Elizabeth Ann Golden, PA-C

Transcription

1 Elizabeth Ann Golden, PA-C Dawes Fretzin Clinical Research Group, LLC Dawes Fretzin Dermatology Group, LLC 8103 Clearvista Parkway, Suite Clearvista Parkway, Suite 220 Indianapolis, Indiana Indianapolis, Indiana Phone (317) Phone (317) Fax (317) Fax (317) Education Finch University of Health Sciences, Chicago Medical School, (North Chicago, IL) Masters of Science in Physician Assistant Practice, 2002 University of Wisconsin-La Crosse, College of Science (La Crosse, WI) Bachelor of Science in Microbiology with Chemistry minor, 2000 Professional Experience Dawes Fretzin Clinical Research Group, LLC (Indianapolis, IN) Sub-Investigator, 2007-Present Dawes Fretzin Dermatology Group, LLC (Indianapolis, IN) Physician Assistant, 2007-Present Community Orthocare (Anderson, IN) Physician Assistant, Dr. Robert Gallee and Associates (Geneva, IL) Physician Assistant, License/Certifications Indiana State Physician Assistant License A NCCPA NCCPA PA surgical boards, special recognition, 2002 CPR/AED Certified ACLS Certified Certified Nursing Assistant Emergency Medical Technician CITI Certification, April 2010, April 2012, February 2014, February 2015, February 2016, January 2017 Clinical Study Experience Psoriasis: Sponsor: Janssen A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chonic Plaque Psoriasis in Pediatric Subjects >/= 6 to < 12 Years of Age; January 2017 to Present. Sponsor: UCB BioPharma

2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmocodynamics of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis. October Present Sponsor: Kadmon A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Efficacy of KD025 in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis who are Candidates for Systemic Therapy or Phototherapy. September Present Sponsor: Novartis A 52-week, multicenter, randomized, double-blind study of secukinumab (300 mg) to demonstrate the efficacy as assessed by Psoriasis Area and Severity Index and Investigator s Global Assessment after 12 weeks of treatment, compared to ustekinumab, and to assess long term safety, tolerability, and efficacy in subjects with moderate to severe plaque psoriasis.august Present Sponsor: Boehringer Ingelheim BI versus Ustekinumab and placebo comparatros in a ramdomized double-blind trial for Maintenance use in Moderate to severe plaque type psoriasis-2 (U1tIMMa-2) March 2016 Present Sponsor: Promius Pharma, LLC A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days November 2015 to September 2016 Sponsor: Baxalta US, Inc A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira in Subjects with Moderate to Severe Chronic Plaque-type Psoriasis October 2015 to Present Sponsor: UCB Biopharma, SPRL/Dermira A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-and-Active- Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Followup to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis May 2015 to Present Sponsor: TOLMAR, Inc. Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multicenter Study Comparing TOLMAR Calcipotriene Ointment, 0.005% to Reference Listed Drug in the Treatment of Plaque Psoriasis March 2015 to June 2016 Psoriatic Arthritis Sponsor: Janssen Research and Development A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis April 2015 to Present Sponsor: Janssen Research and Development A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects with Active Psoriatic Arthritis August 2014 to September 2015 Sponsor: Novartis Pharmaceuticals A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in autoinjectors, to demonstrate efficacy at 24 weeks and to assess the long term 2

3 safety, tolerability and efficacy up to 3 years in subjects with active Psoriatic Arthritis June 2014 to Present Atopic Dermatitis Sponsor: Pfizer A Phase 2B Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter, Dose-Ranging, Study to Evaluate the Efficacy and Safety Profile of PF in subjects with Moderate to Severe Atopic Dermatitis.April Present Sponsor: GlaxoSmithKline A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK Cream for the T reatment of Atopic Dermatitis - February 2016 to Present Sponsor: MedImmune, Limited A Phase 2a, Randomized, Double-blinded, Placebocontrolled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis August 2015 to September 2016 A Phase 3, Randomized, Doulbe-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients with Atopic Dermatitis July 2015 to February 2017 An Open-Label Study of Dupilumab In Patients with Atopic Dermatitis Who Participated In Previous Dupilumab Clinical Trials - June 2015 to Present A phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients with Moderate-to-Severe Atopic Dermatitis February 2015 to June 2016 A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults with Moderate to Severe Atopic Dermatitis Treated with Dupilumab September 2014 to December 2015 Sponsor: Anacor Pharmaceuticals A Multicenter, Open-Label Study of the Long-Term Safety of AN2728 Topical Ointment, 2% in the Treatment of Children and Adolescents (Ages 2 17 Years) With Atopic Dermatitis February 2014 November 2015 Sponsor: Anacor Pharmaceuticals, Inc A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis -February 2014 August 2015 Rosacea Sponsor: Cutanea Life Sciences, Inc A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with Rosacea -December 2015 to Present 3

4 Acne Sponsor: Foamix A Randomized, Double-Blind Study to compare the efficacy, safety and Long-term safety of topical administration or FMX-101 for 1 year in the treatment of Moderate-to-Severe Acne Vulgaris. July Present Sponsor: Valeant A Phase 1b Open-Label, Randomized Sutyd Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison with Tazorac Cream 0.1% in Subjects with Acne Vulgaris under Maximal Use Conditions. June Present Sponsor: Valeant A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris -October 2015 to Present Sponsor: Ranbaxy Phase 4, An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA (isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne -February 2015 to Present Sponsor: Elorac A Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study Evaluating the Efficacy and Safety of Once Weekly High Dose Oral Finasteride in the Treatment of Severe Nodulocystic Acne -September 2015 to Present Chronic Spontaneous Urticaria Sponsor: Novartis Global Clinical Dev. A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Spontaneous Urticaria (CSU) July 2015 to June 2016 Hidradenitis Suppurativa Sponsor: Novartis Institutes for BioMedical A randomized, double-blind, placebo controlled, multiple dose study to evaluate the clinical efficacy, safety, tolerability, dose relation, pharmacokinetics and pharmacodynamics of CJM112 in moderate to severe chronic hidradenitis suppurativa patients July 2015 to February 2017 Actinic Keratosis Sponsor: Therapeutics, Inc A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of a Generic Ingenol Mebutate Gel, 0.015% and Picato Gel, 0.015% in Subjects with Actinic Keratosis on the Face or Scalp July 2016 to Present Sponsor: LEO Pharma A/S Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest May 2015 to Present Sponsor: Perrigo UK Finco Limitetd Par A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo UK Finco Ingenol Mebutate Topical Gel 0.015% to Leo Pharma Inc. Picato Topical Gel 0.015% (Ingenol Mebutate Topical Gel 0.015%), and Both Active Treatments to a Vehicle Control in the Treatment of Actinic Keratosis on the Head Region (Face or Scalp) March 2015 to December

5 Sponsor: Leo Pharma A/S Safety of LEO %, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively February 2015 to September 2015 Common Warts Sponsor: RXi Pharmaceuticals A Prospective, Phase 2a Study to Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone) on the Clearance of Verruca Vulgaris (Common Warts) in Subject Ages Years. July 2016 Current 5