Zhao Lu

• Design and conduct GLP and non-GLP general toxicology and PK/TK studies using rodents and non-human primates; interpret, integrate, and report data to meet requirements of health authorities • Evaluate nonclinical toxicity and immunotoxicity of various types of test articles (e.g., antibody drugs, therapeutic vaccines, cell and gene therapies, oligonucleotides); perform impact assessment and develop testing strategies with clients • Develop and validate nonclinical and clinical methods (e.g., immunophenotyping, receptor occupancy, cytokines, complements, and anti-drug antibody assays) to support new drug development including drugs in clinical and post-marketing phases • Serve as senior report reviewer to peer-review toxicology reports • Work with global cross functional team members, clients, and vendors to trouble-shoot, address scientific and regulatory issues, and meet project milestones • Curate and publish historical control cytokine data from NHPs; deliver presentations in scientific meetings • Review literature and identify relevant articles to support immunology method development and data interpretation • Train coworkers, technicians, and non-scientific staff of ICH, FDA, and OECD guidelines • Serve as IACUC member to review and approve study protocol

• Engaged clients to perform safety and risk assessment, develop comprehensive strategies to obtain regulatory clearance for new food and cosmetic ingredients, dietary supplement, functional foods, and medical device; represented clients to communicate with and present data to FDA • Performed gap analysis and feasibility assessment to facilitate safety assessment for new food ingredients and medical device; applied exposure modeling and consumption analysis to establish safety limit; searched literature and deigned non-clinical/clinical studies to substantiate claims and label strategy for food products and medical device • Authored Generally Recognized as Safe (GRAS) dossiers, white papers, scientific petitions, and notifications to FDA • Developed testing strategies, monitored toxicology studies, and reviewed data and reports • Published articles in peer-reviewed and trade journals; delivered presentations in scientific meetings

• Conducted rumen microbiology studies to increase nutrient absorption and feed efficiency in cattle; developed experimental protocols and wrote reports • Supervised subordinate scientists in their research projects; trained technicians and graduate students to acquire various laboratory techniques • Maintained an active research laboratory in good running order, including maintaining laboratory database, budget management, laboratory equipment calibration & troubleshooting • Promoted laboratory safety as per Occupational Safety and Health Administration standards

Presided research projects to develop functional oils and dietary supplements to reduce obesity and diabetes. Led a research team to develop tocotrienol (unsaturated vitamin E)-fortified grape seed oil to treat obesity. Won 2nd place in the IFT Fruit & Vegetable Division Graduate Research Competition in 2014 Designed and completed experiments to test and validate the effectiveness of tocotrienols on prevention of obesity and insulin resistance in cell and animal models. Yielded two articles published in high impact journals in nutrition (top 5). Conducted and completed research identifying the novel function of tocotrienols on inhibiting fat cell growth. Won 2nd place in the Experimental Biology (EB) Dietary Bioactive Component RIS poster competition in 2014

Managed research projects focused on developing special health-promoting yoghurts made from horse milk and resulted in three publications and one award Identified the bacterial biodiversity in traditional yoghurts sampled from major nomads in China Isolated and validated the probiotics in the traditional yoghurts Won Outstanding Research Scholarship