Kelly Lambrese RN, BSN

Kelly Lambrese RN, BSN
215 Pleasant Street, 5th Floor
Fall River, MA 02721
508 567 5666 office

Education:

• 1984-1986 Community College of Rhode Island - Associate Degree in Nursing
• 1986-1988 Salve Regina University - Baccalaureate Degree in Nursing

Publications:

• Bloodstream Infections Associated with a Needleless Intravenous Infusion System in Patients Receiving Home Infusion Therapy (JAMA – 1995; 275(23)1862-1864)

Continuing Education:

• **N1436 The Obesity Epidemic and the Nurse’s Role, 15 CEU’s, 25Nov2013
• Adult Oncology,7 CEU’s, 5Feb2010
• Wound Care,8 CEU’s, 5Feb2010
• Diabetes Mellitus, 5 CEU’s & Diseases and Disorders of the Gastrointestinal Tract, 10 CEU’s, 17Oct2013

Professional License:

• RN26939 Rhode Island
• RN185536 Massachusetts

Work Experience:

• 2023 - Current: Suite Life Health & Wellness LLC - Chief Patient Experience Officer
  • Responsibilities include development and management of the clinical programs for the infusion center, maintaining relationships with physician practices, and monitoring and improving the patient experience.
• 2008-2012: Pharma Resource - East Providence, RI - Vice President, Clinical Research
  • Responsible for clinical trials conduct which includes clinical recruitment, budget and regulatory affairs, trial management
• 2008-2019 Infusion Resource - East Providence, RI - Corporate Compliance Officer
  • Primary responsibilities include new hire orientation, annual retraining of staff and surveillance of compliance program
• 1998-2008: Health Care Strategies - Bristol, RI - Chief Operating Officer
  • Healthcare Consulting Firm primary responsibilities include providing strategic insight and operational leadership to clients for start-up ventures.
  • Interacts with regulatory agencies and state and local health departments. Conducts training programs.
• 2003-2005: Respiratory Solutions - Lincoln, RI - Vice President Clinical Operations, Staff Trainer
  • Lead and managed all aspects of clinical operations within the organization to include project management and clinical monitoring. Included training, staff development, client relationship building, P & L management and strategic leadership.
• 2000-2005: Clinical Partners LLC, Johnston, RI - Chief Operating Officer
  • Primary responsibilities included: clinical trial recruitment, budget and regulatory affairs, clinical trial management
• 2000-2001: ClinCare Norwood, MA - Site Management Organization, Chief Operating Officer
  • Primary responsibilities included: clinical trial recruitment, budget and regulatory affairs, clinical trial management
• 1994-1998: EvoCare East Providence, RI - Chief Operating Officer
  • Primary responsibilities included: home infusion therapy, ambulatory infusion suites, certified home health agency, infusion pharmacy. Responsible for all activities for all business activities for all business segments, clinical and non clinical activities. Joint Commission and Medicare Certification. Development and implementation of all policies and procedures clinical and non-clinical. Staff education and clinical skills validation. Quality Assurance and improvement committee chairperson. Measured, tracked and reported all data to Medical Advisory Board and Governing Body.
• 1986-1994: T2 Medical Inc. East Providence, RI/ Boston MA - General Manager, Home Infusion Therapy
  • Primary Responsibilities included: oversight of all clinical activities for nursing and pharmacy department. Regional nurse to serve as a clinical resource for the entire country and branches. Joint Commission Accreditation.

Research Experience:

• A Two-Part, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Clinical Trial of XXX in Patients with Moderate to Severe Plaque Psoriasis
• A Double Blind, Placebo Controlled, Multi-Center Study to Assess the Effects of Extended Treatment and Re-Treatment in Patients with Plaque Psoriasis enrolled in XXX Part 2
• A Multi-Center, Randomized, Double-Blind, Placebo – Controlled, Parallel-Group Study to Assess the Safety and Efficacy of XXX In Patients With Chronic Obstructive Pulmonary Disease and Chronic Bronchitis
• A Phase IIIB, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, MultiCenter Study to Evaluate the Safety of 1.0mg/kg Subcutaneously Administered XXX in Adults with Moderate to Severe Plaque Psoriasis who are Candidates for Systemic Therapy

• An Open Label, Multi-Center Study to Evaluate the Safety of 1.0mg/kg Subcutaneously Administered XXX in Adults with Plaque Psoriasis Previously Enrolled in a Study with XXX.
• A Multicenter, Double-Blind, Randomized, Parallel Study Comparing the Efficacy and Safety of XXX 120 mg BID, XXX 240 mg QD, and Placebo in Subjects with Perennial Allergic Rhinitis
• A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, One-Month, MultiDose Study to Evaluate the Tolerability, Pharmacokineticks, Pharmacodynamics and Biological Activity of XXX, and Oral Small Molecule Antagonist of LFA-1 in Subjects with Moderate to Severe Chronic Plaque Psoriasis.
• An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Intramuscular Administration of XXX in Subjects with Chronic Plaque Psoriasis who have Completed Studies.
• A Placebo Controlled, Double-Blind, Double-dummy, Multi-Center 6 Week Study of Orally Administered 60 mg XXX in the Treatment of Adult Patients with Asthma Compared to Treatment with 176 Micrograms XXX.
• A Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel Group, 16-Week Comparison of Asthma Control in Adolescents and Adults Receiving Either XXX Combination Product 100/50mcg BID, XXX 100mcg BID, XXX 50mcg BID, or Oral XXX 10 mg QD
• A 12-Week, Randomzied, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Efficacy and Safety of Fesoterodine Flexible Dose Regimen in Vulnerable Elderly Patients with Overactive Bladder
• A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Three Dose Levels of XXX in the Treatment of Chronic Plaque Psoriasis. Multicenter Dose Ranging Study of the Safety and Efficacy of XXX in Psoriasis.
• A Phase II Randomized, Double-Blind, Placebo-Controlled Study of XXX, A Humanized Monoclonal Antibody that Binds to the CD2 Receptor, Administered by Intravenous Infusion to Adults with Plaque Psoriasis
• A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXX 90 mg qd vs. XXX 50 mg tid in Patients with Osteoarthritis
• A Long Term, Open-label, Safety and Tolerability Study of XXX in Addition to XXX in Subjects with Coronary Heart Disease or Multiple Risk Factors and with Primary Hypercholesterolemia Not Controlled by a Starting Dose (10mg) of XXX.
• An Efficacy and Safety Study of Two Formulations of XXX Compared to XXX in the Treatment of Subjects with Seasonal Allergic Rhinitis Prospective, Randomized, Double-Blind Study Comparing XXX 300 mg PO BID for Five Days with XXX 160/180 mg PO BID Tract Infections
• A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Efficacy and Safety of XXX Tablets in the Treatment of Subjects With Active Ulcerative Colitis
• A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel group, 6-week Study to Evaluate the Efficacy and Safety of XXX 10mg/day When Added to Ongoing Therapy with a Statin Versus Satin Therapy Alone, in Patients with Hypercholesterolemia who Have Not Reached National Choloesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level
• A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXX 90mg Q.D. Versus XXX 75mg B.I.D. in Patients with Rheumatoid Arthritis
• Phase III Study: The Safety and Efficacy of XXX Gel, 0.3% as Compared to XXX Gel, 0.1% and XXX Gel Vehicle in the Treatment of Acne Vulgaris
• A Multi-Center, Double-Blind, Placebo Controlled, Parallel Group Study Comparing the Bioequivalence of XXX Generic Formulation of XXX Topical Gel, 0.75% and XXX Topical Gel, 0.75% in the Treatment of Inflammatory Papules and Pustules of Rosacea Efficacy and Safety of XXX in the Treatment of Severe Chronic Hand Dermatitis Refractory to Topical Therapy.
• A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of XXX in the Treatment of Subjects with Psoriasis
• A Long Term Safety and Efficacy Study of a Fixed Combination of XXX and XXX in Subjects with Acne Vulgaris
• A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% XXX Gel versus Gel Vehicle in the Treatment of Psoriasis
• A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients with Chronic Obstructive Pulmonary Disease (COPD)
• Placebo-controlled Multicenter Study with Etanercept to Determine Safety and Efficacy in Pediatric Subjects with Plaque Psoriasis
• Efficacy and Safety of BAL4079 in the Treatment of Severe Chronic Hand Dermatitis Refractory to Topical Therapy.
• A Phase 3, Multicenter Study of the Efficacy and Safety of Long-term Adalimumab Treatment in the Subjects with Moderate to Severe Chronic Plaque Psoriasis
• A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects with Moderate to Severe Plaque Psoriasis
• An Epidemiologic Study of Xolair ( R ) (omalizumab): Evaluating Clinical Effectiveness and Long -Term Safety in Patients with Moderate to Severe Asthma (EXCELS)
• A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
• A Multicenter, Randomized, Double Blind, Placebo and Allopurinol Controlled, Phase 2 Study to Evaluate Febuxostat in Medical Management of Subjects with Hyperuricosuria and Calcium Oxalate Stones
• A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders (ANDANTE)
• A Phase III Randomized, Double Blind, Placebo Controlled Multi-Center Study of Panobinostat for Maintenance of Response in Patients with Hodgkin’s Lymphoma who are at Risk After High Dose Chemotherapy and Autologous Stem Cell Transplant
• A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR102 (PEG-Irinotecan) when given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Unrescectable Locally Advanced Platinum-Resistant Ovarian Cancer
• A Phase 1, Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients With and Without Impaired Renal Function
• A Multicenter, Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxostat VS Placebo in Joint Damage in Hyperuricemic Subjects with Early Gout
• A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase III Study of Panobinstat in Combination with Bortezomib and Dexamathasone in Patients with Relapsed Multiple Myleoma
• Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of Crizotinib Versus Pemetrexed/Cisplatin or Pemetrexed/Carboplatin in Previously Untreated Patients with Non-Squamous Carcinoma of the Lung Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus
• A Phase I, Randomized, Open-Label, Multi-Center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients
• A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety and Efficacy of Febuxostat and Allopurinol in Subjects with Gout and Comorbidities, Cardiovascular Cormobidities
• A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders (OPERA)
• A Phase 3, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Subjects who are Hospitalized due to Influenza
• A Phase 2A, Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controled, Multiple Dose Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Anrukinzumab in Patients with Active Ulcerative Colitis
• A 12-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily PF-04991532 and Sitagliptin in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
• A Randomized, 3 Arm, Multicentre, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined with Pertuzumab or T-DM1 Combined with PertuzmabPlacebo, Versus the Combination of Herceptin Plus Taxane, as Fist Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer Phase 1B Open-Label Study of the Safety and Clinical Activity of Crizotinib (PF02341066) in Tumors with Genetic Events Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus
• Protocol H9B-MC-BCDS: A Phase 3, Multicenter, Randomized, Double-Blind, PlaceboControlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
• A Randomized Double Blind Phase 3 Efficacy and Safety Study of PF-00299804 Versus Erlotinib for the Treatment of Advanced Non-Small Cell Lung Cancer Following Progression after, or Intolerance to, at Least One Prior Chemotherapy Protocol IM129005: A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)
• Phase 2, Open-Label Single Arm Study of the Efficacy and Safety of PF-02341066 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring a Translocation or Inversion Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus
• 08-PIR-05: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) when given on a Q14 Da or a Q21 Day Schedule in Patients with Metastatic or Locally Advanced Breast Cancer Whose Disease has Failed Prior Taxane-Based Treatment
• Randomized Phase 2 Study of Cisplatin/Pemetrexed with or without Axitinib (AG013736) as First-Line Treatment for Patients with Non-Squamous Non-Small Cell Lung Cancer
• D3820C00006: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opiod-Induced Constipation (OIC) in Patients with Cancer-Related Pain.
• DM200-103: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients with Type 2 Diabetes Mellitus on Metformin Monotherapy
• Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of PF-02341066 vs Standard of Care Chemotherapy (Pemetrexed or Docetaxel) In Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphma Kinase (ALK) Gene Locus
• E7389-G000-205: A Phase 2, Multicenter, Randomized Study of Two Different Dose Regimens of Eribulin Mesylate in Combination with Intermittent Erlotinib in Patients with Previously Treated, Advanced Non-Small Cell Lung Cancer
• SYR-322_402: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subject with Type 2 Diabetes and Acute Coronary Syndrome
• Protocol EFC6521: A Multinational, Randomized, Double Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and who are Undergoing Chemotherapy
• A Phase 2, Randomized, Open Label Study of Figitumumab (CP-751,871) plus Cisplatin (or Carboplatin) and Etopside, Versus Cisplatin (or Carboplatin) and Etoposide Alone, as First Line Treatment in Patients with Extensive-Stage Disease Small Cell Lung Cancer
• Protocol Number IM1260004: A Multicenter, Randomized, Double-Blind, PlaceboControlled Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methrotrexaterotocol
• A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif ®) in Patients with Relapsing Multiple Sclerosis, Protocol WA21092/B
• CA196-004: A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) vs Bevacizumab plus FOLFIRI as SecondLine Treatment for Metastatic Colorectal Cancer
• CA225-315: A Study to Evaluate the Relationship between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients with Advanced Malignancies from Solid Tumors
• HMPL-004-US-02: A Phase IIB, Randomized, Multi-Centre, Double-Blind, PlaceboControlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine
• TDM4370g/B021977: A Randomized, Multicenter, Phase III, Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 VS. Capecitabine + Lapatinib in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
• A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study of Fesoterodine 8 Mg in Overactive Bladder Patients with Sub-Optimal Response to Tolterodine 4 Mg ER
• A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study of Fesoterodine 8 Mg in Overactive Bladder Patients with Sub-Optimal Response to Tolterodine 4 Mg ER
• EN3348-303: A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) with Mitomycin C In the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
• 11-PIR-11 The Beacon Study (Breast Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, A Taxane, and Capecitabine
• MORAb-004-202-CRC: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects with Chemorefractory Metastatic Colorectal Cancer
• A Randomized, Double-Blind, Parallel, Placebo Controlled, Phase 4, Multi-center Study, to assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects after Robotic Assisted Radical Prostatectomy
• BCX1812-303: A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramvir in Hospitalized Subjects with Confirmed or Suspected Influenza Infection IND No. 69,038
• ISN/Protocol 905-UC-050: A Randomized, Double-Blind, Placebo-Controlled, Phase 4, Multi-center Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects after Robotic Assisted Radical Prostatectomy
• AGLU09411: A Phase 4, Open-Label, Prospective Study in Patients with Pompe Disease to Evaluate the Efficacy and Safety of Algluosidase Alfa Produced at the 4000 L Scale
• ED-01: Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
• AZA PH US 2007 PK 006: A Phase 1, Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients With and Without Impaired Renal Function
• 27018966IBS3001: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel System

Footnote: Items are de-identified per request of pharmaceutical companies to maintain anonymity