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 PERSONNEL AND RESPONSIBILITY

PERSONNEL AND RESPONSIBILITY

The names of Dr. K.S. Rao, Dr. R. Stejskal, and Dr. R.G. McConnell appear on the  final study report, indicating that they are the authors of this report, and were responsible for the study.

Following are the principal person involved with study E-77/78 and their specific areas of responsibility:

1.) Dr. Robert G. McConnell - Director, Pathology-Toxicology Laboratory 1970 through 1974.  Dr. McConnell functioned as the Path-Tox advisor on study E-77/78.  He is no longer employed by Searle.

2.) Dr. Suryanarayana K. Rao - Manager, General Toxicology Laboratory, June 1971 until he left Searle in May of 1977. Dr. Rao was the Path-Tox monitor for study E-77/78.  In 1971 Dr. Rao monitored 30 studies, in 1972 forty-seven (47) studies, in 1973 twenty-nine (29) studies and in1974 twenty-five (25) studies.

3.) Dr. Rudolf Stejskal - Senior Research Investigator, Pathologist.  Dr. Stejskal was responsible for the microscopic findings and accuracy of these findings in the study report of E-77/78.  Because Dr. Stejskal joined Searle in July, 1973, he had no input into the pathology protocol. Also, he did not examine all of the slides for this study, but was assisted in that task by Dr. Joseph H. Smith M. D..

4.) Dr. Joseph H. Smith, M.D. - Group Leader and Senior Pathologist at Michael Reese Hospital, Chicago, IL., before joining Searle in June of 1973.  Dr. Smith examined some of the slides for study E-77/78, and supervised the necropsy laboratory.

5.) Tony Martinez - Toxicology Laboratory Supervisor, 1970 through 1973.  Mr. Martinez participated in twelve (12) studies in 1971, Seventeen (17) studies in 1972, and thirteen (13) studies in 1973.  Mr. Martinez supervised the technicians who worked on the study.  He also performed some necropsies.

6.)  David K.T. Kie, B.S., Research Assistant in Pathology Laboratory.  He performed some of the necropsies on E-77/78.

7.)  Robert Spaet - Research Assistant.  He also performed necropsies.

8.)  Bartolome R. Tangonan - Research Technician II - He was involved with preparation of diet mixtures, daily observations, weighing and feeding animals, etc.

9.)  Donna K. Helms - Manager, Safety Evaluation, Project Scheduling, Reporting, and Data Storage, Path-Tox Dept. and Administrative Assistant to Dr. McConnell.

10.)  Patrica Erdenberger - Research Assistant, and Histology lab Supervisor.

11.)  Dr. Eugene Joseph Youkilis - Senior Research Investigator. He performed the opthalmoscopic examinations in study E-77/78.

12.)  Judy A Henderson - August 1972 to present, Research Technician III, Histopathology Dept.  She was involved with tissue processing on study E-77/78.

13.)  Judith R. Schmal - Nov. 1971 to present, Supervisor, Clinical Chemistry Section of Bioanalytical Laboratory.

14.)  Judith A. Beauchamp - Employed Aug, 1970 to present; Supervisor Hematology laboratory since April 1973.

15.)  Barbara (Ross) Bickford - Research Technician, Quality Control Department.  She performed analyses of DKP diet mixtures for study E-77/78.

16.)  Clifford J. Seul - Supervisor, Method Development, Stability Evaluation Laboratory.  He was Barbara Bickford's supervisor at the time the DKP stability study was performed.

17.) Jack Drogt - 1967 to present, Senior Research Assistant, Chemical Development.  Mr. Drogt manufactured the 7 lots of DKP used in the study E-77/78.

18.) Dr. John E. Dutt - Math-Stat. Dept.

19.) John Mellman, Math-Stat Dept.

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 responsible 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.

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 functions in the study are attached as Exhibit 12.