Curriculum Vitae. Michael J. Schmidt, Ph.D.

Transcription

1 Michael J. Schmidt, Ph.D. Curriculum Vitae Last Corporate Responsibilities: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN Director of Quality Assurance for Medical, Toxicology and Drug Disposition, and Animal Science Research. Responsible for a staff of 45, including 3 Managers, 5 Administrative Assistants, and 37 Quality Assurance Representatives. Global coverage for Medical Quality Assurance in the U.S. and Canada, Europe, Central and South America, Africa and the Middle East, and the Asia Pacific Regions. Direct responsibility was general management. The Quality Assurance group s mission was to consult, educate and audit such that Lilly operations worldwide are in compliance with regulatory expectations and corporate quality objectives. Background Information: Place and of Birth Oshkosh, Wisconsin, U.S.A. June 13, 1942 Family Status Married to Barbara A. Schmidt, 32 years Four daughters and 6 grandchildren Education University of Wisconsin Madison, WI B.S. Biology and Psychology, 1964 University of Missouri School of Pharmacy Kansas City, MO M.S. Pharmacology, 1968 Vanderbilt Medical School Nashville, TN Ph.D. Pharmacology, 1971 National Institutes of Health Bethesda, MD Post-Doctoral Neurochemistry in the Pharmacology Research Associate Training Program, 1973 Awards/Honors: Governor s Sagamore of the Wabash Award for community service in Science Education in Indianapolis, 1999 Caulder Award for Creativity, Indianapolis, 1998

2 Hoosier Capitol Girl Scouts Community Service Leader Award, Indianapolis, 1998 Pharmacology Research Associate Training Program Fellowship at the National Institute of Health, 1971 Grass Instruments Fellowship to the Marine Biological Laboratories at Woods Hole, Massachusetts, 1969 University of Wisconsin Alumni Scholarship, 1960 Positions Held: Eli Lilly and Company, Indianapolis, IN Director, Quality Assurance (Medical, Toxicology and Drug Disposition, Animal Science Research) Eli Lilly and Company, Greenfield, IN Director, Pathology and Toxicology Director, Pathology and Developmental Toxicology Director, Toxicology Eli Lilly and Company, Indianapolis, IN Director, Division of CNS, Endocrine and Gastrointestinal Research and Animal Care Services, Director, Division of Cardiovascular, CNS and Endocrine Research and Animal Care Services, Director, Division of CNS and Endocrine Research and Animal Care Services, Head, Department of CNS and Endocrine Research and Animal Care Services, Head, Department of Physiological Research, Research Scientist, CNS Research, Senior Pharmacologist, CNS Research, National Institutes of Health Bethesda, MD Post-Doctoral Fellow, Marine Biological Laboratories Woods Hole, MA Summer Research Fellow, Vanderbilt Medical School Nashville, TN Ph.D. Graduate Student, University of Missouri School of Pharmacy Kansas City, MO M.S. Graduate Student, University of Wisconsin Madison, WI Research Technician, Wisconsin Regional Primate Center, Training and Personal Development Programs: New Managers Program Leadership and Group Dynamics

3 Evaluation of Suggestions Management Appraisal and Coaching Advanced Management Conf. in Results Through People Fostering Innovations Managing P.E. Teams Introduction to the Macintosh Toxicology Topics Overview of SOP Requirements Good Laboratory Practices (GLP) Training Diversity Training Covey Leadership Training International Good Clinical Practices (GCP) Training Academic and Teaching Appointments: Visiting Professor, School of Industrial and Physical Pharmacy, Purdue University, Consultant in Quality and Compliance, Indiana University, 2001 Guest lecturer in Graduate Neuropharmacology, Indiana University School of Medicine, 1979 Guest lecturer in Contemporary Biology, Indiana University, 1977 Guest lecturer in Graduate Neurochemistry at the Institute of Psychiatric Research, Indiana University School of Medicine, Organized and conducted a tutorial course, Cyclic AMP in the Nervous System for post-doctorates at the N.I.H., Professional Society Memberships (Current and Past): American Society for Neurochemistry International Society for Neurochemistry American Society for Pharmacology and Experimental Therapeutics Midwest Regional Chapter Society of Toxicology American Association of Laboratory Animal Science Society for Neuroscience; (President of Indianapolis Chapter, ) Midwest Society of Quality Assurance Society of Quality Assurance Bioresearch Monitoring Committee of the Pharmaceutical Research and Manufacturers Association (PhRMA) (Chairperson and Member of Steering Committee) Professional Activities: Chair, PhRMA Bioresearch Monitoring Committee Conference, Drug Discovery Management Subsection Committee, Pharmaceutical Manufacturers Association, Chair, Science Education Outreach Committee, Eli Lilly and Company, Chairperson of the K -12 Science Education Initiative, Pharmaceutical Manufacturers Association Task Force, 1994 Co-chairman, Winter Conference on Brain Research Fellowship Program, Institutional Animal Care and Use Committee, Eli Lilly and Company, Ph.D. Thesis Committee, University of Texas, San Antonio, TX, 1988 Editorial Advisory Board; Drug Development Research,

4 Editorial Advisory Board; Journal of Neurochemistry, Editorial Advisory Board; Neurobiology of Aging, Ad Hoc Reviewer; Brain Research Science Journal of Pharmacology and Experimental Therapeutics Life Sciences Journal of Neurochemistry Miscellaneous Corporate Responsibilities: Research representative for licensing activities in Japan Research liaison and design planner on two new biomedical research buildings Advocated, designed and managed the Lilly Post-Doctoral Program Chairman of the corporate long-term employee and retiree banquet (reporting to the CEO) Youth Educational Activities: NASA Space Biology Museum Network Board of Advisors Organization Lilly Research Laboratories Science Education Coordination Committee, founding member and chairman Pharmaceutical Manufacturers Association K-12 Educational Initiatives Meeting: Organizer and session leader: Corporate Partnership in Educational Outreach Purdue Educational Outreach Advisory Board, Girl Scouts of America: American Association for the Advancement of Science & Lilly Research Laboratories Partnership on Math and Science for Young Women, Corporate Liaison Lilly Science Explorer Post, Boy Scouts of America, Management Coordinator Use of Animals in Research Outreach Talk, Careers in Science Outreach Talk, Preparation and Presentation Community Involvement: Science Education Foundation of Indiana, Board Member, 1993-Present; chairman Boys & Girls Clubs of Indianapolis, Board Member, Boys & Girls Clubs of Noblesville, Board Member, Ruth Lilly Center for Health Education, Board Member, Youth Ministries Instructor, St. Luke s United Methodist Church, Carmel Dad s Club Softball Coach (15 years) Commission on Adult Ministries, Chairman, St. Luke s United Methodist Church, United Way, Small Business Giving Coordinator, Marion County Council on Aging, Publications: Available upon request. Symposia Participation and Invited Lectures: SCHMIDT, M. J. (1970). The role of cyclic AMP in the nervous system. 1st Annual Meeting of American Society for Neurochemistry. Albuquerque, NM.

5 SCHMIDT M. J. (1971). International conference on the physiology and phamacology of cyclic AMP. Milan, Italy. SCHMIDT, M. J. (1972). Local hormones and second messengers in nervous systems. Winter Conference on Brain Research. Vail, CO. SCHMIDT, M. J. (1973). The psychopharmacology of aging. Duke University. Durham, NC. SCHMIDT, M. J. (1977). The neuropharmacology of cyclic nucleotides. Fall Pharmacology Meeting. Columbus, OH. SCHMIDT, M. J. (1980). Conference on the biological mechanisms in aging. National Institute on Aging. Bethesda, MD. SCHMIDT, M. J. (1980). Symposium on brain neurotransmitters and receptors in aging and age-related disorders. Houston, TX. SCHMIDT, M. J. (1980). New insights into the neurochemistry of aging. Winter Conference on Brain Research. Keystone, CO. SCHMIDT, M. J., FULLER, R. W., AND WONG, D. T. (1987). Fluoxetine, a highly selective serotonin reuptake inhibitor: A review of preclinical studies. Fluoxetine Symposium. Telfs, Austria. SCHMIDT, M. J. (1990). Preservation and promotion of the dual ladder system in the Lilly Research Laboratories. Pharmaceutical Manufacturers Association Fall Meeting. Boca Raton, FL. SCHMIDT, M. J. (1991). Judging the bet in research: assessing research productivity. Pharmaceutical Manufacturers Association Fall Meeting. Philadelphia, P A. SCHMIDT, M. J. (1993). When to quit.., the ultimate decision. Institute for International Research- Pharmaceutical Division. Washington, D.C. SCHMIDT,M.J. (1994). Total Quality Management in the Clinical Trial Process,. Barnett International Conference SCHMIDT, M.J. (1994). From Audits to Improvements. Barnett International Conference, Arlington, VA. SCHMIDT,M.J. (1996). The Role of the Quality Assurance Unit (QAU) in the Clinical Trial Cost Management Program. Barnett International. Philadelphia, FA. SCHMIDT,M.J. (1996). Data Quality Integrity Symposia. PhRMA-FDA Rockville, MD. SCHMIDT,M.J. (1997). Joint Biostatistics & Clinical Data Management Workshop. PhRMA-FDA, Baltimore, MD. SCHMIDT, M.J. (1999). Enhancing Clinical Trial Site Quality and Compliance. Duke Clinical Investigator Training Program. Durham. NC. SCHMIDT, M.J. (2000). Enhancing Clinical Trial Site Quality and Compliance. Michigan Clinical Investigator Training Program. Ann Arbor, MI. SCHMIDT, M.J. (2000). Preventing, Detecting, and Handling Persistent Non-Compliance, Scientific Misconduct and Fraud. Midwest Regional Chapter of the Society for Quality Assurance 2000 Summer Meeting. New Harmony, IN. SCHMIDT, M.J. (2000). Detecting, Correcting, and Preventing Serious and Persistent Non- compliance

6 and Scientific Misconduct. National Society for Quality Assurance 2000 Fall Meeting, SCHMIDT, M.J. (2000). FDA- Industry Partnering: Mission... Vision...Action. National Society for Quality Assurance 2000 Fall Meeting. Invited Academic Seminars: University of Oklahoma School of Pharmacy University of Michigan Medical School Vanderbilt Medical School Chemical Industry Institute of Toxicology Cornell Medical School University of Kentucky Medical School Northwestern University Indiana University Medical School Purdue University N.I.M.H. - St. Elizabeth s Hospital Florida State University School of Pharmacy University of Missouri at Kansas City University of Texas Health Science Center at Houston University of Texas Health Science Center at San Antonio National Institutes of Aging (End) Michael J. Schmidt. Ph.D. (Biography Summary) February 2006 Michael J. Schmidt was born in Oshkosh Wisconsin and attended the University of Wisconsin at Madison, graduating in 1964 with a major in biology and psychology. He worked at the University of Wisconsin Primate Center for 2 years and then entered the graduate program in pharmacology at the University of Missouri at Kansas City, School of Pharmacy. He received a Masters degree in Pharmacology in He then was accepted into the Ph.D. program in pharmacology at Vanderbilt Medical School, graduating in His focus was brain research and drugs affecting the central nervous system. Dr. Schmidt took postdoctorial training in neurochemistry in the Laboratory of Cerebral Metabolism at the National Institutes of Health in Bethesda, Maryland. He then began work as a basic research discovery scientist in pharmacology at Eli Lilly and Company in Indianapolis, Indiana. During his 28-year career at Lilly, Dr. Schmidt moved from the laboratory to hold a number of management positions in the areas of drug discovery research, toxicology, and worldwide quality assurance for pre-clinical and clinical studies. Dr. Schmidt has contributed over fifty full publications to the scientific literature, several book chapters, and numerous abstracts from presentations at scientific meetings. He has chaired meetings in both the research and quality assurance arenas. Professional associations include the Society for Neuroscience, the American Association for Neurochemistry, the American Society for Pharmacology and Experimental Therapeutics, the International Society of Neurochemistry, the Drug Discovery Section of the Pharmaceutical Research and Manufacturers Association (PhRMA), and the Society for Quality Assurance. He was the chairperson of the Bioresearch Monitoring Subsection (QA) of PhRMA. Michael has long been committed to community service and youth education. He was the originator and chairperson of the K-12 Science Education Coordination Committee of Eli Lilly and Company and worked extensively within the drug manufacturing industry to promote science outreach to youth in local communities. Dr. Schmidt served on the board of the Science Education Foundation of Indiana (SEFI), which sponsors the Indiana State Science Fair. He was on the board of the Ruth Lilly Science Center, volunteers as an advisor to the science and youth programming for the Girls Scouts of America (Indianapolis Council), and was a board member of the Indianapolis Boys and Girls Club. In the latter

7 organization, he was instrumental in expanding the camp program to include nature study, science, and experimentation. Recently, he was invited to serve as an advisor on the Space Biology Museum Network, a NASA-based organization. Dr. Schmidt has received numerous recognition awards from organizations for his volunteerism, including the prestigious Sagamore of the Wabash award, presented by the Governor of the State of Indiana for his accomplishments in youth and science education. Dr. Schmidt retired from Eli Lilly in 2001 and became a part-time faculty member at Indiana University, consulting in the areas of quality and compliance. Presently he is a visiting professor at Purdue University and a co-director and lecturer in the Regulatory and Quality Compliance Graduate Certificate and Masters Degree Programs. Periodic consulting assignments in the pharmaceutical industry also occupy Dr. Schmidt. In June of 2002, he formed and launched a youth-education company called Dr. Bones Education- Indianapolis, Inc. to carry his message of the wonder of the body and the beauty of bones, skulls, and skeletons to youth and adults.