Meet Our Experts
Amy Wu, PhD
Senior Program Manager Bioanalytical
Dr. Amy Wu is a Sr. Global Program Manager at WuXi AppTec and she provides technical support for the clinical bioanalytical services. She is also a key contributor to many clinical study teams. Dr. Wu received her B.S. from Beijing University major in Physical and Colloid Chemistry. After that, she received her PhD in Physical Organic Chemistry from Rice University as Harry B. Weiser Research Scholar. Dr. Wu has over 20 years of experience in drug development focusing on Chemistry, Manufacturing, and Controls (CMC) and bioanalysis for big pharma and Contract Research Organizations (CROs). She also has knowledge in Good Practice (GxP) regulations and policies for various agencies. Dr. Wu’s strong scientific and leadership skills awarded her as a recipient of many business awards. She had numerous publications in her field and is an invited speaker at international conferences.
Xiaoxia Li, PhD, DABT
Executive Technical Director Toxicology
Joining WuXi AppTec with more than 15 years of preclinical drug development experience, Dr. Xiaoxia Li provides scientific support to our clients and will enhance the quick response rate for technical questions. She began her career at a preclinical Contract Research Organization (CRO), BOZO (Biology and Zoology) in Tokyo, and then spent over 13 years working as a Study Director at ITR Laboratories in Montreal, Canada. Afterwards, she worked as a Scientific Leader in nonclinical development for a pharmaceutical company in Toronto, Canada, before starting her own consulting firm, Sunrise IDD Inc. Dr. Xiaoxia Li is a Diplomate of the American Board of Toxicology (DABT). She completed her PhD in Pharmacology in Japan and received her MD and MSc in China.
Colton Wong, Ph.D.
Senior Director, Bioanalytical
Dr. Colton Wong is a Senior Director for the small molecule department at WuXi AppTec since 2018. Dr. Wong’s strong leadership skills and extensive experience in the bioanalytical industry have enabled him to build a highly successful team that has produced over 100 methods of clinical study per year for pharmaceutical developers of every size – from small domestic companies to multi-national giants. Dr. Wong and his team continue to enhance the clinical bioanalytical capability of clinical oligonucleotides and small molecular biomarker panels. Dr. Wong also co-leads he international project management teams at global pharmaceutical companies. In this capacity, he is responsible for ensuring compliance with regulatory and quality standards, and on-time delivery. Under his supervision, rapid technical capability advancements led to the small molecule bioanalytical delivery of the first GLP-compliant immunocapture LCMS method, as well as multiple ADC Linker/Payload LCMS, and ultra-sensitive methods. He holds CChem, CSci and MRSC credentials as Chartered Chemist, the Royal Society of Chemistry, UK; Chartered Scientist, the Science Council, UK; and Member of the Royal Society of Chemistry, UK, respectively. Dr. Wong received the Young Scientist Award in the Chinese Bioanalytical Forum in 2019, and that year also won the WuXi AppTec Science Day Competition. He is a regular featured speaker at conferences and webinars worldwide.
Kevin Denny, MBA, DABT
Executive Technical Director, Toxicology
Mr. Denny is a board-certified toxicologist with extensive regulatory and nonclinical toxicology experience managing multiple IND-enabling programs from clinical development to NDA submission. A talented Study Director and Nonclinical Project Team Lead, he has a successful track record of planning, designing, and implementing drug development strategies through all regulatory submissions including IND, CTA, NDA, MAA, BLA and responses to CRLs. He has managed and developed new GLP laboratories in both the United States and France. With his proven capabilities to collaborate and manage nonclinical development across departments, outside investigators and Contract Research Organizations (CROs), he has moved projects into and through clinical development with successful approvals.
Mr. Denny holds master’s degrees in Regulatory Affairs and Quality Assurance and Toxicology as well as an MBA and has authored or co-authored multiple approved NDAs, a BLA approval and multiple IND submissions. Currently, Mr. Denny is using his expertise as a consultant focusing on CNS, neurodegenerative disease, Stroke and Traumatic Brain Injury.
Tina Rogers, Ph.D., MBA, DABT
Senior Technical Director, Toxicology
Dr. Rogers is well-versed in providing preclinical drug development services to biopharma, NIH and DoD. In her extensive leadership positions including as Vice President of Preclinical Sciences at Altasciences (formerly SNBL USA), Executive Vice President and Director of Research at MPI Research (now Charles River), and Vice President of Drug Development at Southern Research Institute, she has served as an advisor and driven both growth and profitability.
Dr. Rogers holds a Ph.D. in Molecular & Cellular Biology and Pathobiology from the Medical University of South Carolina and an MBA from Auburn University. She has a broad technical background including cell biology, immunology, toxicology, cell and gene therapy, sepsis, inflammation, BL-3 and select agents, flow cytometry, and predictive/in vitro toxicology. Dr. Rogers shares her extensive experience serving as a board member for several biotech, academic, and not-for-profit institutions and as a Diplomate of the American Board of Toxicology (DABT).
Janet Kelly, MSc
Senior Technical Director, Toxicology
Ms. Kelly is a highly experienced toxicologist with a strong background in operational and business development and science. After an initial career as a bench scientist, Ms. Kelly spent over 30 years in scientific and operational roles in toxicology at multinational CROs culminating in a year in China overseeing the construction, commissioning and opening of a new non-clinical facility. More recently, she has been acting as an independent consultant in toxicology providing input in to and oversight of a variety of projects for clients in Europe, China, the United States and Japan. Her projects have included study placement and monitoring, design and implementation of packages to support IND filing, and data review and report writing.
Ms. Kelly’s active interest in animal welfare inspired her previous membership in the ABPI Animal Welfare Expert Network, the BioSciences Federation Animal Sciences Group, LANTRA and the European Partnership on Animal Alternatives representing the Contract Research Industry.
Viola Wang, Ph.D.
Senior Project Manager, DMPK
Dr. Viola Wang provides technical support for WuXi AppTec’s global DMPK services in both US and China sites to our international clients primarily. Dr. Wang obtained her B.S. from China Pharmaceutical University majoring in Pharmaceutical Technologies. She then spent several years in Europe and obtained her Masters from King’s College London and subsequently her Ph.D. in Oral Drug Delivery from University College Dublin in Ireland. After moving to the US, she spent two years studying gastrointestinal barrier function at Lankenau Institute for Medical Research outside Philadelphia before starting her roots in preclinical CRO as a study director and associate director of biopharmaceutics in 2011. She has over 10 years of hands-on experience in preclinical drug discovery and development in the field of DMPK.
In addition to her SME role, Dr. Wang can also be reached out to assist any DMPK study related questions for studies conducted in our Cranbury, NJ site.
Alfred W Lordi, M.S.
Director Preclinical Services, DMPK
Mr. Alfred Lodi has served as the Director of Preclinical Services for the WuXi AppTec, Laboratory Testing Division for the past 7 years where he currently directs operations of the Autoradiography, Bioresources, and Formulation departments with operational, client, and project management support. He brings extensive expertise in quantitative whole-body autoradiography (QWBA), tissue distribution (TD), mass balance (MB), human excretion balance studies, drug metabolism & pharmacokinetics (DMPK), animal anatomy, physiology, in vivo techniques, human dosimetry calculations, and laboratory & computer validations. Alfred currently sits as chairperson of the WuXi AppTec New Jersey Institutional Animal Care and Use Committee (IACUC) and the WuXi AppTec New Jersey Environment, Health, and Safety (EHS) Committee.
Alfred received his B.S. in Animal Science from Rutgers University and his M.S. in Biology from Seton Hall University. Alfred has authored over 30 scientific meeting presentations/abstracts on ADME/DMPK, QWBA, and Microautoradiography (MARG). Alfred has previously served terms on the Society for Whole Body Autoradiography (SWBA) Executive Committee as President Ex Officio, President, President-elect, and Secretary. He was also an instructor, organizer, and course planner for the SWBA Courses on QWBA.
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