Michael J
Michael J. Schmidt
1067 Red Maple Way 1127 Maplewood Road
New Smyrna Beach, Fl, 32168 Williamston, Vt., 05679
386-478-1912 802-433-6114
(October-May address) (June-September address)
drbones5000@ Cell phone 386-690-7242
----------------
Michael J. Schmidt. Ph.D.
(Biography Summary)
June 2007
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 two 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 1968. He then was accepted into the Ph.D. program in pharmacology at Vanderbilt Medical School, graduating in 1971. His focus was brain research and drugs affecting the central nervous system. Dr. Schmidt took post-doctorial 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 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 Board, 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. He was a member of the university’s compliance committee. In that capacity he conducted an Organization Compliance Risk Assessment in departments throughout the university. He also coordinated the development of the Clinical Research Standard Operating Policies and Procedures within the Medical School.
Presently Michael 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.
His book Start’em Right-Keep‘em Playing (“How to Coach a Team of Young Ball Players”) will soon be published by iUniverse Publishers.
Dr. Schmidt has been married to his wife Barbara for 33 years. They have four daughters and seven grandchildren. The Schmidts reside in Florida during the winter and in a cabin in the forest in Vermont in the summer. Retirement includes golf, riding, rowing, archery, and grandchildren.
(End)
Michael J. Schmidt
1067 Red Maple Way 1127 Maplewood Road
New Smyrna Beach, Fl, 32168 Williamston, Vt., 05679
386-478-1912 802-433-6114
(October-May address) (June-September address)
Drbones5000@ Cell Phone 386-690-7242
Curriculum Vitae Michael J. Schmidt, Ph.D.
(June 2, 2007)
Last Corporate Responsibilities:
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285
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 and Animal Research 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, 33 years
Four daughters and 7 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
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 1994 – 2001
(Medical, Toxicology and Drug Disposition, Animal Science Research)
Eli Lilly and Company, Greenfield, IN
Director, Pathology and Toxicology 1993-1994
Director, Pathology and Developmental Toxicology 1992-1993
Director, Toxicology 1990-1992
Eli Lilly and Company, Indianapolis, IN
Director, Division of CNS, Endocrine and Gastrointestinal Research and Animal Care Services, 1989-1990
Director, Division of Cardiovascular, CNS and Endocrine Research and Animal Care Services, 1986-1989
Director, Division of CNS and Endocrine Research and Animal Care Services, 1983-1986
Head, Department of CNS and Endocrine Research and Animal Care Services, 1981-1983
Head, Department of Physiological Research, 1978-1981
Research Scientist, CNS Research, 1977-1978
Senior Pharmacologist, CNS Research, 1973-1976
National Institutes of Health
Bethesda, MD
Post-Doctoral Fellow, 1971-1973
Marine Biological Laboratories
Woods Hole, MA
Summer Research Fellow, 1969-1970
Vanderbilt Medical School
Nashville, TN
Ph.D. Graduate Student, 1967 -1971
University of Missouri School of Pharmacy
Kansas City, MO
M.S. Graduate Student, 1965-1967
University of Wisconsin Madison, WI
Research Technician, Wisconsin Regional Primate Center, 1963-1965
Training and Personal Development Programs:
New Managers Program
Leadership and Group Dynamics
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, 2002- present
Masters Degree Project Review and Approval Committee, Purdue University, 2002-present
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, 1975-1977
Organized and conducted a tutorial course, “Cyclic AMP in the Nervous System” for post-doctorates at the N.I.H., 1972-1973
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, 1976-1977)
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, 1998-2000
Drug Discovery Management Subsection Committee, Pharmaceutical Manufacturers Association, 1990-1993
Chair, Science Education Outreach Committee, Eli Lilly and Company, 1990-2001
Chairperson of the K -12 Science Education Initiative, Pharmaceutical Manufacturers Association Task Force, 1994
Co-chairman, Winter Conference on Brain Research Fellowship Program, 1985-1994
Institutional Animal Care and Use Committee, Eli Lilly and Company, 1980-1992
Ph.D. Thesis Committee, University of Texas, San Antonio, TX, 1988
Editorial Advisory Board; Drug Development Research,
Editorial Advisory Board; Journal of Neurochemistry, 1978-1981
Editorial Advisory Board; Neurobiology of Aging, 1976-1977
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, 1991-1996
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
Community Involvement:
Science Education Foundation of Indiana, Board Member, 1993-Present; chairman 1997 -2001
Boys & Girls Clubs of Indianapolis, Board Member, 1994-2004
Boys & Girls Clubs of Noblesville, Board Member, 1996-1998
Ruth Lilly Center for Health Education, Board Member, 1996-1997
Youth Ministries Instructor, St. Luke’s United Methodist Church, 1987-1989
Carmel Dad’s Club Softball Coach (15 years)
Commission on Adult Ministries, Chairman, St. Luke’s United Methodist Church, 1985-1987
United Way, Small Business Giving Coordinator, 1980-1981
Marion County Council on Aging, 1977-1980
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.
SCHMIDT M. J. (1971). “International conference on the physiology and pharmacology 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 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.
SCHMIDT, M.J. (2006). “Conducting Contract Research Successfully: Strategies and Actions”. Midwest Chapter of the Society for Quality Assurance 2006 Meeting. Indianapolis, IN.
Lectures at Purdue University
“The Philosophy and Principles of Inspections and Audits”
“Good Auditors/Bad Auditors…Good Managers/Bad Managers”…a lecture and group exercise
Auditing Exercise: A GLP Toxicology Study Audit
Auditing Exercise: A GCP Clinical Site Audit
“Effective Follow-up After Audits: Principles and Practice”…a lecture and group exercise
“Detecting, Dealing with and Preventing Fraud in Research”
“Therapeutic Drug Use in America and the Role of the Pharmaceutical Industry”
“Conceptualizing, Creating, Copying…and Hoping and Coping to be First: An Overview of the Drug Discovery Process and the Players”
“Discovery Biologists: Who Are They & Their Roles and Responsibilities: Technologies for Drug Candidate Searching and Screening”
“Biotechnology-derived Drug Candidates: Development Considerations”
“The Organization and Administration of Clinical Research: The Sponsor Company”
“Contracting Research in Drug Development: Effective Practices”
“Marketing and Sales: Roles and Responsibilities in Drug Development”
“Making the Product Decision: A Pivotal Point in Drug Development”
“When to Quit…The Ultimate Decision”…a lecture and group exercise
“An Overview of the Drug Discovery, Development and Registration Process and the Documents and Dialogues Involved”
“Preclinical Animal Research: The Documents and Dialogues”…a lecture and group exercise
“Clinical Research: Documents and Dialogues-The Study Protocol” ”…a lecture and group exercise
“Clinical Research: Documents and Dialogues-The Informed Consent Document” ”…a lecture and group exercise
“Clinical Research: Data Collecting and Reporting”
“Clinical Research: A Clinical Investigators’ Start-up Meeting” ”…a lecture and group exercise
“A GLP Wreck: High Road or Low Road”…a case study and group exercise
“A GCP Wreck: High Road or Low Road”…a case study and group exercise
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)
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