Jane Hillard

Qualifications & Training (continued)

• GCP CITI: current certificate holder
• Transmission of ultrasound, x-ray, CT scan, nuclear med., echo and DXA via Dicom since 2011
• Minimental Training: sponsor, national training since 2011
• EDC Experience: sponsor training of Medidata Rave since 2011
• IXRS: sponsor training; Perspective My Trials, PPDI
• Lab Sample Processing: sponsor, central lab specific, local lab & site training since 2011

• A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled study evaluating the efficacy, safety and pharmacokinetics of SAGE-217 in the treatment of adult female subjects with severe postpartum depression. SAGE-201
• A Multicenter, Double-Blind, Placebo-Controlled study evaluating the efficacy, safety, tolerability and pharmacokinetics or Brexanolone in the treatment of Adolescent female subjects with postpartum depression.  SAGE – 304
• An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of Vilaprisan in subjects with uterine fibroids versus standard of care.  BAYER 16953
• An Open-Label Extension Study of DS-5565 For 52 Weeks in Pain Associated with Fibromyalgia. DS5565-A-E312
• A Randomized, Double-Blind, Placebo-and Active-Controlled Study of DS-5565 in Subjects with Pain Associated with Fibromyalgia.  DS5565-A-E310
• A Phase II, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12 week study with a 40 week, active-controlled, double-blind extension to evaluate the efficacy and safety of K-877 in adult patients with fasting Triglyceride levels >500 mg.dL and <200 mg.dL and normal renal function. KOWA 303
• An open label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care. BAYER
• A multi-center, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of SAGE 547-PPD-202 injection in the treatment of adult female subjects with severe postpartum depression and adult female subjects with moderate postpartum depression. SAGE
• A Phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia and non-dialysis – dependent chronic kidney disease. CKD-04
• A Phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral therapy or in whom the hemoglobin measurement in Investigator’s opinion were sufficiently low as to require repletion of iron sucrose to minimize the risk of receiving blood transfusion. IDA-03
• A randomized, double-blind, placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial patients with elevated hsCRP. CANTOS
• An open label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics study of SEL-212 followed by open label Administration of SEL-037 in subjects with symptomatic Gout and Elevated Blood Uric Acid.  SELECTA
• A randomized, double-blind, event-driven, multicenter study comparing the efficacy and safety of Rivaroxaban with Placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an episode of decompensate heart failure.  COMMANDER
• A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of Ticagrelor twice daily on the incidence of cardiovascular death, Myocardial Infarction or stroke in patients with Type 2 Diabetes Mellitus. THEMIS
• A Phase III, double-blind, randomized, placebo-controlled study to evaluate the effects of Dalectrapib on Cardivascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome. (ACS) – DAL-GENE 301
• Phase3, randomized, double-blind, multicenter, placebo controlled study evaluating the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women 18 to 51years of age. M12-815
• A Parallel Group Double-Blind Randomized Placebo Controlled Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Frequent Episodic Migraines.  ALD403-CLIN-006
• A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-Term Treatment with BELVIQ (lorcaserin HCI) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors.  Timi 61
• A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagoix in Subjects with Moderate to Severe Endometriosis-Associated Pain.  AbbVie M12-667
• A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) (the CIBS Study) Synergy ll
• A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain.  M12-665
• A Randomized Double-Blind Study Comparing Oseltamivir versus Placebo for the Treatment of Influenza in Adults.  IRC004
• A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications.  IRC-003
• A Multi-center, randomized, double-blind, parallel arm, 12-week study to evaluate the efficacy and safety of Ezetimibe 10mg when added to Atorvastatin 10mg versus Titration to Atorvastatin 20mg and to 40mg in elderly patients with Hypercholesterolemia at high risk for CHD. M112
• A Randomized, Double-Blind, Placebo-Controlled, safety and efficacy study of Xyrem (sodium oxybate) in subjects with Fibromyalgia.  Ja009
• A Long-term, open-label safety and efficacy study of Xyrem (sodium oxybate) in subjects with Fibromyalgia. Ja010
• A Phase III, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to study the Efficacy and Safety of MK-0431A in patients with Type 2 Diabetes Mellitus. M079
• A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation. Synergy