JULIE ANNE STERNBERG

***** ******* *** . ********, ** 91355 . ab9ay5@r.postjobfree.com .

661-***-****

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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