RESUME

Robert G. Fenton, M.D., Ph.D.

DATE: June, 2016

PERSONAL INFORMATION

**** ******** *****

Clarksville, MD 21029

240-***-****

E-mail: acvwbz@r.postjobfree.com

SUMMARY

I am an MD/PhD with 30 years of experience in clinical and laboratory research. As an oncologist, I worked for many years at the National Cancer Institute and the University of Maryland Cancer Center. I have extensive experience in all aspects of clinical research including writing and implementing phase I, II, and III studies, pharmacovigilance, surveillance, and patient safety. I have written numerous phase I, II, and III clinical trial protocols while at NIH and academia, and have authored many submission and regulatory documents including Investigational New Drug (IND) Applications, Clinical Study Reports, Safety Reports to the FDA, and Periodic Safety Update Reports (PSUR). I am very familiar with regulatory requirements of the other 2 major ICH clinical trial regions (Europe, Japan). I currently work at Jannsen Pharmaceuticals as a HHE Physician and Safety Surveillance Physician involved in a diverse set pharmacovigilance functions.

During my career, I have written 65 peer-reviewed papers published in upper-level medical/scientific journals, many book chapters, peer-reviewed grants that were funded, grant reviews, and have been an ad hoc reviewer for many journals and for the NCI Experimental Therapeutics Study Section. I therefore have excellent writing skills with many years of experience in medical and scientific publications. I have presented data at many scientific meetings in which experiments identifying novel cancer targets and the development of novel therapeutic agents to interdict these pathways were discussed. I continue to read multiple top line medical and scientific journals and have a broad knowledge in medical science including cancer biology and genetics, metabolism and diabetes, immunology/inflammation, infectious disease (i.e. HIV/AIDS), cancer vaccines, vascular biology and angiogenesis, etc.

EMPLOYMENT

January 2016-present:

Health Hazard Evaluation Physician and Safety Surveillance Physician

- Lead on project to align all J&J CCDS clinical and safety sections with PI and SmPC documents worldwide.

- Review data from gap analyses, and perform medical risk assessment on discrepancies between CCDS and PI documents.

- Interact with Medical Safety Officers, Safety Management Team, local Health Authorities and country E2E leads to resolve discrepancies.

- Provide medical and scientific guidance to the Retrospective Labeling Compliance Program.

- Review and finalize HHE documents as needed.

- Perform searches in SCEPTRE database for ICSR evaluations, and to evaluate a variety of PV datasets.

- As SSP, determine causality, expectedness and seriousness on clinical trial reports as well as spontaneous case reports.

March 2013-September 2014. Technical Resources International, Pharmacovigilance and Safety Specialist IV

-Reviewed Expedited Adverse Event reports submitted by clinical sites and triaged cases for closure or submission to the Division of Aids (DAIDS) Medical Officer.

-Provides medical and scientific expertise in HIV/AIDS, including diagnosis and treatment of AIDS-defining events including: infectious diseases (bacterial, fungal, and viral), cancers (Kaposi Sarcoma, Non-Hodgkin Lymphomas, cervical cancer, etc.), dementia, etc.

-Prepared regulatory and scientific documents including Safety Assessments and Safety Reviews for submission to DAIDS.

-Contacted clinical research staffs as needed to ensure the safety of patients enrolled in NIH clinical trials.

-Prepared 7-day and 15-day Safety Reviews for submission to the FDA.

-Performed signal detection analysis and evaluation for specific DAIDS clinical trials, and included data in PSURs.

-Mentored and trained junior staff in signal detection, risk assessment, and preparation of regulatory documents.

-Prepared SOPs for regulatory processes to be used by the safety staff in preparation of regulatory documents. Ensured SOPs were followed.

January 2010-December 2012. Private practice.

-Oncology/hematology: primary physician for patients with a broad range of solid tumors and hematologic malignancies.

-Hematology consults: evaluated and cared for patients with a variety of abnormalities of the coagulation cascade, platelet function, clotting disorders, and bone marrow disorders.

-Diagnosis and treatment of bacterial, fungal, and viral infections associated with cancers and the immunosuppressive therapies.

-Geriatric patient care: provided primary care to elderly subjects in nursing homes and in hospitals.

April 2007-December 2009. Investigator, National Institute on Aging, NIH

- Researcher devising, writing, and implementing novel clinical trials to evaluate causes of diverse aspects of the aging process, and to devise mechanisms to ameliorate these processes. Projects included discerning mechanisms underlying the development of sarcopenic obesity and frailty focusing on metabolic events such as the metabolic syndrome and diabetes, and possible pharmacologic interdiction to improve symptoms associated with these syndromes.

- Prepared and submitted pre-IND and IND documents to FDA

-Chairman, Clinical Research Committee. Reviewed all clinical trials for scientific validity, structure of the clinical trial, all safety issues including informed consent. Collated and summarized reviewer’s comments for presentation to the NIA clinical staff for final approval.

-Laboratory director: development of novel therapies for the treatment of acute leukemia in the elderly. Research focused on using novel combinations of PARP I/II and Akt inhibitors.

-Course Director: Molecular Biology and Immunology, weekly lectures for NIA post-doctoral fellows and students. This was a comprehensive review of genetics, signal transduction, apoptosis, DNA repair, etc. The immunology course covered diverse aspects of innate and adoptive immunity, cytokines/chemokines, immune receptor rearrangement, cellular immunology, vaccines, etc.

April 1998-April 2007. Associate Professor, University of Maryland Greenebaum Cancer Center

-Designed and authored phase I and phase II clinical protocols with supporting documents submitted to IRB and FDA for approval.

-Wrote and submitted grants for funded laboratory research to identify and target signaling pathways in multiple myeloma (MM).

-Identification of the apoptosis regulator Mcl-1 as a critical survival factor in MM.

-Development of in vitro pre-clinical models to identify novel small molecule inhibitors of Mcl-1.

-Attending physician Stem Cell Transplant group. Directed the care of patients receiving autologous or allogeneic stem cell transplants and management of subsequent medical issues, including graft-versus-host disease, infections, and disease recurrence.

-Treatment of infectious diseases associated with transplant immunosuppression including fungal (Aspergillus and Mucor sp.), bacterial (Staphlococcus and gram negative sp.), viral (Cytomegalovirus and Herpes viruses), and other pathogens (Toxoplasmosis, Cryptococcus, etc.).

-Attending physician Acute Leukemia Program. Organized the molecular and pathological diagnosis of patients with diverse types of acute and chronic leukemias, implementation of treatment, and supportive care through induction and consolidation portions of the treatments.

-Diagnosis and treatment of infections associated with acute leukemia and its treatment (bacterial, fungal, and viral infections).

-Attending physician, Multiple Myeloma Program. Treatment and follow-up of patients with MM. Attempted to meld the laboratory pre-clinical program with treatment of patients.

-Attending physician in the Gastrointestinal Cancer Program. Principal investigator of multiple Phase II and Phase III clinical trials for treatment of diverse cancers including colorectal, gastric, hepatocellular, GIST, pancreatic, etc. This included writing protocols, and informed consents for submissions to the CRC and IRB, and implementation of approved protocols in the clinic.

-Member Clinical Research Committee of the Cancer Center. Reviewed and provided written summaries for all clinical trials for patient safety and scientific validity, likelihood for success of the trial, ability to accrue patients, etc.

-For 7 years was an ad hoc member of the NCI Experimental Therapeutics Study Section, reviewing RO1 and R24 grants. Submitted detailed written reviews of assigned grants, and met with the 30-member committee for final evaluation of the proposals.

-Lectured medical and graduate students in subjects including Tumor Immunology, Oncogenes and Tumor Suppressors, and Tyrosine Kinase Function and Inhibition.

June 1989-April 1998. Senior Investigator, National Cancer Institute, Frederic, MD.

-Development of cell line vaccine of melanoma cells over-expressing the co-stimulatory molecule B7-1. This included writing clinical protocol and all regulatory documents submitted to NIH and Recombinant Advisory Committee (RAC) for clinical trial approval.

-Laboratory research to develop novel cancer vaccines to develop T cell immunity directed against renal cell carcinoma (RCC) or melanoma.

-Development of concepts, wrote clinical trial (including informed consent), and implementation of an autologous vaccine trial for RCC.

-Attending physician for inpatients receiving treatment with high-dose IL-2 (with or without LAK cells), IL-1b, GM-CSF, anti-CD3-activated T cells and other trials.

-Attending physician directing the care of patients with Hodgkin Lymphoma, Non-Hodgkin Lymphoma, melanoma, Hairy cell leukemia, and renal cell cancer.

EDUCATION/TRAINING

1976 B.S. University of Cincinnati, Cincinnati, Ohio.

1975: Elected to Phi Beta Kappa

1976: Graduated Summa Cum Laude with Honors

1981 M.S. New York University School of Medicine, New York, NY.

1982 Ph.D. New York University School of Medicine, New York, NY.

1983 M.D. New York University School of Medicine, New York, NY.

1983: Elected to Alpha Omega Alpha

1983-1985: Internship and Residency, Brigham and Women’s Hospital, Boston, Mass.

1985-1988: Oncology Fellowship, Dana-Farber Cancer Institute, Boston, Mass.

CLINICAL TRIALS (since 2007)

A Phase 1 Study of the PARP Inhibitor ABT-888 in Combination with Temozolomide in Acute Leukemias. I. Gojo, MD, PI. R. Fenton, MD/PhD, correlative studies. This is a CTEP sponsored study based on pre-clinical work performed in Dr. Fenton’s laboratory from 2007-2009. Clinical care will be performed with collaborators at the University of Maryland Greenebaum Cancer Center.

Muscle Biopsies in Healthy Volunteers, a Pilot Study. R. Fenton MD/PhD, PI. This study is designed to develop the clinical skills required to safely perform vastus lateralis muscle biopsies and to process and store muscle tissue for molecular and structural studies. In review, 12/2009.

A Randomized Study of the Physiologic and Molecular Effects of Resveratrol in the Healthy Elderly. R. Fenton MD/PhD, PI. This study is designed to determine if administration of oral resveratrol at 2g/d for 3 months increases exercise tolerance and improves molecular determinants of muscle function in overweight volunteers over the age of 60.

PEER-REVIEWED PUBLICATIONS (SELECTED 10 OF 65)

Siders, W.M., Halloran, P.J., and Fenton. RG. Melanoma-specific cytotoxicity induced by a tyrosinase promoter-enhancer/HSV -tk adenovirus. Cancer Gene Ther., 5:281-291, 1998.

Zhang B, Gojo I, Fenton RG. Mcl-l is a critical survival factor for multiple myeloma. Blood. 99:1885-1893,2002.

Zhang B, Prendergast GC, and Fenton RG. Farnesyltransferase inhibitors reverse Ras-mediated inhibition of Fas gene expression. Cancer Res., 62:450-458, 2002.

Rapoport AP, Meisenberg B, Sarkodee-Adoo C, Frankel SR, Mookerjee B, Takebe N, Fenton R, Heyman M, Badros A, Kennedy A, Jacobs M, Hudes R, Ruehle K, Smith R, Kight L, Chambers S, MacFadden M, Cottier-Fox M, Chen T, Phillips G, and Tricot G. Autotransplant for advanced lymphoma and Hodgkin disease followed by post-transplant rituxan/GM-CSF or radiotherapy and consolidation chemotherapy. Bone Marrow Transplant. 29:303-312,2002.

Zhang B, and Fenton RG. Proliferation of IL-6-independent multiple myeloma does not require the activity of extracellular signal-regulated kinases (ERK1/2). J. Cell Physiology. 193:42-54,2002.

Gojo I, Zhang B, and Fenton RG. The cyclin-dependent kinase inhibitor flavopiridol induces apoptosis in multiple myeloma cells through transcriptional repression and down-regulation of Mcl-l. Clin. Cancer Res. 8:3527-3538, 2002.

Zhang B, Potyagaylo Y, Fenton RG. IL-6-Independent Expression of Mcl-1 in Human Multiple Myeloma. Oncogene. 22:1848-1859, 2003.

Zhang B, Arany Z, Mann 0, and Fenton RG. Partitioning apoptosis: a novel form of the execution phase of apoptosis. Apoptosis. 10:219-231, 2005.

Dispenzieri A, Gertz MA, Lacy MO, Gever SM, Fitch TR, Fenton RG, Fonseca R, Isham CR, Ziesmer SC, Drlichman C, Bible KC. F1avopiridol in patients with relapsed or refractory multiple myeloma: a phase 2 trial with clinical and pharmacodynamic end-points. Haematologica. 91:390-393, 2006.

Badros A, Weikel D, Salama A, Goloubeva O, Schneider A, Rapoport A, Fenton R, Gahres N, Sausville E, Ord R, Meiller T. Osteonecrosis of the jaw in multiple myeloma patients: clinical features and risk factors. J Clin Oncol. 24:945-952, 2006.

SELECTED BOOK CHAPTERS

Fenton. RG, and Longo, D.L. Normal cell growth and differentiation. In Harrison's Principles of Internal Medicine, 14th Edition, 1997. AS. Fauci et al. (eds), McGraw-Hili, NY, NY.

Fenton. RG., and Longo, D.L. Cancer Cell Biology and Angiogenesis. In Harrison's 15th Principles of Internal Medicine, 15 Edition, 2005. Braunwald et al. (eds.), McGraw- Hill, NY, NY.

REVIEW ARTICLES PUBLISHED in CLINICAL ONCOLOGY ALERT (2009- 2011)

Role of Autologous Stem Cell Transplant for Multiple Myeloma in the Era of Novel Therapies.

Bendamustine for the Treatment of Indolent Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia.

Strategies for Monitoring Tyrosine Kinase Inhibitor Response in Chronic Phase CML and the Role of Second-Line Inhibitors in Disease Management.

Expanding Role for Arsenic Trioxide (ATO) in the Treatment of Acute Promyelocytic Leukemia.

Novel Therapies for Malignant Melanoma: A New Generation of High-Affinity, Selective BRAF Inhibitors.

Considerations for Surgical Resection of Colon Cancer Liver Metastases after Complete Response to Chemotherapy.

Illustrative Case Series. Renal Cell Carcinoma: A Revolution in Molecularly-Targeted Therapy.

Illustrative Case Series. Adjuvant Treatment of Colon Cancer in a Piano Instructor.

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