Michael J - Purdue University



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

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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

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