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Karen Elsass, BS, DABT, PMP

J.S. Held Acquires Shechter & Everett to Expand Forensic Accounting Capabilities for Family Law Disputes in Florida

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Karen Elsass is a board‑certified toxicologist with more than 20 years of experience designing and managing nonclinical studies for commercial, academic, and government clients, including the National Toxicology Program, the National Cancer Institute, and the National Institute of Allergy and Infectious Diseases. Her expertise spans small‑molecule and biologic drug candidates, including vaccines, oncolytic viruses, and cell‑ and gene‑therapies, and she has led numerous studies supporting Investigational New Drug (IND) applications in compliance with FDA Good Laboratory Practices.

Prior to joining J.S. Held, Karen was a Study Director at two contract research organizations (CROs) overseeing all phases of nonclinical research, including drug formulation and stability, animal welfare, data analysis and interpretation, and regulatory compliance. 

Karen holds a Bachelor of Science in Biochemistry from The Ohio State University.

Key Expertise

  • Toxicology
  • Nonclinical Drug Evaluation
  • Drug Delivery
  • Animal Research
  • Asbestos
  • Project Management

Professional Certifications & Affiliations

  • Diplomate of the American Board of Toxicology (DABT)
  • Project Management Professional (PMP)
  • Member, Royal Society of Biology (MRSB)
  • Society of Toxicology (SOT)
  • Ohio Valley Regional Chapter of SOT (OVSOT) Executive Committee
  • American College of Toxicology (ACT)
  • Project Management Institute (PMI)
  • National Toxicology Program (NTP) Toxicology Discipline Leader (Battelle), 2019 - 2021
  • American Association for Laboratory Animal Science (AALAS), Former Member
  • Society of Quality Assurance (SQA), Former Member

J.S. Held is recognized as an ENR Top 200 Environmental Consulting Firm and industry leader in the Verdantix Green Quadrant for Sustainability & ESG Consulting.