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Telephone: (310) 478-3711 Ext. 42300
Email: jrose@ucla.edu
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.
- Ph.D., Medical Physics, 1975, UCLA
- Sc.M., Radiological Physics, 1968, Johns Hopkins University
- 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.
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.
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.
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.
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.
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.
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.
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.
I was charged with ensuring that manufacturers of laser
products (including laser light show exhibitions) were in compliance
with the Federal Laser Performance Standard.
I enhanced significantly the enforcement of the Standard
through investigative insight, and implemented an ongoing training
program for manufacturers and others
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.
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.
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.
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.
I was President and CEO; and had responsibility for
all sales, fiscal and technical activities associated with the
operation of two computer stores.
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.
I conducted research into the development of more effective
methods of diagnosing arteriosclerosis, ischemia, and heart disease;
and therapeutic hyperthermia.
I designed a geometrically reproducible apparatus for
the manipulation of human cadaver tissue placed in the path of
ultrasonic for tissue characterization.
- Assistant Professor
Department of Radiation Medicine
University of Southern California
Los Angeles, CA 90033
11/76 – 3/78
I served as Director of the Community Radiation therapy
Oncology Group; established an experimental hyperthermia laboratory
for the treatment of mice and humans.
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.
- Nuclear Medicine Science Officer (Physicist)
Tripler Army Medical Hospital
Honolulu, Hawaii
9/67 – 9/71
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.
I designed Tripler’s first Co-60 facility for
external beam radiation therapy; and established their first use
of thermoluminescent dosmitery.
- Acting Supervisory Investigator
Phoenix Resident Post
201 East Indianola
Suite 385
Phoenix, AZ 85012
12/10/90 – 12/14/90
I assumed supervisory authority over the resident post’s
entire staff and operations. As such I directed the activities
of investigators and administrative staff.
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.
- Acting Supervisory Investigator
Santa Ana Resident Post
18004 Shypark Circle South
Suite 140
Irvine, CA 92714
9/24/90 – 10/23/90
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.
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.
- Acting Radiation Protection Officer (RPO)
Radiotherapy Physicist
Fitzsimons Army Medical Center
Aurora, CO 80045-5001
3/1/86 – 4/17/86 (Special Assignment)
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.
I reviewed and updated the radiation training programs,
all radioactive source handling SOPs, and established a more stringent
review of radiation based research.
Recruiter
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
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
Reviewer, medical physics research articles for the journal, Medical
Physics.
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
See above under professional activities
- 11/92, District Nominee: President’s Points of Light
Award
- 5/92, PHS Commendation Medal
- 10/89, Commissioned Corps Special Assignment Award, FDA
- 10/86, USPHS Citation, FDA
- 10/80, Certification of Appreciation, U.S. Army Reserve
- 7/78, “Outstanding Alumni Science Award,” Johnson
- Smith University
- 1975, Member, Society of Sigma Xi
- 1971, Commendation Medal, U.S. Army
- 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.
- 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.
- 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.
- 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.
- Roseboro, J.A.: “Ultrastructure of Hela Cells and Thoracic
Duct Lymphocytes: Pre and Post – Ultrasonic Irradiation,”
Ultrasound in Medicine, 3B, pp 2063-74, 1977.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
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.
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