ROBERT R. FORD, M.D. 9 Raymond Lane Belle Mead, NJ 08502 ...cticon.com/.../2016/06/Ford-Unblinded-CV-Mar-2015.pdf · Jan Bogaerts, Robert Ford, Dan Sargent, Lawrence H. Schwartz,

ROBERT R. FORD, M.D. 9 Raymond Lane Belle Mead, NJ

08502 (609)-651-6887

[email protected]

CURRENT APPOINTMENTS:

Feb.2015 – Present CONSULTANT VirtualScopics 500 Linden Oaks Rochester, New York 14625 Aug. 2014 – Present CONSULTANT Tokai Pharmaceuticals, Inc. One Broadway 14th Floor Cambridge, Massachusetts 02142 Aug. 2013 – Present CONSULTANT Biomedical Systems 77 Progress Parkway St. Louis, Missouri 63043 Jun.2013 – Present SCIENTIFIC ADVISORY BOARD CONSULTANT Imaging Endpoints 9700 N. 91st Street Suite B200 Scottsdale, Arizona 85258 Mar. 2013 – Present ONCOLOGY CONSULTANT CMO EMERITUS BioClinica, Inc. 100 Overlook Center Princeton, NJ 08540 Dec. 2012 – Present CONSULTANT Eisai, Inc. 300 Tice Boulevard Woodcliff Lake, New Jersey 07677 Jan. 2013 – Feb 2014 CONSULTANT Genentech, Inc. 1 DNA Way South San Francisco, California 94080 Dec. 2011 – Jan. 2014 CONSULTANT ACR Image Metrix 1818 Market Street Suite 1600 Philadelphia, Pennsylvania 19103

Robert R. Ford, M.D. Page 2 of 47

Dec 2013 – Present PRINCIPAL Clinical Trials Imaging Consulting, LLC. 9 Raymond Lane Belle Mead, NJ 08502 July 2009 – Feb. 2013 CONSULTANT CoreLab Partners, Inc. 100 Overlook Center Princeton, NJ 08540

2001 – Present CLINICAL INSTRUCTOR, DEPARTMENT OF RADIOLOGY Robert Wood Johnson Medical School New Brunswick, NJ

July 1988 – Present BOARD OF DIRECTORS (RETIRED)

Princeton Radiology Associates, P.A. 3675 Route 27, Suite D Kendall Park, New Jersey 08824 www.prapa.com

732-821-5563 July 1988 – Present HONORARY MEDICAL STAFF (RETIRED)

Department of Diagnostic Radiology University Medical Center at Princeton 1 Plainsboro Rd.

Princeton, NJ 08536 609-853-6500 1998 - Present CLINICAL INSTRUCTOR Department of Diagnostic Radiology Rutgers Medical School New Brunswick, NJ 1988 – 2014 CONSULTANT RADIOLOGIST The Carrier Clinic Belle Mead, NJ 1988 - 2014 CONSULTANT RADIOLOGIST

Princeton University Princeton, NJ

EDUCATION:

1984-88 Weil -Cornell University Medical Center The New York Hospital Department of Diagnostic Radiology New York, NY 10021

1984-88 Memorial Sloan Kettering Cancer Center Department of Diagnostic Radiology

New York, NY 10021 1984 -88 The Hospital For Special Surgery Department of Diagnostic Radiology

New York, NY 10021


1983 Robert Wood Johnson University Hospital Internship in Internal Medicine

New Brunswick, New Jersey

1983 University Medical Center at Princeton Internship in Internal Medicine Princeton, NJ

1983 Robert Wood Johnson University Medical School

Piscataway and New Brunswick, New Jersey M.D. Degree

1979 Rutgers University, Cook College New Brunswick, New Jersey B.S. Degree Major: Biology

ACADEMIC HONORS:

Distinguished Alumni Award-Robert Wood Johnson Medical School Alumni Society (2008) American Medical Association Physician Recognition Award (Sept. 1992-present) Alpha Omega Alpha (1982) Alpha Zeta Honors Fraternity (1979) George H. Cook Honors Award (1979) Dean's List, Cook College, Rutgers University (1975-79)

PRIOR APPOINTMENTS:

Sep. 2006 – Jul. 2009 FOUNDER, CHIEF MEDICAL OFFICER RadPharm, Inc. 100 Overlook Center Princeton, New Jersey 08540 [email protected] www.radpharm.com 609-936-2604

Sep. 2005 – Jul. 2009 BOARD OF DIRECTORS RadPharm, Inc. 100 Overlook Center www.radpharm.com 609-936-2604

1998 – Aug. 2006 FOUNDER, PRESIDENT, CO-CEO AND CHIEF MEDICAL OFFICER RadPharm (Formerly Princeton Radiology Pharmaceutical Research) 103 Carnegie Center, Suite 300A Princeton, New Jersey 08540 609-936-2600

1996-2000 Director MRI Accreditation, Princeton Radiology Associates 1989-1996 Director, Division of Computerized Axial Tomography

University Medical Center at Princeton

1989-1993 Director of Quality Assurance, Department of Diagnostic


Radiology, Medical Center at Princeton 1989-1993 Director of Quality Assurance, Department of Diagnostic

Radiology, Carrier Clinic 1984-1988 Assistant Radiologist, Weil-Cornell University Medical Center

The New York Hospital Department of Diagnostic Radiology

CERTIFICATION:

Diplomate of the National Board of Medical Examiners (1983) Diplomate of the American Board of Radiology (1988) Certificate of Added Qualifications in Neuroradiology – American Board of Radiology (March 2, 1996, Recertification 2009)

LICENSURE:

New Jersey State License #51427 (1988-Current Status: Active) New York State License (1984-Current Status: Inactive)

PROFESSIONAL ORGANIZATIONS:

American Society of Clinical Oncology Alpha Omega Alpha New Jersey Medical Society Mercer County Medical Society American College of Radiology Radiologic Society of North America American Academy of Pharmaceutical Physicians Drug Information Agency

COMMITTEES:

2006-Present Response Evaluation Criteria in Solid Tumors (RECIST) Committee 2007-Present PhRMA Extended Imaging Committee/Pharma Imaging Network for

Therapeutics and Diagnostics 2008-2009 Radiology Society of North America (RSNA) Quantitative Imaging BioMarker

Alliance (QIBA) Volume CT Workgroup 2007-2009 Metrics Champion Consortium (MCC) Steering Committee and Clinical

Imaging Group 2006-2009 American College of Radiology Uniform Protocols for Imaging in Clinical

Trials (UPICT) Steering and CT Protocol Committee

RADPHARM MILESTONES:

• Identified Independent Central Radiology Review as a business opportunity and completed the business proof of concept while in clinical practice at Princeton Radiology Associates

• Incorporated RadPharm as a separate business entity from the PRA clinical practice in 1998. Became President and first employee upon incorporation.

• Recruited Business Manager, CEO, Office Manager and Manager of Clinical Services. • Authored or authorized all process documents governing early manual processes. • Helped formulate concepts for first proprietary business tracking system and data management systems.


• Performed image quality control and image reviews.

• Interacted with Sponsors in business development and protocol development role. • Helped with facilities development, corporate management and HR. • Established new independent office in Princeton, NJ with up to 20 employees. • Identified need to develop digital solutions, identified, recruited and hired CTO. • Increased staffing to 30 and moved to new location in Corporate Park in Princeton. • Hired New COO. • Worked with COO and CSO to establish:

o Quality Assurance Department o Data Management Department o IT Department o Expand Staff

• Established Medical Affairs Department. o Recruited first full time staff radiologist. o Recruited first full time oncologist. o Subsequently recruited 11 staff radiologists and 2 staff oncologists.

• Established the position and recruited Manager of Medical Affairs. • Developed SRS and DDS requirements for electronic Workflow Management System that led to the

implementation of a full business process management system. • Established need for dedicated Submissions team, recruited team Director and worked with the team to

develop RadPharm Image Submission Module for submitting images to FDA in a compliant manner. • Worked with CEO and CSO to accomplish transition of majority interest to a Private Equity Group.

Relinquished titles of President and Co-CEO to focus on role as CMO. • Worked with IT department to establish SRS for new Medical Imaging Platform to be built by Siemens

Corporate Research. • By 2009, there were 350 employees in approximately 90,000 square feet of space with offices in Princeton,

New Jersey and Munich, Germany. RadPharm (formerly Core Lab Partners, currently BioClinica as a merged entity) was involved in 350 international clinical trials, predominately in oncology. Data produced by RadPharm supported 10 successful oncology drug approvals. Revenue in 2008 approached 50 million.

• Resigned from RadPharm on July 3, 2009 to pursue other opportunities. CONSULTANT ACCOMPLISHMENTS at BIOCLINICA (formerly RadPharm):

• Work with external consultants, sponsors, and internal BioClinica resources to further develop a robust reader-monitoring program across all oncology protocols.

• Work with internal resources to develop a new reader-training program. • Recruit and train additional expert readers for the BioClinica neuro-oncology program. • Develop a consensus approach to RANO criteria across all BioClinica neuro-oncology programs.

POSTER SESSIONS: 1. Analysis of the Cause of Discordance between Two Radiologists on the Assessment of Radiographic

Response and Progression for Subjects Enrolled in Breast Cancer Clinical Trials Employing Blinded Independent Central Review Kristin Borradaile, MS, Robert Ford, MD, Michael O’Neal, MD, Kevin Byrne, MD 2010 – American Society of Clinical Oncology Annual Meeting, General Poster Session

2. Analysis of the Rate of Non-target Disease Progression in Patients with Stable or Responding Target

Disease by the Response Evaluation Criteria in Solid Tumors (RECIST) Kristin Borradaile, MS, Robert Ford, MD 2009 – American Society of Clinical Oncology Annual Meeting, General Poster Session

3. The Impact of the Inclusion of Clinical Data Review on Overall Radiographic Response and Progression

in Oncology Clinical Trials as Assessed by Blinded Independent Central Review Nicolette Wangler, BS, Kristin Borradaile, MS, Robert Ford, MD 2009 – American Society of Clinical Oncology Annual Meeting, Poster Discussion


4. First Application of Computed-Assisted Analysis of Digital Photographs for Assessing Tophus Response:

Phase 3 Studies of Pegloticase in Treatment Failure of Gout A.N. Maroli, R. Waltrip, M. Alton, Herbert S. B. Baraf, B. Huang, C. Rehrig, R. Ford 2009 – ACR/ARHP Annual Scientific Meeting

5. Analysis of the Rate of Missing Data, the Rate of Discordance between Readers, and the Rate of Site versus Central Discordance in Clinical Studies of Recently Approved Breast Cancer Agents that have Used Blinded Independent Central Review Kristin Borradaile, Kathy-Ann Cadogan, MBBS, Stacie Somers, Robert Ford, MD 2008 – San Antonio Breast Cancer Symposium, General Poster Session

6. Inter-observer Variability in Radiographic Assessment of Response in Chemotherapy Trials for Pancreatic Cancer Brian Baumann, AB, Robert Ford, MD, Kathy Dasse, PharmD, Kathy Zhou, PhD, Ruth Feldman, MD 2007 – American Society of Clinical Oncology Annual Meeting, General Poster Session

7. Evaluation of the Number of Target Lesions to Analyze in Time to Progression by RECIST

Mithat Gonen, PhD, Lawrence Schwartz, MD, Robert Ford, MD 2007 – American Society of Clinical Oncology Annual Meeting, General Poster Session

8. A Retrospective Exploratory Study of the Variability of Radiologists Measurements in a Selected

Subgroup of Subjects Enrolled in a Clinical Trial Robert W. Ford, Kathy Zhou, PhD, Robert R. Ford, MD 2007 – American Society of Clinical Oncology Annual Meeting, General Poster Session

ARTICLES: 1. Discordance between BICR Readers: Understanding the causes and implementing processes to mitigate

preventable sources of discordance Kristin Borradaile, Robert Ford, MD, Michael O’Neal, MD, Kevin Byrne, MD Applied Clinical Trials – November 2010

2. New Response Evaluation Criteria in Solid Tumors: Revised RECIST Guideline (version 1.1)

E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shanker, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij European Journal of Cancer 45 (2009) 228-247

3. Lessons Learned from Independent Central Review

R. Ford, L. Schwartz, J. Dancey, L.E. Dodd, E.A. Eisenahuer, S. Gwyther, L. Rubinstein, D. Sargent, L. Shanker, P. Therasse, J. Verweij European Journal of Cancer 45 (2009) 268-274

4. Individual Patient Data Analysis to Assess Modifications to the RECIST Criteria

Jan Bogaerts, Robert Ford, Dan Sargent, Lawrence H. Schwartz, Larry Rubinstein, Denis Lacombe, Elizabeth Eisenhauer, Jaap Vrweij, Patrick Therasse, for the RECIST Working Party European Journal of Cancer 45 (2009) 248-260

5. Evaluation of Lymph Nodes with RECIST 1.1

L.H. Schwartz, J. Bogaerts, R. Ford, L. Shankar, P. Therasse, S. Gwyther, E.A. Eisenhauer European Journal of Cancer 45 (2009) 261-267

6. Recommendations for the Assessment of Progression in Randomised Cancer Treatment Trials

J.E. Dancey, L.E. Dodd, R. Ford, R. Kaplan, M. Mooney, L. Rubinstein, L.H. Schwartz, L. Shankar, P. Therasse European Journal of Cancer 45 (2009) 281-289


7. Report of Task Force II: Best Practices in the Use of Medical Imaging Techniques in Clinical Trials:

Consensus from a Public Meeting, October 16-17, 2007, The Medical Imaging Stakeholders Call for Action: Harmonization Across Key Elements and Integration of Imaging in Therapeutic Development – Pharmaceutical Industry, CRO, FDA, and Allied Working Groups Collaborate for Regulatory Guidance Robert Ford, MD, David Mozley, MD Drug Information Journal, Vol. 42, pp. 515-523, 2008

CLINICAL TRIALS PARTICIPATION:

1. A Phase 2 Randomized Open-Label Study of MEDI-551-1088 in Adults with Relapsed or Refractory DLBCL Responsibilities: Training of Expert Reviewers for Independent Review Quintiles, Inc./MedImmune, LLC CD-ON-MEDI-551-1088 (No Date)

2. A Two-Part, Randomized Phase III Double-Blind, Multicenter Trial Assessing the Efficacy and

Safety of Pertuzumab in Combination with Standard Chemotherapy vs. Placebo Plus Standard Chemotherapy in Women with Recurrent Platinum-Resistant Epithelial Ovarian Cancer Responsibilities: CMO Review of a Cohort of Subjects Roche MO28113 (No Date)

3. A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients with Locally Advanced or

Metastatic Urothelial Bladder Cancer Responsibilities: Training of Expert Reviewers for Independent Review F. Hoffman-La Roche Ltd. GO29293 (No Date)

4. Randomized, Multicenter, Phase III Study of Alectinib versus Crizotinib in Treatment-Naïve

Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Lung Cancer Responsibilities: Assumed Lead Physician Position after Program Started. Oversight of the Independent Review Committee, Reader for the Independent Review Committee

F. Hoffmann-LaRoche Ltd. BO28984 (No Date)

5. 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 Responsibilities: CMO Review on a Cohort of Subjects Pfizer, Inc. A8081014 (No Date)

6. 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 Responsibilities: CMO Review on a Cohort of Subjects Pfizer, Inc. A8081005 (No Date)

7. A Double-Blind, Randomized Phase II/III Trial of Active Immunotherapy with Globo H-KLH (OPT-822) in Subjects with Metastatic Breast Cancer Responsibilities: CMO Review on a Cohort of Subjects Optimer Biotechnology, Inc. OPT-822-001 (No Date)

8. A Multicenter, Open-Label, Randomized, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients with Active Acromegaly or Pituitary Gigantism Responsibilities: CMO Review of a Cohort of Subjects Novaritis SCOM230G2304 (No Date)


9. A Phase 1 Study of IDH305 in Patients with Advanced Malignancies that Harbor IDH1R132

Mutations Responsibilities: Charter Development. Training of Expert Reviewers for the Independent Review Novartis CIDH305X2101 (No Date)

10. A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or

Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer Responsibilities: Lead Physician on Charter Development, Implementation of Merck irRECIST Review Process and Oversight of the Independent Review Merck Sharp & Dohme Corp. MK-3475-045 (No Date)

11. A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or

Metastatic Urothelial Cancer Responsibilities: Lead Physician on Charter Development, Implementation of Merck irRECIST Review Process and Oversight of the Independent Review Merck Sharp & Dohme Corp. MK-3475-052 (No Date)

12. A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-

Flouracil in Subjects with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059) Responsibilities: Lead Physician on Charter Development, Implementation of Merck irRECIST Review Process and Oversight of the Independent Review Merck Sharp & Dohme Corp. MK-3475-059 (No Date)

13. A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel

in Subjects with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed after First-Line Therapy with Platinum and Fluoropyrimidine Responsibilities: Lead Physician on Charter Development, Implementation of Merck irRECIST Review Process and Oversight of the Independent Review Merck Sharp & Dohme Corp. MK-3475-061 (No Date)

14. Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761

(Mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma Responsibilities: CMO Review on a Cohort of Subjects Kyowa Hakko Kirin Pharma, Inc. 0761-010 (No Date)

15. A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of

GS-5745 as Monotherapy and in Combination with Chemotherapy in Subjects with Advanced Solid Tumors Responsibilities: Reader Training Gilead Sciences, Inc. GS-US-296-0101 (06461) (No Date)

16. A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with PD-L1-Positive Locally

Advanced or Metastatic Non-Small Cell Lung Cancer Responsibilities: Reader Training F. Hoffman-La Roche, Ltd. GO28754 (No Date)

17. A Phase III, Randomized, Double-Blind, Dummy-Controlled Study of ThermoDox® (Lyso-

Thermosensitive Liposomal Doxorubicin-LTLD) In Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3cm to ≤ 7cm Responsibilities: CMO Review on Cohort of Subjects for Eligibility Review Celsion Corporation 104-13-302 (No Date)


18. A Randomization Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study

of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (CBM) (Checkmate 134) Responsibilities: Supervision of charter development; Oversight of Independent Review, Reader for the Independent Review Committee Bristol-Myers Squibb Research and Development CA209143 (No Date)

19. A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects with

Melanoma Metastatic to the Brain treated with Nivolumab in Combination with Ipilimumab followed by Nivolumab Monotherapy

Responsibilities: Protocol review for Sponsor with attention to imaging components, Supervision of charter development; Oversight of Independent Review, Reader for the Independent Review Committee Bristol-Myers Squibb Research and Development CA209-204 (No Date)

20. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of

ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer Responsibilities: CMO Review on a Cohort of Subjects Aragon Pharmaceuticals, Inc. ARN-509-03 (No Date)

21. A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetic of MPDL3280A Administered Intravenously as a Single Agent to Patients with Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Responsibilities: Reader Training Genentech, Inc. PCD4989g (Jan2015)

22. Phase 3, Randomized, Open-label Study of the Efficacy and Safety of Crizotinib versus Pemetrexed/Cisplatin or Pemetrexed/Carboplatin in Previously Untreated East Asian Patients with Non-Squamous Carcinoma of the Lung Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus Responsibilities: CMO Review on a Cohort of Subjects Pfizer, Inc. A8081029 (Oct2014)

23. Randomized double-blind Phase III trial of FOLF(HA)iri vs. FOLFIRI for second or third line Therapy in irinotecan-naïve patients with metastatic colorectal cancer Responsibilities: Reader for the Independent Review Committee Alchemia Oncology Pty. Ltd. ACO 002 (Sep2014)

24. A Phase III randomized, double-blind, placebo controlled study of BKM120 with fulvestrant, in Postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced

Or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment Responsibilities: Reader for the Independent Review Committee Novartis Pharma AG CBKM120F2303 (Aug2014)

25. A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 with Fulvestrant, in Postmenopausal Women with Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer which Progressed on or after Aromatase Inhibitor Treatment Responsibilities: Reader for the Independent Review Committee Novartis Pharma S.A.S. CBKM120F2302 (Aug2014)

26. A Phase II, Randomized Study of MPDL3280A Administered as Monotherapy or in Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma Responsibilities: Reader for the Independent Review Committee Covance (for Roche) WO29074 (Aug2014)


27. A Randomized, 3-Arm, Multicenter, Phase III Study To Evaluate the Efficacy and The Safety Of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab- Placebo (Blinded For Pertuzumab), Versus The Combination of Trastuzumab Plus Taxane, As First- Line Treatment In HER2-Positive Progressive or Recurrent Locally Advanced Or

Metastatic Breast Cancer (MBC) Responsibilities: CMO Review on a Cohort of Subjects F. Hoffman-La Roche Ltd. BO22589 (Jun2014)

28. An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Failed Crizotinib Treatment Responsibilities: Assumed Lead Physician Position after Program Started. Oversight of the Independent Review Committee, Reader for the Independent Review Committee F. Hoffman-La Roche Ltd. NP28673 (Apr2014)

29. A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients with ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated with Chemotherapy and Crizotinib Responsibilities: Assumed Lead Physician Position after Program Started. Oversight of the Independent Review Committee, Reader for the Independent Review Committee F. Hoffmann-La Roche Ltd. NP28761 (Apr2014)

30. An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Cetuximab versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck Responsibilities: CMO Review on a Cohort of Subjects Quintiles for Eisai E7050-702 (Feb2014)

31. A Randomized, double-blind, multicenter, Phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin – RADIANT – 4 Responsibilities: CMO Review on a Cohort of Subjects, Reader for the Independent Review Committee Novartis Pharmaceuticals Corporation CRAD001T2302 (Jan2014)

32. Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-Care) Responsibilities: Reader for the Independent Review Committee Amgen 20060359 (May2014)

33. A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma Responsibilities: Reader for the Independent Review Committee Amgen, Inc. 20090482 (Apr2013)

34. An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected EGFRvIII-positive Glioblastoma Responsibilities: Oversight of the Independent Review Committee, Reader for the Independent Review Committee Celldex Therapeutics CDX110-04 (Feb2013)


35. A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107

in Newly Diagnosed Patients with Glioblastoma Multiforme Following Resection and Chemoradiation Responsibilities: Reader for the Independent Review Committee ImmunoCellular Therapeutics ICT-107-201 (Dec2012)

36. Phase I/II Single-Arm Open Label Multicenter Study of VB-111 in Patients with Recurrent

Glioblastoma Multiforme Responsibilities: Reader for the Independent Review Committee Vascular Biogenics, Ltd. VB-111-122-CU (Nov2012)

37. A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer

Previously Treated with Anthracyclines and Taxanes Responsibilities: Reader for the Independent Review Committee Eisai Global Clinical Development E7389-G000-301 (Jun2010)

38. A Prospective, Multi-center Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM Responsibilities: Reader for the Independent Review Committee NovoCure Ltd. EF-14 (Jun2010) 39. A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitunumab in Combination with mFOLFOX6 to the Efficacy of Bevacizumab in Combination with

mFOLFOX6 in Patients with Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review Amgen, Inc. 20070509 (May2009)

40. A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in

Patients with Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma Responsibilities: Oversight of the Independent Review Molecular Insight Pharmaceuticals, Inc. MIP-IB12B (May2009)

41. A Pivotal Study of SGN-35 in Treatment of Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL) Responsibilities: Oversight of the Independent Review

Seattle Genetics SG035-0004 (May2009)

42. A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy of MORAb-009 in Combination with Gemcitabine in Patients with Advanced Pancreatic Cancer

Responsibilities: Oversight of the Independent Review Morphotek, Inc. MORAb-009-002 (May2009)

43. A Phase I/II, Open-Label, Multi-Centre Study of Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients with Primary Myelofibrosis (PMF) and Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV-ET MF)

Responsibilities: Oversight of the Independent Review AstraZeneca Pharmaceuticals, LP D1060C00001 (Apr2009)

44. A Phase I-II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety and Efficacy of Microwave Hyperthermia and Thermodox in Patients with Breast Cancer Recurrence at the Chest Wall

Responsibilities: Oversight of the Independent Review Celsion Corporation 105-08-201 (Apr2009)


45. A Phase I dose Escalation Study of the Safety and Pharmacokinetics of XL518 Administered Orally Daily to Subjects with Solid Tumors

Responsibilities: Oversight of the Independent Review Genentech, Inc. MEK4592g/XL518-001 (Apr2009)

46. A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination with AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

Responsibilities: Oversight of the Independent Review Amgen, Inc. 20060579 (Apr2009)

47. Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy of Niltinib versus Best Supportive Care with or without a Tyrosine Kinase Inhibitor (Investigator’s Choice) in Adult Patients with Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

Responsibilities: Oversight of the Independent Review Novartis Pharmaceuticals Corporation CAMN107A2201 (Apr2009)

48. An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients with Genotype 2/3 Chronic Hepatitis C

Responsibilities: Oversight of the Independent Review Novartis Pharmaceuticals Corporation CABF656B2202 (Mar2009)

49. A Pivotal Study of SGN-34 in Treatment of Patients with Relapsed Hodgkin’s Lymphoma (HL)

Responsibilities: Oversight of the Independent Review Seattle Genetics SG035-0003 (Mar2009)

50. A Double-Blind, Randomized, Placebo-and-Active-Controlled Efficacy and Safety Study of the Effects of Bazedoxifene/Conjugated Estrogens Combinations on Endometrial Hyperplasia in Prevention of Osteoporosis in Postmenopausal Women

Responsibilities: Oversight of the Independent Review Wyeth 3115A1-3307-WW (Mar2009)

51. A Phase I Dose Escalation Tolerability Study of ThermoDox® (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA) of Primary and Metastatic Tumors of the Liver

Responsibilities: Oversight of the Independent Review Celsion Corporation 104-06-101 (Mar2009)

52. A Phase 2 Study of XL 184 in Subjects with Progressive or Recurrent Glioblastoma Multiforme in First or Second Relapse

Responsibilities: Oversight of the Independent Review Exelixis, Inc. XL 184-201 (Feb2009)

53. A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study of the 12 Month Effect of Treatment with Once Daily Triamcinolone Acetonide (NASACORT

® AQ Nasal

Spray 110µg) on the Growth Velocity of Children, 3 to 9 Years of Age, with Perennial Allergic Rhinitis (PAR)

Responsibilities: Oversight of the Independent Review Sanofi Aventis XRG5029C/3503 (Feb2009)

54. A Phase II Multicenter Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients with Advanced Basal Cell Carcinoma

Responsibilities: Oversight of the Independent Review Genentech, Inc. SHH4476 (Feb2009)


55. A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast Cancer and Non-Small Cell Lung (NSCLC) Cancers

Responsibilities: Oversight of the Independent Review Schering-Plough Research Institute P04716 (Jan2009)

56. Phase I/II Evaluation of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Sarcoma

Responsibilities: Oversight of the Independent Review Epeius Biotechnologies Corporation CO7-103 (Jan2009)

57. A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma

Responsibilities: Oversight of the Independent Review Epeius Biotechnologies Corporation CO7-110 (Jan2009)

58. A Phase I Study of Deforolimus (MK-8669) and MK-0646 in Patients with Advanced Cancer

Responsibilities: Oversight of the Independent Review Merck MK-8669-004 (Jan2009)

59. A Phase Ib Study of SGN-40 (anti-huCD40 mAb) in Combination with Rituximab and Gemcitabine for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Responsibilities: Oversight of the Independent Review Seattle Genetics, Inc. SG040-0008 (Nov2008)

60. A Phase II, Single-arm, Open-label Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients with HER2-positive Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review Genentech, Inc. TDM4374g (Aug2008)

61. A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus

Responsibilities: Oversight of the Independent Review Theravance, Inc. 0015 and 0019 (Jul2008)

62. A Multicenter, Randomized, Double-Blind, Phase 3 Study of Sunitinib Plus Prednisone versus Prednisone in Patients with Progressive Metatastic Hormone-Refractory Prostate Cancer After Failure of a Docetaxel-Based Chemotherapy Regimen

Responsibilities: Oversight of the Independent Review Pfizer, Inc. A6181120 (May2008)

63. An Open-Label, Phase I Study of Systemic Hedgehog Pathway Antagonist, GDC-0449 in Patients with Locally Advanced or Metastatic Solid Tumors that are Refractory to Standard Therapy or for whom No Standard Therapy Exists

Responsibilities: Oversight of the Independent Review Genentech SHH3925g (Apr2008)

64. Randomized Phase 2 Trial of AG-013736 or Bevacizumab in Combination with Paclitaxel and Carboplatin as First-Line Treatment for Patients with Advanced Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review Pfizer A4061030 (Feb2008)

65. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate

the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects with Perennial Allergic Rhinitis

Responsibilities: Oversight of the Independent Review GlaxoSmithKline FFR101782 (Feb2008)


66. Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus

Docetaxel versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review Imclone IMCL CP12-0606/TRIO-012 (Feb2008)

67. A Phase 1, Open-Label, Dose-Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in

Subjects with Relapsed or Refractory Solid Tumors Responsibilities: Oversight of the Independent Review. Biogen-Idec 212ST101 (Jan 2008)

68. An Open-Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination with Erlotinib

(TARCEVA) for Patients with Recurrent Non-Small Cell Lung Cancer Responsibilities: Oversight of the Independent Review. Merck MK0646-007 (IMG-07-10) (Jan 2008)

69. An Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY2469298)

Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma

Responsibilities: Oversight of the Independent Review. Applied Molecular Evolution AME 06.133v.A (Dec 2007)

70. A Multicenter, Open-Label, 24-Week Regimen of 8 mg Pegloticase I.V. in Symptomatic Gout

Subjects Who Participated in Previous Studies of Pegloticase I.V. Responsibilities: Discussed proposal of evaluating tophi with photo measurements with Sponsor. Wrote proposal for FDA. Participated in FDA meetings and reached agreement with FDA on proposal. Recruited experts to perform reviews. Oversight of the Independent Review. Interacted with sponsor to prepare for regulatory submission of images.

Savient C0409 (Nov 2007) 71. A Randomized, Open-Label, Phase 3 Trial of Erlotinib Alone or in Combination with CP-751,871 in

Patients with Advanced Non-Small Cell Lung Cancer of Non-Adenocarcinoma Responsibilities: Oversight of the Independent Review. Pfizer A4021018 (Nov 2007)

72. A Randomized, Open label, Phase III Trial of CP-751,871 Plus Paclitaxel Plus Carboplatin Versus

Paclitaxel Plus Carboplatin in Patients with Squamous-Cell Non-Small Cell Lung Cancer Responsibilities: Oversight of the Independent Review. Pfizer A4021016 (Nov 2007)

73. A Phase 1/Phase 2 Study of CP-751,871 in Patients with Relapsed and/or Refractory Ewing’s

Sarcoma Family of Tumors Responsibilities: Oversight of the Independent Review. Pfizer A4021020 (Oct 2007)

74. A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's

Sarcoma That Has Relapsed After Standard Systemic Therapy Responsibilities: Oversight of the Independent Review. Schering-Plough P04720 (Oct 2007)

75. A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH717454 as Assessed by

Positron Emission Tomography in Patients with Relapsed or Recurrent Colorectal Cancer Responsibilities: Oversight of the Independent Review. Schering-Plough P04721 (Oct 2007)


76. A Phase 2 Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung

Cancer that is Refractory or Progressive within 90 Days of Completion of First-Line Platinum-based Chemotherapy

Responsibilities: Oversight of the Quality Control Process of received images. Pharmion CNF3140-SCLC-002 (Sep 2007)

77. A Phase 2 Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung

Cancer that is Refractory or Progressive within 90 Days of Completion of First-Line Platinum-based Chemotherapy

Responsibilities: Oversight of the Quality Control Process of received images. Pharmion CNF3140-SCLC-05004 (Sep 2007)

78. A Phase IV, Randomized, Prospective, Multicenter Comparison of an Intermittent Schedule of

Oxaliplatin (IO) Combined with 5-Fluororacil/Leucovorin (FOLFOX)/Bevacizumab versus the Conventional (CO) Mode of Administration of FOLFOX/Bevacizumab Plus Neuropro

Responsibilities: Oversight of the Independent Review. Sanofi-Aventis L-9444 (Aug 2007)

79. A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects with Platinum-Resistant

Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Responsibilities: Oversight of the Independent Review. Biogen-Idec 206OC201 (Aug 2007)

80. A Phase 1/2 Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin with or without

M200 (Volociximab) for the Treatment of Subjects with Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy with a Platinum/Taxane-Based Chemotherapy

Responsibilities: Oversight of the Independent Review. Biogen-Idec 206OC202 (Aug 2007)

81. A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against

Interleukin (CNTO328) in Subjects with B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease.

Responsibilities: Oversight of the Independent Review. Centocor C0328T03 (Aug 2007)

82. A Phase I Trial of Cytolytic T Cell Infusions Against a Single Melanoma-Epitope (Tyrosinase)

Responsibilities: Oversight of the Independent Review Centocor CTL-01(Aug2007)

83. A Pilot Study of Subcutaneous Interferon-Α-2b with Infusion of Drosophila Cell Stimulated

Autologous CD8 Lymphocytes for the Treatment of Advanced Melanoma Responsibilities: Oversight of the Independent Review Centocor CTL-02 (Aug2007)

84. A Randomized Phase II Trial of Subcutaneous Interferon-Α-2b (IFN--2b) and Interleukin-2 (IL-2)

with or without Infusion of Drosophila Cell-Stimulated Autologous CD8 Lymphocytes for the Treatment of Advanced Melanoma

Responsibilities: Oversight of the Independent Review Centocor CTL-03 (Aug2007)


85. A Pilot Study to Evaluate the Treatment of Patients with Metastatic Melanoma Using Autologous

CD8+ Lymphocytes Stimulated Ex Vivo with Drosophila Cells Loaded with Melanoma-Associated Peptides (MART-1, Gp100 and Tyrosinase) Following Administration of a Non-Myeloablative Lymphocyte Depletion with or without Cladribine (2-Cda) or Denileukin Diftitox (DAB IL-2) and Subcutaneous Administration of Interferon-Α-2b (INF-Α-2b) and Interleukin-2

Responsibilities Oversight of the Independent Review Centocor CTL-04 (Aug2007)

86. A Phase II/III Study of MK-0646 in Combination with Cetuximab and Irinotecan for Patients with

Metastatic Colorectal Cancer Responsibilities: Oversight of the Independent Review Merck MK0646-004 (Aug 2007)

87. A Randomized Phase III Trial Comparing the Combination of Fludarabine, BBR 2778 (Pixantrone)

and Rituximab (FP-R) with the Combination of Fludarabine and Rituximab (F-R) in the Treatment of Patients with Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma

Responsibilities: Oversight of the Independent Review Cell Therapeutics PIX303 (Jul2007)

88. A Phase III Randomized, Multicenter Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer Who Failed Both a Taxane and an Anthracycline Chemotherapy Regimen or Failed with a Taxane and for Whom Further Anthracycline Therapy is Not Indicated

Responsibilities: Oversight of the Independent Review. Pfizer A6181107 (Jun 2007)

89. A Phase III, Multicenter Randomized Placebo-Controlled Trial Evaluating the Safety and Efficacy of

Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3693g (Jun 2007)

90. A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety

of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Untreated Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3694g (Jun 2007)

91. A Phase II, Single-Arm, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously

to Patients with HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy

Responsibilities: Oversight of the Independent Review. Genentech TDM4258g (Jun 2007)

92. A Phase I, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients with Either Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) or Advanced or Metastatic Soft Tissue Sarcomas (STS)

Responsibilities: Oversight of the Independent Review. Participated in post trial experts meeting. Infinity IPI-504-02 (Jun 2007)

93. A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin versus Toptecan in

Patients with Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship. Pharmion AMR PH GL 2007 (Jun 2007)


94. A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide,

Carboplatin and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma

Responsibilities: Oversight of the Independent Review. Seattle Genetics 04-05 (Jun 2007)

95. A Phase II, Randomized, Multicenter, Open-Label Study of YM155 Plus Docetaxel and Prednisone

versus Docetaxel and Prednisone Alone in Men with Advanced Hormone Refractory Prostate Cancer (HRPC) in the First-Line Setting

Responsibilities: Oversight of the Independent Review. Astellas 155-CL-014 (Jun 2007)

96. A Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell

Lymphoma Responsibilities: Oversight of the Independent Review. BioCryst BCX1777-203 (Jun 2007)

97. An Open-Label, Phase I, Dose-Escalation Study of PI3-Kinase Inhibitor (GDC0941) in Patients with

Locally Advanced or Metastatic Solid Tumors for which Standard Therapy Either Does Not Exist or has Proven Ineffective or Intolerable

Responsibilities: Oversight of the Independent Review. Genentech GDC4254g (May 2007)

98. An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase

Inhibitor (GDC0941) in Patients with Locally Advanced or Metastatic Solid Tumors for which Standard Therapy Either Does Not Exist or has Proven Ineffective or Intolerable

Responsibilities: Oversight of the Independent Review. Genentech GDC4255g (May 2007)

99. A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of

Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia

Responsibilities: Oversight of the Independent Review. Biogen-Idec 152-CL-201 (Apr 2007)

100. A Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy

in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Responsibilities: Oversight of the Independent Review. Amgen 20062088 (Apr 2007)

101. A Phase I, Multi-Center, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 Administered Orally Twice Weekly for Three Week of a Four Week Course or Twice Weekly without a Drug Holiday to Patients with Advanced Solid Tumors

Responsibilities: Oversight of the Independent Review. Biogen-Idec CNF2024 (Apr 2007)

102. A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. BioNovo BZL101-002 (Apr 2007)

103. A Multi-Center, Open-Label, Single-Arm Trial Evaluating Panitumumab in Combination with FOLFIRI Therapy Following First-line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20060277 (Mar 2007)


104. A Randomized Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab with or

without Apomab in Patients with Previously Untreated Advanced-Stage Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Genentech APM 4074g (Mar 2007)

105. A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent Apomab in

Patients with Advanced Chondrosarcoma or Previously Treated, Advanced Synovial Sarcoma Responsibilities: Oversight of the Independent Review. Genentech APM4171g (Mar 2007)

106. A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination with

AMG 386 in Subjects with Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer Responsibilities: Oversight of the Independent Review. Amgen 20060342 (Feb 2007)

107. A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy

in Subjects with Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck Responsibilities: Oversight of the Independent Review. Amgen 20062079 (Feb 2007)

108. A Phase 2, Randomized, Trial of Chemoradiation with or without Panitumumab in Unresected,

Locally Advanced Squamous Cell Carcinoma of the Head and Neck Responsibilities: Oversight of the Independent Review. Amgen 20062080 (Feb 2007)

109. A Phase II, Randomized Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics

and Efficacy of Multiple Doses of Apomab Administered Intravenously in Combination with Rituximab in Subjects with Follicular, CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma That Has Progressed Following Previous Rituximab Therapy

Responsibilities: Oversight of the Independent Review. Genentech APM4083g (Feb 2007)

110. A Phase III, Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy Two-Arm Study

of Posaconazole vs. Fluconazole in the Treatment of Coccidioidomycosis Responsibilities: Oversight of the Independent Review. Schering-Plough P04558 (Feb 2007)

111. A Phase 3, Randomized, Placebo-Controlled Study of Oral Talactoferrin in Combination with Carboplatin and Paclitaxel as First Line Therapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Agennix LF-0208 (Feb 2007)

112. A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of

Sunitinib in Combination with Bevacizumab, Carboplatin and Paclitaxel in Previously Untreated Patients with Advanced Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3996g (Feb 2007)

113. A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy and Safety Study of

Erlotinib with or without Sunitinib (Su011248) in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Pfizer A6181087 (Feb 2007)


114. A Randomized, Double-Blind, Phase 3 Trial of AMG 706 Plus Best Supportive Care (BSC) versus

Placebo Plus BSC for Subjects with Locally Advanced or Metastatic Differentiated Thyroid Cancer Responsibilities: Oversight of the Independent Review. Amgen 20060173 (Jan 2007)

115. A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma

Subjects Responsibilities: Oversight of the Independent Review. Astellas ISN-155-CL-009 (Jan 2007)

116. A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of

Sunitinib in Combination with Bevacizumab and Paclitaxel in Previously Untreated Patients with Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF4057g (Jan 2007)

117. Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic

Colorectal Carcinoma Treatment with Recombinant NAPC2 Responsibilities: Oversight of the Independent Review.

Nuvelo NAP-0601 (Dec2006) 118. A Phase III, Randomized, Double-Blind, Dummy-Controlled Study of the Efficacy and Safety of

ThermoDox(tm) (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA) Compared to RFA Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma

Responsibilities: Discussed protocol concepts and response criteria early with sponsor and authored preliminary IRC charter. Oversight of the Independent Review.

Celsion Thermodox (Dec 2006) 119. A Phase II, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and

Gemcitabine Plus Bevacizumab in Patients with Platinum Sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

Responsibilities: This protocol was stopped early secondary to high incidence of Gastrointestinal perforation. Established criteria with sponsor to review cases to identify potential risk factors of GIP. Oversight of the Independent Review.

Genentech AVF4095g (Dec 2006) 120. An Open-Label Extension Study to Evaluate the Safety and Clinical Outcomes in Subjects Taking

PEG-Uricase for More than 24 Weeks in Those Subjects Who Completed Treatment in either the C0405 or the C0406 Study

Responsibilities: Discussed proposal of evaluating tophi with photo measurements with Sponsor. Wrote proposal for FDA. Participated in FDA meetings and reached agreement with FDA on proposal. Recruited experts to perform reviews. Oversight of Independent Review. Interacted with sponsor to prepare for regulatory submission of images.

Savient C0407 (Dec 2006) 121. A Phase I Study of MK-0752, a Notch Inhibitor, in Patients with Metastatic or Locally Advanced

Breast Cancer and Other Solid Tumors Responsibilities: Oversight of the Independent Review. Merck 0752-014-04 (Dec 2006)

122. An Observational Study of Avastin® (Bevacizumab) in Combination with Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology), or Locally Recurrent or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3991n


123. A Phase 1/2 Study to Investigate the Safety, Tolerability and Potential Activity of IPI 504 in

Relapsed and/or Refractory Stage IIIb (with Malignant Pleural or Pericardial Effusion) or Stage IV Non-Small Cell Lung Cancer Patients

Responsibilities: Oversight of the Independent Review. Infinity IPI-504-03 (Nov 2006)

124. A Phase I/IIa Dose Escalation Study of MK-0457 Evaluating the Safety, Tolerability,

Pharmacokinetics, and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer

Responsibilities: Oversight of the Independent Review. Merck 0457-002-03 (Nov 2006)

125. An Open-Label, Multicenter, Phase III Trial of ABI-007 vs. Dacarbazine in Previously Untreated Patients with Metastatic Malignant Melanoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, correspondence with FDA regarding Special Protocol Assessment. Abraxis CA033 (Nov 2006)

126. A Randomized Phase III Study of Weekly ABI-007 versus Every 3 Weeks Docetaxel as First-Line

Therapy of Stage IV (Metastatic) Breast Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship. Abraxis CA048 (Nov 2006)

127. A Phase II, Multicenter, Open-label, Single-Arm Study Using Gemcitabine, Capecitabine and

Panitumumab in the First-line Treatment of Subjects with Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

Responsibilities: Oversight of the Independent Review. Amgen 20060107 (Nov 2006)

128. A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate

the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney


129. A Phase II, Multicenter, Open-Label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-Line Treatment of Subjects with Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas


130. A Randomized Phase III Trial of ABI-007 and Carboplatin Compared with Taxol and Carboplatin

as First-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, correspondence with FDA regarding Special Protocol Assessment. Abraxis CA031 (Oct 2006)

131. A Randomized, Phase 3, Study of Sunitinib in Combination with Capecitabine Compared with

Capecitabine in Patients with Previously Treated Breast Cancer Responsibilities: Oversight of the Independent Review. Pfizer A6181099 (Oct 2006)


132. Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs. Placebo as

Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis Responsibilities: Participated in post phase II experts meeting. Discussed concept of using percent opacification on sinus CTs as a measure of efficacy. Participated in Sponsor/FDA pre Phase III meetings. Oversight of the Independent Review.

Schering Plough P04824 (Oct 2006) 133. Evaluation of Changes in Mammographic Breast Density Associated with Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW

Responsibilities: Oversight of the Independent Review. Wyeth 3068A1-400-WW (Oct 2006)

134. A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade® versus Velcade Alone in Subjects with Relapsed or Refractory Multiple Myeloma

Responsibilities: Oversight of the Independent Review. Centocor CO328T06 (Sep 2006)

135. An Open-Label, Randomized Multicenter Trial to Determine Non-Inferiority of Screening

Performance of DBT Compared to FFDM Using Blinded Reads in Women Referred to Screening Mammography Responsibilities: Protocol and process discussed with sponsor. Authored charter. Study closed and independent review not performed.

GE Tomosynthesis (Sep 2006) 136. A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients with Platinum-Resistant Ovarian Cancer

Responsibilities: Oversight of the Independent Review. Sunesis SPO-010 (Aug 2006)

137. A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI with either Panitumumab or Bevacizumab as Second-line Treatment in Subjects with Metastatic Colorectal

Responsibilities: Oversight of the Independent Review. Amgen 20060141 (Aug 2006)

138. A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Responsibilities: Worked with sponsor to develop the concept and process for the retrospective review performed on this study. Iterated with sponsor on charter. Oversight of the Independent Review. Participated at Oncologic Drugs Advisory Committee.

Genentech E2100 139. A Randomized Phase II/III Trial of Paclitaxel plus Carboplatin with or without Bevacizumab in

Patients with Advanced Nonsquamous NSCLC Responsibilities: Oversight of the Independent Review

Genentech E4599 (Aug 2006) 140. A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

Responsibilities: Neuroradiologist reviewer. Oversight of the Independent Review Northwest Biotherapeutics 020221 (Aug 2006)

141. A Randomized Phase 3 Study of Docetaxel in Combination with Sunitinib versus Docetaxel in the First-Line Treatment of Advanced Breast Cancer

Responsibilities: Oversight of the Independent Review Pfizer A6181064 (Aug 2006)


142. A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline versus Ertapenem for the Treatment of Foot Infections in Subjects with Diabetes

Responsibilities: Oversight of the Independent Review Wyeth 3074K-319 (Aug 2006)

143. A Phase I Open Label Study of Picoplatin in Combination with 5-Fluorouracil and Leucovorin (FOLPI) Followed By a Randomized Phase 2 Study of FOLPI versus Oxaliplatin in Combination with 5-Fluorouracil and Leucovorin (FOLFOX) as Initial Therapy in Subjects with Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review Poniard 0501 (Jul2006)

144. A Phase 1/2 Dose-Escalating Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination with Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

Responsibilities: Oversight of the Independent Review Threshold Pharmaceuticals TH-CR-301 (Jul 2006)

145. A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of

The Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects with Advanced Malignancies Responsibilities: Oversight of the Independent Review Schering Plough P04629 (Jul 2006)

146. A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects with Advanced Malignancies

Responsibilities: Oversight of the Independent Review Schering Plough P04630 (Jul 2006)

147. A Phase 2 Efficacy and Safety Study of SU011248 in Patients with Non-Small Cell Lung Cancer and Brain Metastases

Responsibilities: Oversight of the Independent Review Pfizer A6181092 (May 2006)

148. A Randomized, Double Blind, Placebo-controlled, Phase 3 Trial of Docetaxel with or without AMG 706 as First-line Chemotherapy for Subjects with HER2-Negative Locally Recurrent or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20060109 (May 2006)

149. A Phase 2, Multi-Center, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced Non-Squamous Non-small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review Amgen 20060136 (May 2006)

150. A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients with Non-Hodgkin’s Lymphoma

Responsibilities: Oversight of the Independent Review Cytokinetics CY2121 (May 2006)


151. A Phase Ib/II Open-Label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Apo2L/TRAIL Administered Intravenously in Combination with Rituximab to Subjects with Follicular and Other Low-Grade, CD20+, B-cell Non-Hodgkin’s Lymphomas that have Progressed Following Previous Rituximab Therapy

Responsibilities: Oversight of the Independent Review Genentech APO3585g (May 2006)

152. A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects with Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia

Responsibilities: Oversight of the Quality Control Process of received images. J&J EPO-ANE-4008 (May 2006)

153. Study of Oral Vinorelbine in the Treatment of Advanced Breast Cancer

Responsibilities: Oversight of the Independent Review. Novacea 031-001 (May 2006)

154. Safety of Vascugel™ Treatment after the Creation of Arteriovenous Access for Hemodialysis Use

Responsibilities: Oversight of the Independent Review. Pervasis PVS-06-003 (May 2006)

155. A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291, a 5-lipoxygenase Inhibitor, on Biomarkers of Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

Responsibilities: Oversight of the Independent Review. VIA Pharmaceuticals VIA-2291-01 (May 2006)

156. A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Effects of VIA-2291, a 5- lipoxygenase Inhibitor, on Atherosclerotic Plaque and Biomarkers of Vascular Inflammation in Patients with Carotid Stenosis Undergoing Elective Carotid Endarterectomy

Responsibilities: Oversight of the Independent Review. VIA Pharmaceuticals VIA-2291-02 (May 2006)

157. A Phase II Study of AP23573, an mTOR Inhibitor, in Patients with Advanced Sarcoma

Responsibilities: Oversight of the Independent Review. Ariad AP23573-04-202 (Apr 2006)

158. A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients with Progressive or Recurrent GBM

Responsibilities: Oversight of the Independent Review. Novocure EF-11 (Apr 2006)

159. A Randomized, Open-Label, Controlled Phase II Trial of Combination Chemotherapy with and without Panitumumab in the First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20050236 (Mar 2006)

160. A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/oral) Moxifloxacin 400 mg Once Daily to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects with Complicated Skin and Skin Structure Infections (RELIEF Study)

Responsibilities: Recruited an expert who developed the response criteria with the sponsor and recruited additional expert reviewers.

Bayer 11974 (Mar 2006)


161. A Phase III, Randomized, Multi-Center Study of the Efficacy of Weekly Taxoprexin® in Combination with Carboplatin vs. Paclitaxel in Combination with Carboplatin as First Line Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Luitpold POI-04-20 (Mar 2006)

162. An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients with Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

Responsibilities: Oversight of the Independent Review . Medarex MDX-060-04 (Mar 2006)

163. A Randomized, Double-Blind, Phase 2 Study of Erlotinib with or without SU011248 in the Treatment of Metastatic Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Pfizer A6181058 (Mar 2006)

164. Efficacy and Safety of Mometasone Furoate Nasal Spray in the Treatment of Acute Episodes and Recurrences of Sinusitis

Responsibilities: Oversight of the Independent Review. Schering Plough C96-195 (Mar 2006)

165. Efficacy and Safety of 800 mcg or 400 mcg of Mometasone Furoate Nasal Spray or Placebo in the Treatment of Acute Episodes of Sinusitis

Responsibilities: Oversight of the Independent Review. Schering Plough C97-251 (Mar 2006)

166. A Multi-center Phase 2 Open-label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Responsibilities: Oversight of the Independent Review. Oversight of the submission team in preparation for submission of image data if required.

Allos PDX-008 (Feb 2006)

167. Therapy with Supplemental Oxygen, with or without Concurrent RSR 13 (Efaproxiral), in Women with Brain Metastases From Breast Cancer

Responsibilities: Oversight of the Independent Review. Pfizer RSR13 RT-016 (Feb2006)

168. A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Untreated Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20050203 (Feb 2006)

169. A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma


170. A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (Erlotinib) Compared with Tarceva Alone for Treatment of Advanced Non−Small Cell Lung Cancer After Failure of Standard First-Line Chemotherapy

Responsibilities: Oversight of the Independent Review. Genentech OSI3364g (Feb 2006)


171. A Phase III, 24-Week Randomized, Multi-Center, Double-Blind, Controlled Efficacy and Safety Study of Two Dose Regimens of Puricase in Hyperuricemic Subjects with Severe Symptomatic Gout

Responsibilities: Discussed proposal of evaluating tophi with photo measurements with Sponsor. Wrote proposal for FDA. Participated in FDA meetings and reached agreement with FDA on proposal. Recruited experts to perform reviews. Oversight of the Independent Review. Interacted with sponsor to prepare for regulatory submission of images.

Savient C0406 (Jan 2006) 172. A Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer

Responsibilities: Oversight of the Independent Review. Wyeth 3144A1-201-WW (Jan 2006)

173. A Retrospective Study of Clinical and Radiographic Risk Factors Associated with Early-Onset,

Severe Pulmonary Hemorrhage in Bevacizumab-Treated Patients with Advanced Non-Squamous Non Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3729g

174. A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination with Paclitaxel, or Open-Label Bevacizumab in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20050225 (Dec2005)

175. A Phase II Study of the Combination of Bevacizumab with Irinotecan in Malignant Glioma Patients

Responsibilities: Oversight of the Independent Review. Genentech AVF3311s (Dec 2005)

176. A Phase II Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or in Combination with Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse

Responsibilities: Oversight of the Independent Review. Genentech AVF3708g (Dec 2005)

177. A Phase 3 Study of SU011248 in Combination with Paclitaxel versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer

Responsibilities: Oversight of the Independent Review. Pfizer A6181094 (Dec 2005)

178. A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer


179. A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer


180. A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer



181. A Pilot Study of Bevacizumab plus Carboplatin and Paclitaxel in Subjects with Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3744g (Nov 2005) 182. A Phase II Study of Bevacizumab in Combination with First- or Second-Line Therapy in Subjects with Treated Brain Metastases due to Non-Squamous Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Genentech AVF3752g (Nov 2005) 183. An Open-Label, Dose-Escalation Phase I Trial of MK-0646 Given as a Once Weekly, Every Other Week, or Every Three Week Infusion in Patients with Advanced Solid Tumors and Multiple Myeloma

Responsibilities: Oversight of the Independent Review. Merck MK0646-001 (Nov 2005) 184. A Randomized Double-Blind Phase-2 Study of Anastrozole plus Lonafarnib (SCH 66336) or Anastrozole plus Placebo for the Treatment of Subjects with Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review process at study start-up. Schering Plough P03480 (Oct 2005) 185. A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment of Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly with Panitumumab

Responsibilities: Oversight of the Independent Review. Amgen 20050184 (Sep 2005) 186. A Phase II, Open-Label Study of HTI-286 Administered Intravenously as a Single Agent for the Treatment of Non-Small Cell Lung Cancer for Disease Recurrence following Platinum-based Therapy.

Responsibilities: Oversight of the Independent Review. Wyeth 3161K1-200-WW (Sep 2005) 187. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20050147 (Aug 2005) 188. A Randomized Phase 2 Study of SU011248 versus Standard of Care for Patients with Previously Treated, Advanced, Triple Receptor Negative (ER, PR and HER2) Breast Cancer

Responsibilities: Oversight of the Independent Review. Pfizer A6181077 (Aug 2005) 189. Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second–Line Chemotherapy in Patients with Advanced Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Sunesis SPO-0006 (Aug 2005) 190. A Phase III, Open-Label, Prospective, Two-Armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment with the Zevalin (ibritumomab tiuxetan) Study Regimen vs. Observation in Patients with Diffuse Large B-cell Lymphoma Who are in Complete Remission after First-Line CHOP-Rituximab (CHOP-R) Therapy

Responsibilities: Oversight of the Independent Review. Biogen-Idec 106-20 (Jul 2005)


191. A Phase III, Multi-center, open-label, randomized, controlled study of the efficacy and safety of oral LDE225 versus temozolomide in patients with Hh-pathway activated relapsed medulloblastoma

Responsibilities: Took over lead physician role after study start-up. Oversight of Central Review, Reader for the Independent Review Committee

Novartis CLDEC225C2301 (Jul2005) 192. A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of

Oral TK1258 as Second-line Therapy in Patients with Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Responsibilities: Oversight of the Independent Review, Training of Expert Reviewers for the Independent Review Novartis CTKI1258A211 (Jul2005) 193. A Phase II Study of Picoplatin as Second-Line Therapy for Subjects with Small Cell Lung Cancer who have Resistant or Refractory Disease or have Relapsed within 180 Days of Completing First-Line, Platinum-Containing Chemotherapy

Responsibilities: Oversight of the Independent Review Poniard 0402 (Jun2005)

194. A Randomized, Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of 8 mg PEG-Uricase in Two Dose Regimens in Hyperuricemic Subjects with Symptomatic Gout

Responsibilities: Discussed proposal of evaluating tophi with photo measurements with Sponsor. Wrote proposal for FDA. Participated in FDA meetings and reached agreement with FDA on proposal. Recruited experts to perform reviews. Oversight of the Independent Review. Interacted with sponsor to prepare for regulatory submission of images. Savient C0405 (Jun 2005) 195. A Phase 2, Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20040273 (May 2005) 196. A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5- Fluorouracil/Leucovorin in Patients with Metastatic Colorectal Cancers that have Progressed After Standard Chemotherapy

Responsibilities: Oversight of the Independent Review. Genentech TRC0301 (Apr 2005) 197. A Randomized, Open-Label Controlled, Clinical Trial of Chemotherapy and Bevacizumab with and without Panitumumab in the First-Line Treatment of Subjects with Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review. Amgen 20040249 (Feb 2005) 198. A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks every 4 Weeks, in Patients with Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Responsibilities: Oversight of the Independent Review. Kosan KOS-201/NO17532 (Feb 2005) 199. A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer



200. A Multi-Center Phase II Study to Investigate the Safety and Efficacy of Treanda (Bendamustine HCl) in Patients with Indolent Non-Hodgkin’s Lymphoma (NHL) who are Refractory to Rituximab

Responsibilities: Oversight of the Independent Review. Cephalon SDX-105-03 (Oct 2004) 201. A Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination with Dacarbazine (DTIC) Chemotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma

Responsibilities: Oversight of the Independent Review. Onyx 11715 (Oct 2004) 202. A Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination with Paclitaxel/Carboplatin Chemotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma

Responsibilities: Oversight of the Independent Review. Onyx 11718 (Oct 2004) 203. A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)

Responsibilities: Oversight of the Independent Review. Amgen 20040118 (Sep 2004) 204. A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination with Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects with Advanced Metastatic Melanoma

Responsibilities: Oversight of the Independent Review. Bayer 11538 (Sep 2004) 205. A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects with Platinum Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for whom Subsequent Doxil or Topotecan Therapy has Failed

Responsibilities: Oversight of the Independent Review. Genentech AVF2949g (Sep 2004) 206. A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination with Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects with Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Responsibilities: Oversight of the Independent Review. Genentech TOC3258g (Sep 2004) 207. A Randomized Controlled Study of DOXIL/CAELYX (doxorubin HCL liposome injection) and VELCADE (bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

Responsibilities: Protocol review for Sponsor with attention to imaging components, technical manual authorship, project management and supervision, oversight of the quality control process of received images, oversight of submission of image data to FDA. J&J DOXIL-MMY-3001 (Sep 2004) 208. A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine

Responsibilities: Oversight of the Independent Review. Threshold TR-CR-302 (Sep 2004)


209. An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus at Two Dose Levels Compared to Investigator’s Choice of Therapy in Previously Treated Subjects with Mantle Cell Lymphoma

Responsibilities: Oversight of the Independent Review. Wyeth 3066A1-305-WW (Jun 2004) 210. A Phase 3 Randomized, Open Label Comparative Study of Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR 13 (Efaproxiral), in Women with Brain Metastases from Breast Cancer

Responsibilities: Oversight of the Independent Review. Allos RSR13 RT-016 (Apr 2004)

211. A Phase 2 Multicenter Single Arm Trial of ABX-EGF Monotherapy in Subjects with Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels by Immunohistochemistry Following Treatment with Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy

Responsibilities: Oversight of the Independent Review. Oversight of submission of image data to FDA in support of license application. Amgen 20030250 (Apr 2004) 212. An Open-Label Study of AMG 706 in Subjects with Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Responsibilities: Oversight of the Independent Review. Amgen 20040110 (Apr 2004) 213. A Phase III Randomized, Open-Label Study of AMG 706 or Continued Imatinib Mesylate in Subjects with Gastrointestinal Stromal Tumors (GISTs) who Developed Progressive Disease While on Imatinib Mesylate

Responsibilities: Oversight of the Independent Review. Amgen 20040150 (Apr 2004) 214. A Randomized, Open-Label, Multicenter Study Comparing the Safety, Tolerability and Efficacy

of Taxotere IV/Prednisone PO/Oblimersen IV and Taxotere IV/Prednisone PO in Subjects with Androgen Independent Metastatic Prostate Cancer

Responsibilities: Oversight of the Independent Review. Aventis AVE31 39E-3001 215. A Phase 3, Randomized Study of SU011248 vs. Interferon-a as First-Line Systemic Therapy for Patients with Metastatic Renal Cell Carcinoma

Responsibilities: Oversight of the Independent Review. Pfizer A6181034 (Apr 2004) 216. A Phase II Multicenter, Open-Label, Non-Randomized Study of Intravenous RPR109881 Every 3 Weeks in Patients with Metastatic Breast Cancer Progressing after Therapy with Anthracyclines, Taxanes, and Capecitabine

Responsibilities: Oversight of the Independent Review. Aventis XRP9881-2001 (Mar 2004) 217. A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks Subcutaneous (SC) Administration of Aldesleukin 9rh-Interleukin-2[IL-2] to 4 Weeks Intravenous Administration of Rituximab (Rituxan) in the Treatment of Rituximab Naïve Subjects with Follicular Non-Hodgkin’s Lymphoma, Refractory or Relapsed After Previous Chemotherapy

Responsibilities: Oversight of the Independent Review. Chiron IL2006 (Mar 2004)


218. A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel for the Treatment of Advanced Breast Cancer

Responsibilities: Oversight of the Independent Review. J&J DOXIL-BCA-3001 (Mar 2004) 219. A Phase III, Randomized, Placebo-Controlled Study of Oral CCI-779 Administered in Combination with Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Wyeth-Ayerst 3066A1-303-WW (Mar 2004) 220. An Open-Label Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of ABX-EGF in Subjects with Metastatic Colorectal Carcinoma


221. A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks vs. Capecitabine (Xeloda®) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients with Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy

Responsibilities: Oversight of the Independent Review. Aventis XRP9881-3001 (Jan 2004) 222. A Phase II Study of the Efficacy and Safety of SU011248 in Patients with Anthracycline- and Taxane-Resistant Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Pfizer A6181002 (Nov 2003) 223. A Phase II Study of the Efficacy and Safety of SU011248 in Patients with Metastatic Colorectal Cancer Who Have Previously Failed Treatment with Irinotecan, Oxaliplatin and a Fluoropyrimidine, with and without Bevacizumab

Responsibilities: Oversight of the Independent Review. Pfizer A6181003 (Nov 2003) 224. A Pivotal Study of SU011248 in the Treatment of Patients with Cytokine-Refractory Metastatic Renal Cell Carcinoma

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Case review at FDA. Pfizer A6181006 (Nov 2003) 225. An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF plus Best Supportive Care versus Best Supportive Care in Subjects with Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Amgen 20020408 (Oct 2003) 226. A Multicenter, Open-Label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects with Metastatic Colorectal Cancer

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Amgen 20030194 (Oct 2003)

227. A Phase 2 Multicenter Single Arm Trial of ABX-EGF Monotherapy in Subjects with Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Amgen 20030167 (Sep 2003)


228. A Phase II Trial of Novel Epothilone BMS-247550 in Patients with Advanced Breast Cancer Who are Resistant to an Anthracycline, a Taxane and Capecitabine

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA

for review in support of a license application. BMS CA163-081 (Sep 2003) 229. A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of SU011248 in the Treatment of Patients with Imatinib Mesylate (Gleevec, Glivec)-Resistant or Intolerant Malignant Gastrointestinal Stromal Tumor

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Pfizer A6181004 (Sep 2003) 230. A Phase II Open-Label Clinical Trial with Liposomal-Encapsulated Paclitaxel (LipoPac) to Evaluate Antitumoral Efficacy and Safety in Patients with Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Munich Biotech CTLP09 (Aug 2003) 231. A Phase 3 Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer Receiving Radiotherapy with Concurrent Chemotherapy (RT/CT)

Responsibilities: Oversight of the Independent Review. Amgen 20020402 (Jun 2003)

232. A Randomized, Double-blind Study to Evaluate the Effect of AMG 162 versus Zoledronic Acid on the Suppression of Bone Turnover Markers in Women with Breast Cancer–related Bone Metastases

Responsibilities: Oversight of the Independent Review. Amgen 20020413 (Jun 2003) 233. An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin-Containing Regimens

Responsibilities: Oversight of the Independent Review. GSK 20008 (Jun 2003) 234. A Phase III, Randomized, Open-Label, Efficacy and Safety Study of IV Edotecarin vs. Temozolomide or BCNU or CCNU in Patients with Glioblastoma Multiforme at First Relapse After Alkylator-Based (Neo)Adjuvant Chemotherapy

Responsibilities: Oversight of the Independent Review. Pfizer/Pharmacia EDOAGL-87250-001 (May 2003) 235. An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients with Taxane Resistant Non-Small Cell Lung Cancer

Responsibilities: Oversight of the Independent Review. Bayer 10653 (Apr 2003) 236. An Uncontrolled, Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY 59- 8862 in Patients with Taxane-Resistant Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Bayer 10654 (Apr 2003)


237. A Phase II, Multicenter, Uncontrolled Trial of BAY-43-9006 in Subjects with Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Bayer 100555 (Apr 2003) 238. A Phase III Trial of Novel Epothilone BMS-247550 plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer Previously Treated with or Resistant to an Anthracycline and Who are Taxane Resistant

Responsibilities: Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application.

BMS CA163-046 (Apr 2003) 239. A Phase II, Open-label, Multi-center, Open-label trial of the Safety and Efficacy of TARCEVATM (Erlotinib hydrochloride) in Patients with First Relapse of Grade IV Glioma (Glioblastoma Multiforme)

Responsibilities: Oversight of the Independent Review. Genentech OSI2691g (Apr 2003) 240. A Phase II, Open-label, Multi-Center Study to Evaluate the Effect of Tumor-Based HER2

Activation on the Efficacy of rhuMab 2C4 (Pertuzumab) in Subjects with Advanced, Refractory or Recurrent Ovarian Cancer

Responsibilities: Oversight of the Independent Review. Genentech TOC2689g (Apr 2003) 241. A Phase 2, Open-Label Study of HTI-286 Administered Intravenously as a Single Agent for the Treatment of Non-Small Cell Lung Cancer for Disease Recurrence Following Platinum-Based Therapy

Responsibilities: Oversight of the Independent Review. Wyeth 3127K1-200-WW (Apr 2003) 242. A Phase III Randomized Open-Label Study of Irinotecan and Cetuximab vs. Irinotecan as Second Line Treatment in Subjects with Metastatic EGFR – Positive Colorectal Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship. Bristol-Myers Squibb CA225006/EMR-62-202-025 (Mar 2003) 243. A Phase III Randomized Multi-Centered Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil and Leucovorin in Patients with Previously Treated Metastatic, EGFR Positive Colorectal Carcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship. Bristol-Myers Squibb CA225014 (Mar 2003) 244. A Phase II, Multicenter, Open-Label, Single Arm Study of AMG 412 in Combination with Rituximab in Subjects with Recurrent or Refractory Low-Grade, CD20+ B-Cell Non-Hodgkin’s Lymphoma

Responsibilities: Oversight of the Independent Review. Amgen 20010138 245. A Phase II Multicenter, Open Label, Non-Randomized Study of Intravenous RPR109881 Every 3 Weeks in Patients with Metastatic Breast Cancer Progressing after Therapy with Anthracyclines, Taxanes and Capecitabine

Responsibilities: Oversight of the Independent Review. Aventis HMR1275F/2001 (Feb 2003)


246. A Retrospective Review of a Subset of Patients Previously Enrolled in Bayer Phase II Randomized Discontinuation Study of BAY 43-9006 in Patients with Advanced Refractory Cancer

Responsibilities: Oversight of the Independent Review. Bayer 100391 247. A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy with Supplemental Oxygen with or without Compound X in Patients with Locally Advanced, Unresectable Stage IIIa/IIIb Non-Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to the imaging components, advisory role for development of RadPharm charter. Oversight of the Independent Review. Allos Therapeutics RSR13 RT-013 (Jan 2003) 248. A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant idiotype Conjugated to KLH (GTOP-99) and GM-CSF Following the Anti-CD20 Antibody, Rituxan®, in Previously Treated Patients with Follicular Non-Hodgkin’s Lymphoma

Responsibilities: Oversight of the Independent Review. Genitope 2002-09 (Jan 2003) 249. A Phase I Dose Escalating Study of Oral Compound X in Patients with Solid Tumors


for review in support of a license application. Pfizer RTKC-0511-005 (Jan 2003) 250. A Phase I Study of SU011248 in the Treatment of Patients with Malignant Gastrointestinal Stromal Tumor (GIST) who are Intolerant of, or with Disease Progressing on, Imatinib Mesylate (Gleevec)


for review in support of a license application. Pfizer RTKC-0511-013 (Jan 2003) 251. A Phase II Single Agent Study of SU011248 in the Second Line Treatment of Patients with Metastatic Renal Cell Carcinoma

Responsibilities Oversight of the Independent Review. Oversight of the submission of image data to FDA for review in support of a license application. Pfizer RTKC-0511-014 (Jan 2003) 252. A Phase II Study of the Efficacy and Safety of SU011248 in Patients with Advanced Unresectable Neuorendocrine Tumor

Responsibilities: Oversight of the Independent Review. Pfizer RTKC-0511-015 (Jan 2003)

253. A Phase I Study Evaluating the Safety and Tolerability of Compound X in Combination with Docetaxil in Previously Treated Non-Small Cell Lung Cancer Subjects

Responsibilities: Protocol review and review of radiology reads performed on a subgroup of responding subjects. Aventis HMR 1275B/1008 (Dec 2002) 254. A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks versus Capecitabine (Xeloda®) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients with Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy

Responsibilities: Oversight of the Independent Review. Aventis HMR1275B/3001 (Dec 2002)


255. A Randomized Double-Blind, Placebo-Controlled Study of Subjects with Stage III Unresectable Non Small Cell Lung Cancer with Concurrent Chemoradiotherapy Followed by Chemotherapy with or without Compound X

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Amgen 20020115 256. A Randomized, Double-Blind, Placebo-Controlled Study of Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer Treated with Platinum plus Etoposide Chemotherapy with or without Darbepoetin Alfa

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Amgen 20010145 (Oct 2002) 257. A Phase II Study of Tezacitabine with or without 5-Fluorouracil as Second-Line Therapy of Advanced Esophageal Gastric Adenocarcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Chiron TEZ001 (Oct 2002) 258. A Phase 1/2 Multicenter Study to Evaluate the Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Antineoplastic Activity of KW-2871 When Administered to Patients with Advanced Metastatic Melanoma

Responsibilities: Oversight of the Independent Review. Kyowa 2871 (Oct 2002) 259. A Blinded Reading Assessment of the Diagnostic Adequacy of IOMERON® in Cardioangiography, Phlebography, Cerebral Angiography, Visceral/Peripheral Angiography and Body Contrast-Enhanced CT

Responsibilities: Protocol review, supervision of charter authorship, project management and supervision. Bracco PR-IOM-104 (Sep 2002) 260. A Phase II, Multicenter Evaluation of the Safety and Efficacy of Compound X Injectable Emulsion in Second-Line Treatment of Patients with Persistent or Recurrent Stage 3 or 4 Platinum Pre-treated Ovarian Cancer or Primary Peritoneal Carcinoma

Responsibilities: Protocol review, supervision of charter development. Sonus Pharmaceuticals FON-8184-1070 261. A Phase I/II, 24-Week, Multi-Center, Double-Blind, Randomized Dose Ranging Study to Evaluate the Safety and Efficacy of a Human Monoclonal Antibody to X vs. Zoledronic Acid in Patients with Breast Cancer Metastatic to Bone

Responsibilities: Protocol review for Sponsor with attention to imaging components, advisory role in the development of the RadPharm Charter, technical manual, study coordinator manual, case report forms. Chugai Pharma CAL-03 (Aug 2002)


262. An Open-Label, Multi-Center, Single-Arm Phase II Study of Oral GW572016 as Single-Agent Therapy in Subjects with Advanced and Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens

Responsibilities: Protocol review for Sponsor with attention to the imaging components. Supervision of development of a RadPharm charter, study coordinator materials, CRFs, database programming, radiologist training, RadPharm staff training and supervision of project management. GlaxoSmithKline EGF20002 (Aug 2002) 263. An Open-Label, Multi-Center, Phase II Study of Oral GW572016 as a Single-Agent, Second- Line Therapy in Subjects with Metastatic Colorectal Cancer Who Have Progressed on First- Line Therapy with 5 Fluorouracil in Combination with Irinotecan or Oxaliplatin

Responsibilities: Protocol review for Sponsor with attention to the imaging components, supervision of development of a RadPharm charter, study coordinator materials, CRFs, database programming, radiologist training, RadPharm staff training and supervision of project management. GlaxoSmithKline EGF20004 (Aug 2002) 264. Phase IIA, Multicenter, Dose Escalation Studies to Evaluate the Safety and Efficacy of Weekly S-8184 Paclitaxel in Second Line Treatment of Patients for Ovarian Cancer, Peritoneal Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, and Transitional Carcinoma of the Urothelium Respectively

Responsibilities: Oversight of the Independent Review. Sonus SON-1061,3,5,6 (Aug 2002) 265. A Phase 2 Randomized Open-Label Study of Letrozole in Combination with Two Dose Levels and Schedules of Oral CCI-779, or Letrozole Alone, in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer

Responsibilities: Protocol review for Sponsor with attention to the imaging components, supervision of development of RadPharm charter, technical manual, study coordinator manual, CRFs, and associated protocol documents. Provision of RadPharm database programming, staff training and supervision of project management. Wyeth 3066A1-204-WW (Aug 2002) 266. A Phase II Non-Comparative, Multi-Center Trial of BAY 56-3722 (formerly BAY 38-3441) in Patients with Recurrent, Unresectable or Metastatic Renal Cell Carcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Bayer 100364 (Apr 2002) 267. An International, Multi-Center, Randomized, Open-Label Study of Compound X vs. High Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (Central review of x-rays discontinued)

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Millennium M34101-039 (Apr 2002)


268. A Phase IIa Trial to Determine the Preliminary Efficacy, Safety and Tolerance of Intravenous KW-2170 Administered Once Weekly for Three Weeks to Patients with Recurrent or Advanced Non-Small Cell Lung Carcinoma Who Have Failed a First-Line Regimen of Chemotherapy

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Kyowa 2170-US-004 (Mar 2002)

269. A Phase IIa Trial to Determine the Preliminary Efficacy, Safety and Tolerance of Intravenous W-2170 Administered Once Weekly for Three Weeks to Patients with Recurrent or Advanced Colorectal Carcinoma Who Have Failed Standard Therapeutic Regimens

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Kyowa 2170-US-005 (Mar 2002) 270. A Phase IIa Trial to Determine the Preliminary Efficacy, Safety and Tolerance of Intravenous KW-2170 Administered Once Weekly for Three Weeks to Patients with Recurrent or Advanced Hormone Refractory Carcinoma of the Prostate Who Have Failed Standard Therapeutic Regimens

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Kyowa 2170-US-006 (Mar 2002) 271. A Phase IIa Trial to Determine the Preliminary Efficacy, Safety and Tolerance of Intravenous KW-2170 Administered Once Weekly for Three Weeks to Patients with Recurrent or Refractory Locally Advanced or Metastatic Breast Carcinoma Who Have Failed Standard Therapeutic Regimens

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Kyowa 2170-US-007 (Mar 2002)

272. A Phase IIa Trial to Determine the Preliminary Efficacy, Safety and Tolerance of Intravenous KW-2170 Administered Once Weekly for Three Weeks to Patients with Recurrent or Advanced Refractory Ovarian Carcinoma Who Have Failed Standard Therapeutic Regimens

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Kyowa 2170-US-008 (Mar 2002) 273. A Phase I Study to Assess the Histologic Effect and Safety of Preoperative and Postoperative Infusions of IL13-PEI-103 Cytotoxin in Patients with Recurrent Resectable Supratentorial Malignant Glioma

Responsibilities: Protocol review for Sponsor with attention to the imaging components, charter authorship, supervision of technical manual authorship, supervision of study coordinator manual, CRF creation, supervision of RadPharm project management, radiologist training.

Neopharm IL-13-PEI-002 (Mar 2002)


274. A Pre-Operative Effusion of IL13-PEI-103 in Patients with Recurrent or Progressive Supratentorial Malignant Glioma: A Phase I/II Study

Responsibilities: Protocol review for Sponsor with attention to the imaging components, charter authorship, supervision of technical manual authorship, supervision of study coordinator manual, CRF creation, supervision of RadPharm project management, radiologist training.

Neopharm IL-13-PEI-103 (Mar 2002) 275. A Continuation Protocol for Compound X and Dacarbazine in Patients with Malignant Melanoma Who Responded to the Combination of Compound X and Dacarbazine in Protocol X

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Genta GM214 (Feb 2002) 276. A Phase II Trial of Compound X in Patients with Platinum- and Paclitaxel-Resistant Advanced Ovarian Carcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. MGI Pharma MGI 114.27.P98-02 (Jan 2002) 277. A Multi-Center, Open-Label, Phase III Randomized, Active-Controlled Trial Evaluating the Efficacy, Safety and Pharmacokinetics of rhuMAb VEGF (BEVACIZUMAB) in Combination Capecitabine Chemotherapy in Subjects with Previously Treated Metastatic Breast Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Representation of this protocol and Company X to CBER division of the FDA .Inter- and intra-reader variability analysis. Genentech AVF2119g (Sep 2001) 278. A Phase II Multi-Center, Double-Blinded Randomized Active-Control Clinical Trial to Evaluate the Safety and Efficacy of rhuMAb VEGF (BEVACIZUMAB) a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor X in Combination to 5- Fluorouracil and Leucovorin Chemotherapy in Subjects with Metastatic Colorectal Cancer Who are Not Optimal Candidates for First-Line CPT-11

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Representation of this protocol and Company X to CBER division of the FDA. Inter- and intra-reader variability analysis. Genentech AVF2192g (Sep 2001) 279. A Randomized Study of Docetaxel vs. Docetaxel Plus Genasense (Bcl-2 Antisense Oligonucleotide) in Patients with Previously Treated, Non-Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Genta GM304 (Sep 2001)


280. A Phase II Trial of Compound X in Patients with Unresectable Hepatocellular Carcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. MGI Pharma IROF-001 (Sep 2001) 281. A Phase II Study of Compound X in Patients with Refractory or Recurrent Advanced Epithelial Ovarian Cancer Using Every Other Week Dosing

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. MGI Pharma IROF-007 (Sep 2001) 282. A Phase II Clinical and Pharmacokinetic Trial of Compound X in Patients with Recurrent Malignant Glioma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. MGI Pharma IROF-010 (Sep 2001)

283. 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

Responsibilities: Oversight of the Independent Review. Millenium M34100-024 (Sep 2001)

284. 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 the Most Recent Therapy

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. This was a retrospective

collection of films with a retrospective review of imaging findings. Millennium M34100-025 (Sep 2001)

285. A Phase I/II Study of GM-CSF Gene-Modified Autologous Tumor Vaccines in Early and Advanced Stage Non-Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, supervision of RadPharm database programming, radiologist/staff training, project

management and supervision. Cell Genesis D9902 (Aug 2001)

286. A Phase II, Multi-Center Controlled Trial with Stratified Randomization Comparing the Efficacy of Interleukin-2 (IL-2) Plus Histamine Dihydrochloride (HDI) vs. IL-2 Alone to Increase the Duration of Survival in Subjects with AJCC Stage IV Malignant Melanoma with Hepatic Metastasis

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Inter- and intra-reader variability analysis. Maxim MP-8899-0104 (Jul 2001)


287. A Randomized, Double-Blind Phase II Study of Intravenous Compound X Administered Weekly of Patients with Advanced Renal Cell Carcinoma

Responsibilities: Protocol review, charter authorship, radiologist training, RadPharm staff training, project supervision. Wyeth 3066KI-200-US (May 2001)

288. A Phase II, Multicenter Trial of Single-Agent Treatment with OSI-774 in Patients with Histologically Confirmed, Incurable, Locally Advanced or Metastatic Breast Cancer

Responsibilities: Oversight of the Independent Review. Genentech OSI2288g (Mar 2001)

289. A Study to Assess the Reliability and Validity of Methods for the Independent Review of Solid Tumor Radiographic Response

Responsibilities: Primary Investigator, protocol development, SOP development, charter development, subject review, CRF review, radiologist and staff training, expert review panelist, project management and supervision. Oversight of the Independent Review. Merck 5000-001 (Mar 2001)

290. A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Adjuvant Treatment with Compound X in Localized Prostate Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Merck 151-00

291. A Phase II Trial to Evaluate Efficacy of X Immunotherapies for Patients with Follicular B-Cell Lymphoma in “Watch And Wait” Period

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Genitope 2000-04 (Dec 2000)

292. A Phase II Clinical Trial of Intratumoral Administration of Compound X in Advanced Metastatic Melanoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Vical VCL 1005-208 (Nov 2000)

293. A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Compound X In Dose X And Y Administered Once Daily on Growth in Children with Mild Persistent Asthma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member reading panel. Aventis XRP1526B-343 (Oct 2000)


294. A Controlled, Randomized Phase III Trial Comparing the Response to Dacarbazine with and without Compound X in Patients with Metastatic Melanoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee. Genta GM301 (Oct2000)

295. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Compound X Capsules plus Gemcitabine Infusion vs. Placebo Capsules plus Gemcitabine Infusion as Second-Line Treatment of Patients with Advanced, Non-Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee, inter-reader variability analysis. Pfizer 994-016/017 (Oct 2000)

296. A Study Evaluating the Efficacy, Safety, and Tolerability of Compound X in Bi-Dimensionally Measurable, Androgen-Independent Prostate Cancer (study cancelled after 6 months)

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Merck 004-00 (Aug 2000)

297. A Phase IIA Study of the Efficacy and Tolerability of J-107088 in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Merck Banyu RC7491201-00 (Aug 2000)

298. A Phase IIA Study of the Efficacy and Tolerability of J-107088 in Patients with Irinotecan Naïve Metastatic Colorectal Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation

in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, project management and supervision. Merck Banyu RC7491202-00 (Aug 2000)

299. A Phase IIA Study of the Efficacy and Tolerability of J-107088 in Patients with Advanced Non- Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Merck Banyu RC749J203-00 (Aug 2000)


300. A Phase IIA Study of the Efficacy and Tolerability of J-107088 in Patients with Metastatic Urothelial Transitional Cell Carcinoma


301. A Phase IIA Study of The Efficacy And Tolerability of J-107088 in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck


302. Literature Review and Radiology Protocol Development for a Phase I Trial to Quantitate Glycogen Accumulation in the Liver in Response to Compound X

Responsibilities: Consultation with Sponsor, literature review and development of scanning protocol for project, currently on hold, project management and supervision. Consulting for Novo Nordisk

303. A Randomized Phase III Trial of Intratumoral Injection of Compound X Plus Intravenous Cisplatin/5-Fluoruracil vs. Intravenous Cisplatin/5-Fluorouracil Alone in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, member of response evaluation committee, project management and supervision. Pfizer 1042

304. A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouvacil (5-FU) Plus Leucovorin (LV) or Oxaliplatin in a Combination of 5 FU/LV and Oxaliplatin as Second-Line Treatment of Metastatic Colorectal Carcinoma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Preliminary approval was given by the FDA in 2002 based on the radiographically determined time to progression as the primary endpoint. Sanofi EFG4584 (Aug 2000)

305. A Phase II Study of Compound X as Treatment in Patients with Sensitive or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Novus Pharma TPT-II-04


306. A Phase 3 Trial to Evaluate the Safety and Efficacy of Specific Immunotherapy X Compared to Non-Specific Immunotherapy X in Patients with Follicular Non-Hodgkin’s Lymphoma Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Successful discussion with the CBER Division of the FDA of the process and requirements for converting a hard-copy, film-based trial to a trial that would fulfill CBER digital image submission requirements. Inter- and Intra-reader variability analysis. Genitope 2000-03 (Jul 2000)

307. A Double-Blind Study of The Effect of One Year of Treatment With Compound X vs. Placebo on Growth of Children with Asthma

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training) supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Schering-Plough C97-384-08 (Jul 2000)

308. A Phase II, Multicenter, Randomized, Open Label, Dose Comparison Study of the Efficacy and Safety of Recombinant X For Third Line Treatment of Metastatic Breast Cancer in Post- Menopausal Women

Responsibilities: Protocol review, charter authorship, radiology/staff training, project management and supervision. Serono 20823 (May 2000)

309. An Open Label, Single Center Study to Test the Inhibitory Effect of Recombinant X in Metastatic Breast Cancer in Post-Menopausal Women

Responsibilities: Protocol review, charter authorship, radiology/staff training, project management and supervision. Serono 20794 (May 2000)

310. A Multicenter Study Evaluating the Addition of Compound X to 5-Fluorouracil Based Chemotherapy in Subjects with Advanced Refractory Colorectal Cancer

Responsibilities: Protocol review, charter authorship, radiology/staff training, review of a subset of patients, project management and supervision. Sanofi EFC2970 (Apr 2000)

311. A Phase III, Randomized, Open-Label Trial of CHOP Chemotherapy Plus Rituxan (1 DEC- C2B8) vs. CHOP Chemotherapy Alone For Previously Untreated, Clinically Aggressive (IPI >2) Intermediate/ High Grade CD20+ Non-Hodgkin’s Lymphoma

Responsibilities: Protocol review, charter authorship, radiologist/staff training, project management and supervision. Genentech U2035g (Feb 2000)

312. A Phase II Study of Compound X in Patients with Metastatic Renal Cell Carcinoma Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Vical VCL 1102-204 (Dec 1999)


313. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Compound X Capsules plus Gemcitabine Infusion vs. Placebo Capsules plus Gemcitabine Infusion in the Treatment of Patients with Advanced Pancreatic Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee, inter-reader variability analysis. Pfizer 994-011/012 (Nov 1999)

314. A Phase II Study of Direct Gene Transfer of Compound X as an Immunotherapeutic Agent in Patients with Stage III or IV Melanoma with No Treatment Alternatives

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee. Vical 1005-205 (Nov 1999)

315. A Phase II Clinical Study of rhuMAb VEGF in Non-Small Cell Lung Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Inter-reader variability analysis. Post-study close-out, adjudication of site vs. central response assessment results. Genentech AVF 0757g (Sep 1999)

316. A Phase II Clinical Study of rhuMAb VEGF in Colorectal Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Inter-reader variability analysis. Post-study close-out, adjudication of site vs. central response assessment results. Genentech AVF 0780g (Sep 1999)

317. A Randomized, Double Blind, Placebo-Controlled Trial of Immunotherapy with Autologous Loaded Dendritic Cells for Asymptomatic Metastatic Hormone-Refractory Prostate Cancer Responsibilities: Protocol review, charter authorship, radiology/staff training, project management and supervision, member response evaluation committee. Dendreon 9901 (Jun 1999) 318. A Randomized, Double Blind, Placebo-Controlled Trial of Immunotherapy with Autologous

Antigen Loaded Dendritic Cells for Asymptomatic Metastatic Hormone-Refractory Prostate Cancer Responsibilities: Protocol review, charter authorship, radiology/staff training, project management and supervision, member response evaluation committee. Dendreon 9902 (Jun 1999)

319. A Phase II Open Label, Single Arm Trial with Cryopreserved Autologous Antigen-Loaded

Dendritic Cells Hormone Refractory Prostate Cancer Patients with Objective Disease Progression

Responsibilities: Protocol review, charter authorship, radiology/staff training, project management and supervision, member response evaluation committee. Dendreon 9903 (Jun 1999)


320. A Phase II Study of the Efficacy and Tolerability of Compound X in Patients with Metastatic

Non-Small Cell Lung Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee Merck L778123-005 (Jun 1999)

321. A Phase II Study of the Efficacy and Tolerability of Compound X in the Treatment of Metastatic Breast Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee. Merck L778123-007 (Jun 1999)

322. The Effects of Chronic Dosing of Compound X in Hepatic Fat Accumulation and Reversibility as Assessed by Nuclear Resonance Spectroscopy

Responsibilities: Consultation with sponsor re: feasibility of protocol development, literature search, protocol development, site training, site Q/A (qualification and ongoing), study initiation, primary reader for study, project management and supervision, presentation of results at Sponsor project meeting, publication planned. Bristol-Myers Squibb CV145-009 (Apr 1999) 323. A Multi-Center Phase III Randomized, Controlled Study of Compound X Vaccine for

Metastatic Breast Cancer Responsibilities: Member of response evaluation committee, supervised core lab functions, project management and supervision. Biomira Stn-BR-104 (Mar 1999)

324. A Phase II, Open Label, Randomized Trial Of Compound X In Combination with Carboplatinum/Paclitaxel Chemotherapy In Previously Untreated Advanced Non-Small Cell Lung Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision, member response evaluation committee. TAP M00-254

325. A Phase II, Open Label, Randomized Trial Of Compound X In Combination With 5- Fluorouracil In Previously Untreated Metastatic Colorectal Cancer

Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. TAP

326. An Ascending Multiple Dose Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Study

of Compound X in Healthy Volunteers Responsibilities: Consultation with sponsor re: feasibility of protocol development, literature search, technical development of scanning and image analysis parameters for “proof of concept” for quantification of liver steatosis by MRI spectroscopy, protocol development, site training, site Q/A (qualification and ongoing), study initiation, primary reader for study, project management and supervision, presentation of results at Sponsor project meeting, publication planned. Bristol-Myers Squibb CV123-171 (Feb 1998)


327. A Retrospective Radiographic Review of a Subgroup of Subjects from Protocol #9820-31 for

Sponsor X Responsibilities: Protocol review, charter authorship, radiologist/staff training, project management and supervision. Genetics Institute 9820-31

328. A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and

Pharmacokinetics of Compound X in Type 2 Diabetes Subjects Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. Bristol-Myers Squibb

329. A Multicenter, Double-Blind Parallel Study to Compare the Effects of Compound X and Compound Y in Hepatic Fat Content as Measured by Nuclear Magnetic Resonance Spectroscopy

Responsibilities: Consultation with sponsor re: feasibility of protocol development, literature search, Protocol development, site training, site Q/A (qualification and ongoing), study initiation, primary reader for study, project management and supervision, presentation of results at Sponsor project meeting, publication planned. Bristol-Myers Squibb

330. Ascending Multiple Dose Safety, Tolerance Pharmacokinetic and Pharmacodynamic Study of

Compound X in Healthy Volunteers Responsibilities: Consultation with sponsor re: feasibility of protocol development, literature search, Technical development of scanning and image analysis parameters for “proof of concept” for quantification of liver steatosis by MRI spectroscopy, protocol development, site training, site Q/A (qualification and ongoing), study initiation, primary reader for study, project management and supervision, presentation of results at Sponsor project meeting, publication planned. Bristol-Myers Squibb

331. Interstitial Infusion of Compound X Cytotoxin in Recurrent Malignant Glioma: A Phase I/II

Study Responsibilities: Protocol review for Sponsor with attention to the imaging components, charter authorship, supervision of technical manual authorship, supervision of study coordinator manual, CRF creation, supervision of RadPharm project management, radiologist training. Neopharm NCI-NABTT study 9903

332. A Randomized Two-Dose Level, Open Label, Phase II Study of Intravenous Compound X Administered Once Weekly to Patients with Locally Advanced or Metastatic Breast Cancer Responsibilities: Protocol review for Sponsor with attention to imaging components, charter authorship, technical manual authorship, study coordinator manual authorship, CRF review, participation in investigator meeting (site and training), supervision of RadPharm database programming, radiologist training, RadPharm staff training, project management and supervision. RadPharm reviewed a sub-group of patients in this trial. Review was performed retrospectively. Genetics Institute W-AR-3066KI-203-EU

333. A Phase III, Multinational, Randomized Study Of Compound X (Monoclonal Antibody) Combined With Chemotherapy In Patients With HER2 Over Expression Who Have Not Received Cytotoxic Chemotherapy For Metastatic Breast Cancer Responsibilities: Member radiographic Q/A committee, member response evaluation committee, project management and supervision. Genentech Herceptin (Jul 1995)


334. A Phase II, Multinational, Double Blind Study Comparing Recombinant

Humanized Monoclonal Antibody (Compound X) Plus Cyclophosphamide and Doxorubin with Placebo Plus Cyclophosphamide and Doxorubicin in Patients with HER2/NEU Over Expression Who Have Not Received Prior Cytotoxic Chemotherapy for Metastatic Breast Cancer

Responsibilities: Member radiographic Q/A committee, member response evaluation committee, project management and supervision.

REGULATORY EXPERIENCE:

Established RadPharm Image Submission Module for Submission of Images to Division of Medical Imaging and Hematology products at United States Food and Drug Administration. Established RadPharm Quality Plan for Submission of Images to Division of Medical Imaging and Hematology Products at United States Food and Drug Administration Herceptin: Approved September 1998. Responsibilities included: functioning as a radiology reviewer and performed image quality control. Eloxatin: Approved August 2002. Responsibilities included: oversight of the Blinded Independent Central Review on which the endpoint of TTP was dependent. Eloxatin is the first labeled approval based on radiographically determined TTP. Worked with Sanofi to facilitate FDA review. Velcade: Approved May 2003. Responsibilities included: oversight of Blinded Independent Central Review, and development of image submission database. Sutent: Approved January 2006 for Gastro-Intestinal Stromal Tumors (GIST) and Renal Cell carcinoma Responsibilities included: oversight of Blinded Independent Central Review. Oversight of submission of image data to FDA. Participated in FDA case review leading to approval. Vectibix: Approved September 2006: Oversight of Blinded Independent Central Review of four different studies upon which approval was based. Oversight of image submission to FDA. Genasense: Not approved. Responsibilities included: oversight of Blinded Independent Central Review. Testified at Oncologic Drugs Advisory Committee. Dendreon: Not approved. Responsibilities included: participation in Blinded Independent Central Review as a reader. Oversight of Blinded Independent Central Review. Oversight of development of submission of image database. Doxil: Approved 2005. Responsibilities included: oversight of the quality control process of received images, oversight of development of submission image database. Ixempra: Approved October 2007. Responsibilities included: oversight of the Blinded Independent Central Review. Oversight of development of submission image database. Treanda: Approved 2008. Responsibilities included: oversight of the Blinded Independent Central Review and the development of the image submission database. Avastin for Breast Cancer: Approved February 2008. Responsibilities included: oversight of the Blinded Independent Central Review on which the endpoint of PFS was dependent. Oversight of submission of image data to FDA. Participated in Oncologic Drugs Advisory Committee presentation for Genentech. Avastin for Glioblastoma: Approved May 2009. Responsibilities included: oversight of the Blinded Independent Central Review on which the primary end point of PFS was based, oversight of the submission of image datea to the FDA for review, and participation at the Oncologic Drugs Advisory Committee presentation for Genentech.


Provenge Approved 2010. Responsibilities included: participation in Blinded Independent Central Review as a reader. Oversight of Blinded Independent Central Review. Oversight of development of submission of image database. Pegloticase for Gout: Worked with Savient to develop a new standardized methodology for centralized evaluation of tophaeous gout using digital photography. Proposed methodlolgy to FDA, Performed 2 Phase III studies using methodology. Led to favorable vote by Arthritis Drug Advisory Committee after review. Approval status currently pending.

_______________________________________ 18 MARCH 2015 Signature Date

Documents

ROBERT R. FORD, M.D. 9 Raymond Lane Belle Mead, NJ 08502 ...cticon.com/.../2016/06/Ford-Unblinded-CV-Mar-2015.pdf · Jan Bogaerts, Robert Ford, Dan Sargent, Lawrence H. Schwartz,