Hot Topics and Challenges in Drug Development

Register Free: https://www.biopharminternational.com/bp_d/drugd

Event Overview:

With changes and updates happening, learn about some hot topics and challenges happening in the drug development industry. The webinar will focus on new modalities, FDA updates, and resource shortages. The following critical topics will be discussed:

• Unique bioanalytical needs for new modalities
• Latest FDA updates for MIST and drug metabolism and pharmacokinetics (DMPK)
• Bioanalytical assays for oligonucleotides therapeutics
• How the resource shortage could affect a drug development program
• Common mistakes that have big consequences for an investigational new drug program

Who Should Attend:

• • Pharmaceutical
  • Biotech
  • Biopharmaceutical
  • Large pharma companies

Speakers

Dr. Francis Tse
CSO
WuXi AppTec, Laboratory Testing Division

Francis L. Tse came to WuXi AppTec in 2017 as the vice president and chief scientific officer. In 2018, he also became president of Xenobiotic Labs, Inc., a WuXi AppTec CRO acquired in 2014. Prior to joining WuXi AppTec, Dr. Tse served as an assistant professor of pharmacy at Rutgers University and then as vice president of drug metabolism and bioanalytics at Novartis Pharma. Dr. Tse received bachelor’s , master’s and doctorate degrees from the University of Wisconsin-Madison.

Dr. Tse has a wealth of experience in pharmaceutical development and has published more than 130 research articles and six books, including the “Handbook of LC-MS Bioanalysis,” which has also been translated into Chinese (Science Press, Beijing, 2017). Dr. Tse served on the board of directors of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQC) and is a fellow of the American Association of Pharmaceutical Scientists (AAPS), Academy of Pharmaceutical Research and Science (APRS), and American College of Clinical Pharmacology (ACCP). In 2006, he received the prestigious Outstanding 50 Asian Americans in Business award.

Dr. Jing Shi
Executive Director & Head of Large Molecule Bioanalytical Services
WuXi AppTec, Laboratory Testing Division

Jing Shi joined WuXi AppTec in 2014, as executive director and global head of large molecule bioanalytical services in the laboratory testing division. She has extensive experience across various stages of drug development including preclinical/clinical bioanalytical analysis, toxicology, cell line development, process development, biologics drug substance/drug product characterization, and more.

Dr. Shi brings this wide-ranging experience to her work leading WuXi AppTec’s immunochemistry bioanalytical department and managing multisite operations. Together with her team, Dr. Shi provides bioanalytical method development, validation, and sample testing services following good laboratory practice (GLP)/good clinical practice (GCP) guidelines.

Before joining WuXi AppTec, Dr. Shi held leadership positions with AstraZeneca and Sigma in the United States. In her most recent role at Sigma, Dr. Shi headed the immunoassay laboratory, where she was responsible for good manufacturing practice (GMP) lot release/stability testing and GLP bioanalytical testing using immunochemistry and cell-based platforms.

Dr. Shi received a bachelor’s degree in cell biology and genetics from Peking University, and a doctorate in cell biology from the University of Virginia.

Dr. Peter Wang
Senior Director of Drug Metabolism and Biotransformation
WuXi AppTec, Laboratory Testing Division

Dr. Peter Wang joined WuXi AppTec in 2008, and currently serves as senior director of drug metabolism and biotransformation in the lab testing division. In this role, he provides operational, client, and project management support.

Dr. Wang has extensive experience in metabolite identification, having worked in in vitro and in vivo DMPK-related fields for more than 15 years. Prior to his current role, Dr. Wang held a variety of other positions at WuXi AppTec progressing from senior research scientist to group leader, manager and director, before senior director. Before joining WuXi AppTec, he was a senior scientist at FMC, where he served as study director for agrochemical metabolism studies in plants and animals.

Dr. Wang received a doctorate in organic chemistry co-educated by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and the Institute of Natural Medicine, Japan. From 2001–2005, he conducted post-doctoral research in Phase II drug metabolism at College of Pharmacy, University of Florida. Dr. Wang has published more than 40 peer-reviewed and review articles.

Dr. Nan Zhao
Principle Scientist III
LTD DMPK WuXi AppTec

Dr. Nan Zhao earned her Ph.D. in Physics from Georgia State University and her B.S. from Nankai University (Tianjin, China). Dr. Zhao was a staff scientist at the Covance Salt Lake City Laboratory (UT, USA), involved in method development, method validation and sample analysis for small and large molecules primarily using LC–MS and LC-FL. Prior to WuXi AppTec, Dr. Zhao worked for Stoke Therapeutics Inc. as a DMPK Scientist (MA, USA), which is a biopharmaceutical company and develops novel antisense oligonucleotide (ASO) medicines to treat the genetic diseases. She has advanced experience in the development of bioanalytical assays for small and large molecules to support drug discovery projects.

Dr. Nan Zhao joined non-GLP Bioanalytical WuXi AppTec, Shanghai in Oct, 2020 as a principle scientist in charging of establishing analytical platform for quantification of proteins, oligonucleotide and other large molecules.

Dr. Mark Walker
Senior Technical Director, Toxicology
WuXi AppTec, Laboratory Testing Division

Dr. Mark Walker joined WuXi AppTec in 2018. With more than 25 years of preclinical toxicology experience, he provides senior scientific and technical advisory services to the company’s clients worldwide. In this role, he also assists the business development and marketing teams in the development of in vitro (laboratory-based) and in vivo (whole animal model) programs for the safety assessment of new drugs and biotherapeutics intended for submission to the FDA and/or worldwide regulatory agencies.

Dr. Walker’s areas of professional focus are primate toxicology, animal model selection, comparative and integrative toxicology assessments in multiple species, safety assessment program design, and regulatory interactions for investigational new drug (IND) applications. His accomplishments include expanding the overall capabilities and services of multiple organizations, developing and commercializing specialized toxicology disciplines in a good laboratory practice (GLP) environment, and improving the overall utilization of appropriate in vitro and in vivo safety assessment modalities.

Prior to joining WuXi AppTec, Mark served as technical director for Altasciences (formerly SNBL USA), vice president of pathology and laboratory animal medicine at Frontier Biosciences-Chengdu, director of laboratory operations and director of research at Charles River, and senior principal scientist at Covance.

Dr. Walker received bachelor’s degree and doctorate in veterinary medicine from Texas A&M University. He is an active contributor to and regular speaker at the American College of Toxicology and Society of Toxicology. He has published widely in the field of nonhuman primate biology and toxicology, comparative medicine and safety assessment, and regularly participates in both internal (WuXi AppTec Laboratory Services Division) and external (industry-specific) training courses.

Register Free: https://www.biopharminternational.com/bp_d/drugd