schizophrenia (connex2).

o Study in stabilized schizophrenic patients to evaluate the pharmacokinetics of IP and IP when IP is administered from a polyurethane implant.

Phase III Randomized, double-blind, placebo-controlled, three-arm, 12-month, safety and efficacy study of ip monotherapy in subjects with alzheimer's disease followed by a 12-month open-label treatment.

o Ahead 3-45 study: a placebo-controlled, double-blind, parallel-treatment arm, 216 week study to evaluate efficacy and safety of treatment with IP in subjects with preclinical alzheimer's disease and elevated amyloid (a45 trial) and in subjects with early preclinical alzheimer's disease and intermediate amyloid (a3 trial).

o A placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm safety and efficacy of IP in subjects with early alzheimer's disease.

o A phase III, open-label, parallel-group, 2-arm study to investigate amyloid plaque clearance with IP compared with IP in participants with early symptomatic alzheimer's disease.

o A phase Ill, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of IP in patients with early (prodromal to mild) alzheimer's disease.

o A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of

AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer's Type.

o An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with

Dementia of Alzheimer's Type.

A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 when administered to participants with Alzheimer's disease and vascular pathology.

o A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's

Disease.

o Assessment of safety and efficacy measured by amyloid reduction of Remternetug in early symptomatic

Alzheimer's disease. Jl G-MC-LAKC.

o Randomized, Delayed Start, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study of Piromelatine 20 Mg in Participants with Mild Dementia due to Alzheimer's Disease.

o Multicenter, double-blind, parallel-group, randomized, 48 weeks, dose-ranging, placebo-controlled

phase Il trial to evaluate efficacy, safety and tolerability of multiple subcutaneous doses of IP in patients with non-alcoholic steatohepatitis (NASH) and fibrosis.

o A 26-week, phase 2b, 2-part, randomized, double-blind, placebo-controlled, parallel group, doseranging study to evaluate the efficacy and safety of ip administration in adults with obesity.

o A phase 2a, 2-part, randomized, double-blind, double-dummy placebo-controlled, parallel-group (sponsor open) study to assess pharmacodynamics and safety of IP coadministered with IP in adult participants with presumed nonalcoholic steatohepatitis (nash).

o A randomized, double-blind, placebo-controlled, multicentre, phase 3 study evaluating long-term efficacy and safety of IP in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (f2)/fibrosis 3 (f3) stage of liver fibrosis.

A phase 2, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dosefinding, parallel group study to assess efficacy and safety of ip alone and when administered with

IP in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3. oA phase II, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacodynamic

effects of IP in obese subjects with non-alcoholic fatty liver disease

(NAFLD)/ non-alcoholic steatohepatitis (NASH).

o A Phase lla, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis.

Efficacy and safety investigation of NNCOI 94-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial.

o A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and

Efficacy of NGIOI Administered Orally to Patients with Gastroparesis.

o A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as

Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with

Presumed Non-Alcoholic Steatohepatitis (NASH).

o Cardiometabolic risk, obesity and cardiovascular disease in people with spinal cord injury.

o A randomized, double-blind trial to test higher- versus lower-doses of IP on inflammatory markers and platelet biomarkers and nitric oxide formation & endothelial function in secondary prevention (pts w/chronic stable coronary disease).

Zilebesiran as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication.

o Phase Ill, randomized, double-blind, parallel-group, event-driven, cardiovascular safety study with BI

456906 administered subcutaneously compared with placebo in participants with overweight or obesity.

o Multi-center, randomized, double-blind, placebo-controlled study of IP in patients with mildmoderate covid-19.

o A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and

Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19.

A multicenter, randomized, double-blind, parallel group phase Il study to evaluate the safety, tolerability and pharmacokinetics of a second-generation IP material in non-hospitalized participants with mild to moderate coronavirus disease 2019 (covid-19).

o A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody IP for the early treatment of coronavirus disease 2019 (covid-1 9) in nonhospitalized patients.

o A phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody IP given intramuscularly versus intravenously for the treatment of mild/moderate

coronavirus disease 2019 (covid-19) in high-risk non-hospitalized patients.

o A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBl-0451 Compared with Placebo in Non hospitalized

Symptomatic Adults with COVID-19 (PBl-0451-0002).

o A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants.

o A single-dose, open-label, parallel-group, matched trial evaluating the pharmacokinetics of oral IP tablets in subjects with normal renal function and renally impaired subjects.

o A phase Il study to evaluate the safety and efficacy of OQLOII on VEGFR inhibitor associated hand foot skin reaction in cancer patients.

o A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety

Study of Povorcitinib in Participants with Inadequately Controlled Moderate to Severe Asthma.

A Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and Safety of EDP-938 in non-hospitalized adults with acute respiratory syncytial virus infection who are at high risk for complications.

o A Randomized, double blind study assessing the long term effect of Dupilumab on prevention of

Lung function decline in patient with moderate to severe asthma.

o A phase 3 study to evaluate the efficacy, immunogenicity, and safety of respiratory syncytial virus

(RSV) prefusion f subunit vaccine in adults.

o A phase 1/2 randomized study to evaluate the safety, tolerability, and immunogenicity of a modified

RNA vaccine against influenza in healthy individuals.

o A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the

Recombinant MVA-BN@ -RSV Vaccine in Adults 260 Years of Age.

o An open-label, non-randomized, multi-center pivotal Phase 3 study to evaluate the efficacy and safety of PET imaging with [18F] PI-2620 for the detection of tau deposition when compared to post-mortem

histopathology short title: [1 8F] PI-2620 Phase 3 histopathological study.d, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the

Recombinant MVA-BN@ -RSV Vaccine in Adults 260 Years of Age.

o An open-label, non-randomized, multi-center pivotal Phase 3 study to evaluate the efficacy and safety of PET imaging with [18F] PI-2620 for the detection of tau deposition when compared to post-mortem

histopathology short title: [1 8F] PI-2620 Phase 3 histopathological study.