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Contact Information:

Telephone: (310) 478-3711 Ext. 42300
Email: jrose@ucla.edu

Professional Interests and Goals:

My interests are multidisciplinary in that they encompass both research and regulatory affairs. My research interests include the bio effects of ionizing and non-ionizing (including ultrasound) radiation energy as a function of their physical characteristics. At the same time I have maintained an interest in those areas of regulatory oversight of selected industries under the purview of the U.S. Food and Drug Administration (USFDA). Of particular consultative interests to me are the USFDA regulations which govern the current good manufacturing practices (i.e. CGMPs) of the industries involved in medical devices, biotechnology, institutional review boards (IRBs) and lasers. In addition to the foregoing over the last several years I have led joint efforts to formulate biotechnology research projects including UCLA, the USFDA, and the private sector. These efforts gave dealt with research projects in breast cancer diagnosis and treatment (currently at the West LA VA Medical Center), the application of Fourier Transform Infra-red (FTIR) spectroscopy to characterization of mammalian cells, chromosomes, neoplastic tissue, and selected polymers. The ultimate conclusion to these efforts is the formation of a Cooperative Research and Development Agreement (CRADA) under the auspices of the Federal Technology Transfer Act of 1987.


Education:

  1. Ph.D., Medical Physics, 1975, UCLA
  2. Sc.M., Radiological Physics, 1968, Johns Hopkins University
  3. Sc.B., Math-Physics, 1965, Johnson C. Smith University

    Dissertation Title: "Development of an Ultrasonic Device for the Destruction of Thoracic Duct Lymphocytes, in vivo" (UCLA)


Certifications:

Radiological Physics, American Board of Radiology, 1976, No Expiration Date.

Additional Skills:

Besides my demonstrated skills in the area of radiation physics I have performed numerous support activities on behalf of my Agency, thus PHS< through my in-depth knowledge of computers, especially micros. I have aided my district (Los Angeles) in rapidly establishing itself as a preeminent FDA field office in the implementation of computer technology. Further, my understanding of analytical methodology in the identification of radiology compounds in selected produce samples led the Division of Field Science to approve such a project for FY ’91, ’94 and ’95 with me as principle investigator.

Relevant Work Experience:

  1. Senior Regulatory Research Officer
    U.S. Food and Drug Administration
    1521 West Pico Boulevard
    Los Angeles, CA 90015
    11/93 – 11/97

Duties and Responsibilities:
I am charged with developing analytical methodologies characterizing selected irradiated foods and associated packaging materials pursuant to the FDA’s obligation to assure compliance with its regulations regarding irradiating foods for human consumption.

Major Accomplishments:
To date I have conducted experiments on the use of Fourier transform infra-red (FTIR) and Raman spectroscopy to detect and quantitate radiolytic products in DNA, other proteins, including human lymphoblast cells, and lipids extracted from irradiated foods. In addition I have carried out spectral analysis or irradiated (with Co-60 gamma rays) packaging materials composed of various polymers. The data derived from these early experiments are being analyzed for subtle molecular changes that may develop in foods and packaging materials as a result of an insult by ionizing radiation. I am also near completion of the development of a CRADA involving UCLA, FDA, and one or more private firms.
  1. Senior Supervisory Regulatory Operations Officer
    U.S. Food and Drug Administration
    1521 West Pico Boulevard
    Los Angeles, CA 90015
    2/93 – 11/93
Duties and Responsibilities:
I was charged with supervising selected inspectional/investigational activities of three teams of Supervisors, Consumer Safety Officers, Engineers, and Administrators in the Olympic Office of the Los Angeles District. My teams’ responsibilities included the conduct of Good Manufacturing Practices (GMPS) inspection/investigations of medical device, laser manufacturers, and X-ray Assemblers. These obligations also encompassed product induced injuries to consumers while using regulated devices, drugs, and cosmetics.
Major Accomplishments:
I directed, and indeed, directly participated in the investigational activities of two members of my team which resulted in the FDA’s first withdrawal from a manufacturer of a previously approved pre-market approval (PMA) application under the Medical Device Act.

Additionally, two members of my group and I were responsible for the recommendation of the largest civil penalty in FDA’s history against a device manufacturer, $1 million.

  1. Supervisory Investigator
    18004 Skypark Circle South
    Suite 140
    Irvine, CA 92714
    10/90 – 2/92
Duties and Responsibilities:
I was charged with supervising the inspectional/investigational activities of a team of Consumer Safety Officers, Engineers, and Administrators in the Irvine Resident Post of the Los Angeles District. My team’s primary responsibility was the conduct of Good Manufacturing Practices (GMPS) inspectors/investigators of medical devices and laser manufacturers. This obligation also encompassed product induced injuries to consumers while using regulated devices, drugs and cosmetics.
Major Accomplishments:
I directed, and, indeed, directly participated in, the investigational activities of two members of my team which resulted in the FDA’s first withdrawal from a manufacturer of a previously approved pre-market approval (PMA) application under the Medical Device Act.
  1. Electro-Optics Specialist
    U .S. Food and Drug Administration
    1521 West Pico Boulevard
    Los Angeles, CA 90015
    10/86 – 10/90
Duties and Responsibilities:
I was charged with ensuring that manufacturers of laser products (including laser light show exhibitions) were in compliance with the Federal Laser Performance Standard.
Major Accomplishments:
I enhanced significantly the enforcement of the Standard through investigative insight, and implemented an ongoing training program for manufacturers and others

  1. Consumer Safety Officer
    U.S. Food and Drug Administration
    1521 West Pico Boulevard
    Los Angeles, CA 90015
    6/85 – 10/86
Duties and Responsibilities:
I performed inspectional tasks involving firms encompassing almost all areas in which the FDA has a regulatory interest, including foods, medical devices, IRBs, pharmaceuticals, etc.

Major Accomplishments:

I served in the role of an undercover investigator with the result of aiding in the interdiction of illegally imported, so-called therapeutic drugs, into the United States.
  1. Acting Director, Investigations Branch
    U.S. Food and Drug Administration
    1521 West Pico Boulevard
    Los Angeles, CA 90015
    1988 – Present (Acted frequently during this period)
Duties and Responsibilities:
I was responsible for directing the inspectional/investigational activities of the entire Los Angeles District and interacting with other branch chiefs,

District Director, various FDA Centers, and other federal and state agencies including the FBI, Customs, and DEA.
Major Accomplishments:
It was during one of my stints as acting branch chief that we successfully, with the FBI and local authorities, identified an individual that was charged with tampering with IV bags of patients at a local convalescent home. The individual was ultimately incarcerated.
  1. Byte Shop/Brentwood
    Microprocessor Systems Export, Ltd.
    11611 San Vicente Boulevard
    Los Angeles, CA 90049
    12/77 – 6/85
Duties and Responsibilities:
I was President and CEO; and had responsibility for all sales, fiscal and technical activities associated with the operation of two computer stores.
Major Accomplishments:
It was my efforts that initiated and developed the two computer stores, including the design of one which served as a model for an entire chain of such stores.
  1. Member, Technical Staff (Research)
    Jet Propulsion Laboratory/California Institute of Technology
    4800 Oak Grove Drive
    Pasadena, CA 91103
    8/76 – 8/83
Duties and Responsibilities:
I conducted research into the development of more effective methods of diagnosing arteriosclerosis, ischemia, and heart disease; and therapeutic hyperthermia.
Major Accomplishments:
I designed a geometrically reproducible apparatus for the manipulation of human cadaver tissue placed in the path of ultrasonic for tissue characterization.
  1. Assistant Professor
    Department of Radiation Medicine
    University of Southern California
    Los Angeles, CA 90033
    11/76 – 3/78
Duties and Responsibilities:
I served as Director of the Community Radiation therapy Oncology Group; established an experimental hyperthermia laboratory for the treatment of mice and humans.
Major Accomplishments:
As the Director of the Oncology Group I helped commence a breast cancer screening program in a depressed area of Los Angeles; and established the hyperthermia lab.
  1. Nuclear Medicine Science Officer (Physicist)
    Tripler Army Medical Hospital
    Honolulu, Hawaii
    9/67 – 9/71
Duties and Responsibilities:
I was the medical center’s physicist for all applications of ionizing and non-ionizing radiation sources in Radiation therapy, Nuclear Medicine and Diagnostic Radiology, and head of the Radiation Emergency Medical Team (REMT) for the U.S. Army Pacific.
Major Accomplishments:
I designed Tripler’s first Co-60 facility for external beam radiation therapy; and established their first use of thermoluminescent dosmitery.
Special Career Assignments:
  1. Acting Supervisory Investigator
    Phoenix Resident Post
    201 East Indianola
    Suite 385
    Phoenix, AZ 85012
    12/10/90 – 12/14/90


Duties and Responsibilities:
I assumed supervisory authority over the resident post’s entire staff and operations. As such I directed the activities of investigators and administrative staff.
Major Accomplishments:
I arrived in the midst of a major criminal investigation. I established formal written contact with Customs Service resulting in the identification of a major criminal suspect.
  1. Acting Supervisory Investigator
    Santa Ana Resident Post
    18004 Shypark Circle South
    Suite 140
    Irvine, CA 92714
    9/24/90 – 10/23/90
Duties and Responsibilities:
I was charged with supervising the inspectional activities of 10 investigators and one secretary. I was also responsible for the training of newer investigators, including engineers.
Major Accomplishments:
I implemented for the first time a comprehensive work plan for each investigator to reduce significantly the 25-month medical device firm inspection list, doubling FY ’91 output.
  1. Acting Radiation Protection Officer (RPO)
    Radiotherapy Physicist
    Fitzsimons Army Medical Center
    Aurora, CO 80045-5001
    3/1/86 – 4/17/86 (Special Assignment)
Duties and Responsibilities:
I conducted oversight of the safe acquisition, use, and disposal of all the medical center’s radiation sources, both ionizing and non-ionizing, and designed radiotherapy treatment plans.
Major Accomplishments:
I reviewed and updated the radiation training programs, all radioactive source handling SOPs, and established a more stringent review of radiation based research.

Professional Activities:

Commissioned Corps:

Recruiter

Professional Societies:

Laser Institute of America, Member
Commissioned Officers Association, Member
Assn. of Military Surgeons of the U.S., Member
The New York Academy of Sciences, Member
Southern California Federation of Scientists, Member
American Association of Physicists in Medicine, Member
Health Physics Society, Member
International Society, Member
International Society of Health Physics, Member
American Institute of Ultrasound in Medicine, Member
American College of Radiology (Physics), Member
Reserve Officers Association (ROA), Member

Committees and Working Groups:

The Johns Hopkins University Alumni Executive Committee
Los Angeles Chapter, Member
UCLA Alumni Scholarship Committee, District Chairman
Evaluated the new laser detection system that CDRH subsequently
adopted for laser field tests
UCLA, Adjunct Asst. Professor, Department of Radiation Oncology
National University, Adjunct Associate Professor, Math and Science

Editorial boards, reviews:

Reviewer, medical physics research articles for the journal, Medical Physics.


Relevant Volunteer Activities:



Committees and Working Groups:


Graduate and Undergraduate Recruiting, Johns Hopkins University,
Alumni Member, Executive Board
UCLA Medical Center, Present graduate seminars in the areas of
radiological physics, laser technology, and FDA regulatory
compliance requirements.
Counseling Without Walls Foundation, Member, Board of Directors
Alumni Scholarship Committees: UCLA
University Service Award Nominating Committee
1993: UCLA

Editorial boards, reviews:

See above under professional activities


Honors and Awards:
  1. 11/92, District Nominee: President’s Points of Light Award
  2. 5/92, PHS Commendation Medal
  3. 10/89, Commissioned Corps Special Assignment Award, FDA
  4. 10/86, USPHS Citation, FDA
  5. 10/80, Certification of Appreciation, U.S. Army Reserve
  6. 7/78, “Outstanding Alumni Science Award,” Johnson
  7. Smith University
  8. 1975, Member, Society of Sigma Xi
  9. 1971, Commendation Medal, U.S. Army
Papers and Publications:

Peer Reviewed Publications:
  1. Roseboro, J.A.: “A Study of Alternatives to Chemical Fumigation in Mediterranean Fruit-Fly (Drosophila Melanogaster as Model) Disinfection,” JPL Publication (81-Series), August 1981.
  2. Gammel, P.M.: Heyser, R.C.; Le Crosissette, D.H.; Roseboro, J.A.; and Wilkson, R.L.: “The Temperature and Frequency Dependence of Ultrasonic Attenuation in Liver,” Reflections, June 1981.
  3. Roseboro, J.A.; Buchanan, P.; Norman, A.; and Stern, R.: “Effect of Ultrasonic Irradiation on Mammalian Cells and Chromosomes, in-vitro,” Physics in Medicine and Biology, v23, no. 2, pp 324-31, March 1978.
  4. Coover, S.R.; Roseboro, J.A.; and Watson, J.E.: “Electric Charger for Pocket Ion Chamber Dosimeters,” Health Physics, v33, no. 5, pp 474-7, November 1977.
  5. Roseboro, J.A.: “Ultrastructure of Hela Cells and Thoracic Duct Lymphocytes: Pre and Post – Ultrasonic Irradiation,” Ultrasound in Medicine, 3B, pp 2063-74, 1977.
  6. Smokler, M.I.; Anselmo, V.; Frazier, R.; Le Croissette, D.; and Roseboro, J.A.: “Feasibility Study on the Design of a Probe for Rectal Cancer Detection,” JPL Publication (77-Series), May 1977.
  7. Rollins, E.M.; Saylor, W.L.; and Roseboro, J.A.: “Dosimetry of Radium-226 Sources with the Fletcher-Suit Gynecological Applicator,” International Journal of Radiation Oncology, Biology and Physics, November 1976.
  8. Roseboro, J.A.; Norman, A.; Machleder, H.J.; Paulus, H.; and Stern, R.: “The Therapeutic Efficacy of Ultrasound in Treatment of Autoimmune Disease,” Ultrasound in Medicine, 2: 487-500, 1976.
  9. Gopala, Rao U.V.; Rollo, F.D.; and Roseboro, J.A.: “Tumor Dose-Rate Tables Instead of Central Axis Depth Dose Data and Tumor-Air-Ratios,” British Journal of Radiology, 40: 783, 1967.
  10. Roseboro, J.A.; and Brill, Warren: “Report on Battelle N.W. Laboratory ---S.W. Radiological Health Laboratory Alaskan Caribou Muscle Cesium-137 Discrepancies,” Radiological Health Data, 1965
Abstracts:
  1. Wilson, R.W.; Le Croissette, D.H.; Gammell, P.M.; Roseboro, J.A.; and Heyser, R.C.: “Measurement of Attenuation in Tissues Using Time Delay Spectrometry,” Ultrasound in Medicine, v4, pp 557-8, 1978.
  2. Hsu, Thomas H.S.; Fabrikant, Jacob I.; and Roseboro, J.A.: “Kinetics of Spermatogonial Cell Renewal Under Continuous Irradiation at 18 and 45 rads Per Day,” Twenty-Fifth Annual Meeting of the Radiation Research Society, San Juan, Puerto Rico, May 1977.
  3. Roseboro, J.A.; Norman, A.; and Stern, R.: “Ultrasonic Irradiation of Human Thoracic Duct Lymphocytes,” Fifth International Congress on Radiation Research, Seattle, Washington, July 1974.
  4. Roseboro, J.A.; Stern, R.; and Norman, A.: “Development of an Ultrasonic Device for the Destruction of Thoracic Duct Lymphocytes, in-vivo,” Physics in Medicine and Biology, 19(2): 266, March 1974.


Research Proposals: Titles

1) The Development of Analytical Methods for the Characterization of Irradiated Foods and Packaging Materials, 1994-96
2) Reducing The Breast Cancer Risk From Medical X-Rays, 1996-97

THE FOREGOING IS A REPRESENTATIVE ACCOUNTING OF MY SCIENTIFIC ACTIVITIES AND INTERESTS.