Eastern Michigan University

Irwin Martin

Associate Professor

martin 206-C Marshall Bldg

734.487.2512

imartin2@emich.edu

Education

Selected Courses (1982-1983) - Drexel University, College of Business and Administration
Selected Courses (1981-1982) - The Wharton School, University of Pennsylvania
PhD, Zoology (1980) - University of Massachusetts, Amherst
MS, Zoology (1977) - University of Massachusetts, Amherst
BA, Biology, Environmental Studies (1974) - Brandeis University

Teaching Interests

Selected Presentations and/or Publications

Presentations

  • "Dialogues Between Companies and the FDA," at the DIA workshop, First Workshop in Japan for Drug Regulatory Affairs, Tokyo, September 2004.
  • Program Chair, DIA workshop, "Overview of the Pharmaceutical Industry: An FDA-Industry Dialog on the Drug Development Process." Bethesda, MD, February 2003.
  • "What You Should Know About FDA Clinical Investigator Site Inspections in Your Country," at the 2002 ARCS Australia Conference, "Success Through Innovation," Sydney, Australia, July 2002.
  • Program Summary (Industry), DIA workshop, "Effective Agency/Industry Interactions to Expedite Drug Development."  Bethesda, MD, May 2002.
  • Speaker and Panelist, "Industry Board Members Speak on Corporate Governance Issues," Lawrence Technological University, Southfield, MI, April 2002.
  • Program Chair, DIA workshop, "Overview of the Pharmaceutical Industry: A TPD-Industry Dialog on the Drug Development Process." Ottawa, ON, March 2002.
  • Panelist, "Pharmaceutical Specialist Education Models," Basel, Switzerland, March 2002.
  • "The Presence of DIA in Latin American Clinical Research," at the First Latin American Congress of Clinical Research, Mexico City, February 2002.
  • Program Chair, DIA workshop, "Overview of the Pharmaceutical Industry: An FDA-Industry Dialog on the Drug Development Process." Bethesda, MD, November 2001.
  • Session Chair, "Electronic Labeling: Update" and "Comparative Regulatory Policies and Philosophies: Dossier Review in Europe and the United States" at the Drug Information Association (DIA) Annual Meeting, Denver, July 2001.
  • "Efforts to Develop a Paperless System for Pharmaceutical Labeling," at the Healthcare Compliance Packaging Council National Symposium on Patient Compliance, Philadelphia, May 2001.
  • "Paperless Drug Labels: A Reality?" at the PhRMA Scientific and Regulatory Section Meeting, "Challenges Facing the Post Genomics Revolution: A New Age of Drug Discovery and Development," Washington, May 2001.
  • "An Industry Perspective on Drug Development, Drug Marketing and Working with CDER," at the FDA/DIA/RAPS/CDDS workshop, "An Introduction to the Center for Drug Evaluation and Research: CDER 101", Washington, May 2001.
  • "Changing the Paper Paradigm: Benefits of E-Labeling in the Near and Medium Term," at the DIA workshop, 2001: An Information Odyssey.  Navigating Customer Relations, Information Architecture, e-Records, Genomics and the Web, Hilton Head Island, SC, April 2001.
  • Program Chair, DIA workshop, "Overview of the Pharmaceutical Industry: An FDA-Industry Dialog on the Drug Development Process." Bethesda. MD, April 2001.
  • "Global Initiatives for Agency and Sponsor Collaboration:  Paperless Labeling," at the DIA conference, Electronic Document Management: Collaboration Across the Virtual Community, Philadelphia, February 2001.
  • "Preparing for and presenting to an FDA Advisory Committee," at the DIA workshop, West Coast Data Management and Statistics:  A Focus on Emerging Companies, San Francisco, December 2000.
  • Program Chair, DIA workshop, "An Overview of the Pharmaceutical Industry for the Regulatory Agency Manager and Reviewer: The Drug Development Process, the Drug Life Cycle and the People Who Manage Them." Bethesda, MD, November 2000.
  • "Overview of the FDA in 2000," at the Drug Information Association Conference with the Ibero-American Regulatory Authorities, San Jose, Costa Rica, September 2000.
  • "Changing the Paper Paradigm: Electronic Provision of Prescriber Information to Pharmacists," at the Twelfth Annual Meeting of the American Society for Automation in Pharmacy, Palm Beach, Florida, September 2000.
  • Regulatory Affairs Area Chair and Session Chairman, "Comparative Regulatory Agency Policies and Reviews" at the Drug Information Association (DIA) Annual Meeting, San Diego, June 2000.
  • Program Chair, DIA workshop, "An Overview of the Pharmaceutical Industry for the Regulatory Agency Manager and Reviewer: The Drug Development Process, the Drug Life Cycle and the People Who Manage Them" (Pilot Program).  Bethesda, MD, May 2000.
  • Program Committee and Sub-Team Leader and Speaker, Joint FDA and DIA Project Management Training Workshop, Bethesda, MD, May 2000.
  • "Changing the Paper Paradigm: Electronic Provision of Professional Labeling to the Pharmacist and other Health Care Providers," at the DIA workshop on electronic document management, Philadelphia, February 2000.

And over 25 other earlier presentations not listed above.

Publications

Pharmaceutical Development

  • Martin, I.G., S.R.K. Thottempudi and D.A.C. Frattarelli. 2013. Changes to Prescription Drug Pediatric Labeling: Awareness by Practicing Pediatricians. Therapeutic Innovation and Regulatory Science 47(2): 214-218.
  • Garimella, P. and I.G. Martin.  2013. Influence of Clinical Research Investigator Fraud on Clinical Trial Participation. Therapeutic Innovation and Regulatory Science 47(1): 90-94.
  • Daggumalli, J.S.V. and I.G. Martin.  2012. Are Pharmaceutical Market Withdrawals Preventable: A Preliminary Analysis. Drug Information Journal 46(6): 694-700.
  • Yadlapalli, J.S.K.B. and I.G. Martin.  2012.  Seeking predictable subject characteristics that influence clinical trial discontinuation.  Drug Information Journal 46(3): 313-319.
  • Zakaryan, A. and I.G. Martin.  2012.  Regulation of herbal dietary supplements: Is there a better way?  Drug Information Journal 46(5): 532-544.
  • Martin, I.G. 1998. Electronic Labeling: A Paperless Future?  Drug Information Journal, 32(4): 917-919.
  • Martin, I.G. and B.J. Clark.  1988.  A computerized system for clinical investigator data and release of clinical supplies.  Clin. Pharmacol. Ther., 43:169.

Zoology

  • Martin, I.G. 1980.  "Homeochemic":  Intraspecific chemical signal.  Journal of Chemical Ecology, 6:517-519.
  • Martin, I.G. 1980.  An ethogram of captive Blarina brevicauda.  American Midland Naturalist, 104:290-294 (Erratum, 105:416).
  • Martin, I.G. 1981.  The behavior of the short-tailed shrew, Blarina brevicauda, in captive and simulated natural conditions.  Dissertation Abstracts International, 41:2927B (University Microfilms No. 81-01359).
  • Martin, I.G. 1981.  Venom of the short-tailed shrew (Blarina brevicauda) as an insect immobilizing agent.  Journal of Mammalogy, 62:189-192.
  • Martin, I.G. 1981.  Tolerance of conspecifics by short-tailed shrews (Blarina brevicauda) in simulated natural conditions.  American Midland Naturalist, 106:206-208.
  • Martin, I.G. 1982.  Maternal behavior of a short-tailed shrew (Blarina brevicauda).  Acta Theriologica, 27:153-156.
  • Martin, I.G. 1983.  Daily activity of short-tailed shrews (Blarina brevicauda) in simulated natural conditions.  American Midland Naturalist, 109:136-144.
  • Martin, I.G. 1984.  Factors affecting food hoarding in the short-tailed shrew.  Mammalia, 48:65-71.
  • Martin, I.G. 1987.  The untameable shrew.  Massachusetts Wildlife, 37(1):27-30.
  • Martin, I.G. 1998. Electronic Labeling: A Paperless Future? Drug Information Journal, 32(4): 917-919.
  • Martin, I.G. and G.K. Beauchamp. 1982.  Olfactory recognition of individuals by male cavies (Cavia aperea).  Journal of Chemical Ecology, 8:1241-1249.
  • Beauchamp, G.K., I.G. Martin, C.J. Wysocki and J.L. Wellington.  1982.  Chemoinvestigatory and sexual behavior of male guinea pigs following vomeronasal organ removal.  Physiology and Behavior, 29:329-336.
  • Beauchamp, G.K., C.J. Wysocki, J.L. Wellington and I.G. Martin.  1982.  Chemical communication and the accessory olfactory system in guinea pigs.  In:  The Determination of Behavior by Chemical Stimuli:  Proceedings of the Fifth European Chemoreception Research Organization Symposium.  (Jerusalem, November, 1981.)  J.E. Steiner and J.R. Ganchrow, Eds. IRL Press, London.
  • Beauchamp, G.K., I.G. Martin, J.L. Wellington and C.J. Wysocki.  1983.  The accessory olfactory system: Role in maintenance of chemoinvestigatory behavior.  In:  Chemical Signals in Vertebrates.  Vol. 3.  D. Muller-Schwarze and R.M. Silverstein, Eds.  Plenum, New York, p. 73-86.    
  • Zechman, J.M., I.G. Martin, J.L. Wellington and G.K. Beauchamp.  1984.  Perineal scent gland of wild and domestic cavies:  Bacterial activity and urine as sources of behaviorally significant odors.  Physiology and Behavior, 32:269-274.

Additional Information

Professional Experience

Equestrian Holdings, LLC: Owner/Manager, Walnut Hill Farm, Horse Boarding and Training Facility (2003 - present)

Drug Information Association (www.diahome.org): Acting Executive Director, (2003 - 2005), Associate Executive Director, (2003)

FIP Consulting, LLC: Principal, (2001 - 2002)

Pharmaceutical Regulatory Affairs: Consultant (2000 - 2002)

Parke-Davis Pharmaceutical Research Division, Warner-Lambert Company: Vice-President, International Regulatory Affairs, Worldwide Regulatory Affairs (1999 - 2000); Vice-President, FDA Liaison, Worldwide Regulatory Affairs, (1994-1999); Senior Director, Worldwide Regulatory Affairs, (1991-1994); Director, Worldwide Regulatory Affairs, (1990-1991)

The Squibb Institute for Medical Research, Bristol-Myers Squibb Company: Director, U.S. Regulatory Liaison, (1989-1990)

Smith Kline & French Laboratories, Smith-Kline Backman Corporation: Director, Regulatory Affairs, (1986-1988); Associate Director, Regulatory Affairs, (1985); Manager, Anti-Infective Group, Regulatory Affairs, (1983-1985); Management Associate, (1982-1983)

Affiliations and Professional Associations

American Association for the Advancement of Science (1977-2005)

American Society of Association Executives (2003-2005)

Delaware Valley Society of Association Executives (2003-2005)

Drug Information Association (1983-Life): Immediate Past-President (2002), President (2001-2002), President-Elect (2000-2001), Board of Directors (1997-2000), Annual Meeting, Program Chair (1997), Annual Meeting Program Committee, Regulatory Area Chair (1998, 1999, 2000), Annual Meeting Program Committee, Regulatory Track (1995, 1996)

DIA Foundation (Board of Directors: 2002-2005): Chairman Board of Directors (2002), Acting President (2003-2005)

Food and Drug Law Institute (2000-2002)

Regulatory Affairs Professionals Society (1983-2006)

Regulatory PERI Professional Development (PPD) Steering Committee (1995-1998; Founding Chair, 1995-1997)

PhRMA/FDA Computer Assisted NDA Working Group (1992-1995)

PhRMA International Regulatory Affairs Committee (1999-2000)

PhRMA Electronic Regulatory Submission Working Group (1996-1999)

PhRMA Electronic Labeling Task Force (1996-2000)

PhRMA Paperless Labeling Task Force, Chair (1998-2000; 2001-2002): Adjunct member of

PhRMA Regulatory Affairs Coordinating Committee (1998-2000)

Sigma Xi, The Scientific Research Society (1978-2003)

Tufts Center for the Study of Drug Development R&D Advisory Panel (1999-2000)

University of Pennsylvania Alumni Career Network (1982-2005)

Other Academic Affiliations

Clinical Assistant Professor of Pharmacy, College of Pharmacy, University of Michigan (1994-2002) Lecturer, Medicinal Chemistry 625: Drug Discovery and Development

Clinical Associate, Department of Associated Health Professions, College of Health and

Human Services, Eastern Michigan University, 2000 - 2002

Other Work Experience

Staff Scientist, Monell Chemical Senses Center, University of Pennsylvania, 1980-1982

Mental Health Worker, Framingham Union Hospital (Massachusetts), 1974-1975

Mental Health Worker, The Waltham Hospital (Massachusetts), 1973-1974

The School of Health Sciences is part of the College of Health & Human Services, 303 Everett L. Marshall Building, 734.487.0077