Michael J. Whitekus, Ph.D., DABT Toxicology & Drug Safety Expert

Michael J. Whitekus, Toxicology & Drug Safety Expert

Dr. Michael Whitekus is a board certified toxicologist, with advanced degrees in chemistry and toxicology, and over 25 years of academic and industry experience. He has extensive expertise evaluating adverse drug and alcohol events and regularly performs forensic toxicology causation analyses on alcohol, prescription, over-the-counter, and illicit drugs, chemicals, inhaled particles/gases, pesticides, solvents, metals, and environmental contaminants. Dr. Whitekus applies his expertise in toxicology towards resolving civil and criminal disputes involving toxic or chemical agents.

Dr. Whitekus has held various key toxicology positions in industry, most recently working at Pfizer, Inc. as a drug safety team lead and senior study director. As a drug safety expert Dr. Whitekus has authored or reviewed ~180 drug safety reports, authored or contributed to FDA investigational new drug applications and new drug applications (INDs/NDAs), and has evaluated numerous drugs (e.g., Lyrica® and Milnacipran®) in multiple therapeutic areas including allergy, vaccine development, infectious disease, oncology, the central nervous system, the cardiovascular system, metabolic disease (diabetes), and inflammation. As a study director Dr. Whitekus oversaw laboratory operations for the drugs he evaluated. Prior to working at Pfizer, Dr. Whitekus was a laboratory director at BioReliance and provided leadership critical to drug safety evaluation and oversaw laboratory operations for the drugs he evaluated. Dr. Whitekus completed postdoctoral training at the UCLA School of Medicine's Clinical Immunology and Allergy department in conjunction with the Southern California Particle Center and Supersite.

Dr. Whitekus received his undergraduate degree in chemistry and a Michigan provisional secondary teaching certificate (Chemistry/Math) from Eastern Michigan University (EMU). He then was awarded an MS degree in Chemistry from EMU and a PhD degree in molecular and cellular toxicology from Wayne State University. Dr. Whitekus is a graduate of the Borkenstein course on Alcohol and Highway Safety. He is a member of the Society of Toxicology, the Society of Forensic Toxicologists, the American College of Toxicologists, and the National Safety Council (Alcohol, Drugs, and Impairment Division).

Summary

Dr. Whitekus is a board-certified toxicologist, with 25+ years of experience, who regularly performs causation analyses on alcohol, drugs, chemicals, inhaled particles/gases, pesticides, solvents, metals, and environmental contaminants.

Professional Experience

Robson Forensic, Inc.

Associate

2014 to present

Provide scientific and technical investigations, analysis, reports, and testimony toward the resolution of commercial and personal injury litigation of toxicology and human health assessments involving alcohol, prescription and recreational drugs, drugs of abuse, chemicals, toxicants, solvents, pesticides, metals, mold, food allergens, cosmetic products, environmental and occupational agents, related issues, and failure analysis.

Pfizer, Inc., Groton, CT

Drug Safety Team Lead, Toxicology

2008 to 2011
  • Worked on cross functional drug development teams in matrix environment and provide leadership critical for drug safety evaluation and de-risking strategies
  • Designed drug safety programs and studies consistent with ICH/FDA guidelines and under GLP/GMP requirements
  • Directed the initiation, execution and reporting of drug safety studies
  • Provided scientific and operational oversight on ~80 drug safety studies which included interaction with drug safety team lead, protocol generation, oversight of ~2-10 project personnel, execution of project, interpretation of data, written discussion of safety findings and drug safety report generation
  • Oversaw and participated in cross-departmental activities for CNS drug safety program
  • Presented/interpreted results of drug safety studies to program teams with go/no go decision
  • Participated in monthly training meetings on regulatory, toxicology, and drug safety issues
  • Evaluated toxicokinetic reports
  • Authored toxicology reports and contributed to pharmacology and toxicology sections of investigational new drug applications (INDs) and new drug applications (NDAs)
  • Invited participant and reviewer of Pfizer’s toxicology operational reorganization
  • Participated on Lyrica project team. Toxicological Sciences 128(1), 42-56 (2012)
  • Received 6 performance awards for scientific excellence, problem solving abilities and committee involvement

BioReliance Corporation, Rockville, MD

Laboratory Director, Toxicology

2005 to 2008
  • Provided scientific and operational oversight on ~120 drug safety studies which included interaction with client, protocol generation, oversight of 2-15 project personnel, interpretation of study results, discussion of any findings, and generation of drug safety report
  • Reviewed outsourced toxicokinetic reports
  • Provided toxicology advice to clients
  • Created two seminars (1 hour each) on carcinogenicity testing strategies at BioReliance and presented these at workshops around the country along with new scientific and regulatory developments
  • Represented BioReliance during FDA site inspections and provided written responses
  • Updated upper management via senior staff meetings on drug safety program progress
  • Institutional Animal Care and Use Committee (IACUC) scientific representative
  • Evaluated laboratories for compliance with internal SOPs and government regulations
  • Responsible for overseeing work of report writers, study technicians, chemists, pathologists, and outside company contractors. Oversaw work of 15 people

University of California Los Angeles

Assistant Researcher/Post-Doctoral Researcher Clinical Immunology and Allergy, UCLA School of Medicine

2000 to 2005

Emphasis: Inhalation Toxicology, Diesel Exhaust Particles, Allergy, Markers of Oxidative Stress, and Immunotherapy

  • Examined the role of oxidative stress as a potential marker of adverse health effects induced by diesel particulate matter
  • Responsible for study design, procurement and breeding of mice, inhalation treatment, dissection, measurement of in vitro immunological endpoints, data analysis, data presentation and publication of results
  • Journal Expert Peer Reviewer: Journals refereed included Clinical Immunology, Toxicological Sciences, Toxicology and Applied Pharmacology, Environmental Toxicology and Pharmacology
  • Invited to be on Toxicological Sciences editorial board in 2005
  • Oversaw breeding and genotyping of a knock-out mouse colony
  • Promoted to assistant researcher after ~3 years due to quality of work
  • Publication: J. Immunol. 168:2560-2567, 2002

Wayne State University, Detroit, MI

Ph.D. Degree, Institute of Chemical Toxicology

1995 to 2000
  • Hypothesis: Mercury causes autoimmune disease by attenuating CD95-mediated apoptosis
  • Mechanistically explored how mercury attenuates CD95-mediated apoptosis using numerous in vitro assays (western blot, fluorometric, colorimetric, and flow cytometry) on Jurkat and U-937 cell lines and human primary T cells
  • Selected Publications: J. Immunol. 162:7162-7170, 1999; Toxicol Appl Pharmacol.190 (2):146-56, 2003

Parke-Davis Pharmaceutical Research Division, Ann Arbor, MI

Assistant Scientist, Genetic Toxicology Department

1995
  • Evaluated the ability of drugs to cause DNA damage to cells
  • Conducted in vitro micronucleus experiments and evaluated results microscopically
  • Assisted in the maintenance of cell lines

MPI, Mattawan, MI

Metabolism and Bioanalytical Coordinator

1993 to 1994
  • Developed HPLC methods and quantitated drug and metabolite levels in animal plasma samples from drug safety studies
  • Supervised several BS chemists in HPLC lab

Eastern Michigan University, Ypsilanti, MI

Master of Science Degree

1991 to 1993
  • Thesis: Isolated RNA and used RT-PCR to develop a unique in vitro PCR assay system to evaluate testicular toxins
  • Evaluated HSP 27 and HSP 70 as potential markers of testicular toxicity

Teaching Experience

1991 to 1992

  • Eastern Michigan University, Ypsilanti, MI
    Graduate Teaching Assistant
    • Supervised undergraduate general chemistry, life science, and basic chemistry lab

1990

  • Gabriel Richard High School
    Student Teacher for Michigan State Secondary Provisional Certification (Chemistry/Math) Grades 7-12
    • Taught two high school chemistry classes and three high school math classes

Education

Ph.D., Molecular and Cellular Toxicology, Wayne State University, Institute of Chemical Toxicology, Detroit, MI, 2000

M.S., Chemistry (Emphasis in Toxicology) Eastern Michigan University, Ypsilanti, MI, 1993

B.S., Chemistry (Math minor), Eastern Michigan University, Ypsilanti, MI, 1991
Michigan State Secondary Teacher Certification (Chemistry/Math) Grades 7-12

Continuing Education

  • Impairment: A Look at Causes, Data, and Policies, Continuing education workshop organized by the American Academy of Sciences, Seattle, WA, February 2022
  • The Neurobiology and Toxicology of Aggression, Continuing education workshop organized by the American Academy of Sciences, Seattle, WA, February 2022
  • A Tale of Two CSIs, Continuing education course organized by the American Academy of Sciences, Seattle, WA, February 2022
  • Complications of Naloxone Reversals That Still Lead to Death, Organized by The Center for Forensic Science Research and Education, Webinar, 4 Feb 2022.
  • Method Validation of a Comprehensive Drug Screen Using Supported Liquid Extraction and LC/QTOF-MS, Organized by The Center for Forensic Science Research and Education, Webinar, January 2022.
  • Diplomate of the American Board of Toxicology Recertification, 2022-2026
  • The Robert F. Borkenstein course on Alcohol and Highway Safety: Testing, Research and Litigation. Indiana University: Center for Studies of Law in Action; Bloomington, IN, December 2021
  • The Evaluation and Certification of Drug Caused and Related Deaths for Pathologists, Toxicologists and Death Investigators: 2021 (Module III, 8 hours), December 1-2, 2021
  • The Evaluation and Certification of Drug Caused and Related Deaths for Pathologists, Toxicologists and Death Investigators: 2021 (Module II, 12 hours), October 27-29, 2021
  • The Impact of Cannabinoids on Health and Safety, Continuing education course organized by the Society of Forensic Toxicology, Nashville, TN, September 2021
  • Two-Faced Therapeutics, or PK/PD insights into “Bad Drug” Repositioning, Continuing Education course organized by the Society of Forensic Toxicology, Nashville, TN, September 2021
  • Current Trends in Forensic Toxicology Day 5 (3 hours) Cannabis, June 4, 2021
  • Oral Fluid II webinar organized by the Society of Forensic Toxicology, December 2020 Cannabis Impaired Driving Continuing Education webinar course organized by the Society of Forensic Toxicology, September 2020
  • Method Development, Continuing Education webinar course organized by the Society of Forensic Toxicology, September 2020
  • Oral Fluid webinar organized by the Society of Forensic Toxicology, July 2020
  • Current Trends in Forensic Toxicology (online webinar), June 2020
  • Achieving the Standard for Analytical Scope & Sensitivity Testing in Impaired Driving using Laminar Flow Tandem Mass Spec, (webinar), PerkinElmer, April 2020
  • Recommended Specimens, Scope, Cutoffs, and Strategies for DUI/D Testing & the Impact of Stop Limit Tests, Continuing Education course organized by the Society of Forensic Toxicology, San Antonio, TX, October 2019
  • Best Practices for Investigation of Overdose Deaths, Continuing Education course organized by the Society of Forensic Toxicology, San Antonio, TX, October 2019
  • Application of QTOF Techniques: Approaches and Workflows, Continuing Education course organized by the Society of Forensic Toxicology, San Antonio, TX, October 2019
  • ANAB ISO 17025: 2017 & ABFT Accreditation - Bridging the Gaps, Continuing Education course organized by the Society of Forensic Toxicology, San Antonio, TX, October 2019
  • Forensic Toxicology Board Certification Preparation Course, Organized by The Center for Forensic Science Research and Education, Webinar, Completed September 2019
  • Legal Cannabis: Medical, Toxicological, and Public Health Implications, Workshop organized by the American College of Medical Toxicology, San Francisco, CA, April 2019
  • The National Transportation Safety Board (NTSB): Understanding and Preventing
  • Impairment in Transportation, Workshop organized by the American Academy of Forensic Sciences, Baltimore, MD, February 2019
  • Pathology and Drug Related Deaths, Organized by The Center for Forensic Science Research and Education, Webinar, November 2018
  • Novel Psychoactive Substances Symposium, Organized by The Center for Forensic Science Research and Education, Philadelphia, PA, November 2018
  • Weaving Together the Toxicologist and the Drug Recognition Expert, Continuing Education course organized by the Society of Forensic Toxicology, Minneapolis, MN, October 2018
  • The Real C.S.I. Miami – A Collaborative Approach to Death Investigation with an Emphasis on
  • Investigative Postmortem Toxicology, Continuing education course organized by the Society of Forensic Toxicology, Minneapolis, MN, October 2018
  • DUID and Oral Fluid Workshop, Organized by the Society of Forensic Toxicologists, Inc., Albany, NY, June 2018
  • Virtual/Online Symposium: Current Trends in Forensic Toxicology, Forensic Science Education, May 2018
  • Postmortem Interpretive Toxicology; Organized by The Center for Forensic Science Research & Education; Philadelphia, PA, April 2018
  • Opioids, Toxicology, and the Law: Medical-Legal Aspects of the Opioid Epidemic; Organized by the American College of Medical Toxicology and the Society of Forensic Toxicologists; Philadelphia, PA, December 2017
  • Forensic Pharmacology, organized by the Center for Forensic Science Research & Education, June 2017
  • Certified as a Diplomate of the American Board of Toxicology, November 2016
  • Webinar Topic: Marijuana Legalization: Trends & Hot Topics, Occupational Health and Safety, February 2016
  • Marijuana Summit, Governor’s Council on Alcoholism and Drug Abuse, Cherry Hill, NJ, October 2015
  • Completed Advanced Comprehensive Toxicology Course sponsored by the American College of Toxicology, University of Cincinnati, August 2015
  • Safety Evaluation of CNS Administered Therapeutics. Society of Toxicology Continuing Education Course; San Diego, CA, March 2015
  • Advances in Safety Assessment of Medical Devices. Society of Toxicology Continuing Education Course; San Diego, CA, March 2015
  • The Robert F. Borkenstein Course on Alcohol and Highway Safety; Testing, Research and Litigation. Indiana University: Center for Studies of Law in Action; Bloomington, IN, December 2014
  • Current Strategies and Methods for Evaluating Drug-Induced Cardiovascular Toxicity. Society of Toxicology Continuing Education Course; Washington, DC, March 2011
  • The International Conference on Harmonisation Initiatives for Conducting Pharmaceutical Preclinical Safety Studies: New and Revised Guidelines and Challenges. Society of Toxicology Continuing Education Course; Salt Lake City, UT, March 2010
  • Principles and Applications of Toxicokinetics. Society of Toxicology Continuing Education Course; Baltimore, MD, March 2009
  • Practical Strategies for Evaluation of Immunosuppression in Pharmaceutical Development. Society of Toxicology Continuing Education Course; San Diego, CA, March 2006
  • Fundamentals of Risk Assessment and Applications of Recent Methodologies to Difficult Problems. Society of Toxicology Continuing Education Course; Salt Lake City, UT, March 2003
  • Evaluation of Immunomodulation in Safety Assessment. Society of Toxicology Continuing Education Course; Salt Lake City, UT, March 2003
  • A Practical Approach to Blood and Lymphoid Tissue (BLT) in Toxicology Assessments. Society of Toxicology Continuing Education Course; Nashville, TN March 2002
  • Pulmonary Immunotoxicology. Society of Toxicology Continuing Education Course; Philadelphia, PA, March 2000
  • In Vitro Methods for Evaluation Biokinetic Parameters for Risk Assessment. Society of Toxicology Continuing Education Course; New Orleans, LA, March 1999

Professional Presentations

  • 2021
    Presentation Title: “The combined Effect of Alcohol and THC on Driving Impairment”. Presented at the Society of Forensic Toxicology Annual meeting as part of an all-day workshop entitled “The Impact of Cannabinoids on Health and Safety,” 27 September 2021, Nashville, TN.
  • 2022
    Presentation Title:
    “The combined Effect of Alcohol and THC on Driving Impairment”. Presented at the American Academy of Forensic Sciences Annual meeting as part of an all-day workshop entitled “Impairment: A Look at Causes, Data, and Policies,” 21 February 2022, Seattle, WA.

Professional Leadership

2021
Co-Chair of an all-day workshop entitled “The Impact of Cannabinoids on Health and Safety” at the Society of Forensic Toxicology annual meeting, 27 September 2021, Nashville, TN.

Training

  • Completed Becton Dickinson’s week long FACSCalibur training seminar, San Jose, CA, 1999
  • Completed two day interview training course, Farmington, MI, 2013
  • Participated in videotaped mock interview, Farmington, MI, 2013

Professional Memberships

  • Member of the Society of Forensic Toxicology, 2019-present
  • Member of the American College of Toxicology, 2016-present
  • Member of the Society of Toxicology, 1999-present
  • Member of the National Safety Council; Alcohol, Drugs, and Impairment Division, 2020-present

Awards

  • Nominated in 2011 for best drug development team at Pfizer
  • Received Pfizer individual performance awards in 2010 and 2011 for work on drug safety programs
  • Received Pfizer individual performance awards for involvement with SOT Pfizer committee
  • Awarded NIH Post-Doctoral Training Grant: Dates: 9/1/00-8/31/02
  • Received travel awards from the Society of Toxicology and Wayne State University to attend the 2000 Society of Toxicology meeting
  • Recipient of the graduate student immunotoxicology specialty section award, 1999 Society of Toxicology meeting
  • Recipient of the graduate student metals specialty section award, 1998 Society of Toxicology meeting
  • Dean’s list (undergraduate): '86, '87, & '89

Publications

  1. Whitekus, M. J., R.P. Santini, A.J. Rosenspire, and M.J. McCabe, Jr., Protection Against CD95-mediated Apoptosis by Inorganic Mercury in Jurkat T Cells, J. Immunol. 162:7162-7170, 1999
  2. Whitekus, M. J., Ning Li, Min Zhang, Meiying Wang, Marcus A. Horwitz, Sally K. Nelson, Lawrence D. Horwitz, Nicholas Brechun, David Diaz-Sanchez, and Andre E. Nel, Thiol Antioxidants inhibit the Adjuvant Effects of Aerosolized Diesel Exhaust Particles in a murine model for Ovalbumin Sensitization, J. Immunol. 168:2560-2567, 2002
  3. McCabe, M.J., Michael J. Whitekus, Joogyung Hyun, Kevin G. Eckles, Geniece McCollum, and Allen J. Rosenspire, Inorganic Mercury Attenuates CD95-mediated Apoptosis By Interfering with Formation of the Death Inducing Signaling Complex, Toxicol Appl Pharmacol.190(2):146-56, 2003
  4. Finkelman, F. D., M. Yang, T. Orekhova, E. Clyne, J. Bernstein, M. Whitekus, D. Diaz-Sanchez and S. C. Morris. Diesel exhaust particles suppress in vivo IFN-gamma production by inhibiting cytokine effects on NK and NKT cells, J Immunol, 172:3808-3813, 2004
  5. McCabe, Jr., M. J., Eckles, K. G., Langdon, M., Clarkson, T. W., Whitekus, M. J., and Rosenspire, A. J. Attenuation of CD95-Induced Apoptosis by Inorganic Mercury: Caspase-3 Is Not a Direct Target of low levels of Hg2+, Toxicol. Lett., 155(1): 161-70, 2005
  6. Rivera, S.P., Hyun Ho Choi, Brett Chapman, M. J. Whitekus, Mineko Terao, Enrico Garattini, and Oliver Hankinson, Identification of Aldehyde Oxidase 1 and Aldehyde Oxidase Homologue 1 as Dioxin-Inducible Genes. Toxicology 207(3):401-9, 2005

Abstracts

  1. Whitekus, M. J., K.P. Singh, A.J. Rosenspire, and M.J. McCabe, Jr., Inorganic Mercury Attenuates CD95-mediated Cell Death. Mechanisms of Immunotoxicology 12th Annual Conference: Role of Apoptosis in Immunotoxicology, Morgantown, WV, 1997 (Poster Presentation)
  2. Whitekus, M. J. and M.J. McCabe, Jr., Inorganic Mercury Induces Tyrosine Phosphorylation and Attenuates CD95/Fas-mediated Cell Death. The Toxicologist, Vol. 42, No. 1-S, Abstract #1760, pg 357. Society of Toxicology Annual Meeting, Seattle, WA, 1998 (Platform Presentation).
  3. Whitekus, M.J., I. Heimler, and M.J. McCabe, Jr., Mercury Suppresses CD95/Fas-Mediated Apoptosis: A Search for the Mechanism. The Toxicologist, Vol. 48, No. 1-S Abstract #721, pg 154.Society of Toxicology Annual Meeting, New Orleans, LA, 1999 (Poster Presentation)
  4. Whitekus, M.J., B.S. Chelladurai, A.J. Rosenspire and M.J. McCabe, Jr., Dysregulation of CD95-mediated Apoptosis by Mercury. The Toxicologist, Vol. 54, No. 1 Abstract #542.Society of Toxicology Annual Meeting, Philadelphia, PA, 2000 (Poster Presentation)
  5. Fred D. Finkelman, Tatyana Orekhova, Michael Whitekus and David Diaz-Sanchez, Selective inhibition of IFN-g secretion by Diesel Exhaust Particles. The American Academy of Allergy, Asthma, and Immunology Annual Meeting, New York City, NY, 2002 (Poster Presentation)
  6. Whitekus, M.J., M. Zhang, N. Li, M. Horwitz, S.K. Nelson, N. Brechun, D. Diaz-Sanchez and A. Nel, Thiol Antioxidants inhibit the Adjuvant Effects of Aerosolized Diesel Exhaust Particles in a murine model for Ovalbumin Sensitization. The Toxicologist, Vol. 66, No. S-1 Abstract #373 page 77. Society of Toxicology Annual Meeting, Nashville, TN, 2002 (Poster Presentation)
  7. Whitekus, M.J., and D. Diaz-Sanchez, Short-Term Exposure to Inhaled Diesel Exhaust Particles Enhances Asthma-Like Symptoms in the Low IgE Responder C57BL/6 Mouse. The Toxicologist, Vol. 72, No S-1 Abstract #590 page 121. Society of Toxicology Annual Meeting, Salt Lake City, UT, 2003 (Platform Presentation)
  8. Whitekus, M.J., N Brechun, S K Nelson, O Hankinson, and D Diaz-Sanchez, Short-Term Exposure To Inhaled Diesel Exhaust Particles Enhances Asthma-Like Symptoms And Increases Cyp1a1 mRNA Levels. The Toxicologist, Vol. 48, No. 1-S, Abstract #1398. Society of Toxicology Annual Meeting, Baltimore, MD, 2004 (Poster Presentation)
  9. M J Whitekus, S Ritz, D Diaz-Sanchez, Suloraphane, a Potent Phase 2 Inducer, Inhibits the Adjuvant Effect of Aerosolized Diesel Exhaust Particles in a Murine Model for Ovalbumin Sensitization. The Toxicologist, Vol. 84, No. S-1, Abstract #458

v. 03/24/22

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