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PERSONS INTERVIEWED
Credentials were shown and a written Notice of Inspection was issued to Dr. William M. Merino, Directory, Domestic Pharmaceutical Products, Regulatory Affairs Department on April 25, 1977. The following Searle personnel were present at the initial meeting on 4-25-1977.
Robert A. Moe, PhD. - Executive Vice-President
George Clay, PhD. - Group Leader, CNS Pharmacology
Robert Bost, PhD. - Director of Food Products, Regulatory Affairs
Holly Ru Probst - Director, Corporation Information Management Group.
Dave Britton - Director Corporation Information Department
William Merino, PhD. - Director, Domestic Pharmaceutical Products
Richard Viktora - Attorney
James Phelps - Vice-President, General Counsel
Elwood H. Ensor, PhD. - Vice-President
Paul Klimstra, PhD. - Vice-President Pre-Clinical Research and Development
Roger Thies - Attorney
During the course of our investigation one or more of the following Searle personnel were present in the Conference Room which we used for our data review.
Richard Viktora - Attorney
Roger Thies - Attorney
George Clay, PhD. - Group Leader, CNS Pharmacology
Robert Bost, PhD. - Director of Food Products Regulatory affairs
Don Cook, PhD. - Associate Director, Department of Bio Research
Dick Aspinol, PhD. - I. I. D. Group Leader
Bill Jenkins, PhD. - Director, Product Affairs
Fred McIlreath, PhD. - Director, Regulatory Affairs
Paul Landefeld, - Attorney
Most of the time one attorney (R. Viktora or R. Thies) and one scientist were present. During our initial meeting with Searle personnel, James Phelps stated that a Searle monitor must be with us at all times during our data review in order to "protect the data".
During the course of our investigation, various individuals were interviewed in an attempt to obtain all available raw data and reconstruct the manner in which the study was conducted, as accurately as possible. Since many employees involved in the study or support areas are no longer employed at Searle, others were interviewed who had general knowledge of such parameters as statistics and chemistry.
Significant interviews are attached as Exhibits, as referenced. Individuals interviewed were as follows:
1. Donna Helms - Administrative Assistant to Dr. McConnell on 5-18-77, 6-30-77 and 7/1/77 (Exh. #46).
2. Judith Beauchamp - Hematology Lab Supervisor on 6-2-77 (Exh. #47).
3. Barbara Bickford (Nee Ross) - Technician, Department of Analytical Research on 6-1-77 and 6-2-77 (Exh. #48).
4. Clifford J. Suel - Supervisor, Department of Analytical Research and Development on 6-2-77 (Exh. #49).
5. Bartolome R. Tangonan - Research Technician, Pathology Toxicology Department on 6-1-77 (Exh. #50).
6. Tony Martinez - Research Assistant and Toxicology Lab Supervisor on 5-19-77, 6-3-77, 7-7-77, 7-20-77 and 8-2-77 (Exh. #51).
7. Ted Reichert - Supervisory Systems Analyst on 5-24-77 (Exh. #52).
8. Phil Polli - Systems Analyst on 5-24-77 (Exh. #53).
9. Judith Schmal - Clinical Chemistry Section Supervisor on 6-2-77 and 6-7-77 (Exh. #54).
10. Jane Drury - Analytical Chemist, Bioanalytical Dept. 6-7-77.
11. Alan Mitchell - Teratologist on 7-20-77 (Exh. #56).
12. Raymond G. Schroeder - Former Searle Teratologist on 7-18-77 (Exh. #57).
13. Dr. Rudolph Stejskal - Pathologist on 6-23-77.
14. Patricia Erdenberger - Research Assistant and Histopathology Lab Supervisor on various dates (Exh. #58).
Dr. Robert McConnell, Pathology-Toxicology Advisor at the time of this study, was not directly involved with daily procedures. He is no longer employed at Searle.
An attempt was made to interview Dr. K. S. Rao, Monitor of Study P. T. #988S73 on 7-25-77. We were referred to Dr. Rao's attorney, who refused permission for an interview (see Jerome Bressler's memo dated 7-27-77, Exh. #33). |