(16)
20.) Fred Hunter, Technician.
Since the Task Force
investigation in 1975, there has been a
major internal reorganization.
The current organization of
Worldwide Pharmaceutical
Research & Development is attached
as Exhibit #3. The
only change has been the resignation
of Dr. Robert A Moe,
Executive Vice-President. Mr. George
V. O'Bleness, Corporate
Vice-President, is temporarily filling
this position.
Organizational charts
for Preclinical Research and Development
of Products safety
Assessment are also attached as Exhibits
4 & 5. There have
been no changes in these areas to date.
Worldwide Pharmaceutical
Research and Development is respon-
sible for research
and development of Aspartame and is a part
of the Pharmaceutical/Consumer
Product group. The group
President is O.B. Parrish,
who reports to James A Buzard,
Executive Vice-President
for Operations, G.D. Searle & Co.
The current corporate
structure of G.D. Searle & Co. has been
discussed under History
of Business.
P.T. No. 988S73, 115
Week Oral Tumorigenicity Study in the Rat
was conducted between
November 10\971 and February 1974. The
final FDA submission
was dated September 1974. Following is
a yearly breakdown
of key personnel during this study:
1971
Robert Moe - Director,
Biological Research Department.
Robert McConnell -
Director, Pathology - Toxicology Section
K.S. Rao (June, 1971)
- Manager, Toxicology Section.
Tony Martinez - Toxicology
Laboratory Supervisor.
1972
Robert Moe - Director
Biological Research Department
(January through April)
F. Saunders - Director,
Biological Research Department (May
through December).
Robert McConnell -
Director, Pathology - Toxicology Section
K.S. Rao - Manager,
Toxicology Section.
Tony Martinez - Toxicology
Laboratory Supervisor.
(17)
1973 (January to June)
Francis Saunders -
Director, Biological Research Department.
Robert McConnell -
Director, Pathology-Toxicology Section.
K.S. Rao - Manager,
General Toxicology Laboratory.
Tony Martinez - Toxicology
Laboratory Supervisor.
1972 (July to December)
Paul Klimstra - Director,
Pre-clinical Research & Development
Department.
Robert McConnell -
Director, Pathology-Toxicology Section.
K.S. Rao - Manager,
General Toxicology Laboratory.
Tony Martinez - Toxicology
Laboratory Supervisor.
1974
Paul Klimstra - Director,
Pre-clinical Research & Development
Department.
Robert McConnell -
Director, Pathology-Toxicology Section.
K.S. Rao - Manager,
General Toxicology Laboratory.
D. Semler - Toxicology
Laboratory Supervisor.
A more complete listing
of personnel in the Department of
Science, from 1971-1975
is attached as Exhibit No. 64.
This includes the Pathology
- Toxicology Department and other
ancillary areas.
Curriculum vitae for
individuals performing significant func-
tions in the study
are attached as Exhibit 12.
MANUFACTURE AND TESTING
OF SC-19192
Seven batches of SC-19192
(diketopiperazine) were used in this
study. All batches
were manufactured in-house by Searle Chemist
jack Drogt. The lot
numbers, analytical numbers, and quantities
are as follows.
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Lot Number Analytical
Number Quantity (After Milling)
1R 6906
2R 7274
3R 7273
4R 7291 This data removed
in released report
5R (JDR-5-18A) 9129
6R (JDR-5-30A) 9805
7R (JDR-5-30B) 9829
Bach records covering
the manufacture of lots 1R through 5R were
reviewed. Batch records
for lot 6R and 7R could not be located
by Searle personnel.
analytical reports for all seven batches
were reviewed. Copies
of the batch records and analytical records
were obtained and are
attached to this report, along with copies
of pages from Jack
Drogt's laboratory notebook, and other labora-
tory notebooks relating
to the analysis of lots 1R through 7R of
DKP. (See Exhibits
13-23.)
We obtained copies
of three different specification sheets
for
DKP. (See Exhibits
16-18.) We could not determine with certainty
which of the three
specifications sheets was in effect at the
time
that the 7 lots of
DKP used in this study were assayed, because
only one of the three
specification sheets was dated. This
resulted in ambiguities
for two of the parameters measured:
melting point and identity
(IR Spectrum). Specification memorandum
dated Dec. 4, 1969
listed a melting range of 252-256 degrees
C. Another specification
sheet (not dated) entitled "Tentative
Specification For SC-19192",
listed a melting range of 241-246
degrees C. A third
specification sheet entitled "Specification
for SC-19192, Specification
No. C 40606C" (not dated) listed
a melting range "at
about 243 degrees C.".
For identity (IR Spectrum)
the first sheet (dated 12/4/69) speci-
fied that "The
reference standard shall be considered to
be
TJT-12-32 until something
better comes along". The second and
third sheets specify
that the DKP "Conforms to IR #2358".
No data was made available
as to dates, method of preparation and
authentication of DKP
references standards used.
Searle attorney Roger
Thies was contacted about this point
Aug. 1, 1977 and said
he would attempt to obtain information
regarding this point
but later registered doubt as to whether
anything would be found.
We asked Searle personnel
to tell us which of the specification
sheets was valid for
the DKP used in study E-77/78. We were
