David R. Compton, PhD, DABT

David Compton is a highly accomplished and visionary Toxicology Executive, with multifaceted expertise in pre-clinical drug development, gene therapy, toxicology, neuropharmacology, and Good Laboratory Practice (GLP) regulations.

Possesses over 35 years of combined academic, CRO, and pharmaceutical experience, with a focus on therapeutic areas such as anti-nausea, immunology, asthma, oncology, allergy, osteoarthritis, and gene therapy (AAV / lentiviral vectors). A proven record of success in leading drug development activities for gene therapies and abuse liability assessment of small molecules. Leverages exemplary leadership, organizational, and communication skills to drive innovation and achieve exceptional outcomes.

Education

  • University of Texas Medical Branch, Galveston, Texas • Ph.D., Pharmacology and Toxicology
  • Washington University, St. Louis, Missouri • B.A., Chemistry

Certification

  • Diplomate, American Board of Toxicology (DABT) – 1999; Recertification, 2004, 2009, 2014, 2019, and 2024 (pending)

Professional Skills

  • Leadership Provides expert scientific leadership in the areas of toxicology and drug development to program teams and ensures pre-clinical packages that support clinical development.
  • Toxicology Leads the development and execution of an integrated and scientifically sound nonclinical safety strategy from lead identification through IND-enabling GLP studies supporting First-in-Human (FIH)) trial initiation, as well as maintaining an ongoing nonclinical toxicology program supporting continued clinical trial conduct and registration and marketing.
  • Designs, operationalizes, and interprets studies to evaluate therapeutic candidate safety, and overall risk-benefit assessment.
  • A key contributor to the selection and timely development of therapeutic candidates through close interaction with discovery, CMC, clinical, and regulatory functions.
  • Generates concise safety assessments and reports for internal decision-making, as well as regulatory submission documentation, to facilitate health authority reviews in all phases of drug development, including approval processes.
  • Provides strategic advice to project teams and senior leaders, including evaluation of conclusions and potential impacts of safety findings on program and clinical and regulatory strategy.
  • Biodistribution In partnership with project team DMPK lead, applies an understanding of PK / PD and ADME to develop project team strategy and support product advancement.
  • Designs, operationalizes, and analyzes studies to elucidate biodistribution or, for small molecules, determine metabolic fate, drug-drug, and transporter interactions.
  • Applies state-of-the-art allometric scaling and dose prediction models across non-clinical species to the FIH starting dose.
  • Translational and Biomarker Plan Contributes to project transitions across pre-clinical to non-clinical and clinical strategies in close collaboration with discovery and clinical colleagues.
  • Regulatory Manages the preparation and / or presentation of relevant sections of external documents (e.g., Investigator’s Brochure, IND / CTA, PIP, CTD). Reviews all regulatory and health authority documents for the relevant agencies.
  • CRO Selection and Monitoring Principal accountability for delivering critical project data through a network of external study providers. In collaboration with project teams, selects CROs and participates in study design, troubleshooting, data analysis and interpretation, QC and audit, and oversight of final study reports.
  • Flexibility Able to contribute to a portfolio of projects spanning early and late pre-clinical discovery, translational medicine, and clinical development.
  • Clifton Strengths Profile Top 10-character traits: Achiever / Analytical / Input / Learner / Connectedness / Relator / Intellection / Context / Strategic / Responsibility [with 6 (of 10) in Strategic Thinking and 2 (of 10) each in Execution and Relationship Building]

Honors and Awards

  • 2023 Recognizing Novel Achievements (RNA) Award for exemplary / outstanding contributions contributing to corporate success, PTC, New Jersey ($1,400).
  • 2022 RNA for exemplary / outstanding contributions, contributing to corporate success, PTC, New Jersey ($1,100).
  • 2021 RNA Award for exemplary / outstanding contributions, contributing to corporate success, PTC, New Jersey ($1,600).
  • 2017 R&D Science Award in the Publication: Basic and Translational Science category for the North America Hub for the manuscript “Proarrhythmic Mechanisms of the Common Anti-Diarrheal Medication Loperamide: Revelations from the Opioid Abuse Epidemic” in Naunyn-Schmiedeberg’s “Archives of Pharmacology.” Application ranked among the best three in category (125 MyAward Points).
  • 2012 Special Achievement (SPOT) Award ($500) for Accelerated IND Development Project, Sanofi, New Jersey.
  • 2009 SPOT Award ($500) for BiPar (SAR240550, BSI 201) Development Project, Sanofi, New Jersey.
  • 2004 Shining Performance Award, Schering-Plough Research Institute, New Jersey.
  • 2003 “Best Of Everything’” (BOE) Award, Schering-Plough Research Institute, New Jersey.
  • 1994 Students' Choice Award, Faculty of the Year, Department of Pharmacology and Toxicology, VCU, Richmond, Virginia
  • 1990 The Virginia Governor's Schools Certificate of Commendation.
  • 1990 Pharmaceutical Manufacturers Association (now PhRMA) Foundation Award (#90-0133, $20,000), Receptor and Non-Specific Mechanisms of Cannabinoid-Induced Alterations of Neurotransmission.
  • 1989 The Virginia Governor's Schools Certificate of Commendation
  • 1987 Travel Award Marijuana 1987: The Melbourne Symposium on Cannabis, Melbourne, Australia
  • 1986 Academic Excellence Award University of Texas Medical Branch at Galveston, Texas
  • 1986 Jason E. Perlman Research Award University of Texas Medical Branch at Galveston, Texas
  • 1986 Postdoctoral Travel Award Committee on Problems of Drug Dependence, Tahoe City, Nevada
  • 1984 Travel Award American Society of Pharmacology and Experimental Therapeutics, Indianapolis, Indiana
  • 1976-1980 Scholarship Award, Washington University, St. Louis, Missouri
  • 1976 John J. Pershing Scholastic Scholarship Award, Northeast Missouri State University, Kirksville, Missouri (awarded, declined to accept another offer)
  • 1975 Boys State of Missouri St. Clair American Legion Selectee / Honoree

Affiliations

  • American Society of Pharmacology and Experimental Therapeutics (ASPET)
  • American Society of Gene and Cell Therapy (ASGCT)
  • Cross-Company Abuse Liability Council (CCALC)
  • College on Problems of Drug Dependence (CPDD)
  • American College of Toxicology (ACT)
  • International Journal of Toxicology (IJT)
  • New York Academy of Sciences (NYAS)
  • Society of Toxicology (SOT)

Professional Service: American College of Toxicology

  • Nominating Committee 2007-2008
  • Chair, 30th Anniversary Celebration Planning Committee 2008
  • Awards Committee 2008-2010
  • Council (1st term Board member) 2010-2013
  • Council (2nd term Board member) 2013-2016
  • Chair, Website Committee 2013-2014
  • Vice President 2016-2017
  • President-Elect 2017-2018
  • President 2018-2019
  • Past President 2019-2020
  • Copyright Working Group (Presidential appointment) 2021-2022
  • Program Committee (Presidential appointment) 2021-2023
  • ACT representative (Presidential appointment) 2023-present for ICTX-VII organizing committee
  • (17th International Congress of Toxicology, Beijing, China, October 15-18, 2025)

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