David W. Eaker Brings 30 Years of Toxicology and Regulatory Insight to Endpoint Preclinical
David W. Eaker Brings 30 Years of Toxicology and Regulatory Insight to Endpoint Preclinical
A trusted voice in toxicology and regulatory science, Dr. Eaker has spent his career shaping the safety strategies behind impactful medical technologies. He has led GLP-compliant laboratories, authored hundreds of health-risk assessments, and contributed to global standards in biocompatibility and toxicologic evaluation, earning the confidence of regulators, clinical teams, and R&D leaders alike.
Endpoint Preclinical is proud to welcome Dr. David W. Eaker, PhD, DABT, to our Expert Network. A board-certified toxicologist and seasoned program leader, David has spent the past three decades guiding medical devices, drugs, and combination products from early concept through regulatory approval. His career spans industry, consulting, and regulatory-facing leadership roles—establishing him as a trusted authority in toxicology, biocompatibility, and regulatory risk assessment. View David’s Profile
At BD, where he served as Vice President of Preclinical Development and Toxicology, David built and led GLP-compliant laboratories, directed cross-functional safety programs, and authored more than 300 health-risk assessments—supporting a global product portfolio exceeding $15 billion in annual revenue. His thought leadership has shaped industry best practices and informed FDA and ISO working groups across biocompatibility and toxicologic strategy.
At Endpoint, David brings a uniquely integrative approach to preclinical program design. He acts as a program architect, building phased, hypothesis-driven roadmaps that align toxicology, analytical data, and clinical objectives. He supports clients at every stage of development—from experimental design and study data interpretation to regulatory submission and post-market strategy. Whether serving as a fractional advisor or delivering targeted toxicology consulting, his expertise helps teams define gaps, manage risk, and present credible, decision-ready findings.
David’s knowledge of GLP and ISO-compliant laboratory systems is also an asset to clients setting up and optimizing in-house testing or requiring support in study placements. His experience spans general surgery, interventional and model development studies, in-vitro and in-vivo toxicology programs, proof of concept, and cross-disciplinary evidence synthesis—drawing from imaging, pathology, PK, and clinical chemistry data to support comprehensive safety narratives.
Innovative med-tech must address unmet medical needs without compromising patient safety or research ethics. Early, open collaboration—combined with rigorous planning and transparent dialogue with regulators and clinical experts—is key to advancing credible, efficient, and humane preclinical programs. — David W. Eaker, PhD, DABT
We are honored to welcome Dr. Eaker to Endpoint Preclinical. His decades of experience and unwavering commitment to patient-centered innovation will elevate our ability to deliver the highest standards of scientific, regulatory, and operational excellence.
To learn how David can support your preclinical strategy or toxicology program, contact us today.