Program Director/Principal Investigator (Norenberg, Jeffrey, P.): BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Jeffrey P. Norenberg Professor and Director, Radiopharmaceutical Sciences Associate Director, New Mexico Center for Isotopes in Medicine Director, Keck-UNM Small-Animal Imaging Resource eRA COMMONS USER NAME (credential, e.g., agency login) jpnoren EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) INSTITUTION AND LOCATION University of Nebraska, Lincoln, NE UNM, Albuquerque, NM UNM , Albuquerque, NM UNM, Albuquerque, NM NIH, Bethesda, MD NIH, Bethesda, MD University of Washington, Seattle, WA DEGREE (if applicable) YEAR( s) B.S. B.S. M.S. Residency PHS - COSTEP PHS - COSTEP PharmD. 1986 1990 1991 1991 1989 1990 2001 FIELD OF STUDY Biology Pharmacy Pharmaceutical Sciences Nuclear Pharmacy Nuclear Pharmacy PET Nuclear Pharmacy Clinical Pharmacy A. Personal Statement My research background in radiopharmaceutical discovery and development provides me with the knowledge and skills to develop molecular imaging probes designed to target unique cellular biochemical and pathophysiologic expressions of disease. I am a member of the Cancer Biology Program and have developed novel imaging agents targeting lymphoma and leukemia. I have experience in the preparation and characterization of targeted molecular imaging probes; their characterization using in vitro and in vivo methods and models; small-animal biodistribution and imaging studies; image processing, and image data analysis to demonstrate cellular and tissue response following exposure to radiolabeled compounds. I have led research aimed at the discovery and development of radiotracers and radiopharmaceuticals. My experience as an Authorized User and radioactive permit holder will ensure that the aims are conducted in full compliance with all applicable standards of radiation safety and the ethical treatment of animals in research. In summary; my record of sustained, successful, and productive research in the area of radiopharmaceutical discovery and development, and in vivo small-animal PET/SPECT/CT molecular imaging has prepared me to perform as a co-director of the KECK-UNM Animal Models and Imaging Resource (KUMAIR) on this project where our goal is to provide high quality and cost-effective services in animal models for cancer. From the inception of KUMAIR I have had the opportunity to work closely with Dr. Hathaway to engage interested investigators to determine how to best meet their individual needs on the design, execution, and data analysis of experiments involving state-of-the-art PET/SPECT/CT radiopharmaceutical imaging in small animals. B. Positions and Honors Positions and Employment Positions and Employment 1985 1990 - 1991 1991 - 1993 1993 1993 - 1994 1994 - 2004 1998 - Present 2002 - Present 2003 - Present 2004 - 2009 2004 - Present 2006 - Present 2009 - Present Undergraduate Teaching Assistant, Dept of Biology, University of Nebraska, Lincoln, NE Grad Research Assistant, Radiopharmacy, College of Pharmacy, UNM, Albuquerque, NM Instructor, Department of Radiology, Tufts University School of Medicine, Boston, MA Lecturer I, College of Pharmacy, UNM, Albuquerque, NM Clinical Assistant Professor, College of Pharmacy, UNM, Albuquerque, NM Assistant Professor, College of Pharmacy UNM, Albuquerque, NM Director, Radiopharmaceutical Sciences Program UNM, Albuquerque, NM Executive Director and Chairman, Board of Directors, National Assoc. Nuclear Pharmacies Associate Member, Cancer Research and Treatment Center, UNM, Albuquerque, NM Associate Professor, College of Pharmacy, UNM, Albuquerque, NM Associate Director, New Mexico Center for Isotopes in Medicine, UNM, Albuquerque, NM Director, KECK UNM Small Animal Imaging Resource UNM, Albuquerque, NM Professor, College of Pharmacy, UNM, Albuquerque, NM PHS 398/2590 (Rev. 06/09) Page 1 Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): Honors 1985 1989 - 1991 1990 1990 2000 2003 Sarah Welch Outstanding Achievement Scholarship Dean’s List, College of Pharmacy, University of New Mexico United States Public Health Service Outstanding Achievement Citation Department of Interior Meritorious Service Commendation Fellow, American Society of Health System Pharmacists Fellow, American Pharmaceutical Association Other Experience and Professional Memberships American Associate for Cancer Research (AACR), Member 2005 - present Nuclear Science Advisory Committee (NSAC) - Isotope Subcommittee, 2008 - 2011 Society of Nuclear Medicine, 1990 - present Molecular Imaging Center of Excellence, Education Task Force, Member 2007 - present Commission on Radiopharmaceuticals, Chair 2008 - present Board of Directors 2009 – 2012 Radiopharmaceutical Sciences Council (RPSC), Member 1994 - present Immediate Past-President 2009-2010 President 2008-2009 Educational Program Organizer Moderator, Oncology-Clinical Session. 55th Society of Nuclear Medicine Annual Meeting. C. 1. 2. 3. 4. 5. 6. 7. 8. 9. Selected Peer-reviewed Publications (Selected from 40 peer-reviewed publications) Most relevant to the current application Kuehl PJ, Anderson T, Candelaria G, Gershman B, Harlin K, Hesterman JY, Holmes T, Lackas C, Norenberg JP, Yu H, McDonald JD. Regional Particle Size Dependent Deposition of Inhaled Aerosols In Rats And Mice. Inhalation Toxicology 2012;24(1):27-35 (PMID: 22145784) Nayak TK, Dennis MK, Ramesh C, Burai R, Atcher RW, Sklar LA, Norenberg JP, Hathaway HJ, Arterburn JB, Prossnitz ER. Influence of charge on cell permeability and tumor imaging of GPR30-targeted 111inlabeled nonsteroidal imaging agents. ACS Chem Biol 2010; 5(7):681-690. Aillon KL, El-Gendy N, Dennis C, Norenberg, JP, McDondald J, Berkland C. Iodinated NanClusters as an Inhaled Computed Tomography Contrast Agent for Lung Visualization. Molecular Pharmaceutics, 2010;7(4):1274-1282. Honggang Y, Hoppin J, Harlin, K, McDonald J, Kuehl P, Anderson TL, Lackas C, Gershman B, Candelaria G, Hesterman JY, Norenberg JP. Implementation Of A 3D Topographic Thinning Model For Assessing Aerosol Deposition Of Radioactive Assays In Small-Animal CT/SPECT Imaging. IEEE Nuclear Science Symposium Conference Record (NSS/MIC) 2009;3705-3709. Beregeron M, Cadorette J, Beaudoin, Lepage MD, Robert G, Selivanov V, Tétrault M-A, Viscogliosi N, Norenberg JP, Fontaine R, Lecomte R. Performance Evaluation of the LabPET APD-Based Digital PET Scanner, IEEE Transactions on Nuclear Science, 2009;56(1):10-16. Bergeron M, Cadorette J, Beaudoin JF, Rousseau JA, Dumoulin M, Lepage MD, Robert G, Selivanov V, Tétrault MA, Viscogliosi N, Dumouchel T, Thorn S, Dasilva J, Dekemp RA, Norenberg JP, Fontaine R, Lecomte R. Performance Evaluation Of The Labpet™ APD-Based Digital PET Scanner. IEEE 2007;6:4185-4191. Poria RB, Norenberg JP, Anderson TL, Wagner CR, Arterburn JB, Larson RS. Characterization of 177Lulabeled small molecule for non-invasive tumor imaging and radiotherapy. Cancer Biotherapy & Radiopharmaceuticals, 2006:21 (5): 418-426. Norenberg JP, Krenning BJ, Konigs IG, Kusewitt DF, Nayak TK, Anderson TL, deJong M, Garmestani K, Brechbiel MW, Kvols LK. 213Bi-DOTATOC Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors in a Pre-Clinical Animal Model. Clinical Cancer Research 12(3) February 1:897-903, 2006. Nayak TK, Hathaway HJ, Ramesh C, Arterburn JB, Dai D, Sklar LA, Norenberg JP, Prossnitz ER, PreClinical Development Of A Neutral, Estrogen Receptor-Targeted, Tridentate 99mTc(I) Estradiol Pyridin-2yl Hydrazine Derivative For Imaging Of Breast And Endometrial Cancers. Journal Of Nuclear Medicine 2008; 49 (6):978–986. PHS 398/2590 (Rev. 06/09) Page 2 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): D. Research Support Ongoing Research Support CCSG P30 CA118100 (Willman) 09/01/10-8/31/15 NCI/NIH UNM Comprehensive Cancer Center Purpose of Section 9.1.6 Shared Resource: The Keck-UNM small animal models and imaging resource provides value to members of the UNM Cancer Center by providing a comprehensive service in the development and use of animal models for basic and pre-clinical cancer research. Role: Co-Director KUMAIR Number not assigned (Norenberg) Invicro, LLC 12/1-3/12 68Ga labeling of DOTA-conjugated peptides– Task 17 Purpose: The main goal of this project is the optimization and kit formulation of a 68Ga labeled DOTA conjugated peptide. Role: PI Completed Research Support Number not assigned (Norenberg) 7/08-4/09 Lovelace Respiratory Research Institute Imaging the Distribution and Fate of Botulinum Toxin Heavy Chain in Mice A Pilot Study Continued. The purpose of this grant is to obtain information on imaging botulinum toxin heavy chain in mice using SPECT. Role: PI Number not assigned (Norenberg) 7/08-7/10 Bioscan Inc. A University of New Mexico contract for radiopharmaceutical imaging. The purpose of this grant is to perform quantification of a SPECT imaging modality. Role: PI Number not assigned (Norenberg) 6/09-11/09 NuView Radiopharmaceuticals, Inc. In Vivo evaluation of DOTA-alkylamino-NorBIRT, a LFA-1 Targeted Radiopharmaceutical using different animal models of disease. The purpose of this grant was to investigate a novel imaging agent to target leukemia, lymphoma, and inflammation. Role: PI Number not assigned (Norenberg) 6/09-7/09 Savara Pharmaceuticals Inhaled Contrast Agent Imaging. Purpose: The purpose of this grant was to investigate a potential lung imaging contrast agent in mice. Role: PI #DE-Number not assigned (Burchiel, Atcher LANL) 10/09-9/10 Los Alamos National Laboratory, Biosciences Division, DOE OBER subaward Mix Evolution Experimental Investigation. The purpose of this grant is for a UNM contract for radiopharmaceutical support to LANL. Role: Co-Investigator Number not assigned (Norenberg) 2/10-4/11 Pulmatrix Imaging Novel Radiopharmaceuticals in Ferrets (Task 1 and Task 2). PHS 398/2590 (Rev. 06/09) Page 3 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): The purpose of this grant was to evaluate the uptake of a novel Tc-99m radiotracer in the lungs of healthy ferrets. Role: PI Number not assigned (Norenberg) 6/10-12/10 Invicro, LLC In-111 Peptide Distribution in Normal Mice. The purpose of this grant was to evaluate the uptake of a novel In-111 labeled peptide in a normal mouse model. Role: PI Number not assigned (Norenberg) 10/10-3/11 Invicro, LLC SPECT Imaging of I-125 Labeled Antibodies in a Mouse Model. The purpose of this grant was to evaluate the uptake of a novel I-125 labeled antibody in a mouse model of cancer. Role: PI # DE-FG02-08ER64580 (Burchiel) 11/08-12/11 Department of Energy award Purpose:The major goal of this grant is to develop the New Mexico Center for Isotopes and Medicine. Role: Co-PI Number not assigned (Norenberg) 1/10-5/11 Ligocyte Pharmaceuticals, Inc. A Quantitative Comparison of a 99m-Tc Compound in the Lungs of Conscious Rabbits N=4 Purpose: The major goal of this project is to study the uptake of a novel imaging agent in rabbits during imaging. Role: PI Number not assigned (Norenberg) 1/11-7/11 Invicro, LLC Indium-111 labeling of 2 DOTA compounds. Purpose: The major goal of this project is to develop a labeling method for multiple compounds using the radioisotope Indium-111. Role: PI Number not assigned (Norenberg) Invicro, LLC 1/12-6/12 Radiolabeling and SPECT/CT Imaging of NBN, tyrosine, and an anti-RET antibody for labeling validation, study of in vivo targeting and pharmacokinetics – Task 12. Purpose: The major goal of this project is to develop a labeling method for multiple compounds using the radioisotope Indium-111 and I-125 and to perform imaging protocols in tumor and normal animals. Role: PI Number not assigned (Norenberg) Invicro, LLC 11/11-5/12 Laboratory testing of Radiolabeling and SPECT/CT Imaging of NBN and tyrosine for labeling validation, clinical isotope selection, and multi-dose stud – Task 10 Purpose: The major goal of this project is to develop a labeling method for multiple compounds using the radioisotope Indium-111 and I-125. Role: PI Number not assigned (Norenberg) Invicro, LLC 12/1-3/12 DOTA-peptides Ahx-STp (5-18) – Task 11 Purpose: The major goal of this project is to develop a labeling method for peptides using the radioisotope Indium-111. Role: PI PHS 398/2590 (Rev. 06/09) Page 4 Continuation Format Page