Xinrong Chen
Toxicologist and Founder for Abctox Com @Abc Tox
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WORK HISTORY
Toxicologist and Founder for Abctox Com @Abc Tox
Rockville, MD, US
Advise pharma/biotech on toxicology data gap analyses, GLP study design, and data interpretation for small molecules & biologics; safety-driven pipeline strategy.• Review and analyze pharmacology, toxicology, DMPK, and clinical data and propose regulatory strategy for IND, NDA, and BLA submission. • Support Investigational New Drug (IND) regulatory submission to FDA by teaming with regulatory affairs, chemists, and physicians. • Partner with CROs for toxicology strategy development, quote generation, study conduct, data generation, study report development and amendment.• Deliver PDE/OEL reports and human & environmental risk assessments for drugs, medical devices, chemicals, and consumer products.
EDUCATION
University of Maryland Global Campus
MBA (Master of Business Administration)
China Agricultural University
Master's degree
Oklahoma State University
Ph.D.
China Agricultural University
Bachelor of Science
ABOUT XINRONG CHEN
I help biotech, pharmaceutical, and chemical companies anticipate regulatory risks early,…
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