Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT, Greg Erexson Toxicology Consulting, LLC - Qepler Summits And Conferences

Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT

AbbVie Retiree
Greg Erexson Toxicology Consulting, LLC

Globally boarded (DABT, ATS, ERT) toxicology consultant with over 43 years of fulltime work experience. I have an extensive background in all four general employment areas of the toxicology discipline: academia, government, contract and pharmaceutical industry environments.

Consulting services are provided in multiple areas of toxicology including, but not limited to general toxicology, occupational toxicology, assessments of extraneous matter, extractables and leachables, solvents, impurities, degradants, excipients, trace elements, metals, biocompatibility, genetic toxicology, finished product medical devices and combination products as well as their individual components in addition to manufacturing components that are used in the process stream (e.g., filters, tubing, bioreactor liners, containers, films, coatings, inks/pigments, etc.). Experience as an expert toxicologist in litigation events.

Related Sessions:

3rd Annual Highly Potent
APIs Summit 2023

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 22 Feb 2023
  • Virtual,
  • Pharma
Day 2: Thursday, 23 February 2023
CASE STUDY: The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs)
  • History of ADCs
  • Monoclonal Antibody (or Antibodies Selection)
  • Linker Technology
  • Payload/Warhead/Small Molecule Selection
  • Approved/Marketed ADCs and Efficacy
  • Containment Requirements
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3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 11 Oct 2023
  • Virtual,
  • Pharma
Day 1: Wednesday, 11 October 2023
CASE STUDY: How to Write a Toxicological Risk Assessment to Support Extractables and/or Leachables: A Step-by- Step Process
  • Analytical identification of E&L compounds (tentative, definitive and unknowns)
  • No toxicity data exists for your E&L compound: What to do?
  • The E&L toxicology risk assessment process
  • Derivation of maximum daily exposure (MDE) values
  • Regulatory guidance as references for PDE values
  • Toxicology databases to obtain toxicity data
  • Selection of the point of departure to derive the PDE value
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