CURRICULUM VITAE¶

Hyperlinked pdf or at http://anthony.fotenos.com¶

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NAME¶

Anthony Frank Fotenos¶

POSITION¶

Lead Medical Officer, Division of Imaging and Radiation Medicine, FDA¶

EMAIL¶

Anthony.Fotenos@fda.hhs.gov (work)¶

Anthony.Fotenos@gmail.com (home)¶

❡

ADDRESS¶

Stone Hill 718 Pacific St¶

Baltimore, MD 21211¶

PHONE¶

301.796.1487 (work) ¶

410.929.1247 (home) ¶

BIRTHPLACE ¶

California, United States ¶

INSTITUTION AND LOCATION¶

DEGREE¶

DATES (MM/YY)¶

FIELD OF STUDY¶

Brown University, Providence, RI¶

Washington University, St. Louis, MO¶

BS¶

MD, PhD¶

09/95-05/99¶

08/99-05/08¶

Neuroscience¶

Medicine/Neuroscience¶

03/16-now¶

Lead Medical Officer, Division of Imaging and Radiation Medicine, FDA, White Oak, MD¶

07/14-10/20¶

Nuclear Medicine Physician (part-time), Johns Hopkins Bayview, Baltimore, MD¶

07/14-09/20¶

Nuclear Medicine Physician (part-time), Medstar Franklin Square, Baltimore, MD¶

07/14-02/16¶

Medical Officer, Division of Medical Imaging Products, FDA, White Oak, MD¶

07/12-06/14¶

Resident, Nuclear Medicine (two-year program), Johns Hopkins, Baltimore, MD¶

07/13-06/14¶

Resident Scholar, Armstrong Institute for Safety and Quality, Baltimore, MD¶

07/11-06/12¶

Fellow, Clinical Informatics Leadership Program, Johns Hopkins, Baltimore, MD¶

07/11-06/12¶

Fellow, Imaging Informatics, University of Maryland, Baltimore, MD¶

07/09-06/12¶

Resident, Radiology (research track), Johns Hopkins, Baltimore, MD¶

07/08-06/09¶

Resident, Transitional Program, Mercy Hospital, St. Louis, MO¶

06/98-08-98¶

Research Assistant to Michael Stryker, UCSF, San Francisco, CA¶

06/96-08/97¶

Research Assistant to Jerome Sanes, Brown University, Providence, RI¶

06/94-08/95¶

Research Assistant to William Mobley, UCSF, San Francisco, CA¶

06/93-08/93¶

Research Assistant to Morton Cowan, UCSF, San Francisco, CA¶

06/92-08-92¶

Teacher in Math and Debate, Summerbridge, San Francisco, CA¶

12/14-now¶

Diplomate, American Board of Nuclear Medicine (ABNM)¶

09/14-now¶

Medical License (D77104), State of Maryland¶

01/14-now¶

Diplomate, Certification Board of Nuclear Cardiology (CBNC)¶

01/14¶

Lean Sigma for Healthcare Training¶

09/13¶

Level II Cardiovascular CT Training¶

07/09-06/14¶

Medical Training License (P19641), State of Maryland¶

06/12¶

Amyvid Reader Training¶

07/08-06/09¶

Temporary Medical License (2008018193), State of Missouri¶

06/09¶

Diplomate, National Board of Medical Examiners¶

• Fallah J, Agrawal S, Gittleman H, Fiero MH, Subramaniam S, John C, Chen W, Ricks TK, Niu G, Fotenos AF, Wang M, Chian K, Pierce WF, Suzman DL, Tang S, Pazdur R, Amiri-Kordestani L, Ibrahim A, Kluetz PG (2022). FDA approval summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer. Clinical Cancer Research 22.2875.

• Hofling AA, Fotenos AF, Niu G, Fallah J, Agrawal S, Wang SJ, Marzella L (2022). Prostate cancer theranostics: Concurrent approvals by the FDA of the first diagnostic imaging drug indicated to select patients for a paired radioligand therapeutic drug.

Journal of Nuclear Medicine 122.264299.

• Wang SJ, Fotenos AF, Masters SC, Marzella L (2022). Theranostics approach in drug development: is there study efficiency when the prevalence of the molecular target is very high? Theranostics 12(7):3079-3083.

• Niu G, Fotenos AF (2022). FDA clinical review: Locametz new drug application. fda.gov/215833Orig1s000MultidisciplineR.pdf fda.gov/215833Orig1s000TOC.cfm

• Mattay A, Fotenos AF, Ganley C, Marzella L (2020). Brain tau imaging FDA approval of F18-flortaucipir injection. Journal of Nuclear Medicine 61(10): 1411-1412.

• Mattay A, Fotenos AF (2020). FDA clinical review: Prohance efficacy supplement.  fda.gov/media/145708/download¶

• Mattay A, Fotenos AF (2020). FDA clinical review: Tauvid new drug application.  fda.gov/212123Orig1s000IntegratedR.pdf fda.gov/212123Orig1s000TOC.cfm¶

• Chakrabarti K, Fotenos AF, Gorovets A (2020). FDA dosimetry review: Detectnet new drug application. fda.gov/213227Orig1s000OtherR.pdf fda.gov/213227Orig1s000TOC.cfm¶

• Feng Q, Fotenos AF (2020). FDA clinical review: Cerianna new drug application.  fda.gov/212155Orig1s000MultidisciplineR.pdf fda.gov/212155Orig1s000TOC.cfm¶

• Feng Q, Fotenos AF (2020). FDA clinical review: Lymphoseek efficacy supplement. fda.gov/media/150329/download¶

• Feng Q, Fotenos AF (2020). FDA clinical review: Pulmotech MAA new drug application. fda.gov/210089Orig1s000MedR.pdf fda.gov/210089Orig1s000TOC.cfm¶

• Chakrabarti K, Fotenos AF. (2020) FDA dosimetry review: Ga68-PSMA-11 new drug application. fda.gov/drugsatfda_docs/nda/2020/212643Orig1s000OtherR.pdf fda.gov/drugsatfda_docs/nda/2020/212642Orig1s000TOC.cfm¶

• Coquia S, Fotenos AF (2019). FDA clinical review: ExEm Foam new drug application. fda.gov/212279Orig1s000MultidisciplineR.pdf fda.gov//212279Orig1s000TOC.cfm¶

• Qi F, Fotenos AF (2019). FDA clinical review: Ga68-DOTATOC new drug application. fda.gov/210828Orig1s000MultidisciplineR.pdf fda.gov/210828Orig1s000TOC.cfm¶

• Bleich K, Fotenos AF (2019). FDA clinical review: Gadavist efficacy supplement. fda.gov/201277¶

• Fotenos AF, Krefting I, Laniyonu A, Gorovets A, Marzella L (2017). Gadolinium retention after gadolinium based contrast magnetic resonance imaging in patients with normal renal function: FDA medical imaging review comments. fda.gov/FDA-Briefing-Information-for-the-September-8--2017-Meeting-of-the-Medical-Imaging-Drugs-Advisory-Committee.pdf fda.gov/2017-meeting-materials-medical-imaging-drugs-advisory-committee¶

• Holfing A, Fotenos AF (2017). FDA clinical review: Draximage DTPA efficacy supplement. fda.gov/110972¶

• Hofling A, Fotenos AF (2017). FDA clinical review: Dotarem efficacy supplement. fda.gov/108479¶

• Bleich K, Fotenos AF (2017). FDA clinical review: Visipaque efficacy supplement. fda.gov/107579 fda.gov/107568¶

• Fotenos AF, Marzella L (2016). FDA clinical review: Gadavist efficacy supplement. fda.gov/201277-Gadobutrol-Clinical-PREA.pdf¶

• Fotenos AF, Marzella L (2014). FDA clinical review: Gadavist efficacy supplement. fda.gov/N201-277S008-Gadobutrol-Clinical-PREA.pdf¶

• Durand D, Ding A, Grainer J, Agarwal G, Lewin JS, Fotenos AF, Savoie B, Krupinski E, Itri J, Robertson C (2014). Expert witness blinding strategies to mitigate bias in radiology malpractice cases: a comprehensive review of the relevant scientific, professional and legal literature. Journal of the American College of Radiology 11(9): 868-873.¶

• Fotenos AF*, Safdar NM*, Nagy PG, Mezrich R, Lewin JS (2013). Unbiased review of digital diagnostic images in practice: informatics prototype and pilot study. Academic Radiology 20(2): 238-42. *Co-first authors.¶

• Fotenos AF, Nagy PG (2012). What is your purpose for peer review? Understanding different methods. Journal of the American College of Radiology 9(12): 929-30.¶

• Fotenos AF, Eng J (2011). A chance discovery of a retained sponge. In: Wu A (ed). The Value of Close Call in Improving Patient Safety: Learning How to Avoid and Mitigate Patient Harm, pp.151- 158. Oak Brook, IL: Joint Commission Resources.¶

• Fotenos AF (2010). Structural neuroimaging across the adult life-span. Saarbrucken, Germany: Lambert Publishing.¶

• Marcus DS, Fotenos AF, Csernansky JG, Morris JC, Buckner RL (2010). Open access series of imaging studies: longitudinal MRI data in nondemented and demented older adults. Journal of Cognitive Neuroscience 22(12): 2677-2684.¶

• Fotenos AF, Mintun MA, Snyder, AZ, Morris JC, Buckner RL (2008). Brain volume decline in aging: evidence for a relation between socioeconomic status, preclinical Alzheimer's disease, and reserve. Archives of Neurology 65(1):113-120.¶

• Fotenos AF (2007). The voting age should be eliminated. In: Mucha R (ed). At Issue: Should the Voting Age Be Lowered? Stamford, CT: Greenhaven Press.¶

• Fotenos AF, Buckner RL (2006). Cross-sectional and longitudinal brain volume decline in aging and AD. In: Vellas B, Fitten L, Winblad B, Feldman H, Grundman M, Giacobini E, and Kurz A (eds). Research and Practice in Alzheimer’s Disease: Volume 11, pp. 234-238. Paris: Serdi.¶

• Burns JM, Church JA, Johnson DK, Xiong C, Marcus D, Fotenos AF, Snyder AZ, Morris JC, Buckner RL (2005). White matter lesions are prevalent but differentially related with cognition in aging and early Alzheimer disease. Archives of Neurology 62(12):1870-1876.¶

• Buckner RL, Snyder AZ, Shannon BJ, LaRossa G, Sachs R, Fotenos AF, Sheline YI, Klunk WE, Mathis CA, Morris JC, Mintun MA (2005). Molecular, structural, and functional characterization of Alzheimer's disease: evidence for a relationship between default activity, amyloid, and memory. Journal of Neuroscience 25(34):7709-7717.¶

• Fotenos AF, Snyder AZ, Girton LE, Morris JC, Buckner RL (2005). Normative estimates of cross-sectional and longitudinal brain volume decline in aging and AD. Neurology 64(6):1032-1039.¶

• Buckner RL, Head D, Parker J, Fotenos AF, Marcus D, Morris JC, Snyder AZ (2004). A unified approach for morphometric and functional data analysis in young, old, and demented adults using automated atlas-based head size normalization: reliability and validation against manual measurement of total intracranial volume. Neuroimage 23(2):724-738.¶

• Fotenos AF (1995). On the nature of slavery in the plantation South: a question of condition. The Concord Review 6(4):159-172.¶

• Devices@FDA: 3D-RD-S (2023)¶

• Devices@FDA: RefleXion Medical Radiothrapy System (2023)¶

• Devices@FDA: Torch Software (2022)¶

• Drugs@FDA: Pluvicto (2022)¶

• Devices@FDA: Lumipulse G ß-Amyloid Ratio (2022)¶

• Devices@FDA: TheraSphere (2021)¶

• Devices@FDA: Kinepict Medical Imaging Tool 4.0 (2021)¶

• Drugs@FDA: Lutathera (2020)¶

• Devices@FDA: syngo.via MI Workflow (2020)¶

• Devices@FDA: Mydriatic Hyperspectral Retinal Camera (2020)¶

• Devices@FDA: Cercare Medical Neurosuite (2020)¶

• Devices@FDA: Voxel Dosimetry v1.0 (2019)¶

• Devices@FDA: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (2019)¶

• Devices@FDA: MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow (2019)¶

• Devices@FDA: Thoracic VCAR with GSI Pulmonary Perfusion (2019)¶

• Drugs@FDA: Xofigo (2018)¶

• Drugs@FDA: Crysvita (2018)¶

• Devices@FDA: iSchemaView RAPID (2018)¶

• Devices@FDA: ACISTCVi Contrast Delivery System (2018)¶

• Devices@FDA: Retia 2 (2018)¶

• Devices@FDA: ARTIS pheno (2017)¶

• Theranostics: the concurrent approvals and parallel development of Locametz and Pluvicto, diagnostic and therapeutic radiopharmaceuticals. FDA Office of New Drug Products seminar (2022).¶

• Session on regulatory considerations for gastrointestinal acute radiation syndrome product development. NIH NIAID-BARDA-FDA GI-ARS workshop (2022).¶

• Session on clinical considerations for development of novel radiopharmaceuticals. FDA-NRC workshop on enhancing development of targeted alpha emitting radiopharmaceuticals, special focus on Actinium-225 (2021).
  fda.gov/fda-nrc-workshop-targeted-alpha-emitting-radiopharmaceuticals-focus-ac-225-09222021-09222021¶

• Radiation consult question from Office of Oncologic Diseases. FDA Oncology Center of Excellence November 1 Clinical Rounds (2021).¶

• Clinical development of radiopharmaceuticals. FDA oncology therapy development workshop:pivotal steps and avoiding pitfalls for start-ups (2021). youtube.com/watch?v=m6JCn0AQ75g fda.gov/oncology-therapy-development-workshop-pivotal-steps-and-avoiding-pitfalls-start-ups-03302021¶

• Parallel imaging radiopharmaceuticals. Session on emerging issues in radiotherapy, dosimetry, and companion imaging agents. FDA Oncology Center of Excellence  February 22 Rounds (2021).

• Session on safety and efficacy considerations for radiopharmaceutical products. FDA-NRC workshop: enhancing development of novel technologies: radiopharmaceuticals and radiological devices (2020).⏎
  fda.gov/fda-nrc-workshop-enhancing-development-novel-technologies-radiopharmaceuticals-and-radiological¶

• FDA perspective diagnostic clinical development considerations. High Country Nuclear Medicine Conference (2020).¶

• FDA perspective diagnostic clinical development considerations. SNMMI/NCI Third Targeted Radionuclide Therapy Conference (2019).¶

• Update on FDA approach to safety issue of gadolinium retention after administration of gadolinium-based contrast agents. FDA Pediatric Advisory Committee July 20 meeting (2018). fda.gov/2018-meeting-materials-pediatric-advisory-committee¶

• Toward more sensitive endpoints in evaluating the safety of post-GBCA gadolinium retention. FDA Medical Imaging Drug Advisory Committee September 8 meeting (2017).  fda.gov/advisory-committees/medical-imaging-drugs-advisory-committee/2017-meeting-materials-medical-imaging-drugs-advisory-committee¶

• Development of diagnostic tau imaging drugs for Alzheimer’s disease and chronic traumatic encephalopathy. CDER September 30 Scientific Rounds (2015).¶

• Questions in preparation for Phase 3 tau imaging development. CDER March 13 New Drug Rounds (2015).¶

• Evaluating quality in practice: A primer on peer review for nuclear medicine physicians. 
  Society of Nuclear Medicine and Molecular Imaging annual meeting (2013).¶

• Faster than the speed of type: feasibility of a high-performance human-computer search interface for patient-centered radiology ordering based on aggregation and localization of the ACR Appropriateness Criteria. Radiological Society of North America annual meeting (2012).¶

• Localize: reconciling the generic procedure lexicon of the ACR Appropriateness Criteria to the computerized physician order entry system at Johns Hopkins. Society for Imaging Informatics in Medicine annual meeting (2012).¶

• Lowering the barrier to appropriate radiology ordering: the RightRad project. Johns Hopkins 3rd Annual Patient Safety Summit (2012).¶

• Timeshifting cases in diagnostic imaging: a proof-of-concept study. American College of Radiology: Annual Conference on Quality and Safety (2012)¶

• Longitudinal change in whole-brain volume during aging and dementia of the Alzheimer type. Society for Neuroscience annual meeting (2003).¶

• Visual subceptual and perceptual influences on motor actions. European Brain and Behavioral Society annual meeting (1999).¶

• Volume decline associated with aging, Alzeheimer’s disease, and socioeconomic status: structural neuroimaging across the adult life-span. A dissertation presented to the Graduate School of Arts and Sciences of Washington University for the degree of Doctor of Philosophy. Advisor Randy Buckner. Thesis defense October, 2006. Degree awarded May, 2008.¶

• What’s under the mask? Motor and visual perceptual interactions during reaching. A thesis submitted for the degree of Bachelor of Science with Distinction in the Neuroscience concentration of Brown University. Advisor Jerome Sanes. Thesis defense April, 1999. Degree awarded May 31, 1999.¶