Ray Liu Consulting
Applying 30 years of regulatory toxicology experience to pharma/biotech companies in all aspects of nonclinical safety in drug discovery and development. Strengths include creation and execution of customized regulatory toxicology strategies, study design, CRO selection and study monitoring of non-GLP and GLP studies, and writing nonclinical safety sections for regulatory submissions. Nonclinical safety expertise with small molecules, large molecules, and novel delivery platforms. Broad experience in IND-enabling nonclinical safety studies, with specialty areas of toxicology that include developmental and reproductive toxicology, juvenile toxicology, and carcinogenicity studies. Board-certified in toxicology by the American Board of Toxicology (DABT) and member of the Society of Toxicology (SOT) and American College of Toxicology (ACT).
Services Include:
• Conduct due diligence on potential licensing assets
• Develop customized nonclinical safety strategies for novel therapeutics dosed by oral, IV, SC, inhalation routes of administration
• CRO selection, management of timelines, non-GLP and GLP study design, protocol review, study monitoring, interpretation of study data and report review
• Regulatory writing: Investigator Brochures, IND, CTA, white papers
• Address questions from global health authorities, including FDA
About
Ray’s toxicology experience in the pharmaceutical/biotech industry spans 30 years. Born and raised in the UK, his interest in toxicology started with a 1-year college placement at SmithKline, now GSK, at the historic British Special Ops site, The Frythe, Welwyn. Here he analyzed clinical pathology samples from GLP toxicology studies and from an on-site clinical trial facility. He returned to college for his final year to major in toxicology and pharmacology. On completion of his degree, he re-joined SmithKline, this time in Reproductive Toxicology.
Dolly the sheep & Professor Sharp, head of the Roslin Institute, Edinburgh, Scotland (2002).
Ever sensing the desire to see beyond generating high-quality data, Ray felt the call of “the bigger picture”, not only to critically review safety data but also to integrate and interpret it. This set him firmly in pursuit of a PhD in reproductive biology at the University of Central Lancashire and Roslin Institute in Edinburgh, of Dolly the Sheep fame. This PhD brought him to the US to postdoc in reproductive toxicology in Delaware. He then became a study director on non-GLP and GLP toxicology studies, and represented the toxicology function on cross-functional teams on drug discovery and development projects. In this project-team setting, Ray found his calling in toxicology to help teams develop efficient strategies to bring important new medicines to patients.
While enjoying the resources at larger companies, Ray also found the thrill of the smaller biotech environment particularly addictive! The combination of like-minded people pulling in the same direction towards common goals is an incredibly rewarding experience.
Board-certified in toxicology by the American Board of Toxicology (DABT), Ray brings decades of experience in the discovery and development of small and large molecules, across multiple therapeutic areas, including auto-immune/inflammatory disease, oncology, and CNS. Contact Ray below.
