Manager Clinical Research
Resume:
JULIE ANNE STERNBERG
***** ******* *** . ********, ** 91355 . **************@*****.*** .
SUMMARY
Self-motivated and highly organized with refined problem-solving and
decision making skills. Demonstrates effectiveness in problem evaluation
coupled with the ability to generate and implement effective solutions -
especially under pressure. Committed to detail in correctly seeing tasks
to completion. Excellent interpersonal communication skills, resulting in
an effective and cooperative team player and valued leader.
QUALIFICATIONS
* 20 years of clinical research experience in various roles
(Clinical Research Coordinator, Clinical Data Manager, Clinical
Research Associate, QA Administrator, and Senior Regulatory Project
Coordinator/Senior Associate) for several cutting-edge research teams
* Managed the Oncology Research Department of a well known hospital
* 20 years of administrative and computer experience
SKILLS
* Exceptional knowledge of Global Clinical Trial Applications,
Marketing Applications and Approvals, Regulations and Regulatory
Guidance with a high level understanding of industry practices and
standards (GCP, ICH and clinical trial conduct and regulatory
practices)
* Computer literate (Windows 98, Windows XP, Windows Vista, Microsoft
Office including Power Point, SharePoint, IsoTrain)
* Use of document management systems and databases: (InSight Manager,
EPIC, EDMTeams, Documentum (DECADE) and InSight Viewer (IMR)
* Use of electronic data capturing systems: (Oracle, Bioclinica, RAVE,
CTMS and IVRS)
* Excellent written and verbal communication skills
* Superb problem evaluation and resolution capabilities
* Strong time management and project planning skills
* Superior relationship and team building skills
* Detail-oriented with a high level of accuracy
* Typing at approximately 65 WPM
* Professional level spelling skills, dictation
* Medical transcription and terminology
* 10-Key operation by touch
EDUCATION
* Mountain High School, Lake Arrowhead, California
* Medical Transcription, At Home Professions, Garden Grove, California
* Community College currently pursuing a Bachelors of Science degree
EXPERIENCE
2011 MRI SENIOR ASSOCIATE/
to SENIOR REGULATORY PROJECT COORDINATOR
2013 AMGEN, Inc.via Alpha Professionals*
Thousand Oaks, California
* Supported the compilation, submission and archiving of regulatory
dossiers; maintenance of core dossier components, timelines and
associated submissions
* Maintained regulatory document management systems and tracking
systems
* Quality control of regulatory dossiers, archive and tracking systems
within the systems
* Primary Regulatory Operations point of contact between clinical,
manufacturing, global regulatory and publishing teams while
streamlining and implementing processes to improve the regulatory
process
* EPIC dictionary maintenance; maintenance of team Sharepoint sites and
associated documentation
* Electronic document management of ongoing submissions
* Regulatory archive; Quality control; Information requests; Metrics
generation
* Liaison with internal customers to determine key performance and
compliance indicators; liaise with reporting groups and
process/complaint resolution on complex issues
* Development of standards and templates for routine processes
* Training: contribute to the development and roll out of training
documentation and e- manuals
* Contract position for AMGEN, Inc. in the Regulatory Operations
Department
2011 CLINICAL QUALITY ADMINISTRATOR
to Baxter Bioscience via Clinforce*
2011 Westlake Village, California
* Responsible for the research and issuance of all Certificates of
Compliance, Implementation Action Plans and Document Change Requests
via QA Systems Routing
* Facilitation of clinical study contracts approval process
* Acted as liaison between Clinical Development, Project Managers and
Data Management, Vendors and Internal Approvers in order to
continually improve upon the Quality aspect of ongoing audits and
process changes
* Organized and implemented GCP and SOP training for approximately 350
employees
* IsoTrain data system operation including creating new modules,
assigning modules based on employee function and external contractor
training
* Maintained distribution list of active employees and employee
training files
* Management of the CRF printing and CRF binder creation process
* Created and maintained the external vendor and site auditing filing
systems
* 3 month contract position for Baxter Bioscience in the Clinical
Training and Compliance Department
2009 SENIOR CLINICAL RESEARCH ASSOCIATE
to The Angeles Clinic and Research Institute
2011 West Los Angeles, California
* Assisted in the conduct of 21+ clinical research protocols in the
Oncology specialties of Melanoma, Breast, Prostate and Lung cancer
* Presentation and consenting patients to a wide array of clinical
trials
* Patient care, problem analysis and resolution for trial timelines,
treatments and execution of clinical trials
* Reporting of SAEs, record retrieval and follow-up; adverse event and
concomitant medication reporting
* Chart and CRF auditing; data analysis and quality issue resolution
* Data management, CRF completion, query resolution
* Chart review for data input and study eligibility
* Maintenance of patient charts and CRF binders for 150 patients on
active clinical trials
* Liaison between sponsors/CROs and the clinical research team
2007 SENIOR CLINICAL RESEARCH COORDINATOR
to Mannkind Corporation
2008 Valencia, California
* Assisted in the development of 25+ clinical research protocols in the
Diabetes and Oncology specialties including device development
* Liaison between CRO, Study sites and the study sponsor to effectively
execute ongoing clinical trails
* Responsible all data and regulatory documents for the company
including, investigators files and FDA documentation
* Designed consent forms, abstracts, source documents, CRFs, and CRF
guidelines
* Data management, data edits, query issuance and other data aspects
* Assisted with site patient recruitment, enrollment and site visits
2003 SENIOR CLINICAL RESEARCH COORDINATOR
to Huntington Memorial Hospital
2006 Pasadena, California
* Coordinated the operations and departmental activities of the Cancer
Center's Research Department
* Responsible for the IRB processing and maintenance of 60+ clinical
trials
* Implemented studies throughout the hospital and to the surrounding
communities
* Patient eligibility and recruitment
* Clinical trial marketing
* Data management and analysis
* Budgeting aspects of the protocols
2002 CLINICAL RESEARCH COORDINATOR
to Olive View Medical Center/ERI
2003 Sylmar, California
* Coordinated multiple clinical research studies for the Gynecologic
Oncology and Hematologic Oncology specialties
* Processed new trials from pharmaceuticals companies through the
Institutional Review Board and Biosafety committee for approval to
conduct within the center
* Maintained protocols in all IRB aspects (renewals, amendments,
reporting, etc.)
* Severe Adverse Event and Adverse event collecting and reporting
* Completion of clinical research data forms, queries and maintenance
of subject records
* Responsible for regulatory and data documentation for the sponsors,
investigators and FDA
* Compiled protocol budgets and contracts
* Designed consent forms, abstracts, source documents and IND
applications
* Patient recruitment, eligibility and enrollment
* Clinical trial marketing
1998 CLINCAL RESEARCH PROJECT ASSISTANT II/DATA MANAGER
to Cedars Sinai Medical Center/Brentwood Biomedical Research
Institute
2002 Los Angeles, California
* Processed new protocols through the IRB; maintained existing
protocols (Annual reviews/renewals, amendments, SAE and AE reporting
* Completion of clinical research forms (CRFs) and related data queries
* Compiled protocol budgets
* Maintenance of patient charts and regulatory binders for 250 patients
on 12 active clinical trials
* Designed consent forms, abstracts and source documents
* Patient eligibility and enrollment
* Reports, correspondence and transcription
PROTOCOL PARTICIPATION (1998-2011)
1. Berenson, JR: "An Open-Label, Single Intravenous Infusion Dose
Study to Determine the Pharmacokinetics and Pharmacodynamics of
Zoledronate in Cancer Patients with Bone Metastases - Novartis
Pharmaceuticals
2. Berenson, JR: "An Open-Label Extension Study of Intravenous Infusion of
Zoledronate in Cancer Patients with Bone Metastases" - Novartis
Pharmaceuticals
3. Berenson, JR: "Open-Label, Extension Trial of Rapid Intravenous Infusion
of Zoledronate vs. Aredia in Patients with Osteolytic Bone Metastases" -
Novartis Pharmaceuticals
4. Berenson, JR: "Protocol 003 Extension of Rapid Intravenous Injection of
CGP-42446 in Cancer Patients with Osteolytic Bone Metastases" - Novartis
Pharmaceuticals
5. Berenson, JR: "Extension Trial of Intravenous Injection Bolus of
Zoledronate in Any Cancer Patient with Bone Metastases" - Novartis
Pharmaceuticals
6. Berenson, JR: " A Randomized, Double-Blind, Multi-Center, Comparative
Trial of IV Zoledronate (4 mg and 8 mg) vs. IV Aredia (90mg) as an
Adjunct to Standard Therapy in the Treatment of Multiple Myeloma and
Breast Cancer Patients with Cancer-Related Bone Metastases" - Novartis
Pharmaceuticals
7. Berenson, JR: "A Randomized, Double-Blind, Placebo-Controlled, Multi-
Centered Trial to Evaluate the Safety and Efficacy of Zoledronate (4 mg
and 8 mg) Administered Intravenously as an Adjuvant to Anticancer Therapy
to Patients with Any Cancer with Bone Metastases Other Than Breast
Cancer, Multiple Myeloma or Prostate Cancer" - Novartis Pharmaceuticals
8. Berenson, JR: "A Randomized, Double-Blind, Placebo-Controlled Phase III
Trial Evaluating Zoledronate Plus Standard Therapy in Patients with
Recurrent Carcinoma of the Prostate Who Are Asymptomatic with Castrate
Levels of Testosterone and Have Rising PSA Levels Without Radiologically-
Evident Disease" - Novartis Pharmaceuticals
9. Berenson, JR: "A Randomized, Double-Blind, Placebo-Controlled, Multi-
Centered Comparative Safety and Efficacy Study of Intravenous Zoledronate
(4 mg and 8 mg) in Prostate Cancer Patients with Metastatic Bone Lesions
Receiving Antineoplastic Therapy" - Novartis Pharmaceuticals
10. Berenson, JR: "A Randomized, Double-Blind Study of Two Doses of
Zoledronate and Aredia (90 mg) in the Treatment of Tumor Induced
Hypercalcemia" - Novartis Pharmaceuticals
11. Berenson, JR: "Double-Blind, Randomized, Safety and Efficacy Trial of
Intravenous Aredia vs. Placebo for the Palliation of Bone Pain in
Patients with Advanced Prostate Cancer" - Novartis Pharmaceuticals
12. Berenson, JR: "Analysis of Kaposi's Sarcoma-Associated Herpes Virus
(KSHV) in Close Contacts of Patients with Monoclonal Gammopathies" -
Investigator Initiated Study
13. Berenson, JR: "An Open-Label Phase II Study of PS-341 Alone or in
Combination with Dexamethasone in Patients with Multiple Myeloma who
have Relapsed Following Front-line Therapy and are Refractory to Their
Most Recent Therapy" - Millennium Pharmaceuticals
14. Berenson, JR: "A Randomized, Open-Label, Phase II Study of Two Doses of
PS-341 Alone or in Combination with Dexamethasone in Patients with
Multiple Myeloma who have Failed To Respond to or Relapsed Following
Front-line Therapy - Millennium Pharmaceuticals
15. Berenson, JR: "The Pharmacokinetics and Pharmacodynamics of Zoledronic
Acid in cancer Patients with Varying Degrees of Renal Function" -
Novartis Pharmaceuticals
15. Nishikubo, CY: "A Phase II Evaluation of Gemcitabine Plus Taxotere as
therapy for Unresectable Non-Small Cell Lung Cancer" - Eli Lilly
16. Nishikubo, CY: "An Open-Label, Multi-Centered, Randomized, Phase III
Comparator Study of Oral Versus Intravenous Topotecan for Second-Line
Therapy in Patients with Small Cell Lung Cancer (SCLC) who Have Relapsed
Greater Than or Equal to 90 Days After Completion of First-Line Therapy"
- SmithKline Beecham
17. Nishikubo, CY: "A Phase II Study of Irinotecan (CPT-11) in
Adenocarcinoma of the Esophagus and Gastric Cardia" - Pharmacia/Upjohn
18. Nishikubo, CY: "A Phase II Trial of Gemcitabine Plus Cisplatin for
Extensive Small Cell Lung Cancer" - SWOG 9237
19. Bernal, SD: "Use of Agrylin (Anagrelide) in Polycythemia Vera and
Essential Thrombocythemia" - Shire US Inc.
20. Bernal, SD: "A Phase III Multicenter, Open-Label, Randomized Study to
Compare Overall Survival and Safety of Bi-Weekly Intratumoral
Administration of RPR Versus Weekly Methotrexate in Squamous Cell
Carcinoma of the Head and Neck: - PPD/Adventis
21. Bernal, SD: "A Phase III Multicenter, Open-Label, Randomized Study to
Compare the Effectiveness and Safety of Intratumoral Administration of
RPR/INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone
in 288 Patients with Recurrent Squamous Cell Carcinoma of the Head and
Neck"- PPD/Aventis
21. Bernal, SD: "Evaluation of Tolonium Chloride (Toluidine Blue) Rinse in
the Detection of Locally Recurrent or New Primary Oral Cavity Cancers
and Cancer In Situ" - Zila, Inc./ILEX Oncology Services
22. Bernal, SD: "A Randomized Phase II Trial of Carboplatin with
Gemcitabine Using Two Different Treatment Schedules in Patients with
Advanced Non-Small Cell Lung Cancer" - Eli Lilly Corporation
23. Bernal, SD: "A Phase II Study of Oral Xeloda( in Combination with
Intravenous Irinotecan in Patients with Metastatic Colorectal Cancer" -
Roche Laboratories
25. Bernal, SD: "Phase II Study of Topotecan and Gemcitabine for the
Treatment of Non Small Cell Lung Cancer" - GlaxoSmithKline
26. Bernal, SD: "Phase II Study of Topotecan and VP-16 for the Treatment
of Stage D2 Prostate Cancer" - GlaxoSmithKline
27. Bernal, SD: "A Phase III, International, Multicenter, Randomized,
Double-Blind, Placebo-Controlled Trial of Innohep( (tinzaparin sodium)
for the Prevention of Venous Thromboembolism and Prolongation of Survival
in Subjects with Advanced Cancer" - DuPont/Kendle Int'l
28. Bernal, SD: "A Randomized, Phase II Trial to Outline the Efficacy Of
Gemcitabine Containing Regimens (Gemzar/Carboplatin and Gemzar/Cisplatin)
When Used as Preoperative Chemotherapy in Patients With Stage I and II
Non-Small Cell Lung Cancer" - Eli Lilly
29. Bernal, SD: "A Randomized, Phase II Trial Comparing CPT-11 (Irinotecan
HCI; Camptosar( Injection)/Cisplatin with Etoposide/Cisplatin in Patients
with Previous, Untreated Extensive Small Cell Lung Cancer" -
Pharmacia/Theradex
30. Bernal, SD: "Chemotherapy Resistance of Human Respiratory Carcinomas"
- Philippine Government/Pacific Rim Foundation
31. Holschneider, C: " Use of the MediSpectra Optical Detection System
(ODS) as an Adjunct to Colposcopy in the Localization of Squamous Cell
Precancerous Lesions" - Medispectra
32. Pinter-Brown, L: "Phase II study of ONTAK in previously treated
patients with low-grade Non-Hodgkin's Lymphoma (NHL)" - Ligand
Pharmaceuticals
33. Pinter-Brown, L: "A Randomized Phase II Trial of Cisplatin, Etoposide
and Radiation Followed by Gemcitabine vs. Gemcitabine and Docetaxel in
Stage IIIB Unresectable Non-Small Cell Lung Cancer" - Eli Lilly
34. Stafford, BT: "Study of Tamoxifen and Raloxifene."STAR" for the
Prevention of Breast Cancer" - NSABP P2 (STAR)
35. Faddis, D: "A Prognostic Study of Sentinel Node and Bone Marrow
Micrometastases in Women with Clinical T1 or T2 NO MO Breast Cancer" -
ACOSOG Z0010
36. Faddis, D: "A Randomized Trial of Axillary Node Dissection in Women
with Clinical T1 or T2 NO MO Breast Cancer who have a Positive Sentinel
Node" - ACOSOG Z0011
37. Stafford, BT: "Randomized Trial of Post-Mastectomy Radiotherapy in
Stage II Breast Cancer in Women with One to Three Positive Axillary Nodes
- SWOG 9927
38. Stafford, BT: Randomized Phase III Trial of Paclitaxel vs. Paclitaxel
plus Bevacizumab as First-Line Therapy for Locally Recurrent or
Metastatic Breast Cancer - ECOG 2100
39. Stafford, BT: "Treatment with or without Exemestane for Breast Cancer
Patients Who Are Disease Free After Having Completed Tamoxifen Therapy -
NSABP B-33
40. Lam, K: "Study Intergroup Selenium and Vitamin E Chemoprevention Trial
- SWOG S0000 SELECT
41. Stafford, BT: "A Phase III Randomized Trial Comparing Intermittent
Versus Continuous Androgen Suppression for Patients with Prostate
-Specific -Antigen Progression in the Clinical Absence of Distant
Metastases following Radiotherapy for Prostate Cancer" - SWOG JPR-7
42. Stafford, BT: "Intermittent Androgen Deprivation in Patients with Stage
D2 Prostate Cancer, Phase III" - SWOG 9346
43. Stafford, BT: "Central Prostate Cancer Serum Repository Protocol" -
SWOG 9205
44. Faddis, D: "Randomized Trial of Mediastinal Lymph Node Sampling Versus
Complete Lymphadenectomy During Pulmonary Resection in the Patient with
N0 or N1 (less than hilar) Non-Small Cell Carcinoma" - ACOSOG Z0030
45. Faddis, D: "A Prospective study of the Prognostic Significance of
Occult Metastases in the Patient with Resectable Non-Small Cell Lung
Cancer - ACOSOG Z0040
46. Stafford, BT: "A Randomized Phase III Trial of Surgery Alone or Surgery
Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB, II, and
IIIB Non-Small Cell Lung Cancer" - SWOG 9900
47. Cohen, RG: "The Utility of Positron Emission Tomography (PET) in
Staging of Patients with Potentially Operable Non-Small Cell Lung Cancer"
- ACOSOG Z0050
48. Stafford, BT: "A Randomized Phase III Equivalence Trial of Irinotecan
vs. Oxaliplatin/5-Fluorouracil/ Leucovorin in Patients with Advanced
Colorectal Carcinoma Previously Treated with 5-FU" - SWOG 9841
49. Randomized Trial Comparing CMF or AC to Capecitabine in Node Positive
or High-Risk Node Negative Breast Cancer patients - CALGB 49907
50. Stafford, BT: "Randomized Trial Comparing Anastrozole with Tamoxifen in
Postmenopausal Patients with DCIS Undergoing Lumpectomy and Radiation
Therapy" - NSABP B-35
51. Bremner, R: "A Phase III Prospective Randomized, Double-Blind, Placebo-
Controlled Trial of the Epidermal Growth Factor Receptor Antagonist,
ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-
Small Cell Lung Cancer" - NCIC CTG BR.19
52. Stafford, BT: "A Phase III Randomized Double-Blind Study of Letrozole
Vs. Placebo in Women with Primary Breast Cancer Completing Five or More
Years of Adjuvant Tamoxifen" - SWOG JMA-17
53. Williamson, R: "A Randomized Trial of Palliative Radiation Therapy for
Osseous Metastases: A Study of Palliation of Symptoms and Quality of
Life" - RTOG 97-14
54. Stafford, BT: "A Phase III Study of Doxorubicin-Cyclophosphamide
Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks
in Patients with Axillary Node-Positive or High-Risk Node Negative Breast
Cancer" - ECOG 1199
55. Bremner, R: "A Phase III Study of Adjuvant Chemotherapy After Resection
For Patients with T2 N0 Stage 1 Non-Small Cell Lung Cancer" - RTOG 96-16
56. Marquez, S: "A Phase III Study of Conventional Radiation Therapy Plus
Thalidomide (NSC#66847) vs. Conventional Radiation Therapy for Multiple
Brain Metastases" - RTOG BR-0118
57. Williamson, R: "A Phase II Trial of Radiation Therapy With or Without
Casodex in Patients with PSA Elevation Following Radical Prostatectomy
for pT3 N0 Carcinoma of the Prostate" - RTOG 96-01
58. Mannkind Corporation: "Single-Dose, Single Administration Study of
Technosphere Inhalation Powder in Diabetic Subjects with Mild or Moderate
Kidney Disease Compared to Diabetic Subjects with Normal Kidney Function"
59. Mannkind Corporation: "Single-Dose, Single Administration Study of
Technosphere Inhalation Powder in Diabetic Subjects with Mild or Moderate
Kidney Disease Compared to Diabetic Subjects with Normal Kidney Function"
60. Mannkind Corporation: Phase 1, Repeated Single-Dose, Double Blind,
Randomized, Five Treatment Controlled Safety and Pharmacological Response
Evaluation Trial of MKC253 Inhalation Powder in Adult Male and
Postmenopausal Female Subjects With Type 2 Diabetes Mellitus
61. Mannkind Corporation: Phase 1a, Single-Dose, Open-Label, Parallel,
Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled
MKC253 in Healthy Adult Male Subjects
62. Mannkind Corporation: Phase 3 Randomized, Open Label, Multi-Center
Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in
Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
63. Mannkind Corporation: Phase 3 Randomized, Open Label, Multi-Center
Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in
Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
64. Mannkind Corporation: Phase 1/2, Open Label, Non-Randomized Dose
Escalation Study to Evaluate the Safety, Tolerability, Immune Response
and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With
Advanced Melanoma
65. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of
Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With
Previously Treated Unresectable Stage III or IV Melanoma - Mederex 010
(MDX 010)
66. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the
Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With
Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in
Previously Untreated Subjects With Lung Cancer - Mederex 020 (MDX 020)
67. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A Phase 1,
Open-label, Dose-escalation, Multidose Study of MDX-1105 Administered
Every 14 Days in Subjects With Selected Advanced or Recurrent Solid
Tumors - Mederex1105 (MDX 1105)
68. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A Multi-
Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients
with Untreated Stage III (Unresectable) or IV Melanoma Receiving
Dacarbazine Plus 10mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With
Placebo - BMS 024
69. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A Multi-
Center, Open-Label, Phase II Study of Ipilimumab (MDX-010) Extended-
Treatment Monotherapy or Follow-up for Patients Previously Enrolled in
Ipilimumab (MDX-010) Protocols - BMS 025
70. O'Day S, Hamid O; The Angeles Clinic and Research Institute: Adjuvant
immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus
placebo after complete resection of high-risk Stage III melanoma: A
randomized, double-blind Phase 3 trial of the EORTC Melanoma Group - BMS
029
71. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the
Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With
Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in
Previously Untreated Subjects With Lung Cancer - BMS 041
72. O'Day S, Hamid O; The Angeles Clinic and Research Institute: The Effect
of Ketoconazole on the Pharmacokinetic and Pharmacodynamics of
Ixabepilone: a First-Class Epothilone B Analogue in the Late Phase of
Clinical Development - BMS 042
73. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo
Following Radiotherapy in Subjects With Castration Resistant Prostate
Cancer That Have Received Prior Treatment With Docetaxel - BMS 043
74. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Multicenter Treatment Protocol for Compassionate Use of Ipilimumab (BMS-
734016) Monotherapy in Subjects with Unresectable Stage III or Stage IV
Melanoma - BMS 045
75. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Multicenter Treatment Protocol for Compassionate Use of Ipilimumab in
Subjects With Unresectable Stage III or IV Melanoma - BMS 045
(compassionate use)
76. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Parallel, 3-Arm Study to Characterize the Effect of
Ipilimumab on the Pharmacokinetics of Chemotherapy and the Effect of
Chemotherapy on the Pharmacokinetics of Ipilimumab in Subjects with
Untreated Advanced Melanoma - BMS 078
77. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A
Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of
Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced
Melanoma BMS 087
78. O'Day S, Hamid O; The Angeles Clinic and Research Institute: Melanoma
Vaccine in Treating Patients With Stage III Melanoma After Surgery to
Remove Lymph Nodes - Glaxo Smith Klein DERMA
79. O'Day S, Hamid O; The Angeles Clinic and Research Institute: GSK
2132231A Antigen-Specific Cancer Immunotherapeutic as First-line
Treatment of Patients With Unresectable Metastatic Melanoma - Glaxo Smith
Klein PREDICT
80. O'Day S, Hamid O; The Angeles Clinic and Research Institute: Safety -
Millennium TAK-700
81. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A Phase I,
Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-
Activating Enzyme, in Adult Patients With Melanoma - Millennium Melanoma
82. O'Day S, Hamid O; The Angeles Clinic and Research Institute: BRIM 3: A
Randomized, Open-label, Controlled, Multicenter, Global Study on
Progression-free and Overall Survival in Previously Untreated Patients
With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF
Mutation Receiving RO5185426 or Dacarbazine - Roche Pharmaceuticals
83. O'Day S, Hamid O; The Angeles Clinic and Research Institute: Phase 1b'
Open Label, Single Arm, Multicenter Trial to Evaluate the Safety,
Tolerance, Response Rate and Immunological Effects of Repeated
Intratumoral Injections of Adenoviral Transduced Autologous Dendritic
Cells Engineered to Express hIL-12(INXN-3001) in Response to an Oral
Activator Ligand Administered in Intra-Patient Escalating Doses in
Patients With Unresectable Stage III C or IV Malignant Melanoma -
Intrexon Corporation
84. O'Day S, Hamid O; The Angeles Clinic and Research Institute: BOLERO-2:
ER+ Locally Advanced or Metastatic Breast Cancer (Refractory or
intolerant to Letrozole or Anastrozole) in Combination With Exemestane -
Novartis Pharmaceuticals
85. O'Day S, Hamid O; The Angeles Clinic and Research Institute: Phase
Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic
Melanoma - Altor Bioscience
86. O'Day S, Hamid O; The Angeles Clinic and Research Institute: A Phase I
Dose Escalation Study Evaluating MK 1775 in Both Monotherapy and in
Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adult
Subjects With Advanced Solid Tumors -Merck 1775
IND APPLICATIONS AND PROTOCOL PARTICIPATION (2011 - 2013)
AMG 139 - Psoriasis, Crohn's Disease
AMG 151 - Diabetes Mellitus
AMG 157 - Asthma
AMG 167 - Osteopenia
AMG 181 - Ulcerative Colitis; Crohn's Disease
AMG 232 - Oncology
AMG 423 (omecamtiv mecarbil) - Heart Failure
AMG 827 - Psoriatic Arthritis, Crohn's Disease, Rheumatoid Arthritis,
Asthma, Severe Plaque Psoriasis
ENBREL (etanercept) - Rheumatoid Arthritis, Psoriasis, Ankylosing
Spondylitis, Juvenile Rheumatoid Arthritis
EPOGEN (epoetin alfa) - Chronic and End-Stage Renal Disease, Anemia,
Oncology,
ARANESP (darbepoetin alfa) - Heart Failure, Kidney Disease, Anemia,
Oncology
XGEVA (denosumab) - Postmenopausal Osteoporosis, Oncology, Bone Metastases
PROLIA (denosumab) - Postmenopausal Osteoporosis, Oncology
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